MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP) 

OCTOBER 20-21, 2021 

SUMMARY MINUTES 

TABLE OF CONTENTS 

MEETING PURPOSE ................................................................................................................................... 3 

Wednesday: October 20, 2021 ..................................................................................................................... 3 

WELCOME AND INTRODUCTIONS ...................................................................................... 3 

Call to Order/Roll Call ......................................................................................................... 3 

Announcements.................................................................................................................. 3 

AGENCY UPDATES............................................................................................................... 5 

Centers for Disease Control and Prevention ....................................................................... 5 

Centers for Medicare and Medicaid..................................................................................... 6 

Food and Drug Administration............................................................................................. 6 

Health Resources and Services Administration................................................................... 7 

Indian Health Service.......................................................................................................... 7 

National Institutes of Health ................................................................................................ 8 

PNEUMOCOCCAL VACCINES .............................................................................................. 9 

Session Introduction ........................................................................................................... 9 

Considerations for Age-Based and Risk-Based Use of PCV15/PCV20 among Adults and 

Proposed Policy Options....................................................................................................10 

Vote #1: Pneumococcal Vaccines Age-Based Recommendation.......................................22 

Vote #2: Pneumococcal Vaccines Risk-Based Recommendation ......................................24 

ZOSTER VACCINES.............................................................................................................27 

Session Introduction ..........................................................................................................27 

WG Interpretation of the EtR on Use of RZV in Immunocompromised Adults, 

Considerations for Use, and Proposed Policy Options .......................................................28 

Vote: Zoster Vaccine..........................................................................................................36 

INFLUENZA VACCINES........................................................................................................37 

Session Introduction ..........................................................................................................37 

Phase II Safety and Immunogenicity Study of the Co-Administration of Fluzone® High-Dose 

Quadrivalent Influenza Vaccine and a Third Dose of Moderna mRNA-1273 COVID-19 

Vaccine..............................................................................................................................37 

Change in Age Indication for Flucelvax® Quadrivalent........................................................43 
ACIP Meeting Summary October 20-21, 2021 

PUBLIC COMMENT ..............................................................................................................45 

Public Comments: October 20, 2021..................................................................................45 

Thursday: October 21, 2021 .......................................................................................................................51 

WELCOME AND INTRODUCTIONS .....................................................................................51 

Call to Order / Roll Call ......................................................................................................51 

FDA Update.......................................................................................................................51 

CDC Update ......................................................................................................................52 

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES ....................................................52 

Session Introduction ..........................................................................................................52 

Moderna Booster Dose Data..............................................................................................53 

Janssen Booster Dose Data...............................................................................................59 

National Institutes of Health, Mix and Match Booster Study ...............................................65 

Public Comment: October 21, 2021 ...................................................................................67 

v-safesm and VAERS: Third Dose and Simultaneous Vaccination ......................................74 

COVID-19 Vaccine Safety Updates....................................................................................77 

Myocarditis: VAERS...........................................................................................................80 

Myocarditis: VSD ...............................................................................................................81 

VaST Assessment .............................................................................................................84 

COVID-19 Vaccine Effectiveness: Primary Series..............................................................88 

EtR Framework..................................................................................................................93 

Clinical Considerations.......................................................................................................98 

Votes: COVID-19 Vaccine Booster Doses........................................................................102 

Certification ...............................................................................................................................................105 

ACIP Membership Roster .........................................................................................................................106 

Acronyms Used in This document ............................................................................................................115 

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ACIP Meeting Summary October 20-21, 2021 

MEETING PURPOSE 

The United States (US) Department of Health and Human Services (HHS) and the Centers for 

Disease Control and Prevention (CDC) convened a meeting of the Advisory Committee on 

Immunization Practices (ACIP) on October 20-21, 2021. The meeting took place remotely via 

Zoom, teleconference, and live webcast. This document provides a summary of the meeting, 

which focused on pneumococcal, zoster, influenza, and COVID-19 vaccines. 

WEDNESDAY: OCTOBER 20, 2021 

WELCOME AND INTRODUCTIONS 

Call to Order/Roll Call 

Dr. Grace Lee (ACIP Chair) called to order and presided over the first day of the October 20-

21, 2021 ACIP meeting. She conducted a roll call, which established that a quorum was 

present. No potential or perceived conflicts of interest (COIs) were identified or declared. A list 

of Members, Ex Officios, and Liaison Representatives is included in the appendixes at the end 

of this summary document. Dr. Lee acknowledged three transitions among the Liaison 

Representatives in 2021 and expressed great appreciation for the service that these 

longstanding members have provided to ACIP over the years: 

 Dr. Paul McKinney, Association for Prevention Teaching and Research (APTR), who has 

served ACIP for decades as the APTR Liaison Representative. Dr. Richard Zimmerman will 

represent APRT moving forward. 

 Dr. Caroline Quach, Canadian National Advisory Committee on Immunization (NACI). Dr. 

Shelley Deeks will represent NACI moving forward. 

 Dr. Stephan Foster, American Pharmacist Association (APhA), who has served for 21 years 

as the Liaison Representative for APhA. Dr. Michael Hogue will represent APhA moving 

forward. Dr. Foster said that he smiled during the last meeting when it was announced that 

70% of the COVID-19 vaccinations were administered by pharmacists. When he started at 

ACIP, he recalled being asked how to justify that pharmacists were even qualified to give 

vaccines. 

Announcements 

Dr. Melinda Wharton (ACIP Executive Secretary, ACIP/CDC) noted that copies of the slides 

for the day were available on the ACIP website and were made available through a ShareLinkTM 

file for voting ACIP Voting Members, Ex Officios, and Liaisons. She indicated that there would 

be an oral public comment session prior to the vote at approximately 3:45 PM Eastern Time 

(ET) on the first day and approximately 12:00 PM ET on the second day. Given that more 

individuals registered to make oral public comments than could be accommodated, selection 

was made randomly via a lottery. Those individuals who were not selected and any other 

individuals wishing to make written public comments may submit them through 

https://www.regulations.gov using Docket Number CDC-2021-0098. Further information on the 

written public comment process can be found on the ACIP website. 

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ACIP Meeting Summary October 20-21, 2021 

As noted in the ACIP Policies and Procedures manual, ACIP members agree to forgo 

participation in certain activities related to vaccines during their tenure on the committee. For 

certain other interests that potentially enhance a member’s expertise, CDC has issued limited 

COI waivers. Members who conduct vaccine clinical trials or serve on data safety monitoring 

boards (DSMBs) may present to the committee on matters related to those vaccines, but are 

prohibited from participating in committee votes. Regarding other vaccines of the concerned 

company, a member may participate in discussions with the provision that he/she abstains on 

all votes related to that company. ACIP members state any COIs at the beginning of each 

meeting. 

Dr. Grace Lee (ACIP Chair) announced that this would be Dr. Amanda Cohn’s last meeting as 

the ACIP Executive Secretary. She recognized Dr. Cohn for her incredible service to the CDC 

and the ACIP as Executive Secretary over the past 6 years. Dr. Cohn received her medical 

degree from Emory University and completed her training in pediatrics at the Boston Combined 

Residency Program in Pediatrics (BCRP) before coming to CDC in 2004. Dr. Lee first met Dr. 

Cohn when they both were in training and their colleague and former ACIP member, Dr. Hank 

Bernstein, was one of their Clinic Attendings. There is a book that includes messages from 

ACIP members over the past 6 years, including former Chairs. While it did not make it to 

California in time for her trip, she will bring it the next time she comes to Atlanta. Dr. Lee read a 

few comments from the book: 

 “Throughout your tenure as Executive Secretary of the ACIP, you have been grace under 

pressure.” 

 “You have been such a calm hand at the helm guiding the ACIP and the broader national 

public health community through so many challenges. Integrity, humility, intellect, trust in the 

people and the process—these qualities have been your North Star.” 

 “You have been a stupendous leader and importantly a wonderful person. Calm, 

knowledgeable, and always a guiding light through quite a year.” 

 “Amanda has been able to humbly lead people in making a real difference in public policy, 

especially during these unprecedented times of a pandemic, and this has earmarked you for 

greatness.” 

 “Your efforts now, as well as over the previous years, will safeguard the lives and the health 

of millions of persons for years to come. And beyond these meetings, you have created a 

sense of community for all of us. Even during these challenging times, we knew we were all 

in it together.” 

Fond memories include evening meals during the in-person meetings when they were able to 

get together, gathering for the group photographs on the CDC steps, lively committee 

discussions, Amanda’s serious and concerned face and the forever engaging Amanda 

Cohn smile. Dr. Lee ended with a Dr. Seuss quote that someone brought up in the book, which 

is “You’re off to great places, today is your day. Your mountain is waiting, get on your way.” In 

addition to the book that is forthcoming, a framed picture of the ACIP version of Dr. Seuss was 

created for Amanda. Dr. Lee again thanked Dr. Cohn for her incredible service and dedication 

to the ACIP and to the country. They will be forever grateful for her time at ACIP. 

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ACIP Meeting Summary October 20-21, 2021 

Dr. Amanda Cohn (Departing ACIP Executive Secretary, ACIP/CDC) said that she was 

completely overwhelmed and that if they could see her face right then, it would be that smile 

with super, super redness all over it. She emphasized how much she going to miss all of the 

ACIP members, but noted that she would not be going that far away and would still attend all of 

the meetings. She stressed that she could not have done this without the support of all the 

amazing ACIP Members, Ex Officios, and Liaison Representatives who have been like family to 

her, as well as amazing mentors. She said she could not have asked for a better experience at 

this point in her career. She underscored the amazing support staff, Stephanie and Jessica, 

who secretly keep everything going when she cannot. She assured everyone that they would be 

in such good hands with Dr. Melinda Wharton, who has also been another mentor to her over 

her almost 18 years at CDC. She asked everyone to stay in touch and expressed her hope that 

they would be able to meet for dinner sometime in the near future and that she would be invited. 

AGENCY UPDATES 

Centers for Disease Control and Prevention 

Dr. Amanda Cohn reported that the National Immunization Survey-Child (NIS)-Child for the 

years 2018-2020 that reports on children born in 2017 and 2018 was published on October 15, 

2021. This report continues to demonstrate that there was lower coverage among those who 

are uninsured, Black, Hispanic, and living below the federal poverty line than among those who 

were privately insured, White, or living above the poverty line. This further demonstrates 

disparities in vaccine coverage, even with the amazing Vaccines for Children (VFC) Program. 

This report does not highlight what was seen over this past year and a half, which was 

decreased ordering from providers in FY-2020 and FY-2021 compared to FY-2019. There has 

been some rebounding of routine childhood immunizations in the private sector, but this 

continues to lag behind. Routine immunization remains a critical part of full recovery from the 

pandemic. While it remains uncertain what will happen this influenza season, CDC is preparing 

for resumption of seasonal influenza virus circulation. There are concerns that co-circulation of 

flu SARS-CoV-2 and other respiratory illnesses like respiratory syncytial virus (RSV) could place 

a high burden on the healthcare system. CDC is still raising awareness about the importance of 

influenza vaccination with its multi-year Fight Flu communications campaign. CDC is working 

with the Ad Council and is working to increase vaccine uptake overall, with a particular 

emphasis on reaching African American and Hispanic Latinx communities and those at 

increased risk for severe outcomes for influenza. Dr. Cohn highlighted a recent Call to Action 

by the National Adult and Influenza Immunization Summit (NAIIS) on August 23, 2021. This Call 

to Action discussed raising vaccine coverage among US adults, which was the focus of the 

agenda for this meeting. The NAIIS is co-led by CDC, HHS’s Office of Infectious Disease and 

HIV/AIDS Policy (OIDP), and the Immunization Action Coalition (IAC). This highlights the 

tremendous benefits of vaccines, and how low levels of vaccination are made worse by the 

COVID-19 pandemic and ongoing disparities in immunization adult coverage in the US. The Call 

to Action included a series of concrete actions healthcare providers (HCP) can take to improve 

adult vaccination.1 

1 https://www.izsummitpartners.org/call-to-action-adult-immunizations/ 

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ACIP Meeting Summary October 20-21, 2021 

Centers for Medicare and Medicaid 

Ms. Mary Beth Hance provided few updates on CMS activities around COVID-19 vaccines as 

well as routine vaccinations. Specific to COVID-19-related activities, CMS continues to 

provide materials as there are changes around COVID-19 vaccines. Examples include a 

press release that CMS issued in September reflecting the approval of the Pfizer-BioNTech 

booster doses and an informational bulletin that they issued in May around the expansion of 

the Pfizer-BioNTech vaccine to adolescents 12-15 years of age. They continue to update 

additional material, such as toolkits. On August 30, 2021, CMS released guidance relating to 

the American Rescue Plan’s (ARP’s) temporary 100% federal match for state expenditures for 

COVID-19 vaccines and vaccine administration for those enrolled in Medicaid and the 

Children’s Health Insurance Program (CHIP). On September 9, 2021, CMS and CDC 

announced that emergency regulations requiring vaccinations for nursing home workers 

would be expanded to include hospitals, dialysis facilities, ambulatory surgical centers, and 

home health agencies as a condition for participating in the Medicare/Medicaid program. In 

addition, CMS greatly appreciates the support of its CDC colleagues. They have made many 

presentations to state Medicaid programs and other stakeholders on CDC’s COVID-19 

vaccination efforts, including efforts to get booster doses to those in congregate settings, 

efforts to reach adolescents, and efforts for planning for the vaccination of children 5-11 years 

of age. In addition, CDC and CMS continue to emphasize the importance of catching up on 

routine pediatric vaccinations. Again, CMS greatly appreciates this coordination. CMS 

continues to emphasize the importance of routine pediatric vaccinations. As Dr. Cohn just 

mentioned, that is clearly still an important issue. CMS has an InsureKidsNow.gov national 

campaign that has included a number of materials focusing on this that are available to 

stakeholders, states, and grantees. CMS is looking for additional opportunities to amplify this 

message, and continues to look forward to working with CDC on this as well. 

Food and Drug Administration 

Dr. Doran Fink announced that on October 14, 2021, the FDA approved an efficacy 

supplement to support use of Flucelvax® in a quadrivalent cell culture-derived seasonal 

influenza vaccine for use in infants and children 6 months to less than 2 years of age. This 

approval was based on a study of safety and immunogenicity of the Flucelvax® quadrivalent 

vaccine in comparison to a US licensed quadrivalent seasonal influenza vaccine comparator 

that was egg-derived. This now extends the approved use of Flucelvax® to all individuals 6 

months of age and older. In COVID news, October continues to be an extremely busy month for 

the FDA. October 14-15, 2021, the FDA convened its Vaccines and Related Biological 

Products Advisory Committee (VRBPAC) to consider 2 Emergency Use Authorization (EUA) 

amendments for COVID-19 vaccines. On the first day, the committee heard presentations on 

data to support a booster dose of the Moderna COVID-19 vaccine for administration to certain 

individuals at least six months after completion of the primary series with the Moderna COVID19 vaccine. The eligible populations requested by Moderna were the same as those that the 

FDA authorized in September for use of a Pfizer-BioNTech COVID-19 vaccine booster dose: 

individuals 65 years of age and older, individuals 18-64 years of age at increased risk 

of severe COVID-19 following primary vaccination, and individuals 18-64 years of age with 

frequent occupational or institutional exposure to the SARS-CoV-2 virus. The committee voted 

unanimously in favor of authorizing the EUA. There also was some discussion that began on the 

first day and continued into the second day about whether to lower the age range or use of a 

booster dose of the Pfizer and Moderna mRNA COVID vaccines to adult populations less than 

65 years of age without additional risk factors for severe COVID disease or exposure to SARSCOVID-2. The committee was mixed in their discussion, with some members opining that a 

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ACIP Meeting Summary October 20-21, 2021 

lower age limit should be considered and others expressing that 65 years was the appropriate 

age cutoff at this time. The committee ultimately opined that the FDA should consider lowering 

the age cutoff as additional data on the need for a booster dose emerges. On the second day, 

the committee heard data to support use of a booster dose of the Janssen COVID-19 vaccine 

administered at least 2 months after a single dose primary vaccination with the same vaccine to 

individuals 18 years of age and older. VRBPAC voted unanimously in favor of the FDA 

authorizing that EUA amendment request. Finally, the committee heard a presentation on data 

from a study conducted by NIAID regarding safety and immunogenicity of heterologous or mixand-match booster doses of COVID-19 vaccines and then engaged in a discussion of those 

data. VRBPAC members recognized that the study groups were relatively small in number and 

that the study was originally designed to be exploratory. Nonetheless, the committee members 

recognized the need for flexibility in implementation of COVID-19 vaccine programs. Comments 

provided by committee members were in favor of FDA considering these data to support EUA of 

heterologous booster doses to provide a regulatory allowance for mixing-and-matching. The 

FDA has been very busy since last Friday wrapping up its review and working toward 

authorization of the various EUA amendments. They expected to have some announcements 

later in the day. Finally, the FDA also has been reviewing an EUA amendment request from 

Pfizer-BioNTech for use of COVID-19 vaccine in children 5-11 years of age. The FDA will 

convene the VRBPAC on October 26, 2021 to present those data and FDA’s review of the data. 

Health Resources and Services Administration 

Dr. Mary Rubin reported that the National Vaccine Injury Compensation Program (VICP) 

continues to process an increased number of claims. In fiscal year 2021, petitioners filed 22,047 

claims within the program. $210.4 million was awarded to petitioners and $36.5 million was 

awarded to pay attorney’s fees and costs for compensated and dismissed cases. As of October 

4, 2021, HRSA had a backlog of 1477 claims alleging vaccine injury that are awaiting review. As 

of October 1, 2021, 3158 claims alleging injuries and death from COVID-19 countermeasures 

had been filed with the Countermeasures Injury Compensation Program (CICP), including 1357 

claims alleging injuries from COVID-19 vaccines. About 82% of the claims are awaiting medical 

records for review, and about 77 claims are in medical review. More information can be found in 

the CICP website.2 

Indian Health Service 

Ms. Uzo Chukwuma provided an update on Indian Health Service (IHS) activities. IHS 

continues to maintain the COVID-19 vaccine effort that was initiated in September in response 

to agency-wide allocation, distribution, and administration of COVID vaccines within the IHS 

Tribal and Urban Indian Health facilities. As of October 19, 2021, the IHS data from the CDC 

COVID Tracker reported that 2,162,835 COVID vaccines were distributed within the IHS 

jurisdictions and 1,691,651 COVID vaccine doses were administered by the Office of Direct 

Service and Contracting Tribes (ODSCT) and other Indian organizations that chose IHS 

for vaccine distribution. The CDC Tracker also reported that 44.1% of the 2.1 million population 

has received at least 1 dose, while 36.6% are totally vaccinated. In early August, the IHS 

implemented a policy requiring COVID-19 immunizations for all personnel working in IHS 

facilities as an added strategy to minimize the risk of COVID-19 transmission to patients and 

among staff. The IHS Vaccines Task Force (IHS VTF) also promotes vaccine safety among 

American Indian and Alaskan Native (AI/AN) populations by reporting and monitoring through 

surveillance systems. The IHS VTF encourages the use of Vaccine Adverse Event Reporting 

2 https://www.hrsa.gov/cicp/ 

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ACIP Meeting Summary October 20-21, 2021 

System (VAERS) and tracks AEs reported in the IHS Safety Tracking & Response (I-STAR) 

System. IHS collaborates with the CDC and engages tribal leaders and IHS on strategies to 

improve vaccine uptake among AI/AN populations. IHS routinely tracks pediatric immunization 

coverage. Long-term trends indicate a decline in immunization coverage for children 3 years of 

age. With the COVID-19 pandemic, a decrease in coverage was observed. Following onset of 

the COVID-19 pandemic, IHS immunization coverage for 3-year-old series was at 64.7%. IHS 

coverage fell to 57.8% by the end of the third quarter in fiscal year 2021. In response to 

declining childhood immunization coverage, the IHS implemented the Pediatric Immunization 

Improvement Project in May 2021 called “Safeguard our Future: Protect Tomorrow, Vaccinate 

Today.”3 Strategies included communication and a focus on media content such as blogs, 

quotes, provider and parents toolkits, and webinars to focus on and share best practices. The 

health informatics arm of the campaign concentrated on educating in the healthcare community 

by using data and information technology to identify and reach out to patients and recommend 

vaccines. HIS continues working with tribes, states, and CDC to promote childhood and adult 

immunization. The Influenza-like Illness Awareness System (IIAS) showed very low ILI activity 

over 2020-2021. In preparation of the upcoming influenza season, the IHS immunization 

program organized activities that included webinars with presentations from influenza experts, 

dissemination of information such as the ACIP recommendations, and discussions around 

influenza vaccine orders, and research action plans. Recently, the IHS collaborated with the 

CDC on incorporation of influenza vaccinations among AI/AN populations. 

National Institutes of Health 

Dr. John Beigel reported that the National Institute of Allergy and Infectious Diseases (NIAID) 

posted the preliminary findings for the homologous and heterologous booster vaccinations for 

those who have received an EUA COVID vaccine. As noted by Dr. Fink, the findings were 

presented during the VRBPAC meeting the previous week and would be presented during the 

second day of the ACIP meeting by Dr. Atmar. They also have been posted on the medRxiv 

server so that they will be available to the scientific community. NIAID also launched a Phase 2 

trial for people with autoimmune disease who did not respond to the original COVID vaccine. 

This is unique and interesting because it uses not only an extra dose, but also is exploring how 

to modify or pause immunosuppressive therapy to improve the antibody response. NIAID also 

announced 3 large awards in September to conduct research and begin development of 

vaccines against multiple coronavirus types, including viral variants. This is an important step 

toward a pan-coronavirus vaccine. For non-COVID vaccine updates, NIAID announced the 

results of a human immunodeficiency virus (HIV) vaccine, the HVTN 705 study, that was 

conducted in sub-Saharan Africa that did not provide protection against HIV. HIV vaccine 

studies have been very difficult and NIAID continues to support multiple vaccine trials for that. 

NIAID also continues to advance influenza vaccines and just announced a new live attenuated 

influenza vaccine (LAIV) for intranasal administration. Dr. Beigel indicated that additional 

information would be provided in writing and would include links to each topic area. 

3

https://www.ihs.gov/sites/newsroom/themes/responsive2017/display_objects/documents/SafeguardOurFutureVaccineToolkitforPar 

entsandFamilies.pdf 

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ACIP Meeting Summary October 20-21, 2021 

PNEUMOCOCCAL VACCINES 

Session Introduction 

Dr. Katherine Poehling (ACIP, WG Chair) welcomed everyone to the pneumococcal vaccine 

session on behalf of the Pneumococcal Vaccine Work Group (WG) and expressed the 

Pneumococcal Vaccine WG’s sincere thanks to all of the contributors who provided important 

information to guide these discussions. As a reminder, the policy questions presented during the 

September 2021 ACIP meeting included the following: 

 PCV15 Age-based: 

- Should PCV15 be routinely recommended to US adults ≥65 years in series with 

PPSV23? 

 PCV15 Risk-based: 

- Should PCV15 in series with PPSV23 be recommended for U.S. adults aged 19–64 

years with chronic medical conditions* or immunocompromising conditions**? 

 If age-based PCV20 recommendation at age ≥50 years:

- Should PCV20 be routinely recommended to US adults aged ≥50 years?

- Should PCV20 be recommended for U.S. adults aged 19–49 years with chronic medical 

conditions* or immunocompromising conditions**? 

 If age-based PCV20 recommendation at age ≥65 years:

- Should PCV20 be routinely recommended to US adults aged ≥65 years?

- Should PCV20 be recommended for U.S. adults aged 19–64 years with chronic medical 

conditions* or immunocompromising conditions**? 

*Alcoholism, chronic heart/liver/lung disease, diabetes, cigarette smoking 

**Chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human 

immunodeficiency virus infection, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired 

asplenia, sickle cell disease, or other hemoglobinopathies, CSF leak, or cochlear implant 

The WG was very appreciative of the feedback provided during that meeting, which was very 

clear that it was confusing to have different age-based recommendations by vaccine. The 

request was to simplify the policy options for consideration for a vote. The WG took this 

feedback seriously and worked to figure out how to address this request. Early in the process, 

the WG created Guiding Principles which were that: 1) decisions on policy options should be 

supported by the best available evidence; 2) simplifying existing pneumococcal vaccine 

recommendations could help improve vaccine coverage among adults; 3) disparities in 

pneumococcal disease burden and vaccine coverage should be reduced; and 4) timely 

recommendations for each new vaccine should be made after FDA licensure. 

With the feedback and these Guiding Principles, the WG had many discussions and wanted to 

share the rationale for harmonizing at age ≥65 years. As discussed during the last ACIP 

meeting in September, there are no data on the duration of pneumococcal conjugate vaccine 

immunity in adults. Due to the potential waning of immunity, vaccination at 65 years and older 

may be favorable when risk of disease may be higher. When the WG reviewed the data for the 

cost-effectiveness study at 65 years of age and older, there was consistent cost-savings (e.g., 

lower cost and better health outcomes compared to current recommendations) in all of the costeffectiveness analyses. In addition, the proposed risk-based and age-based options still provide 

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ACIP Meeting Summary October 20-21, 2021 

an opportunity for higher pneumococcal conjugate vaccine (PCV) vaccine coverage, which may 

prevent more disease compared with current recommendations and may address health equity 

concerns. 

The plan for this session was to present more data to explain the updated policy questions for 

consideration, which were: 

 Should PCV20 alone OR PCV15 in series with PPSV23 be routinely recommended to US 

adults aged ≥65 years?

 Should PCV20 alone OR PCV15 in series with PPSV23 be recommended for U.S. adults 

aged 19–64 years with certain underlying medical conditions or other risk factors*? 

*alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus, chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human 

immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other hemoglobinopathies, CSF leak, or cochlear 

implant. 

This led to a single risk-based and a single age-based recommendation for pneumococcal 

vaccine, with no recommendation for individuals without any of the identified conditions: 

19-64 Years ≥65 Years

None of the conditions listed 

below No recommendation 

Age-Based Recommendation 

Chronic medical conditions† 

(CMC) 

Cochlear implant, CSF leak Risk-Based Recommendation 

Immunocompromising 

conditions* 

†Examples include alcoholism, chronic heart/liver/lung disease, diabetes, cigarette smoking *Chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, 

human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other hemoglobinopathies 

https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf 

During this session, Dr. Miwako Kobayashi presented considerations for age-based and riskbased use of PCV15/PCV20 among adults and proposed policy options. 

Considerations for Age-Based and Risk-Based Use of PCV15/PCV20 among Adults and

Proposed Policy Options 

Dr. Miwako Kobayashi (CDC/NCIRD) presented the considerations for age-based and riskbased use of PCV15 and PCV20 among US adults and the proposed policy options. Currently, 

the 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal 

polysaccharide vaccine (PPSV23) are recommended for use in US adults. As a reminder, 

PCV15 contains the 13 serotypes included in PCV13 and 2 additional serotypes (22F, 33F). 

These serotypes are referred to as PCV15 non-PCV13 serotypes. PCV20 contains the PCV20 

serotypes, the 2 additional serotypes included in PCV15, and 5 additional serotypes (8, 10A, 

11A, 12F, 15B). These 7 additional serotypes are referred to as PCV20 non-PCV13 types. 

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ACIP Meeting Summary October 20-21, 2021 

PPSV23 contains 4 additional serotypes that are not included in PCV20, referred to as PPSV23 

non-PCV20 types (2, 9N, 17F, 20). 

Pneumococcal disease can be divided into invasive pneumococcal disease (IPD) and noninvasive disease. IPD is a less frequent but severe form of illness such as meningitis, 

bacteremia, or bacteremic pneumonia. Non-invasive disease is a more frequent form of illness 

such as non-bacteremic pneumococcal pneumonia (NBP). Among US adults 19 years and 

older, more than 100,000 hospitalized pneumococcal pneumonia cases occurred in 2017.4 

Approximately 30,000 IPD cases and about 3,000 IPD deaths occurred in 2019.5 Of the 30,000 

IPD cases, 43% occurred in persons ≥65 years of age and about 48% occurred in persons 19-

64 years of age with risk-based indications. This indicates that more than 90% of the adult IPD 

burden is in persons 19-64 years of age with risk-based indications and persons ≥65 years of 

age. 

In this presentation, Dr. Kobayashi referred to adults 19-64 years of age who are currently 

recommended to receive PPSV23 only as those with chronic medical conditions (CMC) and 

those who are recommended to receive both PCV13 and PPSV23 as those with 

immunocompromising conditions (IC). Based on Active Bacterial Core Surveillance (ABCs) data 

for 2018-2019, 27% of remaining IPD burden was due to PCV13 types, 15% of all IPD was due 

to the 2 additional serotypes contained in PCV15, and approximately 30% was due to the 7 

additional serotypes contained in PCV20. Adults with CMCs had a higher proportion of PCV13-

type disease compared with adults with ICs. However, the proportions of additional serotypes 

contained in PCV15 and PCV20 were similar. 

During the September 2021 ACIP meeting, the WG presented multiple policy questions on the 

use of new PCVs. That led to concerns that the new options would be confusing and would 

create more implementation challenges. After further review of data and discussions, the WG 

reframed the policy questions as: 

 Should PCV20 alone OR PCV15 in series with PPSV23 be routinely recommended to US 

adults aged ≥65 years?

 Should PCV20 alone OR PCV15 in series with PPSV23 be recommended for U.S. adults 

aged 19–64 years with certain underlying medical conditions or other risk factors*? 

*alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus, chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human 

immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other hemoglobinopathies, CSF leak, or cochlear 

implant. 

Dr. Kobayashi showed a table comparing the current and proposed options for an age-based 

recommendation, explaining that the proposed age-based option would apply to all adults ≥65 

years of age. The proposed risk-based option would simplify the current risk-based 

recommendations. The majority of the WG members were in support of using either PCV20 

alone or PCV15 in series with PPSV23 for adults ≥65 years of age and using either PCV20 

alone or PCV15 in series with PPSV23 for adults 19-64 years of age with certain underlying 

medical conditions or other risk factors. A few members who were not in favor of these options 

did not agree mainly for 2 reasons. Some members preferred an age-based recommendation at 

≥50 years of age since lowering the age-based recommendation may reduce disparity in 

pneumococcal disease burden in adults 50-64 years of age and may provide more opportunities 

to vaccinate adults before they develop underlying conditions or when a more robust immune 

4 CDC SNiPP, 2017 

5 CDC ABCs, 2018 

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ACIP Meeting Summary October 20-21, 2021 

response is expected. Some members had concerns with the PCV15 options given that it will 

need to be used in series with PPSV23. It is logistically more challenging to administer different 

vaccines and series. Providers need to know the vaccination history to correctly complete the 

vaccine series. If adults only receive PCV15 without returning for PPSV23, they will have lower 

serotype coverage. 

Now to review the available data and WG considerations for an age-based recommendation at 

age 50 versus 65 years. The main reasons in favor of an age-based recommendation at ≥65 

years of age for both vaccines are that: 1) due to potential waning of immunity, vaccination later 

in life may be favorable when risk of disease is higher for either PCV20 alone or PCV15 use 

in series with PPSV23; 2) an age-based option at ≥65 years of age was consistently cost-saving 

compared with current recommendations in cost-effectiveness analyses; and 3) the proposed 

risk-based and age-based options still provide an opportunity for higher PCV coverage, which 

may prevent more disease compared with current recommendations and may address some 

health equity concerns. 

With regard to potential waning of immunity, the risk of pneumococcal disease increases with 

increasing age. US adults ≥50 are expected to live about 30 more years and US adults ≥65 

years are expected to live 19 more years. In the cost-effectiveness analyses, it was assumed 

that the duration of protection from PCV vaccination is about 15-20 years. If adults are 

vaccinated earlier in life, they may not benefit from vaccine protection later in life when their risk 

of disease is higher.6 

As a reminder, cost saving means that the intervention yields higher health outcomes and lower 

costs than the current recommendations in cost-effectiveness analyses. During the September 

2021 ACIP meeting, Dr. Leidner summarized the findings from cost-effectiveness analyses 

conducted by CDC and other groups. Looking at the different scenarios considered in the CDC 

model for age-based use of PCV20 at age 65 and at age 50 compared with current ACIP 

recommendations, use of PCV20 at age 65 years consistently showed that the intervention was 

cost-saving. Use of PCV20 at age 50 years resulted in worse health outcomes in some CDC 

scenarios. The results of cost-effectiveness analyses performed by other groups also showed 

that that PCV20 use at age 65 years was cost-saving in most scenarios. The CDC model 

showed that PCV15 in series with PPSV23 at age 50 resulted in lower health outcomes 

compared with current recommendations. The Merck model showed that the intervention 

prevented more disease than current recommendations, but the intervention was less costeffective compared with use of the series at age 65 years. Therefore, the WG did not consider 

PCV15 use in series with PPSV23 for adults aged 50 years and older. In the CDC model, use of 

PCV15 in series with PPSV23 at age 65 was cost-saving in all scenarios considered. 

In terms of higher PCV coverage and how that may address some health concerns, risk-based 

pneumococcal vaccine recommendations have yielded low vaccine coverage in the target 

population. According to the National Health Interview Survey (NHIS) data in 2018, 

approximately 23% of adults 19-65 years of age with risk-based indications had ever received 

any pneumococcal vaccinations. By race and ethnicity, the Hispanic population had significantly 

lower coverage compared with the white population. By simplifying a risk-based option, vaccine 

uptake may improve in adults with underlying conditions. Another difference in the new riskbased option is that more adults would be receiving conjugate vaccines since the 2 recently 

licensed vaccines are both conjugate vaccines. Conjugate vaccines have the capsular 

6 ABCs Report: Streptococcus pneumoniae, 2018. https://www.cdc.gov/abcs/reports-findings/survreports/spneu18.html 

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ACIP Meeting Summary October 20-21, 2021 

polysaccharide antigens conjugated to a carrier protein and induce a T-cell dependent 

response, whereas the polysaccharide vaccine does not. 

Based on available data, different assumptions were used for PCVs and PPSV23 for the 

duration of protection and vaccine effectiveness (VE) in the CDC cost-effectiveness analysis 

model as presented during the September 2021 ACIP meeting. It was assumed that PCV 

effectiveness does not decline for the first 5 years, whereas it was assumed that PPSV23 has 

linear decline after vaccination. It also was assumed that there is higher VE for PCVs compared 

to PPSV23. Approximately 90% of adults 19-64 years of age currently indicated for 

pneumococcal vaccinations are recommended to receive PPSV23 only. Under the new riskbased policy option, more adults would be recommended to receive one of the new PCVs, 

which may prevent more disease in this group. This also could help address disparity in 

pneumococcal disease burden to some extent. The proportion of CMCs in the Black population 

is higher in adults 50-64 years of age compared with the proportion in the non-Black population. 

Therefore, the new risk-based policy option may prevent more disease in populations with 

higher burden of CMCs before 65 years of age. 

On the use of PCV15 in series with PPSV23, there are many reasons in favor of having an 

option of PCV15 use in series with PPSV23 and use of PCV20 alone: 1) use of PCV15 in series 

with PPSV23 provides broad serotype coverage; 2) use of PSV15 in series with PPSV23 at age 

65 was cost-saving in CDC’s cost-effectiveness analysis; and 3) a PCV13+PPSV23 series is 

currently recommended, so providers have experienced using PCV in series with PPSV23. As a 

reminder, PCV15 provides protection against 2 additional serotypes not contained in PCV13, 

and PPSV23 provides coverage against 9 additional serotypes that are not contained in PCV15. 

Since 2012, adults 19 years of age and older with ICs have been recommended to receive 

PCV13 in series with PPSV23 and all adults 65 years of age and older were recommended to 

receive PCV13 in series with PPSV23 from 2014-2019. In 2019, the recommendation on PCV13 

use was changed to shared clinical decision-making in adults 65 years of age and older without 

ICs, cochlear implant, or cerebrospinal fluid (CSF) leak. In terms of PCV13 and PPSV23 

coverage in adults 65 years of age and older who are Medicare Part A or B beneficiaries, 

coverage of both PCV13 and PPSV23 increased gradually after the age-based recommendation 

in adults 65 years of age and older in 2014.7 

The WG also discussed the possibility of a preferential recommendation for PCV20 over PCV15 

in series with PPSV23. The main reasons in favor of a preferential recommendation were 

implementation challenges associated with use of PCV15 in series with PPSV23 and improved 

protection against the 5 serotypes included in PSV20 but not PCV15. The main reasons against 

a preferential recommendation were that there are no studies directly comparing PCV15 and 

PCV20 efficacy and safety. The potential impact of PCV20 use alone is unknown given lack of 

data on clinical outcomes. Licensure of PCV15 and PCV20 was based on immunogenicity and 

safety, and the clinical relevance of lower immunogenicity for PCV20 compared with PCV13 is 

unknown. There are no PCV20 data in immunocompromised adults. Use of PCV20 alone will 

lose protection against serotypes included in PPSV23, but not in PCV20. 

7 Adapted from: Pneumococcal vaccination among U.S. Medicare beneficiaries aged ≥65 years, 2010 -

2019 | CDC 

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ACIP Meeting Summary October 20-21, 2021 

For Grading of Recommendation Assessment, Development and Evaluation (GRADE), the WG 

reviewed immunogenicity and safety data that compared the new vaccines to current vaccines. 

In 3 Phase 3 trials8 that compared the immunogenicity of PCV15 to PCV13, both given in series 

with PPSV23, the geometric mean titers (GMTs) and percentage of seroresponders after receipt 

of the series were higher in PCV15 recipients for some shared serotypes. In 1 Phase 2 and 2 

Phase 3 PCV20 trials,9 PCV20 recipients had lower responses by GMTs and percent 

seroresponders in most shared serotypes. However, in the Phase 3 trials, PCV20 met noninferiority criteria for all 13 shared serotypes by GMT ratio. In the GRADE assessment, the 

certainty of evidence on the benefits of PCV20 use alone in adults with CMCs or ICs was low. 

Correlative protections are not established, so the impact of these findings against the critical 

outcomes are known. Also, the studies targeted generally healthy adults and did not include 

immunocompromised persons. Therefore, the studies are not representative of the populations 

considered for the risk-based policy option. In adults aged 19-64 years of age who currently 

have pneumococcal vaccine indications, the 4 serotypes included in PPSV23 but not in PCV20 

comprised 12% to 15% of all IPD burden. In adults aged 65 years and older, these serotypes 

comprise 8% of IPD in adults aged 65 years and older when PPSV23 coverage was estimated 

to be around 50% to 60%. The impact of losing protection against these serotypes by use of 

PCV20 alone is unknown. 

To summarize the WG’s considerations for an age-based option for adults 50 years of age and 

older and 65 years of age and older, the main reasons in favor of an age-based option at age 50 

were the possibility of reducing disparity and disease burden in adults aged 50-64 years and the 

possibility of providing more opportunities to vaccinate adults before they develop underlying 

conditions. The reasons in favor of an age-based option at age 65 years were that the potential 

for waning immunity makes it favorable to vaccinate later in life when risk of disease is higher. 

The age-based option at age 65 years was consistently cost-saving in cost-effectiveness 

analyses. The use of the new risk-based and age-based options still provides an opportunity for 

higher PCV coverage in adults compared with current recommendations, which may prevent 

more disease and address disparity issues. 

In summary of the WG’s considerations on PCV20 use alone and PCV15 use in series with 

PPSV23, the advantages of using PCV20 alone are that it is acceptable and feasible to 

implement a single vaccine option. In addition, the intervention was cost-saving in most costeffectiveness analyses and it is expected to provide better protection for the serotypes that are 

covered by PPSV23 alone. The potential disadvantages of using PCV20 are that the clinical 

significance of lower immunogenicity compared with PCV13 is unknown, there are no data in 

immunocompromised adults, and use of PCV20 alone will lose protection against serotypes 

contained in PPSV23 but not in PCV20. The advantages of using PCV15 in series with PPSV23 

are that the combination will provide broad serotype coverage and age-based use at age 65 

years was cost-saving in CDC’s cost-effectiveness analysis. The disadvantages of PCV15 use 

in series with PPSV23 are it is logistically more challenging to administer PCV15 in series with 

PPSV23, providers need to know the vaccination history to correctly complete the vaccine 

series, and the intervention can result in lower serotype coverage if the series is not completed. 

8 V114-016, V114-017, V114-018 adapted from June 2021 ACIP presentation 9 B7471007 (Phase 3), Klein et al. 2021 (Phase 3), Hurley et al. 2021 (Phase 2) adapted from September 2021 ACIP presentation 

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ACIP Meeting Summary October 20-21, 2021 

Unlike PCV13, PCV15 and PCV20 were licensed for use in adults first. PCV15 licensure for use 

in children is expected to occur in early 2022 and in 2023 for PCV20. At this point, how the use 

of these vaccines in children might impact the disease burden in adults is unknown. Based on 

these considerations, the proposed language for the age-based recommendation is: 

Adults 65 years of age or older who have not previously received a pneumococcal 

conjugate vaccine or whose previous vaccination history is unknown should receive a 

pneumococcal conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this 

should be followed by a dose of PPSV23. 

Based on the considerations for risk-based recommendations, the proposed language for the 

risk-based recommendation is as follows: 

Adults aged 19 years of age or older with certain underlying medical conditions or other 

risk factors* who have not previously received a pneumococcal conjugate vaccine or 

whose previous vaccination history is unknown should receive a pneumococcal 

conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this should be followed 

by a dose of PPSV23. 

*alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus, chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized 

malignancy, human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other 

hemoglobinopathies, CSF leak, or cochlear implant. 

Discussion Summary 

ACIP Member Comments 

• Dr. Cohn acknowledged that the Pneumococcal WG’s approach to the proposed 

recommendations had shifted since the last ACIP meeting in September 2021, which was 

demonstrated clearly in Dr. Kobayashi’s presentation during this session. Dr. Cohn 

reiterated that implementation of the adult program is of critical importance right now. The 

discussions that occurred at CDC and among the WG were that having two different agebased recommendations would be more confusing, and that the need to simplify these 

recommendations to potentially improve coverage is critical. Given that this had shifted, 

CDC was open to ACIP members discussing persons 50 years of age. CDC’s concern was 

related to program implementation and the adult program. 

• Dr. Talbot, a Pneumococcal WG member, elaborated on the minority opinion among the 

WG. As an internist, she looked at this as an internist. The majority of physicians on the WG 

who care for adults were very interested in starting at 50 years of age. While they recognize 

that duration of protection is unknown if vaccination begins at 50 years of age, physicians 

are happy to evaluate a booster in the future because they hope their patients live long 

enough and have meaningful lives to require a booster. That would require the PCV15+ 

PPSV23 to be given at 50 years of age. While she would not like it, she would be willing to 

begin at the lower the age to capture people when they are most likely to respond to vaccine 

and to reduce the current disparities of disease that exist. She emphasized that internists 

could keep up with all of the “simple” recommendations if the majority of their patients did 

not have multiple comorbid conditions. While they would prefer to prevent, most of their 

adult patients are already in therapeutic mode by the time they present and there is not as 

much time for all of the necessary preventative measures that are expected of them. Having 

age-based recommendations greatly changes how they practice and does not require them 

to go through a list of 20 different health co-morbidities that are required for every single 

vaccine in addition to mammograms, colonoscopies, and everything else. She emphasized 

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ACIP Meeting Summary October 20-21, 2021 

that the younger age group would respond to vaccine and create a lasting vaccine response 

much better than someone 70 years of age. 

• Dr. Daley emphasized the challenges of risk-based recommendations and inquired about 

whether the WG talked about other means to ensure that the risk-based recommendation 

for persons either 19-50 years of age or 19-64 years of age would be successfully 

implemented to the extent possible. While this is challenging, they would be having the 

same conversation about hepatitis B in a couple of weeks. 

• Dr. Kobayashi indicated that the WG did not go into the details about the specifics of 

implementation, but the hope was that simplification of the recommendations would address 

the current challenges with the different tiers of risk-based recommendations. Having a 

single risk-based recommendation could address some of the challenges, though it is likely 

that more efforts likely will be needed in terms of implementation as well. 

• Dr. Poehling commented that the WG reflected on what happened in children with influenza 

vaccine. For many years there was a recommendation for children at high-risk in terms of 

influenza, but there was very low uptake. When children 6-23 months of age began to have 

an age-based recommendation, there was a significant jump in the risk-based uptake. The 

thought was that a consistent, clear, age-based recommendation and a simplified risk 

condition across age groups would enable much clearer communication in that patients and 

physicians could advocate for better coverage. 

• Dr. Bell pointed out that based on the COVID-19 Vaccines WG discussions, it became quite 

clear that the proportion of the population 50-65 years of age who have chronic medical 

conditions, broadly defined, is very large. While she recognized the concerns about 

implementation of risk-based recommendations, the recommendation would cover a huge 

part of the population of persons 50-65 years of age. Perhaps it could be made clear in 

communication to providers that “risk” in the context of pneumococcal vaccines 

encompasses close to 3/4 of their patient populations. 

• Ms. Bahta expressed concern that many people under 50 years of age would be missed. 

While cost-effectiveness contributes a large component of these recommendations, 

consideration also should be given to a policy that is equitable. While it may cost more, it 

may actually reduce the mortality and morbidity in some diverse communities. 

• Dr. Kotton highlighted the issues regarding possible clinician confusion between various 

vaccines and various definitions of medical conditions and immunocompromised hosts. 

There are different definitions for COVID-19 and pneumococcal disease, and they would 

soon hear and discuss more about the shingles vaccine and immunocompromised hosts. 

Therefore, she advocated for standardization of the definitions—especially for 

immunocompromised patients. 

• Dr. Long agreed the pneumococcal recommendations are very difficult. She stressed that 

more than 45% of severe morbidity, hospitalizations, intensive care unit (ICU) admissions, 

and deaths due to pneumococcus occurred in persons over 65 years of age and more than 

45% occurred in those with underlying conditions. Focusing on both of these groups would 

prevent the vast majority of vaccine-preventable pneumococcal disease. While there are 

many people with underlying conditions between 50-65 years of age, most of those are not 

going to compromise how they would respond to a vaccine. Unlike hepatitis B for risk is 

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based on behaviors, pneumococcal vaccine is not behavior-based. Physicians would have 

to recognize only that some of their patients have any of the CMC or IC diagnoses and need 

to be immunized earlier. Her concern about beginning the recommendation at 50 years of 

age would make it much more difficult to promulgate either PCV20 or PCV15 plus PPSV23 

because if PPSV23 is used in many otherwise healthy Americans, it would raise the 

possibility of a blunted response to subsequent immunization that almost certainly would be 

required. 

• Dr. Cineas commented that as a primary care physician (PCP), she also greatly appreciated 

the efforts toward simplifying the recommendations in order to facilitate implementation. 

Given that there are no data for PCV20 for immunocompromised individuals, she asked 

whether consideration had been given to using PCV20 for age-based recommendation 

either at 50 or 65 years of age and then using PCV15 in series with PPSV23 for those with 

immunocompromised or medical conditions. 

• Dr. Kobayashi indicated that the WG had this discussion early on, but there are no data 

even for PCV15. The data are based on immunogenicity studies, so the potential clinical 

impact the series with either vaccine would have remains unclear. Therefore, the WG 

decided to propose the options presented during previous ACIP meetings. 

• Dr. Brooks observed that among persons 65 years of age and older, the proportion of 

disease caused by the additional serotypes included in PPSV23 but not in PCV20 was 8%. 

The thought about using PCV20 in series with PSV15 and PPSV23 was not as strong 

because this would lose 8%. Compared to 30,000 deaths, 8% is a relatively small number. 

Therefore, he was leaning in favor of using PCV20 by itself for simplicity. The concern about 

those 50-64 years of age is the higher incidence of deaths and hospitalizations due to IPD 

among the African American population, a lot of which can be explained by underlying 

conditions. Regardless of the recommendation, there must be a very clear statement that 

patients with underlying conditions (e.g., 75% of patients) should be vaccinated. Vaccines 

do not work unless they are in someone’s arm versus the refrigerator. By making the 

recommendation relatively simple, more lives will be saved ultimately. Dr. Brooks’ one 

concern about PCV20 alone was that in terms of clinical effectiveness, the only data 

available are immunogenicity data and no actual data regarding the efficacy of PCV20. 

• Dr. Lee agreed with Dr. Brooks that vaccines do not save lives—vaccinations do. The 

importance of getting vaccines into arms cannot be underestimated. Providers need 

flexibility and choice in what they stock in their offices, especially private providers who are 

often purchasing vaccines out of pocket and need to use them efficiently before they expire. 

Their choices may differ depending on the populations they serve, with an anticipated 

request for expansion of use in the pediatric population. She could imagine as a pediatric 

provider that it would be far easier for her to stock PCV15 if she was seeing both children 

and adults as a family practice provider. ACIP had discussions years ago that the most 

important and most effective intervention observed has been pneumococcal conjugate 

vaccines delivered in childhood, which has had the biggest impact on adult burden of 

disease more so than individual vaccines into adult arms. To address equity, she would 

argue that childhood vaccination programs perhaps are going to address equity at a 

population level more meaningfully than individual vaccines. ACIP is asked to make 

decisions that are challenging and difficult in terms of trying to maximize benefits, minimize 

risks to individuals in the population, and consider resource use. This posed a challenge 

since risk-based populations kept coming up. While she did not have an easy answer, it was 

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important to realize that every vaccine coming at them these days was targeting a riskbased population and it would become increasingly difficult to lean on a universal vaccine 

approach as a way to address equity or coverage. 

• Dr. Loehr commented that if it was true that 75% of people 60-65 years of age have 

conditions that would make them eligible for the vaccine, he absolutely agreed with going 

down to age 50. However, this was not his experience and he would need to see some data 

about the 75%. If this is accurate, it would be much easier to cover everybody. His major 

concern with age 50 was two-fold. First, the decline that is probably going to occur over 15 

years is likely to result in the need for a booster. While recognized that by then there would 

be more data, PCV15 and PPSV23 was not cost-effective at age 50. He would be hardpressed to say that he wanted PCV20 at age 50, but did not really want PCV15 and 

PPSV23 until age 65. That would be too awkward for him. Though he did not have a strong 

feeling against going down to age 50, it was not his preferred option and he probably would 

err on the side of going to age 65. 

• Dr. Sanchez said he tended to agree with 65 years of age, although he does not see adults 

over 50 years of age. Essentially, these recommendations would supplant the current ones 

in which PCV13 is given based on shared decision-making. The proposed recommendation 

would be for all persons 65 years of age and older or 50 years of age and older to receive 

the conjugate vaccine and there no longer would be an option for just PPSV23. 

• Dr. Bell cautioned people not to assume that a risk-based recommendation focused on a 

behavioral risk factor like the one they would be considering with hepatitis B would 

necessarily be the least bit transferrable to the pneumococcal recommendation about health 

risk. At some point, she would like to hear actual data, not in the pediatric population for 

whom there also are school entry requirements, but showing that expanding a 

recommendation from a risk group through an age group makes a large difference in terms 

of coverage. Everyone thinks that that is the case, but it is not clear that it actually is the 

case. She was concerned about lumping when maybe lumping was not necessary or 

appropriate. She thought that the incremental benefit of going from age 50 with chronic 

conditions to all age 50 would be low. The incremental benefit may be particularly low in the 

context of having pediatric vaccination with the pneumococcal conjugate vaccines in the 

foreseeable future, which is likely going to change the epidemiology greatly. They might be 

looking at things in a completely different way at that time. While she supported the 

proposed recommendation on the table, she was not totally opposed to the idea of reducing 

the age group to 50 years and above, but would support the WG’s final suggestion and 

would be happy with it. 

• Dr. Kobayashi clarified that she was simply sharing the example of a vaccine that has an 

age-based recommendation that starts at a younger age. At the time of implementation in 

2006, it was for all adults 60 years of age and older. As of 2018, the data on persons 60-64 

years of aged showed slow coverage and disparities. While changing the option was one 

thing, ensuring that implementation actually follows this is probably the key. 

• Dr. Long echoed Dr. Bell’s sentiments and agreed with the 65 and older recommendation. 

She pointed out that they must remember that they were talking about serotype coverage. 

For instance, perhaps 8% of serious disease or lives would be lost from PCV20 without 

PPSV23. It is known that the polysaccharide vaccines perform very poorly, so the hope is to 

eliminate pure polysaccharide vaccines in the near future. Because of the miraculous 

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ACIP Meeting Summary October 20-21, 2021 

performance of conjugate vaccines in younger individuals, the PCV20 vaccine likely would 

perform and eliminate any potential 8% serotype loss from not giving the full PPSV23 

vaccine. Because there is a lack of efficacy data for both of the new vaccines, she would 

prefer at this moment to deal with persons 65 years of age and older for whom there clearly 

would be a benefit and not to go down to an age-base of 50 years. 

• Dr. Loehr’s sense was that everyone agreed with an age-based recommendation for 

persons 65 years of age and older. However, he did not have a clear sense of the members 

for an age-based recommendation for persons 50 years of age and older. If he were voting, 

he would vote at this moment, he would vote for 65 years of age and above and not 50 

years of age and above. He suggested that they vote first for 50 years of age and older to 

know whether that would pass, and then they would not have to vote for 65 years of age and 

above. 

• To go on record, Dr. Lee said that she thought the 65 years of age and older 

recommendation as a cutoff made the most sense given the data in hand and taking into 

account the broader context of the pneumococcal conjugate vaccination program. She 

would not be in favor of lowering the age down to 50 years given they have immunogenicity 

but not efficacy data. 

• Dr. Talbot indicated as an internist who treats adults, she wanted to go on record to support 

a reduction to 50 years of age and older for PCV15 + PPSV23 as well as PCV20, because 

she was not worried about the cost-effectiveness of the PCV15 followed by the PPSV23 as 

most practices would rather invest in 1 vaccine than 2. She also supported voting on 50 

years of age before 65 years of age. 

• Dr. Poehling thanked everyone for the robust discussion, which the WG had as well. Given 

the lack of effectiveness data, she was leaning strongly toward PCV15 and PCV20 knowing 

that childhood vaccinations would soon be expanded to include these vaccines in the near 

future. She also expressed favor for persons 65 years of age and older, with the proviso that 

it would be very important to review the effectiveness of the recommendations in 5 to 7 

years based on real-world data versus best estimates. 

• While Dr. Sanchez agreed with the comments about the age 65 cutoff and favored this 

recommendation, he wondered if perhaps in fairness to the internists there should be a 

separate vote for persons 50 years of age or over to at least go on the record for persons 

50-64 years of age. 

ACIP Ex Officio and Liaison Member Comments 

• Dr. Fryhofer (AMA) said that speaking as a practicing physician, she agreed with Dr. Talbot 

that there are many adults over the age of 50 years who have multiple medical 

comorbidities, and that she greatly appreciated the WG’s attempt to simplify the 

recommendation. She stressed that in terms of real-life implementation, vaccinations are not 

always recorded completely in registries. Therefore, tracking down which vaccine has been 

received is challenging and sometimes impossible. She requested further information about 

what the downside would be of a patient receiving PCV20 + PPSV23, additional clarification 

for the CSF leaks and the cochlear implants, and clarification about whether the 

recommendation would be for an additional PPSV23 dose at 65 years of age or 5 years 

after the previous PPSV23 dose. 

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ACIP Meeting Summary October 20-21, 2021 

• In terms of the downside of PCV20 + PPSV23, Dr. Kobayashi indicated that the 

assumptions for PCV15 and PCV20 were based on available immunogenicity and safety 

data. The WG initially discussed the option of PCV20 in series with PPSV23. However, the 

cost-effectiveness analysis showed that using PCV20 alone as an age-based 

recommendation already was cost-saving, meaning that this would prevent more disease 

and cost compared to the current recommendations. While adding PPSV23 would prevent 

additional disease, the incremental cost was much higher so the additional disease 

prevented was a lot more expensive. Because of that, the WG decided to propose the 

PCV20 option. Regarding the prior pneumococcal recommendation for those 19-64 years of 

age who had cochlear implants or CSF leaks, the recommendation was to give an additional 

PPSV23 dose 5 years after the last dose or after age 65, whichever was later. The WG is 

still discussing what kind of guidance to provide for people who previously received the 

recommended vaccination, including what to do with people who received the risk-based 

recommendation earlier in life. That will be addressed in the clinical guidance. 

• Dr. Goldman (ACP) said that speaking as a private physician dealing with these patients 

every day, physicians are managing diabetes, hypertension, heart disease; explaining 

medications and convincing patients why they need them; recommending eye exams, foot 

exams, colonoscopies, mammograms, vaccines needed as adults; et cetera. As someone 

who teaches his colleagues the vaccine schedule during annual meetings in terms of what 

they should be doing, history has shown that risk-based recommendations are confusing, 

onerous, and actually are a barrier to access to care. A recommendation that is as simple as 

getting a certain vaccine at age 50 and above is easy to digest and understand, is safe for 

patients, and allows more patients to get adequately vaccinated. While he truly appreciated 

the work of the ACIP in terms of considering the population, his primary concern is the 

patient sitting in front of him in terms of what is going to reduce their risk. In his opinion, a 

simplified age-based recommendation at 50 years of age and above would dramatically 

improve access to vaccination, allow his colleagues to quickly and easily digest the new 

recommendations to ensure their patients get the vaccines they need, and prevent a lot 

more disease. With respect to equity, many minority patients are not living long enough to 

benefit from vaccines by age 65 because of social determinants of health (SDOH). This is 

another reason to go down to age 50. Regarding ease of use as a private physician, a single 

dose vaccine would be preferable, even if a booster must be given 15 years later, to having 

to deal with intervals for which patients do not always return for a second dose. 

• Dr. Schmader (AGS) indicated that AGS wanted to go on record in support of the currently 

proposed age-based recommendation for adults 65 years of age as stated based on the 

evidence and advantage, extended beautifully by Dr. Kobayashi, and in agreement with the 

majority of the WG members. The AGS certainly was not opposed to an age-based 

recommendation of 50 and older if a booster is available and effective. 

• Dr. Hayes (ANA) made a statement on behalf of the National Association of Hispanic Nurses 

(NAHN) who went on record as strongly urging the ACIP to consider expanding access of 

pneumococcal vaccines. The benefit of the pneumococcal vaccine is both to the recipient as 

well as to the indirect vaccine benefit for non-vaccinated populations. The NAHN supports 

the following recommendations that are specifically impacting Hispanic populations: 1) 

expansion of recommended age range to include those 50 years of age and over; 2) use of 

a single-dose vaccine regimen to ensure uptake and access to equitable preventative care; 

and 3) increase efforts to reduce health inequity related to vaccines. Dr. Hayes noted that 

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ACIP Meeting Summary October 20-21, 2021 

the NAHN comments were much longer and would be uploaded to the Public Comment 

section of the docket so that everyone could read the full document they submitted. 

• Dr. Grogg (AOA) indicated that to AOA primary care practitioners, simplification would be 

the use of a single vaccine rather than two vaccines. However, they have not discussed the 

time period in terms of whether to give the PCV15 and polysaccharide at 8 weeks apart or 1 

year apart. Either way is likely to decrease compliance. 

• Dr. Zimmerman (University of Pittsburgh) shared an anecdote of a woman in his practice 

who had pneumococcal bacteremia with joint and tendon involvement at less than 65 years 

of age for whom an age-based 50 years and older recommendation might have provided 

protection. While they do not know what serotype she was infected with, there is some 

burden among people who are less than 65 years of age who do not have an identifiable 

risk factor who would benefit from an age-based recommendation. His practice is a 

Federally Qualified Health Center (FQHC). 

Pfizer and Merck Comments 

• Dr. Luis Jodar (Pfizer) thanked the members of the ACIP for the opportunity to speak to 

them and Dr. Kobayashi for a great presentation. On behalf of Pfizer, he provided three brief 

comments on the session’s presentation as ACIP prepared for further discussions and a 

vote. First, it was mentioned earlier by Dr. Cohn that the updated policy options considered 

during this meeting constituted a drastic change of the policy options that were discussed 

during the June and September 2021 ACIP meetings. The policy options discussed in these 

meetings clearly separated the two proposed pneumococcal conjugate vaccinations 

discussed, PVC20 and PCV15. The conclusions of the EtR Framework presentations in 

June and September for PCV20 alone, 50-65 age-based, 19-49 age-based, and 19-64 riskbased recommendations were very favorable toward intervention and were either costeffective or cost-saving. In contrast, the EtR Framework conclusions for the other proposed 

intervention given in series were more uncertain, with no clearly favorable conclusions. 

Pfizer requested that the ACIP vote on the remaining options equally. Pfizer does not 

believe that these options are equal as evidenced by the very different EtR Framework 

conclusions presented during previous meetings. For these reasons and regardless of what 

the ACIP decided during this meeting, Pfizer respectfully requested that the committee vote 

on each intervention separately based on their relevant merit. Second, the WG provided 3 

points of the rationale for harmonizing to the 65 year old age group. These 3 points are 

complex as the discussion showed, and Pfizer believed that they merited further discussion 

by the WG and the ACIP. Of more concern to Pfizer is the potential downstream effects that 

age-based and risk-based recommendations are promoting or exacerbating in terms of 

health equity as pointed out in the previous EtR. Regarding the potential complexity of 

having 2 different age-based cutoffs, there is substance for ACIP making such 

recommendations. For example, the 60 plus recommendation for Zostavax® and the 60 plus 

recommendations for Shingrix. Pfizer respectfully requested that ACIP reconsider, either 

now or in the near future, the use of PCV20 at age 50 for the reasons outlined by the WG 

previously. Finally, Pfizer respectfully asked the committee to provide guidance for those 

people previously vaccinated with PCV13, PPSV23, or both to have the option to receive the 

additional protection provided by PCV20. Currently, people such as immunocompromised 

persons may have received PCV13 almost 9 years ago and could benefit from receiving a 

dose of PCV20. Dr. Jodar emphasized that Pfizer stands ready to work with CDC, the WG, 

and ACIP to provide any additional data to support such deliberations. On a personal note, 

he thanked Dr. Cohn for her partnership over the years and wished her the best. 

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ACIP Meeting Summary October 20-21, 2021 

• Dr. Rick Haupt (Merck) thanked ACIP for allowing Merck to make public comments 

regarding the deliberations and upcoming vote later in the day, and the Pneumococcal 

Vaccine WG for all of its efforts to ensure and simplify recommendations for adult 

pneumococcal vaccination. Merck agreed that the proposed language was consistent with 

the principles set forth by the WG at the beginning of the adult vaccination policy review in 

October of 2020. As a reminder, he made comments in September and provided information 

to the WG about PPSV hypo-responsiveness and stated unequivocally that scientific 

evidence does not support the hypothesis of PPSV-induced hypo-responsiveness when 

there is an adequate interval between doses. PPSV sequential regimens are not detrimental 

to booster immune responses in adults. As reviewed at the September 29, 2021 ACIP 

meeting, the final recommendation language proposed by the WG was economically 

favorable and consistently cost-saving across various scenarios. The language being 

proposed during this session would allow HCPs the option to choose between a sequential 

PCV15+PPSV22 regimen or a single dose of PCV20 regimen based on the risk profile of the 

individual being considered to be vaccinated. Pfizer also expects that the current risk-based 

recommendation would significantly address equity, especially in persons 50-64 years of 

age, which had been the subject of much discussion during these ACIP deliberations. In this 

age group, IC and individuals with CMCs account for 30% of the population, but contribute 

70% of the pneumococcal disease burden. Therefore, it is reasonable to focus on this 

population using a risk-based approach. Merck already has begun taking orders for PCV15 

and would begin distributing doses to customers in the coming weeks. They expect to have 

sufficient supply to meet the demand for recommendation of both the 65 year old age-based 

cohort as well as the 19-64 age cohort with underlying medical conditions or risk factors 

following the vote during this meeting. Finally, Dr. Haupt thanked the WG members and the 

ACIP members for all of their efforts and deliberations regarding the adult pneumococcal 

vaccine policy. Merck looks forward to working with the WG as they start deliberations 

regarding pediatric pneumococcal vaccine policy after the conclusion of the adult policy 

vote. 

Vote #1: Pneumococcal Vaccines Age-Based Recommendation 

Dr. Kobayashi (CDC/NCIRD) showed the first proposed age-based recommendation based on 

the majority of WG members having put this forward as what should be discussed and voted on 

by the ACIP: 

Adults 65 years of age or older who have not previously received a pneumococcal 

conjugate vaccine or whose previous vaccination history is unknown should receive a 

pneumococcal conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this 

should be followed by a dose of PPSV23. 

Discussion Summary 

• Dr. Cohn reminded everybody that after the vote on the age-based recommendation, there 

was a second proposal on the table for the risk-based recommendation. 

• Dr. Bell made a motion to approve the proposed age-based recommendation language as 

written, which Dr. Loehr seconded. 

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ACIP Meeting Summary October 20-21, 2021 

• Dr. Talbot made a motion to amend the proposed age-based recommendation from “Adults 

65 years of age or older” to “Adults 50 years of age or older.” The remainder of the text 

would stay the same. Ms. Bahta seconded this amendment. 

• After reviewing Robert’s Rules of Order, Dr. Lee indicated that the approach would be to 

vote first on the proposed amendment to “Adults 50 years of age or older” and whether the 

recommendation should be changed. They would then return to the main motion depending 

upon the results of the vote on the amended motion. 

Amended Motion/Vote #1: Pneumococcal Vaccines (Age-Base) 

Dr. Talbot made a motion to amend the proposed age-based recommendation to read as 

follows: Adults 50 years of age or older who have not previously received a pneumococcal 

conjugate vaccine or whose previous vaccination history is unknown should receive a 

pneumococcal conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this should be 

followed by a dose of PPSV23. Ms. Bahta seconded this motion to amend. No COIs were 

declared. With 4 affirmative votes, 11 negative votes, and 0 abstentions, the motion to amend 

did not carry. The disposition of the vote was as follows: 

4 Favored: Ault, Talbot, Bahta, Cineas 

11 Opposed: Bell, Brooks, Chen, Daley, Kotton, Lee, Loehr, Long, McNally, Poehling, 

Sanchez 

0 Abstained: N/A 

Initial Motion/Vote #1: Pneumococcal Vaccines (Age-Base) 

Dr. Bell made a motion to approve the proposed age-based recommendation reading as 

follows: Adults 65 years of age or older who have not previously received a pneumococcal 

conjugate vaccine or whose previous vaccination history is unknown should receive a 

pneumococcal conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this should be 

followed by a dose of PPSV23. Dr. Loehr seconded this motion. No COIs were declared. The 

motion carried with 15 affirmative votes, 0 negative votes, and 0 abstentions. The disposition of 

the vote was as follows: 

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

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ACIP Meeting Summary October 20-21, 2021 

Vote #2: Pneumococcal Vaccines Risk-Based Recommendation 

Dr. Kobayashi (CDC/NCIRD) showed the following proposed risk-based recommendation for 

pneumococcal vaccines: 

Adults aged 19 years of age or older with certain underlying medical conditions or other 

risk factors* who have not previously received a pneumococcal conjugate vaccine or 

whose previous vaccination history is unknown should receive a pneumococcal 

conjugate vaccine (either PCV20 or PCV15). If PCV15 is used, this should be followed 

by a dose of PPSV23. 

*alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus, chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized 

malignancy, human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other 

hemoglobinopathies, CSF leak, or cochlear implant. 

Discussion Summary 

• Ms. McNally made a motion to approve the proposed risk-based recommendation language 

as presented. Dr. Daley seconded the motion. 

• Dr. Kimberlin (AAP Red Book) asked for clarity with regard to whether the ACIP was voting 

in favor of both the age-based recommendation and the risk-based recommendation versus 

one or the other. 

• Dr. Lee clarified that the age-based recommendation was for persons 65 years of age and 

older, while the risk-based recommendation pertained essentially to individuals 19-64 years 

of age with underlying medical conditions or other risk factors. 

• Dr. Long pointed out that potentially, the vaccines could be split out. She suggested that the 

language for the proposed risk-based recommendation be changed from “Adults aged 19 

years of age or older” to “Adults aged 19-64 years of age.” 

• Dr. Kobayashi indicated that this clarification could be made. 

• Dr. Brooks expressed concern that the list of underlying medical conditions did not include 

hypertension and obesity, which a large proportion of the population would have and who 

might benefit from getting vaccinated at a younger age. 

• Dr. Kobayashi clarified that while there have been discussions about adding underlying 

conditions, those listed in the proposed recommendation were exactly the same as listed in 

the current risk-based recommendations. At this point, the WG focused on recommending 

the new vaccines. In the future, because suggestions have been received about adding 

other conditions, the WG will review those for consideration and would be happy to revisit 

hypertension and obesity as well. 

• Dr. Long recalled that there were no data to suggest that obesity and hypertension posed 

increased risks for IPD. 

• Dr. Kobayashi indicated that the WG started looking at the risk associated with obesity, but 

had not had time to take a deeper dive into whether certain conditions warrant consideration 

as part of the risk-based recommendation. If warranted, the WG will be happy to review 

those data in more depth. 

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ACIP Meeting Summary October 20-21, 2021 

• Ms. Bahta pointed out that practitioners would be seeing people who received 

pneumococcal conjugate vaccines in infancy and inquired as to whether there would be 

clinical guidance about those persons and whether they should receive vaccination from 19 

years of age onward, given that this may be confusing. 

• Dr. Kobayashi confirmed that the clinical guidance would be reviewed by the WG and 

presented to the ACIP during a future meeting. The clinical guidance will accompany the 

new recommendations. 

• Dr. Hogue (APhA) recognized that the implementation recommendations from CDC would 

come with a publication. However, in the previous recommendation, the interval for the 

dosing of PPSV following conjugate vaccine was clearly stated in the recommendation. He 

asked whether there would be value in the last sentence by stating that, “If PCV15 is used, 

this should be followed by a dose of PPSV23 at least 1 year later” in order to help eliminate 

confusion. 

• Dr. Kobayashi confirmed that the previous votes included the intervals. The WG discussed 

the possibility of harmonizing the recommended intervals to “at least 8 weeks” or “at least 1 

year.” Based on the current discussion, the WG was leaning toward harmonizing to “at least 

8 weeks” because that would give clinicians more flexibility and also would provide an 

opportunity for those with compromising conditions to receive the second dose sooner. 

However, there are data suggesting that waiting longer might induce a better immune 

response—especially in immunocompetent adults. Because of that, the WG’s hope was to 

include that as part of the clinical guidance with some clarity on who might benefit from 

certain intervals. 

Motion/Vote #2: Pneumococcal Vaccines (Risk-Based) 

Dr. Bell made a motion, which Dr. Loehr seconded, to approve the proposed age-based 

recommendation reading as follows: 

Adults aged 19-64 years of age with certain underlying medical conditions or other risk 

factors* who have not previously received a pneumococcal conjugate vaccine or whose 

previous vaccination history is unknown should receive a pneumococcal conjugate vaccine 

(either PCV20 or PCV15). If PCV15 is used, this should be followed by a dose of PPSV23. 

*alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus, chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human 

immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other hemoglobinopathies, CSF leak, or 

cochlear implant. 

No COIs were declared. The motion carried with 15 affirmative votes, 0 negative votes, and 0 

abstentions. The disposition of the vote was as follows: 

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

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ACIP Meeting Summary October 20-21, 2021 

Member Statements 

Subsequent to the votes, Dr. Lee invited ACIP members to make a statement about the 

rationale for their vote and/or to share any additional general comments. 

• Dr. Brooks said that though he voted “yes,” he continued to have some concerns that the 

disparities in outcomes related to IPD may not be totally addressed by these 

recommendations. Although there seems to be evidence related to hypertension or obesity 

not being a higher risk for IPD, he would like to see the data and then theoretically revisit the 

underlying conditions at some time in the near future. 

• Dr. Talbot pointed out that they voted on age ≥65 not for scientific reasons but because that 

was the age chosen for Social Security and Medicare. In 1935, the reason 65 years of age 

was chosen was that the average life expectancy of a man was about 60 years and a 

woman about 64 years. That is not a very scientific way for ACIP to move forward with adult 

immunization. It made sense at one time, but they really need to be more science-based 

going forward in terms of adult immunizations. They should reevaluate the correct age at 

which to vaccinate in order to improve healthcare in adults and older adults. 

• Dr. Kotton emphasized the importance of ensuring that ACIP accumulates clinical data, 

because they are making a recommendation for immunocompromised and other at-risk 

patients largely on immunogenicity. This situation needs to be monitored to ensure that 

robust clinical protection continues and immunologic data are collected. 

• Dr. Loehr thanked the Pneumococcal WG for all of their hard work and recognized that it 

was a very difficult process getting all of these data corralled and presented in a way that 

made sense for ACIP to vote on. He also emphasized the importance of revisiting this in 5 to 

7 years after children have received the vaccinations to consider whether this 

recommendation is still necessary at that time. 

• Dr. Long pointed out it would be increasingly important for those who take care of adults 

who will or will not be impacted by this decision, to submit isolates for serotyping if there is 

IPD. This is not a completely preventable disease and the likelihood is high that 

immunocompromised patients specifically have non-vaccine serotypes. Clinical observations 

will be very important. 

• Dr. Daley thanked his colleagues on the ACIP, pointing out that he learns something new or 

gains a new perspective every time one of them speaks. He stressed that the work does not 

end once ACIP has made a vote or a decision. He agreed with everything his colleagues 

had mentioned in terms of things that need to be monitored very closely. Another of these 

would be coverage in persons 50-64 years of age with CMCs to see if these 

recommendations are achieving the intended goals. 

• Dr. Lee agreed that they need to continue to review the data on effectiveness and not just 

immunogenicity, to monitor access and potential disparities carefully over time, and to 

remember that this is a dynamic decision-making process for which decisions need to be 

reconsidered when the time comes. At some point in the future, it may make sense to lower 

the age group. Given the data available at this point, she felt very comfortable with the 

decision ACIP made on the age-based and risk-based thresholds. 

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ACIP Meeting Summary October 20-21, 2021 

• Dr. Brooks underscored how impressive the work was from the WG. The last time this 

information was presented, it was all over the place. It was not the WG’s fault, but instead 

was the complexity of the topic. Given that the WG was able to distill the information down to 

the 2 votes that were taken that were unanimous, he wanted them to understand how 

deeply he believed the whole committee appreciated what the WG and Dr. Kobayashi did, 

even if there remained some trepidation and concern. 

ZOSTER VACCINES 

Session Introduction 

Dr. Camille Kotton (ACIP, WG Chair) reminded everyone of the zoster vaccine timeline. The 

recombinant zoster vaccine (RZV) was licensed by the FDA in 2017. CDC subsequently 

adopted the ACIP’s recommendation in January 2018. The European Medicines Agency (EMA) 

approved an expanded RZV indication in August 2020 for adults 18 years of age and older at 

increased risk for zoster. A Supplemental Biologics License Application (sBLA) was submitted to 

the FDA in Fall 2020 to support RZV use in immunocompromised persons 18 years of age and 

older. ACIP began reviewing this earlier in 2021. The FDA approved the expanded RZV 

indication for use in immunocompromised adults 18 years of age and up in July 2021. With that 

in mind, the policy question now before ACIP is as follows: 

 Should adults ≥19 years of age who are or will be immunodeficient or 

immunosuppressed due to disease or therapy be recommended to receive two doses of 

the recombinant zoster vaccine for the prevention of herpes zoster and its 

complications? 

 Including but not limited to: 

1. Hematopoietic stem cell transplant (HSCT) recipients 

2. Patients with hematologic malignancies (HM) 

3. Renal or other solid organ transplant (SOT) recipients 

4. Patients with solid tumor malignancies (STM) 

5. People living with human immunodeficiency virus (HIV) 

6. Patients with primary immunodeficiencies, autoimmune conditions, and taking 

immunosuppressive medications/therapies 

For the Evidence to Recommendation (EtR) Framework, the population is defined as 

immunocompromised adults at least 19 years of age. The intervention is 2 doses of RZV 

administered at least 4 weeks apart. The comparison group is no vaccine. Critical outcomes 

include herpes zoster (HZ) or serious adverse events (SAEs). Important outcomes include 

postherpetic neuralgia (PHN), HZ-related hospitalization, immune mediated disease (IMD), 

reactogenicity (Grade 3), graft versus host disease (HSCT), and graft rejection (SOT). 

During the September 2021 ACIP meeting, the WG discussed the economics of vaccinating the 

IC population 19-49 years of age against HZ in the US and the preliminary EtR Framework 

regarding the use of RZV in IC adults ≥19 years of age. The WG subsequently convened 2 

meetings during which they reviewed and discussed the feedback received during the 

September 2021 ACIP meeting, EtR Framework updates, considerations for use of RZV in IC 

adults, and proposed policy options. The presentations during the October 2021 Zoster Vaccine 

session focused on the WG’s interpretation of the EtR Framework regarding use of RZV in IC 

adults, considerations for use, and policy options. 

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ACIP Meeting Summary October 20-21, 2021 

WG Interpretation of the EtR on Use of RZV in Immunocompromised Adults,

Considerations for Use, and Proposed Policy Options 

Dr. Tara Anderson (CDC/NCIRD) summarized the WG’s interpretation of the EtR Framework 

for use of RZV in IC adults, considerations for use, and proposed policy options. She first 

recapped the policy question, 6 groups, and the PICO (Population, Intervention, Comparison, 

Outcomes) questions presented by Dr. Kotton and then summarized the available evidence and 

WG determination for each EtR domain: Public Health Problem, Benefits and Harms, Values, 

Acceptability, Resource Use, Equity, and Feasibility. 

For the public health problem domain, the WG assessed whether HZ in IC adults is of public 

health importance. As previously discussed, millions of persons in the US are 

immunocompromised. In the 2013 NHIS, approximately 7 million adults self-reported 

immunosuppressed status. The prevalence varies by age ranging from 1.6% for those 18-39 

years of age to 4.4% among those 50-years of age, with an overall total of 2.7%.10 There are an 

estimated 3 million among HSCT recipients, patients with HM, renal or SOT recipients, patients 

with STM, and people living with HIV. In addition to these groups, there are an estimated 22 

million with more than 80 diverse autoimmune and/or inflammatory (AI/INF) conditions such as 

systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and inflammatory bowel disease 

(IBD). These patients often have underlying immune defects but generally are not considered 

frankly IC unless they are on immunosuppressive treatments. Importantly, an increasing 

proportion of immunocompromised patients are likely to be treated with immunosuppressive 

medications and therapies.11 

The age-specific prevalence of these conditions is highly variable by condition. HZ is common in 

the general population. There were approximately 1 million cases of HZ per year in the US 

during the pre-HZ vaccine era.12 HZ rates increase with age, with incidence rates ranging from 

about 2 to 9 per 1000 persons.13 As previously noted, the IC population at higher risk for HZ is 

substantial. A systematic literature review regarding the risk of HZ in groups 1-5 noted that the 

median HZ incidence estimates for these IC groups exceeded those reported for 

immunocompetent adults 50 years of age and older. The incidence rate of HZ ranged between 

9 and 95 per 1000 person years. There was variation in study estimates for the cumulative 

incidence and the incidence of HZ within each group and between groups. In the systematic 

review, it was also noted that HZ complications and severe disease were increased in IC 

populations. However, the data were insufficient to assess risk by group.14 

Regarding available data for PHN, approximately 6% to 10% of immunocompromised patients 

experienced PHN versus about 4% overall in administrative claims databases.15 Between 6% 

and 45% experience PHN across immunocompromising conditions and studies.16 

Approximately 3% of IC patients experience disseminated HZ,

17 but it is exceedingly uncommon 

in healthy persons. Between 10% and 17% mortality has been associated with disseminated HZ 

10 Harpaz R, Dahl RM, Dooling KL. Prevalence of Immunosuppression Among US Adults, 2013, JAMA, 2016, 316(23):2547-8. 

Excerpt of Table; Self-reported Immunosuppressed Status 11 See slide 75 in Dr. Anderson’s presentation 12 Harpaz et al. Prevention of Herpes Zoster, MMWR, June 6, 2008, Vol 57, #5 13 Figure: CDC, unpublished data; Updated from Harpaz et al. Clinical Infectious Diseases, Volume 69, Issue 2, 15 July 2019, Pages 

341–344, https://doi.org/10.1093/cid/ciy953 14 McKay et al. Herpes zoster risk in immunocompromised adults in the United States: A systematic review. CID 2020;71(7):e125– 

15 Chen et al. Incidence of herpes zoster in patients with altered immune function. Infection 2014; 42(2): 325–34 16 McKay et al. Herpes zoster risk in immunocompromised adults in the United States: A systematic review. CID 2020;71(7):e125-34 17 McKay et al. Herpes zoster risk in immunocompromised adults in the United States: A systematic review. CID 2020;71(7):e125-34 

34 

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ACIP Meeting Summary October 20-21, 2021 

among renal transplant recipients.18 Finally, 8% of HCT recipients with HZ are hospitalized19 

versus less than about 1% of overall Medicare beneficiaries with HZ.

20 

Regarding the risk of HZ in IC Group 6, the authors of one study evaluating the risk of HZ in 

autoimmune and inflammatory conditions determined that there is an approximately 2- to 4-fold 

higher risk of HZ in patients with autoimmune and inflammatory conditions than in healthy 

individuals.21 Another recent study identified similar results, with an approximately 1.5-fold 

higher risk of HZ for unvaccinated Medicare beneficiaries with autoimmune conditions versus 

those who are not IC.

22 It was noted that the risks varied across conditions and by age groups. 

Age standardized HZ incidence rates varied with the highest rates in patients with SLE, IBD, 

and RA. Age-specific incidence rates among some persons 21-50 years of age can be 

comparable to, or substantially higher than, corresponding rates in healthy adults greater than 

60 years of age—particularly patients with SLE, IBD, and RA.

23 The impact of 

immunosuppressive therapies is another consideration for these patients. The standard of care 

is for patients to be on one or more immunocompromising therapies, the duration of which can 

be months, years, or lifelong. In addition, it is not possible to define high risk subgroups based 

on anticipated therapies since treatments are very different from condition to condition and even 

over time for individual patients based on their response, tolerability, and other factors. 

To summarize important points from WG discussions, IC populations are very heterogeneous, 

both across and within groups and among individuals over time. The risk of HZ and its 

complications is generally higher in IC populations, although there is variability across and 

within groups. It is not feasible to define every possible IC condition and medication/therapy 

combination. In addition, it is important to consider broad recommendations and provider 

guidance for IC populations. The WG extensively reviewed these and other findings and 

concluded that HZ and its complications in IC adults is of public health importance. 

Now moving on to benefits and harms, Dr. Anderson reviewed the available evidence regarding 

how substantial the desirable and undesirable anticipated effects of RZV in IC adults are for 

each main outcome and summarized the WG’s interpretation regarding whether the desirable 

effects outweigh the undesirable effects. A total of 19 studies were included in the evidence 

synthesis. Of these, 9 studies were included in the review of evidence and GRADE analysis 

since they included a comparative group. There were 7 randomized control trials (RCTs) and 2 

cohort studies across several IC populations, including patients with HM, renal transplant 

recipients, solid tumor patients, autologous HSCT (aHSCT) recipients, patients living with HIV, 

patients with immune-mediated diseases (IMD), patients with IBD, and Medicare beneficiaries 

with autoimmune and IC conditions. 

18 Rommelaere et al. Disseminated varicella zoster virus infection in adult renal transplant recipients: Outcome and risk factors. 

Transplantation Proceedings. 2012; 44(9): 2814-2817; and Kirnap et al. Prevalence and outcome of herpes zoster infection in renal 

transplant recipients. Exp Clin Transplant. 2015; Apr;13 Suppl 1:280-3 19 Winston et al. Inactivated varicella zoster vaccine in autologous haemopoietic stem-cell transplant recipients: an international, 

multicentre, randomised, doubleblind, placebo-controlled trial. Lancet (London, England) 2018; 391(10135): 2116–27 20 Izurieta et al. Effectiveness and duration of protection provided by the live-attenuated herpes zoster vaccine in the Medicare 

population ages 65 years and older. CID 2017;64(6):785–93. 21 Yun et al. Risk of Herpes Zoster in Autoimmune and Inflammatory Diseases. Arthritis & Rheumatology 2016;68(9):2328-2337 22 Izurieta et al. Recombinant Zoster Vaccine (Shingrix) real-world effectiveness in the first two years post-licensure. Clinical 

Infectious Diseases, 2021;, ciab125, https://doi.org/10.1093/cid/ciab125 23 Yun et al. Risk of Herpes Zoster in Autoimmune and Inflammatory Diseases. Arthritis & Rheumatology 2016;68(9):2328-2337. 

Excerpt of Table 2. Incidence rate of herpes zoster per 1000 person years by 10 year age group and auto-immune disease or 

comparator cohort. 

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ACIP Meeting Summary October 20-21, 2021 

The outcomes included in the overall GRADE analysis that were considered to be critical 

included HZ and SAEs, which were reviewed during this presentation. The important outcomes 

(PHN, HZ-related hospitalization, IMD, HCT, SOT, and reactogenicity Grade 3) were addressed 

in supplemental slides. For the first critical outcome of HZ, using the efficacy population based 

on 5 studies, the VE estimates ranged from 68% to 100%. Estimates were generally higher in 

young adults within a population and lower for aHSCT recipients. There are 2 peer-reviewed 

cohort studies, Izurieta 2021 and Khan 2021 with VE reported. Izurieta et al reported on 

Medicare beneficiaries, with VE among autoimmune patients of 68% and IC patients of 64.1%. 

Khan et al looked at VA patients with IBD and found adjusted hazard ratios of 0.41 for those 

over 60 years of age who were non-steroid users and 0.34 for those who were steroid users. 

The hazard ratio was zero for persons 50-60 years of age since no cases were reported. 

Using the efficacy population for studies reporting immunogenicity and looking at the vaccine 

response rate for both humoral and cell-mediated immunity (CMI) across the 6 included RCTs, 

these studies show that there was a vaccine response. Starting with humoral immunity, 

response rates ranged from a low of 65.4% to a high of 96.2% at 1 month after the last dose. 

This somewhat decreased at the 12-month evaluation mark, with response rates ranging from a 

low of 51.5% to a high of 91.7%. For CMI, the response rates ranged from a low of 50% to a 

high of 93% at 1 month after the last dose, decreasing to a low of 17.6% and a high of 66.7% 

at 12 months after the last dose. 

Looking at the GRADE Evidence Table for the first critical outcome of HZ, the evidence type 

began at Type 1 for the RCTs. There was no serious risk of bias identified and there were no 

concerns for inconsistency or imprecision. The body of evidence was downgraded for 

indirectness due to not comprising data on all relevant populations under the recommendation. 

The VE estimates ranged from 68.2% to 90.5%, with an overall certainty of Type 2 or moderate 

certainty. For RCTs containing immunogenicity data, the risk of bias was not serious and there 

were no concerns with inconsistency or imprecision. However, the body of evidence was doubly 

downgraded for indirectness due to both studies not comprising the range of populations under 

consideration for the outcome, and also because immunogenicity is a surrogate outcome. This 

evidence was graded Type 3 or low certainty. For the cohort data, the evidence started at Type 

3. There were no serious concerns with risk of bias, inconsistency, or imprecision. However, the 

studies were downgraded due to indirectness and upgraded due to a strong association 

observed among those over 50 years of age. The evidence was graded Type 3 or low certainty. 

For outcome 4, SAEs, 7 randomized studies evaluated multiple IC populations. Overall, SAEs 

were balanced between the vaccine and placebo groups. Using the harms population, or those 

who received at least 1 dose of RZV, there was a risk ratio of SAEs ranging from 0.79 to 1.99. It 

is important to note that this population is significantly ill and thus the high proportion of SAEs in 

both the vaccine and placebo groups are not unexpected. However, the SAEs related to 

vaccination were much less common, ranging from 0.33 to 1.6% in the vaccine group and 0.36 

to 0.76 in the placebo group. For the GRADE Evidence Table for outcome 4, SAEs, the 

evidence type started at Type 1 and the body of evidence was downgraded only for 

indirectness. The proportions of RZV and placebo recipients experiencing any SAEs had risk 

ratios ranging from 0.79 to 1.99, but generally represented a similar proportion of SAEs in both 

groups. This body of evidence was graded with the certainty of Type 2, or moderate certainty. 

To briefly summarize the GRADE results going through each outcome and major findings, the 

details for the important outcomes are available in the supplemental slides for reference. For 

benefits, the body of evidence showed relatively high VE across these heterogeneous IC 

populations, ranging from 68.2% to 90.5%. For PHN and HZ -related hospitalization, there was 

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ACIP Meeting Summary October 20-21, 2021 

little evidence with just one study that reported VE of 89% for PHN and 85% for HZ. For harms, 

SAEs were common and balanced in both vaccine and placebo groups, with risk ratios ranging 

from 0.79 to 1.99. SAEs attributed to vaccination were rare. IMDs were not shown to be 

increased for those in the RZV group. There was little data on HSCT and SOT, with one RCT 

each showing no increased risk of rejection. For reactogenicity, RZV was noted to be 

reactogenic with increased recorded local and systemic reactions in the RZV group. The limited 

data for some harms outcomes highlights the need for additional research as well as provider 

counseling, for example regarding appropriate timing of vaccination for some IC patients. Postmarketing surveillance will be critical to detect any rare SAEs, which were not identified in the 

clinical trials. Upon review of these data, the WG concluded that the desirable anticipated 

effects of RZV in IC adults are large and that the undesirable anticipated effects of RZV are 

small. Overall, the WG concluded that the desirable effects outweigh the undesirable effects 

which favors the intervention of RZV 2 doses at least 4 weeks apart. 

Moving on to the values domain, the WG considered whether IC adults feel that the desirable 

effects of RSV are large relative to the undesirable effects and whether there is important 

uncertainty about or variability in how much IC adults value the main outcomes. There are 

limited data on knowledge, attitudes, and practices (KAP) among IC patients regarding potential 

use of RZV for the prevention of HZ and its complications. In general, HZ vaccination, 

including with zoster vaccine live (ZVL) and RZV is increasing,

24 and RZV series completion 

rates are high by 6 to 12 months after the first dose.25 Although there is currently no ACIP 

recommendation, IC patients recognize the increased risk of HZ and many have already 

received RZV, as noted in a large study of Medicare data where nearly 1 million patients met 

the study definitions of autoimmune and IC and received RZV.26 Concerns related to Grade 3 

reactions may discourage some IC patients from getting RZV. 

In summary, many IC patients desire the ability to receive RZV to prevent HZ and its 

complications. In fact, many are already pursuing vaccination with RSV as part of regular care, 

as shown in the Izurieta et al Medicare analysis. The ACIP HZ WG placed high value on the 

prevention of HZ and its complications in IC adults. Given the burden of HZ and its 

complications in these patients, it is anticipated that more IC patients would pursue vaccination 

with RZV if recommended by ACIP and their provider. Upon reviewing these data, the WG 

concluded that IC adults probably feel that the desirable effects of RZV vaccination are large 

relative to the undesirable effects and that there is probably not important uncertainty or 

variability in how much IC adults value the main outcomes. 

Turning now to the acceptability domain, the WG considered whether vaccination with RZV is 

acceptable to key stakeholders working with IC adults.

27 Primary care physicians’ perspectives 

were captured in a recent University of Colorado Denver KAP survey. The objectives of this 

survey were to assess among PCP serving adults: 1) current practices, attitudes, knowledge, 

and barriers to recommending RZV; and 2) the likelihood of recommending RZV to IC patients 

among the physicians who had not previously recommended RZV to these patients. Physicians 

24 Terlizzi EP and Black LI. Shingles Vaccination Among Adults Aged 60 and Over: United States, 2018. NCHS Data Brief, No. 370, 

July 2020; and Kawai K and Kawai AT. Racial/Ethnic and Socioeconomic Disparities in Adult Vaccination Coverage. Am. J. Prev. 

Med. 2021;000(000):1–9 25 Izurieta et al. Recombinant Zoster Vaccine (Shingrix): Real-World Effectiveness in the First 2 Years Post-Licensure. Clin. Infect. 

Dis. 2021 Sep 15;73(6):941-948; and Patterson et al. Early examination of real-world uptake and second-dose completion of 

recombinant zoster vaccine in the United States from October 2017 to September 2019. Hum. Vaccin. Immunother. 2021 Aug 

3;17(8):2482-2487 26 Patterson et al. Early examination of real-world uptake and second-dose completion of recombinant zoster vaccine in the United 

States from October 2017 to September 2019. Hum. Vaccin. Immunother. 2021 Aug 3;17(8):2482-2487 27 Hurley et al., unpublished data 

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ACIP Meeting Summary October 20-21, 2021 

in existing Vaccine Policy Collaborative Initiative (VPCI) sentinel networks were surveyed. 

Family physician (FP) and general internist (GIM) results were combined, with any differences 

highlighted. 

Regarding physician strength of recommendation for RZV and different types of patients 50 

years of age and older, recommendations for healthy adults, adults anticipating a bone marrow 

or solid organ transplant who were not yet on immunosuppressive therapy, and adults on low 

dose methotrexate were consistent with current ACIP recommendations with 96%, 79%, and 

70% respectively strongly recommending or recommending but not strongly RZV. Regarding 

patients without an ACIP recommendation, the strength of recommendation for RZV varied 

considerably by age and health status, with 67% strongly recommending or recommending 

but not strongly RZV for adults 50 years and older with HIV to 42% strongly recommending or 

recommending but not strongly RZV for adults 50 years and older receiving immunosuppressive 

therapy for a bone marrow or solid organ transplant. Of note, 27% to 42% of respondents noted 

that they defer to a sub-specialist for these IC populations 50 years and older. 

For adults 18 to 49 years of age with an immunocompromising condition, 31% of respondents 

noted strongly recommending or recommending but not strongly RZV. Among physicians who 

had not recommended RSV to IC patients, the likelihood of recommending RSV to a range of IC 

patients 18 years of age and older was very likely for 40% to 48% of respondents and 

somewhat likely for 23% to 33% of respondents. Since these responses were based on how 

likely a respondent would be to recommend RZV to IC patient within the first 6 months of an 

approval and without input from a sub-specialist, these results highlight the importance of 

provider guidance for vaccination of IC patients. 

In summary, given highly specialized care and the increased HZ risk among IC patients, the WG 

noted the vaccination is favored if there are no safety concerns. Although currently available 

evidence was considered acceptable by the WG, it was noted that additional safety data 

represent a research need. Importantly, despite the lack of recommendation from ACIP, many 

physicians are recommending RZV to patients with immunocompromising conditions. Of note, 

physicians need more direction on which patients are eligible for RZV, including a substantial 

minority who would be unlikely to recommend RZV to various IC patients even if it were 

licensed, recommended, and covered by insurance for them without input from a sub-specialist. 

In addition, many specialty organizations are recommending RCV for IC adults. Overall, the WG 

anticipates that acceptability would increase with FDA approval and an ACIP recommendation. 

Upon review of these data, the WG concluded that use of RZV in IC adults is acceptable to key 

stakeholders. 

Moving on to the domain of resource use, the WG considered whether RZV in IC adults is a 

reasonable and efficient allocation of resources. As noted during the September 2021 ACIP 

meeting, 2 studies conducted by GSK and CDC assessed the economics of vaccinating IC 

adults 19-49 years of age against HZ in the US. Both studies compared vaccination with RZV to 

no vaccination and focused on individuals receiving HSCT as the base-case. In both models, 

the vaccination strategy was estimated to be cost-saving when compared to the no vaccination 

strategy. Both models included additional scenarios that focused on other immunocompromising 

conditions, including individuals with HM, SOT patients, patients living with HIV, breast cancer 

patients, and other autoimmune and inflammatory conditions. Most of these scenarios found 

that the vaccination strategy cost per quality-adjusted life-year (QALY) gained ranged from 

being cost-saving to $99,000. In the CDC model scenario that focused on autoimmune and 

inflammatory conditions, the cost per QALY gained was estimated to be $208,000. As noted in 

the base case of HSCT patients, the economic value of RZV appears to be favorable or cost32 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary October 20-21, 2021 

saving. This is influenced by higher HZ incidence and HZ related health care cost and 

reasonable VE. For scenarios focused on other IC patient groups, the economic value of RZV 

vaccination was less favorable relative to stem cell transplant patients given their lower risk of 

HZ severe outcomes and lower healthcare costs. Of note, some autoimmune and inflammatory 

conditions may have the least favorable estimates of RZV use depending on the underlying risk 

of HZ, which was often lower for this group. 

To summarize resource use, considering results across the base-case and scenarios from both 

models, the WG determined the estimated economic values to be generally favorable (i.e., costsaving). Given the higher specialized care and resources typically invested for the base-case 

and other IC populations, the WG did not consider cost-effectiveness assessments to be a main 

driver for decision-making. Upon review of these data, the WG concluded that use of RZV in IC 

adults is a reasonable and efficient allocation of resources. 

In terms of the equity domain, the WG considered what the impact would be of RZV use in IC 

adults on health equity. The NHIS captures HZ vaccination data,

28 including data for ZVL and 

RZV. Overall, in 2018, HZ vaccination coverage among adults 50 years and older and 60 years 

of age and older was 24.1% and 34.5%, respectively. White adults 50 years of age and older 

and 60 years of age and older had higher coverage compared with Blacks, Hispanics, and 

Asians. In an analysis using 2010 to 2019 NHIS data,29 in general race, ethnicity, household 

income, education level, and health insurance type were significantly associated with receipt of 

HZ vaccination among adults 65 years of age and older. The WG anticipates an ACIP 

recommendation would increase access overall since recommendation increases the scope of 

the population eligible to be vaccinated and ensures coverage under the Affordable Care Act 

(ACA). However, there likely will still be challenges with uptake given the previously noted race, 

ethnicity, household income, education level, insurance disparities, variability in health 

insurance coverage, and lack of insurance that may result in out-of-pocket costs for some 

patients. It will be important to continue monitoring RZV vaccination through the NHIS, including 

stratifying by health status and race ethnicity. The WG also noted that equity potentially could 

be monitored at the local level during implementation. Upon review of these data, the WG 

concluded that health equity probably would be increased. 

In terms of the feasibility domain, the WG considered whether RZV in IC adults is feasible to 

implement. RZV is a refrigerator-stable, 2-dose vaccine that can be co-administered with other 

adult vaccinations. The US healthcare system has experience delivering RSV to IC adults aged 

50 years and older. However, very systemic factors challenge the adult vaccination program in 

the US (e.g., complicated reimbursement, lower prioritization of adult vaccines, and 

fragmentation of care). In the previously noted RZV KAP study30 regarding physicians stocking 

and referring patterns, 47% of respondents indicated that they stock and refer for RZV while 

42% indicated they only refer patients to receive the vaccine. Of 89% of respondents who 

referred patients to receive RZV at a location outside of their practice, 80% often were always 

referred to a pharmacy. Respondents indicated that it was easier to refer and identified cost, 

inadequate reimbursement, and not being able to bill Medicare Part D as barriers to stocking the 

vaccine. 

28 Lu P, Hung M, Srivastav A, et al. Surveillance of Vaccination Coverage Among Adult Populations — United States, 2018. MMWR 

Surveill Summ 2021;70(No. SS-3):1–26 29 Kawai K and Kawai AT. Racial/Ethnic and Socioeconomic Disparities in Adult Vaccination Coverage. Am. J. Prev. Med. 

2021;000(000):1–9. 30 Hurley et al., unpublished data 

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ACIP Meeting Summary October 20-21, 2021 

Pharmacies have continued to expand vaccination programs, especially for adults, and are 

already a major provider of RZV. For the manufacturer, approximately 60% to 65% of RZV is 

distributed to and administered in pharmacies. It is anticipated that identification of IC patients 

(e.g., based on immunosuppressive medications, self-reported immunosuppression, and 

standing orders) will be concerns to the pharmacy setting. Additionally, some pharmacies may 

be out-of-network, potentially resulting in out-of-pocket costs for patients. Identification of IC 

patients may be challenging, especially since RZV is delivered in multiple settings. This 

highlights the need for provider and patient education materials and clinical decision support. 

Of note, the majority of jurisdictions have lifelong immunization information systems (IISs), 

which can receive adult immunization information. However, many do not receive health status 

information. Therefore, the WG anticipates that this will increase reliance on other systems such 

as EHRs for decision support. The WG noted that clinical decision support guidance would be 

helpful and that it will be important to promote best practices and encourage providers to upload 

and update RZV vaccination information in jurisdiction IISs. Upon reviewing these data, the WG 

concluded that use of RZV in IC adults is feasible to implement. 

For the overall EtR Framework summary, the WG determined that HZ in IC adults is of public 

health importance. The desirable anticipated effects of RZV use in IC adults are large and the 

undesirable effects are small, which favors the intervention. IC adults probably feel the desirable 

effects of vaccination with RSV are large relative to the undesirable effects. There is probably 

not important uncertainty or variability in how patients value these outcomes. Use of RZV in IC 

adults is acceptable to key stakeholders and is a reasonable and efficient allocation of 

resources. Health equity probably would be increased and the intervention would be feasible to 

implement. The WG therefore concluded that the desirable consequences of vaccinating IC 

adults with RZV clearly outweigh the undesirable consequences in most settings. A strong 

majority of the WG voted to recommend the intervention, with a minority opinion in favor of 

shared clinical decision-making. 

With regard to considerations for use of RZV in IC adults, RZV may be used irrespective of prior 

receipt of varicella vaccine or ZVL. Regarding the dosing schedule, RZV is typically 

administered in 2 doses with the second dose given 2 to 6 months after the first dose. For 

individuals who are or will be immunodeficient or immunosuppressed and who would benefit 

from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after 

the first. As noted in CDC’s General Best Practices Guidelines for Immunization,

31 RZV can be 

co-administered with other adult vaccines at different anatomic sites. Providers should counsel 

patients about expected systemic and local reactogenicity before vaccination. As previously 

noted, timing of vaccination will be particularly important for some IC patients. If appropriate, 

patients should be vaccinated prior to immunosuppression. Otherwise, providers should 

consider timing vaccination when the immune response is likely to be most robust. Of note, RZV 

may be administered while patients are taking antivirals. Overall, the WG noted that providers 

do not want to miss the opportunity to vaccinate IC patients. 

Regarding special populations, persons with a history of HZ should receive RZV. If an individual 

is experiencing an acute episode of HZ, vaccination should be delayed until symptoms abate. 

There is currently no ACIP recommendation for RZV use in pregnancy. Therefore, providers 

should consider delaying RZV until after pregnancy. However, there is no recommendation for 

pregnancy testing prior to vaccination. Regarding breastfeeding, CDC’s General Best Practices 

Guidelines for Immunization advises that recombinant vaccines, such as RZV, pose no risk for 

31 https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html 

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ACIP Meeting Summary October 20-21, 2021 

mothers who are breastfeeding or their infants. Therefore, clinicians may consider vaccination 

without regard to breastfeeding status if RZV is otherwise indicated. Regarding persons with no 

documented history of varicella or varicella vaccination, commercial immunoglobulin G (IgG) 

enzyme-linked immunosorbent assays (ELISAs) can be used to assess varicella-zoster virus 

(VZV) seroconversion after wild type infection. However, sensitivity and specificity can vary. 

Further, no commercially available assays are sensitive and specific enough to reliably detect 

vaccine seroconversion. It is important to note that RZV is not indicated for prevention of 

primary varicella infection and varicella vaccine is contraindicated for many IC patients. Persons 

born in the US prior to 1980 are considered immune to varicella. However, this criterion does 

not apply to IC persons. For persons born in the US after 1980 and IC persons, it is 

recommended to refer to the ACIP varicella vaccine recommendations. Finally, safety data are 

limited regarding use of RZV in VCV naïve persons. 

Regarding policy options, Dr. Anderson presented the WG’s proposed draft recommendation for 

discussion: 

Two doses of recombinant zoster vaccine are recommended for adults aged ≥19 years

who are or will be immunodeficient or immunosuppressed due to disease or therapy for 

the prevention of herpes zoster and its complications. 

Discussion Summary 

• Ms. McNally inquired as to whether there is any clinical guidance on co-administration of 

RZV with adjuvanted influenza vaccine in IC adults. 

• Dr. Anderson responded that CDC’s Clinical Immunization Safety Assessment (CISA) 

Project colleagues indicated that there is an ongoing study to assess co-administration of 

SHINGRIX and FLUAD® and SHINGRIX and Fluzone® in individuals 65 years of age and 

older. The caveat is that it is not a study in IC patients, but there is some safety study 

activity. This is an ongoing study over the next couple of influenza seasons that is currently 

enrolling. CDC will continue to monitor any safety issues in the usual systems such as 

VAERS and VSD. 

• Speaking from the primary care perspective, Dr. Goldman (ACP) expressed appreciation for 

this recommendation because there are still some specialists who are not recommending 

the vaccine in those who are IC—even after 50 years of age. This legitimizes and supports 

the use of this vaccine and should be very helpful. Regarding the fact that many patients do 

not have Medicare Part D, vaccinating at a younger age is important in terms of getting 

people covered after 65 years of age. Many physicians are not allowed to vaccinate their 

patients because of Congressional rules and Part D coverage, though he recognized this to 

be out of ACIP’s scope. He asked what would happen if this recommendation passed in 

terms of persons who are laboratory-negative for varicella but meet the criteria for IC in 

terms of whether to go ahead and give them the RZV vaccine in that case since IC persons 

could not be given ZVL. He expressed his hope that the clinical guidance would provide 

clarification for these individuals. 

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ACIP Meeting Summary October 20-21, 2021 

• Dr. Anderson indicated that this topic has been discussed among the WG members. That is 

a challenging situation because as noted, the available commercial assays make this a 

challenging topic since they typically can detect wild-type infection. However, the sensitivity 

and specificity of those can vary. The reality is that none of the commercially available 

assays are sensitive and specific enough to detect vaccine seroconversion reliably. The 

other reality is that RZV is not indicated for prevention of primary varicella and the vaccine is 

going to be contraindicated for many IC patients. The WG will continue discussing this issue 

and it will be addressed in the Policy Note and fleshed out more in the clinical 

considerations. There are limited safety data regarding the use of the vaccine in people who 

are VCV naïve, and there is a challenge of confirming whether someone who is 

seronegative is truly naïve. 

• Dr. Poehling emphasized that given the high percentage of RZV that is distributed through 

pharmacies, the clarity of information that flows between pharmacies and providers is 

imperative so that all are aware of vaccine status. This also highlights the importance of 

having a universal adult immunization registry so that everyone, including the patient, knows 

what vaccines they have received. 

• Dr. Drees (SHEA) noted that the issue of persons who were born before 1980 arises 

frequently among health care workers (HCW). They are not considered immune because 

unlike the general population, they are HCW. Some HCW who may be 50 years of age or 

older and may test antibody negative, may report having a clinical history of chickenpox. 

With no documentation of that because it was so long ago, the current recommendation is to 

vaccinate them with varicella vaccine. While they also qualify for RZV, the interval is not 

clear. This is a common clinical dilemma for which it would be helpful to have some 

additional clarification. 

• Dr. Anderson indicated that the intent is to address this in the clinical considerations. 

• Dr. Kotton emphasized that the proposed recommendation would take a lot of education and 

robust clinical guidance so that clinicians in the field understand in whom this is best 

indicated. There is often confusion between varicella and zoster vaccines, so appropriate 

support must be provided. As someone who takes care of many IC patients and who has 

seen many patients use this vaccine off-label or pay for it out-of-pocket, she thought the 

proposed recommendation would enhance the protection of IC people against zoster. 

Vote: Zoster Vaccine 

Dr. Tara Anderson (CDC/NCIRD) presented the following proposed recommendation language 

for a vote, with a slight change to the order of the wording to ensure clarity: 

Two doses of recombinant zoster vaccine are recommended for the prevention of 

herpes zoster and its complications in adults aged ≥19 years who are or will be 

immunodeficient or immunosuppressed due to disease or therapy. 

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ACIP Meeting Summary October 20-21, 2021 

Motion/Vote: Zoster Vaccines 

Dr. Ault made a motion, which Dr. Poehling seconded, to approve the proposed zoster vaccine 

recommendation as proposed: Two doses of recombinant zoster vaccine are recommended for 

the prevention of herpes zoster and its complications in adults aged ≥19 years who are or will

be immunodeficient or immunosuppressed due to disease or therapy. No COIs were declared. 

The motion carried with 15 affirmative votes, 0 negative votes, and 0 abstentions. The 

disposition of the vote was as follows: 

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

INFLUENZA VACCINES 

Session Introduction 

Dr. Keipp Talbot (ACIP, WG Chair) reported that the Influenza WG’s activities since the June 

2021 meeting included finalizing and publishing the 2021-2022 ACIP Influenza Statement in the 

Morbidity and Mortality Weekly Report (MMWR) on August 27, 2021.32 The WG’s discussion 

topics have included the recent influenza activity in the Southern and Northern Hemispheres; a 

review of influenza vaccination for older adults; and data from the study of co-administration of 

Fluzone® High-Dose and Moderna mRNA-1273 COVID-19 vaccine. This session included 

presentations on the Phase 2 safety and immunogenicity study of the co-administration of 

Fluzone® High-Dose Quadrivalent influenza vaccine (QIV-HD) and a third dose of Moderna 

mRNA-1273 COVID-19 vaccine from Sanofi Pasteur and a CDC update regarding a change in 

the age indication for Flucelvax Quadrivalent vaccine. 

Phase II Safety and Immunogenicity Study of the Co-Administration of Fluzone® HighDose Quadrivalent Influenza Vaccine and a Third Dose of Moderna mRNA-1273 COVID-19 

Vaccine 

Dr. Ruvim Izikson (Sanofi Pasteur) presented the results of a Phase II open-label study to 

assess the safety and immunogenicity of Fluzone® QIV-HD. This study assessed the 2021-2022 

formulation and a third dose of Moderna mRNA-1273 COVID-19 vaccine administered either 

concomitantly or singly in adults 65 years of age and older who were vaccinated previously with 

the 2-dose schedule of mRNA-1273 vaccine. The study code is QHD00028.

33 This study was 

conducted in partnership with the Biomedical Advanced Research and Development Authority 

(BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) 

at the US Department of Health and Human Services and Moderna, Inc. 

32 https://www.cdc.gov/mmwr/volumes/70/rr/rr7005a1.htm 33 Study Code: QHD00028 https://clinicaltrials.gov/ct2/show/NCT04969276 

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ACIP Meeting Summary October 20-21, 2021 

The rationale for the vaccine selection and study group was that adults 65 years of age and 

older are a critical priority for influenza and COVID-19 immunizations due to the risk of severe 

complications. Based on the COVID-19 vaccine primary series timing and strategy, older adults 

are most likely eligible for COVID-19 boosters and their annual influenza vaccine during the 

same window of time. This creates the risk that many will get vaccinated for either one or the 

other, with the priority being on COVID-19 vaccine. More than likely, influenza will be the missed 

vaccine. The QIV-HD vaccine was selected for this study as it is the most frequently 

administered vaccine among adults 65 years of age and older. The 100μg mRNA-1273 dose 

was selected based on projected regulatory expectations at the time of the protocol design. This 

represents more conservative scenarios by employing the highest dose projected for booster 

authorization. 

This was a descriptive study with approximately 300 participants, 100 per group: Concomitant 

Administration (Group 1), Fluzone® High-Dose Quadrivalent alone (Group 2), and COVID-19 

mRNA vaccine alone (Group 3). This randomized open-label study was conducted in the US at 

6 sites. One inclusion criterion was that participants received 2 doses of their primary series of 

mRNA-1273 vaccine at least 5 months prior to enrollment. The mRNA-1273 vaccine booster 

dose was 100μg. Group 1, the co-administration group, received both vaccines during the same 

visit. Group 2 received the QIV-HD 2021-2022 240μg formulation alone. Group 3 received the 

COVID-19 mRNA vaccine alone. The visit schedule included a pre-immunization blood draw 

and vaccine treatment. At 8 days post-vaccination, safety information was solicited. At 21 days 

after immunization, another blood draw was done for immunogenicity. Dr. Izikson noted that the 

results he would be presenting truncated at day 21, but Sanofi is following these subjects 

through Day 181, which represents 6 months of safety follow-up. It is important to note that 

Group 3 participants who received only mRNA vaccines in the study were offered QIV-HD at 

Day 22 as part of routine medical care, which was voluntary. 

Sanofi, BARDA, and Moderna recognized that the need for co-administration was emerging 

rapidly and was a major point of concern for patients and HCP. Therefore, a timeline with 

aggressive milestones was put in place in order to provide these study results early in the 

influenza season. In early May 2021, internal study endorsement was received within Sanofi 

Pasteur and the FDA protocol was submitted in early June 2021. FDA returned that protocol 

with approval and comment in a very short timeframe of 2 weeks. Institutional Review Board 

(IRB) approval was received on July 1, 2021 and the first subject was enrolled on July 16, 2021. 

The enrollment window was fairly short at just over 2 weeks. The first visit for the last subject 

was August 5, 2021 and the last visit (Day 21) for the last subject was August 31, 2021. 

September included a whirlwind of events. The database was locked on September 13th, the 

laboratory results were completed by September 20th, and the statistical analyses were 

conducted by September 28th in order to be able to provide the Interim Clinical Study Report at 

the beginning of October. 

In terms of demographics by treatment group, ultimately there were more females than male 

participants in the study at 56% female compared to 44% male. The average age for the study 

was 72 years of age, with 76% of subjects between 65-75 years of age and about a quarter 

of participants at 75 years of age and older. The study fell short of the ambition of enrolling a 

more diverse and balanced sample population. There were a couple factors contributing to this, 

including the very short window of enrollment of just over 2 weeks. This led to the majority 

(95.3%) of the population being of white descent. The inclusion criteria required 5 months inbetween primary series vaccinations and enrollment in the study. This meant that the pool of 

eligible enrollees would have had to have completed their primary COVID-19 series by February 

2021, which substantially limited the cohort. 

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ACIP Meeting Summary October 20-21, 2021 

The study’s safety objective was to describe the safety profile of QIV-HD and mRNA-1273 

vaccines administered either concomitantly or singly. The endpoints captured included solicited 

injection site and systemic reactions occurring through 7 days after immunization; unsolicited 

systemic AEs through 21 days after immunization; and SAEs, AESI, and medically-attended 

adverse events (MAAEs) through 6 months after vaccination. As a reminder, the data point was 

truncated at Day 22 for this report. 

To summarize solicited reactions through 7 days after immunization, the combined 

reactogenicity of QIV-HD vaccine and mRNA-1273 vaccine administered at the same visit was 

similar to that after administration of mRNA-1273 alone. About 94% of participants in the coadministration group and 96% of participants in the mRNA-1273 group administered alone 

reported at least one solicited reaction. The QIV-HD vaccine recipients receiving it alone had a 

lower reporting rate of 73%. As a reminder, a Grade 3 reaction is one that interrupts usual 

activities of daily living, significantly affects clinical status, or requires intensive therapeutic 

intervention. Injection site reactions that are measurable at a diameter of 100mm or more are 

recorded as a Grade 3 reaction. About 17% of the co-administration group and 18% of the 

mRNA-1273 vaccine alone group reported at least one Grade 3 solicited reaction. Only 3% of 

QIV-HD vaccine alone recipients experienced the Grade 3 solicited reaction. 

These data can be further broken down into local injection site reactions and solicited systemic 

reactions. The 2 treatments that were received in the co-administration group were administered 

in separate limbs. That allowed an opportunity to compare injection site reactions among the 

cohorts receiving their respective vaccines singly. After injection of QIV-HD vaccines, the 

number of participants in the co-administration group experiencing at least one injection site 

reaction was 61%. This was similar to that of QIV-HD vaccine alone at about 62%. After 

injection of mRNA-1273 vaccine, 82% of participants in the co-administration group and 91% in 

the mRNA-1273 alone group experienced at least one event. Events meeting Grade 3 criteria 

were recorded at about 8% in both the co-administration group in the mRNA-1273 limb and in 

the mRNA-1273 group alone. Only 2 individuals reported a Grade 3 local injection site reaction 

after QIV-HD vaccine, and both were in Group 2. No participants in the co-administration group 

reported Grade 3 local injection site events following QIV-HD vaccine administration. 

The co-administration group and the mRNA-1273 group had similar rates of participants 

experiencing at least one systemic reaction at 80% and 84%, respectively. Systemic 

reactogenicity was lower for QIV-HD vaccine at about 49%. Grade 3 systemic reactions were 

reported for the co-administration group and the mRNA-1273 alone group at about 13% each. 

Only 1 Grade 3 systemic reaction was captured in the QIV-HD vaccine alone group. Injectionsite pain was the most frequently reported local reaction for both vaccines. The frequency of 

administration site pain was lower following QIV-HD vaccines. Overall, injection site reaction 

frequency was similar whether QIV-HD vaccine and/or mRNA-1273 vaccine was administered 

concomitantly or singly. Grade 3 reactions were reported less frequently following QIV-HD 

vaccine compared to that of mRNA-1273. 

In terms of solicited systemic reactions captured through Day 8, fatigue was most frequently 

reported in all treatment groups. This was followed by headache, malaise, and myalgia. The 

overall pattern that emerges is that the co-administration group and the mRNA-1273 group 

alone had similar reporting rates. The frequency of Grade 3 systemic reactions was similar 

between the co-administration and the mRNA-1273 group alone. Grade 3 reactions were 

reported less frequently in the Fluzone® QIV-HD vaccine group. In terms of unsolicited AEs 

through 21 days, 1 participant in the co-administration group experienced 3 immediate 

unsolicited AEs of anxiety, dizziness, and hypertension. The anxiety and dizziness were both 

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ACIP Meeting Summary October 20-21, 2021 

considered Grade 1 events and resulted spontaneously in 1 day. Hypertension was recorded as 

Grade 3 and was considered resolved by Day 10. In Group 2, QIV-HD alone, 1 participant 

experienced 1 immediate unsolicited reaction of Grade 1 dizziness that resolved spontaneously 

in 1 day. Being that it was an adverse reaction, the investigator attributed this event to the 

treatment. Group 3, mRNA-1273 alone, did not have any immediate unsolicited AEs. 

The frequency of unsolicited AEs was similar across treatment groups, though somewhat lower 

in the QIV-HD vaccine alone group. In the co-administration group, 2 subjects experienced 

unsolicited injection site adverse reactions and 1 subject experienced injection site pruritus 

at both injection sites on both limbs. Another participant experienced injection site pruritus in 

only the mRNA-1273 limb. There were 4 unsolicited systemic adverse reactions, including arm 

pain in the mRNA-1273 limb, cough, sinus congestion, and infection. In the QIV-HD vaccine 

alone group, 1 subject experienced unsolicited injection site adverse reactions of injection site 

and 3 subjects experienced 4 events, including unsolicited systemic adverse reactions of back 

pain, dizziness, cough, and nasal congestion. In the mRNA-1273 alone group, 1 subject 

experienced injection site pruritus as an unsolicited site adverse reaction and 6 subjects 

experienced unsolicited systemic adverse reactions. There were 9 events, including diarrhea, 

muscle spasms in the left calf on Days 6 through Day 8, neck pain, dizziness, nasal congestion, 

rhinorrhea, and pruritus. There were no Grade 3 unsolicited injection site adverse reactions or 

Grade 3 unsolicited systemic adverse reactions that were captured in any of the participants of 

the study. Additionally, no SAEs were captured through Day 22. The definition of an MAAE is “a 

new onset or a worsening of a condition that prompts to seek unplanned medical advice at a 

physician’s office or emergency department (ED).” It does not rise to the definition of an SAE, 

such as hospitalization, life-threatening event, or death. Through Day 22, there were 7 

participants and 7 events captured. There was only 1 related MAAE in Group 3 mRNA-1273 

alone group, which was the muscle spasms mentioned earlier that occurred on Day 6 in the 

lower left calf. 

To summarize safety, injection site reaction frequency for QIV-HD vaccine or mRNA-1273 

vaccine was similar regardless of whether the vaccine was administered concomitantly or 

singly. Injection site pain was the most frequently reported injection site reaction for both 

vaccines and tended to be lower following injection of QIV-HD vaccines. The frequency of 

Grade 3 injection site reactions tended to be lower following injection of QIV-HD vaccine 

compared to that of mRNA-1273. Fatigue was the most frequently reported systemic reaction 

in all treatment groups. The frequency was similar in the coadministration group compared to 

that of the mRNA-1273 group alone, but was lower in the QIV-HD vaccine group. Frequency of 

Grade 3 systemic reactions was similar in the coadministration and mRNA-1273 groups and 

lower in the QIV-HD vaccine group. There were no SAEs, no AESIs, and no deaths collected 

through Day 22. To date, no SAEs, AESIs, or deaths have been captured. There were no AEs 

leading to study discontinuation. 

In terms of MAAEs, 1 participant in the mRNA-1273 group alone experienced 1 event that was 

related (e.g., muscle spasms). The frequency of unsolicited AEs and adverse reactions was 

similar across treatment groups, and most of them were systemic in nature. In the coadministration group and the QIV-HD vaccine group, 1 participant in each reported a Grade 3 

unsolicited AE. Those were hypertension immediately following treatment in the coadministration group and a chemical burn to the eye in the QIV-HD vaccine group. There was 1 

participant in the QIV-HD vaccine alone group who had an immediate unsolicited adverse 

reaction of dizziness that was Grade 1 in intensity. 

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ACIP Meeting Summary October 20-21, 2021 

The objectives for immunogenicity were to: 1) describe the immune response elicited by QIVHD vaccine administered concomitantly or singly in each study group; and 2) describe the 

immune response elicited by mRNA-1273 vaccine administered concomitantly or singly in each 

study intervention group. The hemagglutination inhibition antibody responses to each influenza 

strain were conducted. At baseline, the geometric mean titers (GMTs) were similar across all 

groups. At Day 22, the co-administration group and the QIV-HD alone group demonstrated 

substantial and similar responses to treatment. The pre-vaccine titers for both Groups 1 and 2 

were initially high. In H3N2, they were somewhat lower and in H1N1, even lower. For individuals 

exhibiting titers of ≥1:40, based on the high GMTs from the previous slide, it would be expected 

that there would be high pre- and post-titers of 40 or greater, which was demonstrated. Because 

of the lower baseline GMTs in H3N2 and H1N1, it would be expected to see a lower proportion 

of individuals with greater than 40 at baseline. After immunization with QIV-HD vaccine, the 

majority of subjects reached titers of 40 or greater. Given the high baseline titers with both of the 

lineages, reaching a 4-fold rise of seroconversion is not as easily achieved. However, with 

baseline titers that are lower, such as H3N2 and H1N1 groups, a higher proportion of 

participants seroconvert as they are immunized. At baseline, the GMTs were similar across all 

groups. At Day 22, both groups who received the mRNA-1273 vaccine only demonstrated a 14-

fold rise in antibody to SARS-CoV-2. In Group 2 who received only the QIV-HD vaccines, there 

was no substantial change from baseline. 

To summarize the HAI immune response, all 3 treatment groups demonstrated similar GMTs at 

baseline. At Day 22, the co-administration group and the group that received QIV-HD vaccine 

alone demonstrated similar levels of GMT, proportions of participants with titers that were 

≥1:40, and seroconversion rates for each influenza strain. For the SARS-CoV-2 immune 

response, all 3 treatment groups demonstrated similar GMT levels at baseline. At Day 22, the 

co-administration group and the mRNA-1273 group alone demonstrated similar GMT 

concentration levels and proportions of participants with ≥2- and ≥4-fold-rise of antibody titers. 

In terms of the overall interpretation, the hope is that results provide patients and providers with 

confidence that co-administration guidance is supported by these data. The study results 

demonstrate that QIV-HD vaccine and mRNA-1273 vaccine (100μg) can be administered safely 

together without evidence of immunogenicity interference, supporting existing co-administration 

recommendations of COVID-19 and influenza vaccines. 

Discussion Summary 

• Ms. Bahta inquired as to whether there was any explanation for pre-vaccination titers being 

higher. 

• Dr. Izikson pointed out that they immunized these participants early in the season and the 

previous year’s influenza immunization rates were fairly high at about 94%. It is fairly likely 

that the immunogenicity did carry over, especially after years of exposure to these and other 

vaccines as well. 

• Dr. Chen asked whether there was an attempt to blind recipients to the vaccine they were 

being given and the likelihood of any bias from reporting of subjective symptoms. Noting that 

the current clinical considerations allow administration in the same site, he also asked 

whether there was a possibility that there could have been more reactogenicity if delivered 

at the same site versus in this study where vaccines were administered in different arms, 

and/or if this could have changed the immunogenicity. 

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ACIP Meeting Summary October 20-21, 2021 

• Dr. Izikson indicated that the subjects did know what was being received where. He recalled 

that the guidance recommends some distance in time between both vaccine administrations 

when co-administration is offered in a clinic. The concerns are well-received in that there are 

some open questions regarding immunogenicity and safety. While a lot of those questions 

are outside of the scope of the protocol for this study, he agreed that there is potential for 

bias in an open-label study. 

• Dr. Sanchez noted that there were only 1 or 2 individuals over 85 years of age. He also 

asked whether the study participants had been vaccinated only with the Moderna vaccine 

and if any of them had previous COVID infection. 

• Dr. Izikson indicated that the inclusion criteria required that all subjects had been previously 

immunized with the full 2-dose series of the Moderna mRNA-1273 vaccine. Those were the 

only vaccines every subject had received 5 months prior to enrollment. Serostatus and 

confirmation of prior COVID infection was not part of the inclusion/exclusion criteria, so that 

information is not available for stratification of individuals in the study. 

• Dr. Long recalled that Dr. Izikson mentioned that of the 300 participants in the study, close 

to 100 received both vaccines concurrently on the same day, about 100 received influenza 

vaccine alone, and about 100 received mRNA alone. She wondered whether the latter 2 

groups chose that or if they could have gotten one vaccine one day and another vaccine a 

month or two later. 

• Dr. Izikson clarified that this was a prospectively enrolled clinical study in which all 

participants signed an informed consent and were randomized to one of those 3 groups so 

that the investigators could actively compare the co-administration group to either a group of 

individuals who received the QIV-HD vaccine alone or the mRNA-1273 vaccine alone. This 

was to help determine whether there was increased reactogenicity in the co-administration 

group compared to each of these vaccines administered singularly. They all received 

something—either both vaccines at the same visit or QIV-HD vaccine alone or mRNA-1273 

vaccine alone. The Group 3 participants were offered a QIV-HD vaccine after completion of 

their Day 22 activities as part of their routine medical care, which was in regard to the ACIP 

recommendations that older adults receive an influenza vaccine prior to the influenza 

season. However, no additional information was captured regarding the QIV-HD vaccine 

after Day 22. 

• Dr. Long emphasized the importance of being able to answer important public health 

questions, support trust and confidence in vaccination programs, and continue to emphasize 

avoiding missed opportunities for vaccination. While this study was small, she thought it was 

very important and expressed appreciation for the collaboration across companies in order 

to get this done. She also requested further information about the 1 individual who had 

hypertension in Group 1. 

• Dr. Izikson indicated that this participant was being treated for hypertension on a beta 

blocker and presented initially with the 2 other immediate unsolicited AEs of anxiety and 

dizziness. The clinical staff took this participant’s blood pressure, which had reached a 

threshold of 176/78. The person was then observed until they felt better and were advised to 

seek medical care after leaving the office. The person’s blood pressure was taken again the 

next day and was down to 118/69. 

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ACIP Meeting Summary October 20-21, 2021 

Change in Age Indication for Flucelvax® Quadrivalent 

Dr. Lisa Grohskopf (CDC/NCIRD) provided an update on a change in the age indication for 

Flucelvax® Quadrivalent, which was discussed during the June 2021 ACIP meeting. Flucelvax® 

Quadrivalent is one of the US’s inactivated influenza vaccines, all of which are quadrivalent this 

season. This is a cell culture-based vaccine rather than an egg-based vaccine. The age 

indication for Flucelvax® Quadrivalent changed from m ≥4 years to ≥2 years. This was cited in 

the most recent ACIP Influenza Statement that was published in August after this age changed 

was approved by FDA in March 2021. 

The FDA approved an age indication for ≥6 months on October 14, 2021. That change in 

indication was presented during the June 2021 ACIP meeting. This was approved based on a 

randomized trial of immunogenicity and safety of the Flucelvax® Quadrivalent compared to a 

licensed egg-based IIV4, Fluarix® Quadrivalent that has been licensed for a number of years. 

The study was conducted among 2,402 children ages 6 months through 47 months of age. 

Flucelvax® Quadrivalent was given in a 0.5 mL per dose, which is the same dose at which it had 

been licensed previously to be given to children ≥4 years of age. Fluarix® Quadrivalent was 

given at its own approved dose volume of 0.5 mL per dose for children 6 months through 35 

months of age and 0.5 mL per dose for children 36 months through 47 months of age. To 

summarize the results presented during the last meeting, the pre-specified non-inferiority criteria 

for immunogenicity in terms of GMT ratios and difference in seroconversion rates were met for 

all 4 viruses, and rates of solicited and unsolicited AEs were similar between groups. 

To put this approval into the context of what is available for influenza vaccines this season in the 

US, there are 9 influenza vaccines. Inactivated influenza vaccines comprise the largest group of 

these, of which there are 5 standard doses unadjuvanted. Of these, 4 are egg-based (Afluria® 

Quadrivalent, Fluarix® Quadrivalent, FluLaval® Quadrivalent, Fluzone® Quadrivalent) and one is 

cell-culture based (Flucelvax® Quadrivalent). The additional vaccines are approved for 

somewhat narrower age ranges. Fluad® Quadrivalent and Fluzone® High-Dose Quadrivalent are 

for persons ≥65 years of age, Flublok® Quadrivalent (RIV) is approved for persons 18 years of 

age and older. FluMist® Quadrivalent for persons 2-49 years of age. 

Historically, children ages 6 through 35 months of age were approved generally to get a lower 

dose of influenza vaccine at 0.25 mL rather than 0.5 mL for inactivated vaccines that was 

approved for those 3 years of age and older. Beginning several years ago with the expansion 

of the approved age indications for Fluarix® and FluLaval® from 3 years down to 6 months, there 

began to be licensures for 0.5 mL per dose for children 6 through 35 months of age. There are 

still some differences with regard to approved dosing among the 5 vaccines that are now 

approved for children 6 through 53 months of age. Fluarix® and FluLaval® are 0.5 mL per dose, 

Flucelvax® is now also 0.5 mL per dose, Alfluria® Quadrivalent 0.25 mL per dose and Fluzone® 

Quadrivalent is approved for either dose volume. 

ACIP has not historically had specific votes for expansions in age indications for vaccines that 

are already licensed and are just expanding into an age that is already recommended to receive 

influenza vaccine. The plan is for this change to be reflected in the online version of the table of 

available vaccines for the 2021-2022 season.34 The table will be included in the MMWR 

Recommendations and Reports and also will be included in the brief summary of the ACIP 

Recommendations, which is a 4-page summary of the recommendations that has been 

produced since the 2017-2018 season. 

34 https://www.cdc.gov/flu/professionals/acip/2021-2022/acip-table.htm 

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ACIP Meeting Summary October 20-21, 2021 

Given the low influenza activity last season, one common question regards what has been 

occurring in the Southern Hemisphere for the past summer as their season starts in the Spring 

and runs through around October. For the 3 Southern Hemisphere sentinel countries 

(Argentina, South Africa, and Australia) through Week 40 of the surveillance year, Australia and 

Argentina were well below the epidemic threshold and have not risen. South Africa was 

somewhat different in that they recently had a week that just peaked above the epidemic 

threshold. It is not clear whether that might represent a move toward returning baseline activity 

and will have to be followed over time. However, the activity overall has been well below the 

average activity for the 2011-2019 seasons. For the Northern Hemisphere sentinel countries 

(Canada, South Korea, and Denmark) through surveillance through Epi Week 40, the data were 

similar. There has not been much of a peak to date. Based on specimens submitted by sentinel 

surveillance laboratories, activity has remained fairly low.

35 

Looking at US virologic surveillance, FluView is a report that is produced weekly by CDC’s 

Influenza Division surveillance staff based on data from US clinical laboratories and US public 

health laboratories. Numbers of positive tests are broken down by type, Influenza A and 

Influenza B, and by subtypes in some instances. Normally, there is a rather large peak in the 

percent positives. However, activity was relatively level for last season. The percent positive 

specimens shown by the clinical laboratories was approximately 0.1% between May 23, 2021 

and October 9, 2021. Since midsummer, the public health laboratories were beginning to see 

more consistent reporting week-to-week of specimens that are positive. It is too early to call any 

kind of predominance. At this point, there is a mix of H1N1, H3N2, and Bs. Therefore, it is not 

yet possible to make a call on what kind of season this is going to be. As Dr. Cohn pointed out 

at the beginning of the meeting, CDC is preparing for influenza to make a comeback, 

particularly as mitigation efforts are lessened in some places. 

Discussion Summary 

• Dr. Lee inquired as to whether a VCF vote would be required for the change in the age 

indication for Flucelvax® Quadrivalent. 

• Dr. Grohskopf confirmed that a VFC vote would not be required. 

• Dr. Daley asked whether vaccine administration errors are tracked in terms of a child 

receiving twice the dose they are supposed to. 

• Dr. Grohskopf indicated that vaccine administration errors are reportable to VAERS and that 

is a category that is followed. VAERS occasionally publishes papers about certain types of 

errors, several of which have been reported. The frequency with which that occurs and with 

which it is reported probably varies depending upon the type of error, such as giving an 

incorrect dose volume. Errors that sometimes occur in which someone receives a vaccine 

that is not indicated for their specific age. While it was difficult to comment on how frequently 

that occurs off of the top of her head, she offered to supply references to the papers 

reporting errors. 

• Thinking about pandemic preparedness, Dr. Maldonado (AAP) asked whether there would 

be any upcoming updates on highly pathogenic avian influenza (HPAI) in order to get a 

sense of the potential for vaccine platforms being developed in response to those. 

35 WHO FluNet https://who.int/tools/flunet 

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ACIP Meeting Summary October 20-21, 2021 

• Dr. Grohskopf said that while there is not currently an HPAI WG, she will present this 

request for an update for an ACIP meeting in the near future. 

PUBLIC COMMENT 

Public Comments: October 20, 2021 

The floor was opened for public comment on October 20, 2021 at 3:45 PM ET. Given that many 

more individuals registered to make oral public comments than could be accommodated, 

selection was made randomly via a lottery. The comments made during the meeting are 

included here. Members of the public also were invited to submit written public comments to 

ACIP through the Federal eRulemaking Portal under Docket No. CDC–2021–0098. Visit 

http://www.regulations.gov for access to the docket or to submit comments or read background 

documents and comments received. The public comment session was conducted prior to the 

votes. However, the votes were included with their respective sessions for ease of reading. 

Mr. Steve Kirsch 

Executive Director 

COVID-19 Early Treatment Fund 

My name is Steve Kirsch. I’m Executive Director of the COVID-19 Early Treatment Fund. I have 

no conflicts. Today I want to talk about the two “elephants in the room” that the ACIP committee 

members all refuse to acknowledge. The first is the correct values of the VAERS underreporting 

factor, and the second one is the missing of dozens of serious adverse events, including deaths. 

The recognition of either of these “elephants” should cause the committee members to demand 

an immediate halt to the COVID vaccination program. Our first “elephant in the room” is a very 

serious error committed by CDC staff member [bleep] who is the VAERS expert. The ACIP 

committee has relied on [bleep] for interpretation of the VAERS data, but he has misled the 

committee on a critically important issue, the underreporting factor for VAERS this year, 

otherwise known as the URF. 

Dr. Lee requested that the timer be paused and stated the following: Thank you for your 

comment. You know, our committee does appreciate diverse viewpoints that are respectful in 

nature and that are not personally directed at individuals. I will ask that you not name 

individuals. Otherwise, I will need to cut your time short and ask that we move on to the next 

public comment speaker. But we will go ahead and resume the timer, Mr. Kirsch. 

Okay. The committee has been led to believe that VAERS is 100% reported. That is 

preposterous. The VAERS URF is at least 41 for serious adverse events this year. It was 

calculated using methodology outlined in a paper published by five CDC authors published last 

year. I used the anaphylaxis data from the Blumenthal study, a study done at Mass General 

Brigham published on March 8 in JAMA. Those rates, the rates determined in that study, largely 

agree with those found in the Hashimoto study published on June 14 in the Journal of Travel 

Medicine. If you cannot challenge the methodology or the data, the Precautionary Principle 

demands that you accept the result, which is the URF is 41. Now, this has profound 

implications. The myocarditis incidence rate is now 1 in 317 fully vaccinated 16-year-old boys 

for the Pfizer vaccine based on slides presented at the August 30 ACIP meeting. But much 

more important is the death count. There are 7674 deaths reported in VAERS as of today. Let’s 

remove the total of all deaths reported in an average year considering all those background 

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ACIP Meeting Summary October 20-21, 2021 

deaths, so minus 200; 7474 times 41 is 306,000 excess deaths this year. We should have 

stopped the vaccines at 50 deaths. We even used 7 independent methods to validate our 

estimate is correct. None of those other methods use VAERS. I even offered a $1 million prize 

to anyone who can find a material error in either the data or the methodology. Nobody’s claimed 

that price. Contrary to CDC’s claims, we can show causality of all of these deaths because all 

the Bradford Hill criteria are satisfied. So if the vaccines didn’t cause those excess deaths, then 

what did? The committee must answer that question or I believe they should resign. There is a 

second “elephant in the room,” which is the missing safety signals. How can you miss 300,000 

dead Americans as a safety signal? How can you possibly miss pulmonary embolism? It’s 

elevated by over 800 times this year versus previous years. There are dozens more examples 

like these. The committee should either call for an immediate halt to the vaccination program or 

they should resign. Thank you. 

Dr. Robert Edmonds, PhD 

Concerned Individual 

Dear committee, my name is Robert Edmonds. I have no financial conflict of interest to disclose. 

While my remarks are more attuned to tomorrow’s agenda, today I will speak about tinnitus and 

the Johnson & Johnson vaccine. COVID-19 vaccines including Johnson & Johnson’s vaccine 

have saved many lives. Identification, though, of low frequency adverse events connected to 

vaccination are important, not to discourage vaccination but to encourage patient education to 

seek timely care and for provider education to apply the appropriate treatment should the low 

frequency events occur. Peer-reviewed case studies of tinnitus following vaccination potentially 

suggest a small window of time for treatment of tinnitus after onset utilizing corticosteroids. After 

this limited window, though, management is often the only remaining option available. Last 

week, Johnson & Johnson presented data that indicates a combined imbalance from all Phase 

3 trials of 24 versus 9 for tinnitus. Without information about the distribution of preconditions in 

both the vaccine and placebo group, they can only surmise the chance of a coincidental signal 

is 1 in 143 for this scenario. And if the case from Phase 1 is included, 1 in 156 for consideration 

of all phases of development. Note last week’s update increased confidence in tinnitus as a real 

signal. Additionally, the 95% confidence lower bound to the signal already above zero increase 

away from zero with this update as well. Note the confidence intervals and confidence estimates 

have not been provided for these adverse events in any documentation. The Food and Drug 

Administration at this time, unlike the European Medicines Agency, has not recognized tinnitus 

as a related low frequency event. Therefore, I urge an investigation beyond passive monitoring. 

Investigation of this nature would probably first indicate what tinnitus background to compare to, 

like whether comparisons should be conducted against what would include an assumed nonbothersome tinnitus background or only a smaller, more severe, extremely bothersome tinnitus 

background. Without an investigation of this nature, it’d be difficult to detect a tens of percent 

rise in an assumed large background without unique consideration of severity. Additionally, 

more careful examination may or may not identify unique nature to the cases, exclude or include 

other potential causes, and could identify unique cases hard to explain without a causal 

relationship. I’d be happy to expand upon any of these points after these remarks. In closing, I 

return to the trial data, and I will repeat [that] Combined trial data presently indicates that 1 in 

156 chance of there being a coincidental signal. If you agree these events are unlikely to be 

coincidental as the trial data suggests, I urge further investigations with federal and private 

partners to further investigate this matter and communicate those results back to the Food and 

Drug Administration and, if real, meaningfully communicate this to patients and providers as 

well. Thank you for your time. 

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ACIP Meeting Summary October 20-21, 2021 

Erin Costello 

EKCPeopleSuck.com 

I hope you’re all having a fine afternoon. I have two purposes for my statement being made here 

today. First and foremost, I want to thank every committee member for your work and your 

efforts given to helping every member of the public avoid unnecessary and sometimes 

detrimental sickness and disease. I especially want to thank you for agreeing to be a part of this 

committee over the past few years, given the rise in misinformation, which has then caused 

some people to misplace their anger that they feel and place it on you and other members of the 

medical and scientific community. I can imagine how unnerving that can be at times. Myself and 

other parents, and even those of us without kids, have devoted our free time to hopefully 

reversing some of this anger and ignorance. I am even hopeful on some days, though not often 

enough. My last purpose here for speaking today is to express my hope that the recommended 

age for the shingles vaccine be lowered from 50 years of age to 45 years of age. I know myself, 

I would be very much relieved, but mostly I just want to say thank you very much for all of your 

time and your efforts dedicated to this cause. 

Dr. Danyu Lin, PhD

University of North Carolina 

Hi. This is Danyu Lin from the University of North Carolina at Chapel Hill. Our group has been 

estimating the durability of protection for the COVID vaccine from both Phase 3 trials and the 

surveillance data. So today, I’d like to share some of our results. So, first of all, we analyzed the 

Phase 3 trial data published in New England Journal of Medicine for the Pfizer and the Moderna 

trial. And we find that the vaccine efficacy in reducing the risk of symptomatic COVID- 19 is 

about 75% at 6 months of Dose 2 of the Pfizer vaccine, and for the Moderna vaccine it’s about 

90% 6 months after Dose 2. So this suggests that there’s not as much need to give booster to 

the Moderna vaccine recipients as compared to the Pfizer vaccine recipients. Our group has 

also been analyzing the surveillance data from the State of North Carolina. And, I mean, some 

of these results—first of all, we estimated the efficacy in reducing the risk of COVID-19 over a 9-

month period, and we find that both mRNA vaccines are highly effective in reducing the risk of 

hospitalization and death with vaccine effectiveness in the lower 90%, even after 7 or 8 months. 

And Moderna vaccine is more durable than the Pfizer vaccine in reducing the risk of COVID-19 

deaths in the case of the Phase 3 trial. And the durability of protection is similar across 

demographic groups and also are similar for people who are vaccinated at a different time, 

suggesting that waning vaccine efficacy is likely due to the declining immunity rather than the 

emergence of a new variant. And also, we find that the effectiveness of the Johnson vaccine 

drops after 1 month, which suggests that it will be worthwhile to investigate the effectiveness of 

Johnson but as a 2-dose regimen given approximately 1 month apart. And that’s the end of my 

comment. 

Ms. Patricia Barber 

Retired Banker & Non-Profit Executive 

I am Patricia Barber, a retired banker and a non-profit executive. Thank you for this opportunity 

to speak and for the diligent work this committee and staff has done over this difficult and 

lengthy period of crisis in the health of our country. As a senior, I am particularly aware of the 

value that vaccines play in keeping me in good health. From personal experience, and from 

health education, I know that pneumonia is one of the health threats facing older adults and that 

it causes thousands of hospitalizations and deaths each year. Any increase in the effectiveness 

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ACIP Meeting Summary October 20-21, 2021 

of preventing this dangerous infection is an important step in the right direction for all of us. One 

of the things that I and so many others have learned more about through the COVID pandemic 

has been the degree to which our body changes and becomes more susceptible to illness as we 

age. We are now so much more aware that our immune systems declined significantly as we 

age, and we know that the degree and the rapidity with which that occurs seems to vary for a 

number of reasons, but that the decline is inevitable. I hope the committee will factor the full 

impact of this into its deliberations. We know that there are many predictable biological events 

which serve as hallmarks for the body reaching various stages of seniority, from graying hair to 

wrinkles to slow metabolism. We also know that these occurrences don’t all happen at the same 

time in each one of us. Thus, it is important to recognize that aging begins and advances at 

different times and at different paces. We need to keep this in mind so that the changes in our 

immune system, which may not be apparent to the eye, can and will be addressed 

appropriately. Protection from pneumonia is a prime example. While we know that the oldest 

among us are the most at risk, so-called younger cohorts of seniors, those in their 50s 

and 60s, also are experiencing in varying ways and measures—changes that mark the advance 

of age. The old adage “an ounce of prevention is worth a pound of cure” comes to mind. 

Restated for this situation, a broad definition of seniority will protect and save a multitude of 

seniors. 

Dr. Litjen (L.J) Tan, MS, PhD

Chief Policy & Partnerships Officer/Immunization Action Coalition (IAC)

Co-Chair, National Adult and Influenza Immunization Summit (NAIIS) 

Good afternoon, members of the ACIP. I am L.J. Tan, Chief Policy and Partnerships Officer 

for the Immunization Action Coalition or immunize.org, and also Co-Chair for the National Adult 

and Influenza Immunization Summit. I’m also honored to have served as a Voting Member of 

the NVAC, the National Vaccine Advisory Committee, and as a liaison member of the ACIP for 

12 years. Just a few comments regarding the vote of the committee to not amend the agebased pneumococcal policy statement down to 50 years of age. While harmonizing an agebased recommendation is commendable, it shouldn’t have been done at the expense of 

improved health outcomes for a large population of vulnerable persons. Indeed, this seems 

unreasonable when the alternative was another age-based cost-effective, even cost-saving 

recommendation. I’m concerned that the current policy statement appears to show more 

considerations for the vaccine options than the benefits of vaccine recipients. Why? As we all 

know, there remains a large burden of preventable pneumococcal disease today, and we know 

from the implementation of other adult immunization programs that with an age-based 

recommendation down to 50 years of age, we will capture a significant number of persons who 

may go on to become diagnosed with high-risk conditions. Indeed, our current pneumococcal 

high-risk recommendation for adults 19-64 years of age has been in place for many years, and 

we are sitting on low coverage rates hovering at 23.6%. There is no reason to think that simply 

changing the vaccine options will change these low numbers. We have tried and tried with 

various vaccines, and the evidence is clear. Risk-based recommendations in adults are poorly 

implemented. And the data has shown that, indeed, age-based recommendations in adults do 

work. An age-based 50-64 year old recommendation would have provided immediate benefit to 

a high-risk population, rather than keeping them at risk while waiting for some future program to 

catch up and reach effectiveness. We would also have captured a significant number of 

vulnerable persons of racial and ethnic minority and also of lower social economic status who 

may otherwise miss vaccination with a risk-based recommendation. This is an issue of equity. 

And, finally, waning immunity does not seem a good reason to not seize the opportunity to 

reduce a lot of burden of disease today. It seems inappropriate to not implement a cost-effective 

solution that will save more lives and improve equity based on the assumption that immunity 

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might wane 15 to 20 years in the future, regardless of boosters. That said, with the policy 

statement now under consideration, immunization advocates stand ready to work with you to 

address the challenge of implementing a risk-based pneumococcal recommendation and, 

indeed, all other adult risk-based recommendations. On the broader issue of adult 

immunizations, the negative impact of COVID-19 on immunization coverage rates in the US has 

been well-documented. We are aware coverage rates in the adults with very low pre-COVID, 

and we all know that when coverage rates are low, disparities are exacerbated. The pandemic 

devastated already low adult immunization coverage rates. And we were delighted that Dr. 

Cohn mentioned the Call to Action that was developed at a National Adult and Influenza 

Immunization Summit. I urge all of us to consider these standards for care going forward. I 

would like to thank this amazing committee for the incredible body of work that you all have 

done to protect the health of the country and, in particular, over the past 2 years as you continue 

to engage in getting out of the pandemic and back to life. We stand ready to work to implement 

your important recommendations. 

Mrs. Jeanette Contreras, MPP 

National Consumers League (NCL) 

My name is Jeanette Contreras and today I am representing the National Consumers League 

which, for over 120 years, has championed the safety and efficacy of vaccines as life-saving 

medical interventions. We extend our gratitude to this committee for the opportunity to present 

public comments. Our founder, renowned social reformer Florence Kelley, supported vaccines 

as a key factor in mitigating a smallpox outbreak near the end of the 19th Century. Her stalwart 

advocacy for immunizations has informed our bedrock principles for increased access to and 

vaccine confidence among consumers. In the US, nearly 50,000 people die each year from 

pneumonia, and Americans living with underlying health conditions are at a higher risk of 

acquiring the illness. Given the prediction of a more active flu and pneumonia season this year, 

the threat to older Americans and those living at greater risk of infection is especially high. 

Coupled with the ongoing threat of COVID-19, a rising number of Americans who recover from 

the coronavirus will find themselves susceptible to respiratory infections. We are pleased that 

the FDA has approved 2 new pneumococcal vaccines that offer broader protection than existing 

options. Consumers rely on the scientific expertise of the FDA and CDC to make 

recommendations based upon the best available evidence. We are encouraged that ACIP is 

considering recommending the pneumococcal vaccine for young adults with underlying health 

conditions and adults over age 50. Providing clear age-based recommendations can help to 

increase the rate of vaccine uptake. Providing risk-based recommendations for young adults 

with underlying conditions increases equitable access to immunizations. These 

recommendations would be particularly significant for vaccine uptake in communities of color 

who suffer disproportionately from chronic medical conditions at younger ages. As we work to 

reduce the risk of serious illness and death this winter, a vaccine to prevent against 

pneumococcal disease is more relevant than ever. Ensuring our most vulnerable Americans 

have access to these important preventative tools must be our priority. The National Consumers 

League will continue to instill vaccine confidence in consumers and look forward to swift 

recommendations by this committee on the use of these new and improved pneumonia 

vaccines. We appreciate your consideration of our views on this important public health topic. 

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Joanna Colbourne 

Deputy Executive Director

National Foundation Infectious Diseases (NFID) 

Good afternoon. I am Joanna Colbourne, Deputy Executive Director of the National Foundation 

for Infectious Diseases, or NFID. On behalf of NFID, thank you for the opportunity to address 

the ACIP, which plays an important role in guiding US immunization policy and protecting public 

health. COVID, flu, and pneumococcal disease are vaccine preventable diseases that together 

caused millions of illnesses and thousands of hospitalizations and deaths among vulnerable 

populations, which include older adults and those with chronic health conditions. Although there 

are safe and effective vaccines available to prevent these diseases, research shows a lack of 

awareness on the part of many individuals who are at higher risk for serious complications. 

Given that fewer than half of US adults typically receive an annual flu vaccine, NFID 

commissioned a survey in August 2021 to better understand beliefs about flu and 

pneumococcal disease, as well as attitudes and practices around vaccination during the 

COVID-19 pandemic. The survey found that 44% of US adults are unsure or do not plan to get 

vaccinated against flu this season. Of further concern, the survey found that nearly 1 in 4 who 

are at higher risk for flu-related complications said they were not planning to get vaccinated. 

Although last flu season saw historically low flu activity, we could see flu surge in the US this 

season with relaxed COVID-19 mitigation strategies, increased travel and the reopening of 

schools and businesses. Now more than ever, it is essential that everyone aged 6 months and 

older receive an annual flu vaccine. Even in cases when flu vaccination does not completely 

prevent infection, it can reduce the duration and severity of illness and can help prevent serious 

complications, including hospitalization and death. The survey also revealed an alarming lack of 

knowledge about pneumococcal disease. Among adults who are at higher risk for the disease, 

51% are not familiar with pneumococcal disease and only about a third reported that they have 

been advised to get vaccinated. Healthcare professionals play a critical role in protecting their 

patients from vaccine-preventable diseases. Both healthcare professionals and the public must 

understand immunization recommendations for all vaccine-preventable diseases. This fall, 

millions of people will be rolling up their sleeves for additional doses of COVID-19 vaccines. 

Although COVID and flu vaccines can be given at the same time, there continues to be 

confusion as well as practical concerns about implementation. Clear, consistent guidance from 

CDC is essential to eliminate confusion. At the recent NFID news conference to kick off flu 

season, CDC Director Rochelle Walensky urged everyone to get vaccinated against influenza 

each year. NFID stands ready and willing to continue working with CDC throughout flu season 

to educate the public and healthcare professionals about recommended vaccines. Thank you 

for your time and attention and hard work. 

Ms. Meredith Whitmire 

National Association of Nutrition and Aging Services Programs (NANASP) 

Thank you and thank you for the opportunity to present to you. My name is Meredith Whitmire, 

representing the National Association of Nutrition and Aging Services Program. We commend 

you for the extraordinary work you continue to do throughout the COVID-19 pandemic—work 

that certainly has saved lives. I have one simple request today. Please immediately reconsider 

your decision not to vote on extending coverage of newly approved and updated pneumococcal 

vaccines to all those aged 50 and older. As an organization which has been advocating on 

behalf of pneumococcal vaccines for older adults since 2014, we do appreciate that you are 

considering coverage for all those 65 and older. However, after reviewing the evidence from the 

Pneumococcal Working Group, it seems evident that these vaccines would benefit a broader 

aged community, particularly as we begin the flu pneumonia season that is expected to be a 

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very active one. Further, many younger adults with chronic conditions are susceptible to 

pneumococcal disease, as discussed by the Working Group. These conditions 

disproportionately are found in populations of color and often go undiagnosed, meaning that 

these adults would be missed via the risk-based recommendations. Additionally, as was 

discussed earlier, the Working Group highlighted that one of the approved vaccines only 

requires one shot, another potential way to increase equity among vaccine recipients. As we 

stated in oral testimony in September, another compelling reason to recommend approval now 

is CDC’s own guidance that pneumonia vaccines can be administered along with COVID-19 

vaccines. As more Americans, especially older Americans and those with chronic conditions 

either get their first or second doses of COVID-19 vaccines or their boosters, it would be such a 

convenience to have both done on the same visit. Just as you have moved swiftly and 

decisively at different junctures on COVID-19 vaccine recommendations, we believe the same 

urgency is needed with respect to these pneumococcal vaccines for all adults 50 and older. 

Older adults have been disproportionately impacted by the pandemic, and so have younger 

adults with chronic conditions. We should avert the same situation with pneumonia. Finally, we 

also commit to doing all necessary education to inform the older adults we work with and others 

who would be eligible about the need for and availability of these new vaccines. 

THURSDAY: OCTOBER 21, 2021

WELCOME AND INTRODUCTIONS 

Call to Order / Roll Call 

Dr. Grace Lee (ACIP Chair) called to order and presided over the meeting. She conducted the 

roll call during which no conflicts were identified or declared. A list of Members, Ex Officios, and 

Liaison Representatives is included in the appendixes at the end of this summary document. 

FDA Update 

Dr. Doran Fink (FDA/CBER) made a brief statement regarding the FDA regulatory actions the 

previous day. He announced that during the previous afternoon, FDA authorized the Moderna 

COVID-19 vaccine for use as a single booster dose at least 6 months following completion of a 

primary series of the Moderna COVID-19 vaccine in individuals 65 years of age and older and 

individuals 18 through 64 years of age who either are at increased risk of severe COVID-19 

following primary vaccination or who have frequent institutional or occupational exposure to the 

SARS-CoV-2 virus. Additionally, FDA authorized the Janssen COVID-19 vaccine for use as a 

single booster dose at least 2 months after the single dose primary vaccination in individuals 18 

years of age and older. Finally, FDA authorized use of all 3 of the available COVID-19 vaccines 

for use as heterologous booster doses following completion of a primary vaccination with any 

of the 3 authorized COVID-19 vaccines. Because need for a booster dose is determined by the 

immunity elicited by the primary vaccination or primary vaccination series, the populations 

eligible for heterologous booster dose and the appropriate interval between completion of the 

primary vaccination or primary vaccination series and the booster dose is the same as those 

populations who are eligible for the booster dose of the primary series. The dosing interval is 

also the same as the dosing interval authorized for the vaccine used for the primary vaccination. 

All of these authorizations followed discussion/recommendations of the FDA VRBPAC the 

previous week. 

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CDC Update 

Dr. Rochelle Walensky (CDC Director) said that she was delighted to say a few words, 

especially during yet another busy two days of meetings and the discussions. She began by 

simply saying “thank you.” For over a year, this committee has met to discuss COVID-19 

vaccines, analyze the studies and ever-evolving data, establish a framework for equitable 

delivery, analyze the safety data, and make recommendations that keep people safe and 

protected against disease. Despite the enormity of the task, the ACIP did not waver in their 

commitment to the work in front of them. She emphasized how grateful she was to have them to 

provide insight, guidance, and recommendations. As always, the ACIP had a tremendous 

amount of work ahead of them throughout the day. Each presentation would be evidencepacked, and she stressed how appreciative she was for the heavy lift they were about to 

undertake, from a discussion on the benefits and safety of a booster dose of Moderna for those 

at greatest risks, to the best way to protect those who have received the Janssen vaccine, to a 

conversation about heterologous vaccine series and what could be extrapolated from the clinical 

trials and laboratory studies to real-world data. ACIP’s votes are important, and of equal 

importance is how the committee approaches each type of data and frames their 

recommendations. She reminded everyone that when she spoke with ACIP in September, she 

made 3 commitments to ACIP to: 1) never lose sight of their collective goal to protect as many 

people as possible from COVID-19; 2) stand with them moving forward and facing new 

decisions and new twists and turns in this pandemic; and 3) listen to them and learn not just 

from their votes, but from their discussion and deliberation. These past 20 months have taught 

them many things, but mostly to have humility. Everyone is constantly learning about this virus, 

growing the evidence base, and accumulating more data. None of them individually can predict 

what may happen next, and none of them individually can know exactly what to do, but together 

they can be prepared and make the best recommendations to protect the greatest number of 

people. She emphasized that she was listening and eager to learn from ACIP’s perspectives. 

Over the coming days, CDC will release clinical considerations and public health guidance that 

will turn these decisions into practice. CDC’s recommendations will address not only who should 

receive a booster dose, but also include what vaccine they should receive, how, and when. It 

would be through ACIP’s conversations that CDC would explore the nuances of this guidance 

and then communicate it to the public. In closing, Dr. Walensky shared her deep thanks to the 

ACIP team at CDC. They have spent countless hours preparing for these meetings, responding 

to data requested from the WG and full committees, presenting the evidence, and establishing 

the framework for ACIP’s recommendations. They are an incredible, dedicated, tireless, and 

committed team. She thanked everyone for giving her the chance to speak with them and for 

the hard work they were about to do and reiterated that she would be there listening and looking 

forward to hearing the discussions. 

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES 

Session Introduction 

Dr. Matthew Daley (ACIP, WG Chair) provided the session introduction on behalf of the ACIP 

COVID-19 Vaccines WG. There have been over 45 million cases of COVID-19 in the US over 

the course of pandemic. Even though the epidemiologic curve looks somewhat better than it did 

the previous month, there were still about 75,000 new cases per day on average in the US. 

Currently, there are approximately 1000 deaths in the US every day. This is an important place 

to make the point that for most individuals in most circumstances, deaths from COVID-19 is 

vaccine-preventable. 

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ACIP Meeting Summary October 20-21, 2021 

Over the last 6 weeks, the COVID-19 Vaccines WG considered booster doses for COVID-19 

vaccines. This included review of real-world VE studies from the US and abroad, RCT safety 

and immunogenicity data regarding booster doses, NIH heterologous or mix-and-match study 

results, GRADE of the evidence regarding boosters, and the EtR Framework regarding 

implementation, values acceptability, resource use, and equity in the consideration of the use 

of booster doses in the US. In addition, the WG pivoted to prepare for critical decisions coming 

up around the use of COVID-19 vaccines in a younger pediatric age group 5-11 years of age. 

This has included a review of SARS-CoV-2 seropositivity in children and a much closer look at 

the current pediatric COVID-19 infection epidemiology. 

As Dr. Fink just announced, the FDA expanded the Moderna COVID-19 vaccine EUA to include 

a single booster dose to be administered at least 6 months after completion of the primary 

series in the following groups: 1) individuals 65 years of age and older; 2) individuals 18 through 

64 years of age at high risk of severe COVID-19; and 3) individuals 18 through 64 years of age 

with frequent institutional or occupational exposure to SARS-CoV-2. The FDA also expanded 

the Janssen COVID-19 EUA to include a single booster dose to be administered at least 2 

months after completion of the primary series for individuals ≥18 years of age. In addition, the 

FDA amended the EUAs to allow for each available vaccine to be given as a heterologous or 

mix-and-match booster dose in eligible individuals following completion of primary vaccination 

with a different COVID-19 vaccine.

36 

This session included presentations on Moderna booster dose data, Janssen booster dose 

data, the NIH mix-and-match booster dose study, v-safesm and VAERS data on third dose and 

simultaneous vaccination, vaccine safety updates, myocarditis updates from VAERS, 

myocarditis updates from VSD, a Vaccine Safety Technical Work Group (VaST) summary, 

COVID-19 VE for the primary series, EtR Framework, clinical considerations, policy questions, 

and a vote on Moderna and Janssen booster doses. 

Moderna Booster Dose Data 

Dr. Jacqueline Miller (Moderna) reviewed the updated Phase 3 efficacy data from the postmarketing study, discussed how that informed Moderna’s decision to submit a booster dose 

application, and presented safety and immunogenicity data on the booster dose. The EUA for 

Moderna’s COVID-19 vaccine is for a 50 μg booster and is particularly authorized for patients at 

increased risk of severe complications, including those over 65, those over 18 but younger than 

65 at high risk for severe COVID-19, and those with frequent institutional or occupational 

exposure. Additionally, the fact sheet will reference the ability to use the Moderna booster dose 

as a booster for other vaccines’ primary series. 

First to review the booster dose in terms of how it is different from the 100 μg 3-dose primary 

series that was authorized for certain populations, it was noted in August that patients with 

SOTs or who were otherwise immunocompromised did not always develop neutralizing 

antibodies to any of the authorized vaccines. Therefore, Moderna submitted and had authorized 

a 100 μg dose to be given at least 1 month after the second dose. This is really a 3-dose 

primary series for patients with compromised immune systems and was not the indication being 

discussed during this session. The focus of this discussion was other populations who received 

the 2-dose 100 μg primary series and the administration of a third dose at least 6 months after 

36 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takesadditional-actions-use-booster-dose-covid-19-vaccines 

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ACIP Meeting Summary October 20-21, 2021 

completion of the 2-dose series with a 50 μg booster. At this point, approximately 1.6 million 

Americans in the immunocompromised population had received a third dose of 100 μg, for 

whom the safety data would inform part of the discussion later in the afternoon. 

To review an update from Moderna’s Phase 3 efficacy trial and the incidence of COVID-19 

disease being seen among subjects through their follow-up period, a follow-up was completed 

of the blinded efficacy analysis through March 2021. After the EUA authorizations of Moderna’s 

vaccines, the subjects in the placebo group who were all at increased risk for COVID-19 were 

offered crossover vaccinations in order to continue to follow them and learn from this study. 

After these subjects received crossover vaccinations, Moderna continued to compare incidence 

rates. There was a final blinded efficacy analysis comparing the vaccine group versus the 

placebo group through March of 2021. At that time, up to 5.3 months of median follow-up 

showed that efficacy remained at 93.2%. Efficacy against severe disease throughout the same 

period remained at 98.2%,

37 which was very similar to the results discussed in December 2020. 

Importantly, cases reported in the trial during the time of this follow-up were sequenced and it 

was noted that the original strain with the D614G mutation and the Alpha variant were by far the 

most commonly circulating strains during this period of follow-up. 

An exploratory analysis of antibody persistence and boosting was performed during the same 

period of February through March 2021 (Study 201B),38 during which other strains began to 

emerge in the US. As variants began to emerge in other parts of the world, the Beta variant in 

Africa and Gamma variant in South America were being tested for throughout Moderna’s 

program using serum from recipients of mRNA-1273 to assess how well it was able to neutralize 

antibodies against those variants and whether a 50 μg booster could increase the breadth of 

coverage in terms of neutralizing antibody responses. At 1 month after Dose 2, all subjects 

developed neutralizing antibody titers to the original strain and most subjects developed 

neutralizing antibody titers against the 2 variants that were tested. At 6 to 8 months, all but 1 

subject had neutralizing antibody titers to the original Wuhan strain. Approximately half of 

subjects lost the ability to neutralize the Beta, Gamma, and Delta variants by 6 to 8 months 

later. This was probably due to a combination of lower neutralizing antibody titers to begin with 

and the known waning of antibody persistence that happens with all vaccines over time. Those 

subjects were given a 50 μg booster and all were above the lower limit of quantification of the 

assay for all 4 of the strains. The fold rises between 23- and 44-fold in an exploratory research 

grade assay. 

Phase 3 Study 301 assessed the incidence rates of COVID-19 disease in vaccinated individuals 

from July to August 2021 when Delta began to become the most commonly reported variant. As 

mentioned earlier, there was an original group of subjects who were vaccinated with mRNA1273 in the Phase 3 study between July and October 2020. Then there was an originally 

randomized placebo group who received the placebo between July and October, but who 

ultimately were crossed over to receive mRNA-1273 in January to March 2021. While a true 

efficacy trial no longer could be conducted with the placebo group, there were still 2 groups for 

whom relative incidence rates could be compared. One group included subjects who were 

vaccinated about a year ago and the other group of subjects who were vaccinated about 6 to 8 

months ago at this point. Meanwhile, Moderna is closely following the reported cases of COVID19, which are still being assessed and confirmed by the adjudication committee as the subjects 

progress through efficacy follow-up. The most cases reported until July 2021 included 23 in 

January 2021. In July, 81 cases were observed and 169 cases were observed in August. This 

37 El Sahly, NEJM, 2021 38 Research VSV pseudoneutralization assay used; Adapted from Choi et al., Nature Medicine 2021 

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was nearly a difference between what had been observed previously, which prompted Moderna 

to take additional action and perform additional analyses. 

In a comparison of incidence rates overall and by age groups (18-64 years and ≥ 65 years), the 

overall incidence rate in the earlier-vaccinated group was 77.1 per 1000 person years compared 

to 49 per 1000 person years in the later-vaccinated group, for a relative difference of 36.4%. 

That was statistically significant in that the 95% confidence interval ruled out the value zero. The 

same was true in both of the age strata. In the oldest age group for severe disease, the group 

difference was even larger.

39 

In terms of why a 50 μg dose was chosen, the primary goal was to use the dose that could be 

most optimally effective for boosting. The principle was to expose subjects to the dose that they 

needed, but not expose them to more than they needed. Lower booster doses than those used 

in primary series of other vaccinations have been shown to reactivate immune memory. A key 

example is Tdap. Lowering the dose also increases the ability to supply mRNA-1273 in the US 

and worldwide. In terms of the study design, this was an extension of the same Phase 2 studies 

discussed in December 2020. The placebo group in the Phase 2 study also were crossed over 

to receive mRNA-1273 primary vaccination and they did not participate further in this study. 

There were 2 additional groups. One group was primed to 50 μg of mRNA-1273 and the other 

was primed to 100 μg of mRNA-1273. The reason the Phase 2 study was chosen even though it 

had a smaller sample size was because the Phase 3 studies had just finished their vaccinations, 

so they had not progressed long enough in the study to receive a booster dose. The sample 

size for the immunogenicity set was 146 and 149 subjects, respectively. That rose to 173 and 

171 subjects with safety, resulting in a total of 344 subjects as the total safety database who 

received the 50 μg dose. Immunogenicity of this booster dose was compared with a subset in 

both studies, so a total of 1000 subjects provided the immunogenicity data. 

In terms of demographics, the mean age was 52 years. The majority of subjects were female 

and most subjects were white. Moderna is increasing the sample size of the subjects they will 

boost, which is ongoing in the Phase 3 study in order to evaluate a larger and more diverse 

population for the safety, immunogenicity, and effectiveness of the booster dose. To review the 

safety data, similar to the Phase 3 study, solicited adverse reactions were collected in the diary 

cards for 7 days after the booster dose; unsolicited AEs were for 28 days post-booster; and 

SAEs, MAAEs, deaths, and AEs leading to discontinuation were collected through the end of 

the study. The local solicited symptoms were the same as those presented to ACIP in 

December 2020 (e.g., pain, erythema, swelling, and axillary swelling or tenderness). 

In terms of solicited adverse reactions with 7 days post-booster from the 50 μg booster after the 

100 μg primary series compared to the pivotal Phase 3 study because those are the data 

included in the fact sheet, the reported rates were approximately comparable for the booster 

dose compared to Dose 2 of the primary series overall. For all of the solicited adverse reactions, 

the only reaction that was reported more commonly after the booster dose than the second 

dose was axillary swelling and tenderness. Most events remained mild to moderate in severity, 

and their median duration was less than 3 days. For solicited systemic symptoms, overall 

reports tended to be lower than after the second dose of the primary series. Once again, most 

events were mild to moderate in severity and the median duration was less than 2 days. The 

rates of unsolicited AEs were approximately equal to what was observed previously. There have 

been no vaccine-related SAEs or deaths in Study 201B to date. 

39 Baden et al., MedRxiv, 2021 

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Moving to the immunogenicity data for the 50 μg booster dose in terms of the original strain and 

the Delta variant, the strategy for demonstrating the effectiveness of the booster dose was to 

conduct immunobridging to the subset of the Phase 3 study. That was because the Phase 3 

study was linked to the original 94% efficacy and 93% efficacy which was durable for 5 months. 

In addition, demonstrating immunobridging offers confidence that immunogenicity will be 

restored to the level it was post-Dose 2. This study aligns with FDA guidance pertaining to 

licensure of COVID-19 vaccines. The 2 co-primary endpoints were in terms of GMT ratios or 

GMR and 1 in terms of seroresponse rates. Dr. Miller presented 2 analyses for each. The first 

one was pre-specified in the protocol and the second was an additional analysis that was 

requested upon filing. GMR was from the original specified hypothesis and aligned with the 

guidance for a statistical criterion in which the lower limit of the GMR had to be above 0.67 and 

the point estimate had to be above 1.0. For the group who received the 50 μg dose (pooled for 

50 μg prime and 100 μg prime group) the GMR was 1.7 with a lower limit of 1.5, which met the 

point estimate criterion of ≥1.0. The criterion also was met if only the group who received the 

100 μg primary series was considered, in which case the point estimate was 1.8 with a lower 

limit of 1.5. 

There was a second pre-specified hypothesis based on seroresponse rates. Seroresponse in 

this case was predefined as a 3.3-fold rise in titers. In the case of the pivotal Phase 3 study, it 

was compared to pre-Dose 1 titers. The 3.3-fold increase was selected because the 

characteristics of the assay when subjected to statistical analysis suggested that the inherent 

variability of the assay supports discrimination at the 3.3 pooled level. In the case of the pooled 

primary series group, the seroresponse rate was 94%. The lower limit was above ≥ -10%. The 

statistical criterion was ≥ -10%, so the criterion was met. Based on a 4-fold rise from pre-booster 

titers, as requested by the agency and limited only to the group who received the 100 μg 

primary series, the seroresponse rate was 88%. The lower limit was -16, so the criterion was not 

met. 

To evaluate that criterion a little bit further to understand why it was not met, the pre-booster 

titers remained quite high, particularly with respect to the Wuhan strain on which this hypothesis 

was based. Subjects who did not meet 4-fold rise had 4 times higher pre-booster titers 

compared to those who did meet 4-fold rise. Pre-booster titers were 108 among those who met 

the ≥ 4-fold rise and 492 among those who did not. Nonetheless, both groups achieved postvaccination GMTs well above the level of 1000. In terms of the correlate of protection analysis 

that was performed by the NIH, the threshold of 1000 was associated with protection that was 

approximately 96%. Although a correlative of protection has not been established, there has 

been an association of increasing neutralizing antibody titers, particularly above 1000 with 

protection against infection. 

Now turning to individual fold rises overall and then by age group. Overall for the Wuhan strain, 

there was an approximately 12-fold increase pre-booster to post-booster among persons 18-64 

years of age that rose to about 18-fold in subjects ≥65 years. The older adults, who are at 

greater risk of complications of COVID-19, achieved a 17.9-fold GMFR to Wuhan-1 D614G. In 

terms of cross-protection with the Delta variant, there was an overall fold rise of approximately 

16-fold among persons 18-64 years that rose to 22-fold in those ≥65 years of age. 

To summarize safety, rates of adverse reactions after the 50 μg booster dose were comparable 

to those observed after Dose 2. Pain remains the most common solicited local adverse reaction 

in both groups. Headaches, fatigue, and myalgia were the most common systemic adverse 

reactions both groups. The majority were mild to moderate in severity. Axillary swelling or 

tenderness was the only adverse reaction more frequently reported after the booster as 

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compared to Dose 2 in Study 301. No vaccine-related SAEs or deaths were observed in Study 

201B. Currently, there is a mean of 3 months of follow-up after the booster dose administration. 

Regarding immunogenicity, the pre-specified co-primary hypotheses were met on the pooled 

dataset. These were not met in the additional analysis on seroresponse. The 50 μg booster 

dose following the 100 μg primary series resulted in higher antibody titers to the original virus 

(D614G) than post-Dose 2, and this was statistically significant with the GMR of 1.8 and a lower 

limit on the 95% confidence interval of 1.5. There was a 13-fold increase from pre-booster titers 

for the original virus and a 17-fold rise from pre-booster titers for the Delta variants. Consistently 

high antibody titers were seen in those 18-64 years of age and those ≥65 years of age. 

Discussion Summary 

• Additional information was requested by Dr. Poehling on the 2 vaccine-related MAAEs and 

by Dr. Sanchez on the SAEs—even if they were not thought to be vaccine-related and 

whether any thrombotic events were seen at all. 

 Dr. Miller indicated that the 2 vaccine-related MAAEs were cases of headache and 

rash. What led to their assessment as being vaccine-related was the timing at which 

they occurred. They were comparable to the data being collected as part of routine 

solicited adverse reactions. In terms of the SAEs, she noted that in the 100 μg 

primary series group and there was 1 tendon rupture, 1 spontaneous abortion. In the 

50 μg primary series group, there was 1 older gentleman who had a DVT and 

pulmonary embolism and 1 female 89 years of age who had bradycardia and a 

pacemaker placed, and post-operatively had a case of pericarditis. These were 

assessed as serious, but not vaccine-related. The older gentleman had was 71 years 

of age, had a past medical history of hypertension, and developed his DVT and 

pulmonary embolism 79 days after receipt of the booster dose. The time period, age, 

and risk factors contributed to the investigators’ assessment. 

• Dr. Long asked whether Moderna’s intent was to use the exact same packaging for the 

primary series and booster and merely instruct administrators to withdraw a different 

volume. 

 Dr. Miller confirmed that this is the plan. Administration of the booster dose will be a 

.25 mL volume. Moderna is going to pro-actively conduct education to make sure 

that it is understood how this should be given. There will be a “Dear Healthcare 

Provider” letter, the information is updated on Moderna’s Fact Sheet, Moderna’s 

medical teams will present webinars, free training will be provided, there will be a 

24/7 hotline, and information will be posted on Moderna’s website about how to 

administer the booster dose. 

 Dr. Loehr referred to Dr. Coyle’s comment as part of the docket for this meeting that 

the American Immunization Registry Association (AIM) expressed concerns about 

the process of drawing half of the dose (.25 mL) being confusing for the American 

registries and in terms of keeping track of vaccines. He asked whether Moderna 

could make it easier for public health to order and manage their vaccine. 

 Dr. Cohn added that the context of AIM’s concern was related to the same vial being 

used for both a primary series dose and a booster dose in that using the same 

National Drug Code (NDC) does not allow for the inventory and product 

management and tracking of individuals who received doses. 

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 Dr. Miller said that while she understood the concern with regard to the code, she 

would have to take this question back to the group as it was outside of her area of 

expertise, which is development. 

 Dr. Lee added that not only are the billing codes important from a tracking and 

administration standpoint, but also there is concern about administration errors that 

could occur if people are asked to draw different doses from the same vial. It also is 

important to be able to track this in terms of vaccine safety surveillance systems, and 

it is helpful to have a specific code for pediatrics for this reason. While she 

recognized that this is a broader question, she emphasized that she wanted to make 

sure they were clear on this publicly because it will help post-market safety 

surveillance systems as well as our post-market effectiveness data systems to make 

sure that people got the right dose and to have a good understanding of safety that 

does not require assumptions. 

• Dr. Cohn expressed appreciation for all of the companies making an effort in the initial trials 

to include diverse populations. While that level of attention to enrolling diverse populations 

has become more difficult for all of the companies, it is important to continue to maintain an 

emphasis on that to ensure that they do not go backwards with regard to the progress that 

has been made on inclusive enrollment in clinical trials. 

 Dr. Miller stressed that Moderna agrees and underscored that this trial was 

conducted at a time before they instituted the Inclusion and Diversity Board and all of 

efforts put into place in the Phase 3 study. That is a major reason that Moderna 

thinks it is important to continue to capture data—not only to have a larger safety 

database from the study with the 50 μg per dose, but also to continue to ensure that

the results are generalizable. She explained that the reason she focused on the 

immunobridging study was because in the COVID study, they saw no differences in 

efficacy between various racial groups. 

• Dr. Long observed that the age groups were lumped together as 18-64 years and 65 years 

and older and asked whether more definition could be provided within the large age range of 

18-64 years. 

 Dr. Miller pointed out that while the question was relevant, it was difficult to break the 

age group down further in the Phase 2 study due to the small sample size overall. 

The Phase 3 study did not have age groups above 65 years. The analysis was 

adjusted for various stratification factors. They assessed age as a confounding factor 

as well as for comorbid medical conditions, and then looked at whether subjects 

were healthcare workers and not assuming that they had higher exposure rates. The 

difference was the same about 36% difference regardless of how they adjusted for 

the potentially confounding factor. So I don't have more age stratification than that. 

• If the geometric mean antibody was compared in individuals pre-Dose 2 of the 2-dose series 

with pre-booster GMT, Dr. Long wondered what could be learned about the relative risk for 

myopericarditis in people with high antibody titers when they get their second dose for 

instance. 

 Dr. Miller indicated that while she would not be able to provide a very precise answer 

as she did not have the pre-Dose 2 titer data in mind for this presentation, this was 

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discussed at length during the December meeting. After the first dose, about half of 

the subjects had neutralizing antibody titers, but a good percentage of subjects 

needed the second primary series to achieve neutralizing antibody titers. While there 

are probably differences in titers between pre-Dose 2 and pre-booster, they are not 

the same population. What is important is that the antibody titers have waned 

substantially and would be a lot lower pre-booster than they were post-Dose 2. 

• Dr. Hogue (APhA) reported that pharmacists are concerned about the booster dose in terms 

of the sterility of the product, given that now the number of entries into a vial with a needle 

potentially could be doubled. He asked whether Moderna had conducted any studies to 

assess continued product stability, sterility, and integrity of the rubber stopper. This is a very 

concerning issue and perhaps might make the case that it would be helpful if Moderna had a 

separate product that was designed just for boosters with a smaller volume. 

 Dr. Miller indicated that Moderna has conducted multiple studies and that this was 

part of the overall submission. What will be in the labeling information is that 20 

entries into the vial are the maximum that can be used, and that is supported by 

data. There are also sterility data to support all of the storage and handling 

information in the filing. In the context of the pandemic, this is the way the 50 μg 

booster dose is being managed. This is consistent with how other pandemics have 

been managed with different doses for potentially different populations, such as the 

2009 H1N1 pandemic. Moving forward, Moderna is considering packaging the 

product differently. That also is relevant to the pediatric vaccination program that 

Moderna has ongoing in which they will be pressing forward with lower doses in the 

primary series. 

Janssen Booster Dose Data 

Dr. Penny Heaton (Janssen) presented booster dose data for Janssen’s Ad26.COV2.S 

COVID-19 vaccine. More than 14 million adults in the US have received Janssen’s vaccine. 

While the single dose has provided durable efficacy against COVID-19, the data shared during 

this session was intended to highlight the opportunity to further increase protection with a 

booster dose. As a reminder, the Ad26.COV2.S vaccine and development strategy were 

different. First, the initial Phase 3 study evaluated the safety and efficacy of a single dose 

regimen for efficient pandemic response globally. Second, the data from this study showed that 

protection is durable. The efficacy of a single dose has persisted for at least 6 months. Third is 

the unique immunoprofile with antibody titers that peak later and persist for at least 8 to 9 

months. Cell-mediated immunity (CMI) is especially strong with CD4 and CD8 T-cell responses 

that are likewise durable. 

Although durability is very clear, it is also evident that there is room to boost protection, 

particularly against symptomatic infection. Janssen believes that a homologous booster dose 

aligns with the US priority to optimally protect individuals against any COVID infection. Data 

from Janssen’s booster studies show how the Ad26 vaccine can support this goal. The data 

show that a booster dose is safe and increases protection, including against symptomatic 

COVID-19. More than 9000 individuals have received a booster dose of the Ad26 vaccine in 

Janssen’s blinded RCTs. Janssen’s second large, randomized Phase 3 study evaluated 2 

doses of Ad26, and a single dose with a booster that was given 2 months later. Efficacy against 

symptomatic disease was 94% in the US and 74% globally, and there was complete protection 

against severe COVID. This study also found a similar reactogenicity profile after each dose. 

Antibody titers increased rapidly, consistent with an anamnestic response. In a separate study, 

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a booster was given at 6 months to induce even higher titers, with a 12-fold increase. While 

there were not enough cases caused by Delta in Janssen’s RCTs to evaluate efficacy against 

this variant, they do have 2 lines of evidence that give Janssen confidence in its efficacy against 

the strain. The first is a large real-world evidence study in the US that was conducted when 

Delta became dominant showed similar efficacy as in Janssen’s RCTs. Further, the booster at 6 

months showed an increased breadth of immune response with neutralizing antibody titers 

against variants of concern, including Delta. 

Regarding data from the final analysis of Janssen’s pivotal single-dose trial in the US, the 

efficacy of the Ad26 vaccine was 70% against symptomatic disease. Plotted over time, the 

efficacy did not wane for at least 6 months. A similar level of protection was seen in a real-world 

evidence cohort study showing that Ad26 remained effective in the US even as the Delta variant 

surged and remained stable for at least 6 months. That was through the end of August. The 

primary endpoint of the single dose study was also met. Globally, efficacy was 75% against 

severe COVID-19 after a single dose, and efficacy likewise persisted. In addition, protection 

against severe disease caused by emerging variants remained strong. However, looking 

globally at VE against symptomatic disease, a trend was observed that decreased over time. An 

interrogation of the data show that the reduction in global VE for symptomatic COVID appeared 

to be driven by the emergence of variants rather than declining immune responses. Three 

variants with VE below 50% (Gamma, Lambda, and Mu) became prevalent in regions in 

countries outside of the US during the period of analysis. 

The vaccine’s durability is also reflected in the persistent humoral and CMI. Recall that while 

antibodies are needed to prevent SARS-CoV-2 infection and to confine the virus to the upper 

respiratory tract, CD8-positive T-cells are important for preventing spread down the respiratory 

tree and severe disease. It is the totality of the immune response that protects against COVID19; that is, the combination of persistent antibodies and a strong and persistent CD8-positive Tcell response. The latter is the hallmark of the adenoviral vector-based vaccines. That is why 

strong protection is seen against severe COVID-19 hospitalizations and deaths despite the 

lower antibody levels elicited by Ad26 as compared to the antibody titers reported for the mRNA 

vaccines. 

With regard to Study COV3009 that evaluated the booster dose at 2 months after the single 

dose, Janssen refers to the second dose as a booster dose for two reasons. First, essentially all 

participants had the antibody after the single dose. Second, the rise in antibody after Dose 2 

had the profile of an anamnestic response. This second Phase 3 study was a large global 

randomized placebo-controlled trial conducted in 9 different countries across 3 continents. Once 

the Janssen vaccine was authorized for emergency use, the study allowed unblinding and 

offered any participants on placebo to receive the Janssen vaccine. Of the more than 31,000 

participants who received the single dose, 53% received the booster before the crossover was 

completed. Therefore, they were part of the double-blind analyses presented during this 

session. Among the participants evaluated for efficacy, 25% were at least 60 years of age. 

Here we show the efficacy of the single dose and booster studies. In the US, VE against 

symptomatic COVID reached 94% after the booster dose. Globally, VE against symptomatic 

infection improved to 75% post-booster. There was complete protection against severe 

outcomes. However, due to the limited follow-up time after the booster for the unblinding, the 

number of cases that occurred during the observation period and the double-blind part of this 

study were limited. 

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Janssen also has additional immunogenicity data from other studies that evaluated boosters at 

different time points. Booster doses have been given at 2 and 3 months after the single dose in 

younger and older adults and 6 months after initial vaccination in younger adults. Responses 

were evaluated looking at binding antibody and also wild-type and pseudovirus neutralization 

assays, and the neutralizing responses correlated strongly. A booster administered at each of 

the time intervals resulted in increased antibody levels for those 18-55 years of age. Similar 

increases were observed in those 65 years of age and older. Importantly, when the booster was 

given at 6 months after the primary dose, it resulted in a 12-fold increase. Overall, these studies 

showed that a booster dose of Ad26 enhances immune responses, and the benefit may be 

greater when given at 6 months or later. This finding and the durable efficacy profile are 

reassuring for those in the US who received the Janssen vaccine more than 2 months ago. 

Dr. Macaya Douoguih (Janssen) presented Janssen’s safety experience with the Ad26 

booster dose. Cumulative exposure to a booster dose of Ad26 includes 9220 participants across 

5 clinical studies Janssen has performed. The preponderance of data on the booster dose 

comes from Study COV3009, Janssen’s Phase 3 pivotal 2-dose study in which the second dose 

was administered 2 months after the primary vaccination. To review the reactogenicity for the 

booster dose administered at a 2-month interval in Study 3009, since local reactogenicity was 

similar between the primary and booster dose, Dr. Douoguih reviewed only the systemic 

reactogenicity during this presentation. In terms of systemic reactogenicity for individuals 18-59 

years of age and ≥60 years, the data showed that solicited and systemic AEs were less 

common and generally of lower severity with the booster dose compared to the primary dose in 

both age cohorts. Notably, the frequency of fever following the booster dose was approximately 

half of what it was after the primary regimen in the younger cohort. The frequency of events was 

lower in the cohort of older adults, and Grade 3 events were low overall. There were no Grade 3 

fevers in the older adults after either the primary or booster dose. 

Looking at the 6-month reactogenicity profile from Study COV1001, which was Janssen’s first 

in-human study and preliminary blinded data from Study COV2008, which is ongoing, a subset 

of participants in Study COV1001 was boosted at 6 months following the primary dose. The 

frequency of solicited and systemic AEs was lower with the 6-month booster than the primary 

dose. While the numbers were limited, the systemic events were also milder in severity. Study 

COV2008 is an ongoing randomized double-blind trial of participants originally enrolled in 

Janssen’s single-dose pivotal trial, Study 3001. This study is evaluating 3 different dose levels 

of an Ad26.COV2.S booster at least 6 months after the primary vaccination. There are 127 

participants who are estimated to have received the dose level being considered as a booster, 

and blinded safety data are available on a total of 83 participants to date. While the dose level 

data remains blinded, it is reassuring to note that no Grade 3 systemic reactogenicity events 

have been reported. Overall, giving a booster at 2 or 6 months did not result in any increase in 

solicited reactogenicity compared to the primary dose and in some cases showed a trend 

toward decreased reactogenicity. 

Regarding unsolicited AEs from the safety subset of Study COV3009, diversity was very good 

demographically in the Phase 3 study and was very closely matched in the safety subset as 

well. Overall, the frequency of unsolicited AEs was similar between groups and similar to the 

single-dose pivotal study. The rate of unsolicited adverse events was 15% in the Ad26 group 

compared to 10.9% in the placebo group after the first dose. This imbalance was driven by 

vaccine-associated events such as fatigue, injection site reactions, and headaches that were 

captured outside of the safety subset. The rate of unsolicited AEs also was similar between the 

groups after the second dose. Rates were balanced in the full analysis set as well for any 

MAAEs, any SAE, any SAE not due to COVID, and deaths. The number of deaths was 

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numerically higher in the placebo group at 13 versus 4. Among those who died, none in the 

Ad26 group were considered related to the vaccine and none were due to COVID. Of the 13 

deaths, 6 in the placebo group were attributable to COVID-19. 

In terms of Study COV3009 data on AEs and AESI, following the identification of a safety signal 

for the very rare events of thrombosis with thrombocytopenia syndrome (TTS) in the postauthorization data, TTS was considered an AESI in Janssen’s clinical studies. In Study 

COV3001, 1 case of TTS occurred in each group. The participant in the Ad26 group 

experienced thrombocytopenia at 86 days following vaccination, followed by cellulitis and deep 

vein thrombosis (DVT) approximately 100 days post-vaccination, and also was diagnosed with 

COVID-19 during this event. Anti-platelet factor 4 (anti-PF4) results were not reported. In the 

placebo group, 1 participant had a DVT on day 27 during the double-blind phase and 

subsequently developed a pulmonary embolism 2 days later in combination with 

thrombocytopenia. Neither case met CDC criteria for definitive TTS. 

Because there were no confirmed TTS cases in the study and because these events are 

extremely rare, Janssen looked into post-marketing data collected by the government in the 

United Kingdom (UK) for the AstraZeneca (AZ) 2-dose vaccine since it is more sensitive than 

other viral vectored COVID-19 vaccines. With 24.9 million first doses and 24 million second 

doses administered, the estimated rate of blood clots with concurrent low platelets was 15.1 

cases per million following the first dose and 1.9 cases per million with the second dose. The 

overall case fatality was 17%, with 66 deaths occurring after the first dose and 6 deaths 

occurring after the second dose. The government’s interpretation was that there was no 

indication of an increased risk of these events after the second dose in any age group.40 

Regarding some AEs for Study COV3009, there were 3 selected due to imbalances observed in 

the single-dose pivotal study (embolic and thrombotic events, convulsions or seizures, and 

tinnitus). No imbalance was seen in Study COV3009 from thrombotic events to seizures. 

Although the numbers are small, an imbalance was observed of tinnitus following the first dose 

and then no difference after the booster. Guillain-Barre Syndrome (GBS) and facial paralysis 

are events of interest for all COVID-19 vaccines, for which no imbalance was seen in Study 

COV3009. A numerical imbalance between the Ad26 and placebo group was observed for 

arthritis, which was not observed in Janssen’s single-dose pivotal study of 40,000 participants. 

In Study COV3009, imbalances were observed due to events that occurred 28 days after the 

primary dose. There were no clear patterns of differences between the Ad26 and placebo 

groups, and a large proportion of cases were apparent exacerbations of existing conditions. The 

majority of these events were non-serious, and there was no imbalance in the 28-day period in 

terms of events following a booster dose. 

In the context of greater VE with the booster dose, this study showed that the reactogenicity and 

safety profile of booster at 2 or 6 months was similar to the single-dose primary regimen. The 

incidence and severity of local AEs was also similar regardless of the timing of the booster. 

Systemic AEs appeared to be lower and of milder severity at 6 months relative to 2 months. The 

large, randomized placebo-controlled Study COV3009 did not identify any new safety signals for 

AEs, SAEs, or AESIs at the booster dose. Global post-marketing surveillance of the 2-dose AZ 

COVID-19 vaccine suggests that rare TTS events are much less frequent after the second dose 

than after the first. No TTS cases following the booster dose have been observed for Ad26. 

Janssen will revise its ongoing and planned post-authorization studies to incorporate follow-up 

40 https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-ofyellow-card-reporting 

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of booster doses in addition to the primary doses. 

Dr. Heaton (Janssen) concluded that Janssen’s randomized placebo-controlled trial provides 

strong evidence of the safety and efficacy of a homologous boost of Ad26 vaccine. The Ad26 

vaccine immunoprofile is unique and a strong and persistent CD8-positive T-cell response is a 

hallmark of the platform. CMI, including CD8-positive and CD4-positive T-cell responses with 

maturation of potent neutralizing antibody are all important contributors to protection, and that 

protection is higher with the booster dose. As shown in Study COV3009, the point estimate 

of accuracy was 94% against all symptomatic disease in the US, matching the peak efficacy 

reported for the mRNA COVID vaccines. Further, the magnitude of the safety information from 

an RCT is also unique to the Janssen program. More than 9000 participants have received a 

homologous Ad26 boost that provides a large safety database showing that the booster dose is 

safe and well-tolerated. Janssen believes this robust data package supports the administration 

of a homologous booster dose for Janssen-vaccinated individuals. The data show how the 

Janssen COVID-19 vaccine can help further protect individuals from COVID-19. As such, 

Janssen strongly supports the VRBPAC recommendation, which provides flexibility for 

administering a booster dose of Ad26. More than 14 million persons who received their COVID19 vaccination with Ad26 have the information needed to determine the timing of the booster 

dose, at least 2 months following the first dose or at 6 months or later to maximize durable 

protection. Any person who may get a booster in the future will likewise have the right data 

for scheduling their booster. 

Discussion Summary 

• Dr. Talbot pointed out that the last safety slide regarding TTS following the second dose was 

the AstraZeneca vaccine that was used in the UK, but they had stopped using that vaccine 

in young, healthy women prior to most of them getting a second dose. It was not clear to her 

that these data were helpful since the main risk group for that syndrome was removed from 

the group getting the vaccine, making it difficult to determine the impact of a second dose 

because of the change in the denominator. 

 Dr. Douoguih emphasized that the difference was still fairly substantial and striking in 

terms of the denominator. However, it is not replacing any data that Janssen would 

generate with its vaccine and they do think it is important to monitor this. 

• Referring to Slide 12, Dr. Daley requested additional details regarding the difference in 

symptomatic COVID efficacy against symptomatic COVID-19 in the US (95%) compared to 

globally (75%) in terms of what explained the difference. 

 Dr. Heaton pointed out that the Alpha variant was the predominant strain in the US at 

the time they upped efficacy to 94%. The efficacy against new variants was 63%. 

There were no Delta cases at the time of the study. Following real-world evidence on 

a month-to-month basis, a single dose has been 70% to 80% efficacious depending 

on the severity of the disease. They also continue to assess neutralizing antibody 

titers. Those data also show good neutralization of the Delta strain currently 

circulating, which they are continuing to monitor as well. 

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• Dr. Grogg inquired about whether there were any additional data on immunocompromised 

patients in terms of booster efficacy. 

 Dr. Heaton indicated that there were not very many immunocompromised patients in 

the randomized controlled studies. In their real-world evidence study, there were 

29,000 individuals who met the definition of immunocompromised. That includes 

active cancer, a history of organ or stem cell transplant, primary immunodeficiencies 

or HIV in the first year, or being on immunosuppressive therapies. The effectiveness 

of the vaccine was 67% against hospitalizations in those individuals. Janssen is 

continuing to follow this over time, as well as safety, pharmacovigilance, and the 

effectiveness data. They do have efficacy on individuals with comorbidities, which 

was 77.9% against all symptomatic disease. The numbers become increasingly 

smaller in terms of severe immunocompromise, making it difficult to draw any 

conclusions. 

• Dr. Sanchez asked whether any pregnant women were included in the study and if so, 

whether there were any AEs or other data on pregnant women and the vaccine. 

 Dr. Douoguih responded that while they did not include pregnant women in their 

efficacy studies, they do have a separate clinical study that will enroll approximately 

400 pregnant women in the second and third trimester and that began in September 

and is ongoing. 

 Dr. Maree, Janssen’s Chief Medical Officer, added that they do have limited 

information on pregnancy outcomes following vaccination. There are 54 reports from 

clinical trial data and 320 pregnancy reports from post-authorization spontaneous 

and solicited data sources, including 58 cases reporting breastfeeding. No safety 

signals have been identified. A pregnancy registry is ongoing, and it would be 

modified to encompass the evaluation of the booster dose as authorized. 

 Dr. Ault reminded everyone that during one of the first times the Janssen vaccine 

was discussed, mention was made that the Ebola vaccine had the same vector and 

there was a lot of experience with pregnancy and that vaccine. 

• Dr. Lee asked whether Janssen is doing any post-Dose 1 and post-Booster assessments in 

terms of anti-PF4 antibody measurement, which she asked because a lot of what efforts are 

centered on are trying to mitigate risk as much as possible both from disease and 

vaccination. That might actually provide some information about whether a different boost 

would be appropriate, such as in young women for example. 

 Dr. Douoguih confirmed that Janssen is looking at anti-PF4. They started by 

looking at participants who had and did not have thromboembolic events in both 

the vaccine and placebo groups within the COVID program. They also are 

evaluating people who are in Ad26-based vaccine studies with non-COVID 

vaccines for comparison. Preliminarily, they are seeing PF4 positivity in both the 

placebo and vaccine groups, so the numbers are fairly small. There probably will 

be more to report on this in the coming months as they continue this analysis. 

 Dr. Lee added that to broaden the question to other manufacturers as a 

discussion point, it could be incredibly helpful to similarly assess cardiac 

enzymes post-booster dose or post-Dose 2, even in asymptomatic individuals, 

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who are enrolled in clinical trials in terms of understanding whether there are any 

patterns and whether risk can be further mitigated with ACIP recommendations. 

National Institutes of Health, Mix and Match Booster Study 

Dr. Robert Atmar (Baylor College of Medicine) reported that the Mix and Match Study was an 

open label, non-randomized, adaptive design, multicenter study to evaluate the safety, 

reactogenicity, and immunogenicity of COVID-19 booster vaccines in persons who completed 

an EUA vaccine regimen at least 12 weeks earlier. Participants were 18 years of age and older, 

healthy or with stable underlying disease, not immunocompromised, not pregnant, and with no 

history of SARS-CoV-2 infection by history and consented to participate in the study. 

Approximately 50 persons per EUA vaccine group, with approximately even numbers of persons 

18-55 years of age and 56 years of age and older, were enrolled sequentially in 3 stages. The 

first stage began in early June. Participants received 100 μg dose of Moderna vaccine. 

Participants received the Janssen vaccine in the second stage, and the Pfizer vaccine was 

administered in the third stage. There were 9 groups total. A safety call was made at Study Day 

8, and the participants were returned or will return on Study Days 15 and 29 and at 3, 6, and 12 

months for blood draws and safety evaluations. 

In terms of the characteristics of the study participants, approximately 50 persons per group 

were enrolled. The mean age per group ranged from 48-57 years. The distribution of the study 

population by race and ethnicity did not fully represent that of the US population. The average 

time from completion of the EUA regimen to boost progressively increased across the stages 

due to the sequential enrollment set forth in the study design. It also tended to be shorter for 

those who received the Janssen EUA vaccine regimen versus those who received an mRNA 

vaccine under EUA. There were 2 persons (1 in Group 4 and 1 in Group 6) who had evidence 

of prior SARS-CoV-2 infection based upon a high antibody level to the N protein at baseline. 

When other participants in Group 5 developed COVID-19 on Study Day 27, none of these 

individuals were excluded from the analyses Dr. Atmar presented. 

Regarding the antibody assays being evaluated in the study, pseudovirus neutralization assays 

are being performed in the laboratory of Dr. David Montefiore at Duke University. IgG binding 

antibody assays are being performed in Dr. Adrian McDermott’s laboratory at the Vaccine 

Research Center (VRC) at the NIH. The virus strains of focus for this presentation included 

D614G N from the Montefiori Lab and 4-plex for Wa-1 and 10-plex Fit for Purpose (FFP) for 

Alpha, Delta, and Wa-1. 

In terms of the immunogenicity results for day 15 and where available Day 29, the lowest 

antibody titers at baseline tended to be in those who received the Janssen vaccine initially and 

was followed by those who received the Pfizer and then Moderna vaccine. All groups showed a 

boost by Study Day 15. For those boosted with Moderna, antibody levels were level or 

decreasing slightly by Day 29, while those boosted with the Janssen vaccine had slightly higher 

antibody levels on average by Day 29. Data are not yet available for Day 29 for the Pfizer 

vaccine recipients. The lowest post-boost titers were in those who received the Janssen vaccine 

initially and then were boosted with the Janssen vaccine. The magnitude of responses in the 

younger and older age strata were similar, so only the pooled data were presented for each 

group. Looking at the IgG binding antibody responses as measured in a non-validated 10-plex 

ELISA to the Wa-1 strain, Alpha variant, and Delta variant, all groups had increases in antibody 

levels after boost. The highest levels achieved were to the Wa-1 strain, followed by antibody 

levels to those for the Alpha, and with Delta variants being progressively somewhat lower. The 

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patterns of responses in the different vaccine groups were similar to those seen earlier. Notably, 

the range of antibody levels decreases after boosting. 

With respect to safety, there were 2 unrelated SAEs. The first was acute renal failure due to 

rhabdomyolysis from a fall that occurred 30 days after a Moderna boost. The second was an 

episode of acute cholecystitis that occurred 24 days after Janssen boost. No pre-specified 

study-halting rules were met. No new onset chronic medical conditions occurred through Study 

Day 29. There was one related AESI based on it being a medically-attended visit for a person 

who developed severe vomiting, which was determined to be related to their Janssen boost. 

The frequency of unsolicited AEs deemed related to the booster vaccine was similar across the 

booster groups and most were Grade 1 or 2 in severity. There were 4 unsolicited AEs deemed 

to be related and severe. In addition to the vomiting for the Janssen-boosted individual 

mentioned previously, severe vomiting occurred in 1 person boosted with the Moderna vaccine. 

In the Ad26.COV2.S booster group, 1 individual experienced severe fatigue and 1 experienced 

solicited AEs, including both injection site and systemic reactogenicity, and were basically as 

expected based on what has been reported in prior clinical trials. The most common events 

were injection site tenderness, followed by malaise, myalgias, and headaches. Most reactions 

were mild or moderate in severity. 

Some of the limitations of this study are that it was non-randomized, open-label, and subjects 

were enrolled sequentially for the different stages. The study was not designed to compare 

between boosts. For example, intervals between primary vaccines and boost were not 

controlled for. Correlates of protection are not completely elucidated, and they are even less 

well-understood for severe disease and death. While only antibody data were presented during 

this session, cellular immune response data also are being analyzed but are not yet available. 

These data also only represent early time points from the trial, though the vaccines may differ in 

time to reaching peak responses and they have different durability of those responses. 

In conclusion, use of the Moderna, Janssen, and Pfizer vaccines as boosters led to anamnestic 

serologic responses in all 3 EUA-dose vaccine groups. When given primary EUA COVID-19 

vaccine, heterologous boosts elicited similar or higher serologic responses as compared to their 

respective homologous booster responses. mRNA vaccines resulted in higher antibody levels in 

the first 28 days after the boost, and no safety concerns were identified. More information 

related to the study results are available in the preprint.

41 

Discussion Summary 

• Dr. Brooks asked whether the smallest boost occurring after a Janssen primary series was 

related to the interval between the primary vaccine and the boost, given that the data 

showed that the response was much better after 6 months as opposed to 2 or 3 months. 

• Dr. Atmar clarified that he reported on the magnitude of the level achieved post-boost. The 

antibody responses seen after Janssen vaccine is known not to achieve the same levels as 

after an mRNA vaccine. Therefore, those who received the Janssen vaccine did not achieve 

as high a level after a boost. That is not particularly surprising and is consistent with what 

has been reported after the primary vaccine regimen with the Janssen vaccine. In terms of 

antibody levels peaking, the Day 29 levels were somewhat higher for the Janssen vaccine. 

With the Moderna vaccine, a peak was observed at Day 15. 

41 Preprint: https://www.medrxiv.org/content/10.1101/2021.10.10.21264827v2 

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• Dr. Poehling inquired as to whether there were any cases of exacerbation among people 

with stable chronic conditions. 

• Dr. Atmar indicated that there were isolated cases of high blood pressure. However, there 

was nothing persistent that was considered to be an exacerbation of anyone’s underlying 

condition. 

• Given that the risk of serious illness is highest in people over 75-80 years of age, Dr. 

Schmader (AGS) asked how many subjects in this study were over 75 years of age. 

• Dr. Atmar indicated that there were 2 to 3 individuals. In the Janssen group boosted with 

Pfizer, there were no participants in that age range. 

Public Comment: October 21, 2021 

The floor was opened for public comment on October 21, 2021 at 12:16 PM ET. Given that 

many more individuals registered to make oral public comments than could be accommodated, 

selection was made randomly via a lottery. The comments made during the meeting are 

included here. Members of the public also were invited to submit written public comments to 

ACIP through the Federal eRulemaking Portal under Docket No. CDC–2021–0098. Visit 

http://www.regulations.gov for access to the docket or to submit comments or read background 

documents and comments received. The public comment session was conducted prior to the 

votes. However, the votes were included with their respective sessions for ease of reading. 

Mrs. Erica DeWald 

Director, Strategic Communications & Partnerships

Vaccinate Your Family 

I’m Erica DeWald, Director of Strategic Communications and Partnerships with Vaccinate Your 

Family. Thank you so much for the opportunity to speak today. As the committee continues to 

evaluate the COVID-19 vaccine for children, I wanted to share our board’s thoughts around 

requiring the vaccine for school entry. As you may know, our Co-Founders Rosalynn Carter 

and Betty Bumpers were instrumental in the passage of laws requiring vaccination for school 

entry back in the 1980s. Vaccinate Your Family continues to support school vaccine 

requirements that keep our children safe from deadly, infectious diseases. While that primary 

series of vaccines ought to be completed by age 2, school requirements ensure that no children 

fall through the cracks of the healthcare system and could be caught up on needed vaccines 

prior to entering kindergarten. Traditionally, vaccines are not added to the requirements for 

daycare and school attendance until they have been on the market for an extended period of 

time. Childhood safety data for each vaccine on the recommended schedule helps ensure 

parental acceptance of vaccines. School and daycare requirements should be in put in place 

as the final mile to ensure that children remain safe from deadly infectious diseases in their 

place of learning. There are several parameters that should be in place prior to considering 

vaccine requirements for school/daycare attendance: 1) parental acceptance; 2) broad 

availability of the vaccine; 3) physician or provider support for the vaccine; 4) full licensure of the 

vaccine; 5) stable and adequate vaccine supply; 6) addition of the vaccine to immunization 

information systems, also known as registries; 7) adequate data to assure vaccine safety; 8) 

significant uptick in the recommended population, in this case children, to reduce the 

compliance burden on both schools and childcare systems; 9) coverage for the vaccine and 

delivery in private health insurance plans; and 10) for vaccines that are not federally-funded 

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already, sufficient funding to purchase the vaccine through the VFC Program, Section 317 

Program, or a state program. While data supporting the overall safety of COVID vaccines is 

well-established, the multiple criteria typically in place prior to considering the school-based 

requirement have not yet been met. Therefore, Vaccinate Your Family is urging State 

Legislators, Governors, and Health Commissioners to first ensure that necessary parameters 

have been met prior to considering the addition of COVID-19 vaccinations for children to the list 

of requirements for school attendance. As for our full statement, please visit our website at 

vaccineyourfamily.org. Thank you so much for your time today. 

Karyne Jones, MPA

President & CEO 

National Caucus and Center on Black Aging (NCBA) 

My name is Karyne Jones and I’m the President and CEO of the National Caucus and Center 

on Black Aging. NCBA has a 52-year history of working to improve the quality of life and health 

and well-being for older African Americans and other communities of color. I know this 

committee has many different and competing factors to consider when making the tough 

decision on the use of vaccines, but I cannot help but use my time to express my 

disappointment in the committee’s decision not to expand the age-based recommendation for 

pneumococcal vaccines to age 50 and older. CDC data has shown that previous meetings 

confirmed that the recommendation for those over the age of 50 would not only be cost-effective 

but help to bring equity to populations that historically have low immunization rates, namely the 

population my organization represents. I submitted a joint written comment for this meeting with 

Dr. Yanira Cruz, who’s the President of the National Hispanic Council on Aging (NHCA), and we 

titled that comment “When America Gets a Cold, Communities of Color Get Pneumonia.” 

Yesterday’s vote was an important opportunity to work towards ending the reality of this 

committee’s missed chance, as several voting and liaison members of this committee noted 

yesterday. Individuals aged 50-64 will respond to the vaccine much better than someone over 

65 who has experienced advanced decline of the immune system. Further, it was noted that 

while we certainly need to take cost-effectiveness into account, we also must support policies 

that are equitable and will ultimately reduce mortality and morbidity in diverse communities. The 

last point I will raise with you for yesterday’s discussion, which I think was worth repeating, is 

the very real fact that while it is a nice idea that people in their 50s could live another 30 years 

and thus require a booster shot, many patients from black and brown communities will not live 

to 65 due to chronic conditions, environmental factors outside of their control, and the effects of 

a lifetime of inequitable care. Why wouldn’t we offer them protection earlier in their life span 

when we will have a greater chance of strengthening their immune system before chronic 

conditions set in? ACIP’s reluctance to make these vaccines available to as many Americans as 

possible is shortsighted and it sends a confusing message to the American public. 

Unfortunately, what’s clear to me and to many of my counterparts who represent diverse 

communities is that this decision does very little to improve health communities of color and 

addressing health disparities. Thank you very much. 

Mrs. Linda Rehkopf

Patient 

My name is Linda Rehkopf and I have a primary immune deficiency (PID) along with a 

predisposition to developing ARDS (acute respiratory distress syndrome), which I’ve survived 5 

times prior to the COVID years. So, when the whole world inhaled in March 2020 because of a 

pandemic, I thought “Welcome to my very scary world.” My family goes to extraordinary lengths 

to keep me safe. I would like to know as you deliberate vaccine protocols where is the data on 

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patients with primary immune deficiencies? I’ve been able to find just one study on vaccine 

response in patients with PID. I tried to enroll, but it was full and I was denied participation. So, 

because I’m not in a study group at NIH or John’s Hopkins, or other places, I’ve only ever gotten 

a “yes” or “no” answer on my lab tests for antibodies to COVID. But I know from my own 

research that these tests exist. I know of multiple studies to determine numeric antibody levels 

in solid organ transplant patients. I know that NCI has a study on B- and T-cell response to 

COVID. Without minimizing those patient groups, I would like to know when the ACIP will have 

similar data for patients with PID. When will the test for the numeric level of antibody production 

after vaccination be widely available to the patient population I represent? And will our family 

members, those in our bubble, will they be able to get antibody levels tested? It seems that we 

can but only if we know how or who to ask or where to look. Others in the autoimmune and PID 

community still have to argue with their pharmacists, doctors, and public health personnel just to 

get a third dose, not a booster, which this committee recommended in late July and August. The 

language from this committee matters. How it is communicated to the public and the patient 

advocacy groups matters. I urge you to develop antibody testing guidance for those of us in the 

primary immune deficiency community and for our families. I urge you to allow our family 

members to get third shots and booster shots outside of your guidelines presently. I encourage 

routine testing for the numbers, not just positive or negative emojis, because knowing the 

numeric level of antibodies I produce along with B- and T-cell response will help me decide 

when it’s safe to go outside my house and exhale. Thank you for your time. 

Dr. David Wiseman 

Synechion 

Thank you. I was a senior J&J scientist and have since received research fees outside of 

vaccines. I received funding from Steve Kirsch and [unclear]. Please see our written comments. 

Thank you ACIP and VRBPAC for diligently wrestling difficult issues, but you are only as 

effective as the data presented to you and your understanding of how your words will be used to 

shape policy. FDA’s Dr. Krause was charged with Pfizer’s withholding data from FDA. We 

suggested that waning immunity data were withheld from ACIP. While their advisory committee 

decisions are not binding, FDA and CDC have stretched recommendations on boosters. The 

distinctions between the Pfizer EUA and the Comirnaty® BLA vaccines do not appear to have 

been explained to you and are increasingly blurred, including by CDC. The discussion of flu with 

the EUA Moderna vaccine yesterday opens a regulatory back door. A non-voting ACIP 

discussion about vaccines in pregnancy preceded a CDC Health Advisory, despite Comirnaty® 

saying that data are sufficient to inform pregnancy risks. Do pregnant women know that CDC 

has two studies where there is a quote “urgent need to monitor the safety of these vaccines,” or 

do they know these studies requested informed consent or parental permission waivers? 

Pregnant women are effectively mandated to unknowingly participate in a medical experiment. 

Do you endorse this? The smaller limited mix-and-match study labeled “preliminary” in its 

medRxiv pre-print version, was a subject to a VRBPAC non-voting discussion, but we now see 

FDA’s ruling, but not VRBAC’s intent, creating therapeutic chaos and a safety tracking 

nightmare. You appear unaware that these vaccines are classified by FDA’s gene therapy 

products and what that means long-term and that Comirnaty® has not been evaluated for 

carcinogenicity, genotoxicity, or male fertility. Safety signals remain unaddressed. They show 

VAERS signals greater than myocarditis, deaths 200 to 300 times higher compared with flu 

vaccines, coagulopathy 400 to 500 times the Pfizer or Moderna and 1400 for Janssen, 

myocardial infarction 300 to 400 times. The case for boosting is largely based on small 

immunobridging studies, with no established immune correlates of protection. It relies on Israeli 

data for efficacy where there was significant statistical concern, and where following primary or 

booster vaccination increasing severe cases precedes that for unvaccinated people, suggesting 

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transmission issues. You are being asked to evaluate Janssen’s safety and efficacy data 

because the FDA has admitted it is not verified. It seems every regulatory safeguard is being 

tossed out. America trusts you to follow the science and transcend politics. Your decisions have 

much broader consequences, such as mandates. Don’t base decisions on extrapolations and 

extrapolations of improperly reviewed data. We urge you to challenge CDC and FDA and to 

demand answers. Thank you for your work. 

Candace K. Johnson 

Kidney Transplant Patient

Participant in the Johns Hopkins Study for Antibodies

Transplant Recipient and Immunocompromised Patient Advocacy Group (TRAIPAG) 

Good afternoon. My name is Candace Johnson. I’m a kidney transplant patient, a participant 

in the Johns Hopkins study for antibodies and T- and B-cell, and a member of the TRAIPAG 

advocacy group. My message today is to strongly encourage the FDA and CDC to reconsider 

their guidance on antibody testing. Current data is based on information through July or earlier. 

Dr. Dorry Segev, Associate Vice Chair for Research and Professor of Surgery and 

Epidemiology at Johns Hopkins, wrote an article in The Hill this weekend that we have much 

better antibody tests now. In listening this morning, vaccine studies on efficacy are based on 

antibody response. Labs are run on a routine basis to gauge health status. Why not add 

quantitative antibodies to the list? Without testing and collecting this data, especially on 

breakthrough infections, we’ll never know how effective actual levels are. Dr. Segev’s research 

has indicated that higher antibody levels neutralize more COVID than lower levels. So, these 

tests clearly prove something. To quote his words, “It’s time to check antibodies and take the 

guess work out of this pandemic.” This is particularly critical for immunocompromised people. 

Quoting Dr. Segev again, “Vaccination does not necessarily mean strong immunity.” I am a 

perfect example of that. With 3 doses of the Moderna vaccine, on the Roche scale my 

antibodies are less than 0.4%. I know I must double mask and social distance to keep myself 

and others as safe as possible, but what about others who may not have produced antibodies 

and don’t know it? Using antibody test levels will give us an understanding of where we stand in 

terms of protection. Thus, as this panel is doing today, please consider regular testing so that 

we can make informed decisions. Not measuring antibodies is flying blind. On yet another very 

important note, our family members and caretakers continue to suffer along with us as we 

quarantine and do everything in our power to protect ourselves. I urge the FDA and CDC to 

include these individuals in the group of those eligible for booster shots so that they can not only 

protect themselves, but also protect us if they get COVID. Thank you for the opportunity to 

make these comments and for listening. Your diligence and your compassion is greatly 

appreciated. 

Laura Burns 

Double Transplant Recipient

Participant in Johns Hopkins Studies on Vaccine Efficacy in Lung Transplant Recipients

Transplant Recipient and Immunocompromised Patient Advocacy Group (TRAIPAG) 

My name is Laura Burns. I'm a double transplant recipient and a participant in 4 of the Johns 

Hopkins studies on vaccine efficacy in lung transplant recipients, led by Dr. Dorry Segev. I am 

also a member of TRAIPAG. We urge you to adopt the Moderna and Janssen EUA changes 

announced by the FDA yesterday and to allow the mixing-and-matching of vaccines. At the last 

ACIP meeting, I asked you to specifically authorize boosters for our close contacts who form our 

bubble. Our members implore you to include them this time around and to address this issue in 

your discussion. As Dr. Walensky said, our job is to protect as many people as possible. We’re 

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also concerned by the use of the term “booster” for a second dose following the J&J. The FDA 

panel universally opined last week that this was in actuality a second priming dose, not a 

booster, because it brings vaccine efficacy from around 70% to over 90%, making it closer to 

the mRNAs. So, they authorized it for everyone 18 and older and after just two months, but what 

about the immunocompromised who have no response to the first J&J? We cannot assume they 

won’t need 3 doses to be primed. And how are they to know whether they respond to a second 

dose? As a doctor, wouldn’t you order an antibody test? In your decision-making, you have 

relied extensively on studies which measure antibodies as a proxy for vaccine efficacy. 

Shouldn’t we? The written comment submitted to the op-ed in The Hill by Dr. Segev is called 

“It’s Time to Check Antibodies and Take the Guess Work Out of This Pandemic.” I urge you to 

read it. When you have a medical issue, doctors want labs, which inform them as to your status. 

Not measuring antibodies is flying blind. We can no longer say we don’t know what antibody 

levels mean. That might have been somewhat true in July, but it’s not true now. We have a very 

good sense of what antibodies mean and that they correlate with neutralization and actual 

clinical protection. More and more studies are showing this. They’re not perfect, but many tests 

done in clinical medicine aren’t perfect. The way to use antibodies is to test them and 

incorporate them into the bigger picture of individualized patient counseling. Dr. Sanchez, you 

have often raised the question in past meetings, “If we don’t test for antibodies, how will we ever 

find the correlate of protection?” Indeed, how will we? So, please approve the Moderna and 

Janssen boosters. Allow the immunocompromised who got J&J to get a third dose as you did 

for the mRNA. It’s a question of equity in allowing for mix-and-match. I thank you very much for 

all of your hard work and for your kind attention. 

Ms. Sarah Barry

Independent Vaccine Advocate 

Thank you to all of the ACIP for continuing to do critical work during this time. My name is Sarah 

Barry. I am independent pro-vaccine advocate and I am grateful for the opportunity to speak 

today. First, I would like to update you all on the status of anti-vaccine legislation in Ohio. I’m 

happy to report that HB-248, which was written and supported by Ohio’s anti-vaccine lobbyists, 

is officially dead. As a reminder, HB-248 would have made it illegal for anybody to require any 

vaccine, not just the COVID vaccine. Attempts were made to create a new, more watered down 

version of HB-248 called HB-435, but at this time, it appears that both bills are dead in the 

water. I would caution that although this is good news, anti-vaccine activists in Ohio still have a 

tight grip on the legislature. I strongly believe that a heightened awareness of the political 

lobbying anti-vaxxers do all over the country is necessary to combat vaccine hesitancy and this 

information. Most recently, I obtained and provided to the Ohio Capital Journal footage of Ohio 

Senator Andrew Brenner speaking to a group of anti-vaccination advocates about alternative 

treatments for COVID-19, one of whom suggested gargling diluted bleach as a preventative. 

Senator Brenner then shared that he will be introducing a bill that will prohibit discrimination 

“against people or information that deals with alternative therapies, such as what you’ve been 

discussing today.” I’ve talked before during ACIP public comment about how prior to the 

pandemic, the anti-vax community has allowed and sometimes explicitly endorsed abusive 

treatments and cures for autism, such as using bleach enemas or chelation. I strongly believe 

that if a forceful campaign against such abuse had been implemented prior to the pandemic that 

we would not be in as bad of a position as we are in today. It is incumbent on all of us to 

recognize the outside influence anti-vaxxers have on our political landscape and to realize that 

the trickle down effects of ignoring that influence will lead to worse health outcomes for all 

people in this country. Yes, I have most certainly worked hard on my own to expose the antiscience and anti-vax sentiments within the Ohio legislature by working directly with reporters 

and journalists who will take me seriously, but there is nothing stopping you all as individuals 

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from doing the same in your own communities. And I think that your position as being on ACIP 

will help lend credibility and not make it as hard for you to be taken seriously as it sometimes is 

for me, and if you need help with this, I do invite you to message me on Twitter at my handle 

42believer. I will close my statement by sharing with you all the mental toll my advocacy has 

taken on me. As a visible pro-vaccine advocate, I have been subjected to online abuse by 

extremists, such as the Proud Boys, and also what I worry are intentional efforts to intimidate 

me at my home. For many months now, there have been regular anti-vax protests across the 

street from where I live. Some days, the anxiety literally makes me throw up. I will not stop 

because we all know that this issue is that important. I know that such abuse might make it hard 

to do this advocacy on your own, but I urge you. It is so important to take it seriously and to not 

let people strike you down and discontinue your advocacy. And please, continue having these 

important conversations. Thank you for your time. 

Mr. Mark Gibbons 

President, RetireSafe 

Thank you for the opportunity to speak today. My name is Mark Gibbons. I’m a husband, a 

father, a veteran, and a man who has passed the demarcation line of mid-Century birthday. I’m 

also the President of RetireSafe, a non-profit advocacy organization giving voice to the 

concerns of older Americans. Health and healthcare, while always of major importance, now 

rank at the top list of concerns of virtually all adults, but especially those of us who are 

approaching Medicare and Social Security eligibility or are already enrolled. And it is through 

that reality I wrote my remarks. First, thank you for your tireless work that you have done this 

year. Surely, no year in history has been as complex or as important. I had hoped to be given a 

time slot to speak yesterday before your vote on the new pneumonia vaccine, but our point 

remains the same. Those of us over 50 know we are vulnerable to flu, and that’s why we get 

vaccinated each year. Please know our concern about how vulnerable we are to pneumonia as 

well. While it is true that the older one is, the higher rate of pneumonia among our age group. 

People my age, 58, over 50 but under 65, are unfortunately well-represented among millions of 

people who receive hospitalization for pneumonia in any given year and sadly among the 50k 

who die from it. We are vulnerable because many of us are beginning to have chronic illnesses 

that are not yet diagnosed or don’t have health insurance or are genetically predisposed. Maybe 

that is because over 40% of us are overweight—a factor that many recent studies have linked to 

susceptibility to pneumonia or because we smoke and we don’t tell our doctor that we do. 

Whatever the reason, 65 is not a magic moment when we go from low risk to high. It’s a 

continuum that advances. I’m not looking forward to telling our community of supporters that 

they may not yet be eligible for vaccines which can protect them from this dangerous disease, 

but on their behalf, I want to respectfully suggest that ACIP consider widening the margins of 

protection—not in several years but much, much sooner. We need your help. Thank you. 

Mr. Burton Eller 

National Grange 

My name is Burton Eller. I’m from the National Grange, the nation’s oldest organization 

representing agricultural, rural, and small town life in America. Allow me to begin this with some 

harsh facts. In urban areas, most people live about 4 miles away from a hospital, but the 

distance is twice that in rural America. Lack of access to healthcare where we live accounts for 

55% of what could be preventable hospitalizations or death. Rural life expectancy is 2 years 

shorter. Since 2015, 181 rural hospitals have shut their doors and 1 out of every 4 that remain 

are struggling. Fewer healthcare providers and facilities, longer distances to obtain care or 

receive community services, lower wages, fewer employment opportunities, and less access 

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to technology—these factors result in very serious healthcare concerns for rural Americans. We 

all had a very hard winter last winter, but the situation in rural America was already operating 

with significant disadvantages. No one solution will solve all these problems, but you can 

depend on Grange members and all rural Americans to do their part in climbing out. We do 

understand that prevention is a key factor in health security, and that is the major point we want 

to make today. Rural life has risk factors that may not show up in clinical studies but, 

nevertheless, are very real. For example, just before COVID, the National Center for Health 

Statistics reported that the age adjusted rates for influenza and pneumonia were higher in rural 

counties than in urban. We are worried as we enter this pneumonia and flu season this year. 

Hopefully, COVID will continue to decline, but will there be significant twindemics of these other 

two dangerous diseases? If so, we already know that we will be playing catch up from the start 

unless action is taken now. We thank ACIP for its work on new pneumonia vaccines, but we had 

hoped that age 50 would have been the designation point to help get us on a jump start basis. 

We will do everything we can to make certain rural America knows what’s available to them and 

why it is so important to protect themselves and their families. We will work with you in every 

way to our common goal. Thank you. 

Dorit Reiss, PhD 

Professor of Law 

University of California

Hastings College of The Law 

My name is Dorit Reiss. I’m a Professor of Law in the University of California Hastings College 

of The Law. Thank you again to the committee for all your hard, intensive work in these trying 

times. Today I want to talk to you as someone who teaches administrative law and emphasize 

the need for explanation and transparency. I want to touch on four things. First, after your 

previous meeting, the CDC Director changed from the committee’s fourth recommendation. It’s 

the job of the CDC Director to decide, and she does not need to be a “rubber stamp.” But even 

when she deviated from the committee’s recommendation, the public deserved to know why. I 

would urge the CDC Director in the future to clearly and openly state the reasons for deviating 

from any committee recommendation. She may have more public-oriented point of view through 

the committee, more policy-oriented, but as in other administrative contexts, the public desires 

to know the basis on which decisions are made, including why this director decided to deviate. 

The committee’s deliberations are public. We heard several explanations from members. We 

need similar from the director. Second, the committee does not post an explanation, but when 

you make recommendations about boosters and mix-and-match, the public will have questions. 

We are already hearing following the FDA meeting questions on if the data is not there about 

mix-and-match, why recommend the preference for the same vaccine? You have to make 

recommendation even in uncertainty, but the people implementing them are going to have to 

explain. Every year you put out immunization schedules and in them you give explanations. If 

your committee could consider adding a short explanation to recommendations where the 

stance is uncertain, I think it will be very helpful for people who have to put their 

recommendations into practice. Third, as mentioned by the previous speaker, we still have 

strong disparities in vaccine access. That’s not your area. You do not control access, but the 

message from the committee is that these priorities need to be made—prioritizing bringing 

vaccines to people who have not received them. For example, vaccine clinics are going to be 

where people are providing support to people who need time to get a vaccine could be useful, 

and the statement that in providing that additional resources, prioritizing neighborhoods and 

groups badly hit by the pandemic would also be helpful. And finally, I want to remind you, and 

I’m saying this because many oral comments are really helpful, but you do not have to legally 

provide oral comments and that they have been used and will be used to create anti-vaccine 

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propaganda and legitimize it as coming from the CDC. If you have staff members summarize 

the major issues in recent comments submitted 72 hours before emitting, you may achieve 

more meaningful public participation by providing issues across commenters and maybe giving 

the committee a chance to consider them carefully. Thank you for your time. 

Kelly Moore, MD, MPH

Chief Executive Officer (CEO)

Immunization Action Coalition 

Thank you, Dr. Lee. I’m Dr. Kelly Moore, the CEO of Immunize.org, also known as the 

Immunization Action Coalition. I’m a former ACIP member and the former Chair and current 

member of the Viral Hepatitis Work Group. My comments relate to your upcoming hepatitis B 

policy consideration. There’s been a lot of discussion about the relative merits of risk-based 

versus age-based adult vaccine recommendations. Some have asked for evidence that agebased recommendations work better. There’s quite a bit of it. As my colleague LJ Tan noted 

yesterday, our risk-based pneumococcal vaccine recommendations are poorly implemented, 

with just over 23% of high-risk individuals vaccinated, while 69% of those subject to an agebased pneumococcal recommendation are vaccinated. We can also point to similar low 

coverage rates under the old influenza risk-based recommendations years ago set aside in 

favor of age-based recommendations, and the current risk-based adult hepB and hepA vaccine 

recommendations. Programmatically, unless risks are easily defined and obvious, risk-based 

recommendations for preventive interventions are weak solutions to population-wide problems. 

The current risk-based hepB and pneumococcal recommendations favor those who are more 

highly educated, with advanced health literacy, who have no problems accessing medical care 

and advocating for their needs, and who have healthcare providers who find ways to incorporate 

vaccine risk screening in their practices. That is no way to deploy vaccines to address health 

disparities. Every person is at some degree of risk of hepatitis B infection that rises and falls 

over their lifetime. Of all the acute hepB cases reported to CDC, only 1 in 3 reports a known risk 

factor and 2 out of 3 acute hepB cases reported leave risk factor blank or indicate no risk factor 

present. HepB vaccination provides lifelong protection. Whether you choose to travel, or 

develop diabetes, or share a home with a person with hepatitis B, you’re protected. That’s why 

our age-based childhood vaccination program has been such a phenomenal success. We have 

set national hepatitis B elimination goals, but rates are rising in middle aged adults. We cannot 

eliminate hepatitis B in the United States without a new approach. To make no change is the 

definition of insanity if you define insanity as “doing the same thing repeatedly and expecting a 

different result.” You will hear that the Work Group discussed an age-based adult 

recommendation with an upper age limit, with risk-based above that age, as well as a simple 

universal adult recommendation. I can support either choice, but we cannot continue, and all 

of the Work Group agrees, in more of the same. 

v-safesm and VAERS: Third Dose and Simultaneous Vaccination 

Dr. Anne Hause (CDC/NCEZID) reminded everyone that the COVID-19 vaccines are being 

administered under the most intensive vaccine safety monitoring efforts in US history. CDC is 

monitoring the safety of these vaccines through 4 complimentary systems: v-safesm, VAERS, 

VSD, and CISA. There are also additional systems in place managed by government partners. 

This presentation focused on data from VAERS and v-safesm.

42 

42 Full list of U.S. COVID-19 vaccine safety monitoring systems: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html 

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ACIP Meeting Summary October 20-21, 2021 

As a reminder, VAERS43 serves as an early warning system for vaccine safety. It is comanaged by CDC and FDA. Anyone can submit a VAERS report, regardless of the possibility of 

the vaccine causing the event or the clinical seriousness of the event. The key strengths of 

VAERS include rapid detection of safety issues and detection of AEs. Limitations of VAERS 

include that it is a passive surveillance system that relies on voluntary reporting, has 

inconsistent quality and completeness of information, reporting biases, and cannot determine 

causality of AEs. As of October 10, 2021, there were 4,990 reports to VAERS following Dose 2 

of Janssen or Dose 3 of mRNA COVID-19 vaccines. The median age was 64 years and 63% of 

the reports were from women. Race or ethnicity was unknown or incomplete for 49% of the 

report, and 39% were from persons who identified as white, non-Hispanic.44 

Overall, 94% of the 4,990 VAERS reports following Dose 2 of Janssen and Dose 3 of mRNA 

COVID-19 vaccinations were non-serious. This varied slightly by vaccine manufacturer, but is 

similar to what has been observed for COVID-19 vaccines overall and other vaccines in general. 

Among serious reports, the most common AE according to VAERS was extra dose 

administered. Among non-serious reports, the most common AE was interchange of vaccine 

products. This may mean that the additional dose was given in error or given outside of 

recommendations at the time. Per federal law, VAERS reports include reports of 

hospitalizations, prolongation of existing hospitalization, life-threatening conditions, permanent 

disability, congenital deformity, or birth defects or death. Also, please note that these AEs are 

not mutually exclusive and a report may include more than one AE. 

Among the millions of persons who have received a third dose of mRNA or second dose of 

Janssen COVID-19 vaccine, there were 30 reports of deaths to VAERS. There were no reports 

of death following Dose 2 of Janssen. The median age was 79 years. The median time elapsed 

from a third dose to death was 2 days. A CDC physician reviewed the available documentation 

including death certificates to determine a preliminary impression of cause of death (COD). It 

was not possible to determine the COD for 8 reports due to insufficient data. VAERS also is 

monitoring reports of AEs following co-administration of COVID-19 vaccines and other vaccines. 

Most reports to VAERS did not specify the vaccine type administered with the COVID-19 

vaccine. Influenza and zoster vaccine were among the most common vaccine type specified. 

The most commonly reported AEs included extra dose or expired product, systemic symptoms, 

or AEs unique to Zoster. VAERS will continue to monitor AEs following co-administration. 

Now turning to data from v-safesm. As a reminder, v-safesm is a voluntary smartphone-based 

safety surveillance system. v-safesm allows existing participants to report that they are receiving 

an additional dose of COVID-19 vaccine, and new participants enter information about all doses 

of COVID-19 vaccine received and complete health surveys on their most recent dose. v-safesm 

health surveys are sent during the week following each dose of vaccine and include questions 

about local injection sites and systemic reaction and health impacts, including inability to 

perform normal daily activities, inability to work or attend school, and/or inability to receive 

medical care. Additional health surveys are sent weekly through 6 weeks after vaccination and 

at 3, 6, and 12 months after vaccination. The key strengths of v-safesm are that it is easy and 

quick to use, includes active outreach to participants, and collects longitudinal data. The key 

limitations include that enrollment in v-safesm is voluntary and requires a smartphone, and 

cannot determine causality of AEs. 

43 https://vaers.hhs.gov/ 44 Includes data collected during August 12–October 10, 2021 

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ACIP Meeting Summary October 20-21, 2021 

Over 274,000 v-safesm participants had reported an additional dose of COVID-19 vaccine to vsafesm as of October 10, 2021. Among the participants, 52% were female, 39% were 65-74 

years of age, 90% identified as non-Hispanic, and 84% identified as white. In terms of patterns 

of vaccination for v-safesm participants who reported an additional dose, over 98% of 

participants reported a third dose from the same manufacturer as the primary mRNA vaccine 

series. Most participants reported 3 doses of Pfizer-BioNTech vaccine. Looking at the top 10 

solicited reactions reported at least once during Day 0-Day 7 after Dose 3 of Moderna or PfizerBioNTech vaccine, pain, fatigue, myalgia, and headache were among the most frequently 

reported solicited reactions for both vaccines. 

Reactions and health impact events reported at least once during Days 0-7 after Pfizer 

BioNTech vaccine by dose showed that injection site reactions, systemic reactions, any health 

impact, inability to perform daily activities, and inability to work were all less frequent following 

Dose 3 than Dose 2. Notably, this analysis included 188,514 participants who completed at 

least one survey in the first week after each dose, with data collected during August 12–October 

10, 2021. Dose 2 was compared to Dose 3 to assess statistically significant differences (p-value 

<0.05) using a multivariable generalized estimating equations model that accounted for the 

correlation between registrants and adjusted for demographic variables. Looking at reactions 

and health impact events reported at least once during Day 0-7 after Moderna vaccination by 

dose, injection site reactions were more frequently reported following Dose 3 of Moderna 

vaccines than Dose 2, while systemic reactions, health impacts, and inability to work were less 

frequent following Dose 3 than Dose 2. While these differences were statistically significant, 

the magnitude was small. 

v-safesm also is monitoring reactions reported following co-administration of COVID-19 vaccine 

and other vaccines. Over 65,000 v-safesm participants reported receiving another vaccine at the 

time of their COVID-19 vaccination. Most (89.9%) were 18-75 years of age. Nearly 90% of coadministered vaccine is given with Dose 3 of COVID-19 vaccines. v-safesm will continue to 

monitor reactions following co-administration. 

These data are subject to a number of limitations. First, both VAERS and v-safesm are voluntary 

systems and are likely not representative of the vaccinated US population. Second, additional 

dose recommendations included immunocompromised persons who completed a primary 

period of mRNA COVID-19 vaccine. However, v-safesm does not include specific information 

about immune status. Additional dose recipients likely included immunocompromised and nonimmunocompromised persons, and immunocompromised persons might have different 

reactogenicity than an immunocompetent person. Third, approximately half of mRNA third 

doses are among persons aged 65 years and older, who may have different reactogenicity than 

persons in different age groups. Fourth, at this time, data are limited to determine patterns of 

AEs after receipt of second dose of Janssen or from a manufacturer different than the primary 

series. This also limited the ability to identify rare AEs. Finally, complete medical record review 

of deaths following vaccination reported to VAERS is dependent on the availability of medical 

records, death certificates. and autopsy reports, which may be delayed or not available. 

To summarize, no unexpected patterns of AEs were observed. However, the data are limited at 

this point to identify rare AEs. Nearly all (≥92%) reports to VAERS were non-serious. Most 

commonly reported were vaccination errors and systemic symptoms. Most v-safesm participants 

reported a primary mRNA vaccine series followed by Dose 3 from the same manufacturer. For 

Pfizer-BioNTech, local and systemic reactions were reported less frequently following Dose 3 

than Dose 2. For Moderna, local reactions were reported slightly more frequently and systemic 

reactions slightly less frequently following Dose 3 than Dose 2. VAERS and v-safesm will 

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ACIP Meeting Summary October 20-21, 2021 

continue to monitor safety of additional doses of COVID-19 vaccination. Additionally, the 

Vaccine Safety Datalink (VSD) will incorporate additional doses into its ongoing safety 

monitoring, and CISA will be available to consult on clinically complex AEs. ACIP will be 

updated as additional data become available. 

COVID-19 Vaccine Safety Updates 

Dr. Tom Shimbukuro (CDC/NCEZID) presented an overview of myocarditis following COVID19 vaccination, an update on the safety of Janssen COVID-19 vaccine, and a brief analysis on 

the safety of Janssen COVID-19 primary vaccination followed by an additional mRNA COVID19 vaccination. He reported that evidence from multiple safety monitoring systems in multiple 

countries supports the finding of an increased risk of myocarditis and myopericarditis following 

mRNA COVID-19 vaccination.45 The risk is highest in adolescents and young adults, higher in 

males compared to females, and higher following Dose 2 compared to Dose 1. Symptom onset 

clusters within a few days of vaccination, mostly within a week, and cases have tended to be 

clinically mild. Dr. Shimbukuro then provided highlights from FDA, Department of Defense 

(DoD), and Department of Veterans Affairs (DVA) monitoring in addition to briefly mentioning 

some international surveillance efforts and providing an update on the CDC investigation of 

long-term effects of myocarditis. 

First to highlight updates from a presentation that Dr. Hui-Lee Wong from FDA gave at 

VRBPAC46 the previous week on surveillance of myocarditis and pericarditis and mRNA 

COVID-19 vaccination in the FDA’s Biologics Effectiveness and Safety (BEST) Initiative. Within 

BEST, FDA has assessed myocarditis and pericarditis in the first 1-7 days following receipt of 

mRNA COVID-19 vaccines in terms of incidence rates and incidence rate ratios for Moderna 

versus Pfizer-BioNTech COVID-19 vaccination. To summarize the key points, the incidence rate 

estimates are highest in males 18-25 years of age. More events are observed post-Dose 2 than 

post-Dose 1. There was a wide range of incidence rates among the four BEST databases, with 

wide confidence intervals. Based on the preliminary results, the incidence rate ratio estimates 

comparing Moderna versus Pfizer vaccines, the FDA analysis does not support a significant 

difference for males 18-25 years between the 2 vaccines. However, the estimates had large 

uncertainty. 

The Military Health System (MHS) continues to identify and follow patients with myocarditis 

following COVID-19 vaccination. The overall rate of myocarditis within 7 days of vaccination is 

10 cases per million doses, but the risk is strongly dependent on patient age, sex, and vaccine 

dose and type. The rate of myocarditis in males under 20 years of age after the second dose is 

greater than 100 cases per million doses. Approximately two-thirds of patients report feeling 

fully recovered within 6 weeks of diagnosis. The standard American College of Cardiology 

(ACC) recommendations limits strenuous activity for 3 to 6 months. Follow-up within the MHS is 

ongoing.47 

45 Gargano et al. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the 

Advisory Committee on Immunization Practices — United States, June 2021. MMWR Morb Mortal Wkly Rep 2021;70:977–982; 

Mallapaty S. Heart-inflammation risk from Pfizer COVID vaccine is very low. Nature. 2021 Oct 8. doi: 10.1038/d41586-021-02740-

y; Myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in Ontario. Available at: Myocarditis and 

Pericarditis Following Vaccination with COVID-19 mRNA Vaccines in Ontario: December 13, 2020 to August 7, 2021 

(publichealthontario.ca); Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis. Available at 

Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis | European Medicines Agency (europa.eu); 

and Paterlini M. Covid-19: Sweden, Norway, and Finland suspend use of Moderna vaccine in young people "as a precaution". 

BMJ. 2021 Oct 11;375:n2477 

46 https://www.fda.gov/media/153090/download 47 Courtesy of Margaret Ryan MD, MPH, Defense Health Agency (DHA) 

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ACIP Meeting Summary October 20-21, 2021 

The DVA and the VA conduct active surveillance Rapid Cycle Analysis (RCA) for COVID-19 

vaccines. They use a weekly analysis comparing observed to expected numbers of prespecified outcomes from historical rates, adjusting for sequential tests. They also conduct nearreal-time chart reviews for assessment of specific incident events, including an initial chart 

review to assess presumptive events and more detailed chart review. There have been 3.5 

million total Moderna doses administered, 3.1 million total Pfizer-BioNTech doses administered, 

and limited use of the Janssen vaccine in the VA population of approximately 270,000 doses. 

The vaccinated population is 89% male and 60% aged 65 years and older. The Janssen 

vaccinated cohort is somewhat younger than the mRNA vaccinated cohort. There have been no 

statistical signals for myocarditis or pericarditis with any of the COVID-19 vaccines, although 

limited data are available for Janssen. Of the 7 chart-confirmed myocarditis or myopericarditis 

cases in the VA surveillance, 6 were in males and 1 was in a female. The median age was 37 

years. The median onset was 3 days, with most occurring after Dose 2. The highest rate was 

observed in persons 18-39 years of age and all cases clinically resolved. The conclusion is that 

the absence of a myocarditis signal in the VA data are likely due to age differences in the VA 

population.48 

There is ongoing surveillance in other countries, particularly in Israel where the Pfizer vaccine 

has been used, but also in Canada, Europe, and elsewhere. The findings have been generally 

consistent with what has been observed in the US in terms of an increased risk of myocarditis 

with mRNA vaccination. In some cases, such as in Canada and some of the Nordic countries, 

the risk is higher for Moderna compared to Pfizer.49 

To briefly update the CDC enhanced surveillance for myocarditis outcomes after mRNA COVID19 vaccination in VAERS case reports, the purpose of this enhanced surveillance activity is to 

assess functional status and clinical outcomes among individuals reported to have developed 

myocarditis after COVID-19 vaccination who have met the case definition. It is a 2-component 

survey conducted at least 90 days after the onset of myocarditis symptoms. It includes a patient 

survey, followed by a healthcare provider survey. Data collection began in late August and is 

anticipated to continue at least through November. As of August, VAERS had received 826 

reports of myocarditis or myopericarditis after COVID-19 vaccination that met the case 

definition. To date, around 680 patients have reached the 90-day post-myocarditis diagnosis 

window. Of these, 282 have received at least one phone call. Of the 282 patients who have 

received at least one call, 168 have completed the survey and 67 were unreachable or declined 

to participate. Of the 168 patients surveyed, 132 provided cardiologist or health care provider 

contact information. Contacting the cardiologist or the healthcare provider they are seeing as an 

outpatient is the last step in the sequential process. Of the 132 providers, 26 have completed 

the survey. The remaining 106 are in the process of being contacted, and CDC will continue to 

collect information.50 

48 Courtesy Fran Cunningham, Pharm D, Department of Veterans Affairs 49 a) Mevorach et al. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med. 2021 Oct 6. doi: 

10.1056/NEJMoa2109730; b) Witberg et al. Myocarditis after Covid-19 Vaccination in a Large Health Care Organization. N Engl J 

Med. 2021 Oct 6. doi: 10.1056/NEJMoa2110737; c) https://www.publichealthontario.ca/-/media/documents/ncov/epi/covid-19-

myocarditis-pericarditis-vaccines-epi.pdf?sc_lang=en; d) Paterlini M. Covid-19: Sweden, Norway, and Finland suspend use of 

Moderna vaccine in young people "as a precaution". BMJ. 2021 Oct 11;375:n2477; e) 

https://www.ema.europa.eu/en/news/comirnaty-spikevax-possible-link-very-rare-cases-myocarditis-pericarditis 50 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myo-outcomes.html 

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ACIP Meeting Summary October 20-21, 2021 

Moving to an update on the safety of Janssen COVID-19 vaccine, Dr. Nair from the FDA 

presented post-authorization safety data for Janssen during the VRBPAC meeting for which the 

full presentation has been posted online.51 Based on the data presented, the most commonly 

reported AEs to VAERS after Janssen COVID-19 vaccination were systemic and local 

reactions. This study reviewed some existing safety concerns and described some emerging 

potential safety concerns following Janssen vaccination. CDC and FDA will continue to follow 

cases of GBS and TTS reported to VAERS. Information regarding these AEs is currently 

communicated in the EUA Fact Sheets. FDA and CDC continue to assess cases of myocarditis, 

pericarditis, immune thrombocytopenia, and thromboembolic events reported to VAERS 

following Janssen COVID-19 vaccination. FDA’s near-real-time surveillance has not revealed 

any safety signals for these AEs at this time. 

CDC conducts RCA through the VSD. This is near-real-time sequential monitoring for prespecified surveillance outcomes of interest that is conducted weekly. A relatively small number 

of Janssen vaccinations have been administered compared to mRNA COVID-19 vaccinations at 

about 440,000 compared to 14 million total mRNA COVID-19 vaccinations. No statistical signals 

have been detected for any VSD RCA pre-specified surveillance outcomes following Janssen 

COVID-19 vaccination in the 1-21 day risk interval. Descriptive analyses indicate an imbalance 

of GBS cases following Janssen vaccination compared to mRNA COVID-19 vaccination, with 

proportionally more GBS cases beings observed after Janssen COVID-19 vaccination. 

A CDC health alert went out in April after CDC and FDA detected cases of cerebral venous 

sinus thrombosis (CVST) with thrombocytopenia after receipt of the Janssen COVID-19 

vaccination. There was a pause on vaccination while CDC and FDA assessed the signal, and 

vaccination was resumed shortly thereafter.52 Since that time, CDC and FDA have continued to 

closely monitor TTS cases after Janssen vaccination. As of October 13th there were 47 

confirmed cases after 15.3 million doses administered. Looking at reporting rates by age group 

and by sex, the basic epidemiology or trends have not changed from earlier presentations that 

have been given during previous ACIP meetings. The reporting rates are higher in females 

compared to males, and highest in the females 30-39 years of age and 40-49 years of age. 

These cases include 5 deaths related to complications from TTS. The median age in these 

deaths is 37 years, and 4 of the 5 were female. All 5 had CVST, none received Heparin, and the 

median platelet count was 15,000. Anti-PF4 antibody ELISA testing was performed on 4 of the 

5, and all were positive with optical density values >2.0.

53 

To summarize Janssen COVID-19 vaccine safety monitoring, the current evidence suggests a 

causal association for TTS, though the condition is rare. Most cases have been in women, with 

most being 18-49 years of age. Monitoring in VAERS and VSD suggests a possible association 

between GBS and the Janssen COVID-19 vaccination. CDC, FDA, and federal partners will 

continue to assess emerging potential safety concerns, which include myocarditis/pericarditis, 

immune thrombocytopenia (ITP), and thromboembolic events. 

As mentioned earlier, the VSD conducts RCA. In terms of the safety of Janssen COVID-19 

primary vaccination followed by an additional mRNA COVID-19 vaccine dose based on data 

from the VSD as of October 16th, approximately 14.3 million doses have been administered and 

around 7.2 million members are fully vaccinated. A relatively small number of individuals (about 

5,400) are suspected to have had a Janssen plus an mRNA dose. Splitting out from that ~5,400 

the individuals who received a Janssen primary dose plus an mRNA dose with a minimum 

interval of 60 days between doses resulted in a total of 3,662 individuals. In terms of the 

51 https://www.fda.gov/media/153132/download 52 https://emergency.cdc.gov/han/2021/han00442.asp 53 Source of doses administered: https://covid.cdc.gov/covid-data-tracker/#vaccinations 

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ACIP Meeting Summary October 20-21, 2021 

demographics of the 3,662 individuals with that vaccination combination, there were slightly 

more males than females. That is consistent with Janssen vaccination in general in the VSD. 

Looking at VSD pre-specified surveillance outcomes among the 3,662 persons who received a 

Janssen primary vaccination and the subsequent mRNA vaccination at a minimum interval of 60 

days after the Janssen primary dose, 2 pre-specified surveillance outcomes were detected in 

the 1- to 42-day risk interval. There was an acute myocardial infarction in a male between the 

ages of 50-64, with an interval between the Janssen primary and the subsequent mRNA 

COVID-19 vaccination of 125 days. In addition, there was a seizure in a female in the age range 

25-29 years, with an interval between the Janssen primary and the mRNA vaccination of 142 

days. 

To summarize the VSD data of heterologous dose safety, limited data are available on the 

Janssen primary vaccination followed by an additional mRNA COVID-19 vaccination at a 

minimum interval of 60 days after the Janssen primary. There is a lack of evidence to date of a 

safety problem with respect to any of the pre-specified VSD surveillance outcomes for this 

vaccination practice. Dr. Shimbukuro emphasized to partners in the healthcare community, the 

public health community, and members of the public that they all could participate in vaccine 

safety monitoring. This can be done by anyone reporting AEs following COVID-19 vaccination to 

VAERS even if they are not sure the vaccination caused the AE; COVID-19 vaccine recipients 

enrolling in v-safesm, parents or guardians enrolling their children who receive COVID-19 

vaccine in v-safesm, and HCP encouraging their patients to enroll in v-safesm.

54 

Myocarditis: VAERS 

Dr. John Su (CDC/NCEZID) reported that as of October 6th, a combined total of 402,469,096 

doses of Pfizer-BioNTech, Moderna, and Janssen COVID-19 vaccine had been administered. 

During that time period, a total of 3,336 reports of myocarditis or pericarditis were made to 

VAERS, among which 2,459 were myopericarditis and 877 were pericarditis alone. As a 

reminder, myocarditis and myopericarditis are referred to collectively as myopericarditis. 

Through October 6th, the pattern remained similar to past updates where most reports were 

after Dose 2. Among the Dose 2 reports, most were after Pfizer-BioNTech vaccine. In terms of 

descriptive characteristics, the overall epidemiological trends remained the same. Generally 

after Dose 2, there was a younger median age, a slightly earlier median time to symptom onset, 

and a greater proclivity towards males relative to after Dose 1. 

While in the past observed versus estimated expected counts by age groups were presented, it 

was thought that perhaps a more neutral way of presenting those data would be to present 

reporting rates by age and vaccine manufacturer. Of the mRNA vaccines, there were 

366,062,239 doses of Dose 1 or Dose 2 of the mRNA vaccines administered. Inclusive of both 

sexes, reporting rates exceeded the estimated 1 to 10 per 100,000 person-years observed in 

background incidence after Dose 2 for Pfizer among persons 12-24 years of age and after Dose 

2 of Moderna among individuals 18-29 years of age. 

In terms of reporting rates for males after mRNA vaccines, there were 169,740,953 doses 

administered to males for Dose 1 and Dose 2 combined. For Pfizer Dose 2, reporting rates 

among persons 12-29 years of age exceeded the background rate. For Moderna Dose 2, 

reporting rates among persons 18-29 years of age exceeded the background rate. There were 

193,215,313 doses of mRNA vaccines administered to females for Dose 1 and Dose 2 

combined. The reporting rates for females did not appear to exceed background incidence. 

54 vsafe.cdc.gov/en/ 

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ACIP Meeting Summary October 20-21, 2021 

Taking into consideration that COVID-19 vaccines have been in use for less than a year and 

that there was a lower incidence of myocarditis among females relative to males, after Moderna 

Dose 2 for persons 18-29 years of age, there was a potential increased incidence of myocarditis 

among males relative to females. However, it is important to note that this possibility is not firm. 

With regard to care and outcomes, there were 1,640 reports among persons 29 years of age or 

younger. Of those, 877 met the CDC case definition of myopericarditis or myocarditis. Of those 

877, most (829) were hospitalized. Of the 829 who were hospitalized, 789 were discharged. 

Three-quarters of those who were discharged were known to have recovered from their 

symptoms at time of the report. Overall, a pattern was seen that was consistent with past 

updates. 

To summarize, as of October 6th there were a total of 3,336 reports of myopericarditis or 

pericarditis to VAERS. The epidemiology has remained consistent with previously reported 

updates. Myocarditis is being seen primarily in younger males after Dose 2 of mRNA 

vaccination. The limited follow-up information in VAERS case reports suggests that most 

patients recover from their symptoms. Reporting rates of myocarditis exceed background rates 

among males after Dose 2 of Pfizer for people 12-29 years of age and Dose 2 of Moderna for 

persons 18-29 years of age. All of these data are from VAERS and are subject to the limitations 

of VAERS (e.g., voluntary reporting, inconsistent quality/completeness of information, reporting 

biases, and inability to determine causality of AEs). 

Myocarditis: VSD 

Dr. Nicky Klein (KPNC) reminded everyone that the VSD was established in 1990 as a 

collaborative project between the CDC and 9 integrated healthcare delivery organizations, with 

data on more than 12 million members of VSD healthcare sites. The aims of the RCA are to: 1) 

monitor the safety of the COVID-19 vaccines weekly using pre-specified outcomes of interest 

among VSD members; and 2) describe the uptake of COVID-19 vaccines over time among 

eligible VSD members overall and in strata by age, site, and race/ethnicity. Surveillance began 

in December 2020. While a total of 23 outcomes are being monitored, the focus of this 

presentation was on the outcome of myocarditis/pericarditis based on COVID-19 vaccine uptake 

and primary analyses data through 10/09/2021. 

At the time of this analysis, over 14.2 million doses of COVID-19 vaccines had been 

administered in the VSD population. To date, nearly 72% of the VSD population has been fully 

vaccinated. The vast majority of vaccines distributed and administered to VSD members have 

been Pfizer and Moderna mRNA vaccines. Just under 450,000 doses of Janssen have been 

administered. Looking at the first dose by week of administration among persons 18-39 years of 

age, administration over time has not varied much and was very similar between the Pfizer and 

Moderna vaccine products. Most VSD members in that same age group received Dose 2 of the 

Pfizer vaccine at Day 21 as per the recommended intervals, with some scattered days around 

that in the week or two afterward. Similarly for Moderna, most people in that age group received 

their second dose on Day 28, again with small variability in a week or so afterward. 

Now moving on to the analytic strategy for RCA monitoring. For the primary analysis, the 

number of outcomes observed in the risk interval of 1-21 days after COVID-19 vaccination were 

compared to the number expected. The expected outcomes were derived from the “vaccinated 

concurrent comparators” who were in a comparison interval on Days 22-42 after COVID-19 

vaccination. On each day that an outcome occurred, vaccinees who were in their risk interval 

were compared with similar vaccinees who were concurrently in their comparison interval. 

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ACIP Meeting Summary October 20-21, 2021 

Comparisons were adjusted for age group, sex, race/ethnicity, VSD site, and calendar date. 

Based on the most recent surveillance, myocarditis/pericarditis met the signaling criterion of 

having a 1-sided p-value of less than 0.0048. There were signals in the VSD for myopericarditis 

for all ages based on adjusted analyses by VSD site, age, sex, race/ethnicity, and calendar 

date. 

Focusing now on a subgroup analysis of cases of confirmed myopericarditis after mRNA 

vaccine, chart reviews were completed through October 9, 2021 for 132 of 135 cases identified 

anytime post-vaccination among persons 12-39 years of age. There are 3 chart reviews 

pending. All cases following initial chart review were adjudicated by either an infectious disease 

clinician or a cardiologist. This adjudication confirmed that 103 of the 138 (78%) were 

myocarditis/pericarditis cases. Of those, 74 were among persons 12-39 years of age and 44 

were among persons 18-39 years of age in the 0-21 days after Dose 1 and 39 were among 

persons 18-39 years of age in the 0-7 days after Dose 1. 

In terms of the day of onset of confirmed myocarditis/pericarditis among persons 12-39 years of 

age after one dose of mRNA vaccine, the cases clustered within the first week after vaccination. 

Normal temporal scan statistics identified 3 overlapping clusters between Days 0-4, Days 0-3, 

and Days 0-5. These all had p-values of <0.0001. Looking at confirmed myocarditis/pericarditis 

for Days 0-7 risk interval among persons 12-39 years of age products and dose and the 

vaccinated concurrent competitors with the same analysis showed previously, the rate ratio for 

both mRNA vaccines was nearly 22 and they were all statistically significant. Given that Pfizer 

included persons 12-39 years of age and Moderna included persons 18-39 years of age, these 

two rate ratios could not be compared. The takeaway is that for both vaccines in VAERS, the 

Day 3-7 risk intervals were associated with an elevated rate ratio of myopericarditis. For the 

confirmed cases in the Day 0-7 risk interval among persons 18-39 years of age, there was an 

elevated rate ratio after both mRNA vaccines that was statistically significant. Numerically, the 

rate ratio after Moderna may be higher than the rate after Pfizer. This may indirectly suggest 

that Moderna might have a higher rate than after Pfizer. For Pfizer only among persons 12-17 

years of age in the 0-7 and 0-21 day risk interval by dose, the number of events in the risk 

interval was up to 30 after both doses in 0-21 days and there were zero events in the 

comparison interval. The rate ratios were very high, but could not be estimated precisely 

because there were cases in the comparison interval that were very high. The lower bound of 

the confidence interval was elevated for both the Dose 1 analysis and the Dose 2 analysis. 

To summarize myocarditis/pericarditis for Moderna versus Pfizer, the analyses of the vaccinated 

concurrent competitors indicated that both Pfizer and Moderna are associated with increased 

risk of myocarditis/pericarditis in persons 12-39 years of age. As a reminder, Pfizer results 

included persons 12-39 years of age and while Moderna’s included persons 18-39 years of age. 

The analysis of the vaccinated concurrent comparators indirectly suggests that Moderna 

vaccine is associated with more risk of myocarditis/pericarditis than Pfizer vaccine. However, to 

directly test whether the risk of myocarditis/pericarditis after Moderna differs from that after 

Pfizer, a head-to-head comparison was conducted on persons 18-39 years of age with the 

same confirmed cases of myocarditis/pericarditis through October 9th. Looking at the days 

between Dose 1 and Dose 2 for confirmed cases in the 0-21 risk interval, the same pattern was 

seen in the entire VSD population in the same age group that most individuals received their 

second doses per recommended 21 days after Pfizer or 28 days after Moderna or shortly 

thereafter. During the first 7 days after vaccination, the incidence rate after Moderna was higher 

than after Pfizer. 

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ACIP Meeting Summary October 20-21, 2021 

This analysis differed from what was shown in terms of the vaccinated concurrent comparators 

because in this case, Moderna and Pfizer vaccinees were directly compared only during the risk 

interval within groups. These groups were comprised of individuals inside the risk intervals of 

either 0-7 days or 0-21 days after vaccination. Individuals were in the same categories of age 

group, sex, race/ethnicity, and VSD sites and on the calendar day when an mRNA vaccinee had 

myocarditis/pericarditis. The rate ratios were estimated with 95% confidence intervals, or the 

rate post-Moderna divided by the rate post-Pfizer. The null hypothesis was tested that the rate 

of myocardial/pericarditis after vaccination does not differ 

between Moderna and Pfizer. For example, a 28-year-old male had myocarditis on June 28th. 

He had been vaccinated on June 23rd and therefore was within the 0-7 day risk interval. The 

comparators for this case include everyone who on June 28th was within the 0-7 day postvaccination risk interval after either vaccine. That is, they were vaccinated between 6/21 and 

6/28. 

In terms of the results of myocarditis/pericarditis in persons 18-39 years of age directly 

comparing Moderna versus Pfizer, the adjusted rate ratio was 2.56 after both doses of vaccines 

in the 0-7 day risk interval. That was statistically significant in the lower bound of the confidence 

intervals and had a significant p-value. The results were similar for the 0-21 day risk interval. 

The results after Dose 2 also were very similar in the 0-7 and 0-21 day risk intervals. Looking at 

myocarditis/myopericarditis and excluding pericarditis from this analysis among persons 18-39 

years of age directly comparing Moderna versus Pfizer, there was a statistically significant 

elevated rate ratio of 2.24 during the 0-7 day risk interval after both doses. That was similar also 

for Dose 2. While the 0-21 day interval was similar, it just missed statistical significance. In this 

head-to-head comparison of Moderna versus Pfizer there was an elevated rate ratio regardless 

of whether the analysis included myocarditis, both sexes, or males. This analysis also shows 

that the rate ratio was elevated for both sexes and that the Moderna vaccine was not associated 

with more myocarditis than Pfizer in males particularly. There were 13.3 excess cases per 

million doses when comparing Moderna to Pfizer after Dose 2 for both sexes. 

To summarize, for the initial analysis of the vaccinated concurrent comparators RCA analysis, 

the VSD formally signaled for myocarditis/pericarditis 21 days after both mRNA doses in the 

overall VSD populations, including all ages ≥12 years. In the subgroup of individuals 12-39 

years of age, the rate ratio for myocarditis/pericarditis was elevated after both Pfizer and 

Moderna during Days 0-21 after vaccinations, especially during Days 0-7. As a reminder, the 

Pfizer results included persons 12-39 years of age and the Moderna results included persons 

18-39 years of age. In the subgroup analyses, both mRNA vaccines were associated with 

myocarditis/pericarditis in persons 12-39 years of age. In terms of summary of the head-to-head 

comparison of Moderna versus Pfizer among persons 18-39 years of age, the rates of 

myocarditis/pericarditis after Moderna were significantly higher than after Pfizer during both the 

0-21 and 0-7 day risk intervals. The results were consistent when the analyses excluded 

pericarditis. Comparing Moderna versus Pfizer during the 0-7 days after Dose 2, there were an 

estimated 13.3 excess cases of myocarditis/pericarditis per million doses. Among persons 18-

39 years of age, there were no clear clinical differences amongst myocarditis/pericarditis cases 

between Moderna and Pfizer recipients. Most had a hospital length of stay of 1 day and none 

were admitted to the Intensive Care Unit (ICU). The takeaway for all of these analyses together 

is that both mRNA vaccines were associated with increased risk of myocarditis/pericarditis for 

persons 18-39 years of age as was Pfizer for persons 12-17 years of age. The head-to-head 

comparison provides evidence that the risk of myocarditis/pericarditis is higher after Moderna 

than after Pfizer. 

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VaST Assessment 

Dr. Keipp Talbot (VaST Chair) provided a summary from the VaST WG. As a reminder, the 

objectives of the VaST WG are to: 1) review, evaluate, and interpret post-authorization/approval 

COVID-19 vaccination safety data; 2) serve as the central hub for technical subject matter 

expertise from federal agencies conducting post-authorization/approval safety monitoring; 3) 

advise on analyses, interpretation, and presentation of vaccine safety data; and 4) provide 

updates to the ACIP COVID-19 Vaccines WG and the entire ACIP on COVID-19 vaccine safety. 

VaST continues to review COVID-19 vaccination safety data from passive and active 

surveillance systems. US safety monitoring systems include VAERS, VSD, FDA’s BEST 

System, VA, Indian Health Service (IHS), and DoD. In addition, there are data from Israel, 

Canada, and the Global Advisory Committee on Vaccine Safety (GACVS). Special evaluations 

are underway, such as follow-up studies on myocarditis cases. From December 21, 2020 to the 

present, VaST has had 38 independent meetings to review vaccine safety data and 10 joint 

meetings with the COVID-19 Vaccines WG focused on safety. VaST previously reviewed US 

safety for the September 22, 2021 ACIP vote on boosters. This session focused on an overview 

of selected Moderna and Janssen COVID-19 vaccination safety data; VaST assessments of 

Moderna and Janssen COVID-19 vaccination and heterologous boosting, VaST’s future plans. 

In terms of myocarditis/pericarditis, myocarditis following mRNA COVID-19 vaccination was first 

identified in May 2021.

55 CDC issued clinical guidance for myopericarditis following vaccination, 

and the data were presented at the VRBPAC meeting in June 2021. Data and the VaST 

assessment were presented to ACIP later in the month of June56 and an MMWR was published. 

EUA Fact Sheets were revised with Pfizer’s warning added on June 25, 2021. Even when 

Pfizer-BioNTech received its final FDA approval, information on myocarditis/pericarditis was 

included in the package insert.57 Data available to date show association of myocarditis with 

both mRNA vaccines in adolescents and young adults, with association among males greater 

than females. Some systems show greater risk after Moderna than Pfizer. This includes data 

from the US VSD and DoD and from Canada and Scandinavian countries. Other US safety 

monitoring systems do not show a difference between the 2 mRNA vaccines. Hence, further 

data are being compiled to understand the differences between the safety systems, optimal 

management strategies, and long-term outcomes. 

In terms of Moderna COVID-19 vaccination safety data specifically and Dose 3, there clinical 

trial data based on a 50 μg dose in 173 participants. There was no evidence of increased 

reactogenicity following a booster dose relative to Dose 2, with the exception of increased 

axillary swelling/tenderness of the vaccination arm.58 There are post-authorization safety data 

for Moderna Dose 3 using the 100 μg dose as the 50 μg dose59 has not previously been 

available. These data come from v-safesm and VAERS. Only people who are 

immunocompromised are currently recommended to receive a third dose of Moderna, but it is 

unclear whether these were just patients who are immunocompromised. Approximately 14,000 

persons reported Dose 3 to v-safesm. Local reactions were reported slightly more frequently and 

systemic reactions slightly less frequently following Dose 3 than Dose 2. VAERS had 

approximately 1,400 reports after a third dose. Over 92% of reports were non-serious. 

55 https://www.cdc.gov/vaccines/acip/work-groups-vast/index.html 56 https://www.cdc.gov/vaccines/acip/meetings/slides-2021-06.htm 57 https://www.fda.gov/media/151707/download 58 https://www.fda.gov/media/153087/download 59 Hause A, ACIP October 21, 2021 

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Now to discuss the safety of the Janssen vaccine, specifically with regard to TTS60 and GBS.61 

TTS surveillance continues in VAERS, which identified reports of CVST and TTS. The use of 

the vaccine was paused temporarily on April 13th. EUA Fact Sheets were updated with warnings 

about TTS and the pause was lifted on April 23rd. Through October 13th, there have been 47 

cases of TTS. Most cases were in women 18-49 years of age and evaluation is ongoing. While 

increasing rates have not been observed, there has been a steady rate. VAERS identified 

reports of GBS higher than expected, especially in males greater than females. EUA Fact 

Sheets were updated with information about observed risk on July 12th. Through July 24th, 130 

cases of GBS have been identified and observed reports have been higher than expected 

across multiple age groups. 

In terms of Janssen COVID-19 vaccination safety data for Dose 2, there are clinical trial data.62 

Approximately 9,000 participants received 2 doses at least 2 months apart. Approximately 2,700 

have had at least 2 months of safety follow-up. No new safety signals have been identified 

following a second dose. Interpretation of the data is limited by a small sample size and short 

interval, particularly for the 6-month interval post-Dose 1. There are some post-authorization 

safety data from people who decided to get a second dose without a recommendation.63 In vsafesm, there have been 83 reports and in VAERS there have been 39 reports. All the reports 

were non-serious in VAERS. 

To summarize the VaST assessment, there appears to be a slightly increased risk of 

myocarditis among persons 18-39 years of age after receipt of the Moderna primary series 

compared with Pfizer primary series, especially in males. Preliminary data from a follow-up 

study based on data from patients and parents suggest that the cases are generally mild, but 

this study is ongoing. In terms of Janssen COVID-19 vaccination, the risks for TTS and GBS 

appear to be unchanged from earlier assessments. While they are serious, they are rare. It is 

important to continue to communicate the balance of benefits and risks to the public and 

patients. 

In summary of the VaST assessment of booster doses, for Moderna COVID-19 vaccination 

there are limited data on risk of myocarditis after Dose 3. It is important to remember that the 

data available are based on the original 100 μg dose. Data on the safety of the reduced 50 μg 

dose are available only from a small clinical trial. It is unclear whether the risk of myocarditis will 

be the same or reduced with the reduced dose of the Moderna booster. For Janssen COVID-19 

vaccination, there are limited trial data and data from safety monitoring systems for Dose 2. 

Risks for TTS and GBS after booster dose are unlikely to be greater than with primary 

vaccination. Again, it is important to communicate the balance of benefits and risks to the public 

and patients. 

In terms of the VaST assessment of the heterologous booster, preliminary data from NIH mixand-match study64 and limited data from post authorization safety data suggest that boosting of 

Janssen COVID-19 vaccine recipients with an mRNA vaccine, or of mRNA COVID-19 vaccine 

recipients with Janssen COVID-19 vaccine, poses no additional safety risk compared with 

homologous boosting. There is no evidence to date of safety concerns with respect to any of the 

pre-specified VSD surveillance outcomes for Janssen COVID-19 vaccine recipients to receive 

an additional dose of mRNA COVID-19 vaccine. 

60 Shimabukuro T, ACIP October 21, 2021 61 https://www.fda.gov/media/153132/download 62 https://www.fda.gov/media/153130/download and https://www.fda.gov/media/153129/download 63 Hause A, ACIP October 21, 2021 64 Atmar R, ACIP October 21, 2021 

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ACIP Meeting Summary October 20-21, 2021 

With regard to next steps, VaST will continue to review safety regarding additional and booster 

doses as data become available; continue to collaborate with global vaccine safety colleagues 

on key issues that impact the benefit-risk balance; and provide updates to the ACIP COVID-19 

Vaccines WG and ACIP during future meetings. 

Discussion Summary 

• Dr. Sanchez recalled comments earlier about co-administration of the zoster vaccine with 

the COVID vaccine, which he has been asked a lot about. He anticipated that the topic of 

co-administration also would arise in future meetings with regard to smallpox vaccine. 

 Dr. Shimabukuro indicated that the observation earlier was specific to when COVID 

vaccines are administered with zoster vaccine. It is known from monitoring zoster 

vaccine that HZ is an AE reported after zoster vaccine, for which there are probably 

many reasons. One thing is that it is possibly something that a provider would not 

expect, so it gets noticed and reported to VAERS. However, it is not totally 

unexpected based on monitoring zoster vaccine alone. There is no evidence that 

administering the two vaccines increases the risk for AEs. There is some type of 

disproportionality, but it is probably the result of the of the co-administered zoster 

vaccine and is not related to a COVID-19 vaccination. 

• Dr. Long noted that while they like to talk about excess cases, to consider a case of 

traditional myocarditis as the baseline for myopericarditis following mRNA vaccines did not 

hold water and is not clinically relevant. These are not the same patients, so it is comparing 

apples and oranges. While she knows there is no question that there is an association, she 

did not think they should get hung up on trying to tell the public the number of excess cases, 

because they are not the same disease. 

• Dr. Lee inquired about whether there are estimates by gender and age for GBS following 

receipt of the Janssen vaccine. 

 Dr. Shimabukuro indicated that the age distribution of the Janssen cases in the 

various reports has been younger than for the mRNA vaccination reports in VSD. 

There also has been a different age distribution observed in VSD monitoring where 

the Janssen vaccinated cases were somewhat lower than the mRNA vaccinated 

cases. It was unclear if that was the result of the way the program was rolled out or 

something else. 

 Dr. Nair added that an article was recently published in JAMA discussing the cases 

of GBS that occurred following the Janssen vaccine, for which they will circulate the 

link. This was a case series of 130 GBS cases for which the median age was 56 

years, with roughly 60% men and 40% women. Essentially, 86% of those cases were 

in the age range of 18-64 years and 14% were older than 65 years of age. 

 Dr. Klein indicated that the mean age of the cases after receipt of Janssen vaccine 

was 48 years and there were no cases amongst individuals greater than 65 years of 

age. 

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• To avoid confusion, Ms. McNally requested that someone explain why the VSD and DoD in 

the US and Canada and Scandinavian countries were showing a greater risk while the FDA 

BEST systems and the VA were not. 

 Dr. Shimabukuro indicated that VAERS is a spontaneous reporting system. It is not a 

population-based; large, linked database; or EHR claims database system. VAERS 

is subject to the limitations of passive reporting. That said, looking at the VAERs data 

in terms of the reporting rates by age, sex, and product type, the interpretation is that 

no obvious signs are observed for a differential risk though there are some trends. 

They are not able to conduct the type of head-to-head formal statistical comparison 

as was done in VSD, so there are limitations to how VAERS data can be interpreted. 

 Dr. Cunningham said that in regard to DVA, it was likely due to the age of the patient 

population. While cases of myocarditis and myopericarditis were observed within 

their results, they did not signal. The majority of their patients who have received the 

vaccine are over 65 years of age, and myocarditis and myopericarditis occurs in the 

younger patient population. Their trends do follow that of the other systems in that 

they have more male patients and the myocarditis and myopericarditis occur in a 

short period of time after the vaccination and after Dose 2. 

 Dr. Forshee from FDA/CBER noted that with regard to active surveillance systems in 

particular and the slightly different results they are seeing, there are a couple of 

things to keep in mind when interpreting these results. The first is that these are still 

rare outcomes, which impacts certainly in the analysis. The confidence intervals are 

large, even in the meta-analysis they conducted of the four data partners that they 

use. There are also some differences in the patient pools and the different sites, 

such as geography. The BEST analysis was limited to people 18-25 years of age, 

which is a narrower age range than some of the others that have been reported. 

They also looked at males 18-25 years of age in their analysis. 

• ACIP members highlighted the following topics of interest for further exploration: 

 The Moderna versus the Pfizer associated risks with myocarditis is interesting and 

suggests that the etiology or pathogenesis of this occurrence might be related to 

some direct effect of the spike protein and the cardiac muscle. It would be interesting 

to better understand whether there may be a relationship with the larger Moderna 

dose of 100 μg in terms of the pathogenesis. 

 While both Pfizer and Moderna vaccines have been connected to myopericarditis, 

especially in people 12-39 years of age, nothing can really be said about Moderna 

for individuals 12-17 years of age who have received Moderna. Therefore, it is not 

terribly clear whether the youngest in the group who received Pfizer vaccine are 

more or less likely to have pericarditis. 

 Perhaps it would be worth considering incorporating chest pain as a solicited AE not 

only for clinical trials, but also for the manufacturers, particularly in thinking about 

expansion of vaccine to the pediatric population. Dr. Shimabukuro said that 

consideration could be given internally to adding chest pain, but it is somewhat nonspecific compared to myocarditis. 

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ACIP Meeting Summary October 20-21, 2021 

 While the need for a second dose for Janssen recipients was clear, concern 

remained about administration of a second dose due to the risk for TTS and GBS. 

More information about this would be beneficial. The opportunity for a heterologous 

boost is priceless at this point in the pandemic and in the understanding of the risks 

for TTS in young women with Janssen and myocarditis in young men with mRNA, 

particularly given that the full outcome is not yet understood. 

 Information about the relative use of the Janssen vaccine in individuals over 65 years 

of age would be beneficial to know. 

 Incidence of the risk of myocarditis associated with COVID-19 disease itself is 

important to consider. Dr. Oliver indicated that she would distribute the paper 

published out of Israel that compared the risks following COVID-19 infection to 

vaccination, which demonstrated a substantial rate of myocarditis associated with 

COVID infection. 

COVID-19 Vaccine Effectiveness: Primary Series 

Dr. Jefferson Jones (CDC/NCIRD) presented a summary of VE for the Moderna and Janssen 

vaccines using data available from CDC platforms or published via CDC’s MMWR and briefly 

summarized a global VE systematic review. Due to time constraints, VE study methods, 

platform descriptions, Pfizer data, and other details were included in supplementary slides for 

this presentation. Dr. Jones presented data by risk group, outcome, product and by pre-delta 

versus post-delta time period or time since vaccination for evidence of waning. Results 

presented previously to ACIP suggested that VE against infection had declined for mRNA 

vaccines, while studies for VE against hospitalization showed small to no reductions. 

Focusing on recent data, 4 state public health departments provided rates of cases by month of 

vaccination, age, and vaccine type. Based on cases reported for July 2021, decreasing case 

rates were seen in the Moderna cohorts with more recent vaccination (e.g., May and June). This 

suggests waning protection and was consistent in all age groups. Janssen denominators were 

lower and confidence intervals were wider, but increased case rates were seen among people 

vaccinated in March versus people vaccinated during other months. Younger age groups had 

higher case rates in all months for both vaccines. Rates were higher among Janssen recipients 

than among Moderna recipients. Hospitalization rates were not available from this data source. 

A different dataset, Cosmos, was used for hospitalization rates. This dataset utilizes data from 

over 700 participating hospitals and 10,000 clinics in all 50 states that use the Epic health 

record system. In terms of COVID-19 hospitalizations through August 2021, the Moderna 

COVID-19 hospitalization rates did not substantially differ depending on the month of 

vaccination. For Janssen, hospitalization rates were higher in those vaccinated in the most 

recent 2 months, June and July. For both vaccines, rates were higher among those ≥65 years of 

age than among younger age groups. Rates were higher among Janssen recipients than among 

Moderna recipients. 

Regarding VE among people ≥65 years of age, New York State (NYS) updated their data from a 

prospective study of adults in NYS that were published in the MMWR and presented during a 

previous ACIP meeting.65 VE calculated using a hazards proportion method were updated and 

presented by vaccine product and month of vaccination. These results included approximately 

155,000 cases and 40,000 hospitalizations. For Moderna, all ages had similar trends with 

65 Rosenberg et al. MedRxIV. https://www.medrxiv.org/content/10.1101/2021.10.08.21264595v1.full.pdf 

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ACIP Meeting Summary October 20-21, 2021 

decreases over time as Delta became the prominent variant in circulation. In August, small 

differences in VE were seen by cohort, with lower VE observed among those vaccinated in 

January and February compared with those vaccinated in April, suggesting waning VE against 

infection. VE decreased over time for Janssen, particularly for younger age groups. VE was 

higher in those vaccinated more recently, but the 95% confidence intervals were wide and 

frequently overlapped. In general, for both vaccines, no large differences were seen in VE by 

age. In terms of VE against hospitalization for NYS, no substantial decreases were seen for 

Moderna among persons 18 to 49 years of age or aged 50 to 64 years of age. Moderna had a 

small decrease among persons ≥65 years of age, but remained at above 94%. VE for Janssen 

was lower than VE for Moderna. For Janssen, clear decreases in VE over time or in VE by 

month of vaccination were seen. For both vaccines, VE did not differ by month of vaccination, 

suggesting no waning in VE against hospitalization by month of vaccination. For both vaccines, 

VE for ≥65 years of age was lower than VE for younger ages. 

The Increasing Community Access to Testing (ICATT) platform was presented previously and 

has been updated. ICATT is a nationwide, community-based platform that utilizes COVID-19 

testing performed via pharmacies and partners. VE is calculated using a test-negative case 

control design. Looking at VE against symptomatic infection for the Moderna vaccine, VE 

against symptomatic infection was lower during the Delta period than during pre-Delta, and 

waned during both periods. For persons ≥65 years of age, VE was lower than for other age 

groups. However, no clear trend has been seen over time. For the Janssen vaccine, there was 

a lack of sufficient pre-Delta samples. VE against symptomatic infection during the Delta period 

appeared to be stable over time, and there were no clear differences by age. However, the 

confidence intervals are wide among the older age groups. 

The Surveillance Platform for Enteric and Respiratory Infectious Organisms (SUPERNOVA) is a 

platform with data from 5 VA hospitals using a test-negative case-control design that was 

presented previously. It was updated with data through September 17th and stratified by age 

group. The updated data showed that VE remained lower in people 65 years of age and older at 

78% than in younger ages at 95%. Analyzing VE by time from vaccination among all ages 

showed a decline in VE against hospitalization. VE was lower in people vaccinated 120 days or 

more prior at 82% than in those people vaccinated more recently at 90%, but the 95% 

confidence intervals overlapped 

To summarize VE among people ≥65 years of age who received Moderna, VE against 

hospitalization was lower in people ≥65 years of age compared with VE in younger adults. 

Some studies showed moderate declines in VE against infection and small declines in VE 

against hospitalization. For Janssen, VE was lower compared with mRNA vaccines for VE 

against infection and hospitalization. The evidence of VE over time was inconsistent across 

studies. Fewer data were available so VE estimates were less reliable for Janssen compared 

with mRNA vaccine estimates. 

Now looking at VE for adults aged <65 years with underlying medical conditions, the data 

presented excluded those with immunocompromising conditions since that group already was 

authorized to receive a booster dose. The Influenza and Other Viruses in the Acutely Ill (IVY) 

Network is a collection of 21 medical centers in 18 states. VE was estimated using a testnegative case-control design for VE against hospitalization among immunocompetent adults 

≥18 years for the period of March 11 through September 15, 2021 for Moderna and Janssen 

vaccines. For Moderna recipients, VE was higher for all ages among people with no chronic 

conditions and remained high for people vaccinated 120 days or greater prior. For people with 

chronic conditions, VE was lower than for people without chronic conditions. VE was mildly 

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ACIP Meeting Summary October 20-21, 2021 

lower for people vaccinated greater than 120 days prior among the chronic condition group, but 

the 95% confidence intervals overlapped. For Janssen vaccine recipients, insufficient data were 

available to calculate VE by age and by time vaccinated. VE in people with chronic conditions 

was lower than VE in people without chronic conditions. Again, the confidence intervals 

overlapped. VE for Janssen was lower than VE for mRNA vaccines. 

The VISION Network involves over 185 hospitals. Through this network, VE against COVID-19 

ED and urgent care (UC) visits was estimated among immunocompetent adults without chronic 

conditions for the period of June-September 2021 using a test-negative case control design. In 

all age groups (18-44, 45-64, ≥65), Moderna VE was higher than Janssen VE. In all age groups, 

Moderna VE showed a modest waning trend and there was no consistent pattern of waning for 

Janssen. For adults with chronic conditions, Moderna VE was higher than Janssen VE in all age 

groups. For Moderna, modest waning was observed in persons 45-64 year of age and persons 

≥65 years of age. For Janssen, no consistent waning was seen. For both vaccines, waning in 

VE was more pronounced in the oldest age group. In all age groups, Moderna VE was higher 

than Janssen VE against hospitalization for adults with chronic conditions. In all age groups, 

Moderna VE showed a modest waning trend but was most pronounced among persons ≥65

years of age. Again, Janssen showed no consistent waning in VE. 

In summary, for adults aged less than 65 years with underlying medical conditions there was a 

mild decline in VE against hospitalization, ED, and urgent care visits among Moderna recipients. 

Nevertheless, VE remained high. For Janssen, VE was lower compared with VE for mRNA 

vaccines for both infection and hospitalization and there was no consistent evidence of waning. 

Data looking at VE for workers employed in occupations with high risk of exposure to SARSCoV-2 was not updated and was previously presented to ACIP. The Healthcare, Emergency 

Response, and Other Essential Workers Surveillance Study-Research on the Epidemiology of 

SARS-CoV-2 in Essential Response Personnel (HEROES-RECOVER) platform includes a 

cohort of over 4000 healthcare workers, first responders, and other frontline workers in 8 US 

locations who were vaccinated almost exclusively with the mRNA vaccines. Results from this 

platform showed that VE against infection decreased with increasing time from vaccination 

from 85% to 73%, but confidence intervals overlapped. VE during Delta was 66% and during 

pre-Delta was 91%. The study did not have sufficient power to look at time since vaccination 

during both the pre-Delta and Delta periods and no difference in VE was seen between the 

mRNA products.66 

In terms of global data, there is an ongoing systematic review conducted by the World Health 

Organization (WHO) and the International Vaccine Access Center (IVAC) at Johns Hopkins 

University (JHU). The IVAC/WHO review shows that CDC results are consistent with other 

published studies. Studies that were captured included those from the US, UK, Canada, and 

Qatar. Most studies included pre-Delta data and published data from CDC studies, some of 

which have been presented. The forest plot of VE against death and severe disease, 

including hospitalization, showed VE of 89% to 100% for Moderna. For Moderna, VE against 

any infection ranged from 75% to 100%. VE specifically against asymptomatic infection ranged 

from 70% to 90%.67 

66 https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm 67 https://view-hub.org/resources 

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ACIP Meeting Summary October 20-21, 2021 

Next to review a pre-print study conducted in the US that examined VE over time since 

vaccination. This study was funded by Moderna and used a test-negative design with Kaiser 

Permanente Southern California (KPSC) patients. There were 8153 cases diagnosed between 

March and July 2021, each of which was matched with 5 controls. VE against infection with 

Delta declined from 94% for those 14 to 16 days after the second dose and declined to 80% 

for those vaccinated 151 to 180 days after the second dose. VE in individuals ≥65 years of age

or older was lower (75%) compared with VE in younger persons (88%). VE against 

hospitalization over time was not presented in the manuscript due to small numbers, but was 

greater than 96% for Delta and non-Delta.68 

Returning to the IVAC/WHO systematic review for Janssen vaccine, VE against severe disease 

ranged from approximately 60% to 85%, which was lower than the estimates for mRNA 

vaccines. VE against any infection or symptomatic disease ranged from 12% to 95%, but many 

studies had wide confidence intervals because of the small numbers of people who had 

received the Janssen vaccine. 

Next to highlight a study that examined Janssen VE against medically-attended infection and 

hospitalization over time in the US.69 This Janssen-funded cohort study used HealthVerity 

insurance claims data and matched approximately 390,000 vaccinated individuals between 

March and July 2021 with approximately 10 unvaccinated controls each by location, age, sex, 

and comorbidity index. VE was estimated using a proportional hazards design. Medicallyattended COVID-19 was defined as COVID-19 ICD-10 code or PCR-positive results, and 

COVID-19 hospitalization was defined as a discharge diagnosis of COVID-19 or any COVID-19 

positive test within 21 days of hospitalization. It was assumed that there was 40% unreported 

vaccination in the control group. After assuming under-reporting of 40% of vaccination, the 

correction increased the VE point estimates by approximately 8% to 10%. The study found VE 

against medically-attended COVID-19 and VE against hospitalization to be stable over time. 

Without correcting for unreported vaccination, VE was found to be lower in people ≥50 years of 

age (54%) than in people 18-49 years of age (75%). VE against hospitalization was lower for 

persons ≥50 years of age (71%) than for people 18-49 years of age (79%). 

Several limitations leading to biases or potential biases should be considered for VE studies in 

general. Individuals prioritized for vaccination early in vaccination campaigns were often those 

at high-risk for SARS-CoV-2 infection and/or severe COVID-19, such as frontline workers, older 

adults, and long-term care facility residents. This could lead to overestimations of waning of VE 

when comparing VE in those vaccinated early with those recently vaccinated. However, highrisk groups may practice prevention measures more frequently and lead to over-estimation of 

VE estimates. After vaccination, people may change their behavior, engaging in riskier activities, 

or seek testing less because of confidence of protection. However, some studies report 

vaccinated people practice preventive measures more frequently. The use of a test-negative 

study design partially addresses test-seeking behavior. As more time elapses since vaccination, 

it is possible that there may be more misclassification of vaccination status. For instance, 

vaccination status is not documented for some people and may result in falsely assigning them 

to the unvaccinated group. In addition, SARS-CoV-2 infection and subsequent population 

infection-derived immunity will increase over time in the unvaccinated group, resulting in 

protection from further infection and leading to an apparent waning of VE. 

68 Bruxvoort, medRxiv, https://www.medrxiv.org/content/10.1101/2021.09.29.21264199v1 69 Polinski et al., medRxiv, https://www.medrxiv.org/content/10.1101/2021.09.10.21263385v1.full.pdf 

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In summary, Moderna VE against infection declines over time. Both circulation of the Delta 

variant and increasing time from vaccination appear to contribute to these declines. For people 

≥65 years of age, VE against hospitalization is lower compared with VE in younger adults. 

Some studies show moderate declines in VE against infection and small declines in VE against 

hospitalization. For adults <65 years of age with underlying medical conditions, there is a mild 

decline of VE against both hospitalization and against ED or EC visits, but VE remains high. For 

people in occupations with a high-risk exposure to SARS-CoV-2, there currently are no 

Moderna-specific data available at this time. For mRNA vaccines, one study showed that VE 

against hospitalization was declining. For the Janssen vaccine, VE against both infection and 

hospitalization was lower compared with VE for mRNA vaccines. Evidence of waning of VE over 

time was inconsistent across studies. However, fewer data are available and VE estimates for 

the Janssen vaccine are less reliable. 

Discussion Summary 

• While protection or effectiveness against infection, hospitalization, and severe disease was 

clearly outlined, it is important not to be confused by protection against infection as that has 

not been the goal of this vaccine. 

• Regarding mention that the persons who were vaccinated first were much sicker than those 

who were vaccinated later, concern was expressed that these data seemed to be comparing 

apples and oranges and as such might not be applicable. Even with the HCW, many 

hospital systems were counting the number of comorbid conditions and persons with 6 or 

more comorbid conditions were first in line. 

• It is important to separate HCW and frontline workers who had underlying conditions from 

those who were young and otherwise healthy. Then the risk of pericarditis/myocarditis or 

TTS must be weighed looking at more severe disease in these individuals and over time. 

 Dr. Jones responded that they can work with the platform to determine what data 

potentially could be developed on that front. For now, they could compare with the 

other platforms (e.g., NYS, IVY, and VISION) that also assessed younger age 

groups or specifically the IVY and VISION groups that looked at younger age groups 

with chronic conditions. There is likely applicability to those that were in the general 

population versus the HCW group showing VE decreasing more for infection and 

having smaller declines in hospitalization. 

• It is difficult to interpret the data on the Delta variant due to the very wide confidence 

intervals. While no doubt there has been some waning and a change in the Delta variant 

that impacted VE for Moderna, it may not be as striking as it seemed based on the data 

shown. 

 Dr. Dooling concurred about potential confounding in the health status of people who 

received vaccine earlier in the vaccine roll-out and how that might be affecting the 

VE being observed over time since vaccination. The Moderna long-term study of 

their RCT recipients and the follow-up study in which they crossed over and 

vaccinated placebo recipients do provide some informative data in that these were all 

trial study participants who were randomized at the beginning. In that study, which 

was presented earlier by Moderna, a slight decrease in VE was observed for people 

who were vaccinated earlier in the program. 

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 Dr. Jones added that there have been two types of evidence, the pre-Delta versus 

Delta and then the time from vaccination. 

• If a person has an increased risk because of their occupation, it could be a failure to follow 

non-pharmaceutical interventions (NPIs) such as masking, ventilation, physical distancing, 

et cetera. In terms of booster doses, the American public should not receive a diluted 

message about the importance of layering all NPIs. This is extremely important, especially 

for those with occupational risk or others who have a higher risk of encountering the virus. 

Prevention of severe disease is very important. Trying to prevent all forms of infection might 

be too much to ask of either a primary series or booster. 

• In terms of potential confounders influencing estimates of VE over time, perhaps there is a 

better way to characterize or quantify the impact of increasing risk behaviors or increasing 

natural infection among control groups that would lead to a better understanding of the 

extent to which these may be influencing current VE estimates. For instance, perhaps a 

10% change in risk behaviors could be modeled to ascertain how much of an impact that 

would have on VE estimates. 

 Dr. Ferdinands acknowledged the challenge in trying to assess differences that might 

be associated with changes in risk behavior, given that they are very hard to 

characterize. That is a limitation of the VISIONS data. 

 Dr. Jones added that they would discuss the modeling suggestion with their other 

platforms and would get back to ACIP. 

EtR Framework 

Dr. Kathleen Dooling (CDC/NCIRD) reviewed the EtR Framework for Moderna and Janssen 

COVID-19 vaccine booster doses. As a reminder, vaccine policy development is conducted 

in close coordination with FDA. It begins with a data review of the evidence and is followed by 

FDA regulatory allowance, which was received the previous day. That is followed by ACIP 

deliberation and recommendations for input into CDC vaccine policy. At the time of this 

presentation, CDC recommended the following groups for Pfizer BioNTech COVID-19 vaccine 

boosters: 

 The following recipients of Pfizer-BioNTech COVID-19 vaccine primary series should 

receive a single booster dose ≥6 months after completion of the primary series: 

- ≥65 years – ≥18 years and reside in long-term care settings 

- Aged 50-64 years with certain underlying medical conditions 

 The following recipients of Pfizer-BioNTech COVID-19 vaccine primary series may receive a 

single booster dose ≥6 months after completion of the primary series based on their

individual risks and benefits: 

- Aged 18-49 years with certain underlying medical conditions 

- Aged 18-64 years at increased risk for SARS-CoV-2 exposure and transmission 

because of occupational or institutional setting 

The policy questions addressed during this session were: 1) Among risk groups for whom CDC 

recommends a Pfizer BioNTech booster dose, should those who received a Moderna COVID-19 

vaccine primary series be recommended to receive a single Moderna COVID-19 booster dose 

(50ug) ≥6 months after completion of the primary series?; and 2) Among people aged ≥18 years

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who were initially vaccinated with Janssen COVID-19 vaccine, should a booster dose of 

Janssen COVID-19 vaccine be recommended 2 months or more after receipt of the initial dose? 

To date, more than 189 million people in the US have been fully vaccinated. Approximately 105 

million (~66%) fully vaccinated persons have received the Pfizer primary series, approximately 

70 million (~37%) have received the Moderna primary series, and approximately 15 million 

(~8%) have received a dose of Janssen COVID-19 vaccine.70 

In terms of the public health problem, there have been almost 45 million cases of COVID-19 in 

the US since the beginning of the pandemic. The current wave, during which Delta variant 

predominated, peaked in early September and has been on the decline since then. Similarly, 

the daily trends in the number of hospitalized COVID-19 cases has been declining in the US 

over the past several weeks.71 In July and August 2021, hospitalization rates dramatically 

increased among unvaccinated individuals and increased only slightly among the fully 

vaccinated.72 Among the various age groups, hospitalization was 9-15 times higher among 

unvaccinated compared to vaccinated persons.

73 

Hospitalization is not the only debilitating consequence of COVID-19. Long COVID-19 

conditions are a wide range of new, returning, or ongoing health problems people can 

experience 4 or more weeks after first being infected with SARS-CoV-2 virus. The prevalence of 

post-COVID-19 conditions among both vaccinated and unvaccinated persons has been 

reported at between 5% and 80% depending upon on the study.74 The prevalence of long 

COVID-19 among fully vaccinated persons who develop COVID-19, ranges from 5% reported in 

the study out of the UK in adults75 to 19% in a study of Israeli healthcare workers.76 Among 

COVID-19 cases in that same UK study, the odds of developing long-COVID were reduced by 

almost half among fully-vaccinated compared to unvaccinated cases. 

To summarize the VE of the primary series of both Moderna and Janssen as Dr. Jones 

emphasized in his detailed presentation, waning of mRNA vaccines has been more pronounced 

against infection than against hospitalization. Compared to the pre-Delta period, VE generally 

has been lower in the Delta period. As demonstrated in published studies mostly involving 

mRNA vaccines, waning protection against infection was most pronounced in July during the 

Delta wave.77 Nanduri et al reported VE among nursing home residents that was lower than 

what was found in younger adults, and it waned over time. Conversely, VE against 

hospitalization has remained fairly constant over calendar time.78 VE against hospitalization also 

was constant when analyzed as time since vaccination. Janssen VE was lower than that 

observed for mRNA vaccines. 

In summary of VE, more than 189 million people in the US are fully vaccinated. That is 

approximately 57% of the total population. Hospitalization rates are 9-15 times higher in 

unvaccinated as compared to fully vaccinated adults. The Moderna primary vaccine series has 

been used to vaccinate about 37% of those fully vaccinated. It appears to have declined against 

70 https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed October 20, 2021 71 https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed October 19, 2021 72 https://covid.cdc.gov/covid-data-tracker/#hospitalizations Accessed 10.20.2021 73 https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination 74 Cabrera Martimbianco AL, Pacheco RL, Bagattini ÂM, Riera R. Frequency, signs and symptoms, and criteria adopted for long 

COVID-19: a systematic review. Int J Clin Pract 2021;e14357. Epub May 11, 2021. PMID:33977626 75 Antonelli, M et al. “Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom 

Study app: a prospective, community-based, nested, case-control study.” The Lancet Infectious Diseases (2021) 76 Bergwerk, M et al. "Covid-19 breakthrough infections in vaccinated health care workers.” New England Journal of Medicine (2021) 77 Nanduri et al (nursing home residents), Rosenberg, et al, Puranik, et al, (Pfizer), Puranik, et al (Moderna), Fowlkes et al (HCW, 

first responders), Keehner, et al (HCW, first responders) 78 Tenforde, et al, Rosenberg, et al, Puranik, et al (Pfizer), Puranik, et al (Moderna), Bajema et al 

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infection over time and during the Delta period. On the other hand, there have been minimal to 

no declines in VE against hospitalization in younger adults and mild declines observed in some 

study platforms among older adults. Approximately 8% of fully vaccinated people received the 

Janssen COVID-19 vaccine. This vaccine has shown lower VE compared to mRNA vaccines. 

However, study platforms have shown persistent VE over time against infection and 

hospitalization—even among older adults. 

In terms of the evidence for benefits and harms of Moderna and Janssen COVID-19 boosters, 

the population examined for Moderna were adults ≥18 years of age at least 6 months or more 

following the primary regimen and Janssen booster dose and for Janssen were persons ≥18 

years who completed a COVID-19 vaccine primary series ≥2 months following the primary 

regimen. The intervention was a Moderna COVID-19 vaccine booster dose (mRNA-1273, 50 μg,

IM) or a Janssen COVID-19 vaccine booster dose (Ad26.CoV2.S, 5x1010 VP, IM), and the 

comparison was those who received the primary series but no booster dose. The outcomes 

were consistent with those assessed for the Pfizer booster doses: symptomatic laboratoryconfirmed COVID-19 (critical), hospitalization due to COVID-19 (critical), death due to COVID19, transmission of SARS-CoV-2 infection, SAEs (critical), and reactogenicity. 

The evidence retrieval for Janssen booster doses yielded 2 clinical trial records and no 

observational VE studies. Similarly, the evidence retrieval for a Moderna booster dose 

as intervention yielded 2 clinical trial records and no observational VE studies. Moderna’s data 

for immunogenicity of a 50 μg booster following the primary series of 100 μg came from a study 

of 149 subjects. A larger group with immunogenicity data available following the primary series 

was used as a comparison group. At 28 days following the booster dose, neutralizing antibody 

titers were 1.8 times those in the comparison group, thus meeting the pre-specified endpoint for 

non-inferiority. However, no clinical outcomes were assessed and participants were not 

randomized to the intervention or comparison group. Therefore, the evidence type to assess the 

prevention of symptomatic COVID was Type 4, or very low certainty. There were no data 

available to assess prevention of hospitalization, death, or transmission of SARS-CoV-2. With 

respect to possible harms, no SAEs were attributed to the 171 subjects assessed for safety of a 

Moderna COVID-19 booster at 50 μg. The proportion with any SAE was balanced between the 

intervention and the comparison arm. In terms of reactogenicity, 10.8% of the Moderna 50 μg 

booster group experienced a Grade 3 or more severe reaction compared to 19.7% of the 100 

μg primary series comparison group. Both of these harms outcomes were downgraded as a 

result of the study design, risk of bias, and small study size. Both were judged to be Type 4 

evidence. 

Janssen’s evidence for use of a booster dose was primarily generated from a clinical trial in 

which subjects were randomized to receive 2 doses of Janssen vaccine 56 days apart versus 

placebo. Wherever possible, the effects of the booster dose administered to approximately 7484 

participants was compared to a primary dose administered to over 19,000 participants in their 

initial clinical trial. The Janssen COVID-19 booster dose seems to be more effective at 

preventing symptomatic laboratory-confirmed COVID-19 than the primary dose alone. However, 

because participants were not randomized to the intervention and comparison groups and the 

results were compared across 2 separate studies that differed in time and geography, the 

evidence type was very low, Type 4. The Janssen booster dose may be more effective than the 

primary dose at preventing hospitalizations and deaths due to COVID, but because of concerns 

with study design, risk of bias from considerable dropout, and imprecision resulting from small 

numbers of outcomes, the evidence type for both was Type 4. There were no data to assess the 

prevention of transmission. For SAEs, over 8000 participants who received the Janssen booster 

dose were compared to placebo recipients. The proportion with any SAEs was balanced 

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between the booster and the placebo arms. However, three SAEs were attributed to the 

Janssen COVID booster dose by study staff. Those were facial paralysis, pulmonary embolism, 

and cerebrovascular event. With respect to reactogenicity, the proportion with Grade 3 reaction 

or a more severe reaction following a booster was similar to or less than after the primary dose. 

Because of loss to follow-up, short duration of follow-up, indirect comparison, and imprecision, 

the evidence was Type 4, or very low certainty for both arms that were assessed. 

Another way to assess the benefit of a booster dose is calculating the number of people needed 

to vaccinate with a booster dose to prevent one hospitalization. An analysis for Pfizer, Moderna, 

and Janssen COVID-19 vaccine booster doses was based on current estimates of VE following 

the primary series and the estimated increase in protection resulting from a booster. The ≥65 

years of age group required the fewest people to receive a booster dose to prevent a 

hospitalization, whereas younger adults required more people to be vaccinated with a booster to 

prevent a hospitalization. 

Large-scale and rigorous post-authorization safety surveillance has identified safety issues that 

may be too rare to see in standard clinical trials. As discussed in detail during the safety 

presentations earlier in the day, myocarditis and pericarditis have been observed following the 

Moderna COVID-19 primary series. This has been noted and included in the EUA Fact Sheet. 

The risk was noted to be particularly high within 7 days following the second dose and was 

highest among males under 40 years of age. Although most cases resolve, the long-term 

sequelae are not fully understood.79 The highest reporting rate has been in males 18-24 years 

of age in the 7 days following Dose 2 and has been reported at 39 cases per one million doses 

administered.80 

TTS has been identified following Janssen primary vaccination. TTS involves blood clots with a 

low level of platelets and has been reported at the highest rates in females 18-49 years of 

age.

81 The highest reporting rate in females 30-39 years of age in the 21 days post-dose has 

been 10 cases per one million doses administered.82 GBS has been identified following receipt 

of Janssen vaccine. The highest reporting rate has been seen in males 50-64 years of age and 

has been reported at 16 cases per one million doses administered.83 

Heterologous boosting, also known as mix-and-match, could provide important immune benefits 

and enhanced feasibility of implementation of a booster dose program as presented earlier in 

the day by Dr. Atmar. To recap, the NIH-sponsored study showed that use of Moderna, 

Janssen, and Pfizer BioNTech COVID-19 vaccines as boosters led to strong serologic 

responses in groups primed by all 3 of those vaccines. For a given primary COVID-19 vaccine, 

heterologous boosts elicited similar or higher serologic responses as compared to their 

respective homologous boosting responses. mRNA vaccines resulted in higher antibody titers 

in the first 28 days after the boost. Although the study arms were small, involving somewhere 

between 49 to 53 subjects, no safety concerns were identified. 

79 Moderna COVID-19 Vaccine Fact Sheet for Health Care Providers (fda.gov) 80 VAERS 81 Janssen COVID-19 Vaccine Fact Sheet for Recipients and Caregivers (fda.gov) 82 VAERS 83 Janssen COVID-19 Vaccine Fact Sheet for Recipients and Caregivers (fda.gov); Rosenblum et al. MMWR, Volume 70, Issue 32 

— August 13, 2021 (cdc.gov) 

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In terms of values and acceptability with regard to booster doses, published studies completed 

in August before the recommendation for booster doses showed that 76% to 87% of vaccinated 

adults reported that they would get a booster dose if available.84 This increased to 93% in one 

survey of adults if the booster was recommended by their PCP. Prior to booster doses being 

recommended on September 23rd, approximately 3 million additional doses had been 

administered, presumably mostly to immunocompromised individuals. Following the booster 

dose recommendation, the total number of booster or additional doses increased to 

approximately 10.9 million. The vast majority of booster doses have been administered to 

people 65 years of age and older.85 

Regarding the feasibility and implementation of boosters, most recipients of the 3 available 

vaccines completed their primary vaccine regime more than 6 months ago. That is 12.9 million 

potentially eligible persons for Janssen, over 47 million for Pfizer-BioNTech, and over 39 million 

for Moderna. Among the total portion who would be eligible to receive a booster dose, almost 18 

million people are over 65 years of age and about 21 million are younger people.86 

Implementation of the booster dose within long-term care facilities (LTCF) has already begun. 

CDC’s Federal Retail Pharmacy Program (FRPP) provides vaccination support to LTCF, 

including on-site vaccination clinics where needed, to help residents access vaccines in the 

local community. Over 8 million doses were administered during the LTCF facility program rollout that occurred from December 2020 to March 2021. That included 6.2 million (76%) Pfizer 

BioNTech doses and 1.9 million (24%) Moderna doses in that initial roll-out. Thus far, the 

program support for booster doses has been restricted to Pfizer BioNTech recipients based on 

current FDA and CDC guidance. This has left anybody who initially received Moderna or 

Janssen unable to participate in the LTCF program. 

Now turning to the domain of resource use. All COVID-19 vaccines, including booster doses, 

will be provided free of charge to the US population. Although free to the end-user, health 

systems or health departments incur costs for vaccination program planning and 

implementation. Fees for administration of COVID-19 vaccines recommended by ACIP and 

CDC are reimbursed by insurance and other federal programs. Ultimately, cost-effective 

analyses for COVID-19 vaccines will take on increased importance in the future when the public 

health emergency is over. 

For the domain of equity, race/ethnicity is known for the approximately 9.8 million people with a 

booster or additional dose administration. That represents about 90% of all of the additional 

doses or booster doses that have been administered since August 13th. Both Black nonHispanic and Hispanic Latino groups comprise a lower share of booster dose recipients 

compared to their fraction of the US population. It should be noted that these data are not agestandardized.87 It is important to note that while COVID-19 disease and COVID-19 vaccination 

vary by socioeconomic and sociodemographic groups, VE does not vary by race/ethnicity or 

economic variables. At present, only recipients of the Pfizer BioNTech COVID-19 vaccine 

primary series have been recommended to receive a booster, thus creating an inequity for 

recipients of Moderna or Janssen. Moreover, Janssen COVID-19 vaccine may have been used 

84 Axios Ipsos Poll. August 2, 2021; Axios Ipsos Poll. August 30, 2021; Marist Poll. September 3, 2021; 

https://maristpoll.marist.edu/polls/npr-pbs-newshour-marist-national-poll-covid-september-3-2021/; Morning Consult Poll. August 

25, 2021. https://morningconsult.com/2021/08/25/covid-booster-shot-poll/; Reuters/Ipsos Poll. September 1, 2021. 

https://www.reuters.com/business/healthcare-pharmaceuticals/most-vaccinated-americans-want-covid-19-booster-shotsreutersipsos-poll-2021-09-01/ 85 Immunization Data Lake. Data as of October 19, 2021. 86 CDC Immunization Data Lake. Data as of September 9, 2021 87 Immunization Data Lake Aggregate Dataset (includes TX). Data reported as of 19OCT2021 0600. 

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more commonly for outreach to homeless or medically-underserved communities because it is a 

single-dose regimen. 

In summary, the WG maintained that the top priority should be to continue vaccination of 

unvaccinated individuals. The goals of the booster program should be the prevention of severe 

disease, including hospitalization and death. Other considerations also are important, such as 

maintaining workforce and healthcare capacity, prevention of transmission, and individual 

benefit/risk balance. The balance of benefits and risks varies by age. For example, adults 65 

years of age and older have the clearest benefits over risks. For Moderna vaccine, benefits are 

incrementally smaller with decreasing age, given the high effectiveness maintained for the 

primary series. Also, myocarditis risk is higher among young adults. For Janssen, the benefits 

may be smaller across all age groups compared with mRNA vaccines and TTS risk is higher 

among young females. 

For people who received Moderna COVID-19 vaccine as a primary series, the WG supported 

using a single booster dose ≥ 6 months following the primary series in certain populations, 

which is consistent with CDC-recommended populations for Pfizer BioNTech COVID-19 

booster. For people who received Janssen COVID-19 vaccine as a primary vaccination, the WG 

supported using a single booster ≥ 2 months following the initial dose in all people ≥ 18 years of 

age. A single dose of Janssen COVID-19 vaccine results in lower VE and antibody levels 

compared to an mRNA vaccine primary series. Data demonstrate that a single dose of Janssen 

or mRNA COVID-19 vaccine boosts immune responses in these individuals. 

Discussion Summary 

• It is important to remember that some international individuals may have received a WHO 

pre-qualified vaccine before coming to the US and that consideration must be given to 

whether there will be latitude within these clinical considerations for them to receive a mixand-match booster dose. 

 Dr. Dooling indicated that this is under active consideration and certainly will be part 

of the clinical considerations. 

Clinical Considerations 

Dr. Sujan Reddy (CDC/NCEZID) reviewed updates to the interim clinical considerations for 

Moderna and Janssen COVID-19 vaccine booster doses in terms of indications for vaccine 

boosters doses, heterologous (mix-and-match) booster dosing, booster administration, the 

definition of “fully vaccinated,” co-administration with other vaccines, and contraindications and 

precautions. She reviewed the indications for a booster dose following an mRNA COVID-19 

primary series, which Dr. Dooling presented earlier, noting that they were slightly different from 

what the FDA announced the previous day. 

As a reminder, for the category of people who “may receive” an mRNA booster, an individual 

risk/benefit assessment was recommended that considers factors such as the following: 

 Individual risk factors for SARS-CoV-2 infection: 

- Risk of exposure (occupational or institutional settings) 

- Risk of infection (time since completion of primary series) 

 Potential impact of SARS-CoV-2 infection: 

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- Risk for severe infection (underlying conditions) 

- Risk associated with a person’s circumstances (living with/caring for at-risk 

individuals or consequences of inability to meet obligations due to infection) 

 Potential benefits of booster: 

- Reduced risk of infection, including severe infection 

 Potential risks of booster: 

- Rare risks of serious adverse events (myocarditis, pericarditis, anaphylaxis) 

- Common risks of transient local and systemic symptoms 

For people who received a Janssen primary dose, the indications for boosters is much simpler: 

 People aged ≥18 years who received a single dose Janssen primary series should receive 

a single Janssen COVID-19 booster dose at least 2 months after completing their primary 

series. 

The considerations for heterologous (mix-and-match) booster dosing are as follows: 

 The same product that was used for the primary regimen should be used for the booster: 

- If that is not available or another product is preferred, heterologous boosting with a 

single dose of any of the authorized COVID-19 vaccine boosters is acceptable 

 Heterologous dosing may be considered for the booster dose only: 

- If all doses of the primary series and additional dose (if indicated for moderately to 

severely immunocompromised people who received 2 doses of mRNA vaccine) 

should utilize the same vaccine product. 

 Individual benefit-risk assessment may inform which booster product to use: 

- Availability of booster product 

- Risk profile of vaccine boosters, including rare events 

 Interval should follow the interval recommended by the primary series: 

- People who received a single dose Janssen primary series can receive a mRNA 

COVID-19 booster dose at least 2 months after completing primary series. 

 If Moderna vaccine booster is used, the booster dose and volume should be utilized (50μg in 

0.25ml): 

- Pfizer-BioNTech and Janssen booster doses are the same dose as primary vaccine. 

- If an individual who is moderately to severely immunocompromised received a 

primary dose of Janssen vaccine and receives a booster dose using Moderna, the 

50μg dose should be used. 

In terms of administration of COVID-19 vaccines, the Pfizer BioNTech recommendations are 

unchanged for primary, additional, and booster doses. The booster dose is the same for 

persons ≥18 years of age. In future weeks, that likely will change. For Moderna, the booster 

dose is 50 μg for persons ≥18 years of age. However, the additional dose among those who are 

immunocompromised is 100 μg. For Janssen, everyone ≥18 years of age would be getting a 

booster dose at least 2 months from their initial dose. The booster interval is based on 

homologous dosing (booster product is the same as primary series). The heterologous (mixand-match) booster interval is dependent on the recommendation for the primary series. 

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The definition of “fully vaccinated” has not changed with these booster recommendations. 

People who completed their primary series, which is a 2-dose mRNA vaccine series or a single 

dose of Janssen, are considered fully vaccinated at least 2 weeks after completion of their 

primary series. This definition applies to all people, including those recommended to receive an 

additional dose due to their immunocompromised status and those who are recommended for a 

booster dose. People who received a booster dose should still follow the guidelines for fully 

vaccinated people to minimize the spread of SARS-CoV-2.88 

Similar to primary and additional doses, the COVID-19 vaccine boosters may be given with 

other vaccines without regard to timing. This includes all 3 of the authorized or approved 

vaccines. This also includes simultaneous administration of COVID-19 vaccines and other 

vaccines on the same day. If multiple vaccines are administered in a single visit, it is 

recommended that each injection be administered in a different injection site.89 People have a 

contraindication to subsequent vaccine doses if they had a severe allergic reaction such as 

anaphylaxis after a previous dose or to a component of the vaccine. People also have a 

contraindication if they have had an immediate allergic reaction of any severity to a previous 

dose or a known diagnosed allergy to a component of the vaccine. A known polysorbate allergy 

is a contraindication to Janssen vaccine and a precaution to the other vaccine products. People 

who have a contraindication to mRNA vaccines, such as those who have a polyethylene glycol 

(PEG) allergy, have a precaution to the Janssen vaccine.90 Additional tools are available for 

recognizing anaphylaxis.91 

There are potential rare risks for mRNA vaccines, such as myocarditis and pericarditis. The risk 

of myocarditis and pericarditis is highest in males 12-30 years of age, but this is based on 

current data from the primary series. People who develop myocarditis or pericarditis after 

receipt of mRNA vaccine are recommended to defer a COVID-19 booster dose until at least the 

clinical syndrome has resolved completely. Consulting the clinical team may assist with 

decisions around proceeding with a subsequent doses and timing.92 

For the Janssen booster dose, there is a rare risk for TTS. Based on what was observed with 

the primary series, the highest risk is among women 18-49 years of age. For people who 

develop TTS after Janssen primary vaccine, the booster dose of Janssen is not recommended 

by experts. These individuals may receive a dose of an mRNA booster shot at least 2 months 

after their Janssen dose and after the clinical condition has stabilized. Conversations between 

the patient and their clinical team may inform decisions about the use of an mRNA COVID-19 

vaccine booster and timing of the booster.

93 

GBS is another known rare risk of Janssen vaccines. For people who develop GBS after 

Janssen primary vaccine, there are not a lot of data on the safety of administering either a 

Janssen or mRNA booster dose for this exact situation. Experts recommend that individuals 

who are in this situation should be made aware of their different options, including receiving an 

mRNA vaccine booster at least 2 months from their Janssen dose. The Janssen vaccine may 

still be utilized as a booster in these individuals, particularly if their GBS occurred over 42 days 

after vaccination or was assessed to be related to a non-vaccine factor such as other infections. 

88 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html 89 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Coadministration 90 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Contraindications 91 https://www.cdc.gov/vaccines/covid-19/downloads/IntermConsid-Anaphylaxis-covid19-vaccine-sites.pdf 92 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#underlying-conditions 93 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#janssen-vaccine-certain-populations 

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ACIP Meeting Summary October 20-21, 2021 

Again, conversations between the patient and their clinical team may assist with decisions about 

administration of the COVID-19 vaccine booster and timing of the booster. 

Discussion Summary 

• It will be very important to distinguish what constitutes an additional dose versus a booster 

dose. This is especially important in terms of those who received Janssen as the primary 

vaccine, Moderna since the booster dose would be 50 μg versus 100 μg as part of a primary 

series, and when speaking to the public since this can be confusing. 

• There is concern with regard to the Moderna product in that a primary series and booster 

dose will be drawn from the same packaging. While pharmacy and EHR inventory 

management systems are set up to be able to draw down and account for all doses, those 

who administer vaccine would greatly appreciate the differentiation between a half-dose and 

a booster dose on the packaging by way of NDC codes and CVX codes. 

• Although the data so far do not show any indication of a safety problem with coadministration of COVID-19 vaccination with other vaccines, monitoring this will become 

even more important once children begin to be vaccinated. 

 Though concern was expressed regarding co-administration of mRNA COVID-19 

vaccine with ACAM2000 due to its association with pericarditis, Dr. Cohn 

emphasized that ACAM2000 is currently being used only in the military population. 

However, CDC will take this into consideration and will think about the right way to 

address this potential concern. 

• It was suggested that perhaps the language could be softened regarding use of the same 

product, given that some vaccinators would interpret this as the law rather than in terms of 

flexibility. There was support for more permissive use of a mix-and-match approach in the 

recommendation as well as the clinical guidance. For equity purposes, this would allow 

more flexibility for clinicians in the field to more easily adapt and serve the populations who 

they take care of as they see fit. 

• While ACIP continues to state that their decisions should be supported by the best available 

evidence, the available evidence suggesting that people under 50 years of age should 

receive a booster at this point is unclear—setting aside Janssen. ACIP would be abdicating 

its responsibility not only to allow people to be immunized if they should be immunized, but 

also to protect them from immunizations that they do not need that have AEs. For instance, 

the data suggest that HCW do not have increased exposure from their work. Instead, they 

are more likely to be exposed in non-work community settings. It was not clear to all ACIP 

members that otherwise healthy individuals under 50 years of age need a booster vaccine at 

this time with either Moderna or Pfizer. To mitigate the harm, perhaps there needs to be 

some age restriction on the otherwise worried-well. 

• Another workforce issue to take into consideration is the challenge with staffing capacity that 

is resulting in the need to triage patient care, including routine care. Allowing for the 

flexibility to receive a booster in order to reduce the risk of infection and missed days of work 

would make a major difference, especially in terms of the nursing workforce. 

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ACIP Meeting Summary October 20-21, 2021 

• Flexibility could be beneficial in some congregate settings, such as among people who are 

incarcerated. 

• Notably, ACIP’s vote language is often “front page news” and clinical considerations do not 

receive as much attention. Perhaps more explicit language could be included about the 

importance of vaccinators paying close attention to the clinical considerations, especially 

with regard to vaccine-associated risk and risk mitigation. 

• It is critically important to make clear that the total number of mRNA doses is 3 for those 

who are not immunocompromised (initial 2-dose series and 1 booster dose at least 6 

months later) and that the total number of doses for immunocompromised persons is 4 (3-

dose primary series and 1 booster dose at least 6 months later). 

• There is an ongoing need for patient education at an appropriate health literacy level and in 

multiple languages, which should continue to be a major priority. 

Votes: COVID-19 Vaccine Booster Doses 

Dr. Lee (ACIP Chair) expressed appreciation for everyone’s honesty and willingness to speak 

up and represent the diverse viewpoints from the ACIP, emphasizing that this is exactly what 

the committee is supposed to do. She also recognized that part of their charge for the day was 

to look forward and not spend too much time looking backward, pointing out that they were not 

re-evaluating a prior decision. From the perspective of implementation and equity, the goal was 

to consider the current status of the pandemic and determine how to move forward together. 

She stressed that she wanted everyone to be able to express their viewpoints, but with the 

recognition that they were in a different context than they were a month ago. 

Dr. Kathleen Dooling (CDC/NCIRD) presented the following proposed language for votes on 

Pfizer BioNTech and Janssen COVID-19 vaccine booster doses, with revisions based on the 

discussions throughout the day: 

Motion/Vote #1: Proposed Language for a Pfizer BioNTech Booster Dose 

A single COVID-19 vaccine booster dose is recommended at ≥6 or more months after 

completion of an mRNA primary series in the same risk groups for who CDC recommended a 

booster dose of Pfizer BioNTech under the FDA’s Emergency Use Authorization. 

Motion/Vote #2: Proposed Language for a Janssen Booster Dose 

A single COVID-19 vaccine booster dose is recommended for persons aged ≥18 years at ≥2 or

more months after receipt of the initial Janssen dose under the FDA’s Emergency Use 

Authorization. 

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ACIP Meeting Summary October 20-21, 2021 

Motion/Vote #1: 

Draft Interim Recommendation for a Pfizer BioNTech COVID-19 Vaccine Booster 

Dr. Bell made a motion for ACIP to adopt an interim recommendation stating that “A single 

COVID-19 vaccine booster dose is recommended at ≥6 or more months after completion of an

mRNA primary series, in the same risk groups for who CDC recommended a booster dose of 

Pfizer BioNTech, under the FDA’s Emergency Use Authorization.” 

Dr. Sanchez seconded the motion. No COIs were declared. The motion carried with 15 

affirmative votes, 0 negative votes, and 0 abstentions. The disposition of the vote was as 

follows: 

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

Motion/Vote #2: 

Draft Interim Recommendation for a Janssen COVID-19 Vaccine Booster 

Ms. Bahta made a motion for ACIP to adopt an interim recommendation stating that “A single 

COVID-19 vaccine booster dose is recommended for persons aged ≥18 years at ≥2 or more 

months after receipt of the initial Janssen dose under the FDA’s Emergency Use Authorization.” 

Dr. Ault seconded the motion. No COIs were declared. The motion carried with 15 affirmative 

votes, 0 negative votes, and 0 abstentions. The disposition of the vote was as follows: 

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

Member Statements 

Subsequent to the vote, Dr. Lee invited ACIP members to make a statement about the rationale 

for their votes and/or to share any additional general comments: 

• Dr. Talbot: I think a lot of what I was concerned about has been said, but I just want to 

reiterate for Vote #1, Moderna still has very good VE. There will be some confusion with the 

higher versus the lower dose. So, those that are not at high risk should really be thoughtful 

about getting that dose. But I think the clinical considerations will be incredibly important. I 

did vote “yes” to simplify the recommendations for the American public and the American 

healthcare system, but I do think we need to be very aware of potential complications. 

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ACIP Meeting Summary October 20-21, 2021 

• Dr. Chen: I’m really pleased with our discussion today. I think that I heard from my 

colleagues a breadth of thoughts and I think that they were really terrific for me to hear. 

Certainly from my point of view, I really appreciated that we were finally able to look at, 

consider, and recommend a mix-and-match approach as part of our way to boost people’s 

immunity, especially for the people who need it. I think we’ve already discussed that there is 

data that there are some people that really don’t need the booster dose at this time, and I 

guess I’d like to just remind the American public now that there are the other nonpharmaceutical interventions and that we need to all have a multilayered approach when 

we’re out in public, to continue to mask, keep employee distance, and try to have indoor 

ventilation and improved environment for the workspace. Those sorts of things are an 

important part and we’re not just going to vaccinate ourselves out of this situation, but it 

really is a multi-layered approached. I think that we had a great discussion and the outcome 

was what I was hoping for, so thank you. 

• Dr. Poehling: Thank you for the opportunity to speak. One of the things that was stated 

earlier was that we focused a lot on the booster dose. The WG emphasized, and we want to 

reiterate, the importance of increasing primary coverage for the entire population. That 

needs to remain an important focus. I completely agree with Dr. Chen about the importance 

of using other mitigating factors. Through those recommendations for those who the balance 

is favorable, we want to encourage people to make [inaudible]. Thank you. 

• Dr. Daley: Thanks so much. I want to make a quick comment with regard to vaccine safety. 

Dr. Shimabukuro has, at prior ACIP meetings, reminded us all that the vaccine safety 

surveillance is the most intensive that has ever been undertaken, we’re using that data to 

better quantify these rare risks, and it’s a crucial factor in the decisions that we’re making. 

But I think we want to just be cognitive to the fact that that intensive degree of vaccine safety 

surveillance is going to continue in the context of boosters and that data is going to be 

brought before this committee. So, every bit as much of safety surveillance with the primary 

series is going to be in place for the booster doses. Thank you. 

• Ms. McNally: Similar to the comment that was made earlier in the meeting where we talked 

about “vaccines don’t save lives, but vaccinations do,” I have this same feeling about our 

recommendations and implementations. So our recommendations are one step of the way, 

but it’s going to be so important as everyone mentioned for us to make sure that in our 

implementation, patients are truly educated about the benefit/risk balance based on their 

own personal situation. And it is the hardest thing for us to do, but I would encourage all of 

us to go beyond the recommendations at this point and do our best to educate our 

communities, our provider teams, and partner with public health. I’m going to say our hope 

is that we will also in the future be able to have those discussions with school communities 

and much broader communities than this. We look to our CDC partners here in the room 

and beyond for their expertise and for their continued dedication to ensure that these public 

health education efforts are prioritized, as they are so important for us to be able to do the 

right thing. 

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ACIP Meeting Summary October 20-21, 2021 

CERTIFICATION 

Upon reviewing the foregoing version of the October 20-21, 2021 ACIP meeting minutes, Dr. 

Grace Lee, ACIP Chair, certified that to the best of her knowledge, they are accurate and 

complete. Her original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC. 

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ACIP Meeting Summary October 20-21, 2021 

ACIP MEMBERSHIP ROSTER 

CHAIR 

LEE, Grace M, MD, MPH 

Associate Chief Medical Officer for Practice Innovation 

Lucile Packard Children’s Hospital 

Professor of Pediatrics, Stanford University School of Medicine 

Stanford, CA 

Term: 8/4/2021 – 6/30/2023 

EXECUTIVE SECRETARY 

WHARTON, Melinda, MD, MPH 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

Atlanta, GA 

MEMBERS 

AULT, Kevin A, MD, FACOG, FIDSA 

Professor and Division Director 

Department of Obstetrics and Gynecology University of 

Kansas Medical Center 

Kansas City, KS 

Term: 10/26/2018 – 6/30/2022 

BAHTA, Lynn, RN, MPH, CPH 

Immunization Program Clinical Consultant 

Infectious Disease, Epidemiology, Prevention & Control Division 

Minnesota Department of Health 

Saint Paul, Minnesota 

Term: 7/1/2019 – 6/30/2023 

BELL, Beth P, MD, MPH 

Clinical Professor 

Department of Global Health, School of Public Health 

University of Washington 

Seattle, WA 

Term: 7/1/2019 – 6/30/2023 

BROOKS, Oliver, MD, FAAP 

Chief Medical Officer 

Watts HealthCare Corporation 

Los Angeles, CA 

Past President, National Medical Association 

Term: 7/26/2021 – 6/30/2025 

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ACIP Meeting Summary October 20-21, 2021 

CHEN, Wilbur H, MD, MS, FACP, FIDSA 

Professor of Medicine 

Center for Vaccine Development and Global Health 

University of Maryland School of Medicine 

Baltimore, MD 

Term: 12/23/2020 – 6/30/2024 

CINEAS, Sybil, MD, FAAP, FACP 

Associate Professor of Medicine, Pediatrics, and Medical Science (Clinical) 

The Warren Alpert Medical School of Brown University 

Associate Program Director 

Brown Combined Residency in Internal Medicine and Pediatrics 

Providence, RI 

Term: 7/28/2021 – 6/30/2025 

DALEY, Matthew F, MD 

Senior Investigator 

Institute for Health Research, Kaiser Permanente Colorado 

Associate Professor of Pediatrics 

University of Colorado School of Medicine 

Aurora, CO 

Term: 1/4/2021 – 6/30/2024 

KOTTON, Camille Nelson, MD, FIDSA, FAST 

Clinical Director, Transplant and Immunocompromised Host Infectious Diseases 

Infectious Diseases Division, Massachusetts General Hospital 

Associate Professor of Medicine, Harvard Medical School 

Boston, MA 

Term: 12/23/2020 – 6/30/2024 

LOEHR, Jamie, MD, FAAFP 

Owner, Cayuga Family Medicine 

Ithaca, New York 

Term: 7/26/2021 – 6/30/2025 

LONG, Sarah S, MD 

Professor of Pediatrics 

Drexel University College of Medicine 

Section of Infectious Diseases 

St. Christopher’s Hospital for Children 

Philadelphia, Pennsylvania 

Term: 12/24/2020 – 6/30/2024 

MCNALLY, Veronica V, JD 

President and CEO Franny 

Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2022 

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ACIP Meeting Summary October 20-21, 2021 

POEHLING, Katherine A, MD, MPH 

Professor of Pediatrics and Epidemiology and Prevention 

Director, Pediatric Population Health 

Department of Pediatrics 

Wake Forest School of Medicine 

Winston-Salem, NC 

Term: 7/1/2019 – 6/30/2023 

SÁNCHEZ, Pablo J, MD 

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital Columbus, Ohio 

Term: 7/1/2019 – 6/30/2023 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University 

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 

EX OFFICIO MEMBERS 

Centers for Medicare and Medicaid Services (CMS)

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification Centers 

for Medicare and Medicaid Services 

Baltimore, MD 

Food and Drug Administration (FDA)

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications 

Office of Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD 

Health Resources and Services Administration (HRSA)

RUBIN, Mary, MD 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

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ACIP Meeting Summary October 20-21, 2021 

Indian Health Service (IHS)

CLARK, Matthew, MD, FAAP, FACP 

Physician 

Chair, IHS National Pharmacy & Therapeutics Committee 

Durango, CO 

Office of Infectious Disease and HIV/AIDS Policy (OIDP)

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

National Institutes of Health (NIH)

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) 

Bethesda, MD 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

American Academy of Pediatrics (AAP)

MALDONADO, Yvonne, MD 

Senior Associate Dean for Faculty Development and Diversity 

Professor of Pediatrics and Health Research and Policy 

Chief, Division of Pediatric Infectious Diseases 

Stanford University School of Medicine 

Stanford, CA 

American Academy of Pediatrics (AAP) 

Red Book Editor 

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine 

Birmingham, AL 

American Academy of Physician Assistants (AAPA)

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants 

Alexandria, VA 

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ACIP Meeting Summary October 20-21, 2021 

American College Health Association (ACHA)

CHAI, Thevy S., MD 

Director of Medical Services 

Campus Health Services 

University of North Carolina at Chapel Hill Chapel Hill, 

NC 

American College Health Association (ACHA) (alternate) 

MCMULLEN, Sharon, RN, MPH, FACHA 

Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health 

Ithaca, NY 

American College of Nurse Midwives (ACNM)

HAYES, Carol E., CNM, MN, MPH 

Lead Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast Atlanta, GA 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

In partnership with University of Rwanda and University of Illinois, Chicago 

American College of Obstetricians and Gynecologists (ACOG)

ECKERT, Linda O, MD, FACOG 

Professor, Department of Obstetrics & Gynecology 

Adjunct Professor, Department of Global Health 

University of Washington 

Seattle, WA 

American College of Physicians (ACP) 

GOLDMAN, Jason M, MD, FACP 

Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic University, Boca 

Raton, Florida 

Private Practice 

Coral Springs, FL 

American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics Geriatrics 

Division Chief 

Duke University and Durham VA Medical Centers 

Durham, NC 

America’s Health Insurance Plans (AHIP)

GLUCKMAN, Robert A, MD, MACP 

Chief Medical Officer, Providence Health Plans 

Beaverton, OR 

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ACIP Meeting Summary October 20-21, 2021 

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA 

Washington, DC 

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA)

RITTLE, Charles (Chad), DNP, MPH, RN Assistant 

Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA)

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA)

HOGUE, Michael D., PharmD, FAPhA, FNAP 

Dean and Professor of Loma Linda University School of Pharmacy 

Director, Center for Interprofessional Education & Practice 

Loma Linda, CA 

Association of Immunization Managers (AIM)

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health 

Bismarck, ND 

Association for Prevention Teaching and Research (APTR) 

ZIMMERMAN, Richard, MD, MPH 

Professor 

University of Pittsburgh School of Medicine 

Department of Family Medicine and Clinical Epidemiology 

Pittsburgh, PA 

Association of State and Territorial Health Officials (ASTHO)

SHAH, Nirav D, MD, JD 

Director 

Maine Center for Disease Control and Prevention 

Augusta, ME 

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ACIP Meeting Summary October 20-21, 2021 

Biotechnology Industry Organization (BIO)

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

Council of State and Territorial Epidemiologists (CSTE)

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

Council of State and Territorial Epidemiologists (CSTE) (alternate) 

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

Canadian National Advisory Committee on Immunization (NACI)

DEEKS, Shelley, MD, MHSc, FRCPC, FAFPHM 

Deputy Chief Medical Officer of Health, Department of Health and Wellness, Nova Scotia 

Associate Professor, Dalla Lana School of Public Health, University of Toronto 

Chair, National Advisory Committee on Immunization 

Halifax, Nova Scotia 

Infectious Diseases Society of America (IDSA)

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 

International Society for Travel Medicine (ISTM)

BARNETT, Elizabeth D, MD Professor of 

Pediatrics 

Boston University School of Medicine 

Boston, MA 

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

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ACIP Meeting Summary October 20-21, 2021 

National Association of County and City Health Officials (NACCHO) (alternate) 

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease 

Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine 

Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health 

Seattle, WA 

National Association of Pediatric Nurse Practitioners (NAPNAP)

STINCHFIELD, Patricia A, RN, MS, CPNP 

Director 

Infectious Disease/Immunology/Infection Control 

Children's Hospitals and Clinics of Minnesota 

St. Paul, MN 

National Foundation for Infectious Diseases (NFID)

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

National Foundation for Infectious Diseases (NFID) (alternate) 

DALTON, Marla, PE, CAE 

Executive Director & CEO 

National Foundation for Infectious Diseases (NFID) 

Bethesda, MD 

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD Professor and Chair 

University of Medicine and Dentistry of New Jersey Robert Wood 

Johnson Medical School 

New Brunswick, NJ 

Pediatric Infectious Diseases Society (PIDS) 

O’LEARY, Sean, MD, MPH 

Associate Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

Pediatric Infectious Diseases Society (PIDS) (alternate) 

SAWYER, Mark H, MD 

Professor of Clinical Pediatrics 

University of California, San Diego School of Medicine 

San Diego, CA 

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ACIP Meeting Summary October 20-21, 2021 

Pharmaceutical Research and Manufacturers of America (PhRMA)

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur 

Swiftwater, PA 

Society for Adolescent Health and Medicine (SAHM)

MIDDLEMAN, Amy B, MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center 

Oklahoma City, OK 

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine 

Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA 

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ACIP Meeting Summary October 20-21, 2021 

ACRONYMS USED IN THIS DOCUMENT

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics 

ABCs Active Bacterial Core Surveillance 

ACA Affordable Care Act 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices 

ACOG American College of Obstetricians and Gynecologists 

ACP American College of Physicians 

AE Adverse Event 

AESI Adverse Events of Special Interest 

AHIP America’s Health Insurance Plans 

AI/INF Autoimmune and/or Inflammatory Conditions 

AI/AN American Indian and Alaskan Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association 

AMI Acute Myocardial Infarction 

Anti-PF4 Anti-Platelet Factor 4 

AOA American Osteopathic Association 

APhA American Pharmacists Association 

APRN Advanced Practice Registered Nurse 

APTR Association for Prevention Teaching and Research 

ARDS Acute Respiratory Distress Syndrome 

ARP American Rescue Plan 

ASPR Office of the Assistant Secretary for Preparedness and Response 

ASTHO Association of State and Territorial Health Officers 

AZ AstraZeneca 

BARDA Biomedical Advanced Research and Development Authority 

BCRP Boston Combined Residency Program in Pediatrics 

BEST Biologics Effectiveness and Safety Initiative 

BLA Biologics License Application 

CDC Centers for Disease Control and Prevention 

CICP Countermeasures Injury Compensation Program 

CMC Chronic Medical Condition 

CMI Cell-Mediated Immunity 

CMS Center for Medicare and Medicaid Services 

COD Cause of Death 

COI Conflict of Interest 

CSF Cerebrospinal Fluid 

CSTE Council of State and Territorial Epidemiologists 

CVST Cerebral Venous Sinus Thrombosis 

DFO Designated Federal Official 

DHA Defense Health Agency 

DoD Department of Defense 

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs 

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ACIP Meeting Summary October 20-21, 2021 

DVT Deep Vein Thrombosis 

ED Emergency Department 

EHR Electronic Health Record 

ELISA Enzyme-Linked Immunosorbent Assay 

EMR Electronic Medical Record 

ET Eastern Time 

EtR Evidence to Recommendation 

EUA Emergency Use Authorization 

FDA Food and Drug Administration 

FFP Fit for Purpose 

FP Family Physician 

FRPP Federal Retail Pharmacy Program 

GBS Guillain-Barré Syndrome 

GI Gastrointestinal 

GMR Geometric Mean Ratios 

GMT Geometric Mean Titers 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

GSK GlaxoSmithKline 

HCP Healthcare Personnel / Providers 

HSCT Hematopoietic Stem Cell Transplant 

HCW Healthcare Workers 

HHS (Department of) Health and Human Services 

HIV Human Immunodeficiency Virus 

HM Hematologic Malignancies 

HPAI highly pathogenic avian influenza 

HRSA Health Resources and Services Administration 

HSCT Hematopoietic Stem Cell Transplant 

HZ Herpes Zoster 

IAC Immunization Action Coalition 

IBD Inflammatory Bowel Disease 

IC Immunocompromising Conditions 

ICATT Increasing Community Access to Testing 

ICD International Classification of Diseases 

ICD-10-CM International Classification of Diseases 10 Clinical Modification 

ICU Intensive Care Unit 

IDSA Infectious Disease Society of America 

IgG Immunoglobulin G 

IHS Indian Health Service 

IHS VTF IHS Vaccines Task Force 

I-STAR System IHS Safety Tracking & Response System 

IIS Immunization Information System 

IIV Inactivated Influenza Vaccine 

IMD Immune-Mediated Disease 

IPD Invasive Pneumococcal Disease 

ISD Immunization Services Division 

ISO Immunization Safety Office 

ITP Immune Thrombocytopenia 

IVAC International Vaccine Access Center 

JAMA Journal of the American Medical Association 

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ACIP Meeting Summary October 20-21, 2021 

JTM Journal of Travel Medicine 

JHU Johns Hopkins University 

KAP Knowledge, Attitudes, and Practices 

KPNC Kaiser Permanente Northern California 

KPSC Kaiser Permanente Southern California 

LAIV Live Attenuated Influenza Vaccine 

LTCF Long-Term Care Facilities 

MAAE Medically-Attended Adverse Event 

MHS Military Health System 

MMWR Morbidity and Mortality Weekly Report 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada 

NAHN National Association of Hispanic Nurses 

NAIIS National Adult and Influenza Immunization Summit 

NANASP National Association of Nutrition and Aging Services Programs 

NAPNAP National Association of Pediatric Nurse Practitioners 

NBP Non-Bacteremic Pneumococcal Pneumonia 

NCBA National Caucus & Center on Black Aging, Inc. 

NCHS National Center of Health Statistics 

NCI National Cancer Institute 

NCIRD National Center for Immunization and Respiratory Diseases 

NDC National Drug Code 

NEJM New England Journal of Medicine 

NFID National Foundation for Infectious Diseases 

NHANES National Health and Nutrition Examination Survey 

NHCA National Hispanic Council on Aging 

NHIS National Health Interview Survey 

NIAID National Institute of Allergy and Infectious Diseases 

NIH National Institutes of Health 

NIS-Child National Immunization Survey-Child 

NMA National Medical Association 

NNDSS National Notifiable Diseases Surveillance System 

NNV Number Needed to Vaccinate 

NPIs Non-Pharmaceutical Interventions 

NVAC National Vaccine Advisory Committee 

NYS New York State 

ODSCT Office of Direct Service and Contracting Tribes 

OID Office of Infectious Disease 

OIDP Office of Infectious Disease and HIV/AIDS Policy 

PCP Primary Care Provider/Practitioner 

PCV13 13-Valent Pneumococcal Conjugate Vaccine 

PHAC Public Health Agency Canada 

PHN Postherpetic Neuralgia 

PhRMA® Pharmaceutical Research and Manufacturers of America® 

PICO Population, Intervention, Comparison, Outcomes 

PID Primary Immune Deficiency 

PIDS Pediatric Infectious Disease Society 

PPE Personal Protective Equipment 

PPSV23 23-Valent Pneumococcal Polysaccharide Vaccine 

117 
 

 

ACIP Meeting Summary October 20-21, 2021 

QALY Quality-Adjusted Life-Year 

QIV-HD High-Dose Quadrivalent Influenza vaccine 

RA Rheumatoid Arthritis 

RCT Randomized Controlled Trial 

RSV Respiratory Syncytial Virus 

RZV Recombinant Zoster Vaccine 

SAE Serious Adverse Event 

SAGE Strategic Advisory Group of Experts 

SAHM Society for Adolescent Health and Medicine 

sBLA Supplemental Biologics License Application 

SDOH Social Determinants of Health 

SHEA Society for Healthcare Epidemiology of America 

SLE Systemic Lupus Erythematosus 

SME Subject Matter Expert 

SOT Solid Organ Transplant 

ST3 Serotype 3 

STM Solid Tumor Malignancies 

SUPERNOVA Surveillance Platform for Enteric and Respiratory Infectious Organisms 

TTS Thrombosis with Thrombocytopenia Syndrome 

UC Urgent Care 

UK United Kingdom 

URF Underreporting Factor 

US United States 

USG US Government 

VA (US Department of) Veteran’s Affairs 

VAERS Vaccine Adverse Event Reporting System 

VaST WG Vaccine Safety Technical Work Group 

VE Vaccine Efficacy 

VE Vaccine Effectiveness 

VFC Program Vaccines for Children Program 

VICP Vaccine Injury Compensation Program 

VRBPAC Vaccine and Related Biological Products Advisory Committee 

VRC Vaccine Research Center 

VSD Vaccine Safety Datalink 

VZV Varicella-Zoster Virus 

WG Work Group 

WHO World Health Organization 

ZVL Zoster Vaccine Live 

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