MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP)

JULY 22, 2021

SUMMARY MINUTES

TABLE OF CONTENTS

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

Thursday: July 22, 2021............................................................................................................. 2

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

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES ..................................................... 3

Introduction......................................................................................................................... 3

GBS after Janssen COVID-19 Vaccine: VAERS ................................................................. 5

GBS after Janssen COVID-19 Vaccine: VSD...................................................................... 7

VaST assessment of GBS after Janssen COVID-19 Vaccine.............................................. 8

Johnson & Johnson/Janssen Comments ...........................................................................11

Public Comments...............................................................................................................12

COVID-19 Vaccines: Benefit-Risk Discussion....................................................................17

Work Group Interpretation and Next Steps.........................................................................21

Data and Clinical Considerations for Additional Doses in Immunocompromised ................22

Certification...............................................................................................................................28

ACIP Membership Roster .........................................................................................................29

Acronyms Used in the Document..............................................................................................38
ACIP Meeting Summary July 22, 2021

2

MEETING PURPOSE

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

Disease Control and Prevention (CDC) convened an emergency meeting of the Advisory 

Committee on Immunization Practices (ACIP) on July 22, 2021. The meeting took place

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

meeting, which focused on Guillain-Barré Syndrome (GBS) after Janssen COVID-19 vaccine

and review of the data and considerations for additional COVID-19 vaccine doses in 

immunocompromised persons.

THURSDAY: JULY 22, 2021

WELCOME AND INTRODUCTIONS

Dr. José R. Romero (ACIP Chair) called to order and presided over the meeting. He welcomed 

everyone and thanked them for their attendance and the time they are dedicating to the COVID19 effort.

Dr. Amanda Cohn (ACIP Executive Secretary) indicated that copies of the slides for the day 

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

ACIP Voting Members, Ex Officios, and Liaisons. She indicated that there would be an oral 

public comment session at approximately 1:15 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

https://www.regulations.gov using Docket Number CDC-2021-0070. 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 

conflict of interest (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 stated COIs at the beginning of 

the meeting. No votes were taken during this emergency meeting.

ACIP is accepting applications and nominations for new members to fill upcoming vacancies. 

Applications should be submitted by August 1, 2021 for the 4-year term beginning July 1, 2022.

The application and additional information can be found on the ACIP website at

https://www.cdc.gov/vaccines/acip/apply-for-membership/index.html.

Dr. Romero (ACIP Chair) conducted a roll call, during which one COI was declared by voting 

member Dr. Sharon Frey, who is the Site Principal Investigator (PI) at St. Louis University for 

the Moderna and Janssen SARS-CoV-2 vaccine trials in adults. A list of Members, Ex Officios, 

and Liaison Representatives is included in the appendixes at the end of this summary 

document.
ACIP Meeting Summary July 22, 2021

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CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES

Introduction

Dr. Matthew Daley (ACIP, WG Chair) introduced the COVID-19 Vaccines WG session, first 

providing a COVID-19 pandemic update. After a heavy caseload in the winter, there has been a 

sharp decline with a nadir in early June. However, cases have been rising in the last number of 

weeks. The current rise has been in parallel with and likely a consequence of the Delta variant.

As of July 21, 2021, 339 million vaccine doses have been administered in the United States 

(US) and more than 161 million individuals in the US are fully vaccinated. This equates to 57% 

of the population 12 years of age and older.1

To place the discussion in some context, Dr. Daley provide an overview of COVID-19 vaccine 

safety monitoring in the US. It is important to state that COVID-19 vaccines have been 

monitored under the most intensive vaccine safety monitoring program ever in US history, with 

ongoing surveillance monitoring through multiple systems from 6 federal agencies. These 

monitoring systems have demonstrated that hundreds of millions of people in the US have 

safely received COVID-19 vaccines. As a vaccine researcher, Dr. Daley said it gave him great 

reassurance to know that this monitoring is ongoing on a daily basis and that this is independent

and across multiple federal agencies.2 Two of these systems are the Vaccine Adverse Event 

Reporting System (VAERS) and the Vaccine Safety Datalink (VSD).

VAERS is the nation’s early warning system for vaccine safety, which is jointly managed by the 

CDC and the Food and Drug Administration (FDA). VAERS accepts all reports from everyone

regardless of the plausibility of the vaccine causing the event or the clinical seriousness of the 

event. VAERS has a number of key strengths. It is able to detect potential safety problems

rapidly, has the ability to detect rare adverse events (AEs) that cannot be detected in clinical 

trials, and is national in scope. However, it is also important to highlight some of the key 

limitations of VAERS. At times, the information reported to VAERS is incomplete or clinically 

inconsistent. VAERS is also subject to reporting bias, overreporting and underreporting, 

generally cannot determine cause and effect. However, it can generate signals that are then 

investigated in other systems.

The VSD is comprised of 9 participating and integrated health care organizations that contribute 

data on over 12 million persons per year. The VSD is an active surveillance system in that it 

does not rely on spontaneous reporting from individuals, which is an important distinction. The 

VSD has rich and detailed clinical data on these 12 million individuals. This includes detailed 

immunization records, outpatient emergency department (ED) and hospital data, procedure 

codes, and birth and death certificates. The VSD is able to manually review electronic health 

records (EHRs), which can be particularly useful in determining whether a case is a true case 

and that symptoms in fact started after vaccination. The VSD has rich clinical data and can 

rapidly perform manual review of EHRs when necessary.3

1 https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases; https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacctotal-admin-rate-total

2 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/reporting-systems.html

3 https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html
ACIP Meeting Summary July 22, 2021

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It is a reflection of this intense vaccine safety monitoring that several rare serious adverse 

events (SAEs) have been detected following COVID-19 vaccination, such as thrombosis with 

thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccine. On April 23, 2021 the 

ACIP met to review the data and reevaluate benefit/risk in the context of these new data.

Additionally, myocarditis had been detected following mRNA COVID-19 vaccines.

4

Consequently, the ACIP met on June 23, 2021, to review the safety data and reevaluate 

benefit/risk in light of this new data.5 Reports of GBS following Janssen COVID-19 vaccine 

prompted the July 22, 2021 meeting to review and reevaluate the benefit/risk in the context of 

the reports.6

To provide some additional context for the day’s conversation, GBS is a rare neurologic disorder

in which the immune system damages nerves and myelin sheaths around nerves. This causes 

muscle weakness and can cause paralysis. An estimated 3,000 to 6,000 cases of GBS are

reported annually in the US. Typically, these follow several different types of infectious illnesses

that are typically triggered by gastrointestinal (GI) and respiratory infection. While most people 

fully recover from GBS, the recovery period is long and difficult. It is important to note that some

people have permanent nerve damage from GBS. The risk for GBS in the US is highest in 

males and persons over 50 years of age.

GBS has been reported at a higher rate in the 42 days following Janssen COVID-19 

vaccination. Due to this, a warning was added to the FDA Emergency Use Authorization (EUA) 

fact sheets.7 The warning reads, “Reports of adverse events following use of Janssen COVID19 vaccine under Emergency Use Authorization suggest an increased risk of Guillain-Barré 

Syndrome in the 42 days following vaccination. GBS has not been reported following mRNA

vaccines.”

GBS has been reported following other vaccines. It was reported following the 1976 swine 

influenza vaccine at an approximate rate of 10 GBS cases per 1 million vaccine doses

administered. There have been mixed findings in subsequent influenza seasons, but the 

magnitude of any potential increased risk appears to be much less than the risk GBS from 

natural influenza infection. In addition, GBS cases have been reported following the Shingrix 

zoster vaccine. A causal relationship has not been established, but a warning was added to the 

package insert due to the approximately 3 to 6 excess cases of GBS per million doses 

administered in persons 65 years of age and older in the 6 weeks following Shingrix vaccination. 

No increased risk of GBS has been observed for other vaccines.8 While over 30 other prespecified outcomes are being monitored through this intensive vaccine safety surveillance, no 

other safety signals have been detected.

To highlight how the ACIP responds to reports of AEs following vaccination, the Vaccine Safety 

Technical Subcommittee (VaST) reviews data from all of the US government vaccine safety 

surveillance systems and other sources. In addition to comprehensive detailed review by VaST,

the COVID-19 Vaccines Work Group (WG) also reviews these data and then puts them into the 

context of the benefit/risk balance. Following review by VaST and the COVID-19 Vaccines WG, 

these data are presented in a public ACIP meeting during which the data and benefit/risk 

assessment are presented to ACIP for review, discussion, and consideration of 

4 https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e4.htm

5 https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e4.htm 

6 https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm

7 https://www.fda.gov/media/146305/download; https://www.fda.gov/media/146304/download

8 DeStefano, F, et al. Clinical Infectious Diseases 69.4 (2019): 726-731; https://www.fda.gov/media/108597/download; Baxter, R, et 

al. Clinical infectious diseases 57.2 (2013): 197-204
ACIP Meeting Summary July 22, 2021

5

recommendations for use of COVID-19 vaccines. The COVID-19 Vaccines WG meets weekly. 

Since the June 2021 ACIP meeting, the WG has reviewed the GBS cases after Janssen 

COVID-19 vaccination, engaged in detailed discussions regarding the benefit/risk balance in 

light of this new information, and reviewed data and considerations for additional COVID-19 

vaccine doses in immunocompromised persons.

As has been stated for many months, immunocompromised people and their close contacts 

should be vaccinated against COVID-19. While it is important to note that reduced immune 

responses to vaccination have been observed in some immunocompromised people, serologic 

testing to assess immune response to vaccination is not recommended for anyone, including for 

immunocompromised people. It is also important to note that immunocompromised people

should be counseled to continue a number of current prevention measures in addition to 

vaccination. These include wearing a mask, keeping socially distanced, and avoiding crowds. 

Clinical guidance for additional COVID-19 vaccine doses will be updated pending regulatory 

allowance from the FDA.9

GBS after Janssen COVID-19 Vaccine: VAERS

Dr. Meghna Alimchandani (FDA) provided an overview of GBS after Janssen COVID-19 

Vaccine in VAERS. She emphasized that one of the key strengths of VAERS is that it can 

rapidly detect potential safety issues, including new or rare AEs. Some major limitations of a 

spontaneous AE reporting system are that some reports have missing or inaccurate data and 

the reported diagnoses are not verified.

Two methods are used to identify preliminary reports of GBS after Janssen COVID-19 vaccine 

in VAERS. FDA medical officers review incoming serious reports daily and/or automated 

queries on the VAERS database using the following Medical Dictionary for Regulatory Activities 

(MedDRA) coded preferred terms (PT): acute polyneuropathy, autoimmune polyneuropathy, 

axonal and demyelinating polyneuropathy, demyelinating polyneuropathy, Guillain Barré 

syndrome, Miller Fisher syndrome. A key limitation of the analysis presented during this session 

was that the cases had not been adjudicated to determine whether they met the Brighton

collaboration case definition for GBS. The diagnosis of GBS is based on clinical features, 

cerebrospinal fluid (CSF) testing, and nerve conduction studies. It is important to keep in mind 

that because of the limited availability of medical records, identified cases were not assessed 

according to the Brighton criteria.

As of June 30th, 100 reports were identified of GBS after the Janssen COVID-19 vaccine in 

VAERS. Of those, 95% were serious and involved hospitalization, 61% were males, 38% were 

females, and 1 patient died. The median age was 57 years, with 83% occurring in patients less 

than 55 years of age. The median time to onset was 13 days. For this assessment, 21-day and

42-day risk windows were used. The majority (98%) of the cases occurred in the 42-day risk 

window. Two cases were not included in the 42-day risk window given that 1 occurred outside of 

the 42 days and 1 did not specify time to onset. When the 21-day risk period was applied, 84% 

of cases were found to have occurred in that window. As a reminder, there were no medical 

records for the majority of these cases and very limited follow-up information was available at 

the time of the analysis. However, work is ongoing to collection additional information.

9 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html
ACIP Meeting Summary July 22, 2021

6

To further characterize selected cases among the 95 (95%) patients who were hospitalized, 10 

patients were intubated and/or required mechanical ventilation. The 1 death occurred in a 57 

year old man with a past medical history of heart failure, stroke, hypertension, and diabetes. He 

developed pain and weakness 5 days post-vaccination. It was reported that he went to the 

hospital in an ambulance. Diazepam was prescribed and he was sent home. Several days later, 

he developed extreme weakness and pain and returned to the hospital. He was hospitalized for 

11 days, including 6 days on a ventilator, and he completed a course of intravenous 

immunoglobulin. He died 25 days after vaccination. There were 24 reports that described

bilateral facial paresis. Notably, there have been case reports in the literature of bilateral facial 

paresis occurring in the context of GBS reported after the AstraZeneca (AZ) COVID-19 vaccine.

Also identified in VAERS were 12 reports of unilateral Bell’s Palsy and 6 reports mentioned 

recent illness (e.g., generalized rash, upper respiratory infection, or flu-like symptoms) 1-2 

weeks before GBS. No reports listed concomitant vaccines.

In the observed-to-expected (O/E) analysis of the 100 reports in the 42-day risk window, broad 

age bands were used of 18-29 years, 30-39 years, 40-49 years, 50-64 years, and 65 years and 

older. As noted earlier, 98 cases occurred in the 42-day risk window, which is why that risk 

window assumption was used in this analysis. The number of vaccine doses administered was 

provided by the CDC. The background rate was adjusted for increased incidence of GBS with 

increasing age based on a systematic review and meta-analysis by Sejvar et al focused on 

population incidence of GBS.10 Striking in the O/E analysis is that the number of observed cases 

exceeded the number of expected cases across age groups. These calculations were repeated 

using different background rates and using the 21-day risk window. Those additional 

calculations are provided on the back-up slide 18. While the rate ratio was elevated across age 

group in the O/E analysis assuming a 42-day risk window, it was highest in the younger age 

groups under 65 years. An additional O/E analysis was performed that further stratified the age 

groups under 65 years. The rate ratio was highest at around 7 for persons 40-49 year of age 

and 50-64 years of age.

As Dr. Daley pointed out earlier, the EUA fact sheets were updated on July 12th, with a new 

subsection added under Warnings and Precautions in the EUA fact sheet for healthcare 

providers (HCP) stating, “Reports of adverse events following use of the Janssen COVID-19 

vaccine under emergency use authorization suggest an increased risk of Guillain-Barré 

syndrome during the 42 days following vaccination.” The EUA fact sheet for recipients and 

caregivers also was updated.

In a crude comparison of VAERS GBS reporting rates for mRNA vaccines per million doses 

administered, the Janssen reporting rate was elevated and slightly different from the mRNA 

vaccines. There are many limitations to this analysis. First, it looked at doses administered. 

While there is a 2-dose series for the mRNA vaccines, this analysis looked at cumulative totals 

rather than by dose. The number of the case counts of the VAERS reports for the mRNA 

vaccines may include duplicate reports, these reports were not manually reviewed, and the 

results are from the automated queries using code encoded PTs. Additional analyses were not 

performed for Moderna or Pfizer and BioNTech because the reporting rate was so low. The 

number of cases were few and within the expected background rate for the mRNA vaccines.

10 Sejvar JJ, Baughman AL, Wise M, Morgan OW. Population incidence of Guillain-Barré syndrome: a systematic review and metaanalysis. Neuroepidemiology. 2011;36(2):123-33.
ACIP Meeting Summary July 22, 2021

7

The AZ COVID-19 vaccine is not licensed or authorized in the US. It uses the chimpanzee 

adenoviral vector platform. The FDA and CDC are in close communication with colleagues in 

European Medicines Agency (EMA) in terms of safety updates for the AZ COVID-19 vaccine. As 

of the end of June, a total of 227 cases of GBS had been reported to EudraVigilance for the AZ 

COVID-19 vaccine. These cases were reviewed by the EMA’s Pharmacovigilance Risk 

Assessment Committee (PRAC) earlier in July. The PRAC recommended an update to the 

product information for the AZ vaccine to include a warning for GBS following vaccination with 

the AZ COVID-19 vaccine.

In summary, 100 preliminary reports of GBS after Janssen COVID-19 vaccine were identified in 

VAERS as of June 30, 2021. Analyses identified that observed reports were greater than 

expected across multiple age groups, without respect to Brighton Collaboration criteria. The 

reporting rate for GBS is higher for Janssen than for mRNA vaccines. On July 12, 2021, the 

authorized EUA Fact Sheets were updated to include new information about GBS. In terms of 

next steps, work will continue to obtain follow-up information and medical records. The Janssen 

reports will continue to be evaluated in order to determine whether they meet the Brighton

criteria. Based on the number of confirmed cases after that review and assessment, the O/E 

analysis for GBS after Janssen will be updated. Follow-up will continue on updates from the 

FDA Biologics Effectiveness and Safety System (BEST), the Center for Medicare and Medicaid 

Services (CMS) databases, and the CDC VSD active surveillance system.

GBS after Janssen COVID-19 Vaccine: VSD

Dr. Nicola Klein (Kaiser Permanente Northern California) reported on Rapid Cycle Analysis 

(RCA) findings to date on a GBS analysis after Janssen COVID-19 vaccine being led by Kaiser 

Permanente Northern California in close collaboration with the Marshfield Research Clinic and

the CDC. She reminded everyone that the VSD is a collaborative project between CDC and 9

integrated healthcare organizations that was established in 1990 and includes EHR information 

on over 12 million members. The specific aims of this VSD RCA project during the period from

September 2020–August 2023 are to: 1) monitor the safety of COVID-19 vaccines weekly using 

pre-specified outcomes of interest among VSD members; and 2) describe the uptake of COVID19 vaccines over time among eligible VSD members and in strata by age, site, and 

race/ethnicity. As of July 10, 2021, over 12.4 million doses of COVID-19 vaccines have been 

administered in the VSD. To date, 65.8% of the age-eligible VSD population has received their

first dose and 61.5% are fully vaccinated. The vast majority of vaccines given have been the 

mRNA vaccines. Over 349,000 doses of the Janssen vaccine have been given, among which

over 44,000 were administered to those 65 years of age and over.

The primary analyses used vaccinated concurrent comparisons with sequential tests. This 

involves evaluating vaccinated individuals in the 21 days after vaccination compared to other 

individuals who also are vaccinated, but are further away from their last vaccine dose by

between days 22 and days 42, who are the comparators. In the 21-day risk interval from either 

dose of any mRNA vaccines, the rate ratios were adjusted for VSD site, age group in 5-year age 

increments, sex, race/ethnicity, and calendar date. A sequential test required 1-sided P-value of

<0.0048 for a signal. This keeps the probability of a false positive signal due to chance alone

below 0.05 in 2 years of surveillance. GBS was pre-specified as well as a number of other 

outcomes that would be included in analysis if they were confirmed. Cases initially underwent a 

quick review for confirmation, and then they were included in this analysis. However, they were

subsequently removed if not confirmed after a chart review and adjudication that takes place 

later in time. At the time of this analysis, there were no signals for any of the outcomes being 

followed on the weekly basis, including GBS that had a 1-sided P-value of 0.828 and an 
ACIP Meeting Summary July 22, 2021

8

adjusted rate ratio of 0.69. The outcome events in the 21-day risk interval also were compared 

after Janssen vaccine, again comparing outcome events between the vaccinated individuals

with vaccinated comparators. There were no signals after Janssen vaccine for any of the prespecified outcomes listed. There were 8 cases of GBS in the risk interval for GBS, but the 

adjusted rate ratio was 1.19 and the 1-sided P value was 0.682.

Turning to the chart review summary as of July 3, 2021, there were 40 GBS cases initially 

identified within the 1-98 days following any mRNA vaccine. After a quick review, 16 of 39 were 

ruled, 1 is pending, 23 of the 39 proceeded to full review, 21 of the 23 underwent complete

review and adjudication with Brighton level criteria and 2 are pending. Adjudication confirmed 19 

of the 21 as GBS following any mRNA vaccine: 1 case was post-vaccination Day 0; 8 cases

were post-vaccination Days 1-21; 8 cases were post-vaccination days 22-42; and 2 were case 

post-vaccination days 43-98. The 8 cases in the post-vaccination Days 1-21 window contributed 

to the analysis. The chart review of GBS syndrome following the Janssen vaccine as of July 3rd

identified 14 cases within the 1-98 days following Janssen and all 14 were quick reviewed. Of 

these, 2 were ruled out, 12 of the 14 proceeded to full review, 10 of the 12 completed review

and adjudication, and 2 are pending. Adjudication confirms 8 of the 10 as GBS following the 

Janssen vaccine. Of those, 7 were post-vaccination Days 1-21 and 1 was in post-vaccination

Days 22-42.

In terms of the characteristics of the confirmed GBS cases in 1-21 days, 75% cases in the 

mRNA group were over the age of 65 and 100% of the cases after Janssen were 18-64 years of 

age. Overall, similar proportions in each group had on-going illness at the time of the chart 

review. In terms of unadjusted incidence rates of chart-confirmed GBS 1-21 days after 

vaccination, it is important to note that the study was not designed to do a head-to-head 

comparison of mRNA versus Janssen vaccine. That said, after mRNA vaccines there were the 8 

confirmed cases in the 1-21 day interval among just over 11.7 million doses. That translates to 

an unadjusted rate of 0.7 (0.3 - 1.3) per million doses and an unadjusted rate per 100,000

person years of 1.2 (0.5 – 2.3). In comparison, 7 GBS cases were confirmed in the 1-21 day risk 

interval out of 345,000 doses for an unadjusted rate per million doses of 20.2 (8.1- 41.7) and an 

unadjusted rate per 100,000 person years of 35.2 (14.2 - 72.5).

So in summary, the VSD has not identified a signal for any outcome in primary analyses, 

including GBS after mRNA or Janssen vaccines. The analyses do not include a head-to-head

comparison of Janssen to mRNA vaccines. However, the chart-confirmed unadjusted incidence 

rates of GBS during the 21 days after the Janssen vaccine was much higher than during the 21 

days after the mRNA vaccine. The weekly update of Janssen in the VSD has been minimal, in 

the range of 2,500 to 11,000 doses a week. The investigators strongly believe that continued 

VSD monitoring of GBS is warranted and will continue to chart review every case of GBS within 

the 1-98 days following any COVID-19 vaccine.

VaST assessment of GBS after Janssen COVID-19 Vaccine

Dr. Grace Lee (ACIP, VaST Co-Chair) reported that as of July 21, 2021, there were 339 million 

doses administered of whom 187 million individuals have received at least 1 dose and 162 

million people are fully vaccinated in the US. There is significant variability in vaccination rates

by state and by community. The tremendous benefits of COVID-19 vaccines are observed in 

reducing death rates in states and communities that are highly vaccinated. This also 

demonstrates the tremendous opportunities there are to continue to protect families and

communities against COVID-19 morbidity and mortality.
ACIP Meeting Summary July 22, 2021

9

In terms of the focus of this meeting on the particular AE of GBS and estimating the potential 

risks associated with vaccination, the role of VaST is to ensure that vaccine safety is being 

carefully monitored and that any risks are communicated to the ACIP, and hence to the public,

in a timely and transparent manner. There is an estimated rate of about 1 in 70,000, which is the 

midpoint of current estimates for the risk of GBS. This means that 69,999 individuals who 

receive vaccines do not have this AE.

ACIP’s responsibility is to ensure that the best possible recommendations are provided for the 

for the US population on the use of COVID-19 vaccines, and that its assessments about the 

benefits and risks of vaccination are placed in the context of the dynamic burden of disease that

the US is experiencing, while also recognizing that the US is also a member of the global 

community and that infections do not respect borders. ACIP members must acknowledge the 

importance of these AE in individuals, as well as the immense benefits of vaccination in 

preventing poor health and economic outcomes for the population. ACIP will continue to 

mitigate these risks whenever possible in close partnership with provider and public health 

communities.

VaST has had 28 independent meetings to review vaccine safety data since December 21, 

2020 and 6 joint meetings with the COVID-19 Vaccine WG to discuss safety issues. Since 

ACIP’s June 23, 2021 meeting, VaST shared a WG report following its meeting on June 28th on 

GBS following Janssen vaccine. During that meeting, VaST reviewed data from VAERS

demonstrating that the observed number of preliminary cases of GBS after a Janssen vaccine 

was greater than expected in those 18 years and older and in all age groups. No geographic

clustering was observed in the VAERS data. At the same time, VaST noted that the observed

versus expected recording rates were not elevated for mRNA vaccines. In the VSD and 

Veteran’s Administration RCAs presented that day, no statistical signals for GBS were identified

for any COVID-19 vaccines. However, the rate of GBS following the Janssen vaccine was 

higher than for the mRNA vaccines in the VSD. VaST noted that GBS cases were reported after 

receipt of AZ COVID-19 vaccine, which is used in other countries. VaST members discussed 

the need for review and adjudication of VAERS case reports of GBS using Brighton 

collaboration criteria, and ongoing monitoring of GBS in all persons who receive the Janssen 

COVID-19 vaccine in the US.

11

Following that meeting, the EMA announced the addition of a warning for GBS following the AZ 

COVID-19 vaccine on July 9, 2021. On July 12th, the FDA announced revisions to the Janssen 

COVID-19 vaccine EUA fact sheets for providers and for patients to include information about 

an observed increased risk of GBS following vaccination.12 During its meetings on July 12th and 

July 19th, the VaST WG reviewed key updates on GBS from the federal safety system, which 

were shared earlier in this ACIP meeting by Drs. Alimchandani and Klein. As a reminder, GBS 

can occur following a respiratory or GI illness. Background rates of GBS generally increase with 

age and risk is greater in males than in females. To summarize the findings regarding GBS 

cases per million doses of COVID-19 vaccines administered in VAERS and VSD for those 18 

years and over, the rate of GBS following the Janssen vaccine ranged from 8-20 per million 

doses in VAERS and the VSD. In contrast, the rate of GBS following mRNA vaccines ranged 

from 0.7 to 1.1 per million doses in the two systems, with an expected background rate of 

approximately 1.6 cases of GBS expected in the 42-day window per million doses given.

11 https://www.cdc.gov/vaccines/acip/work-groups-vast/index.html; https://www.ema.europa.eu/en/news/meeting-highlightspharmacovigilance-risk-assessment-committee-prac-5-8-july-2021; https://brightoncollaboration.us/guillain-barre-and-miller-fishersyndromes-case-definition-companion-guide/

12 https://www.fda.gov/media/146304/download; https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID19+Vaccine-Recipient-fact-sheet.pdf
ACIP Meeting Summary July 22, 2021

10

VaST discussed these findings and felt that the risk for GBS following Janssen COVID-19 

vaccine is substantially different than the risk following mRNA vaccines and the expected 

background rates, with a median onset of 13 days in VAERS and more commonly recorded in 

males than females. Of note, fewer individuals receive Janssen in the US. It represents less 

than 4% of all vaccine doses administered in the US. VaST also noted that GBS cases have 

been reported following SARS-CoV-2 infection in the literature, with a median onset of 12-14 

days post-infection.13 VaST also discussed the importance of medical record review of the 

VAERS cases in process using Brighton collaboration criteria and the need to confirm the 

diagnosis of GBS and further characterize the clinical presentation, severity, and outcomes of 

GBS cases following Janssen vaccine. They also discussed the need to continue to assess 

benefit/risk balance given the dynamic epidemiology of COVID-19 infection.

The VaST WG will continue to monitor and support the response to safety data in the US. The 

US safety monitoring systems will continue to track anaphylaxis and myocarditis following 

mRNA COVID-19 vaccines and TTS and GBS following Janssen COVID-19 vaccines. The 

VaST WG also will continue to monitor the pre-specified adverse events of special interest

(AESI) in each of the federal agencies monitoring safety and is appreciative of the 

communication and the collaboration among the federal agencies responsible for vaccine safety 

surveillance in the US, as well as the communication and collaboration with global partners, in 

monitoring the safety landscape overall. The ACIP will continue to incorporate safety data into 

decision-making about vaccine use, including ongoing assessments about the benefit/risk 

balance that are contextualized to real-time data and risk mitigation strategies that support 

informed discussions with patients and the public about the benefits and risks of available 

vaccines, as well as clinical guidance to support early detection and appropriate management of 

potential AEs.

Summary of Discussion (Alimchandani, Klein, & Lee)

• In response to a question regarding whether there was a sense about what proportion of 

GBS cases tend to be confirmed through adjudication, the Clinical Immunization Safety 

Assessment (CISA) has started reviewing cases. They have assessed 7 cases so far and 

have seen a very small number. CISA had good consensus that 3 cases were clearly 

Brighton Level 2 GBS, with characteristic of GBS regardless of etiology. GBS is reported 

with Bell’s Palsy, which has been seen in some of the cases reviewed so far. Cranial 

neuropathies in GBS, specifically with a facial nerve, is seen in about 30% to 50% of 

patients depending upon what series of all-comers is reviewed. 

• ACIP members expressed interest in further information on the following topics related to 

GBS following Janssen COVID-19 vaccination:

➢ Breakdown of race/ethnicity and geographic location

➢ Further information about the severity of the cases in terms of the number admitted 

to the Intensive Care Unit (ICU)

➢ Rate of GBS cases reported due to COVID-19 infection

13 Aldawi et al., Can J Neurol Sci 2021; Sheikh et al., J Neuroimmunol 2021; Sriwastava, J Neurol Sci 2021
ACIP Meeting Summary July 22, 2021

11

Johnson & Johnson/Janssen Comments

Dr. Mathai Mammen (J&J/Janssen) reported that Johnson & Johnson/Janssen has been busy 

at work since the start of the COVID-19 pandemic with a dedication to developing a single-dose 

vaccine that can be easily distributed and that is safe and effective in helping to combat the 

pandemic’s effects worldwide. They are fully aligned with FDA on the addition of information

regarding the cases of GBS that have been observed following vaccination with the Janssen 

vaccine. They had some recently published data on variant coverage and durability of the 

immune response that they wanted share with the ACIP to provide additional context for the 

day’s discussion. As everyone is aware, the pandemic is evolving in the US and globally. The 

Delta variant makes up the large majority of COVID-19 cases in the US at this point whereas 

just a couple of months ago it was not present at all. Vaccines are needed that cover current 

and future variants and that are durable in protection.

Importantly, everyone is still learning about the duration of protection and the breadth of 

coverage against this evolving varied landscape for each of the authorized vaccines. In that 

context, Dr. Mammen shared some newly evolving data showing that antibody titers against

variants continue to rise after Day 29, including against Delta. This suggests further maturation 

of the immune response. These effects are sustained through Day 239 or approximately 8 

months. There is a comparable response to all variants analyzed by 8 months, including the 

Delta variant. It is critical to understand that there are components to the immune system 

outside of neutralizing antibodies that play a very important role in preventing infection. As 

reported in recent publications, the J&J/Janssen vaccine induces very strong CD4-positive and 

CD8-positive T-cell responses that are comparable across variants. It is important to note that 

the mutations in the virus seen have not shown up in T-cell epitopes. Therefore, it is not 

surprising that the T-cells induced by J&J/Janssen vaccine are comparably active against all the 

variants currently known.

The CD8-positive T-cells in particular are the body’s primary mechanism to clear infected cells.

Of note, this persistence also has been observed and has a comparable response to variants

for non-neutralizing functional antibodies induced by the vaccine. At this stage, J&J/Janssen

does not know whether all of these immune data and others recently reported are predictive of 

clinical efficacy, but do believe that all of these components of the immune response are 

important and they are all persistent. They will have a better view on clinical efficacy in the 

coming weeks.

Dr. Joanne Waldstreicher (J&J/Janssen) provided a high-level overview and the J&J/Janssen 

view on the benefit/risk profile. As noted earlier, there are 100 cases of GBS from VAERS out of 

the more than 12 million people in the US who have received the Janssen vaccine, giving an 

overall reporting rate of 8 cases per million people vaccinated. This is in the context of the 

different published rates of GBS in the US, which have ranged from 1-5 cases per million 

people. To provide further context in relationship to other vaccines, the estimated risk of GBS 

reported with the H1N1 vaccine is approximately 3 cases per million, the estimated risk with 

shingles vaccine is 5-8 cases per million people vaccinated, and the estimated risk with TTS is 

approximately 3 cases per million people vaccinated. Dr. Waldstreicher emphasized that these 

cases are not just numbers. They are people and they matter deeply to J&J/Janssen.
ACIP Meeting Summary July 22, 2021

12

They do have some data on the risk of GBS with COVID, one published study and one internal 

population-based analysis, that they were able to share showing that the risk of developing GBS 

after COVID is much higher than any of the risks presented during this meeting. That is why it is 

necessary to consider these risks in the context of the overall benefits of preventing COVID.

Looking at estimates of the potential benefit over a 1-year period in terms of hospitalization and 

death per 1 million people vaccinated with either the Janssen vaccine or no vaccine in the 

setting of different levels of transmission, for every 1 million people vaccinated, even in the 

setting of very low transmission, many hospitalizations and deaths are avoided and the benefits 

outweigh the risk of GBS and TTS. The overall benefit/risk seems favorable even in the very low 

transmission setting, but particularly so as transmission is higher as seen in various parts of the 

US and globally. This is especially important as has been seen with the new variant profile 

emerging, as well as the recent surge in case counts.

There is still a need to vaccinate as many people as possible, both in the US and globally. The 

pandemic continues to evolve in the presence of many who remain unvaccinated and the 

variant landscape is changing rapidly and unpredictably. Multiple vaccine options are needed in 

the global public health toolbox. In this context, the Janssen vaccine offers important benefits.

Newly published data that Dr. Mammen just shared demonstrates persistent humoral and 

cellular immune responses through 8 months, independent of variant. As a single dose with 

simple storage conditions, the vaccine has particular public health benefits in the US and 

globally. The global context is critical. As mobility resumes and variants continue to emerge,

there is no question that the US population will remain vulnerable so long as large segments of 

the globe remain unvaccinated. For many parts of the globe, the single dose and easily 

transportable vaccine is critical. Finally, J&J/Janssen agrees with the FDA’s statement that the 

known and potential benefits clearly outweigh the known and potential risk.

Public Comments

The floor was opened for public comment during the July 22, 2021 ACIP meeting at 1:15 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–2021–0070. Visit http://www.regulations.gov for access to the docket or to submit 

comments or read background documents and comments received.

Larry Saltzman, MD

Board Certified Family Physician

Executive Research Director, Leukemia & Lymphoma Society

Blood Cancer Survivor

Thank you for the opportunity to speak to you today. I’m Dr. Larry Saltzman, a Board Certified

Family Physician, Executive Research Director for the Leukemia and Lymphoma Society and a 

blood cancer survivor—now for over 11 years. I’m here today to urge CDC to implement a 

COVID-19 vaccine booster program. We need a large-scale nationwide clinical trial to assess 

their safety and effectiveness. As a family physician, I emphasize preventative medicine, 

including immunizations for all. In my career, I have seen cases of tetanus, measles, and other 

diseases that are now preventable. In October 2009, I self-diagnosed my lymphoma, confirmed 

as atypical chronic lymphocytic leukemia and small cell lymphocytic lymphoma. I’ve been 

treated on multiple occasions, including chemotherapy, the removal of the right side of my colon 

due to lymphoma blockage, and years of oral targeted anti-cancer drugs. My most recent
ACIP Meeting Summary July 22, 2021

13

relapse was quite severe. From October 2019 through January 2020, I was hospitalized on five 

separate occasions and treated with three different courses of chemotherapy. The culmination 

of these treatments was CAR-T immunotherapy, where my white blood cells were genetically

reprogrammed and reinfused so they could act as little Pac-Men, hunting down and destroying 

my blood cancer. As I returned home in February 2020, I was looking forward to recovery and 

normal activities until SARS-CoV-2 essentially shut down the world and created a very hostile 

environment for me and all blood cancer patients to live in. A 2021 publication in Nature

Medicine by Bange found mortality rates as high as 55% among patients with COVID-19 who 

also have hematologic cancer. Severe COVID-19 infection is preventable with the available 

vaccines. I received the COVID-19 mRNA vaccines in January and February 2021. However, I 

made no detectable antibodies to the spike protein. Based on an ongoing study by the

Leukemia and Lymphoma Society published online today in Cancer Cell, we estimate 25% of 

blood cancer patients, or 250,000, in the USA did not have an antibody response to the vaccine.

There are estimated to be 5 million immunocompromised patients at risk in America, including 

any condition that requires chemotherapy or immune suppressive treatments. We have been 

advised by the CDC that masks are no longer recommended in most settings. Patients like me 

are left in the lurch. I am in quarantine. I do not trust all unmasked to be vaccinated. I’m hearing 

too many stories of immunocompromised people like me who are taking matters into their own 

hands. Thank you for your time and consideration.

Thair Phillips

Healthcare Leadership Council

Seniors Speak Out

Good afternoon. My name is Thair Phillips of Seniors Speak Out. For the 20 years before I 

became eligible for Medicare and the 8 years since, I have been an advocate for the concerns 

of older Americans. It is important to remember that well before COVID, pneumococcal 

diseases were a serious threat to seniors. We know that as we grow older, our protective 

immune responses are weakened and that increases our vulnerability to infectious diseases 

such as pneumonia. Each year, about 1.3 million people visit emergency departments with 

pneumonia and nearly 50,000 people will die from it, many of whom are older Americans. That 

has not changed and will continue to be our reality post-pandemic. In fact, there is perhaps 

good reason to be concerned that post-COVID, we may be even more at risk due to lung 

damage among COVID survivors, deferred medical care for comorbidities, and an increased 

sedentary lifestyle during pandemic-driven quarantine. I know that this committee has enormous 

issues before it, but it is a matter of life and death to many seniors who rightfully want to do

everything they can to protect themselves as this first post-pandemic flu and pneumonia season 

approaches. Eighty percent of the deaths during the pandemic were older Americans over the 

age of 65. We can’t let them again bear so heavy a burden. We, and by that I mean we older 

Americans, lead the country in protecting ourselves from COVID, as those 65 and older have 

the highest rate of vaccination among all age groups, with 89% having received at least one 

dose compared with 68% for people ages 18 to 64. We understand the risks and we can and do 

make carefully thought out decisions to protect ourselves. What we need is access as quickly as 

possible to preventive measures that make a difference. There are now two FDA-approved

vaccines that offer greater protection against pneumonia. We need your help in making them 

available to us now. This fall, as the normal vaccination period begins, and with a threat of an 

intense flu season, seniors will need every tool available to keep themselves healthy. It would 

be disappointing if the availability of these new medicines was hindered in any way. As shown 

during COVID, we know that when necessary, this committee can move quickly. I think this is 

one of those times that requires prompt attention. Every scientific advancement in vaccines 
ACIP Meeting Summary July 22, 2021

14

saves lives, so I urge the committee to expedite the review and approval of these new vaccines 

to further empower our generation with the medicines we need to protect ourselves.

Robert Mnookin, LLB

Professor, Harvard Law School

I’m Robert Mnookin, a Law Professor at Harvard. Last December, because I had end-stage 

kidney disease, my daughter Jennifer Mnookin lovingly donated a kidney for me at UCLA. Her 

kidney was flown on the red-eye to Boston and was transplanted into me at Mass General. The 

good news is my kidney function is now in the normal range. The bad news is that the powerful 

immunosuppressant drugs I take to prevent organ rejection make me not only more susceptible 

to infections of all kinds, including COVID-19, but less likely to be protected by the standard 

vaccination protocol. Like many transplant recipients, my two shots of Pfizer provided me with 

no antibody protection against COVID-19. A spike antibody test shows my antibody level at

zero—completely undetectable. I know, and you know, that an additional shot might provide lifesaving protection for people like me with little risk, yet I and people in my position currently can’t 

get authorized access to a third shot, even if our physician’s clinical judgment favors it. In the 

broader debate concerning the wisdom of boosters for the general population, your committee 

must persuade the CDC to stop ignoring the critical special needs of organ transplant patients 

and others who are immunocompromised and allow access to a third shot now. My situation is 

not unusual. A Johns Hopkins study of transplant recipients and other immunocompromised 

individuals showed that nearly half had no immune response to their vaccines. A third shot 

would likely make a meaningful difference for many of us. A French study reported in the New 

England Journal of Medicine showed that among the 59 patients who lacked antibody response, 

after two shots, 44%, nearly half, developed antibodies with a third shot with no serious adverse 

events. An observational study from Johns Hopkins had similar results. Other nations—France, 

Israel and Great Britain—are taking action now to promote boosters for transplant recipients and 

the immunocompromised. And, yet, when I asked my doctors about getting a third shot, they

told me that they currently lacked any authority to recommend it or provide access. I understand 

how dangerous COVID could be for me. An Israeli study showed that 40% of severe vaccine 

breakthrough cases in the hospital were among immunocompromised people, and the Delta 

variant is making this situation worse. As breakthrough cases become more common, people 

like me aren’t protected, even if we carefully limit our interaction to vaccinated people. This 

situation needs to change. Your committee must tell the CDC not to ignore the special needs of 

immunocompromised people. Please show the leadership and the compassion necessary to 

recognize the scientific and moral imperative allowing a third shot to this group now. Encourage 

the CDC to follow the French, Israeli, and British example and explicitly recommend that the 

United States permit a booster for this population.

Mr. Mark Gibbons

President and CEO

RetireSafe

Good afternoon. This is Mark Gibbons. I’m President and CEO of RetireSafe. Thank you, 

committee, for allowing me to speak. RetireSafe is an organization whose mission is to educate

and advocate on behalf of older Americans on issues including Social Security, Medicare,

health, safe retirement, and financial well-being. Currently, there are nearly 70 million 

Americans over the age of 60. Due to immune system decline as part of aging, as well as the 

prevalence of chronic disease comorbidities, many of them are particularly vulnerable to

infectious diseases such as influenza, pneumococcal pneumonia, and of course, COVID-19.

Vaccines for these and other conditions can truly be a matter of life or death, and we are 
ACIP Meeting Summary July 22, 2021

15

grateful for the continued work by ACIP to evaluate and improve critical vaccines for COVID-19.

While we are encouraged by the progress made towards vaccinating older Americans against 

COVID-19, we are increasingly concerned that experts are predicting the flu and pneumonia 

season to be more serious than last year now that states across the country are relaxing 

COVID-19 restrictions. In the US, it is estimated that more than 150,000 hospitalizations from 

pneumococcal pneumonia occur each year, and about 5% to 7% of those who are hospitalized 

from it will die. The death rate is even higher in those age 65 years and older due to the strength 

of the body’s immune system declining over time. Given this increased vulnerability and in light

of encouraging news that the FDA has recently approved two new and improved vaccines for 

pneumonia, we are particularly focused on what is being done to ensure we are doing 

everything possible to protect American seniors. Will seniors have access to the best available 

vaccines to ensure they are as protected as possible? These new vaccines offer hope and even 

greater protection against life threatening disease for some of the most vulnerable in our 

population. They only have to have access to them. We urge ACIP to consider expediting the 

vote on these vaccines ahead of the upcoming October meeting to ensure the broadest 

availability possible for America’s seniors ahead of this year’s flu pneumonia season.

Thank you very much.

Ms. Claire Hannan 

Association of Immunization Managers

I’m Claire Hannon, Executive Director of the Association of Immunization Managers. I wanted to 

take this opportunity to thank the committee for its steadfast commitment to evidence, data, and 

science. I would also like to recognize and thank the public health workers across the nation

and throughout the US territories and Pacific Island nations for their dedication in containing the 

pandemic and vaccinating the adult population. Today’s meeting of the ACIP is just one of 15

special meetings that have been conducted in addition to regularly scheduled meetings

conducted in public since the pandemic began. During these committee meetings, members 

review findings and discuss vaccine research and scientific data. The recommendations of the 

committee’s medical and public health experts guide in the use of COVID vaccine and ensure a 

vigilant watchful eye on all potential side effects. To the committee and the expert staff and 

leadership of the CDC, thank you. At the start of this pandemic, our public health workforce was 

significantly less than previous years. According to data from the Association of State and 

Territorial Health Officials, the number of public health workers went from 236,000 at the start of 

the H1N1 pandemic in 2009 to 206,000 workers at the start of the pandemic in COVID-19.

Turnover in public health is high. Of the 64 federally funded state, territorial, and large city 

immunization programs, 32 have experienced turnover with their Program Manager since 2019.

The burnout and exhaustion in public health is real. To all the public health workers, and 

especially the Immunization Program Managers, thank you. They’re working long days, nights,

and weekends to plan and implement. The vaccination campaign has resulted in much success 

and impact 68% of adults with at least one shot, 160 million people fully vaccinated, and 336 

million doses administered. Epidemiologists at Yale University estimate that New York City’s 

vaccination campaign has prevented 250,000 COVID-19 cases, 44,000 hospitalizations, and 

8300 deaths. Between January 1, 2021 and June 15, 2021, 98% of hospitalizations and 98.8% 

of deaths from COVID-19 were in those who were not fully vaccinated. So, clearly our work is 

not done. But again, I just want to say thank you to the committee and all those involved in 

these efforts. The nation is extremely grateful.
ACIP Meeting Summary July 22, 2021

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Mr. Phillip Canuto

Renal Transplant Recipient

Member, Johns Hopkins Vaccine Study

My name is Phil Canuto and I live in Akron, Ohio. My cousin gave me a kidney 19 years ago.

I’m in the Johns Hopkins Vaccine Transplant Study, and I tested negative for COVID antibodies

after both of my Pfizer jabs. I appreciate the opportunity to represent immunosuppressed

patients today. I urge you, beg you even, to recommend that we be able to receive a third

vaccine dose and to allow doctors to make an additional dosing decision on a case-by-case 

basis. When a friend got her first Pfizer shot, she cried with happiness for the freedom the shot 

offered her. But those of us who are immunosuppressed have no such freedom. Instead, we 

exist in an uncertain limbo. We’re told to behave as if we are not vaccinated. Continue to mask 

up, our doctors say. Social distance, avoid crowds, and poorly ventilated spaces. And now the 

Delta virus variant increases our risk. So what are we to do? Many of us must take risks that

could lead to exposure, illness, and death. Hundreds of us lied to pharmacies and immunization 

sites about our previous vaccinations trying to get an extra unauthorized dose. I know that’s 

what I’ll be doing if additional doses are not sanctioned. And we long for a fuller life. For me, it’s 

for family, music, and food. I can’t wait to see my stepdaughter’s new Colorado home, to hear 

Lyle Lovett live in concert, to eat a medium rare steak at the Diamond Grill. But I’m retired. I can 

control my activities. What about transplant patients who must check out groceries or manage 

an office? They have no safety net. They risk exposure every day. So please, recommend 

additional shots for us. I know even then there will be uncertainty. I know there is no guarantee 

that a third or even a fourth dose will provide us with full immunity, but I want that chance. And 

even if that extra dose doesn’t keep me from getting sick, maybe it can help me avoid a

ventilator or death. Neither Johns Hopkins nor the French have found meaningful adverse 

events in patients who have taken a third dose. So the risk of these extra shots, while not 

nothing, seems very, very small. But the benefit could open up the world to us again. Thank you 

for this opportunity to speak.

Mrs. Erica DeWald

Director, Strategic Communications and Partnerships

Vaccinate Your Family

Thank you for the opportunity to comment. My name is Erica DeWald. I am Director of Strategic 

Communications and Partnerships for Vaccinate Your Family, a national nonprofit organization 

committed to protecting people of all ages from vaccine-preventable diseases. I’m also a mother 

and a daughter who has celebrated each and every age expansion for the COVID-19 vaccine.

I’m hopeful I’ll be able to protect my two young children against this really devastating disease, 

as we’ve heard in these comments thus far, in the near future. Our organization deeply

appreciates the work of this committee. Your careful deliberations this morning show firsthand 

how carefully you consider even the rarest safety signal for all vaccines, not just COVID-19.

Transparency is key in these conversations. As you all know, risk-benefit is a difficult calculation

for many of us to make, especially when it’s regarding our own health and that of our loved

ones. The information you share, particularly in plain terminology, helps all of us better

communicate the risk benefit of vaccines versus the diseases they prevent when speaking to 

the public. And I would like to take this opportunity to remind you that the public overwhelmingly 

supports vaccines. The proof is in the 160 million people in the US now fully vaccinated against 

COVID-19. In fact, trust in vaccines increased after the FDA, ACIP, and CDC worked together 

to investigate concerns about low platelet counts in combination with blood clots following 

vaccination with the Janssen COVID vaccine. That interagency coordinated communication is 

key to continuing to increase confidence. But people do want more information and answers to 
ACIP Meeting Summary July 22, 2021

17

their questions. It’s critical that we direct people with questions to science-based information. My 

hope is that they will seek out reputable sources such as CDC and a trusted healthcare 

professional or advocacy organizations like my own, Vaccinate Your Family. Thank you again 

for your time today and for all you do.

Mr. Gilmore, John

Executive Director

Children’s Health Defense New York

My name is John Gilmore. I am the Executive Director of Children’s Health Defense New York.

We’re an advocacy organization working on a wide range of issues affecting the health and 

well-being of children, including vaccine rights and vaccine policy. I also lost my mother to 

COVID last year when she contracted it in her nursing home here in New York, so this is an 

issue I take very seriously. My comment today is that the identification of Guillain-Barré

syndrome as an injury associated with the Johnson & Johnson COVID shot following so closely

on the discovery of the association with myocarditis after millions of doses have been 

administered underscores how little we really know about the potential side effects not only of 

the Johnson & Johnson product, but also the COVID products currently used in the United 

States. This lack of knowledge is exactly why these products are only available under an

Emergency Use Authorization. This lack of knowledge about both immediate and long-term 

impacts of these products screams for caution and prudence in the use of these products. In 

light of our lack of information, in combination of the Countermeasures Injury Compensation 

Program placing the overwhelming burden of risk upon the person receiving the shot, we 

believe it is incumbent upon the ACIP to reject any measures to coerce compliance with 

compulsory vaccination measures by both public and private actors. A person receiving the shot 

should make this decision based on their own evaluation of the risks and benefits of doing so.

These decisions should be made for minor children only by their parents and no one else. Now

some states on a related issue are citing the lack of knowledge about these products and the

lack of guidance from ACIP as a reason to disallow any medical exemptions written by the 

patient’s own treating physicians. I have already encountered personally several instances of 

these refusals in New York, and I’m sure they are occurring elsewhere. Consequently, I believe 

the ACIP should issue a policy when it comes to the medical exemptions deferring to the 

opinion of the treating physician in all instances, especially given our lack of information that we 

have right now. So, thank you for the opportunity to speak today. Have a good day.

COVID-19 Vaccines: Benefit-Risk Discussion

Dr. Hannah Rosenblum (CDC/NCIRD) reminded everyone that the current COVID-19 mRNA 

vaccine policy is that COVID-19 vaccines are recommended for persons 12 years of age and 

older in the US under FDA’s EUA. This presentation focused on the risks and benefits of the 3 

COVID-19 vaccines recommended for persons aged 18 and older in the US. First to frame this 

presentation, the goal of this analysis was to assess the benefit/risk balance of the Janssen 

vaccine given recent reports of GBS in vaccine recipients. The previously presented analyses 

for TTS and Janssen vaccine and myocarditis and mRNA vaccines were updated so that the 

benefit/risks of COVID-19 vaccines could be assessed and discussed comprehensively.
ACIP Meeting Summary July 22, 2021

18

Since January 2020, there have been more than 33 million cases of COVID-19. Overall, these 

have been declining since January 2021. While this past Spring the number of COVID-19 cases 

was decreasing, the end of June appears to have been a nadir in the US. Over the last few 

weeks, the number of cases has begun to rise. For the benefit-risk assessment, case incidents 

and hospitalization rates were used from the week ending June 19th. Because that may 

represent the trough for COVID-19 cases, these estimates should be interpreted in the context 

of this trend.14 The CDC’s forecast of new COVID-19 cases through August 14, 2021 and new 

COVID-19 hospitalizations forecasted through August 16, 2021 predict that the number of daily 

COVID-19 cases and hospital admissions likely will increase.15 NOWCAST projections of the 

proportions of circulating SARS-CoV-2 variants from CDC’s COVID Data Tracker provide timely 

estimates while accounting for limited sequence data availability. Based on recent NOWCAST 

data for the most recent week through July 17th, the Delta variant comprises the largest 

proportion at more than 80%.16

Turning to the potential harms following COVID-19 vaccine, a greater than expected number of 

cases of GBS, a rare neurological disorder, have been reported following Janssen vaccine.

These have been within 2 weeks of vaccination, mostly in males, and in those aged 50 and 

older. TTS, a rare but clinically serious AE, also has been observed following Janssen vaccine.

Most cases of TTS have been in females 18-49 years of age. ACIP is familiar with the TTS 

benefit/risk balance assessment, discussions from April after the pause, and the ultimate 

resumption of vaccine administration when benefits were felt to outweigh risks. Myocarditis is 

also rare, but has been observed following mRNA vaccination. This has been commonly 

observed in young males under 30 years of age and more frequently after the second dose. The 

benefit/risk balance for adolescents and young adults was presented recently to ACIP. The 

focus of this session’s presentation was on adults 18 years of age and older.

In summary, while overall COVID-19 incidence has been decreasing, the US may have reached 

a low point in June. The US has begun to see cases and hospitalizations rising in recent weeks.

Variants of concern (VOC) continue to spread, with the Delta variant currently found in more 

than 80% of US cases. The rare AEs of TTS and GBS for Janssen vaccine and myocarditis for 

m/RNA vaccines have been observed after COVID-19 vaccination.

Moving to the benefits and harms analysis for Janssen COVID-19 vaccine, a similar direct 

estimation approach was used as the one used in April for TTS and recently for myocarditis to 

estimate the direct benefits and risks of Janssen vaccination. The benefits included estimation 

of COVID-19 cases, hospitalizations, ICU admissions, and deaths prevented per 1 million doses

of Janssen vaccine. These calculations were based on the most recent age- and sex-specific 

incidence of hospitalizations from COVID-NET ending the week of June 19th, vaccine efficacy

(VE) against hospitalization, and symptomatic COVID-19 from the Phase 3 trial and assumed a 

120-day period of not being vaccinated. The potential harms of the Janssen vaccine also were 

estimated per 1 million doses by age and sex using GBS cases from VAERS through June 30, 

2021. The same was estimated for TTS using VAERS data through July 8, 2021.

14 https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases from July 21, 2021 

15 https://www.cdc.gov/coronavirus/2019-ncov/science/forecasting/forecasts-cases.html; https://www.cdc.gov/coronavirus/2019-

ncov/science/forecasting/hospitalizations-forecasts.html

16 https://covid.cdc.gov/covid-data-tracker/#variant-proportions
ACIP Meeting Summary July 22, 2021

19

For benefits, in the Phase 3 clinical trial, the Janssen vaccine was found to have an overall 

efficacy of 66% against symptomatic laboratory-confirmed COVID-19. VE against hospitalization 

was 93%. VE against deaths due to COVID-19 was 100%. Both persistence of antibody 

response following vaccination and activity against a variety of variants, including the Delta 

variant, have recently been shown.17 In terms of the cases of GBS reported to VAERS following 

Janssen vaccine by sex and age group, over 12 million doses had been administered and 98 

cases with age and sex information had been reported to VAERS as of June 30, 2021. Cases 

were greatest among males 50-64 years of age, with a reporting rate of 15.6 per million doses.18

As of July 8, 2021, there have been 38 cases of confirmed TTS reported following receipt of 

Janssen COVID-19 vaccine. Cases were greatest among females 30-49 years of age, with a 

reporting rate of 8.8 per million doses.

Now turning to the predicted cases of COVID-19 hospitalizations, ICU admissions, and deaths

that are prevented compared to the estimated number of GBS and TTF cases for every million 

Janssen doses over 120 days by age group and sex. For females 18 to 29 years of age, it is 

estimated that for every million doses, 8900 cases of COVID-19, 700 hospitalizations, 50 ICU 

admissions, and 5 deaths would be prevented and 1 GBS case cases might be seen. For males 

aged 18 to 29 years, it is estimated that 6600 cases of COVID-19, 300 hospitalizations, 60 ICU 

admissions, and 3 deaths would be prevented and 2 GBS cases might be seen. For females 30-

49 years of age, it is estimated that 10,100 COVID-19 cases, 900 hospitalizations, 140 ICU 

admissions, and 20 deaths would be prevented and 6-7 GBS cases and 8-10 TTS cases might 

be seen. For males 30-49 years of age, it is estimated that 7600 COVID-19 cases, 650

hospitalizations, 150 ICU admissions, and 25 deaths would be prevented and 7-8 GBS cases 

and 1-2 TTS cases might be seen.

For individuals 50-64 years of age, the benefit risk balance is even more favorable with still 

more COVID-19 outcomes prevented compared to GBS and TTS cases. For females in this age 

group, it is estimated that 29,000 COVID-19 cases, 5900 hospitalizations, 1250 ICU admissions, 

and 840 deaths would be prevented and 8-10 GBS cases and 0 TTS cases might be seen. For 

males in this group, it is estimated that 36,600 COVID-19 cases, 11,800 hospitalizations, 3300

ICU admissions, and 2300 deaths would be prevented and 7-8 GBS cases and 0 TTS cases 

might be seen.

The same direct estimation approach is used to estimate the benefits and risks per million 

doses of mRNA vaccine. Benefits were again estimated to include COVID-19 cases,

hospitalizations, ICU admissions, and deaths prevented. Calculations were based on the most 

recent age- and sex-specific incidence of hospitalizations from COVID-NET ending the week of 

June 19th, as well as mRNA vaccine efficacy observed in Phase 3 trials, and also using a 120-

day period. Potential harms of the mRNA vaccines have been estimated per million doses by 

age and sex using various data through June 30th. The Phase 3 clinical trials for Pfizer and 

Moderna mRNA vaccines showed overall efficacy of 94%-95%, with VE against COVID-19 

hospitalization of 89%-100%.19 Persistence of antibody response and activity against a variety

of variants were also noted for mRNA vaccines and were demonstrated for several months.20

17 https://www.nejm.org/doi/full/10.1056/NEJMc2108829?query=featured_home

18 Source of doses administered: FDA, through June 30, 2021

19 Polack FP et al. N Engl J Med 2020; DOI: 10.1056/NEJMoa2034577; Frenck RW et al. N Engl J Med 2021; DOI: 

10.1056/NEJMoa2107456; Baden LR et al. N Engl J Med 2021; DOI: 10.1056/NEJMoa2035389

20 https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html
ACIP Meeting Summary July 22, 2021

20

As of June 30th, there have been about 141 million second mRNA vaccine doses administered21

and 497 cases of myocarditis reported following the second dose. The greatest number of 

cases has been observed in persons 18-29 years of age, with a reporting rate of 24.3 per million 

doses. For females 18-29 years of age it was estimated that 12,800 COVID-19 cases, 750 

hospitalizations, 50 ICU admissions, and 5 deaths would be prevented and 3-4 myocarditis 

cases might be seen. For males 18-29 year of age it was estimated that 9600 COVID-19 cases, 

300 hospitalizations, 60 ICU admissions, and 3 deaths would be prevented and 22-27 

myocarditis cases might be seen. For females 30-49 years of age it was estimated that 14,600 

COVID-19 cases, 950 hospitalizations, 140 ICU admissions, and 20 deaths would be prevented 

and 1-2 myocarditis cases might be seen. For males 30-49 years of age it was estimated that 

11,000 COVID-19 cases, 700 hospitalizations, 160 ICU admissions, and 24 deaths would be 

prevented and 5-6 myocarditis cases might be seen.

For females 50-64 years of age, it is estimated that 17,500 COVID-19 cases, 1700 

hospitalizations, 375 ICU admissions, and 125 deaths would be prevented and 1 myocarditis 

case might be seen. For males in this group, it is estimated that 14,700 COVID-19 cases, 1900 

hospitalizations, 500 ICU admissions, and 150 deaths would be prevented and 1 case of 

myocarditis might be seen. For females 65+ years of age, it is estimated that 32,000 COVID-19 

cases, 6200 hospitalizations, 1300 ICU admissions, and 900 deaths would be prevented and 

less than 1 myocarditis case might be seen. For males in this group, it is estimated that 52,700 

COVID-19 cases, 12,500 hospitalizations, 3500 ICU admissions, and 2400 deaths would be 

prevented and less than 1 case of myocarditis might be seen.

To summarize the overall reporting rates for these rare AEs, 3 cases of TTS have been 

observed per million Jensen doses among all adults. For GBS, 7.8 cases per million doses of 

Janssen vaccine have been reported. For myocarditis, 3.5 cases per million doses of mRNA 

vaccine have been reported. There are some limitations of the benefit-risk estimates. The model 

likely underestimates benefits for a few reasons. First, cases in general may be underreported 

and COVID-NET might not capture all COVID-19-associated hospitalizations. The model uses 

case incidence and hospitalizations from a snapshot in time and does not account for rising 

case counts. Second, these benefits are estimated over 120 days following vaccination, but 

protection from vaccination likely lasts longer. Third, the prevention of post-COVID-19 

conditions is not accounted for. A few additional limitations to mention are that some of the 

hospitalizations used might be related to diagnoses other than COVID-19. The VE used was 

from clinical trials because there are limited data about real-world efficacy for input. Certain 

estimates for harms were from crude numbers of AEs reported to VAERS, which is a passive 

surveillance system. Not all events that are reported following vaccination have been confirmed 

to meet case definitions.

In terms of the benefit-risk interpretation and summary, this direct approach benefit-risk 

assessment for Janssen vaccine and similar direct benefit-risk assessment for mRNA vaccines 

each considers individual benefits of vaccination versus individual risks, which can help inform 

policy. Each shows a balance of benefits that far outweighs potential risks. As described, this 

relative balance of benefits and risks for individuals varies by age and by sex.

21 Source of doses administered: https://covid.cdc.gov/covid-data-tracker/#vaccinations; some age- and sex-specific doses

administered data were imputed
ACIP Meeting Summary July 22, 2021

21

Work Group Interpretation and Next Steps

Dr. Sarah Mbaeyi (CDC/NCIRD) presented the COVID-19 Vaccine WG’s interpretation of the 

benefits and risks of COVID-19 vaccines. After a period of decline, COVID-19 cases are rising 

again. This is fueled by the spread of the highly transmissible Delta variant, which now accounts 

for 83% of US cases. Over two-thirds of US adults have received at least one COVID-19 

vaccine dose, and approximately 60% are fully vaccinated.22 However, coverage varies in the 

population by age, geographic location, race, and ethnicity, among other factors. At the local 

level, low vaccination coverage places individuals and communities at risk. Hotspots have 

emerged in areas where vaccination coverage is lagging.23 mRNA vaccines account for the 

majority of the over 338 million COVID-19 vaccine doses administered in the US to date.

Janssen accounts for 4% of doses administered, which remained consistent before the April 

pause.24

However, willingness to receive Janssen vaccine remains lower since the April pause. Among 

people who have not yet received a COVID-19 vaccine but plan to get one, 26% said they 

would be willing to get a Janssen vaccine. To inform ACIP discussions, CDC conducted a 

survey of jurisdictions to better understand the current use of Janssen vaccine and how it 

relates to patient choice, access, and vaccine equity at the state and local levels. Eighty-three 

percent of jurisdictions reported that most vaccination sites offer more than one type of vaccine 

at that site, which helps to ensure that patients have a choice in vaccine product. In addition, 

Janssen vaccine is used in a variety of populations and settings including in rural populations, 

mobile clinics, corrections populations, persons experiencing homelessness, primary care 

provider offices, among college students, and among other groups.

25 Thus, Janssen vaccine 

likely remains important for reaching disproportionately affected populations and for achieving 

vaccine equity.

The benefits of the currently authorized COVID-19 vaccines are unequivocal. All of the vaccines 

are effective against COVID-19, including serious outcomes like severe disease, hospitalization, 

and death. Available evidence also suggests that currently authorized vaccines offer protection

against known circulating variants, including the Delta variant. A growing body of evidence

indicates that people fully vaccinated with an mRNA vaccine are less likely to have symptomatic 

infection or to transmit SARS-CoV-2 to others.26 However, rare SAEs have been reported after 

vaccination, including TTS and GBS after Janssen vaccination and myocarditis after mRNA 

vaccination. While rare but potentially serious risks of COVID-19 vaccines have been reported,

the updated benefits/risk evaluation that Dr. Rosenblum presented continues to show that the 

benefits of vaccination outweigh these risks across vaccine types, age, and sex. The model 

demonstrates that for every million doses of vaccine administered, thousands of

hospitalizations, ICU admissions, and deaths can be prevented.

22 As of July 21, 2021 https://covid.cdc.gov/covid-data-tracker/#vaccinations

23 https://www.cdc.gov/coronavirus/2019-ncov/images/communication/covid-data 

tracker/Vaccinations_By_Case_Rate_FINAL_07072021.pdf

24 As of July 21, 2021. https://covid.cdc.gov/covid-data-tracker/#vaccinations

25 Source: CDC Jurisdictional Pulse Survey 07/16-2021 1700, N=40 

26 https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html; Nasreen S, et al. "Effectiveness 

of COVID-19 vaccines against variants of concern, Canada." medRxiv (2021); Stowe J, et al. ”Effectiveness of COVID-19 vaccines 

against hospital admission with the Delta (B.1.617.2) variant.” Public Health England. 2021; Sheikh A, et al. "SARS-CoV-2 Delta 

VOC in Scotland: demographics, risk of hospital admission, and vaccine effectiveness." The Lancet (2021).
ACIP Meeting Summary July 22, 2021

22

Taken together, the WG’s interpretation was that vaccination continues to be critical during this

period of rapidly increasing cases and spread of variants of concern. The reported AEs of TTS, 

GBS, and myocarditis are potentially serious and should be communicated transparently with 

the public. Even with the new GBS safety signal, the benefits of vaccination of Janssen 

vaccination continue to outweigh the risks. In addition to the benefit-risk profile, the WG 

discussed the importance of patient choice in vaccine product, access to vaccines for 

disproportionately affected populations, confidence in patients and providers to understand the 

benefits and risks of vaccines and to make informed decisions, the need for communication and 

educational materials around these rare risks, and the implications of any change in vaccine 

recommendations on global vaccine confidence and use.

The WG reaffirmed that all eligible persons should receive a COVID-19 vaccine. Patients and 

providers should be aware of both the benefits and risks of COVID-19 vaccination when 

choosing a vaccine product. The WG expressed strong support for the continued use of 

Janssen vaccine according to the current recommendations. The WG also emphasized the 

importance of clinical education and communication materials to help support patient-provider 

decision-making. CDC will be updating its clinical considerations27 to state that persons with a 

prior history of GBS can receive any of the authorized vaccines. However, given the possible 

association between Janssen vaccine and GBS, patients with a history of GBS and their clinical 

team should discuss the availability of mRNA vaccines to offer protection against COVID-19.

The clinical considerations also will provide information on GBS signs and symptoms and when 

to seek care. CDC also will be updating other clinical resources and tools, such as the standing 

orders and pre-vaccination checklists. In addition, CDC will be updating some of its 

communication materials, including information for providers on talking to patients about 

Janssen vaccine safety and updated frequently asked questions.

The following questions were posed for ACIP consideration and deliberation:

1. What is the ACIP’s interpretation of the benefits and risks of COVID-19 vaccines?

2. Does ACIP agree with the WG’s interpretation that Janssen COVID-19 Vaccine should 

continue to be used according to the current recommendations?

Data and Clinical Considerations for Additional Doses in Immunocompromised

Dr. Sara Oliver (CDC/NCIR) reviewed the COVID19 Vaccine WG’s response to COVID-19 

vaccine response among immunocompromised people, response to an additional dose of 

COVID-19 vaccine among immunocompromised people, and frequently asked questions about 

vaccination in this population. In terms of the process for additional doses in any population, 

there first would be a review of the data to assess the safety, immunogenicity, and 

implementation of any updated guidance or recommendation. Then there would be regulatory 

allowance by FDA. There are a variety of mechanisms by which this could occur. For example, 

one way is an EUA amendment that would allow for recommendations under EUA. Another 

possibility is a Biologics License Application (BLA), which would allow for ACIP to make off-label 

recommendations as is done for a variety of other vaccines. Once there is regulatory allowance,

CDC or ACIP could have a clinical update with clinical considerations or recommendations for 

use.

27 Updates will be posted at: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html
ACIP Meeting Summary July 22, 2021

23

It has been estimated that immunocompromised people comprise approximately 2.7% of US 

adults.

28 This includes people with solid tumor and hematologic malignancies; receipt of solidorgan or hematopoietic stem cell transplantation (HSCT); severe primary immunodeficiencies; 

persons living with human immunodeficiency viruses (HIV); and treatment with

immunosuppressive medications such as cancer chemotherapeuticagents, TNF blockers, 

certain biologic agents (e.g., rituximab), and high-dose corticosteroids.

Data from the pandemic also show that immunocompromised persons are more likely to get 

severely ill from COVID. They also are at higher risk for prolonged SARS-CoV-2 infection and 

shedding, viral evolution during infection and treatment, and low antibody titers to SARS-CoV-2 

variants. In addition, they may be more likely to transmit SARS-CoV-2 to household contacts.

Recent studies have demonstrated a higher proportion of vaccine breakthrough cases that 

occur among immunocompromised people. In one US study, 44% of hospitalized breakthrough 

cases were immunocompromised. This was 40% in an Israeli study.29

To summarize the VE studies among immunocompromised persons for mRNA vaccines, one 

study30 evaluated VE 7-27 days after a second dose of the Pfizer-BioNTech vaccine. This study 

found 71% VE against SARS-CoV-2 infection compared to 90% overall. VE was slightly higher 

at 75% protection against symptomatic COVID. Another study31 at least 7 days after a second 

mRNA dose found 80% VE against SARS-CoV-2 infection among people with inflammatory 

bowel disease (IBD) on immunosuppressive medications. This study also found that VE was 

quite low at 25% after the first dose. Another study32 evaluating VE at least 14 days after the 

second mRNA vaccine dose found 59% VE against COVID hospitalization from 14 days after 

the second dose among immunocompromised persons compared to 91% among those without 

a documented immunocompromising condition. It was this specific hospitalized cohort where 

44% of breakthrough cases had a solid or hematologic malignancy or a history of a solid-organ

transplant. The percent of subjects with antibody response after two mRNA vaccine doses by 

immunocompromising condition and study was updated with additional studies since the last

ACIP meeting. Hemodialysis patients have the highest proportion with an antibody response, 

while those who have a history of organ transplant have the lowest percent response. In 

general, studies that were able to compare response after Dose 1 and Dose 2 compared poor 

response to Dose 1.33

Moving to the emerging data on response to an additional dose of a COVID-19 vaccine in 

immunocompromised people, 4 studies looked at the antibody response in

immunocompromised populations. The optimal data in this situation would be to have clinical 

VE documenting protection against infection or illness. However, in many circumstances there 

are data only on antibody response. While it may not tell the full story, something can be 

learned from these data. While many of these studies have small numbers, among those who 

had no antibody response to an initial mRNA series, 33%-50% did develop a detectible antibody 

response to an additional dose.34

28 Harpaz et al. Prevalence of Immunosuppression Among U.S. Adults, 2013. JAMA 2016

29 See references for slide 7 at the end of Dr. Oliver’s slide set

30 Chodick et al. Clinical Infectious Diseases, ciab438, https://doi.org/10.1093/cid/ciab438

31 Khan et al. Gastroenterology (2021). https://www.gastrojournal.org/article/S0016-5085(21)03066-3/pdf

32 Tenforde et al. medRxiv preprint: https://doi.org/10.1101/2021.07.08.21259776

33 See reference list for slide 9 at the end of Dr. Oliver’s slide set

34 See references list for slide 11 at the end of Dr. Oliver’s slide set
ACIP Meeting Summary July 22, 2021

24

Looking more closely at the Kamar study35 of Anti-SARS-CoV-2 antibodies before each dose 

and one month after the third dose in a study population of solid-organ transplant recipients, the 

prevalence of Anti-SARS-CoV-2 antibodies was 40% before the third dose and 68% overall 4 

weeks after the third dose. Looking only at patients who had been seronegative before the third

dose, 44% were seropositive at four weeks after the third dose. In addition, no SAEs were 

reported after the administration of the third dose and no acute rejection episodes occurred.

Looking more closely at the Maxime study36 on the reactogenicity of a third mRNA vaccine dose 

in a cohort of patients on hemodialysis, no patients developed side effects that required 

hospitalization. Symptoms reported after the third dose were consistent with what has been 

seen after the second dose. Most symptoms were mild or moderate.

Internationally, several countries have commented on policies for additional doses for 

immunocompromised individuals. France37 has recommended that a third dose 4 weeks after 

the second dose be given for patients who are severely immunocompromised. The UK38 has a 

proposal for additional doses of COVID vaccine for immunocompromised people 16 years and 

older, but a formal recommendation and decision are pending. Israel39 announced a policy

recently for an additional dose for people living with organ or stem cell transplants, blood 

cancer, autoimmune disease, and treatment with specific immunosuppressive medications.

In summary, immunocompromised people are at an increased risk of poor outcomes from 

COVID. Studies indicate a reduced antibody response in immunocompromised people following 

a primary vaccine series compared to healthy vaccine recipients. Emerging data suggest that an 

additional COVID-19 vaccine dose in immunocompromised people may enhance antibody

response in some and increase the proportion who respond. In small studies, the reactogenicity 

of a third dose of mRNA vaccine was similar to prior doses.

Now moving to frequently asked questions about vaccination of immunocompromised people. In 

terms of which immunocompromised groups should be considered for an additional dose once 

allowed by regulatory mechanisms, it is likely that the most benefit would be focusing on 

conditions and treatment associated with moderate to severe immunocompromise. This would 

include those on active or recent treatment for solid tumor and hematologic malignancies; 

receipt of a solid-organ or recent stem cell transplant; severe primary immunodeficiency; 

advanced or untreated HIV; and treatment with immunosuppressive medications such as cancer 

chemotherapeutic agents, TNF blockers, certain biologic agents (e.g., rituximab), and high-dose 

corticosteroids. There are chronic conditions associated with varying degrees of immune deficit, 

such as asplenia and chronic renal disease. Different medical conditions and treatments can 

result in varying degrees of immunosuppression. A patient’s clinical team may be able to assess 

the degree of altered immunocompetence and optimal timing of vaccination.

In terms of whether immunocompromised people should undergo antibody testing following 

COVID-19 vaccination, the utility of serologic testing or cellular immune testing to assess 

immune response to COVID vaccination has not been established. The exact correlation 

between antibody level and protection from COVID remains unclear. In addition, commercial 

antibody and cellular immune testing may not be consistent across laboratories. For all of these 

reasons, serologic (antibody) testing or cellular immune testing to assess response to

35 Kamar et al. (2021) NEJM Three Doses of an mRNA Covid-19 Vaccine in Solid-Organ Transplant Recipients (nejm.org)

36 Maxime et al. (2021) medRxiv doi: https://doi.org/10.1101/2021.07.02.21259913

37 dgs_urgent_n43_vaccination_modalites_d_administration_des_rappels.pdf (solidarites-sante.gouv.fr)

38 C1327-covid-19-vaccination-autumn-winter-phadvicease-3-planning.pdf 

39 https://govextra.gov.il/media/30095/meeting-summary-15122020.pdf
ACIP Meeting Summary July 22, 2021

25

vaccination outside of the context of research studies is not recommended in the US at this 

time.

Regarding whether there are data to support a mixed-dose series in immunocompromised 

people, such as a Janssen vaccine followed by an mRNA COVID vaccine, studies in Europe40

have assessed heterologous primary series, specifically an AZ and a Pfizer vaccine, in the 

general adult population and found immunogenicity to be at least equivalent to a homologous 

series. A large UK trial, the Com-COV study, found that 1 dose of AZ plus 1 dose of Pfizer 

resulted in superior immunogenicity compared with 2 doses of an AZ vaccine, but lower 

antibodies than 2 doses of Pfizer. In addition, an increase in systemic reactogenicity was 

observed with heterologous schedules. However, evidence is needed regarding the safety and 

immunogenicity using a mixed-dose approach with mRNA vaccines and a Janssen vaccine in 

immunocompromised persons.

With regard to what infection prevention measures should be maintained following COVID 

vaccination, immunocompromised people should be counselled about the potential for a 

reduced immune response to COVID vaccination and the need to continue to follow prevention 

measures,41 such as wearing a mask, social distancing, and avoiding crowds. Given that less 

than half of the immunocompromised persons had a detectible antibody response after an 

additional dose, these measures should be maintained for immunocompromised persons even if 

additional doses are given. Close contacts of immunocompromised people should be

encouraged to be vaccinated against COVID.

With respect to whether there is a role for monoclonal antibody use in immunocompromised 

people, monoclonal antibodies are currently authorized by FDA for emergency use in persons 

with SARS-CoV-2 infection who are at high risk for progressing to severe COVID and

hospitalization. While monoclonal antibodies are not yet authorized for SARS-CoV-2 infection, 

studies are underway.

With regard to the implications for an EUA of the COVID vaccines with respect to considerations 

for additional doses in immunocompromised persons, the FDA has authorized mRNA vaccines 

as a 2-dose series and Janssen COVID vaccines as a single dose. At this time, no data have 

been submitted to the FDA to support amendments to the EUA for this population. However, 

CDC and ACIP will closely monitor for any updates to the data and to regulatory mechanisms.

Meanwhile, immunocompromised people should continue to follow infection prevention

measures. Close contacts who are of age to be vaccinated should be vaccinated against

COVID-19 to protect their immunocompromised friends and family. Early treatment with

monoclonal antibodies may be beneficial in this population as well.

In terms of next steps, the WG will continue to assess additional studies of safety and 

immunogenicity of additional doses in immunocompromised people; assess additional studies

and expert opinion regarding subpopulations of immunocompromised people who may benefit 

the most from an additional dose; determine acceptable intervals, as well as mix-and-match 

schedules; and await all of the data that can support a regulatory allowance, which could 

40 1) Borobia et al. Reactogenicity and Immunogenicity of BNT162b2 in Subjects Having Received a First Dose of ChAdOx1s: Initial

Results of a Randomized, Adaptive, Phase 2 Trial (CombiVacS). Available at SSRN: https://ssrn.com/abstract=3854768; 2) Shaw 

et al. Heterologous prime-boost COVID-19 vaccination: initial reactogenicity data, ISSN 0140-6736, 

https://doi.org/10.1016/S0140-6736(21)01115-6; 3) Hillus et al. Safety, reactogenicity, and immunogenicity of homologous and 

heterologous prime-boost immunization with ChAdOx1-nCoV19 and BNT162b2: a prospective cohort study. medRxiv; 2021. DOI: 

10.1101/2021.05.19.21257334; 4) Schmidt et al. medRxiv preprint (June 15 2021): https://doi.org/10.1101/2021.06.13.21258859 

Click to add text; 5) Liu et al. Lancet preprint (June 25, 2021): http://dx.doi.org/10.2139/ssrn.3874014

41 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html
ACIP Meeting Summary July 22, 2021

26

possibly include an FDA amendment of the EUA or a BLA for additional doses of COVID-19 

vaccines.

The WG posed the following questions for ACIP to consider and deliberate:

1. What additional data does ACIP need to inform these discussions?

2. Thoughts on the focus of “moderate to severe” immunocompromised populations, once 

authorized/approved?

Summary of Discussion (Rosenblum, Mbaeyi, & Oliver) 

• ACIP expressed interest in information on the following with respect to additional data 

needed and the focus of “moderate to severe” immunocompromised populations:

➢ Whether immune compromised people who do not respond to the initial 2-dose 

series followed by a third dose should receive a fourth dose

➢ Length of time after receipt of monoclonal antibody administration before receipt of a 

vaccine, with the understanding that the type of immunocompromise, degree, and 

underpinnings differ

➢ Potential implications of giving a third dose to people who have high antibody levels 

(e.g., perhaps myopericarditis is the result of making too much spike protein 

antibody, maybe hemodialysis patients do not need a third dose given their robust 

antibody response)

➢ The possibility of offering a third dose to immunocompromised individuals through a 

study or Investigational New Drug (IND) route for this population in order to provide 

earlier access

➢ Whether large datasets such as the VSD could be queried to find potential 

breakthrough cases among vaccinated immunocompromised individuals, 

understanding that a complicating factor is that many people seem to have gotten 

vaccinated outside of the healthcare system and that a lot of work would be required 

to ensure that the data are of high enough quality to analyze

➢ Possible safety signals for those who have obtained additional doses of vaccine in 

an unsupervised fashion

➢ Equity and the potential for some people to be left behind, in that patients who tend 

to be more educated and more empowered to take care of their own healthcare are

likely the ones getting additional doses

➢ Determining a target level antibody among immunocompromised persons

➢ Immunocompromised people are not vaccine-hesitant and already are having their 

antibodies measured on a regular basis, so this seems like a potential place for 

shared decision-making with their clinician(s), though this could prove difficult 

because the immunocompromised population is heterogenous

➢ More information on studies being planned for persons 12 to 18 years of age

➢ A better understanding of what could be done to expedite the BLA process

• In response to potential recommendation for antibody testing prior to a third dose, Dr. Oliver 

pointed out that many of the assays for COVID and spike antibody are under EUA by FDA 

as well. There is concern with the variety of cut points and thresholds across the assays. 

Without a correlative protection, it is not clear what testing positive on one test and negative 

on another test necessarily means as it relates to vaccine response, clinical protection 

against disease, or vulnerability to COVID-19. 
ACIP Meeting Summary July 22, 2021

27

• Dr. Fink, FDA, assured the ACIP voting and liaison members and the public that FDA is 

working as rapidly as possible to conduct a thorough and comprehensive review of all 

regulatory submissions for COVID-19 vaccines with the goal of ultimately approving safe 

and effective COVID-19 vaccines for use in the US. They appreciate the comments that 

have been made by committee members, liaisons, and the public about the need for better 

protection amongst immunocompromised populations. This is truly an important scientific 

issue and an important public health issue. And FDA is actively exploring all regulatory 

options for providing access to additional doses of authorized vaccines in situations where 

the data suggest that the benefits would outweigh the risks. Ultimately, FDA is a data-driven 

agency such that any regulatory action or regulatory mechanism for access would rely upon 

submission supportive data to the FDA for consideration.

• Several ACIP members and liaisons emphasized the critical importance of getting the 

unvaccinated vaccinated in order to protect those who are immunocompromised, and 

stressed that boosters alone are not likely to be sufficiently effective. While boosters are 

important, so is creating a circle of protection for individuals, their families, their friends, their 

neighbors, and their loved ones. It has been reported that 13 million doses of COVID 

vaccine are about to expire. Every day, vaccine doses are being wasted because there are 

not enough people taking advantage of getting vaccinated. Now the Delta variant is rampant 

and there are increasing rates of infection. This is a great opportunity for those who are not 

vaccinated to get vaccinated.
ACIP Meeting Summary July 22, 2021

28

CERTIFICATION

Upon reviewing the foregoing version of the July 22, 2021 ACIP meeting minutes, Dr. Jose 

Romero, ACIP Chair, certified that to the best of his knowledge, they are accurate and 

complete. His original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC.
ACIP Meeting Summary July 22, 2021

29

ACIP MEMBERSHIP ROSTER

CHAIR

ROMERO, José R, MD, FAAP 

Arkansas Secretary of Health 

Director, Arkansas Department of Health 

Professor of Pediatrics, Pediatric Infectious Diseases 

University of Arkansas for Medical Sciences 

Little Rock, Arkansas 

Term: 10/30/2018-06/30/2021 

EXECUTIVE SECRETARY

COHN, Amanda, MD 

Senior Advisor for Vaccines 

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 

BERNSTEIN, Henry, DO, MHCM, FAAP 

Professor of Pediatrics 

Zucker School of Medicine at Hofstra/Northwell 

Cohen Children’s Medical Center 

New Hyde Park, NY 

Term: 11/27/2017-06/30/2021 
ACIP Meeting Summary July 22, 2021

30

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 

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 

FREY, Sharon E, MD 

Professor and Associate Director of Clinical Research 

Clinical Director, Center for Vaccine Development 

Division of Infectious Diseases, Allergy and Immunology 

Saint Louis University Medical School 

Saint Louis, MO 

Term: 11/27/2017-06/30/2021 

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 

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: 7/1/2016 – 6/30/2021 

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 
ACIP Meeting Summary July 22, 2021

31

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
ACIP Meeting Summary July 22, 2021

32

Indian Health Service (IHS) 

WEISER, Thomas, MD, MPH 

Medical Epidemiologist 

Portland Area Indian Health Service 

Portland, OR 

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 
ACIP Meeting Summary July 22, 2021

33

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 
ACIP Meeting Summary July 22, 2021

34

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) 

FOSTER, Stephan L, PharmD CAPT 

(Ret) USPHS 

Professor, College of Pharmacy 

University of Tennessee Health Sciences Center 

Memphis, TN 

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) 

McKINNEY, W Paul, MD 

Professor and Associate Dean 

University of Louisville School of Public Health and Information Sciences

Louisville, KY 

Association of State and Territorial Health Officials (ASTHO) 

SHAH, Nirav D, MD, JD 

Director

Maine Center for Disease Control and Prevention

Augusta, ME 
ACIP Meeting Summary July 22, 2021

35

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) 

QUACH, Caroline, MD, MSc 

Pediatric Infectious Disease Specialist and Medical Microbiologist 

Medical Lead, Infection Prevention and Control Unit 

Medical Co-director – Laboratory Medicine, Optilab 

Montreal-CHUM 

Montreal, Québec, Canada 

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
ACIP Meeting Summary July 22, 2021

36

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
ACIP Meeting Summary July 22, 2021

37

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 
ACIP Meeting Summary July 22, 2021

38

ACRONYMS USED IN THE DOCUMENT

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics

ACC American College of Cardiology 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices

ACOG American College of Obstetricians and Gynecologists

ACP American College of Physicians 

AE Adverse Event

AESI Adverse Events of Special Interest 

AGS American Geriatric Society 

AHA American Heart Association 

AHIP America’s Health Insurance Plans

AIM Association of Immunization Managers 

AMA American Medical Association

AOA American Osteopathic Association 

APhA American Pharmacists Association 

APTR Association for Prevention Teaching and Research

ASTHO Association of State and Territorial Health Officers 

AZ AstraZeneca

BEST Biologics Effectiveness and Safety System 

BLA Biologics License Application

CAR-T Chimeric Antigen Receptor T-Cell Therapy

CBER Center for Biologics Evaluation and Research 

CDC Centers for Disease Control and Prevention

CISA Clinical Immunization Safety Assessment 

CMI Cell-Mediated Immunity 

CMS Center for Medicare and Medicaid Services

COD Cause of Death

COI Conflict of Interest 

COVID-19 Coronavirus Disease 2019 

CSTE Council of State and Territorial Epidemiologists 

CVST Cerebral Venous Sinus Thrombosis 

DoD Department of Defense

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs

DVRPA Division of Vaccines and Related Product Applications 

ED Emergency Department 

EHR Electronic Health Record 

ELISA Enzyme-Linked Immunosorbent 

EMA European Medicines Agency 

EtR Framework Evidence to Recommendations Framework

EUA Emergency Use Authorization 

FDA Food and Drug Administration

GBS Guillain-Barré Syndrome 

GI Gastrointestinal 

GRADE Grading of Recommendations, Assessment, Development and Evaluations
ACIP Meeting Summary July 22, 2021

39

HAN Health Alert Network 

HCP Health Care Personnel / Provider / Professional 

HCW Health Care Workers 

HHS (Department of) Health and Human Services

HIV Human Immunodeficiency Viruses 

HRSA Health Resources and Services Administration 

HSCT Hematopoietic Stem Cell Transplantation 

IBD Inflammatory Bowel Disease

ICU Intensive Care Unit 

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IM Intramuscular 

ISO Immunization Safety Office

ISTM International Society for Travel Medicine 

IVIG Intravenous Immune Globulin 

J&J Johnson & Johnson 

MASO Management Analysis and Services Office 

MedDRA Medical Dictionary for Regulatory Activities 

MIS-C Multisystem Inflammatory Syndrome in Children 

MMWR Morbidity and Mortality Weekly Report

MRI Magnetic Resonance Imaging 

mRNA Messenger Ribonucleic Acid 

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 

NIH National Institutes of Health

NMA National Medical Association 

NSAIDS Nonsteroidal Anti-Inflammatory Agents

O/E Observed-to-Expected 

PHAC Public Health Agency Canada 

PhRMA® Pharmaceutical Research and Manufacturers of America®

PI Principal Investigator

PIDS Pediatric Infectious Disease Society 

PRAC Pharmacovigilance Risk Assessment Committee 

PT Preferred Terms 

RCA Rapid Cycle Analysis 

RCT Randomized Controlled Trial

RR Relative Risk

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SARS Severe Acute Respiratory Syndrome 

SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus-2 

SHEA Society for Healthcare Epidemiology of America 

SMEs Subject Matter Experts
ACIP Meeting Summary July 22, 2021

40

TTS Thrombosis with Thrombocytopenia Syndrome 

UK United Kingdom

US United States

VA (US Department of) Veteran’s Affairs 

VAERS Vaccine Adverse Event Reporting System

VaST ACIP COVID-19 Vaccine Safety Technical Work Group 

VE Vaccine Effectiveness

VOC Variant of Concern 

VSD Vaccine Safety Datalink

VTE Venous Thromboembolism 

WG Work Group

WHO World Health Organization