MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP) 

DECEMBER 16, 2021 

SUMMARY MINUTES 

TABLE OF CONTENTS 

MEETING PURPOSE ................................................................................................................................... 2 

THURSDAY: DECEMBER 16, 2021............................................................................................................. 2 

WELCOME AND INTRODUCTIONS ...................................................................................... 2 

Call to Order/Roll Call ......................................................................................................... 2 

Announcements.................................................................................................................. 2 

Welcoming Remarks........................................................................................................... 3 

Food and Drug Administration Update ................................................................................ 3 

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES ..................................................... 4 

Session Introduction ........................................................................................................... 4 

Update on Thrombosis with Thrombocytopenia Syndrome (TTS) ....................................... 5 

VaST Summary................................................................................................................... 8 

Updates to the Benefit/Risk Assessment for Janssen COVID-19 Vaccine: Applying the 

Evidence to Recommendation (EtR) Framework................................................................11 

Janssen COVID-19 Vaccine Statement .............................................................................18 

Public Comment.................................................................................................................25 

Vote: Updated Recommendations for Use of the Janssen COVID-19 Vaccine ..................29 

COVID-19 Vaccine Safety Surveillance in Children 5-11 Years of Age ..............................32 

Update on the COVID-19 Omicron Variant.........................................................................34 

CLOSING REMARKS............................................................................................................39 

CERTIFICATION.........................................................................................................................................40 

ACIP MEMBERSHIP ROSTER ..................................................................................................................41 

ACRONYMS USED IN THIS DOCUMENT.................................................................................................50 
https://www.regulations.gov 

ACIP Meeting Summary December 16, 2021 

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 December 16, 2021. The meeting took place remotely via 

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

which focused on updates regarding the risk of thrombosis with thrombocytopenia (TTS) related 

to the Janssen COVID-19 vaccine, a vote on updated recommendations for use of the Janssen 

COVID-19 vaccine, and an update on the COVID-19 Omicron variant. 

THURSDAY: DECEMBER 16, 2021

WELCOME AND INTRODUCTIONS 

Call to Order/Roll Call 

Dr. Grace Lee (ACIP Chair) called to order and presided over the December 16, 2021 ACIP 

meeting and conducted a roll call, which established that a quorum was present. Dr. Wilbur 

Chen reported the potential perception of a conflict of interest (COIs) in that his employer, the 

University of Maryland, receives a grant from Emergent BioSolutions, Inc. for the development 

of a shigella vaccine. No other COIs were declared. A list of Members, Ex Officios, and Liaison 

Representatives is included in the appendixes at the end of this summary document. 

Announcements 

Dr. Melinda Wharton (ACIP Executive Secretary, 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 2:10 PM Eastern Time (ET). 

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 using Docket Number CDC-2021-0133. Further information 

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

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. 

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MEETING WELCOME AND INTRODUCTIONS
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary December 16, 2021 

Welcoming Remarks 

Dr. Sam Posner (Acting Director, CDC/NCIRD) thanked everyone for joining another 

important ACIP meeting. Through collective efforts, the US has made incredible progress with 

the COVID-19 vaccination program in the past year with more than 200 million Americans fully 

vaccinated and 55 million having received a booster dose. The ACIP was critical in achieving 

the success that has been seen, even among the serious continued challenges. The ACIP 

members have met more frequently than in any other year ever with more than 13 meetings 

and 40 Work Group (WG) calls just for COVID. While they thought they were finished for the 

year, everyone is committed to the mission of the ACIP and are ready to respond when 

important information becomes available to review and discuss in order to ensure vaccine 

safety. The hard work by the Vaccine Safety Technical WG (VaST) and the COVID-19 Vaccine 

WG is greatly appreciated. The effectiveness and sustainability of the COVID-19 and routine 

immunization programs rests on CDC’s standard process of transparently reviewing data with 

expert advisors and soliciting the ACIP’s input on how to adjust vaccine recommendations. Dr. 

Posner expressed gratitude for the ACIP’s service and dedication to improving health and wellbeing for everyone. 

Food and Drug Administration Update 

Dr. Doran Fink (FDA/CBER) reported that the Food and Drug Administration’s (FDA’s) action 

earlier in the week to authorize updates to the contraindications and warnings information in the 

Janssen COVID-19 vaccine fact sheet for healthcare providers (HCP) and to provide similar 

updates to the fact sheet for vaccine recipients and caregivers followed a review of updated 

data on TTS following use of the Janssen COVID-19 vaccine in the US. These data, which 

would be presented in more detail later in the afternoon, were evaluated as part of FDA’s 

coordinated involvement with the CDC VaST WG in their ongoing safety surveillance for 

COVID-19 vaccines. Based on these data, FDA determined that revisions to the Emergency 

Use Authorization (EUA) Fact Sheets were necessary to ensure that HCP, vaccine recipients, 

and caregivers are adequately informed about the risk of TTS and to ensure that this risk is 

mitigated to the fullest extent possible. Updates to the fact sheet warning language include 

additional specificity regarding the definition of TTS, the strength of evidence to support a 

causal relationship with the vaccine, and the magnitude of the risk. The Fact Sheets now inform 

that TTS has been reported following use of the Janssen COVID-19 vaccine in both males and 

females across a wide range of ages, with the greatest risk of TTS among females 30-49 years 

of age at a rate of approximately 1 case per 100,000 vaccinations as reported through passive 

surveillance and an overall case fatality rate of approximately 15% or 1 fatal case out of every 7 

TTS cases reported. Additionally, data on TTS following the AstraZeneca (AZ) COVID-19 

vaccine, which is another adenovirus-vectored COVID-19 vaccine being used exclusively 

outside of the US, suggests a class effect for a risk of TTS following adenovirus-vectored 

COVID-19 vaccines in general. With these data in mind, a contraindication against use of the 

Janssen COVID-19 vaccine has been added for individuals with a history of thrombosis with 

thrombocytopenia following the Janssen COVID-19 vaccine or any other adenovirus-vectored 

COVID-19 vaccine. 

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ACIP Meeting Summary December 16, 2021 

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES 

Session Introduction 

Dr. Matthew Daley (ACIP, WG Chair) noted that the Coronavirus Vaccines WG thought it 

would be helpful to reflect back on the previous year. On December 11-12, 2020, the ACIP met 

and discussed Pfizer BioNTech COVID-19 vaccines and voted on its use under EUA. The first 

COVID-19 vaccine was administered on December 14, 2020 in the US outside of clinical trials. 

The ACIP met on December 19-20, 2020 for a discussion of Moderna’s COVID-19 vaccine and 

voted on EUA of that vaccine. The ACIP has met 13 times with respect to COVID-19 

vaccination in 2021 and there have been 42 ACIP COVID-19 Vaccine WG calls. Critically and 

most importantly, almost 600 million COVID-19 vaccine doses have been delivered in the US. 

Of these, at least 486 million COVID-19 vaccine doses have been administered in the US. This 

represents 202 million people in the US who are fully vaccinated against COVID-19. In addition, 

55 million people in the US have received a booster dose. This represents a tremendous 

achievement on the part of the US healthcare delivery system, including state and local public 

health systems. It also is a tremendous achievement on the part of vaccine manufacturers. 

More than that, this represents disease averted and lives saved. There are no data for the 

counter-factual, meaning that it is unknown how bad the pandemic would have been if not for 

these vaccines. However, given how effective the currently authorized and licensed vaccines 

are at preventing hospitalization and death from COVID-19, this certainly represents many 

thousands of lives saved. 

As Dr. Fink has just discussed, a number of FDA updates to the EUA Fact Sheets for the use of 

the Janssen COVID-19 vaccine were issued on Tuesday, December 14, 2020. Specifically, the 

updates are as follows: 

Contraindication: 

Do not administer the Janssen COVID-19 vaccine to individuals with a history of thrombosis with 

thrombocytopenia following the Janssen COVID-19 Vaccine or any other adenovirus-vectored 

COVID-19 vaccines (e.g., AstraZeneca’s COVID-19 vaccine which is not authorized or approved 

in the United States). 

Updated Information:

Cases of TTS following administration of the Janssen COVID-19 vaccine have been reported in 

males and females, in a wide age range of individuals 18 years and older, with the highest 

reporting rate (approximately 1 case per 100,000 doses administered) in females ages 30-49 

years; overall, approximately 15% of TTS cases have been fatal 

To review several ACIP activities with regard to Janssen COVID-19 vaccine, the VaST WG met 

on December 6, 2021 and the ACIP COVID-19 Vaccines WG met on December 9, 2021 to 

review and discuss these new data. Prior to the December 16, 2021 ACIP meeting, the ACIP 

COVID-19 Vaccines WG reviewed an updated benefit/risk analysis with respect to Janssen 

COVID-19 vaccination, examined the patterns of use of this vaccine since the pause in April 

2021, and engaged in detailed discussions about updates to policy options for the use 

of COVID-19 vaccines in the US. Dr. Daley concluded with a review of the agenda for the day. 

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ACIP Meeting Summary December 16, 2021 

Update on Thrombosis with Thrombocytopenia Syndrome (TTS) 

Dr. Isaac See (CDC/NCEZID) presented an update on TTS. As a reminder, thrombosis occurs 

when blood clots block blood vessels. Platelets (thrombocytes) are colorless blood cells that 

help the body form blood clots. Thrombocytopenia is the medical term for low blood platelet 

count. A low count is usually considered to be less than 150,000 platelets per microliter (μL) of 

blood. TTS is a new syndrome that has been recognized to occur after receipt of adenoviralvectored COVID-19 vaccines. In the US, the only authorized adenoviral-vectored COVID-19 

vaccine is the Janssen or Johnson & Johnson COVID-19 vaccine. As the name suggests, TTS 

is characterized clinically by blood clots with low platelet counts. There are several early reports 

about TTS, both in the US and abroad.1 

One type of thrombosis is cerebral venous sinus thrombosis (CVST). This is a somewhat rare 

type of blood clot involving large veins inside the head. CVST can be a very serious condition, 

and the most severe TTS cases often involve CVST. CVST is often under-diagnosed due to its 

nonspecific presentation. When patients die from CVST early in the disease course, the 

immediate mechanism of death is often brain herniation resulting from either a large 

hemorrhage in the brain, multiple hemorrhages, or diffuse brain edema. Reported prognostic 

factors for poor short-term outcomes of CVST include anatomical characteristics of disease 

(brain herniation and hemorrhage) or features of the clinical presentation (seizures, depressed 

consciousness, altered mental status). 

To recap the initial US events concerning TTS, the FDA granted EUA authorization for the 

Janssen COVID-19 vaccine on February 27, 2021. The first post-authorization doses of 

Janssen were given March 2nd. On April 13th, CDC and FDA announced a pause in the use 

of Janssen COVID-19 vaccine after identification of 6 cases of CVST with thrombocytopenia 

following vaccination. On April 23rd, the ACIP met and reviewed data on TTS following Janssen 

vaccination and reaffirmed its recommendation for the vaccine. The pause was subsequently 

lifted. CDC’s interim considerations and website and FDA’s fact sheets were updated with 

information about the risk of TTS, particularly in women <50 years of age.2 The ACIP reviewed 

Janssen COVID-19 vaccine benefit/risk data again in light of Guillain-Barré syndrome (GBS), 

with TTS data included. 

Surveillance data for this presentation came from a collaboration between the Vaccine Adverse 

Event Reporting System (VAERS) and CDC’s Clinical Immunization Safety Assessment Project 

(CISA Project). The initial case findings occurred through searches of the VAERS database. 

Confirmation required medical records review and cases were presented to CISA experts, 

including from the fields of hematology and neurology, to confirm that the clinical syndrome was 

TTS and to rule out other causes of thrombosis and thrombocytopenia. The working case 

definition for TTS following COVID-19 vaccine differs slightly between Tier 1 and Tier 2 cases. 

Both require a platelet count of <150,000 cells/μL. Tier 1 cases are those where there is 

thrombosis in an unusual location (e.g., CVST, abdominal venous or arterial thrombosis). For 

these cases, a positive PF4 enzyme-linked immunosorbent assay (ELISA) test is not required. 

Tier 2 cases are those with thrombosis only in a more typical location (e.g., pulmonary 

embolism or deep vein thrombosis of extremity). For these, a positive PF4 ELISA test is 

1 https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clotslow-blood; https://jamanetwork.com/journals/jama/fullarticle/2779731; 

https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e2.htm?s_cid=mm7018e2_w 

2 https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html; https://www.cdc.gov/vaccines/covid-19/clinicalconsiderations/covid-19-vaccines-us.html; https://www.fda.gov/media/146304/download; 

https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e4.htm 

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ACIP Meeting Summary December 16, 2021 

required. Reports where the only sites of thrombosis are ischemic stroke or myocardial 

infarction are excluded. Cases with concurrent COVID-19 infection were excluded, given that 

COVID-19 is known to be a cause of both thrombosis and thrombocytopenia. Dr. See reviewed 

descriptive epidemiology and reporting rates for TTS cases receiving Janssen COVID-19 

vaccine March 2–August 31, 2021; summarized information about all deaths among TTS cases 

following Janssen COVID-19 vaccine confirmed by December 9, 2021; and reporting rates for 

TTS deaths receiving Janssen COVID-19 Vaccine March 2–August 31, 2021. 

Regarding the epidemiology of US TTS cases following Janssen COVID-19 vaccination for the 

time period March 2–August 31, 2021, the median age of patients with TTS was 44.5 years. 

Most were females and almost half of the cases occurred in women less than 50 years of age. 

Most patients were reported to be white non-Hispanic. Among the cases, 29 involved a CVST. 

None of the patients with TTS were pregnant or postpartum and no cases occurred in a patient 

with diagnosed thrombophilia. Among the cases, 7 were known to have a past SARS-CoV-2 

infection. The median time from vaccination to symptom onset was 9 days. The median time 

from symptom onset to hospital admission was 5 days. A total of 39 of the cases were 

vaccinated before the pause on April 13th and all cases occurred after a first dose of Janssen 

vaccine. 

For the most part, the specific risk factors for TTS are not known. In terms of general risk factors 

for venous thrombosis in patients with TTS following Janssen COVID-19 vaccination, the most 

common venous thrombosis risk factor was obesity, occurring in 46% of patients. However, 

39% percent of patients did not have any venous thrombosis risk factors (e.g., obesity, 

hypertension, diabetes, systemic estrogen therapy, or other venous thrombosis risk factors). 

Regarding the outcomes of TTS cases all were hospitalized and 36 or 2/3 of those, were in the 

intensive care unit (ICU). For patients who survived hospitalization, the median length of 

hospital stay was 9 days, with a range of 1 to 132 days and an interquartile range of 6 to 17 

days. Eight patients died during hospitalization, 9 were discharged to a post-acute care facility, 

and 37 were discharged to home. 

Regarding reporting rates for TTS following Janssen COVID-19 vaccination in terms 

of cases per million doses, the highest rates of TTS were reported in women between 30-39 

years of age and women 40-49 years of age, which is a finding that has been seen previously. 

The current language on the CDC website discusses the increased risk of TTS in women aged 

less than 50 years. The reporting rate for women 18-29 years of age is similar to the reporting 

rates for women 50-64 years of age and for men 40-49 years of age at around 4-5 cases per 

million doses. Comparing the reporting rates that were shown during the previous presentation 

to ACIP in July 2021, the rates are now slightly higher for all age groups and overall 20% higher. 

The rates for men 30-49 years of age are now about twice what was presented before. For men 

50-64 years of age, there is about a 50% increase, with the overall for men at about a 50% 

higher rate than what was previously presented. 

Transitioning to focus specifically on deaths in patients with TTS following the Janssen COVID19 vaccine based on all deaths that had been confirmed as of December 9th, there were 8 

confirmed TTS deaths in persons vaccinated with Janssen vaccine by August 31st. An additional 

TTS death was confirmed in a patient who was vaccinated after August 31st, bringing the total to 

9 confirmed deaths. All 9 occurred after Dose 1 of Janssen vaccine. The median age of patients 

who died is 45 years, which is similar to the overall median age of TTS patients of 44.5 years. 

Of the 9 deaths, 7 were in females and all were reported in non-Hispanic white persons. The 

most common underlying condition was obesity, which was present in 7 of the 9 deaths. 

However, 2 of the deaths occurred in patients without any known medical conditions. 

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ACIP Meeting Summary December 16, 2021 

To summarizes some of the clinical features of the 9 deaths, all patients had features consistent 

with severe CVST (e.g., large or multiple cerebral hemorrhages; evidence of intracranial edema 

and/or mass effect; depressed consciousness and/or seizure). Of the 9 deaths, 7 had confirmed 

CVS. While 2 did not have specific brain imaging before death that would be needed to 

diagnose CVST, the location of the brain hemorrhages was suggestive of CVST. That is, the 

clinical presentation for all deaths was consistent with what is seen from deaths in CVST in 

general. None of these patients received IV heparin for treatment and 4 received a craniectomy 

or craniotomy to try to treat the brain hemorrhage. The median time from symptom onset to 

admission was 3 days. This is shorter than observed for TTS patients overall of 5 days, 

meaning that these patients do present for care sooner than the typical TTS patient. In addition, 

the median time from hospital admission to death was 1 day, with a maximum of 2 days. It has 

been striking on reviewing these cases how rapidly a patient’s status deteriorates and results in 

death. 

To recap the total TTS and dates of death counts previously presented to ACIP and the reasons 

for those presentations, the purpose of the meeting on April 23rd was to discuss resolution of the 

Janssen pause at which time 7.98 million doses of Janssen COVID-19 vaccine had been given 

and there were 15 TTS cases and 3 deaths. The purpose of the meeting on May 12th was for 

general follow-up on TTS at which time 8.73 million doses had been given and there were 28 

TTS cases and 3 deaths. During the July 22nd meeting, there was an updated benefit-risk 

discussion that included GBS. At that time, 12.5 million doses had been given and there were 

38 total TTS cases and 4 deaths. The case counts were revised comparing previously 

presented data with data as of December 9, 2021. It is now known that there were 39 cases and 

5 deaths in persons who were vaccinated by April 23rd . In May, the cases are now known to be 

42 and deaths 6. In July, cases are now known to be 50 and deaths 6. 

For the calculation of death reporting rates presented during this meeting, there were 54 known 

total cases and 8 known total deaths among persons vaccinated by August 31st. The highest 

TTS death reporting rate was for women 30-39 and 40-49 years of age of approximately 2 

deaths per million Janssen doses. The 9th death was not used for these calculations because of 

vaccination after August 31st, which was in a woman under 30 years of age. The proportion of 

TTS cases resulting in death was 13% for those vaccinated before the pause and 20% for those 

vaccinated after the pause. In addition to the 9 deaths confirmed to date, 2 additional possible 

TTS deaths following Janssen COVID-19 vaccination have been identified. Both of these deaths 

were in persons vaccinated before the pause and they share many clinical and epidemiologic 

features in common with the 9 confirmed deaths, including symptom onset between 7-14 days 

after vaccination, large cerebral hemorrhage with mass effect, thrombocytopenia, and rapid 

progression from admission to death. The difference is that these 2 cases did not have definitive 

imaging to identify CVST, nor did they have imaging performed that might have identified other 

thromboses present before the patients expired. These 2 deaths have been reviewed with the 

CISA Project investigators. They are difficult to confirm as TTS cases because without a 

documented thrombosis, they do not technically meet the TTS definition. However, the CISA 

Project investigators were concerned that clinically, it appeared that TTS with CVST could be 

the underlying cause of hemorrhage.3 

3 Source of doses administered: https://covid.cdc.gov/covid-data-tracker/#vaccinations; Reporting rate = TTS cases per 1 million 

Janssen COVID-19 vaccine doses administered 

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ACIP Meeting Summary December 16, 2021 

In summary, the US TTS case reporting rate following Janssen COVID-19 vaccination is higher 

than what was previously presented to ACIP, and the case reporting rate for men 40-49 years of 

age and women 50-64 years of age is similar to that for women 18-29 years of age. The US 

TTS deaths following Janssen COVID-19 vaccination have typical features of severe CVST, a 

clinical course from symptoms to admission, and rapid admission to death. These deaths are 

more common than what was known when data were previously presented to ACIP, with a TTS 

death reporting rate following Janssen vaccination of approximately 2 TTS deaths per million 

doses for women aged 30-49 years of age. The proportion of TTS cases with deaths did not 

decrease after the Janssen pause. The main limitations of this work are possible underdiagnosis of CVST and the fact that VAERS is a passive surveillance system. Both of these 

limitations mean that the case and death reporting rates shown might be underestimates of the 

true incidence rates. 

VaST Summary 

Dr. Keipp Talbot (VaST Chair) reminded everyone that the objectives of the VaST WG are to: 

1) review, evaluate, and interpret post-authorization and approval of COVID-19 vaccination 

safety data; 2) serve as the central hub for technical subject matter expertise from federal 

agencies conducting post-authorization and 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. 

Since December 21, 2021, the VaST WG has had 45 meetings to review vaccine safety data. 

On April 12th, the VaST WG met and had the first review of CVST with thrombocytopenia. At 

that time, 6 cases were identified as rare to very serious adverse events (SAEs) following 

vaccination with the Janssen vaccine. Risk factors for CVST with thrombocytopenia were not 

well-understood, and the decision was that timely and transparent communication with HCP and 

the public was crucial to maintain confidence in the COVID-19 vaccination program. After that 

meeting, a Health Alert Network (HAN) communication was released on April 13th with 

recommendations for clinicians regarding diagnosis and treatment of CVST with 

thrombocytopenia, recommendations for public health regarding case reporting through VAERS, 

and recommendations for the public concerning clinical signs and symptoms to monitor after 

vaccination. 

The ACIP met again on April 14th and 23rd. On the 14th, the ACIP reviewed cases of CVST with 

thrombocytopenia after COVID-19 vaccination and discussed the need for additional information 

to support evidence-based decision-making, including age- and gender-specific risk estimates 

and evaluation of the benefit/risk balance of using the Janssen vaccine in specific subgroups. 

On April 23rd, the ACIP discussed the risk of TTS, which appeared to be highest in females less 

than 50 years of age in which 15 cases were reported that were rare but serious. Other risk 

factors for TTS were not well-established. Risk mitigation strategies included minimizing 

exposure in high-risk populations, increasing awareness, ensuring timely diagnosis and 

management of TTS, and educating patients about the benefits and risks of available vaccines. 

A decision was made at that time that the VaST WG would continue to monitor TTS or other 

thromboembolic disease and thrombocytopenia in all available vaccine safety surveillance 

systems; and would update the ACIP COVID-19 Vaccines WG, the ACIP Secretariat, and the 

ACIP on a regular basis. 

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ACIP Meeting Summary December 16, 2021 

A Morbidity and Mortality Weekly Report (MMWR) was published via early release online April 

27, 2021 that included updated recommendations on the Janssen COVID-19 vaccine.4 

Subsequently, the VaST WG continued to review TTS and Janssen COVID-19 vaccination 

during May through December 2021. The VaST WG heard regular updates on TTS data from 

VAERS, Vaccine Safety Datalink (VSD), and other safety systems. The VaST WG assessments 

of Janssen COVID-19 vaccination safety was re-presented to ACIP on May 12th with a focus on 

TTS and on July 22nd with a focus on GBS.5 

TTS was again reviewed during a regularly-scheduled VaST WG meeting on December 6, 

2021. At that time, 54 TTS cases and 9 deaths had been reported following the Janssen 

COVID-19 vaccination in the US through August 2021. The TTS case reporting rate following 

Janssen vaccine was higher than previous estimates in men as well as women and in a wider 

age range. Follow-up investigations have provided more evidence for the relationship between 

Janssen COVID-19 vaccination and TTS and associated severe outcomes, including death and 

neurologic problems. The VaST WG recognizes the public health benefits of the Janssen 

COVID-19 vaccine. However, the additional TTS cases and reported deaths are concerning. 

The VaST WG felt that the new data on TTS risk needed to be put into the context of the 

benefit-risk assessment and presented to the ACIP COVID-19 Vaccines WG and the ACIP. 

Discussion Summary (See & Talbot) 

• Dr. Poehling requested further information regarding why additional cases from earlier were 

just now being discovered. 

 Dr. See indicated that there are sometimes lags in reporting and in getting 

information confirmed. In addition, continued refinement of the search strategy and 

evaluation process and a better understanding of TTS have resulted in better at 

detection and evaluation of cases. 

 Dr. Shimabukuro reminded everyone that this was a new condition in Spring 2021. 

With continued refinement in the search strategies and assessment of cases, 

retrospective reviews of the data have been done frequently. The additional cases 

were identified and classified based on these retrospective reviews. 

• Ms. Bahta inquired as to whether any neurological sequelae have been identified among the 

54 cases. 

 Dr. See indicated that they do not have long-term data at this point. There is some 

information on the status of the 9 who were discharged to a facility after their hospital 

stay who were not considered well enough to return home, even with help. Among 

those 9, it is not clear whether the patients’ status at discharge differed from their 

previous status. Among these 9 patients, 1 had many comorbidities before the TTS 

diagnosis. While there was not a description of the neurologic status of another 

patient, the patient was not able to provide their own consent for transfer to the 

facility. This suggests potentially significant functional impairment. For the other 7, 

4 MacNeil JR, Su JR, Broder KR, et al. Updated Recommendations from the Advisory Committee on Immunization Practices for Use 

of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among 

Vaccine Recipients — United States, April 2021. MMWR Morb Mortal Wkly Rep 2021;70:651-656. DOI: 

http://dx.doi.org/10.15585/mmwr.mm7017e4 

5 TTS, thrombosis with thrombocytopenia syndrome; GBS, Guillain-Barré syndrome; https://www.cdc.gov/vaccines/acip/workgroups-vast/index.html 

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ACIP Meeting Summary December 16, 2021 

information available was variable. There was significant impairment present for 

these 7, including 5 with hemiplegia and many additional impairments, 2 who had no 

movement in some of their extremities, 1 who was still intubated, and 2 with other 

significant neurological impairments. Notably, only 29 of the identified cases involved 

CVST. The others involved thrombosis at other locations such as pulmonary 

embolism or PVT. While they may have sequelae that are not neurologic, they could 

still be significant. 

• Dr. Loehr asked whether any additional information was available regarding the background 

rate for this syndrome for the general population. 

 Dr. See indicated that the background rate for this syndrome, or for syndromes that 

look very much like this, are not known exactly. There is a study that is not yet 

published that tried to estimate the background rate for CVST and thrombocytopenia 

and hospitalizations. That rate is a couple orders of magnitude lower than seen 

following vaccination. 

• Dr. Poehling asked whether there is any evidence of TTS occurring when the Janssen 

COVID-19 vaccine is used as a booster dose. 

 Dr. See reported that while no cases of TSS have been observed following the 

Janssen COVID-19 booster doses, the number of booster doses was somewhat 

small at this point. 

• Ms. McNally inquired as to whether there have been any health literacy assessments 

completed on the EUA Fact Sheets for the Janssen COVID-19 vaccine, and whether there 

are any data regarding whether people are reading the Fact Sheets in advance of getting 

vaccinated with any of the COVID-19 vaccines. 

 Dr. Fink indicated that the FDA strives to ensure that the language in the Fact Sheets 

for vaccine recipients and caregivers is written at an appropriate level of 

comprehension. While he did not believe they conducted a formal health literacy 

evaluation, he will check and will follow up with the ACIP. 

 Regarding whether people are reading the fact sheets, Dr. Wharton indicated that 

they would check on this and get back to the ACIP. 

 Dr. Lee emphasized that while informed consent is a process that all clinicians try to 

use every time they interact with patients, the concern that it may be challenging to 

consistently and reliably implement across the board is an important one in terms of 

making sure that people have full information about the benefits and the risks. 

• Dr. Lee observed that even with the newly presented information, it is potentially challenging 

for clinicians mitigate the risk of severe complications. Given that early recognition and 

appropriate management appear to have been done, there remains a challenge. 

 Dr. See said this was his impression as well for the most part. The patients who have 

TTS and then die present somewhat quickly. When they finally are diagnosed, it 

appears that progression is too rapid in most cases for much more to be done. 

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ACIP Meeting Summary December 16, 2021 

 In terms of the challenges of mitigating risk, Dr. Poehling recalled that when the 

ACIP heard this information in April, the thought was that receiving heparin was 

making this condition worse and they wanted people to clearly understand that 

heparin should not be used. One interpretation is that while none of the patients who 

died after the pause received heparin, it did not seem to mitigate risk. 

• Dr. Duchin asked whether for the Tier 2 category of thrombosis in a typical location that had 

a negative PF4 ELISA any assessment was done to look for signals for that syndrome. 

 Dr. See responded that this was probably outside the scope of what he has been 

working on, which has been focused on characterizing the patients who meet the 

definition and have TTS. 

 Dr. Shimabukuro added that CDC is still actively working with its surveillance 

partners and the FDA to assess thromboembolic events without thrombocytopenia 

after COVID-19 vaccination. The ACIP will be provided with updated information 

when it becomes available. 

 To follow-up, Dr. Daley requested confirmation on whether not only thromboembolic 

events without thrombocytopenia are being monitored across all the surveillance 

systems, but also there has not been evidence of elevated risk of those syndromes 

to date. 

 Dr. Shimabukuro indicated that active surveillance has not shown consistent 

evidence of an elevated risk. CDC is currently engaged with its FDA colleagues to 

analyze the passive surveillance data, the results of which they will be happy to 

present to the ACIP during a future meeting. 

Updates to the Benefit/Risk Assessment for Janssen COVID-19 Vaccine: Applying the

Evidence to Recommendation (EtR) Framework 

Dr. Sara Oliver (CDC/NCIRD) presented updates to the benefit/risk assessment for the 

Janssen COVID-19 vaccines, applying the EtR to recommend framework similar to what was 

done in April 2021. The policy question remains the same, “Should vaccination with the Janssen 

COVID-19 vaccine (1 dose) be recommended for persons 18 years of age and over under an 

Emergency Use Authorization?” 

Regarding the public health domain, the unfortunate milestone of over 50 million cases reported 

in the US was recently reached. After steady declines in case counts through September and 

October, there has been an increase in cases reported from November to date in December. 

The 7-day average as of December 13th reached over 117,000 cases per day.6 During the 

timeframe of August 29-December 11, 2021, the Delta variant has represented nearly all 

circulating SARS-CoV-2 variants circulating in the US. However, the Omicron variant currently 

represents an estimated 3% of strains in the US.

7 

6 https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed December 14, 2021 7 https://covid.cdc.gov/covid-data-tracker/#variant-proportions Variant Proportions, August 29 - December 11, 2021 

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ACIP Meeting Summary December 16, 2021 

To recap TTS after the Janssen vaccine in the US, through August 31, 2021 there have been 54 

cases of TTS identified for an overall reporting rate of 3.8 per million Janssen doses. Rates are 

the highest among females 30-49 years of age, but the risk is no longer exclusively clustered in 

this population. Through December 2, 2021, there have been 9 TTS deaths for an overall 

reporting rate of 0.57 per million doses. The rates of TTS deaths have been highest among 

females 30-49 years of age. 

For a summary of what is known about TTS after the AZ vaccine in Europe, the European Union 

(EU) reported approximately 10 cases per million vaccinated adults in April 2021. Most cases 

were in women less than 60 years of age within 2 weeks of receiving the first vaccine dose. In 

an update in September 2021, the European Medicines Agency (EMA) safety committee, the 

Pharmacovigilance Risk Assessment Committee (PRAC), updated the product information by 

removing the previous statement reporting that TTS cases occurred mostly in women less than 

60 year of age. At this time, they showed that 43% of cases were in males and nearly 40% 

occurred in vaccinated persons over 60 years of age. In updated data through December from 

the UK, over 400 cases of blood clots with low platelets were reported, with an overall reporting 

rate of 15 per million doses. Half of the cases were in women with a broad range of 18-93 years 

of age. They reported a 17% case fatality. Most cases occurred after the second dose, but 47 

cases and 6 deaths were reported after the second dose.8 

Based on reports of TTS after adenovirus vector vaccines, some countries have updated their 

COVID-19 vaccine policy. The WG evaluated vaccine policy from 16 countries.9 Note these are 

primarily higher-income countries with broad access to mRNA and adenovirus vector vaccines. 

This is not meant to be globally representative of all adenovirus vector vaccine policy. All 16 

countries with publicly available vaccine policy and broad vaccine access had recommendations 

for use of the AZ vaccine. Among these 16 countries, 30% (5) halted use of the vaccine; 44% 

(7) use the vaccine, but have a preferential recommendation for other COVID vaccines; 12% (2) 

recommend use only in older ages; and 12% (2) recommend use of the vaccine in all ages and 

populations. Of the 16 countries, 12 also had recommendations for use of the Janssen COVID19 vaccine. Among these 12 countries, 25% (3) halted use of the vaccine; 33% (4) had a 

preferential recommendation for other COVID vaccines; 8% (1) does not have a preferential 

recommendation, but recommended use only in older ages; and 33% (4) recommend use of the 

vaccine in all ages and populations. 

8 https://www.who.int/news/item/16-04-2021-global-advisory-committee-on-vaccine-safety-(gacvs)-review-of-latest-evidence-of-rareadverse-blood-coagulation-events-with-astrazeneca-covid-19-vaccine-(vaxzevria-and-covishield); 

https://www.ema.europa.eu/en/documents/prac-recommendation/signal-assessment-report-embolic-thrombotic-events-smq-covid19-vaccine-chadox1-s-recombinant_en.pdf; https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-

vaccine-safety-update-vaxzevria-previously-covid-19-vaccine-astrazeneca-8-september-2021_en.pdf; 

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-ofyellow-card-reporting#yellow-card-reports 

9 Australia, Canada, Denmark, Finland, France, Germany, Israel, Japan, Mexico, Netherlands, Norway, Philippines, South Africa, 

Spain, Sweden, United Kingdom 

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ACIP Meeting Summary December 16, 2021 

As an example, this is language from National Advisory Committee on Immunization (NACI) 

Canada:10 

 A complete series with an mRNA COVID-19 vaccine should be preferentially offered to 

individuals in the authorized age group without contraindications to the vaccine. 

 A viral vector COVID-19 vaccine may be offered to individuals in the authorized age group 

without contraindications to the vaccine to initiate a series when other authorized COVID-19 

vaccines are contraindicated or inaccessible. Informed consent should include discussion 

about the risk and symptoms of VITT, as well as the need to seek immediate medical care 

should symptoms develop. 

 A booster dose of an authorized viral vector vaccine should only be considered when other 

authorized COVID-19 vaccines are contraindicated or inaccessible. Informed consent 

should include discussion about the risk and symptoms of VITT, as well as the need to seek 

immediate medical care should symptoms develop. 

In summary, there have been recent increases in reported COVID-19 cases and the US is 

reporting cases of the Omicron variant. Globally, TTS cases have been reported after 

adenovirus vector vaccines, including both Janssen and AZ COVID-19 vaccines. This has 

resulted in changes to vaccine policy for adenoviral vector vaccines in many higher-income 

countries with access to alternative vaccines.11 

Moving to the benefit/risk domain, the first Janssen COVID-19 benefit/risk analyses for the US 

was presented in April 202112 when the WG presented a benefit/risk analysis to inform decisionmaking during the Janssen COVID vaccine pause. In July 2021,

13 a benefit/risk review was 

presented of all COVID vaccine-associated events, including TTS, GBS, and myocarditis. The 

focus of the updated benefit/risk analysis for the Janssen vaccine during this session was in the 

context of additional data, sufficient vaccine supply, and widely-available mRNA COVID-19 

vaccines. 

For this assessment of the benefit/risk balance, the benefits were calculated per one million fully 

vaccinated people and stratified by the age groups 18-49 years, 60-64 years, and 65 years and 

over. Age- and sex-specific hospitalization rates were used from COVID-NET14 and age and 

vaccine-specific VE estimates came from the Influenza and Other Viruses in the Acutely Ill 

Network (IVY Network).15 Benefits were calculated over a 180-day period. Harms also were 

calculated per one million fully vaccinated people. TTS rates came from the previously-reported 

presentation from VAERS, and previously-presented data on GBS16 and myocarditis17 rates 

from VAERS also were included. In terms of the vaccine-specific estimates of effectiveness 

against COVID-19 hospitalization from the IVY Network18 that were used as inputs into the 

model, the Janssen age-specific estimates ranged from 69% to 76% vaccine effectiveness (VE) 

and the mRNA age-specific rates ranged from 88% to 92% VE. 

10 https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization/naci/ 

recommendations-use-covid-19-vaccines.html 11 Recommendations-use-covid-19-vaccines-en.pdf (canada.ca) 12 MacNeil et al. http://dx.doi.org/10.15585/mmwr.mm7017e4 13 Rosenblum et al. http://dx.doi.org/10.15585/mmwr.mm7032e4 14 https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html 15 Self et al. MMWR 2021 16 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/02-COVID-Alimchandani-508.pdf 17 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/04-COVID-Oster-508.pdf 18 https://www.cdc.gov/mmwr/volumes/70/wr/mm7038e1.htm; For age strata specific estimates, adjusted for continuous age in 

years, calendar date (biweekly), HHS region, sex, and race/ethnicity 

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ACIP Meeting Summary December 16, 2021 

There have been some notable changes in the methods from the original benefit/risk 

assessment of the Janssen vaccine that was first presented in April 2021. At that time, it was 

assumed that all COVID hospitalizations were occurring among unvaccinated. The model now 

accounts for some COVID hospitalizations occurring among vaccinated persons. In the original 

model, it was assumed that there were equal sex-specific risks of COVID hospitalization, ICU 

admission, and death. Now it is possible to use age- and sex-specific rates. In April, it was 

assumed that VE against hospitalization was 90% for the Janssen vaccine based on the 

randomized clinical trial (RCT). An age-specific VE between 69%-76% was used in the updated 

model based on real-world observational data. Hospitalization rates were used in the April 

model from the week ending March 27th, which had lower rates overall than in the current model 

that used rates from the week ending November 13th. In the original model, a 30-day time 

horizon was used, which accounted for a possible expected delay in vaccination that could 

occur if the Janssen vaccine was no longer available. Now the vaccine supply is sufficient, the 

time horizon is 180 days and is more in line with what is known about duration of protection. In 

terms of the reporting rates of TTS following the Janssen COVID-19 vaccination, TTS is most 

common among women 18-49 years of age who have reporting rates of 8.7 TTS cases per 

million Janssen doses. 

To guide the benefit/risk discussion, this presentation presented the benefits and risks of the 

Janssen vaccine compared with no vaccine by age and by sex. The differential benefits and 

risks of the Janssen vaccine were compared with mRNA vaccines, including in the risks of GBS 

and myocarditis. Looking at COVID-19 associated hospitalizations prevented by Janssen 

COVID-19 vaccine compared with TTS cases expected per million fully vaccinated people, 

many more COVID hospitalizations would be expected to be prevented over 6 months than TTS 

cases expected for all age and sex groups. Focusing only on the benefits and risks among 

females, many more hospitalizations would be prevented when including other potential risks 

than TTS and GBS cases expected. Still focusing on females and adding the benefits and risks 

of the mRNA vaccines compared to the Janssen vaccine, the mRNA vaccines would be 

expected to prevent more COVID hospitalizations and would have fewer cases of myocarditis 

expected than of TTS or GBS. Considering the same analysis exclusively among males, 

comparing the Janssen vaccine with the mRNA vaccine in males, the mRNA vaccines prevent 

more COVID hospitalizations than the Janssen vaccine in all age groups. In males 18-49 years 

of age, more cases of myocarditis would be expected from the mRNA vaccines than TTS or 

GBS cases from the Janssen vaccine. In the older age groups among males, GBS would 

become the largest vaccine-associated risk. 

It is important to note that there are differences in the severity of these vaccine-associated 

events. For myocarditis after mRNA COVID-19 vaccines,

19 a 3-month follow-up showed that 

over half reported no symptoms and over 90% are “fully recovered” by a cardiologist or 

healthcare provider. There have been no confirmed deaths. For TTS after the Janssen COVID19 vaccines,20 there is an approximately 15% mortality rate and 17% required discharge to a 

post-acute care or rehabilitation facility. For GBS after the Janssen COVID-19 vaccines,21 there 

is about a 1% mortality rate and 10% required mechanical ventilation. 

19 ACIP Presentation, Dr. Oster: November 2, 2021 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/04-

COVID-Oster-508.pdf 20 Presentation, Dr. See 21 ACIP Presentation, Dr. Alimchandani: July 22, 2021 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/02-

COVID-Alimchandani-508.pdf 

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ACIP Meeting Summary December 16, 2021 

There are several limitations to the benefit/risk analysis. This analysis considers direct benefits 

and risks over a 180-day period comparing vaccine to no vaccine. The model compares a 

single-dose Janssen series with a 2-dose mRNA series. The model assumes a static 

hospitalization rate and VE over a 6-month period and does not account for booster doses or for 

prior infection. In summary, this was a direct benefit/risk assessment of the Janssen COVID-19 

vaccines and TTS, which considered individual benefits of vaccination versus individual risk. 

Using current VE estimates, the benefit/risk balance of the Janssen COVID-19 vaccine is still 

favorable for all age and sex groups compared with no vaccine. When compared to the 

benefit/risk balance for mRNA vaccines, the Janssen vaccine prevents fewer COVID-19 

associated hospitalizations, ICU admissions, and deaths and there are more severe health 

impacts from TTS and GBS after a Janssen vaccine compared to impacts from myocarditis 

after the mRNA COVID-19 vaccines. In a setting where mRNA and the Janssen vaccines are 

both widely available, the benefit/risk balance for mRNA COVID-19 vaccines is likely more 

favorable across all age and sex groups. 

Moving to values, acceptability, and feasibility a large-scale nationally-representative survey 

was conducted to assess individual confidence in each of the COVID-19 vaccines available in 

the US before, during, and after the temporary pause for the Janssen vaccine. The results show 

loss of confidence in the Janssen vaccine, which persisted over time even after the halt was 

lifted.22 In terms of daily reported doses given by the manufacturer,

23 providers are 

administering about 1.9 million doses per day on average (including first, second, and additional 

doses). This is approximately 44% decrease from the peak of around 3.4 million doses reported 

on April 13, 2021. Looking at COVID-19 vaccine administration by vaccine type, over 488 million 

COVID-19 vaccine doses have been administered in the US, of which 17.2 million Janssen 

doses have been administered. Approximately 56 million people in the US have received a 

booster dose, of which about 870,000 were Janssen booster doses. While some vaccine 

recipients received the same vaccine type of vaccine for their primary and booster dose, others 

received one type for their primary series and a different type for their booster dose (e.g., 

heterologous prime boost or the mix-and-match). Among those who received Janssen for their 

primary series, 40% received a Moderna booster, 30% received a Pfizer booster, and about 

28% received a Janssen booster.24 

Since the pause, the US has been administering around 110,000 doses of the Janssen COVID19 vaccine per week since early September. Since authorization in late October, approximately 

around 100,000 booster doses of the Janssen COVID-19 vaccine have been administered per 

week. Approximately 65,000 doses of Janssen COVID-19 vaccine have been administered per 

week since September among males. Since authorization, about 50,000 booster doses per 

week have been administered to males. About 45,000 primary doses have been administered 

weekly since early September to females, which is lower than the doses administered among 

males. However, similar numbers of booster doses have been administered each week among 

males and females since the booster dose authorization for Janssen COVID-19 vaccine. 

22 Rader, et al. Persistent drop in confidence following US recommended pause of Ad26.COV2.S vaccine administration. Data 

updates as of December 2021. 23 The New York Times. Covid-19 Vaccinations: County and State Tracker. https://www.nytimes.com/interactive/2020/us/covid-19-

vaccine-doses.html. Accessed December 15, 2021 

24 CDC. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total. Accessed December 15, 2021 

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ACIP Meeting Summary December 16, 2021 

Jurisdictions were surveyed for their use of the Janssen vaccine in December 202125 and 

reported that overall, the Janssen vaccine is available to nearly all populations and many 

specific populations. Jurisdictions also highlighted that while being offered widely, the Janssen 

vaccine is the preferred option in some more transient or transitional settings. Some jurisdictions 

highlighted that it may be the only option at some settings, such as correctional facilities, 

homeless shelters, or airport clinics. When asked about a possible impact if the Janssen 

vaccine was no longer recommended, jurisdictions highlighted issues with access for those who 

prefer a single-dose vaccine or an alternative to the mRNA vaccines. They also mentioned 

decreased confidence in COVID-19 vaccines and disruptions to logistics flow. 

Regarding the equity domain, the patterns of race and ethnicity for the Janssen COVID-19 

vaccine are very similar to those for the mRNA vaccines.26 Jurisdictions also were asked about 

revised recommendations and populations that could be impacted. Based on how doses are 

currently being used, changes in recommendations may impact various populations such as 

those experiencing homelessness, incarcerated individuals, home-bound populations, migrant 

or seasonal populations, rural populations, racial/ethnic minorities, those at higher risk of 

COVID-19, college students, and those in long-term care facilities.27 

In summary, the context of the benefit-risk review in April 2021 was a setting of limited supply of 

both the mRNA and the Janssen vaccines. It was estimated that if use of the Janssen vaccine 

was not resumed, it could take nearly 3 months for all vaccine-intending adults to complete a 

COVID-19 vaccine series based on supply at that time. Within that context, ACIP reaffirmed its 

recommendations for use of the Janssen vaccine in all persons 18 years of age and over under 

FDA’s EUA that included a warning that rare clotting events might occur after vaccination, 

primarily among women 18-49 years of age. The MMWR that was published shortly thereafter 

stated, “Education around the risk for TTS with Janssen COVID-19 vaccine, as well as the 

availability of alternative COVID-19 vaccines, is required to guide vaccine decision-making.” 

In July 2021, GBS after the Janssen COVID-19 vaccine was identified and the benefit-risk 

balance was reassessed. ACIP determined that overall, the benefits of COVID-19 vaccination in 

preventing COVID morbidity and mortality outweigh the risk for these rare SAEs, but 

acknowledged that the balance of these benefits and risks varied by age and by sex. An 

additional case review and ongoing safety surveillance have identified previous and newlyoccurring TTS cases, including deaths. The context of this presentation of the updated benefitrisk balance of the Janssen COVID-19 vaccine is that the US is no longer in the setting of 

limited vaccine supply. These data were presented to the COVID-19 Vaccines WG the previous 

week. The WG discussed several proposed policy updates for use of the Janssen COVID-19 

vaccine. The four policy options discussed by the WG were as follows: 

 Policy Option #1: Reaffirm recommendations for all age and sex categories in the setting of 

FDA’s warning on the EUA and guidance in CDC’s clinical considerations. 

 Policy Option #2: Recommend the Janssen COVID-19 vaccine only for older adults with a 

cut-off of either ≥50 years or ≥65 years of age.

 Policy Option #3: Recommend against use of the Janssen COVID-19 vaccine for all 

persons. 

 Policy Option #4: Make a preferential recommendation for mRNA COVID-19 vaccines over 

the Janssen COVID-19 vaccines. 

25 Jurisdictional survey on Janssen vaccine, December 12-15, 2021 (n=46) 26 CDC. Vaccine Task Force. Vaccine Data Section/Data, Analytics & Visualization Task Force. Data updates as of December 15, 

2021 27 Jurisdictional survey on Janssen vaccine, December 12-15, 2021 (n=46) 

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ACIP Meeting Summary December 16, 2021 

For the first policy option to reaffirm recommendations for everyone, the pros would be that it 

allows flexibility and choice and would allow for the use of the vaccine in harder-to-reach 

populations. However, the cons are that it may lead to more cases of TTS and GBS. The 

burden is on the individual to make decisions for the type of vaccine received and for health 

departments or providers to convey that risk. At-risk populations for COVID may have limited 

opportunities for discussions of this risk associated with the vaccine. At-risk populations for 

COVID may also be at risk for barriers to rapid TTS identification and treatment. For the second 

policy option to recommend the Janssen vaccine only for older adults, the pros are that it would 

remove the vaccine from the most at-risk population and hopefully reduce TTS cases. Agebased recommendations can be easier to communicate and implement. Regarding cons, the VE 

is lower for the Janssen vaccine compared to the mRNA vaccines, so these recommendations 

may provide less protection in a population that is known to be at risk for severe disease from 

COVID-19. In the US, most older adults already have initiated a COVID-19 vaccine primary 

series. This would remove the option of the Janssen vaccine for younger men, who are at 

higher risk of myocarditis. In addition, it would not remove the vaccine from the population of 

older adults who are at most at-risk for GBS. If a cut-off ≥50 years of age is used, there are still 

cases and deaths from TTS reported in those 50-64 years of age. There have been 2 deaths in 

females 50-64 years of age and the TTS rate among females 50-64 years of age is similar to 

that for women 18-29 years of age. 

For the third policy option to recommend against use of the Janssen vaccine for everyone, the 

pros are that there would be no further cases of TTS or GBS after the Janssen COVID-19 

vaccine and no further deaths due to TTS or GBS after the vaccine. For cons, this option would 

remove choice from individuals for primary series and booster and would limit options for those 

with contraindications to mRNA vaccines. Importantly, it may have global implications around 

confidence in the Janssen COVID-19 vaccine that could impact global vaccine supply. For the 

fourth option of a preferential recommendation for mRNA COVID-19 vaccines over the Janssen 

COVID-19 vaccine, the WG acknowledged that the benefit-risk balance is more favorable for 

mRNA in all ages and sexes. This includes higher VE and less SAEs. This option would allow 

for flexibility and choices and for a vaccine option for someone who may have contraindications 

to mRNA vaccines. For cons, this option places the burden on the individual to make the 

decision for the type of vaccine received. At-risk populations may have limited opportunity for 

discussion of the risk associated with vaccine. While a preferential recommendation does 

provide more guidance than currently exists, there may be confusion around how to implement 

a preferential recommendation. 

The WG reviewed the data, policy options, and pros and cons and had several conclusions. In 

the setting where there are no alternative COVID-19 vaccines, the benefits of the Janssen 

vaccine outweigh the risk. This is important in global situations where there may not be other 

COVID-19 vaccines available. Due to both higher VE of the mRNA vaccines and the severity of 

safety issues seen with the Janssen vaccines, in the setting of widely-available mRNA vaccines 

in the US, the benefit-risk balance of the mRNA COVID-19 vaccines is more favorable than for 

the Janssen COVID-19 vaccine. Based on reviewing the totality of the data, the WG supported 

a preferential recommendation for mRNA vaccines. This is similar to many other countries with 

mRNA and adenovirus-vector vaccines widely available. The WG will continue to review 

available data on VE and safety. Updates to the recommendations can be made as needed. 

Education around the risks associated with adenovirus-vector vaccines will be critical for those 

who may choose to receive a Janssen vaccine. Importantly, ensuring access to mRNA vaccines 

in all individuals is critical. The jurisdictional survey revealed that there may be some 

populations and settings where Janssen is being used as the main vaccine offered. If Janssen 

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ACIP Meeting Summary December 16, 2021 

COVID-19 vaccine is the only vaccine offered to some harder-to-reach populations, this could 

result in inequitable distribution of risk for TTS and GBS. 

Possible language for a preferential recommendation: 

 mRNA COVID-19 vaccines are preferred over the Janssen COVID-19 vaccine for the 

prevention of COVID-19 for those ≥18 years of age.

 Janssen COVID-19 vaccines may be offered when other authorized COVID-19 vaccines 

are contraindicated or inaccessible. 

 This includes vaccines administered as a part of the primary series and booster doses. 

Possible additional guidance if the ACIP votes for a preferential recommendation: 

 Education about the risk for adverse events, including TTS or GBS after the Janssen 

COVID-19 vaccine, is required to guide vaccine decision-making. 

 Janssen COVID-19 vaccines may be offered to the following populations: 

- Persons with a contraindication to mRNA COVID-19 vaccines (e.g. severe allergic 

reaction after a previous dose or to a component of an mRNA COVID-19 vaccine) 

- Persons who would otherwise remain unvaccinated for COVID-19 due to limited access 

to mRNA COVID-19 vaccines 

- Persons who would prefer the Janssen COVID-19 vaccine despite safety concerns 

identified 

 Vaccine providers should start the two-dose mRNA COVID-19 vaccine series, even if there 

is uncertainty about how the patient will receive their second dose. Two-dose mRNA 

COVID-19 vaccines can be used in any population or setting. 

With all of this in mind, ACIP was asked to discuss the question: “Given the review of benefits 

and risks, what recommendation does ACIP feel is appropriate for use of the Janssen vaccine?” 

Janssen COVID-19 Vaccine Statement 

Dr. Penny Heaton (Janssen Pharmaceutical Companies of Johnson & Johnson)

emphasized that based on the data, Janssen is confident in the positive benefit/risk profile of its 

vaccine. It is saving lives in the US and on every continent around the globe. This vaccine is 

different in that it is long-lasting, offers high levels of protection, provides breadth of protection, 

has flexible dosing, and is easy to store and transport. In many low- and middle-income 

countries, this vaccine is the most important and sometimes only option. Even in the US, given 

its durable protection, it may be the preferred choice for people who cannot or will not return for 

multiple vaccinations. The safety and well-being of those who use the Johnson & Johnson 

vaccine continues to be Janssen’s number one priority. They strongly support education and 

awareness of rare events, such TTS, and also has several studies underway to help identify 

factors that may be associated with the development of TTS and the mechanism by which it 

occurs. 

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ACIP Meeting Summary December 16, 2021 

Although rare, Janssen recognizes that the incidence of TTS associated with the Johnson & 

Johnson vaccine is highest in women 30-49 years of age and that it can be fatal if not treated. 

While TTS continues to be a rare event, cases of COVID-19 are not. In fact, they are surging in 

the US and around the world. The pandemic continues to cause high rates of mortality and 

morbidity, and critically ill patients are at high risk of both venous and thromboembolic 

complications from COVID-19. A recent study from Oxford showed an estimated 435 cases of 

CVST and portal vein thrombosis (PVT) occur per million patients with COVID-19. These events 

occur more commonly in females and the risk post-COVID-19 is much higher than the risk 

observed post-vaccination. As COVID-19 cases continue to rise during the holiday season, 

there is a pressing need to protect those at highest risk. Although progress of vaccination 

coverage has been remarkable, fewer than 1 person in 5 is fully vaccinated and boosted in the 

US. In the setting where many people do not return for a second dose or a booster, the 

durability of the single-shot Johnson & Johnson vaccine as a primary regimen could make 

crucial differences in saving lives in the US and around the world. 

There have been several studies of the real-world effectiveness following a single shot of the 

Johnson & Johnson vaccine. One of those studies that was conducted by Johnson & Johnson 

was recently posted as a pre-print. These data are unique in that they demonstrate that even a 

single shot of the Johnson& Johnson vaccine provides durable protection against infections and 

hospitalizations through at least 6 months. This study also demonstrated a durable benefit 

across all subgroups of age, sex, and comorbidity. As increasingly more has been learned 

about the durability of protection of the Janssen COVID-19 vaccine from real-world data across 

multiple studies, the benefits are being observed in terms of cumulative deaths and 

hospitalizations avoided. Janssen modeled the benefit/risk over 1 year assuming 75% 

effectiveness across different transmission intensity scenarios. These data, modeled against 

being unvaccinated, showed a positive benefit/risk across gender and age groups. This remains 

important for those who cannot or will not return for follow-up vaccination. Efficacy against 

severe disease matters and durability matters. A single shot of the Janssen vaccine also 

generates strong immune responses and long-lasting immune memory. These data are 

reflected in the immune profile of the Johnson & Johnson vaccine. 

Antibody titers peak later than the mRNA vaccines and persist and mature over time, increasing 

in breadth. There is a 12-fold rise in antibody titer when a booster is given 6 months after the 

primary vaccination. Janssen is confident in the durability of protection. Further, the Johnson & 

Johnson COVID-19 vaccine has induced broad antibody responses against a variety of different 

variants. Data from a clinical study confirm the immune profile of the vaccine, both humoral and 

cellular. It is unique. Antibody titers peak later than mRNA vaccines. They persist and they 

mature over time, increasing in breadth as also demonstrated in a recent publication in the New 

England Journal of Medicine.

28 T-cell responses also persist at least 8 months post-vaccination, 

which is important in the prevention of severe disease. The implications of the Janssen vaccine 

durability data, in contrast to published data on the mRNA vaccines, have not yet been fully 

evaluated and discussed by this committee in terms of their potential impact on effectiveness. 

This durability may be crucial in the US setting where less than 20% of the US population are 

vaccinated and boosted. 

28 Barouch et al. N Egl J Med 2021; 385:951-953 

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ACIP Meeting Summary December 16, 2021 

The committee described the lower level of effectiveness in comparison to the mRNA vaccines. 

Janssen has seen even higher efficacy post-booster in global clinical trials. In fact, the efficacy 

after a Johnson & Johnson booster dose was 94% protection against symptomatic COVID-19 in 

the US and 100% protection against severe or critical COVID-19. Janssen has a global vaccine 

and the world is depending on them. Janssen is one of the largest suppliers of COVID-19 

vaccines to the African Union (AU) and COVAX, which enables equitable distribution of COVID19 vaccines to the 190 participating countries, including 92 low- and middle-income countries. 

Janssen already has shipped hundreds of millions of doses of vaccine and is committed to 

shipping hundreds of millions more in 2022. 

The Johnson & Johnson COVID-19 vaccine is a life-saving tool for individuals in high-risk 

populations and for those where follow-up for multiple vaccinations may be challenging, or 

where available healthcare resources are low. This week, the US crossed yet another grim 

milestone in the history of this pandemic. More than 800,000 people in the US have lost their 

lives to COVID-19. Dr. Heaton has lost loved ones during this pandemic and recognized that 

many attending the meeting had as well. They must save individuals in the US and facilitate 

equitable access, both in the US and around the world. In this setting where many people do not 

return for a second dose or a booster, the durability of this single shot Johnson & Johnson 

vaccine is a primary regimen to make a crucial difference in saving lives in the US and around 

the globe. 

Discussion Summary (Oliver & Heaton) 

• Dr. Long inquired as to whether Janssen is exploring the administration of a second dose 

soon after the first dose to have a shorter period of time before decreased effectiveness and 

if so, how much safety data there is on a second dose. 

 Dr. Heaton indicated that Janssen is exploring this. The FDA approved the Janssen 

COVID-19 Fact Sheet that there is flexibility in giving a second dose. It may be given 

at least 2 months and up to 6 months after the single dose, or even longer. This is 

based on Janssen’s clinical trial data. Janssen has a large safety database 

comprised of over 9000 individuals, some of whom received a booster dose in the 

randomized placebo-controlled trial. 

 Dr. Macaya Douoguih (Janssen) added that a little over 8000 participants from other 

clinical studies have received the second dose at that interval, which is included in 

the 9000 individuals in the database. 

• Dr. Loehr requested a reference for the number of people that Dr. Heaton reported were 

getting TTS or CVST from COVID-19 infection. He also pointed out that while the benefit of 

Janssen’s product being a single-dose vaccine had been emphasized, it seemed to him that 

it was at least a 2-dose vaccine due to the strong recommendation to get a booster dose 2 

months later. Even the people who only want to get 1 dose would still need to return for a 

second dose 2 months later. Therefore, the emphasis that it is a 1-dose vaccine may not be 

as critical as noted. 

 Dr. Heaton indicated that the information regarding TTS or CVST from COVID-19 

infection was published by Oxford a week or two previously and that she would 

provide the exact citation. This paper looked at thromboembolic events with COVID19 infection, with a focus on the rare events of CVST and venous thrombosis. 

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 In terms of the single-dose emphasis, Dr. Heaton recalled that Dr. Oliver talked 

about the fact that for people who may not return for boosters, the single-dose 

regimen can be important. Perhaps even more important than that is the profile of 

the vaccine. It is likely that that the durability profile seen with a single dose will be 

seen after a booster dose. Because the booster was just recommended in October, 

there has not yet been ample time to follow the recipients over 6-8 months. If the 

same level of durability is seen with the second dose, this would be 94% protection 

against any symptomatic COVID-19 and 100% protection against severe disease. 

That is the potential value of a second dose. Janssen’s clinical trials were set up to 

evaluate the single dose and then the booster dose. In thinking about the decision 

for the day, it is also about the durability profile. 

• Ms. Bahta pointed out that while ACIP’s role is a commitment to the American public, 

consideration also must be given to how their decisions impact global equity as well as US 

national equity. With that in mind, she asked what impact a change in the recommendation 

for Janssen vaccines in the US might have in distribution globally. 

 Dr. Lee said she thought it would be hard to predict the future and that her 

perspective was that there may not be a one-to-one correlation. She also recognized 

that the ACIP has a heavy burden and a great responsibility to both to the US 

population and the global population. 

 Dr. Heaton said that Janssen is working with the World Health Organization (WHO) 

and other authorities around the world and has been talking with them over the last 

couple of days to make sure that they were all well aware of the data. Janssen is 

committed to providing 900 million doses of vaccine worldwide to continue to 

address the COVID pandemic. 

• Dr. Daley recalled that Dr. Heaton mentioned that the cases of TTS were fatal if not treated 

and his interpretation of the data presented by Dr. See was that in some cases, TTS could 

be fatal even if recognized and treated appropriately. 

• Thinking about Dr. Oliver’s presentation, Dr. Long said she was struck by how Canada 

handled this and suggested that perhaps another option for the US would be to state 

something to the effect of, “Janssen COVID-19 vaccine could be limited to use in the 

following situations . . .” rather than stating that “mRNA vaccines are preferred.” Historically, 

preference has been more nuanced and not quite as concrete. She asked whether the WG 

believed there would be a difference between limiting under general circumstances and just 

exerting preference for another vaccine and how this might be interpreted by vaccine givers 

and public. 

 Dr. Oliver clarified that the NACI language she shared from Canada was just an 

example from a country that is somewhat similar to the US in the language they 

have. The WG is happy to adapt and adjust the proposed language based on ACIP 

discussion. If there is a vote for a preferential recommendation, guidance can be 

included in the clinical considerations. 

 Dr. Cohn added that they acknowledged that there is a difference in the way that she 

was describing this. If ACIP was to vote based on the way that the options were set 

up, it would be a vote against use of the Janssen vaccine except in certain 

circumstances. 

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 Dr. Long emphasized that this ultimately would mean recommending a vaccine for 

the very same people regardless of whether it was preferential or if it was a vote 

against use except in limited circumstances. 

 Dr. Oliver added that there was discussion among the WG members around what 

limiting would mean for “absolutely cannot be used except in certain circumstances.” 

 Dr. Sanchez stressed that this was a very difficult decision-making process and that 

he could not recommend a vaccine that is associated with a condition that may lead 

to death such as this with 100,000 women and 30-49 years old potentially having a 

condition with a case fatality rate of 15%. There are other vaccines available and as 

noted, the Janssen product is no longer really a single dose vaccine. He thought they 

should state that the Janssen vaccine would be preferred only for those who have 

contraindications to the mRNA vaccines. There are also other therapies such as 

monoclonals and pills that are on the horizon for early disease. The AZ vaccine has 

seen cases with a second dose, which may occur with booster doses of Janssen 

vaccine. He is not recommending the Janssen vaccine to any of his patients’ parents 

and agreed with Dr. Long that if continued use is recommended, it should be limited 

to certain people. 

 Dr. Daley highlighted that it is possible now to better quantify the risk of this adverse 

event that is very serious, but also continues to be very rare. There is still going to be 

a need for highly effective COVID vaccines globally across multiple platforms. The 

WG did not specifically talk about the distinction between “limited” and “preferential.” 

However, they were very acutely aware of the fact that the language choice is 

critically important. Thinking about the jurisdictional survey, he wondered whether 

there was a sense among responders regarding what impact a limited use or 

preferential recommendation might have on the means by which local and state 

public health potentially could get mRNA vaccines to difficult-to-reach populations, 

including multiple doses. 

 Dr. Oliver pointed out that because the survey was done within a short turnaround, 

continued engagement with the jurisdictions would be helpful in order to learn more. 

There are some advantages now that were not available a year ago, such as 

improvements in refrigeration, shipping, and handling storage issues with the mRNA 

vaccines. They also have learned over time in engaging with groups at CDC that 

directly work with at-risk populations that assurance that it is acceptable to initiate the 

series even if they cannot guarantee receipt of a second dose in exactly 21 or 28 

days later is key. 

 Dr. Brooks expressed concern that a strong preferential recommendation against 

Janssen vaccine may be too restrictive for a vaccine that is likely being 

disproportionately used among people who are under-represented minorities, 

homeless, et cetera and could have worldwide implications. Perhaps the preferred 

language could be more specific and show when mRNA vaccines are preferred 

versus the Janssen vaccine. 

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 Dr. Loehr expressed respect for Dr. Sanchez’s perspective and recognized the 

drawbacks of the Janssen vaccine. However, he viewed this as an issue of the 

trolley problem and ethics in which the trolley driver must decide whether to go down 

one track and have one person die or go down a different track and have 10 people 

die. If the Janssen vaccine is taken away and people are choosing to/or cannot get 

the mRNA vaccine, there will be complications from getting COVID-19 disease. Even 

though there are significant risks with the Janssen vaccine, he wants that vaccine to 

be available if it is the only option and was not comfortable saying it should not be an 

option. He was very comfortable saying it should be a preferential recommendation. 

 Dr. Bell said she thought the bottom line pertained to balance and that making a 

preferential recommendation with additional guidance in the clinical considerations 

would be the best route. She did not feel comfortable in the context of plenty of 

mRNA vaccine with the ACIP not making a clear and strong statement that reflects 

the recognition that there are concerns about the rare but oftentimes fatal side 

effects. The best way to do that would be to make a preferential recommendation. 

Informed consent is complex and she was concerned that many people do not have 

all of the information that they would need to give informed consent, which is another 

rationale for making a preferential recommendation. Some people may opt for the 

Janssen vaccine even after being appropriately informed, so it would not be right for 

ACIP to make that option unavailable to them. Dr. Sanchez’s response was precisely 

the kind of response they hope providers would make when a patient asks them, 

“What do you think about this?” Perhaps the ACIP being clearer about making a 

preferential recommendation in favor of mRNA vaccines supports the kind of 

guidance to individual patients that Dr. Sanchez is providing. While Dr. Bell 

emphasized that while she would not recommend a Janssen vaccine to her family 

members, the ACIP has to recognize that different people make different choices. If 

they are appropriately informed, the Janssen vaccine option should be available to 

them. 

 Dr. Talbot agreed that if the ACIP makes a preferential recommendation, the 

language would have to be extremely clear and extremely strongly worded. The 

presentations discussed the advantages of this vaccine in that it is being used in 

populations that have very little say in their care, possibly lower health literacy, and 

less access to care such as those in prisons, homeless persons, and those living in 

rural areas. People in these settings often do not have the same health literacy and 

access to health care. There is concern that the Janssen vaccine will be used 

because it is easy, but there are serious risks. Whatever wording is chosen must be 

incredibly clear and strongly worded in order to protect those who do not have 

access to as much medical information. 

 Dr. Lee added that clearly if people have a contraindication to an mRNA vaccine and 

wish to have protection, it seemed reasonable to have access to the Janssen 

vaccine that would provide that protection. The clinical guidance should be clear 

about this. She was leaning toward the preferential recommendation option to ensure 

that there is access to the vaccine, while also making clear when it seems 

appropriate to use. She feels that ACIP’s role is to think about not only the benefitrisk balance, but also to implement mitigation as much as possible through its 

recommendations. She also recognized that it was far harder for the country to 

implement mitigation by relying on individuals to have equitable access to the full 

information on benefits and risks, particularly in their preferred language and at an 

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appropriate health literacy level. She fully agreed that one population should not bear 

a disproportionate burden of those risks because that is the only choice that they 

have. 

 As a practicing physician, Dr. Goldman reported that patients presenting for visits are 

asking which vaccine they should use. This is really not the time for a long and 

drawn out discussion and 2- to 3-hour review of data to explain to them what the 

risks and benefits are in as detailed a way as CDC explains. Patients want a clear 

and concise answer about what vaccine they should get, and they depend upon the 

physician to tell them this. A preferential clear and concise recommendation from the 

CDC is key, with the caveat that though there is a risk of the extremely rare side 

effect of TTS, this vaccine can be used in some populations. It is important not to 

eliminate this vaccine completely because it is useful in certain populations. Also, the 

evidence is showing that this is not a 1-dose vaccine and probably should be a 2-

dose vaccine. He said he would not necessarily be in favor of age-based, agerestricted, or gender-restricted recommendation. 

 Dr. Zahn observed that from a local public health standpoint, his agency and other 

agencies around the country had concerns about offering only the Janssen vaccine 

to disadvantaged populations, homeless populations, and jailed or prison 

populations for ease once the AEs were identified due to the associated ethical 

issues. He thought by and large, local public health agencies will be making every 

effort to offer mRNA vaccines in all of those settings and to try to ensure access to 2 

doses. Patients present to public health clinics who say they do not want the mRNA 

vaccine for variety of reasons other than contraindications, and that they want the 

Janssen vaccine despite the concerns being conveyed. Public health clinics are 

administering the Janssen vaccine to people every day who would remain 

unvaccinated if the vaccine did not continue to be available. 

 Speaking as a practicing physician, Dr. Fryhofer expressed appreciation for 

convening an emergency ACIP meeting to get data to the public promptly about the 

rare but deadly TTS risk and the fact that it is not just limited to young women but 

crosses all ages and both sexes. This whole process should increase confidence in 

the US vaccine surveillance system. When this vaccine was discussed during earlier 

ACIP meetings, it was recommended by the ACIP under FDA EUA, and then the 

CDC clarified in the clinical guidance the increased risk in women 18-49 years of 

age. She agreed that it is now clear that the Janssen vaccine is not a 1-dose vaccine 

and that another dose will be needed. Since many patients are missing this point, 

she expressed her hope that the FDA would approve the Janssen vaccine as a 2-

dose series. She agreed that this vaccine needs to be made available for ease of 

storage and transportation. In addition, a variety of vaccine platforms are needed in 

that it is unclear what the next variant may be or what twists or turns the COVID-19 

pandemic will take. 

 Dr. Duchin agreed with the preferential recommendation strategy that preserves the 

availability of the Janssen vaccine for those who would not otherwise be immunized 

or prefer it, with adequate understanding of the risks and benefits. He also was 

impressed by the discussion around the need to include the second or booster dose 

in the messaging around what is necessary for full protection, and expressed hope 

that they could return to the discussion about whether that should be part of the 

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definition of “fully vaccinated.” It appeared from the conversation that many of the 

ACIP members felt that the booster dose was essential to being fully protected. 

Public Comment 

The floor was opened for public comment during the December 16, 2021 ACIP meeting at 2:35 

PM ET. Given that many more individuals registered to make oral public comments than could 

be accommodated during this meeting, 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-2021-0133. Visit http://www.regulations.gov for access to the docket or to 

submit comments or read background documents and comments received. 

Ms. Elizabeth Ditz 

Vaccinate California 

I would like to thank the committee members for their tireless work over the last 2 years, and the 

efforts you have made to make the decision factors public and transparent. I am speaking as 

myself and as an active member of a Facebook group, Vaccine Talk, that has almost 79,000 

members worldwide. Some of the Vaccine Talk members are physicians, virologists, and other 

professionals involved in vaccine safety. We use the experts to volunteer their time to educate 

other members. I’ve also learned from people not in the Vaccine Talk groups, 

such as Kimberly Manning, MD, whose stories from her Grady community have taught me so 

much about meeting people where they are. Based on the questions posed to Vaccine Talk, I 

would say that the primary response to all COVID vaccines is anxiety. Many are anxious about 

the safety and efficacy of the available vaccines. Others are anxious about when they will be 

able to get the vaccines for their children. For those anxious about vaccine safety, those 

anxieties can sometimes be relieved. One noticeable feature is the general public, as 

represented by the members of Vaccine Talk, don’t understand or under-value that all 

vaccinations have improved public health. There is an overemphasis on the direct vaccine 

effects. In my view, the US government overall has had less than optimal messaging about the 

safety and value of vaccination to prevent COVID-19 and other diseases. The v-SafeSM program 

has been generating a vast amount of data, but little has been shared in a timely manner. 

Likewise, data from the Vaccine Safety Datalink and Rapid Cycle Analysis is almost invisible to 

the general public. Going forward in public health planning, crafting a more robust and effective 

public information platform would reduce vaccine hesitancy. As you know, there is a large 

literature on how to address vaccine hesitancy. I hope the government can recruit and train 

community-level experts. Also, having a general presentation on v-SafeSM in each meeting 

would not be a waste of time. Thank you very much. 

Dorit Reiss, JD 

Professor of Law 

University of California

Hastings College of the Law 

First of all, thank you committee for giving me a chance to comment again. My name is Dorit 

Reiss. I’m a Professor of Law at UC Hasting College of the Law and I want to raise three issues. 

First, I want to reiterate what Ms. Ditz said and thank the committee for its hard and transparent 

work holding these meetings continuously over the past year. I hope the process continues to 

be respected because keeping open advisory committee meeting, as happened for example for 

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ACIP Meeting Summary December 16, 2021 

the change related to 16- and 17-year-old boosters can undermine trust and legitimacy, 

especially when there is uncertainty, as here, we really need the committee’s input 

and transparency help. Second, the process points, I realize within the emergency meetings, 

there are things you cannot do. But although ACIP is likely uniquely able to recommend 

vaccines, your recommendations need to be explained and communicated to the public and the 

immunization community by organizations on the ground. These groups need to have an idea 

about what’s coming. I realize it takes time, but it sounds like the VaST committee knew of this 

at least this December 6th, and the meeting slides were not up until noon Eastern Time today. It 

would be appropriate to put up information so businesses have to address this beforehand, as 

early as you can, and as early as you provide these community members, at least in some form, 

at least shortly. Because communication takes work as well. And I will add that although I do 

think you should generally consider moving to well-designed written comments instead of “oh, 

here was an emergency meeting.” That’s probably impractical, but we need to realize that when 

people are not afraid of commenting starting the morning of, the value of public comments 

would be limited. Finally, I appreciate your caution in recommending. I would like to encourage 

the committee to remember that there are groups for whom mRNA vaccines may be a higher 

risk than the risk of J&J, or as pointed out by members, that will not use mRNA vaccines. Your 

language in the slide we’ve seen before talks about “may be offered mRNA vaccines.” I would 

urge the committee to consider moving to a “should be offered mRNA vaccine” where people 

who cannot safely take the mRNA vaccine should be offered the J&J vaccine, when people 

cannot safely take the mRNA vaccine or will not take them, to increase vaccination rates 

generally. Thank you very much for your time. 

Ms. Shoshana Fishbein 

Families Fighting Flu 

Hello. My name is Shoshana Fishbein and I represent Families Fighting Flu. Thank you for your 

time today. I first want to thank ACIP for all their hard work during this pandemic and beyond for 

improving recommendations for adult and childhood vaccines. As you make this difficult 

decision today, Families Fight Flu, a national flu vaccination and education organization, 

reminds you of the importance of preventing COVID because we’re entering a season where flu 

and COVID-19 are co-circulating. We need to be clear in our messaging that both vaccines are 

necessary to prevent overwhelming our healthcare system. We know that there are often 

concerns about side effects from vaccines, and we’ve heard many of these in the case of flu 

vaccination. However, in the context of today, we also need to keep in mind that vaccine equity 

is an issue and other countries look to the US for guidance on vaccines and donations, 

especially in the case of COVID-19. Viruses don’t know geographic boundaries and the US is a 

leader in vaccination. The recommendations you make today for all vaccines and flu and 

COVID-19 do matter and we appreciate all of your hard work. Thank you. 

Robert Edmonds, PhD 

Concerned Individual 

Dear committee, today I will again speak about tinnitus and the Johnson & Johnson or Janssen 

vaccine. COVID-19 vaccine, including Janssen vaccine, has saved many lives. Identification of 

low-frequency adverse events connected to vaccination are important, not always to discourage 

vaccination but to encourage patient education to seek timely care and for provider education to 

apply the appropriate treatment should these low-frequency events occur. We reviewed case 

studies of tinnitus following vaccination, which potentially suggests 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. Janssen at a prior meeting presented 

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ACIP Meeting Summary December 16, 2021 

the data that indicates from 3001 an imbalance that has a P value of 0.0096 combined 

imbalance from all Phase 3 trials of 24 versus 9 that has a P value of 0.007. The EMA 

recognizes this link after reviewing post-authorization reports. I have asked officials at the CDC 

and FDA whether they have reached out to the EMA and what made them conclude there is still 

not sufficient evidence that there is not a link after reviewing the EMA’s analysis. I have not 

gotten a response. Many theories have been floated as to the causal mechanism in peer-review 

literature and potentially includes a version of micro clotting. No active follow-up is known to 

have occurred. So for now, these are just ideas that have been postulated. Follow-up is 

important because it may not just have implications just for Janssen potentially. AstraZeneca 

has an imbalance with tinnitus, albeit less statistically significant, and while Janssen reported an 

imbalance the trial data, to Janssen’s credit, did capture a measure of the tinnitus background. 

Nine cases were observed in the nearly 37,000 combined placebo groups with Janssen data. 

Zero cases were observed within, again, the nearly 37,000 combined placebos of the mRNA’s 

trials to the best of the public’s knowledge, thus leading to the question, could the mRNA trials 

be sensitive to measuring a signal with tinnitus? I never imagined this time last year I would be 

speaking to a committee like this. I only bring this issue forward, again, this isn’t a little ringing in 

all cases. After developing tinnitus myself and dealing with an amplitude that rang at months 

24/7 above a truck radio while driving, this is a place I don’t want others to find themselves in. 

People very often don’t notice or care, and when they do, doctors often don’t know what to do. 

Please follow-up with us. Please learn from us. Those with this adverse event include a prior 

ACIP member. Again, I agree that the public should get vaccinated against COVID. This is 

simply about providing information about what to do in these rare instances. Thank you for your 

time. 

Ms. Claire Hannan, MPH 

Executive Director 

Association of Immunization Managers 

Good afternoon. I’m Claire Hannan, Executive Director of the Association of Immunization 

Managers representing state, territorial, and urban area immunization program managers. 

Thank you to the advisory committee for convening this unscheduled meeting to provide 

guidance on the use of the Janssen COVID vaccine. It is critical that our nation’s immunization 

experts meet regularly to review and monitor vaccine safety data and in a transparent and open 

forum. The J&J vaccine plays a unique role in the COVID vaccination response. Frequent 

populations for use are with individuals experiencing homelessness, residents in corrections 

facilities, and patients being discharged from hospitals. The 1-dose completion also provides an 

accessible option for those completing vaccination for travel or employment. Maintaining 

vaccine options, as well as providing transparent safety data and expert advice, are important 

to support confidence in vaccines. So, thank you for holding this transparent and open meeting. 

I also want to take this opportunity to acknowledge the 1-year anniversary of the launch of the 

COVID vaccine campaign and 486 million doses administered with over 200 million people fully 

vaccinated. This is absolutely incredible given where we were just one year ago. Sadly, more 

than 800,000 Americans have lost their life due to COVID, but a Commonwealth Fund analysis 

estimates that the COVID vaccination program in the United States has prevented over 

1,087,000 deaths and over 10 million hospitalizations. Finally, I want to draw attention to a 

current challenge affecting COVID vaccine program management. COVID vaccine thresholds 

limit the amount of vaccine that awardees can order and have been put in place to manage 

inventory and reduce waste. Although vaccine supply is plentiful in the US, awardees are not 

able to order vaccine above their threshold amounts unless they submit a detailed justification. 

The threshold and resulting justifications cause delay and cancellation of provider orders and 

place a heavy burden on public health staff to justify vaccine need on a weekly basis. Share the 

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ACIP Meeting Summary December 16, 2021 

goal of reducing waste, but the thresholds and over estimation of inventory at the federal level 

are limiting operations and the ability to meet demand for vaccines. We look forward to 

continuing to work with the White House and HHS leadership and the Countermeasures 

Acceleration Group (CAG) and CDC to resolve this issue. Thank you for the opportunity to make 

comments today. 

Dr. David Wiseman, PhD 

Synechion, Inc. 

The concluding comments at last meeting advocated for transparency and expression of 

diversity. I wrote a letter to you then and await the pleasure of your reply. I have submitted 

additional comments. Given the circumstances of this meeting, concerns about opacity are 

deepened, having only now seeing the presentations, in particular, Dr. Oliver’s, which was only 

posted around the time she began. Again, I am simply shocked. I’m not a fan of any of the 

COVID vaccines, but my old employer and sometime client, I believe, is a vehicle here of 

regular misdirection. You’re simply asking the wrong questions. A run analyses suggest a 

limited window of all-cause mortality benefit of these vaccines, outside of which, at both ends, 

there appears to be significant detriment. Although TTS is important, there are unexplained 

safety signals for all vaccines far stronger, including discoagulation, death, and myocardial 

infarction. We submitted this weeks ago to FDA and CDC at various meetings. According to the 

founder of BioNTech, the DNA-based vaccines may carry a risk of insertional mutagenesis. Also 

critical is that some key Pfizer and Janssen analyses have not been verified by FDA. That goes 

also for . . . [unclear]. How can you make any decisions based on that? In addition to 

reevaluating the use of all vaccines, you must consider estimates of VE reduction against 

Omicron to 30% to 48%, toxicity of cumulative dosing, and reduced benefit for greater risk. 

Attempting to boost our way out of new variants is the immunological equivalent of heroin 

addiction. What is the subclinical risk of TTS or other discoagulation? These drugs are not 

classical vaccines but gene therapy drugs. Are you concerned that CDC is not accurately 

representing the nature of these vaccines, depriving Americans of fully informed consent? Now 

to children. Additional concerns, other than the unverified data and the full risk-benefit analysis, 

which is off by 26 times in the wrong direction with at least a 4-time risk over benefit. Pfizer 

changed their formulation for everyone, and it differs from the one that was used in the clinical 

study. The change may improve stability and increase the effective dose worse than the safety 

profile. The change may also affect distribution of the lipid nanoparticles, thereby affecting 

safety and efficacy. Use of Pfizer’s drug in children is akin to using a car seat with poor 

regulatory oversight. The eyes of the world are on you. Your decisions are being mirrored in 

other countries. Millions of subject mandates and other harsh measures, including imprisonment 

and loss of employment. The opacity here deepens mistrust within America and reverberates 

globally. Would ACIP want to be responsive for long-term detriments, as well as unjust 

imprisonment based on reliance of flawed data? So, in the spirit of transparency, I’m happy to 

take questions now or later. Thank you. 

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Vote: Updated Recommendations for Use of the Janssen COVID-19 Vaccine 

Dr. Sara Oliver (CDC/NCIRD) presented the following proposed wording for an ACIP vote: 

“mRNA COVID-19 vaccines are preferred over the Janssen COVID-19 vaccine for the 

prevention of COVID-19 for all ≥18 years of age.” 

She reiterated that in the guidance that would accompany this recommendation clarifies that this 

includes vaccines administered as a part of the primary series and as a booster dose. Because 

there was a question about specifically saying “for persons with a contraindication to mRNA 

COVID-19 vaccines,” she clarified that the only firm contraindication is for those with a severe 

allergic reaction to a previous dose or a component of the mRNA vaccine. That is the 

contraindication listed in the FDA EUA. There also is some additional guidance around a 

precaution for those who had myocarditis after a first dose in terms of getting a second dose of 

an mRNA vaccine. That is all included on the clinical considerations website. 

Discussion Summary 

• Related to several concerns expressed about the word “preferred” not being strong enough 

and a request to use the term “strongly preferred,” Dr. Wharton acknowledged the strength 

of the ACIP’s desire for this to be a preferential recommendation, but reminded everyone 

that the ACIP does not make “strong” or “weak” recommendations. They make 

recommendations and this is the language that has been used in the past for preferential 

recommendations. The comments made during the discussions will be incorporated in 

CDC’s communications, guidance, and implementation strategies. However, the vote 

language must be consistent with other ACIP vote language. 

 Dr. Brooks pointed out that they may be under-estimating the strength of “preferred,” 

especially given how rare it is for ACIP to vote to prefer one vaccine over another. 

 Dr. Lee agreed and emphasized that every preferential vote that ACIP has made has 

had an impact on the way vaccines have been used. 

 Dr. Fink (FDA) added that the language being shown aligned with the language that 

was added to the Fact Sheet for vaccination providers in addition to the new 

contraindication language and new language about reported rates of TTS, which 

appears in the Warning Statement. The Warning Statement also was updated to be 

more specific about the clinical case definition for TTS and to further specify that 

available evidence supports a causal relationship between TTS and this vaccine. 

The Fact Sheet for vaccine recipients and caregivers was revised to include 

appropriate language for comprehension by the lay public, including information 

about reported rates of TTS and the fatality rates for TTS in the section about who 

should not get the vaccine. These documents are posted to the FDA website and are 

publicly available. 

 Some apprehension persisted among the ACIP members about not including 

stronger language within the vote itself, given that not everyone reads the clinical 

guidelines. 

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ACIP Meeting Summary December 16, 2021 

• Ms. McNally inquired as to the status of the Vaccine Injury Table for the Countermeasures 

Injury Compensation Program (CICP) and if not yet developed, she encouraged 

accelerating the development of that table due to the TTS and myocarditis issues. 

 Dr. Rubin from the Health Resources and Services Administration (HRSA) indicated 

that the CICP has not yet developed or published a countermeasures injury table for 

COVID-19 countermeasures. Pending establishment of a COVID-19 

countermeasures injury table, claims are still filed as non-table injuries and eligibility 

of compensation is being determined on a case-by-case basis. She reminded 

everyone that other COVID-19 countermeasures outside of COVID 19 vaccine are 

covered. HRSA is discussing this internally and will take the suggestion into 

account. 

• Regarding implementation of a preferential recommendation, Ms. McNally asked whether 

someone could address what strategies pharmacies would employ to deal with this. Dr. Lee 

indicated that they would seek a response to this inquiry and report it back later. 

Motion/Vote: Updated Recommendations for Use of the Janssen COVID-19 Vaccine 

Dr. Poehling made a motion to approve the proposed language for an ACIP vote on the updated 

recommendations for use of the Janssen COVID-19 vaccine stating that, “mRNA COVID-19 

vaccines are preferred over the Janssen COVID-19 vaccine for the prevention of COVID-19 for 

all ≥18 years of age.” Dr. Bell seconded the motion. No COIs were declared, with the proviso 

that Dr. Chen did not believe his declaration of the potential perception of a COI due to his 

employer, the University of Maryland, receiving a grant from Emergent BioSolutions, Inc. for the 

development of a shigella vaccine posed an actual COI for this vote on the use of Janssen 

COVID-19 Vaccine. 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 votes, Dr. Lee invited ACIP members to make a statement about the 

rationale for their votes and/or to share any additional general comments: 

• Ms. Bahta observed that while the discussion regarding education materials and language in 

the EUA focused on providing a risk assessment of 1 per 100,000 doses administered, she 

thought the bigger issue was the consequence of this event. While there is a higher 

frequency of myocarditis with mRNA COVID-19 vaccines, the ACIP voted to prefer the 

mRNA vaccines over the Janssen vaccine. With that in mind, she stressed the importance of 

including the severity of the side effect that is a driving factor for this recommendation. 

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ACIP Meeting Summary December 16, 2021 

• Dr. Chen expressed appreciation for how hard their CDC colleagues had been working 

behind the scenes to provide much more precise estimates of the rates, determine the risks, 

et cetera. There were no real surprises to him. He thought they continued to grapple with the 

fact that TTS is a serious disease that has that 15% fatality rate, which sounds scary. Even 

though the numbers are small numbers, this is a rare event. He was happy that they 

wrangled over this preference, tackled it together, and came to a unanimous vote. He 

emphasized the importance of the clinical consideration section being crystal clear. He deals 

with the yellow fever (YF) vaccine on a daily basis in his travel clinic, which also has a 

serious but very rare AE that can be fatal. There is some nice language in the precaution 

section of the YF vaccine recommendations that communicates risk clearly, because there 

is no other alternative for YF vaccine. This language could serve as an example for 

communicating the highest risk for Janssen vaccine. 

• Dr. Poehling thanked the VaST team, CDC team, FDA, and the many people behind them 

all who are working so hard to identify both the benefits and the risks of all of these 

vaccines. She believed this meeting demonstrated the benefit and the strength of all the 

work that is being done, and she appreciated coming together and sharing this discussion 

and recommendation openly and transparently. It was interesting that this occurred in the 

week that the US crossed the milestone of more than 800,000 people in the US having lost 

their lives to COVID-19. COVID-19 death is now vaccine-preventable in the vast majority of 

persons. She hoped that as people looked at the discussion from throughout the day, they 

would recognize the strength of the vaccine recommendation, the encouragement that all 

persons who are eligible for vaccines and boosters receive them, and that other precautions 

(e.g., masking, social distancing, hand sanitizing) continue to be used as the holidays 

approached and Omicron was coming. 

• Dr. Daley reminded everybody that this recommendation was, in part, a reflection of the 

strength of the US’s vaccine safety surveillance system. Safety surveillance continues daily 

and includes surveillance of all vaccine platforms and booster doses. He also expressed 

appreciation for the transparency of this process. These new data were immediately brought 

to the VaST WG. The VaST WG then immediately presented the data to the COVID-19 

Vaccine WG, and the ACIP was convened quickly. He reiterated that these are interim 

recommendations that would be revisited if the circumstances change with respect to 

effectiveness, durability of the immune response, effectiveness against variants, and/or 

safety. While the ACIP makes vaccine recommendations for the US, there are global 

implications. There may be settings in which there may be just a single vaccine available. 

The best COVID-19 vaccine one can get is the one that is available immediately. In the 

global circumstance, if only the Janssen COVID-19 vaccine available—the benefits of 

vaccinating at that moment in time strongly outweigh the risks. 

• Ms. McNally echoed the sentiments regarding the strength of the US safety monitoring 

system and the action based on the resulting data. However, monitoring is only one 

component. Communication to the public is an important element of this as well. The better 

the patient education around this issue and other issues, the more beneficial it will be in 

terms of vaccine confidence. Everyone must continue to be focused on this effort and the 

fact that this is a shared responsibility. 

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ACIP Meeting Summary December 16, 2021 

• Dr. Lee highlighted that the scientific deliberations on this topic were critical for the vote 

during this meeting, but some of the points that were brought to the forefront by various 

members were not just about the vote language in this instance. The underlying concern 

was one that they all shared with regard to the importance of how the risk information is 

communicated to the public. The committee members made a strong request that there be 

full transparency about the fact that the balance of benefits and risks, vaccine safety, access 

to vaccines, and equity drove the recommendation decision. There is a need for strong 

language around the importance of all of those aspects in how this information and decision 

are communicated to the public. This is shared responsibility. The ACIP’s CDC colleagues 

will work hard to ensure that this is reflected in the clinical considerations. The provider 

community, public health community, public, and the media can to help communicate the 

importance of this information. There continue to be gaps in equity and access to full 

information about COVID-19 vaccines. This recommendation highlights that gaps continue 

to exist. 

COVID-19 Vaccine Safety Surveillance in Children 5-11 Years of Age 

Dr. John Su (CDC/NCEZID) presented an update on COVID-19 vaccine safety surveillance 

data for children 5-11 years of age. First to review v-safeSM data. v-safeSM is a voluntary CDC 

smartphone based monitoring program. Participants receive a daily text message for the first 

weeks after vaccination, after which they receive text messages on a more periodic basis to find 

out whether they have experienced any health outcomes. As of December 12th, v-safeSM 

includes 41,232 participants 5-11 years of age. All of them have received Dose 1 and 23,583 

have had Dose 2 of the Pfizer COVID-19 vaccine. For context, 7.1 million doses have been 

administered to children 5-11 years of age across the US. This population is roughly equal in 

male and female distribution and most are of white and non-Hispanic race and ethnicity. 

Looking at reactions and health impact events reported by children 5-11 years of age at least 

once 0-7 days after Pfizer-BioNTech vaccine by dose as of Dec 12, 2021, there was generally a 

slightly greater proportion of participants reporting outcomes after Dose 2 relative to Dose 1. 

The outcome categories included any injection site reaction, any systemic reaction, any health 

impact, unable to perform daily activities, unable to attend schools, and needed medical care. 

Regardless of dose, very few (~1%) reported needing to seek medical care and most of those 

were for outpatient clinic visits. For participants reporting any systemic reaction during the week 

after vaccination by days since vaccination, most people reported systemic reactions within the 

first day or two after vaccination, but systemic reactions drop off considerably after that. Most of 

the systemic reactions reported tended to be transient in nature. The top 5 solicited reactions 

included pain, fever, fatigue, headache, and myalgia—all of which were observed during preauthorization clinical trials. Fever was determined by temperature (mild = 38.0–38.4 C; 

moderate = 38.5–38.9 C; severe = 40.0+ C). A slightly greater proportion of participants 

reported these symptoms after Dose 2 relative to Dose 1. That said, the proportion within each 

dose reporting severity tended to be comparable between doses. 

To briefly summarize, most reported reactions were mild to moderate in severity. Most were 

reported the day of vaccination, slightly more frequently after Dose 2, and transient in nature. 

For both Dose 1 and Dose 2, missing school was infrequently reported and around 1% reported 

seeking medical care—mostly outpatient in nature. The local and systemic reactions were 

reported at a similar frequency as per clinical trials. Some limitations of the v-safeSM data include 

that the v-safeSM population likely does not represent all of the vaccinated US population. It is a 

voluntary opt-in program, so this is a selected population that might have some reporting bias. 

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ACIP Meeting Summary December 16, 2021 

In addition, data describing the second dose of Pfizer’s vaccine is limited at this time. Updates 

can be provided in the future as the data mature. 

Now to review some data from VAERS. As a reminder, VAERS is the nation’s passive early 

warning system for vaccine safety. As of December 10th, there were 3,233 reports to VAERS 

among children 5-11 years of age after COVID-19 vaccination. That is in the context of 7.1 

million doses administered, of which 5.1 million doses were Dose 1 and 2 million were Dose 2. 

The median age was 9 years, with a roughly even distribution between males and females. The 

counts of reports tend to increase by age. Within age, the distribution by sex is comparable. 

Most reported children were non-Hispanic white or race/ethnicity data were unknown or not 

reported. The median time from COVID-19 vaccination to symptom onset in children 5-11 years 

of age was the day of or the day after vaccination. The most frequent AEs among 3,152 (97%) 

non-serious reports were either a vaccination error of some sort or symptoms that were 

observed during pre-authorization clinical trials, including fever, headache, and fatigue. When a 

vaccine error was reported, frequently the reports specified that no AEs occurred as a result of 

that error. That would explain why no AE is reported very frequently either. The most frequently 

reported AE among the 81 serious reports included fever, vomiting, and chest pain. “Serious” 

means fulfilling federal criteria such as hospitalization, prolongation of existing hospitalization, et 

cetera. Many of the 81 serious reports reflected potential myocarditis, such as elevated troponin 

or chest pain. Some might reflect potential multisystem inflammatory syndrome (MIS), such as 

fever or C-reactive protein increase. 

There were 2 reported deaths, both of which are still under review. Both involved children with 

complicated medical histories and frail health. One female was 5 years of age who had a history 

of twin-to-twin transfusions, spastic cerebral palsy, seizure disorder, and continuous positive air 

pressure (CPAP) at night. She was admitted to the pediatric intensive care unit (PICU) because 

of respiratory failure due to infection with rhinovirus and mycoplasma. To stabilize and transfer 

her to the floor and because of her history, she was observed overnight after vaccination and 

was found to have an uneventful evening. She was discharged home and the night prior to 

death she was at her baseline state of health, but the following morning was found pulseless 

and not breathing. Unfortunately, they were unable to resuscitate her. The second child was a 

female 6 years of age who suffered a near drowning incident that led to severe hypoxic 

encephalopathy, spastic cerebral palsy, dysautonomia, neurogenic bladder, and frequent 

urinary tract infections (UTIs). The extent of the dysautonomia was such that the pain from a 

distended bladder would be enough to affect her vital signs. Though she was vaccinated without 

issue, 10 days afterwards she developed fever and lactic acidosis, progressive weakness, 

flaccid paralysis, and loss of her gag reflex. Notably, those particular functions remained 

preserved with past stressors. This was new for her, and unfortunately she continued to 

decompensate. She ultimately experienced respiratory failure, hypotension, and died. The 

autopsy was unrevealing. 

There were 10 reports to VAERS of myocarditis in the context of 7.1 million doses administered. 

Of the 3,233 reports, 14 were of myocarditis. Of those, 5 are pending follow-up information. 

Follow-up information was obtained on the other 9, with 8 meeting the CDC working case 

definition for myocarditis and 1 still under review. Of the 8 reports that met the case definition, 4 

were male, 4 were female, 6 were after Dose 2, and 2 were after Dose 1. Based on the data 

obtained on the 8 confirmed cases that met the case definition, the clinical picture looks very 

much like the presentations seen in older children. There are outcomes for 6 of these 8 children. 

For 5 of the 6, the patient’s symptoms were resolved at the time of the report. The 6th was 

recovering at the time of the report, but that was a couple of months ago. It seems that for many 

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ACIP Meeting Summary December 16, 2021 

of these, the symptoms were mild. Notably, 1 of these children had a fairly long onset. The 

onset range is from 0-4, but was almost 2 weeks for one patient. This patient had a headache 

and gastrointestinal symptoms 3-4 days before presenting with chest pain, which actually 

represents viral myocarditis. 

Now to review some data from the VSD. As a reminder, the VSD is a collaboration of 9 

integrated healthcare organizations across the US that share data (e.g., immunization records, 

outpatient visits, vital statistics, and other data) on over 12 million persons per year all linked by 

study identifications (IDs). This provides an easy means of identifying people with potential AEs 

of interest who can then be followed up by chart review or electronic health record (EHR) review 

to get a good idea of what happened to identified people. Because of that robust organization, 

the VSD is able to perform near real-time monitoring as data become available. Myocarditis is 

one of the numerous conditions that the VSD is actively monitoring. As of December 14th, there 

were 333,000 doses of COVID-19 vaccine administered to children 5-11 years of age. Of those, 

226,000 were of Dose 1 and 107,000 were of Dose 2. There were no confirmed reports with 

myocarditis in either the 0-7 or 7-21-day risk windows. Data are being monitored as they evolve. 

To summarize, during November 2-December 10, 2021 VAERS received 3,233 reports among 

children 5-11 years of age. Over 7.1 million doses of the vaccine had been administered as of 

December 9th. The median age was 9 years, most children were of non-Hispanic white race and 

ethnicity. The median time to onset was the day of vaccination. While the majority (97%) of the 

reports were non-serious, there were 2 reports of death in children with complicated medical 

histories. There were 8 reports meeting the case definition for myocarditis, but the clinical 

course appeared mild. The most common AEs were vaccination errors or symptoms observed 

in pre-authorization clinical trials. Between v-safeSM and VAERS, the reported race and ethnicity 

was comparable. For v-safeSM, reactions following Dose 2 were slightly more frequent. Most 

reactions were mild to moderate in severity and transient in nature. Regardless of dose, no 

more than 10% of children reported missing school and few (~1%) reported seeking medical 

care. There have been no reports of myocarditis in the 0-7 or 0-21-day risk windows in VSD to 

date. 

Discussion Summary 

• Dr. Daly emphasized that it was good to see these early data for this age group. He 

observed that the 2 cases mentioned in which individuals died following vaccination would 

be investigated carefully by VAERS. As a pediatrician, he stressed that these were children 

with special health care needs who were medically fragile and at greatly increased risk of 

respiratory disease. If such children get a respiratory disease, it is often severe and puts 

them at significantly increased risk of severe outcomes if they develop COVID-19. While 

people may be concerned by these reports, he reiterated that these children were medically 

fragile at baseline and were likely to have increased risk from COVID-19 as well. 

Update on the COVID-19 Omicron Variant 

Dr. Heather Scobie (CDC/NCIRD) provided an update on the COVID-19 Omicron variant. A 

new variant of SARS-CoV-2 (B.1.1.529) was reported to the WHO on November 24, 2021. This 

new variant was first detected in specimens collected on November 11, 2021 in Botswana and 

November 14, 2021 in South Africa. B.1.1.529 was classified as a variant of concern (VOC) 

named Omicron by WHO on November 26, 2021 and by the US SARS-CoV-2 Interagency 

Group (SIG) on November 30, 2021. On December 1, 2021, the first case of Omicron was 

confirmed in the US. 

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Omicron was classified as a VOC based on its detection in multiple countries, including in 

people with no travel history; its potential increased transmissibility; and the presence of a large 

number of mutations in the spike gene (S-gene), including 15 mutations in the receptor binding 

domain. These mutations may lead to reduction in the efficacy of some antibody treatment and 

a reduction in neutralization by sera from vaccinated or convalescent individuals. In terms of 

what is currently known about Omicron, it is likely to be more transmissible than the original 

SARS-CoV-2. It is likely that vaccinated people with breakthrough infection or people without 

symptoms can spread the virus to others. However, more data are needed to know if Omicron 

causes more severe disease or death than infection with other known variants. Vaccines are 

expected to protect against severe illness, hospitalization, and death. However, breakthrough 

infections in people who are fully vaccinated are expected to occur. Scientists are still working to 

determine how well existing treatments for COVID-19 work, but some treatments are likely to be 

less effective.29 

In the United Kingdom (UK), Omicron cases are growing rapidly despite Delta. The Delta variant 

and one of its sub-lineages, AY.4.2, had higher growth rates than other variants. This resulted in 

Delta’s success in dominating the viral landscape. Omicron has an even steeper slope than 

Delta. With its calculated growth rate of 0.35 per day, or an inferred doubling time of every 2 

days, Omicron is predicted to surpass Delta by mid-December in the UK.30 South Africa has 

documented Omicron spread, with a doubling time of every 3.4 days in a province with high 

population immunity. The country has also shown an increased risk of reinfection associated 

with Omicron. Norway documented a large Christmas party outbreak, with an attack rate of over 

70% where most of the people infected were vaccinated with two mRNA doses. There were no 

hospitalizations associated with the outbreak.31 

As of December 15th, 37 US jurisdictions had reported an Omicron case.32 Details of early 

Omicron cases were recently reported in the MMWR by CDC co-authors. As of December 8th, 

43 cases with full case details have been identified in 22 states in the US, 33% of which have an 

international travel history. Others had exposure to domestic travel, large public events, and 

household transmission. Of the cases, 79% were fully vaccinated. Overall, 32% had a booster 

dose, but a portion of these had recently received their additional dose within 14 days before 

symptom onset. A limitation of initial Omicron case descriptions is that people with recent 

international travel or participation in large public events might be more likely to be vaccinated. 

Finally, 14% of cases were previously infected.33 

As part of the response to Omicron, CDC is monitoring genomic surveillance and vaccine 

breakthrough. CDC works with partners on scientific experiments to answer important questions 

about the Omicron variant and also monitors vaccine administration and VE. CDC continues to 

support state, local, tribal, and territorial health departments in their responses. CDC also 

29 https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-classifications.html; https://www.cdc.gov/coronavirus/2019-

ncov/science/science-briefs/scientific-brief-omicron-variant.html 30https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1040076/Technical_Briefing_31 

.pdf

31 Grabowski et al. https://www.medrxiv.org/content/10.1101/2021.12.08.21267494v1; Pulliam et al. 

https://www.medrxiv.org/content/10.1101/2021.11.11.21266068v2; NIPH. https://www.fhi.no/en/news/2021/preliminary-findingsfrom-outbreak-investigation-after-christmas-party-in-o/ 

32 https://www.cdc.gov/coronavirus/2019-ncov/variants/omicron-variant.html 

33 MMWR: SARS-CoV-2 Omicron Variant —United States, December 1–8, 2021 

https://www.cdc.gov/mmwr/volumes/70/wr/mm7050e1.htm?s_cid=mm7050e1_w 

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ACIP Meeting Summary December 16, 2021 

continues to update recommendations related to travel, prevention strategies, and holiday 

activities based on the most recent evidence.34 

There is a multifaceted genomic surveillance system for analyzing SARS-CoV-2 variants 

circulating in the US. This includes the national SARS-CoV-2 strain surveillance, CDCsupported contracts with several commercial diagnostic laboratories, and sequences that 

partners randomly sampled, deposited, and tagged in public repositories (e.g., GISAID and 

NCBI). CDC estimates that if a variant is circulating at 0.1% frequency, there is a greater than 

99% chance that it will be detected in the national genomic surveillance. To further increase the 

surveillance sensitivity, enhanced genomic surveillance for S-gene target failure (SGTF) was 

conducted during November 28-December 10, 2021. This consisted of rapid sequencing for 

SGTF by PCR-based-type diagnostic tests, which were then referred for further confirmation by 

genomic sequencing. This approach was successful at identifying many of the early Omicron 

cases. Voluntary airport-based genomic surveillance programs were expanded in Atlanta, New 

York City, Newark, and San Francisco.35 

Based on the latest national Nowcast productions of the proportions of leading SARS-CoV-2 

variants from CDC’s COVID Data Tracker, the Delta VOC has maintained its dominance at 98% 

to 99% since August and over 50% since late June. Omicron was first detected and specimens 

collected during the week ending November 27th, resulting in less than 0.1% proportion during 

that week. Nowcast projections for Omicron increased to 0.4% for the week ending December 

4th and 2.9% for the week ending December 11th. Delta is now at 96.7%. Only three weeks after 

Omicron was first reported to the WHO, preliminary results have been posted from 15 laboratory 

neutralization studies with vaccinee sera using both pseudoviruses and live viruses. All studies 

show large reductions in neutralization of Omicron viruses of 15- to 127-fold compared with 

wild-type viruses. One study showed an 11-fold reduction compared with Delta, which is known 

to be further reduced compared to wild-type. 

The actual reduction may be underestimated because Omicron neutralization was below the 

limit of assay detection for most individuals who received 2 doses of mRNA or 1 dose of the 

Janssen vaccine. These values had to be imputed or ignored to calculate a full deduction. The 

impact of the Omicron variant on neutralization with vaccinee serum is greater than previously 

reported with any other variant, including the Beta variant that had previously the had the 

greatest observed impact. In more positive news, neutralization of Omicron was above the limit 

of detection in many vaccinated people who had either received a booster dose or vaccinated 

people that had been previously infected. Given the limits of detection in these types of assays, 

it is difficult to evaluate whether people have the minimal levels of antibodies thought to be 

needed to protect against severe disease. T-cell response also appears to be largely preserved 

against Omicron, with the exception of a few HLA types. 

Within the last few days, preliminary results posted from South Africa have observed 70% 

protection for Pfizer vaccine against COVID-19 hospitalization and 33% protection against 

infection during the current Omicron wave. This is reduced compared with the Delta variant 

which had 93% protection against hospitalization and 80% protection against infection. 

Booster vaccination was not evaluated in this study. The authors also noted that the risk 

34 https://www.cdc.gov/coronavirus/2019-ncov/variants/omicron-variant.html; https://www.cdc.gov/coronavirus/2019-

ncov/science/science-briefs/scientific-brief-omicron-variant.html 35 https://www.cdc.gov/mmwr/volumes/70/wr/mm7050e1.htm?s_cid=mm7050e1_w; https://www.cdc.gov/coronavirus/2019-

ncov/variants/omicron-variant.html 

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ACIP Meeting Summary December 16, 2021 

of hospital admissions among [inaudible] COVID-19 was 29% lower for the Omicron variant 

compared with the ancestral lineage after adjusting for vaccination status.36 A study by Andrews 

et al looking at Pfizer VE against infections with Delta and Omicron versus time since 

vaccination for 2 and 3 vaccine doses in the UK, study investigators observed decreased 

protection against Omicron with increasing times since receipt of the second dose at 35% VE 

against infection observed for Omicron versus 64% for Delta at 25-plus weeks. Two weeks after 

the Pfizer booster dose, VE against hospitalization increased to 76% against Omicron 

compared with 73% for Delta.37 

The prevention strategies to slow the spread of the Omicron variant in the US include 

vaccination, which is recommended for everyone 5 years of age and older; and booster doses, 

which are recommended for all persons 18 years of age and older. Other prevention strategies 

include increased use of masking, improved ventilation, wider and more frequent testing 

(including self-testing), and adherence to guidance on quarantine and isolation.38 Vaccine 

manufacturers are conducting booster studies of current vaccines and second generation 

vaccines against the Omicron variant. Moderna is testing a higher dosage of their existing 

vaccine against the Omicron variant. They are also evaluating 2 multivalent vaccines for the 

Beta and Delta variants against Omicron and developing an Omicron-specific vaccine. Pfizer is 

evaluating Alpha, Beta, and Delta boosters against Omicron, as well as developing an Omicronspecific vaccine. No Omicron-specific booster vaccine study results have been shared to date.39 

In summary, the currently authorized vaccines work against known variants. Given the 

increased risks related to the Delta and Omicron variants, it is important to increase uptake of 

primary vaccination in booster doses in all eligible populations. CDC is closely monitoring realworld VE and breakthrough infections using multiple methods, populations, and outcomes. CDC 

continues to monitor emerging variants including their prevalence and impact on disease 

incidence, severity, and vaccine breakthrough. The ACIP will continue to review evidence 

submitted for boosters in any next-generation vaccines to address evidence of diminished VE 

related to variants or waning immunity. This is a changing landscape and CDC will 

communicate promptly about emerging evidence. 

Discussion Summary 

• Dr. Fryhofer asked whether there were any specifics on how the Moderna and Janssen 

COVID-19 vaccines were reacting against Omicron, and whether she had any details about 

the NIH study mentioned in the news. 

 Dr. Scobie emphasized that it is still very early. A nice study was completed by 

Moderna using a neutralization assay, which showed that the booster doses appear 

to protect well or at least was less defective against Omicron. VE data are still 

needed for the other authorized US vaccines. They planned to meet with the NIH the 

next day and would have more details to provide to the ACIP in the future. 

36 covery-holdings-ltd.mynewsdesk.com/pressreleases/discovery-health-south-africas-largest-private-health-insuranceadministrator-releases-at-scale-real-world-analysis-of-omicron-outbreak-based-dot-dot-dot-3150697.pdf 37 Andrews et al.. https://khub.net/documents/135939561/430986542/Effectiveness+of+COVID19+vaccines+against+Omicron+variant+of+concern.pdf/f423c9f4-91cb-0274-c8c5-70e8fad50074 38 https://www.cdc.gov/mmwr/volumes/70/wr/mm7050e1.htm?s_cid=mm7050e1_w 15 39 https://investors.modernatx.com/news/news-details/2021/Moderna-Announces-Strategy-to-Address-Omicron-B.1.1.529-SARSCoV-2-Variant/default.aspx; Pfizer investor brief: https://investors.biontech.de/static-files/47b4131a-0545-4a0b-a353-

49b3a1d01789 

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ACIP Meeting Summary December 16, 2021 

• Given the need for boosters for better protection against Omicron, Dr. Kotton wondered 

whether ACIP might need to make a recommendation for boosters for immunocompromised 

persons sooner than 6 months after their third dose of mRNA vaccine. 

 Dr. Scobie replied that she had not assessed this question in terms of how 

neutralization studies would evaluate specific populations, and did not know whether 

the early studies had looked into this. 

 Dr. Oliver added that the ACIP would be updated as additional information becomes 

available. 

 Dr. Drees stressed that answering whether a booster is needed earlier for the 

general population due to Omicron also should be considered. 

 Dr. Scobie encouraged the ACIP to think about earlier booster doses based on what 

was being seen with the Omicron variant. Neutralization is not very good after 2 

doses and is better with boosters, especially for vulnerable immunocompromised 

patients who may be much more vulnerable to Omicron in the next few months and 

represent approximately 3% of the US population. 

• Dr. Maldonado noted that reports were being made by large health centers in South Africa, 

for example, that children are less likely to have transmission of Omicron but are more likely 

to be hospitalized if they are infected with it. In addition, it was not clear whether mention 

that there was a 50% increased risk of hospitalization with infection regarded incidental 

infection or was separate from incidental infections in children being hospitalized for other 

reasons. She wondered if anyone had information about the health system study conducted 

on this. 

 Dr. Scobie replied that this study was referenced in her slides, there is a booklet 

about it, and she heard that these data were to be published the previous day in the 

New England Journal of Medicine (NEJM).40 While she had not yet seen the 

publication, the presentations she had seen cited a 20% increased risk in younger 

children. Given that there were no 95% confidence intervals, she was hesitant to talk 

about the 20% during this presentation. Once the publication is released, they can 

review the details and clarify the information regarding severity in children. 

• Dr. Gluckman wondered whether there were any clinical trials with a third dose being given 

shortly after the second dose within 1 to 2 months or at some interval other than 6 months to 

address this issue of when a third dose may be needed. He pointed out that while there 

should be information within 3 to 4 months about the effectiveness of an Omicron booster, 

they need to be prepared for the fact that people who have a third dose may have waning 

immunity to Omicron as time goes on and might need another booster at some point before 

a year. 

 Dr. Oliver indicated that while they were not aware of any specific manufacturerconducted clinical trials to evaluate this, they could follow global real-world VE data 

and would be happy to review and bring to ACIP what is available. 

40 Preliminary results for Omicron from South Africa: https://discovery-holdings-ltd.mynewsdesk.com/pressreleases/discoveryhealth-south-africas-largest-private-health-insurance-administrator-releases-at-scale-real-world-analysis-of-omicron-outbreakbased-dot-dot-dot-3150697.pdf 

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ACIP Meeting Summary December 16, 2021 

 Dr. Fink reported that a couple of clinical trials already have been conducted to 

assess booster dose intervals shorter than 6 months for mRNA vaccines, which have 

been published. One is the NIH mix-and-match trial and the second is the trial 

conducted in the UK. Those trials evaluated the safety and immunogenicity of a 

booster dose and included intervals shorter than 6 months, but they do not speak to 

the need for a booster dose at those decreased intervals. 

CLOSING REMARKS 

Dr. Grace Lee (ACIP Chair) took a moment to express her sincere gratitude to her ACIP and 

CDC colleagues for their time, knowledge, and commitment to struggling mightily through these 

issues as individuals and as a group. Many of them have not had a break since the pandemic 

started. Though perhaps they originally thought the pandemic was going to be a sprint, it has 

turned out to be a marathon. While it seemed like a year later things would get easier for the 

ACIP, the pandemic continues and the deliberations are getting harder and more complex. On 

behalf of herself and Dr. Wharton, she expressed gratitude and hope that the ACIP members, 

CDC team members, federal partners, and liaisons all would have an opportunity to rest and 

recharge during the holiday season. With that, she said she was calling this the last meeting of 

2021. 

39 
 

 

 

ACIP Meeting Summary December 16, 2021 

CERTIFICATION 

Upon reviewing the foregoing version of the December 16, 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. 

40 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary December 16, 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 

41 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary December 16, 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 

42 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary December 16, 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 

43 
 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary December 16, 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 

44 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary December 16, 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 

45 
 

 

 

 

 

 

 

 

ACIP Meeting Summary December 16, 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 

46 
 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary December 16, 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 

47 
 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary December 16, 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 

48 
 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary December 16, 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 

49 
 

 

ACIP Meeting Summary December 16, 2021 

ACRONYMS USED IN THIS DOCUMENT 

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics 

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 

AHIP America’s Health Insurance Plans 

AI/AN American Indian/Alaskan Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association 

AOA American Osteopathic Association 

APhA American Pharmacists Association 

APRN Advanced Practice Registered Nurse 

ASTHO Association of State and Territorial Health Officers 

AZ AstraZeneca 

CAG Countermeasures Acceleration Group 

CDC Centers for Disease Control and Prevention 

CICP Countermeasures Injury Compensation Program 

CISA Project Clinical Immunization Safety Assessment Project 

CMS Center for Medicare and Medicaid Services 

COI Conflict of Interest 

COVID-NET COVID-19-Associated Hospitalization Surveillance Network 

CPAP Continuous Positive Air Pressure 

CSTE Council of State and Territorial Epidemiologists 

CVST Cerebral Venous Sinus Thrombosis 

DFO Designated Federal Official 

DoD Department of Defense 

DSMB Data Safety Monitoring Board 

ED Emergency Department 

EHR Electronic Health Record 

ELISA Enzyme-Linked Immunosorbent Assay 

EMA European Medicines Agency 

EMR Electronic Medical Record 

ET Eastern Time 

EtR Evidence to Recommendation 

EU European Union 

EUA Emergency Use Authorization 

FDA Food and Drug Administration 

FQHC Federally Qualified Health Center 

GACVS Global Advisory Committee on Vaccine Safety 

GBS Guillain-Barré Syndrome 

GMC Geometric Mean Concentration 

GMR Geometric Mean Ratio 

GMT Geometric Mean Titers 

50 
 

 

 

ACIP Meeting Summary December 16, 2021 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

HCP Healthcare Personnel / Providers 

HCW Health Care Workers 

HHS (Department of) Health and Human Services 

HRSA Health Resources and Services Administration 

ICU Intensive Care Unit 

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IIS Immunization Information Systems 

IM Intramuscular 

ISD Immunization Services Division 

ISO Immunization Safety Office 

IVY Network Influenza and Other Viruses in the Acutely Ill Network 

LTCF Long-Term Care Facilities 

MMWR Morbidity and Mortality Weekly Report 

MI Myocardial Infarction 

MIS Multisystem Inflammatory Syndrome 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada 

NAPNAP National Association of Pediatric Nurse Practitioners 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCHHSTP National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 

NCIRD National Center for Immunization and Respiratory Diseases 

NEJM New England Journal of Medicine 

NFID National Foundation for Infectious Diseases 

NHSN National Healthcare Safety Network 

NIAID National Institute of Allergy and Infectious Diseases 

NICU Neonatal Intensive Care Unit 

NIH National Institutes of Health 

NMA National Medical Association 

OID Office of Infectious Disease 

OIDP Office of Infectious Disease Policy and HIV/AIDS 

PCP Primary Care Provider/Practitioner 

PCR Polymerase Chain Reaction 

PHAC Public Health Agency Canada 

PICO Population, Intervention, Comparison, Outcomes 

PICU Pediatric Intensive Care Unit 

PIDS Pediatric Infectious Disease Society 

PPE Personal Protective Equipment 

RCA Rapid Cycle Analysis 

RCT Randomized Controlled Trial 

RN Registered Nurse 

RNA Ribonucleic Acid 

ROA Route of Administration 

RR Relative Risk 

rRT-PCR Real-Time Reverse Transcription Polymerase Chain Reaction 

RT-PCR Reverse Transcriptase Polymerase Chain Reaction 

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

51 
 

 

ACIP Meeting Summary December 16, 2021 

SDOH Social Determinants of Health 

SHEA Society for Healthcare Epidemiology of America 

SME Subject Matter Expert 

TTS Thrombotic Thrombocytopenia Syndrome 

UK United Kingdom 

URI Upper Respiratory Infection 

US United States 

USG United States Government 

UTI Urinary Tract Infections 

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 

VOC Variant of Concern 

VRBPAC Vaccine and Related Blood Products Advisory Committee 

VSD Vaccine Safety Datalink 

WG Work Group 

WHO World Health Organization 

52