MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP) 

SEPTEMBER 1, 2022 

MEETING SUMMARY 

CONTENTS 

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

THURSDAY: SEPTEMBER 1, 2022 .............................................................................................................2 

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

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

CDC Announcements ......................................................................................................... 2 

FDA Announcements.......................................................................................................... 3 

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

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

Update on SARS-CoV-2 Variants and the Epidemiology of COVID-19Epidemiology of 

COVID-19 & COVID-19 Vaccine Coverage......................................................................... 5 

Immunology of SARS-CoV-2 Variants: Antigenic Cartography............................................ 9 

Updates to COVID-19 VE During Omicron.........................................................................15 

COVID-19 Vaccine Safety Update: Primary Series in Young Children and Booster Doses in 

Older Children and Adults ..................................................................................................18 

Public Comment.................................................................................................................23 

Booster Doses of Moderna COVID-19 Vaccines in Adults, Adolescents, & Children..........28 

Pfizer-BioNTech COVID-19 Omicron-Modified Bivalent Vaccine........................................37 

EtR Framework: Bivalent COVID-19 Vaccine Booster Doses.............................................42 

COVID-19 Pre-Exposure Prophylaxis Guidance ................................................................55 

Interim Clinical Considerations for COVID-19 Vaccines: Bivalent Boosters........................56 

COVID-19 Vaccines WG Interpretation ..............................................................................60 

Vote #1: Pfizer-BioNTech COVID-19 Bivalent Vaccine in Individuals ≥12 Years of Age.....62 

Vote #2: Moderna COVID-19 Bivalent Vaccine in Individuals ≥18 Years of Age.................62 

CERTIFICATION.........................................................................................................................................65 

ACIP MEMBERSHIP ROSTER ..................................................................................................................66 

ACRONYMS USED IN THIS DOCUMENT.................................................................................................75 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary September 1, 2022 

MEETING PURPOSE 

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

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

Immunization Practices (ACIP) on September 1, 2022. The meeting took place remotely via 

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

which focused on the epidemiology of COVID-19 and SARS-CoV-2 variants; immunology of 

SARS-CoV-2 variants; updates to COVID-19 vaccine effectiveness (VE) and vaccine safety; 

Moderna bivalent COVID-19 vaccine; Pfizer-BioNTech bivalent COVID-19 vaccine; Evidence to 

Recommendations (EtR) Framework assessment of bivalent COVID-19 booster doses; Clinical 

Considerations update; and votes on Moderna COVID-19 bivalent vaccine in individuals ≥18 

years of age and Pfizer-BioNTech COVID-19 bivalent vaccine in individuals ≥12 years of age. 

THURSDAY: SEPTEMBER 1, 2022 

WELCOME AND INTRODUCTIONS 

Call to Order/Roll Call 

Dr. Grace Lee (ACIP Chair) called to order and presided over the September 1, 2022 ACIP 

meeting. She conducted a roll call, which established that a quorum was present. No conflicts of 

interest (COIs) were declared. A list of Members, Ex Officios, and Liaison Representatives is 

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

CDC Announcements 

Dr. Melinda Wharton (ACIP Executive Secretary, CDC) began by explaining that although 

this meeting originally was announced as a 2-day meeting with a 2-hour session the second 

day, ACIP did anticipate using that time as the committee was expected to complete its 

business during the first day. At the time the meeting was scheduled, it was unclear exactly 

when the Food and Drug Administration (FDA) would complete the regulatory action and it was 

anticipated that a 2-day meeting might be necessary. Given that the FDA was able to complete 

the regulatory actions, a 1-day ACIP meeting was expected to be sufficient. 

Proceeding with meeting logistics, Dr. Wharton noted that copies of the slides for the day were 

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

ACIP Voting Members, Ex Officios, and Liaisons. She indicated that the ACIP is at its heart a 

public body. Engagement with the public and transparency in the ACIP processes is vital to the 

committee’s work. She indicated that there would be an oral public comment session prior to the 

vote at approximately 12:15 PM Eastern Time (ET). To create a fair and more efficient process 

for requesting to make an oral comment, people interested in making an oral comment are 

requested to submit a request online in advance of the meeting. Priority is given to these 

advanced requests, and if more people request to speak than can be accommodated, a blind 

lottery is conducted to determine who the speakers will be. Speakers selected in the lottery for 

this meeting were notified in advance of the meeting. Members of the public also can submit 

public comments through https://www.regulations.gov using Docket Number CDC-2022-0103. 

Information on the written public comment process, as well as information on how to make a 

comment, can be found on the ACIP meeting website. 

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ACIP Meeting Summary September 1, 2022 

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

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

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

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

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

members are prohibited from participating in committee votes on issues related to those 

vaccines. Regarding other vaccines of the concerned company, a member may participate in 

discussions with the provision that he or she abstains from all votes related to the vaccines of 

that company. ACIP members state any COIs at the beginning of each meeting. 

FDA Announcements 

Doran Fink, MD, PhD (CBER/FDA) reported that the reason this ACIP meeting was convened 

was because the previous day FDA, under its Emergency Use Authorization (EUA) authority, 

authorized 2 modified mRNA COVID-19 vaccines formulated to have bivalent strain 

compositions. The bivalent vaccine manufactured by Pfizer-BioNTech and has been authorized 

for use as a booster dose in individuals ≥12 years of age who are at least 2 months removed 

from completion of their COVID-19 vaccine primary series or at least 2 months removed from 

their most recent booster dose with a monovalent originally authorized COVID-19 vaccine. The 

bivalent vaccine manufactured by Moderna it is authorized for use in individuals ≥18 years of 

age who are at least 2 months removed from either completion of their primary series or their 

most recent booster dose with a monovalent originally authorized COVID-19 vaccine. Each of 

these bivalent vaccines contains a component for the original ancestral SARS-CoV-2 strain that 

was the basis for the originally authorized COVID-19 mRNA vaccines and a component for the 

Omicron BA.4 and BA.5 sub-lineages. These bivalent vaccines will replace the use of the 

original monovalent vaccines as booster doses in the populations who are eligible to receive 

them. Therefore, individuals ≥12 years of age who will be boosted with the Pfizer vaccine now 

will receive the bivalent vaccine. The original monovalent is no longer authorized for that 

population and likewise for Moderna for individuals ≥18 years of age. 

FDA authorized these bivalent vaccines with the goal of improving the protection afforded by 

vaccine booster doses by having the vaccine strain composition more closely matched to the 

currently circulating SARS-CoV-2 strain, the vast majority of which in the US is now BA.5, and 

additionally by retaining the original strain component for which there is extensive experience in 

terms of these vaccines being safe and effective. In its authoritarian, FDA considered a totality 

of evidence that consisted primarily of an extrapolation approach based on data from clinical 

trials with similar bivalent vaccine formulations consisting of original the Omicron BA.1 sublineage components and extensive experience with the use of the original monovalent primary 

series and booster dose vaccines. All of these data represent data collected with human 

experience. Additionally, FDA considered supportive data from some animal studies that 

provided additional reassurance about the extrapolation approach. FDA encourages everyone 

who is eligible for these bivalent booster vaccines to get them to improve their protection against 

disease caused by SARS-CoV-2, including serious consequences of COVID-19 such as long 

COVID-19. FDA especially encourages individuals who have been waiting to get their booster 

dose who are far out from their last booster dose to take advantage of the authorizations of 

these bivalent vaccines heading into the Fall and Winter months for which modelling has 

predicted that COVID-19 disease activity will increase. 

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ACIP Meeting Summary September 1, 2022 

Discussion Summary 

Dr. Wharton indicated that with FDA’s regulatory action approving the updated bivalent booster 

the previous day, the ACIP has an opportunity to update and simplify its recommendations for 

vaccine use. The hope is that this is the start of moving toward with a more usual type of 

vaccine recommendations and process, as well as more normal cadence of ACIP meetings. 

While this will be a transition, it is an important move toward simpler recommendations and 

updated vaccines that are expected to provide protection. She expressed gratitude to the ACIP 

for their ongoing support. 

Dr. Lee thanked Drs. Wharton and Fink for setting the stage for the day. The ACIP is hopeful 

that in moving into the next phase of the pandemic, they also can move into the next phase 

of the ACIP meeting schedule. 

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES 

Session Introduction 

Dr. Matthew Daley (ACIP, WG Chair) provided the session introduction on behalf of the ACIP 

COVID-19 Vaccines Work Group (WG). He began with highlights of the global impact of the first 

year of COVID-19 vaccinations based on mathematical modelling of transmission and infection 

in 185 countries from December 2020 through December 2021.

1 Based on this modeling, 

COVID-19 vaccinations are estimated to have prevented between 13.7 to 15.9 million deaths 

globally. This represents an estimated 63% reduction in total COVID-19 deaths globally. 

To provide an update on the use of the Novavax COVID-19 vaccine, Novavax is a protein 

subunit vaccine that has been authorized for emergency use. Novavax COVID-19 vaccine is 

now recommended as a 2-dose primary series for people ≥12 of age in the US. A total of 

670,000 doses of this vaccine have been distributed across all US states and territories. A total 

of 3.2 million doses have been purchased by the US Government (USG). As of August 25, 

2022, approximately 14,000 doses have been administered. This includes 2,591 individuals who 

have received the full 2-dose primary series.2 

The ACIP COVID-19 Vaccines WG had a busy August. The WG reviewed extensive data 

regarding bivalent boosters and the broader context in which bivalent boosters are authorized. 

This included data from multiple clinical trials of bivalent boosters, including those with an 

Omicron component that have demonstrated safety and immunogenicity in more than 1700 

adults both with and without prior SARS-CoV-2 infection. As referred to by Dr. Fink, this 

includes data from more than 1,400 individuals who received a bivalent vaccine with an 

Omicron component specifically. In addition, the WG reviewed antigenic cartography and the 

immunologic implications of SARS-CoV-2 variants, setting the context for bivalent vaccines. The 

WG also reviewed modelling data focused on pandemic outcomes in various scenarios, 

including the potential impact of new variants and varying vaccine/booster coverage. In addition, 

the WG reviewed extensive data regarding rare events of myocarditis after COVID-19 

vaccination. The WG also reviewed the epidemiology of COVID-19 disease and variants, 

including currently dominant omicron BA 4/5 variant. Through all this, the WG has engaged in 

1 Watson, Barnsley, Toor et al. Lancet Infectious Diseases. 22:9(P1293-1302). https://doi.org/10.1016/S1473-3099(22)00320-6 2 COVID Data Tracker: https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop Accessed 

8/26/22 

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ACIP Meeting Summary September 1, 2022 

broad discussions regarding the use of bivalent boosters in people of all ages who are currently 

recommended to receive a booster. 

Update on SARS-CoV-2 Variants and the Epidemiology of COVID-19Epidemiology of 

COVID-19 & COVID-19 Vaccine Coverage 

CDR Heather Scobie, PhD, MPH (CDC/NCIRD) provided an update of the variants and 

epidemiology of COVID-19. The Omicron variant has 5 main sub-lineages numbered BA.1 

through BA.5, which are further divided into hundreds of sub-lineages. Omicron has been 

shown to have increased transmissibility but decreased severity relative to previous lineages. 

Omicron has many mutations in the spike gene (S-gene) that are associative with lower VE, 

with reduced neutralization by sera from vaccinated or convalescent individuals. There also is a 

reduction in efficacy of some monoclonal antibody treatment.3 

Based on trends in weighted variant proportion estimates and Nowcast data for the US from 

May 22, 2022 through August 27, 2022, Omicron sub-lineages have been over 99% 

predominant for many months. The BA.2 sub-lineage BA.2.12.1 sub-lineage have been 

displaced by the BA.4 and BA.5 sub-lineages. For the week ending August 27, 2022, BA.5 

comprised 88.7% of sequences. BA.4.6 comprised 7.5% and BA.4 comprised 3.6%.4 Based on 

the estimated numbers of reported COVID-19 cases by variants based on the variant proportion 

and scaled by the number of nucleic acid amplification tests (NAATs), including polymerase 

chain reaction (PCR) tests, the trends highlight that the more recent waves caused by the BA.4 

Omicron sub-lineages and the BA.4 and BA.5 sub-lineages have been much smaller than the 

initial Omicron wave related to the BA.1 sub-lineages.5 Looking at Nowcast estimates of variant 

proportions across the 10 HHS regions August 21–27, 2022, BA.5 represented the majority of 

circulating lineages in all regions during the most recent week.6 

Looking at COVID-19 trends since the beginning of the pandemic, the number of cases 

associated with the Alpha variant was relatively small compared to the Delta and Omicron 

variants. Nationally reported cases started increasing in April, leveled off in June and July, and 

have been decreasing in August. There had been over 94 million reported COVID-19 cases in 

the US as of August 30, 2022.7 Looking at the daily number of reported COVID-19 cases 

overlaid with a 7-day moving average of NAAT percent positivity, which is a marker of 

transmission intensity, the trends aligned remarkably well in late 2020 through early 2022. The 

trends become uncoupled starting in May, with numbers of reported COVID-19 cases leveling 

off while NAAT positively in late July increased to a high of 20% related to increased 

transmission, decreased provider-based testing, and increased at-home testing that is largely 

unreported. This resulted in an underestimation of reported cases. However, NAAT positivity in 

case counts have decreased during August, suggesting a decrease in overall transmission.8 

3 https://www.cdc.gov/coronavirus/2019-ncov/variants/omicron-variant.html; and https://www.cdc.gov/coronavirus/2019-

ncov/science/science-briefs/scientific-brief-omicron-variant.html 4 https://covid.cdc.gov/covid-data-tracker/#variant-proportions Accessed August 26, 2022 5 Data sources: https://covid.cdc.gov/covid-data-tracker/#variant-proportions and https://covid.cdc.gov/coviddatatracker/#trends_newtestresultsreported_7daytestingpositive_00 

6 https://covid.cdc.gov/covid-data-tracker/#variant-proportions Accessed August 26, 2022 7 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed August 31, 2022 8 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_newtestresultsreported_7daytestingpositive_00 

Accessed August 31, 2022 

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ACIP Meeting Summary September 1, 2022 

In terms of weekly trends in the rates of COVID-19-associated hospitalizations by age group 

from COVID-NET, higher hospitalization rates always have occurred in the 65+ age group, 

followed by people 50−64 years of age and 18−49 years of age. Since April, hospitalization 

rates have increased more in the 65+ year age group compared to those among younger adults 

for whom there were not large increases in hospitalization rates.9 Data from a Morbidity and 

Mortality Weekly Report (MMWR)

10 published the previous Friday showed that there has been a 

widening gap over time between hospitalization rates in older and younger adults and that age 

remains a strong risk factor for COVID-19 illness severity. Data from the same MMWR show 

that the median age of patients with COVID-19-associated hospitalization increased across the 

3 periods, while the percentage of hospitalizations that were likely COVID-19-related decreased 

slightly between the Delta and Omicron periods. The percentage of cases with underlying 

conditions, immunosuppression, and residing in long-term care facilities (LTCF) increased, while 

outcomes related to clinical severity decreased. These trends were likely related to a 

combination of increasing vaccinations, waning immunity, changes in COVID-19 treatments, 

and differences in variant severity over time. 

Looking at the 3-week moving average of age-adjusted rates of COVID-19-associated 

hospitalizations by race and ethnicity. Throughout the pandemic, American Indian and Alaskan 

Native (AI/AN), Black, and Hispanic persons have been disproportionately affected by COVID19-associated hospitalizations compared with White and Asian Pacific Islander persons. The 

scale of these disparities has decreased after the Omicron surge, but hospitalization rates are 

still highest among AI/AN and Black persons.11 In terms of COVID-19-related deaths, US trends 

in the daily number of provisional COVID-19 deaths have been reported to the National Vital 

Statistics System (NVSS) since the start of the pandemic. NVSS data come from death 

certificates and are generally considered to be more reliable than the death data reported 

through COVID-19 surveillance. There have been over 1,042,000 deaths due to COVID-19 

reported cumulatively in the US as of August 27, 2022. Omicron has caused a sizable number 

of deaths despite decreased relative severity because of high case numbers.

12 Data on weekly 

trends in COVID-19-associate mortality rates from NVSS by age group13 show that higher 

mortality rates are consistently observed in older age groups, most notably among those aged 

75+ years, 65−74 years, and 50−64 years. Similar to hospitalizations, a recent increase has 

been observed in death rates for older ages, especially for adults ages 75+ years. Data on 

weekly trends in age-adjusted COVID-19-associated mortality rates from NVSS by race and 

ethnicity show that higher mortality rates have been observed throughout the pandemic among 

Black persons, AI/AN persons, and Hispanic persons compared with White persons. Since April, 

there has been less evidence of disparities in mortality rates by race and ethnicity, but mortality 

rates were low overall relative to earlier in the pandemic. 

As of August 24, 2022 almost 224 million people in the US have been vaccinated with a primary 

series, which is 72% of people ≥5 years of age, while 49% people ≥5 years of age have 

received a first booster dose and 34% of people ≥50 years and older have received a second 

booster dose. Despite progress, there are still important differences in primary series 

vaccination coverage by age and booster dose coverage by race, ethnicity, and disability 

status.14 Looking at adjusted rates of COVID-19 cases by vaccination status, case rates in 

people with a primary series increased during waves associated with Delta and Omicron 

9 Source: COVID-NET; https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html Accessed August 26, 2022 10 Havers et al. MMWR 2022; 71(34);1085–1091. https://www.cdc.gov/mmwr/volumes/71/wr/mm7134a3.htm?s_cid=mm7134a3_w 11 COVID-NET: https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network Accessed August 23, 2022 12 https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm Accessed August 31, 2022 13 https://data.cdc.gov/NCHS/Provisional-Weekly-Deaths-by-Region-Race-Age/tpcp-uiv5 14 https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed August 24, 2022 

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ACIP Meeting Summary September 1, 2022 

variants. However, case rates for unvaccinated people have always exceeded those for 

vaccinated people. In July, unvaccinated people ages ≥5 years 2.4 times higher risk of testing 

positive for COVID-19 compared to people vaccinated with at least the primary series.15 

Regarding age-adjusted rates of COVID-19-associated hospitalizations by vaccination status 

and receipt of a booster dose, hospitalizations for COVID-19 have been consistently higher 

among unvaccinated than vaccinated people over time. In June, unvaccinated adults ages ≥18 

years and older had 4.6 times higher risk of COVID-19 associated hospitalizations compared to 

those vaccinated with a primary series and at least 1 booster dose.16 Looking at age-adjusted 

rates of COVID-19 associated deaths by vaccination status and receipt of booster doses, in 

July, unvaccinated people ages ≥5 years had 8 times the risk of dying from COVID-19 

compared to people vaccinated with a primary series and at least 1 booster dose. This was a 

decrease from 20 times higher during January through March 2022. This analysis reported a 

decrease in the rate ratio from earlier in the year, possibly related to waning immunity and 

increased community transmission of the Omicron sub-lineages as well as other factors.17 

In data from July 2022,18 people ages 50 years and older with a second booster dose had 14 

times lower risk of dying from COVID-19 compared to unvaccinated people the same age and 3 

times lower risk of dying from COVID-19 than people of the same age with 1 booster dose. 

These data suggest that getting a second COVID-19 vaccine booster dose can enhance 

protection that might have decreased over time after received the last dose. Unvaccinated 

people are at much higher risk of severe COVID-19 illness than vaccinated people. Most (75%) 

vaccinated people who get severe COVID-19 illness have multiple risk factors including older 

age (most ≥65 years, but with risk increasing with age) and underlying medical conditions 

(immunosuppression, diabetes, chronic kidney disease, chronic lung disease, chronic 

cardiovascular disease, or chronic neurologic disease. Antiviral drugs can help reduce the risk 

of severe illness in people at higher risk.19 

In summary, CDC continues to monitor emerging variants like the sub-lineages of Omicron, 

including their prevalence and impact on disease incidence, severity, and VE over time. Racial 

and ethnic minority groups have been disproportionately affected by COVID-19-associated 

hospitalization and mortality. These inequities have decreased over time, but have not been 

eliminated. Recent trends show evidence of increasing severe illness, including hospitalization 

and deaths in people of older age and people with underlying health conditions. Current 

vaccines offer protection against severe COVID-19 illness and death, so it is important to stay 

up-to-date (UTD) with vaccination, including receipt of all booster doses in eligible populations. 

Therapeutics and multiple prevention measures should be used to protect people at higher risk 

of severe COVID-19 illness regardless of vaccination status. 

15 https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed August 24, 2022 16 https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination Accessed August 3, 2022 17 https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed August 24, 2022 18 https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccinbooine-status Accessed August 24, 2022 19 Yek et al. MMWR 2022;71:19–25. https://www.cdc.gov/mmwr/volumes/71/wr/mm7101a4.htm; Taylor et al. MMWR 2022;71:466-

473: http://dx.doi.org/10.15585/mmwr.mm7112e2 and unpublished COVID-NET data, as described here; Malden et al. MMWR 

2022; 71(25);830-833: https://www.cdc.gov/mmwr/volumes/71/wr/mm7125e2.htm; Gold et al. MMWR 2022; 71(25);825-829: 

https://www.cdc.gov/mmwr/volumes/71/wr/mm7125e1.htm; Najjar-Debbiny et al. CID 2022;, ciac443, 

https://doi.org/10.1093/cid/ciac443; Dryden-Peterson et al. medRxiv 2022.06.14.22276393; 

https://doi.org/10.1101/2022.06.14.22276393 

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ACIP Meeting Summary September 1, 2022 

Discussion Summary 

Dr. Poehling expressed appreciation for the data showing that the hospitalization rates are 

increasing, particularly for those over 65 years of age. It is commonly said that COVID-19 is 

more severe in adults than children, and she thought it was important to highlight that deaths 

and hospitalizations are more common in adults than children. However, children are 

hospitalized with COVID-19 all of the time. This is not a benign disease in children. She asked 

whether there are any data comparing baseline hospitalization rates across age groups. 

Dr. Scobie indicated that during times of increased case incidence, hospitalization increases in 

all age groups. The trend she was talking about was that the relative increase is currently higher 

in older age groups. Taking them out, there are increases in all age groups. 

Dr. Brooks emphasized the importance of framing the current situation on September 1, 2022. 

He was encouraged by the reduction in the disparities of African Americans and Alaskan 

Natives in terms of case rates, hospitalization rates, death rates. He believes a lot of this 

attributable to the efforts of the CDC and others to get out messaging that is targeted to these 

communities. Vaccination rates have leveled off in terms of disparities. The fact that the death 

rate is higher among the unvaccinated compared to those with the primary series and 1 or 2 

booster underscores the importance of continuing to get boosted. Some of the population get 

COVID-19 vaccine weary and decide they are okay with the primary series and 1 booster. 

Dr. Duchin (NACCHO) emphasized that these data clearly show the importance of booster 

doses in preventing severe disease, particularly among older adults and those with underlying 

health conditions. He requested additional information about how CDC is thinking about 

measuring the impact of post-acute sequelae or long COVID-19 and the potential benefit 

of vaccination in that context. 

Dr. Scobie indicated that this is not assessed through ongoing surveillance because of the 

difficulty of reports in collecting the data systematically, but there are plans for ongoing repeated 

surveys that will be implemented to assess the importance of booster doses. 

In terms of VE against long COVID-19, Dr. Link-Gelles indicated that the research generally has 

been mixed and inconclusive. However, there clearly is some benefit for prevention of initial 

infection, especially close to booster vaccination, and prevention of the severe disease that has 

been associated with a higher likelihood of long COVID-19. The lack of a standard definition 

globally, the inability to track patients longer-term, and the lack of diagnostic testing for long 

COVID-19 have complicated the ability to measure VE. However, this does remain a research 

priority. Perhaps during a future ACIP, a summary of the available information on this topic 

could be presented. 

Dr. Sanchez asked whether it has been possible to analyze similar data in pregnant women 

to determine the effect of the primary series and boosting on COVID-19 hospitalization and 

mortality in that population. 

Dr. Scobie indicated that this information may be available through COVID-NET, but she did not 

have that information. Information on pregnancy status was not collected as part of the vaccine 

impacts surveillance data she presented on the cases and deaths by vaccination status. Along 

with the request for a summary of long COVID-19 information, she could make a request for 

data on vaccine impacts on pregnant women from to colleges and the ACIP Secretariate. 

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ACIP Meeting Summary September 1, 2022 

Dr. Fleming-Dutra added that CDC is hoping to address questions about COVID-19 vaccine use 

in pregnant women in terms of effectiveness and their infants during a future ACIP meeting. 

Dr. Lee emphasized that while the burden of severe disease and hospitalization is higher 

among older adults than children, it is important to keep in mind that COVID-19 is the fourth or 

fifth leading cause of death in children. She also asked whether there are any data comparing 

unvaccinated and potentially uninfected people in terms of severity during Omicron among 

those who were unvaccinated in Alpha or Delta, particularly in the context of the graphs Dr. 

Scobie showed on hospitalization rates. There is a perception that if the Omicron wave is less 

severe, it is not necessary to worry about it that much. The Omicron wave is occurring in a 

background of people who have had infection and vaccination, so the population is very 

different from an immune perspective than it was during the Alpha and Delta waves. 

Dr. Scobie clarified that the results she showed were descriptive and did not adjust for the 

impacts of vaccination and would have to be interpreted in that light. While the particular study 

she described did not address Dr. Lee’s point, she indicated that there are a number of 

publications that did that type of analysis and took into account immunity status that have shown 

that Omicron is less severe than previous variants. The issue is that there are so many more 

Omicron infections because of increased transmissibility. The reduced severity of Omicron is 

not something to take lightly because with a higher chance of getting the disease, there will 

continue a large number of hospitalizations and deaths. 

Looking at Slides 22 and 23, Dr. Sanchez observed that there are a lot of issues to address with 

respect to counseling patients about booster dosing in terms of the high seroprevalence among 

people who have had COVID-19 already. The data from June 2022 showing very high 

seroprevalence among the general population attests to the need for booster dosing and that 

they should be recommending it. There are a lot of questions about whether to get a booster 

now or wait until the Fall. The data suggest that even in an era of high natural infection, booster 

dosing presumably also has contributed to the decrease in hospitalization and mortality. 

Immunology of SARS-CoV-2 Variants: Antigenic Cartography 

Natalie J. Thornburg, PhD (CDC/NCIRD) provided an update on the immunology of Omicron 

variants, specifically focusing on the technique of antigenic cartography that laboratorians are 

using to estimate how different viruses are from each other, which can inform vaccine selection. 

Lineage numbers are not necessarily reflective of how different viruses are from ancestral 

viruses. The antigenic visualization method is used to determine how closely related different 

viruses are antigenically rather than in the genetic context. BA.5 is not necessarily more distant 

from the vaccine strain than BA.2 or BA.3 just because of the number. It is customary to look at 

virus lineages and viral variances in phylogenetic trees, which are generated according to 

genetic differences and not antigenic differences, which is not how the immune system sees 

viruses. The immune system sees viruses as shapes. Antibodies see the shape of a spike 

protein and not the linear sequence of nucleotides or amino acids. Antigenic cartography is a 

method to measure how different viruses might look to antibodies after vaccination or infections. 

Antigenic cartography uses a matrix algorithm called a matrix completion-multiple dimensional 

scaling algorithm to generate a map. It originally was developed for H3N2 influenza viruses 

using hemagglutination inhibition (HAI) titers. Either 2- or 3-dimensional maps can be generated 

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ACIP Meeting Summary September 1, 2022 

using this method to see how closely related viruses are. This graphic provides an illustration of 

how antigenic cartography might be done:

20 

A matrix of viruses in sera is used to do neutralization assays and a checkerboard of the results 

is created from the neutralization assays. The method of cartography is not limited by the kind of 

sera or neutralization technique one is using. What is important in this method is that 

information is known about the material being used in the assay to know the history of the sera 

being used and the sequence of the virus being used. This is demonstrated in the above 

graphic in that this particular study inoculated hamsters with different viruses with known 

sequences and then collected serum at Day 7 and Day 26 from those hamsters that had 

antibodies raised against specific viruses. This showed that 2 different neutralization assays 

could be used due to virus neutralization assays, which are in the shell of a different virus with 

just the spike protein from SARS-CoV-2 with a known sequence or an authentic virus (a virus 

that has been isolated from a respiratory specimen from an infected person). Neutralization 

assays are then done to generate a matrix of neutralization titers, which is shown in the square 

with the red, yellow, and green boxes. For every individual virus, there is a neutralization titer 

against a specific serum that is used to create the map. 

The titers generated from the neutralization assays of the different hamster serums can be used 

to create a distance map. In a lot of the maps that are being generated right now for 

coronaviruses, each square is a 2-fold difference change in neutralization titers. The distance 

table can be used to generate the antigenic map on which the viruses can be color coded. Most 

publications have been using empty squares for sera and filled circles as viruses to see how 

closely related they are as shown in these illustrations: 

20 Mykytn et al. Science immunology. 2022 

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There are advantages and disadvantages to this method. The advantages include that it is 

extremely easy to interpret because it is possible to look at the antigenic map above to see that 

in this case, antigen BE is pretty far from antigen LE, but BN and LE are pretty closely related. 

This method is fairly accurate and provides a really good overview rather than just looking at 

sequence alignments, which can be complex. This method also provides quantification and 

allows for predictions about how easily a virus might escape an antibody response. There are 

some drawbacks as well. This can be an over-simplification and there can be assay bias. For 

example, a map generated with pseudo virus neutralizations might look different than a map 

generated with authentic virus neutralization or animal sera versus human sera. There can be 

outlier effects, and there always is map uncertainty in that the dots are not actually as finite as 

they might not look in a map where there is some uncertainty. 

In terms of what is known about how antigenically similar Omicrons are from earlier viruses and 

how antigenically related they are to each other, this is a reminder of the Omicron lineages and 

sub-lineages in the amino acid variations that have been observed in the spike protein. This is 

not the full spike protein. It is just a few regions in some areas where there were adverse event 

variations between Omicron lineages:

21 

The end-terminal domain is shown in a blue square and the receptor-binding domain, which is 

where most of the potent neutralizing antibodies would be binding the receptor-binding domain 

and blocking ACE2 binding, is shown in the red square. The downstream of the receptor-binding 

domain is shown at the bottom. 

21 Tuekprakhon et al. Cell 2422-2433.e13. 2022 

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These are some of the amino acid differences projected onto the structure of the receptorbinding domain:

22 

In the above illustration, the unique amino acids to BA.4/BA.5 are shown in B on the left in red. 

The different variant amino acids on the right are projected onto the ACE2 footprint where the 

spike receptor binding domain binds ACE2. There are some common to most of the Omicrons 

to BA.1, BA.2, BA.3, but not BA.4/BA.5 shown in white. Unique to BA.4/BA.5 is shown in red 

and unique to BA.2 is shown in magenta. It is pretty complex such that just looking at this, it 

would not necessarily be possible to say which one of these Omicrons is most different from 

ancestral virus or which is most likely to escape vaccine or neutralization. 

Three antigenic maps from peer-reviewed publications include Omicron viruses, 2 of which are 

2-dimensional and 1 of which is 3-dimensional. Only 2 of these maps include BA.4 and BA.5 

type sequences. In this this one, investigators were able to look at the BA.1 and lineages of 

omicron but not BA.4 and BA.5 because this was submitted before the emergence and broad 

circulation of BA.4 and BA.5. This study used convalescent sera from unvaccinated persons to 

generate antigenic cartography for BA.1 and BA.2:

23 

The squares in the above maps are sera from convalescent patients and the circles are viruses. 

Red is Delta, light blue is ancestral viruses, green is Alpha, yellow is Beta, and Omicron viruses 

are light pink and dark pink off to the right. The takeaway from this is that Omicron viruses are 

more distantly related from ancestral viruses from the earlier variants and there is a more 

dramatic difference looking at individuals who had been vaccinated only as opposed to infected, 

using infected sera. 

22 Tuekprakhon et al. Cell 2422-2433.e13. 2022 23 Van der Straten et al. Immunity 2022 

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ACIP Meeting Summary September 1, 2022 

In this study published in the summer24 includes analyses of BA.4 and BA.5 and is a 3-

dimensional map with the front, top, and side view views shown here: 

While this is somewhat harder to look at and understand, this study also uses pseudovirus 

neutralization data. The investigators used serum from breakthrough BA.1 infections, so these 

participants had been vaccinated and then were infected with Omicron. They also had a panel 

of human monoclonal antibodies that they used to generate these maps. This map indicates 

that the omicron viruses cluster together, but consistent with the earlier study, cluster away from 

ancestral virus. They are quite antigenically distinct from the ancestral Wuhan virus. In this 

analysis, BA.4 and BA.5 are more distant to Wuhan than other Omicron viruses. 

This is the last of the 3 published maps Dr. Thornburgh showed from a study25 that used 21 

known monoclonal antibodies, pseudovirus neutralization, and neutralization using post-third 

dose sera: 

Each square in this one represents a 2-fold change in neutralization. This map is also 3-

dimensional. It is shown here in 1 panel instead of 3 that the investigators generated by showing 

arrows on the bottom to identify which dimension is which. The black circle is ancestral virus 

strain D614G. BA.1 viruses at the top left are clustered somewhat away from BA.2 viruses 

toward the right in different colors of blue. There are a couple different variations of BA.2 lineage 

viruses. BA.4 and BA.5 viruses are toward the top right-hand corner. This map indicates that 

BA.4 and BA.5 might be most distantly antigenically related to ancestral virus compared to other 

Omicron lineage viruses. 

24 Tuekprakhon et al. Cell 2422-2433.e13. 2022 25 Wang et al. Nature. 2022 

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ACIP Meeting Summary September 1, 2022 

Looking at these maps, it is easy to think of circles and squares as finite, but using 

bootstrapping, it is possible to see that there is overlap between Omicron lineages. 

Bootstrapping is a statistical method to estimate sampling distribution. There can be individual 

variation in the assays, viruses, and individual sera that are used. This map is from some 

aggregated data that was published in May 2022 that demonstrates that there is quite a bit of 

overlap in the antigenic maps between the Omicron viruses:

26 

The dark blue is ancestral and omicron viruses are showing in different shades of pink and red, 

and they cluster away from ancestral virus. There is some overlap, but using that aggregated 

data, either BA.1 or BA.4 viruses may be further away from ancestral viruses. 

In conclusion, antigenic cartography is an analysis method to visually represent how 

antigenically related or distant viruses are to each other. They can be generated either in 2 or 3 

dimensions, and the maps cluster Omicron variants away from ancestral and earlier virus 

variants. Initial examinations of Omicron lineages indicate that BA.4 and BA.5 viruses may be 

more antigenically distinct than BA.1 viruses. Notably, all of the published assays were done 

with pseudovirus neutralization. There are a number of studies underway that are using 

authentic viruses, so those data are expected to vary somewhat between different studies and 

between the serum panels that are being utilized. 

Discussion Summary 

Dr. Loehr commented that this was a very interesting way of representing the differences. He 

requested clarity on whether the distance Dr. Thornburgh was describing was basically how 

many antibodies were being generated from each individual variant so that the farther way, 

there are different antibody titers. 

Dr. Thornburgh indicated that the distance is the change in neutralization titer between 2 

different viruses. If 1 square is a 2-fold distance and the serum from a vaccinated person is 

measured against the vaccine strain and then one of the Omicrons, if it is 6-fold lower, it might 

be 3 squares separated. 

26 Aggregated Omicron neutralization data (last update 2022-05-26) 

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ACIP Meeting Summary September 1, 2022 

Dr. Duchin (NACCHO) noted that an article was published the previous day in the New England 

Journal of Medicine (NEJM) from Portugal that found that previous SARS-CoV-2 infection had a 

protective effect against BA.5 infection and they found that this protection was maximal for a 

previous infection with BA.1 or BA.2. He asked whether Dr. Thornburgh could comment on 

those findings in the human population in the context of the antigenic cartography work 

Dr. Thornburgh responded that in terms of actual protection, data always trump any laboratory 

data being generated because it is real-world evidence of a protection rather than this very 

limited view of neutralization of viruses. This is a laboratory setting serum collection. There are 

limitations to this kind of analysis in terms of certainty. In the bootstrapped aggregated data, 

there was an overlap between Omicron. It is not terribly surprising that there is cross-protection 

between Omicrons. There are differences between omicrons, but there are not 50 differences. 

There are 3 amino acid changes or 10 amino acid changes. BA.2 is pretty similar to BA.4/5. It 

only has 3 differences in the spike protein, so with previous infection with BA.2, it does not 

surprise her that there is really good protection to BA.4/5. The same goes for BA.1. There are 

more changes when comparing BA.1 to BA.4 and BA.2 in comparison to BA.2 versus BA.4/5. 

The time since last infection matters as well because it is not just the sequence. It is waning of 

neutralizing antibody response in addition to the sequence of the virus to which one is being 

exposed. 

Referring to Slide 7, the Van der Straten study, Dr. Sanchez observed that the more recent 

BA.4 and BA.5 variants were not included, but there was quite a distance of Omicron BA.1 from 

serum. This may explain some of the breakthrough infections. 

Updates to COVID-19 VE During Omicron 

LCDR Ruth Link-Gelles, PhD, MPH (CDC/NCIRD) provided updates on COVID-19 VE in the 

US during Omicron among children and adults organized by outcome and then by age within 

the outcomes of infection, emergency department/urgent care (ED/UC) visits, and 

hospitalizations. Starting with infections, the Increasing Community Access to Testing (ICATT) 

platform is national community-based drive-through testing data from pharmacies. This platform 

relies on self-reported vaccine history and uses a test-negative design in which the population is 

persons with at least 1 COVID-like symptom and a positive NAAT test and controls are 

symptomatic with a negative NAAT test. Models are adjusted for the variables of race, ethnicity, 

gender, patient state, site Census tract’s Social Vulnerability Index (SVI), circulating cases

of COVID-19 by zip code in the last 7 days, pharmacy partner, and test date. This analysis 

focused the BA.4/BA.5 predominant period during July 2, 2022 through August 20, 2022.27 

Looking at relative VE for 3 versus 2 doses against symptomatic infection by age group, 

estimates for individual age groups are less important here than the overall trend, which is the 

same across age groups. There is less follow-up time for children 5−11 years of age due to the 

booster recommendation being more recent. However, the trend so far is the same as for older 

age groups. As a reminder, it has been observed previously that primary series VE against 

infection wanes to 0 within a few months, so these results should be taken in that context. In 

terms 3- versus 0-dose absolute VE against symptomatic infection and 4- versus 3-dose relative 

VE among adults 50−64 years of age, waning at or close to 0 VE is observed within a few 

27 CDC preliminary unpublished data. Prior infection excluded, other methods based on: Fleming-Dutra KE, Britton A, Shang N, et 

al. Association of Prior BNT162b2 COVID-19 Vaccination With Symptomatic SARS-CoV-2 Infection in Children and Adolescents 

During Omicron Predominance. JAMA. Published online May 13, 2022. doi:10.1001/jama.2022.7493 

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ACIP Meeting Summary September 1, 2022 

months of 3 doses as with younger age groups. There is potentially less waning of the fourth 

dose, although the follow-up time is limited given when the recommendation was made. 

Moving to ED/UC visits, VISION is a multi-state network of electronic health records (EHRs) 

Like ICATT, it uses a test-negative design with cases having COVID-like illness (CLI) and a 

positive PCR and controls having CLI with a negative PCR. VE is adjusted by propensity to be 

vaccinated weights, calendar time, region, local virus circulation, and age. Vaccination is 

determined via EHRs and state and city registries. Regarding VE during Omicron midDecember through mid-Jul 2022 for children 5−11 years of age and adolescents 12−15 years of 

age by time since last dose, similar patterns are seen across age groups with VE of 2 doses 

against ED/UC visits waning substantially. In adolescents 12−15 years of age, there is a nice 

bump in VE with a third dose. However, there were not enough children 5−11 years of age with 

booster doses to provide an estimate in that age group.28 Looking at adult VE during the BA.2 

and BA.4/BA.5 periods, similar patterns are observed in the 2 time periods with waning by time 

since the most recent dose. During the BA.4 and BA.5 period when more data were available on 

the fourth dose, it appears that the fourth dose wanes somewhat more slowly compared to 2 

and 3 doses.29 

Looking at a new VE platform that has not been shared previously with the ACIP, COSMOS is 

an opt-in database of more than 162 million patient records drawn from healthcare 

organizations using the Epic EHR platform. Like other the platforms presented, this is a testnegative design focused on Omicron BA.2 and BA.4 and BA.5 periods among children and 

adolescents 5–15 years of age. Cases were symptomatic with a positive SARS-CoV-2 test 

within 14 days before or 3 days after the encounter, and controls were symptomatic with a 

negative SARS-CoV-2 test14 days before or 3 days after the encounter. There were not enough 

vaccinated hospitalized children to assess VE for hospitalizations, so this analysis focuses on 

ED and UC visits only. Similar patterns were seen with this platform as were seen in VISION, 

with waning of 2 and 3 doses among children 5−11 years of age and adolescents 12−15 years 

of age. There were wide confidence intervals, especially around the third dose.30 

VISION results for mRNA VE for hospitalizations among immunocompetent adults ≥18 years of 

age by number of doses and time since last dose receipt between late March and late July 

2022, VE against hospitalization continues to be higher and more sustained over time versus 

less severe outcomes. Estimates were not included for the 14 to 149 days after the second 

dose due to small numbers of people recently finishing their primary series during the summer. 

VE during BA.4 and BA.5 was generally similar to VE during BA.2 predominance. So far, the 

fourth dose shown appears to be waning somewhat more slowly compared to the third dose, 

although, the confidence intervals are too wide to be conclusive.31 

Data were assessed from CDC’s Influenza and Other Viruses in the Acutely Ill (IVY) platform 

from the December 2021 through July 2022 Omicron period among adults ≥18 years of age who 

were hospitalized at 21 medical centers in 18 states. Cases have CLI illness and a positive PCR 

or antigen test and controls have CLI and a negative PCR. Looking at VE among 

immunocompetent adults during Omicron predominance, the fourth dose is estimated only 

among adults s ≥50 years of age. As with VISION, waning was seen of the second and third 

28 CDC, preliminary unpublished 29 BA.2/BA.2.12.1 estimates: Link-Gelles et al. MMWR: https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e1.htm; BA.4/BA.5 

estimates: CDC, preliminary unpublished data. 30 CDC, preliminary unpublished data 31 BA.2/BA.2.12.1 estimates: Link-Gelles et al. MMWR: https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e1.htm; BA.4/BA.5 

estimates: CDC, preliminary unpublished data 

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doses, though there was more sustained VE against infection. There was not enough statistical 

power to estimate VE in the IVY Network of 2 or 4 doses, but 3-dose VE had evidence of 

waning. 

To summarize, VE against severe disease continues to be higher and more sustained over time 

than VE against infection. VE during BA.4 and BA.5 predominance was generally comparable to 

VE during BA.2 predominance. A third dose provided significant additional protection against 

infection and severe disease in all ages. While the third dose did wane, especially against 

infection, it appears to have waned slightly more slowly compared to the second dose, with 

similar patterns seen across age groups. Fourth-dose coverage was too low to draw 

conclusions, but additional benefits were demonstrated against all outcomes with slower waning 

apparent—especially against hospitalization. 

Discussion Summary 

Dr. Long requested clarification regarding whether it was that VE against BA.4 and BA.5 

hospitalization was equal to and had the same decay as it did against earlier, suggesting that 

there would be no seeming advantage of the bivalent vaccine against Omicron BA.4 and BA.5 

in the short-run and that VE in the long-run against hospitalization is unknown. 

Dr. Link-Gelles clarified that these data all were from the monovalent vaccines. No data were 

provided for bivalent vaccines. Slide 14 is hospitalization data among immunocompetent adults 

for monovalent vaccine only with currently used vaccines. For BA.2 and BA.4/BA.5, the patterns 

are generally the same. She cautioned against interpreting lower VE during BA.4/BA.5 using 

these data because of the wide confidence intervals. But the same general pattern is seen in 

that there is some indication of waning of the third dose and the fourth dose seems to bump 

back up, perhaps even a little higher than the initial third dose. These are much higher VEs 

and more sustained effectiveness for hospitalization than what was seen for infection, but it is 

an indication that the bivalent vaccine should provide at least similar or better protection against 

Omicron since it will be a better match. 

Dr. Poehling said the way she was interpreting these data was that the primary series wanes a 

lot, and it is the third and fourth booster doses that provide important protection against severe 

disease, even when using the monovalent vaccine. 

Dr. Link-Gelles confirmed that interpretation. A pattern has been seen for every variant so far 

that the primary series provides some protection, but it is relatively limited and wanes quickly 

and the third dose is key for having more sustained protection. Early indications are that the 

fourth dose likewise provides additional benefit in those for whom it is recommended. 

Dr. Long asked how confident Dr. Link-Gelles was about that last statement. Looking at the 

data, the studies and average times since the fourth dose were 27 days, 38 days, and 84 days 

or 90 days before significant waning was seen. Considering the small number of subjects and 

the wide confidence intervals, she asked Dr. Link-Gelles to tell her statistically whether she was 

confident about the last statement—not about what everything else has shown, but what this 4-

dose to boosters has shown that there is slower waning. 

Dr. Link-Gelles emphasized that the issue is there was relatively limited follow-up time after the 

fourth dose because of when it was recommended. The number of cases who have been 

hospitalized after receipt of a fourth dose are fairly low, so she did not think that they could 

conclude that there is or is not waning of a fourth dose. The basic indication is that a little extra 

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protection is provided after a fourth versus a third dose. Certainly, there is extra protection after 

a distant third dose. Compared to the individuals who got 3 doses more than 120 days ago, 

there is a definite benefit of the fourth dose. But she thinks it is way too early to conclude one 

way or the other about waning of a fourth dose. 

COVID-19 Vaccine Safety Update: Primary Series in Young Children and Booster Doses 

in Older Children and Adults 

Tom Shimabukuro, MD, MPH, MBA (CDC/NCEZID) provided an update vaccine safety, with a 

focus on CDC vaccine safety monitoring systems, the safety of primary series mRNA COVID-19 

vaccination in children ages 6 months–5 years, and the safety of mRNA COVID-19 booster 

vaccinations in people ≥5 years of age. As a reminder, one of the systems CDC uses is the 

Vaccine Adverse Event Reporting System (VAERS).32 VAERS is the nation’s spontaneous 

reporting or passive surveillance system that is comanaged by CDC and FDA. VAERS accepts 

reports from everyone regardless of the plausibility of the vaccine causing the event or the 

clinical seriousness of the event. Key strengths of VAERS are that it can rapidly detect potential 

safety problems and can detect rare adverse events (AE). The key limitation is that as typical 

with passive surveillance, cause and effect generally cannot be determined from VAERS data 

alone. v-safeSM is a voluntary CDC smartphone-based monitoring program for COVID-19 

vaccine safety.33 It uses text messaging and web surveys to check in with vaccine recipients 

after vaccination. It solicits participant reports on local injection site reactions, systemic 

reactions, and health impacts. Parents can register and complete surveys on behalf of their 

child. The Vaccine Safety Datalink (VSD) is CDC’s EHR-based system for surveillance and 

research. It is a collaborative project between CDC and 9 integrated healthcare organizations. 

Rapid Cycle Analysis (RCA) is done in the VSD, which is near real-time sequential monitoring. 

The aims are to monitor the safety of COVID-19 vaccines weekly using prespecified outcomes 

of interest and to describe uptake of COVID-19 vaccines over time in the VSD population. 

The first part of this presentation focused on the safety of primary series vaccination in children 

6 months−5 years of age. Looking at US reports to VAERS after the primary series of Pfizer 

vaccine among children 6 months−4 years and of Moderna vaccines among children 6 

months−5 years of age, over 890,000 doses of Pfizer vaccine and over 664,000 doses of 

Moderna vaccine had been administered during the analysis period. There were 496 reports 

after receipt of Pfizer vaccine and 521 reports after Moderna vaccine. The key takeaway is that 

98% of these reports for both Pfizer and Moderna were classified as non-serious and there were 

no reports of myocarditis for either of these vaccines. The most frequent Medical Dictionary for 

Regulatory Activities (MedDRA) preferred terms34 in VAERS reports following the primary series 

of Pfizer and Moderna vaccines were very similar and primarily systemic reactions. 

In terms of v-safeSM enrollment among children following Pfizer and Moderna vaccination, about 

890,000 primary series of Pfizer vaccine have been administered to children 6 month through 

≤4 years of age and about 664,000 children 6 months through ≤5 years of age have received 

the primary series of Moderna. Enrollment in v-safeSM includes 14,725 children following 

Moderna vaccination and 8,541 children following Pfizer vaccine. In terms of health impacts 

reported in children aged 6 months to ≤2 years of in the 0 to 7 days following vaccination by 

dose, injection site reactions and systemic reactions are commonly reported for both Moderna 

and Pfizer vaccines. The reactogenicity profiles for Dose 1 are quite similar for Moderna and 

32 http://vaers.hhs.gov 33 https://vsafe.cdc.gov 34 https://www.meddra.org/how-to-use/basics/hierarchy 

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Pfizer vaccines. For Dose 2, there is higher reporting for injection site reactions, systemic 

reactions, and health impacts for Moderna that is not seen for Pfizer, for which there might be 

slightly lower reporting for Dose 2. Dose 3 data are not yet available for Pfizer, but this 

information will be available in the future as more time elapses. The patterns are similar for 

children 3−5 years of age, with injection and systemic reactions being fairly commonly reported 

after both vaccines. The Dose 1 reactogenicity profile for Moderna and Pfizer look quite similar, 

with some higher reporting for reactogenicity following Moderna but not for Pfizer. 

Moving onto VSD data, these are the VSD COVID-19 vaccine RCA pre-specified surveillance 

outcomes and the settings in which they are monitored: 

Based on the analysis period through August 13, 2022 about 50,000 Pfizer primary series doses 

and about 52,000 Moderna doses have been administered, so just over 100,000 total primary 

series mRNA COVID-19 vaccinations in the age groups 6 months–4 years (Pfizer-BioNTech) 

and 6 months–5 years (Moderna). To date, there have been no statistical signals detected for 

any prespecified surveillance outcomes for either mRNA COVID-19 vaccine. 

In summary of primary series vaccination in children ages 6 months−5 years of age, the initial 

safety findings of both mRNA COVID-19 vaccines are consistent with those observed in the 

clinical trials. Systemic and local reactions are commonly reported AEs. Vaccination errors also 

are being reported to VAERS. There have been no unexpected safety findings to date and there 

is no evidence of an increased risk for myocarditis following mRNA COVID-19 vaccination 

in children 6 months−5 years of age. 

Moving to COVID-19 vaccine safety of booster doses 6 months−5 years of age, based on 

reports to VAERS following first and second mRNA COVID-19 booster vaccinations for all 

mRNA vaccines combined, a substantial number of first booster doses and a decent number of 

second booster doses have been administered. A smaller number of first booster doses have 

been administered for children 5−11 years of age. Regarding the most frequent MedDRA 

preferred terms in reports to VAERS following the first booster dose in children ages 5−11 

years, the top 10 clinical outcomes are mainly systemic and local reactions. Among children ≥12

years of age, proportionately in these older age groups, there are not that many error reports 

than seen with the younger age groups. Many of the serious reports likely represent COVID-19 

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disease or signs and symptoms associated with COVID-19 disease. Vaccine breakthrough 

infection was reported in 618 out of 7,217 serious reports. Following the second booster dose in 

persons ≥50 years of age, there was a similar pattern of COVID-19 breakthrough disease and 

signs and symptoms likely associated with COVID-19 disease commonly reported for serious 

reports. 

VAERS reporting rates of verified myocarditis per million mRNA COVID-19 first and second 

booster vaccinations in the 0−7 days post-vaccination, males 12−29 years of age had elevated 

reporting rates for myocarditis compared to background rates. This was not seen for males in 

≥30 years of age or in any of the age groups for the females. There have not been any elevated 

reporting rates for males or females for second booster dose in individuals ≥50 years of age. 

This table compares VAERS reporting rates of verified myocarditis per 1 million mRNA COVID19 vaccinations of Pfizer-BioNTech and Moderna combined in Days 0–7 post-vaccination: 

The trend here is that the reporting rates for myocarditis per million doses administered 

in the Days 0−7 post-vaccination are consistently higher following Dose 2 compared to the first 

booster dose. They exceed background rates in the age groups of males 5−49 years of age and 

females from 12−29 years of age. A general trend here is that reporting rates for myocarditis 

appear to be higher for Dose 2 compared to the first booster dose. The caveat is that this is 

based on spontaneous reporting and is subject to reporting biases. 

Looking at data on reactions and health impact events reported by v-safeSM participants 5−11 

years of age at least once in Days 0−7after homologous Pfizer vaccination by dose, the takehome message is that reported reactogenicity (e.g., injection site, health impacts) tends to be 

fairly similar for booster doses compared to Dose 2 for Pfizer in this age group. Among 

adolescents 12−17 years of age, there are more self-reported local and systemic reactogenicity 

and health impacts are similar as in the younger children. Booster dose reactogenicity appears 

to be fairly similar to Dose 2 reactogenicity in this age group for Pfizer vaccination. Looking at vsafeSM participants ≥18 years of age, both Moderna and Pfizer are included because Moderna is 

available in this age group. For Moderna, there may be slightly more reporting of reactogenic 

events. The trend here is that the booster dose reactogenicity appears to be slightly lower than 

Dose 2 reactogenicity, but may be somewhat higher than Dose 1. Reported reactogenicity 

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following Moderna may be slightly higher than for Pfizer, but the same general pattern is 

observed for Pfizer as observed for Moderna. Booster dose reactogenicity may be slightly 

lower reporting for booster doses compared to Dose 2. In terms of individuals ≥50 years of age, 

second booster dose data were available. There was higher self-reported reactogenicity for 

Moderna compared to Pfizer. Dose 2 had the highest reported reactogenicity. For both vaccines 

there was a trend of decreasing reported reactogenicity for the first booster dose and the 

second booster dose after Dose 2 with a primary series. 

In terms of safety in the VSD, about 94,000 booster doses have been administered among 

children 5−11 years of age, about 265,000 in adolescents 12−16 years of age, and about 2.2 

million Moderna dose one booster doses and about 2.8 first booster doses for Pfizer among 

persons ≥18 years of age. In children 5−11 years of age for the first booster dose, there have 

been no statistical signals for any prespecified surveillance outcomes. In the 1−21-day risk 

interval after the first booster in people ≥12 years of age, there was a statistical signal for 

myocarditis and pericarditis in the combined Pfizer/Moderna grouping. These are individuals 

who received the Pfizer primary series and Pfizer first booster plus those who received the 

Moderna primary series and Moderna first booster. There were no signals for any other prespecified outcomes. 

A more detailed analysis was performed to assess the signal for myocarditis and pericarditis 

during the 0−7-day risk interval post-vaccine versus the comparison interval 22−42 days postvaccination with the first booster. Among persons 12−15 and 16−17 years of age from Pfizer 

data, for males 12−15 years of age, there was a statistically significant elevated adjusted rate 

ratio of 18.5 (1.85 – 551.84). That translates into 61.7 (20.0 – 143.9) excess cases per million 

doses administered in the 0−7-day risk interval compared to the 22−42-day post-vaccination 

control comparison interval. For persons 16−17 years of age, the adjusted rate ratio was not 

estimable because there was an 8 to 0 split between the intervals, but it was statistically 

significant because the lower bound of the confidence interval was 2.03. For person 18−39 

years of age for the combined doses and males with a primary series of Pfizer and a Pfizer 

booster, elevated adjusted rate ratios were observed that were statistically significant. 

Regarding VSD incidence rates of verified myocarditis/pericarditis in the 0–7 days after PfizerBioNTech vaccination in people 5–39 years of age following Dose 2 and the first booster dose, 

Most Dose 2 incidence rates were higher than the first booster dose incidence rate. However, 

the case counts were small case counts and the confidence intervals were wide, so there was 

not much statistical difference. However, there were exceptions. In persons 16−17 years of age 

for males and females, a higher incidence rate was seem following the first booster Dose 2 for 

males at 188 compared to 137 and for females at 36.4 compared to 9.3. However, the counts 

were relatively small and the confidence intervals were wide. Those estimates of the incidence 

rates were not statistically different. Regarding the Moderna incidence rates, data were 

available for persons 18−29 and 30−39 years of age, the incidence rates were higher for males 

than for females. 

In summary of mRNA COVID-19 vaccine safety of booster doses in people ≥5 years of age, the 

safety findings were generally consistent with those observed for primary series vaccination. 

The evidence suggests an increased risk for myocarditis following the first booster dose. 

However, myocarditis is a rare event following mRNA COVID-19 booster vaccine. CDC has 

verified 131 myocarditis case reports to VAERS in people ≥5 years of age after 123 million 

mRNA COVID-19 booster vaccinations. The risk is primarily observed in adolescent and young 

adult males. There has been no statistical signal for myocarditis to date in children 5−11 years 

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of age following the first booster dose. In VAERS data, the reporting rates of myocarditis are 

lower following the first booster dose versus Dose 2 of the primary series. As a reminder, the 

reporting rates are higher for Dose two compared to Dose 1 of the primary series. In VSD 

analyses, myocarditis and pericarditis incidence following the first booster dose and Dose 2 of 

the primary series were similar, though case counts were small and confidence intervals around 

point estimates were wide. 

CDC monitors the following pregnancy and reproductive health outcomes/topics in multiple 

systems including v-safeSM, the v-safeSM pregnancy registry, VSD, VAERS, and the Clinical 

Immunization Safety Assessment Project (CISA): 

For the outcomes studied, there have been no concerning findings for pregnancy and 

reproductive health outcomes following COVID-19 vaccination. Data on COVID-19 vaccine 

safety during pregnancy and reproductive health outcomes following vaccination will be 

presented during a future ACIP meeting. 

Discussion Summary 

Dr. Long asked whether there is any information on the interval between first and second dose 

in those who got myocarditis or did not and/or any information on the interval between Dose 2 

and the booster in the populations assessed and those who had myocarditis or not. This is so 

much more common after the second dose, perhaps there is some kind of existing underlying 

issue that predisposes certain people to myopericarditis. There generally is a longer interval 

between Dose 2 and the first booster, so it would be interesting to know by interval who had 

myopericarditis and whether the duration of the interval had any effect. Noting that about 50% of 

people in this age range had natural COVID-19 infection, with or with or without vaccine on 

board, she wondered whether there is any information on whether people who got myocarditis 

at the booster stage had a recent natural COVID-19 infection. 

Dr. Shimabukuro indicated that in the VSD, there was little variability in the interval between first 

and second doses. Because the schedule was followed closely, there is not enough variability 

there to draw any conclusions. There also is little variability in the interval between Dose 2 and 

the first booster dose. The case counts from myocarditis are still small, so there is not enough 

information on intervals to draw any firm conclusions about that at this time. The best data come 

from Canada where, because of differences in the recommendations in the provinces, there is 

substantial variability between the first and second doses of the primary series. Canada has 

data showing that the longer the interval between the doses, the lower the risk for myocarditis. 

While there is some evidence that extending the interval may reduce the risk of myocarditis, 

there is not enough variability in the US for a pretty rare outcome to be able to draw any 

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ACIP Meeting Summary September 1, 2022 

conclusions. However, it is worth looking into further. In terms of whether people who got 

myocarditis at the booster stage previously had natural COVID-19 infection, not every infection 

is captured in EHRs. Therefore, they do not always know for certain whether cases may have 

been infected. There are not sufficient data now to draw any conclusions about whether having 

natural infection and then receiving a booster may put people at higher risk for myocarditis than 

those who have not had natural infection who get a booster. 

Dr. Klein added that the myocarditis/pericarditis case definition for the VSD excludes individuals 

who had AIDS or COVID-19 infection 60 days prior to myocarditis. 

Dr. Poehling recalled that before the approval in this age group, there was a lot of discussion 

about the concern that the vials look very similar. She encouraged manufacturers to move 

forward to develop more distinct vials to reduce the likelihood of vaccine errors. 

Dr. Daley asked Dr. Shimabukuro to put the vaccines errors in VAERS in the context of other 

vaccines in terms of whether this is partially a function of the new vaccine or it reflects different 

doses in different ages, and whether he knew about SAEs among those who experienced 

vaccine administration errors. 

Dr. Shimabukuro indicated that there is evidence that when a new vaccine comes to market or 

there is a new recommendation for an age group, there are increases in reports of errors to 

VAERS during the initial uptake period while providers are getting use to the products. That 

tends to decrease over time, so this may be the reason for the current errors being reported. 

The problem also may be magnified by recommendations coming rapid fire, and then perhaps 

the issues regarding packaging. The overwhelming majority of these error reports do not report 

an adverse health event. When there are AEs associated with these error reports, they tend to 

be similar to what is seen in general. Looking at the data, there were no SAEs associated 

with one of the error reports among the younger children. For children 5−11 years of age, 4 of 

the events were classified as serious. Although they met the regulatory definition of serious, 

they did not appear to be clinically serious. The one concern might be that if a child gets an 

adult dose of an mRNA vaccine whether that will put them at increased risk for myocarditis. 

However, they have not seen a case of this occurring. 

Public Comment 

The floor was opened for public comment during the September 1, 2022 ACIP meeting at 12:20 

PM ET. All speakers submitted a request in advance of the meeting and the final list of public 

commenters was determined via a lottery. Everyone was reminded that the ACIP appreciates 

diverse viewpoints that are respectful in nature and issue-focused. The comments made during 

the meeting are included in this document. Members of the public also were invited to submit 

written public comments to ACIP through the Federal eRulemaking Portal under Docket No. 

CDC-2022-00103. Visit http://www.regulations.gov for access to the docket or to submit 

comments or read background documents and comments received. 

Elizabeth Fashing 

Parent of Two Children 

My name is Elizabeth Fashing. I am a parent to 1 children, one 9 and one just recently turned 5. 

I am asking our committee today to please not delay consideration of the booster availability to 

children under 12. Our whole family did get COVID-19 this past April, and 3 of us were fully 

vaccinated, but unfortunately my 4-year-old had to suffer the consequences of getting COVID 

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ACIP Meeting Summary September 1, 2022 

without the benefit of vaccine protection and he was the sickest among us. He had 

gastrointestinal issues and a high fever for a week, and I do not think that it was fair for him to 

have to suffer from this disease without the benefit of vaccine protection because of the delay in 

approving the vaccine for the under 5 population. And he is just now going to be fully vaccinated 

in about a week, because we just started the Pfizer series on him a couple of months ago as 

soon as it became available to his age group. I’m not a medical professional. I’m not a research 

scientist. I understand that there are special liability issues and considerations for studying 

medications in young children, but those cautions cannot be to the detriment of getting children 

access to life-saving vaccines. There is going to be another pandemic, and it could very well be 

more deadly to children, and we cannot delay them care due to over-cautions. So, I would like 

to ask that the administration of medical and vaccine trials be revamped to ensure that our most 

vulnerable are included from the beginning in trials. Thank you. 

Dorit Reiss, JD 

Professor of Law 

University of California 

Hastings College of the Law 

My name is Dorit Reiss. I am a Professor of Law at the University of California Hastings College 

of the Law. Thank you again for the opportunity to comment and for your thorough, careful work. 

I have 4 points to make. First, I’m concerned about the process for bringing the BA.5/BA.5 

boosters forward. FDA’s VRBPAC committee comes with very little data, and no human trials, 

and has not been reconvened, and there is still no direct human data. I think something like this 

needs more transparency to open deliberation, and I am grateful to ACIP for giving such a 

thorough deliberation of the data and knowing where it stands, but it would have been nice to 

have it earlier. I realize we have no other mitigation measures in place, that hundreds are dying 

every day, and there is real pressure to act, and it’s exactly at this time that expert agencies 

need to act to maintain confidence and cutting costs does not help. If lack of transparency 

decreases usage, where is the benefit? I also understand that ACIP needs to respond to what it 

has for a suggested recommendation, help with clarity, and to address all ages, which is good, 

but the process is concerning. Second, I’ve heard from colleagues in the medical field that there 

is substantial confusion as to when people should give boosters, including the new boosters, 

after a recent infection. Guidance from ACIP on the timing of boosters after reinfection would be 

really, really helpful in relation to the new one. Third, I want to remind everyone that Dr. 

Shimabukuro set out for us in detail the vaccines we currently use in the United States. Though 

Pfizer, Moderna, and Novavax have an extremely strong safety record, they’re not risk-free. But, 

the risks are small and, by and large, those thinking to deter others from vaccinating have to 

resort to misleading tactics like misrepresenting VAERS reports, misrepresenting non-casual 

reports from the trial data, and attributing death and harm to vaccine with no evidence or against 

the evidence. We could wish the vaccines were more effective against infection, but they’re safe 

and they prevent hospitalization and death as again described here. The extent of 

misinformation contained about the vaccine led to many unnecessary deaths and harm and is 

built on a tower of lies. And finally, I would like to ask again that the hardworking and dedicated 

ACIP staff put up the topic for an emergency meeting when you announce the emergency 

meeting. I think it will help people decide whether to request to comment and help them tailor 

comments before the meeting and not in align, like September emergency meeting. Aligning 

boosters would not be that much additional work. I know the staff has worked really hard 

over the last few years. 

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ACIP Meeting Summary September 1, 2022 

Patricia Neuenschwander, MSN, RN, CPCP 

Self 

I’ve been a nurse for over 28 years and have given public comment several times to this 

committee, but this one takes the cake. Let me start with the absurdity that you are asking for 

public comments before you present the data being used to evaluate the safety or efficacy of 

these products. The fact that this committee is meeting today to consider recommending 

products that have not gone through any human trials, you have gone from junk science to no 

science. The FDA granted Emergency Use Authorization yesterday without convening with the 

VRBPAC committee to provide any expert opinion. It’s absurd! Are you really going to use data 

extrapolated from different, unnamed experimental products or mouse studies to recommend 

these products to millions of Americans? You consider this rigorous science? Absurd! The study 

using the extrapolated Pfizer product, not the product you’re here for today, had 600 adults age 

55 or older, yet authorization is given for 12-year-olds and older? Absurd! After 1 month—1 

month using a rapidly waning product, the immune response of the participants who receive a 

new bivalent vaccine were [unclear]. What immune response data? No data on better protection 

from infection, transmission, hospitalization, or death? Just better antibody production? Which I 

will remind the committee has not been shown in randomized clinical studies to mean better 

protection. It’s absurd! The FDA says the safety data accumulated from the other experimental 

products is relevant to these products because, “they are manufactured using the same 

process.” So, any product that uses the same manufacturing process is deemed automatically 

safe? Absurd! Use of these products will require unvaccinated people to take 2 doses of the old 

vaccine with the original strain that’s been long gone before being eligible to take the new 

boosters. It’s absurd! The FDA says the booster you receive does not need to be from the same 

manufacturer as your primary vaccination or previous booster. Where is the clinical trial? It’s 

absurd! Providers should offer all vaccines for which a person is eligible for with this 

experimental product without any clinical trials? Absurd! If recommended, the new booster, by 

the way, fourth or fifth dose if you’re keeping score, with no long-term safety will be the CDC’s 

definition of up-to-date. This will impact millions of people’s abilities to maintain employment, 

attend school, go to college, or participate in any activity that has the requirement of being “fully 

vaccinated!” It’s absurd! You have the opportunity to do the ethical, morally right thing today. 

Help your providers blindly trust you. The data is not there, and you know it. Do not return us to 

unethical human experimentation. Put an end to this absurdity and require rigorous, large-scale 

clinical trials before you put your name on these products. Or you can choose to look the other 

way and potentially put millions of people in grave danger of harm. Please do your job. 

Mary Mahoney 

Advocate for Older Adults 

Good afternoon. My name is Mary Mahoney and I am speaking on behalf of myself and my 

family. I want to start by thanking this committee for your ongoing commitment to ensuring 

Americans have access to safe and effective protections against this devastating virus. As 

COVID-19 continues to evolve, I am encouraged to see how the science continues to evolve 

along with it. When the vaccines were initially approved and made available, each member of 

my family was eager to receive our dose. The vaccine has provided us with the protection we 

were desperately needing in order to return to so many meaningful aspects of our lives that had 

been on hold such as going to school, attending church, and being around the older adults that 

we love. When the booster shots were approved or recommended, we were just as eager to 

follow the guidance of this committee and our physicians in adding as much needed layers of 

protection. We now find ourselves once again looking to this advisory committee and the CDC 

for clear and straightforward guidance on who should receive the newly approved bivalent 

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ACIP Meeting Summary September 1, 2022 

booster doses and when. As my children head back to school, and we are all heading back into 

another flu and pneumonia season, we are eager to gain access to the best protection available 

to us to ensure a strong immunity as possible against COVID-19. I urge this committee to 

provide clear guidance on this, on the use of the new bivalent booster shots and that every 

eligible American understands how and when to take this next step in protecting ourselves and 

our families. Thank you for your time. 

Meghan Rapp 

Self 

Good afternoon. My name is Megan Rapp. I speak today to enthusiastically endorse boosters 

as a tool in preventing the spread of COVID and protecting against severe disease. I’d like to 

thank you for the work you are doing to make bivalent boosters available to people 12-plus. I 

also speak today on behalf of my 1 1/2-year-old daughter, Caroline, because Caroline is really 

too little to speak, though she can say “all done.” She is also too little to follow the CDC’s 

guidance on personal responsibility around COVID mitigation, such as assessing risk, wearing a 

mask, getting therapeutics, or accessing boosters. I speak today to call on you and other federal 

agencies like the FDA to immediately do everything in your power to stop leaving children like 

Caroline behind with regards to COVID. Let’s speak to the issue of vaccine uptake for under 5. 

Parents like me were told under 5 vaccines would be coming in February, then March, then 

April, etc. I kept asking CDC and FDA leadership, “When would my daughter be able to get a 

COVID vaccine, too?” “Soon,” you said. Children are vulnerable and this takes more time. I 

wonder why, for the most vulnerable, the agencies tasked with keeping my child safe instead 

allowed delays which left her more vulnerable and for longer. While we waited for that under 5 

vaccine rollout for Caroline, she and every single other toddler in her class got COVID. This 

artificially-created delay in taking more time for young children’s boosters will have the same 

impact. Kids will get COVID. Parents will decide that kids don’t need the booster since they just 

had COVID. Children get left behind on the next variant booster when the new strain crops up 

and the loop continues. Have we learned nothing from the primary vaccine rollout for children? 

Delays don’t magically increase vaccine update. I speak to urge you to create a plan for 

authorizing bivalent boosters for kids under 12 now, based on the same criteria for adults, 

similar to the way the annual flu vaccines are authorized. If you have legitimate reasons not to 

do this, we parents deserve to know. I deserve to know if Caroline will finally be able to go to a 

Christmas service this year or meet Santa in person. Please do better for Caroline and children 

who can’t assess personal risk and who are too little to wear a mask. Take decisive actions now 

to bring timelines together. Young children need access to boosters in order to be, as Caroline 

would say, “all done” with COVID, too. Thank you. 

Julie Boom, MD 

Texas Children’s Hospital 

Baylor College of Medicine 

Thank you. The last two and a half years have been a sobering reminder of the discomfort and 

devastation that infectious diseases can cause in our lives. Despite the relentless work of the 

medical and scientific communities to develop SARS COVID vaccines, we have lost over 

1,040,000 lives to COVID-19. In addition, over 200,000 US children have lost 1 or both parents 

to COVID-19. Gratefully, COVID-19 vaccines have dramatically decreased hospitalization rates 

and deaths since their implementation. Despite strong vaccine effectiveness and outstanding 

uptake by persons over 65 years of age, COVID-19 vaccine uptake has been suboptimal, 

especially amongst children. From a recent summary of CDC data shared by the American 

Academy of Pediatrics, 60% of teens 12 and older have received 2 doses of COVID-19 vaccine 

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ACIP Meeting Summary September 1, 2022 

doses, while only 30% of children 5 to 11 years of age have received 2 doses. Sadly only 7% of 

children 6 months to 5 years have received 1 or more COVID-19 vaccines. Even though 

children have experienced much lower hospitalization and death rates compared to adults, over 

1,700 children have died from COVID-19 since the beginning of the pandemic. As you examine 

the evidence to recommend bivalent COVID-19 boosters for persons 12 years and up, I urge 

you to consider one of the most important factors contributing to low vaccine uptake—vaccine 

hesitancy. Unfortunately, vaccine hesitancy is not only impacting COVID-19 vaccine, but also 

routine childhood vaccines. As evidenced by wastewater surveillance, polio myelitis has found 

its way back into United States and has caused a preventable case of paralysis in an 

unvaccinated adult in New York. Even though many thought a series pandemic would diminish 

anti-vaccine sentiment, the opposite has occurred. Espousing personal liberty and individualism, 

many have spread information on social media preying on worried parents, many who are just 

trying to do the best thing for their child. Beyond Polio, we are now faced with the spread of 

monkeypox. Sadly, the first US death from monkeypox occurred in my County, Harris County. 

At Texas Children’s Hospital, we are again working quickly and diligently to partner with our 

local and state health departments to ensure we can assist with vaccination of persons at risk 

or who have been exposed to monkeypox. As a general pediatrician with 27 years of experience 

and Director of the Immunization Project at Texas Children’s Hospital, I know that vaccines are 

the best way to protect persons from contagious diseases. We must do everything we can to 

eliminate vaccine-preventable diseases in our communities and globally, which includes not 

only recommending and administering vaccines, but clearly communicating vaccine safety and 

benefit information and to address misinformation and hesitancy. I urge you to give these 

factors your every consideration today. Thank you. 

Katherine Falk 

Parent and Vaccine Advocate 

Oakland, California 

I want to again thank the committee for all their work. I’ve commented before. We are in our 

third year with this pandemic, and while I’m excited about a new and hopefully better booster, 

I’m also somewhat trepidatious—not about any risk from the vaccine itself. I’ll be getting it along 

with my whole family as soon as we can, but about the public reception and willingness to take 

advantage of it. In Alameda County where I live, 90.4% of us got 1 shot, 83.3% got 2, but only 

56.4% got a booster. This is all ages. Combine this with the lack of real push for mask wearing 

anymore, and no wonder this season could have been referred to as hot zone summer. We 

need better communication and clear messaging from our public officials and the CDC, and for 

the booster, carefully managed expectations. The other thing I want to bring up is VAERS, 

because I’m seeing it brought up a lot online. Anti-vaxxers are hard at work as usual doing their 

utmost worst to scare people into skipping boosters for themselves and their children, and they 

are using VAERS as one of their tools. I’ve started describing VAERS to people as a tip line. I 

think that’s a good analogy since a tip line is an important part of any law enforcement or public 

safety system, even if some of the tips themselves are not helpful or even accurate. But I think 

the VAERS website could use some refreshing and the communication about what it is and isn’t 

needs to be clear and reiterated at every level. Thank you. 

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ACIP Meeting Summary September 1, 2022 

Abraham Alahmad, PhD 

Associate Professor in Pharmacology 

Texas Tech University Health Sciences Center 

Good afternoon. My name is Abraham Alahmad. I’m an Associate Professor in Pharmacology 

Texas Tech University Health Sciences Center. First, I would like to thank the committee and 

staff for outstanding effort to put forth in this meeting and the past and during this pandemic, 

ensuring that lifesaving vaccines are recommended in a transparent manner to the public. My 

only comment and concern today that I share with the committee is the rather confusing 

information about booster and vaccination rate among children below the age of 12, which had 

been lagging in uptake as we’re heading to the full winter season and time of the year. In the 

past year, have been shortly worsening when it comes to the most cases, hospitalizations, and 

deaths. These vaccines are very safe. They still hold on against Omicron variant. They have 

been quite a [unclear] here based on the number of COVID-19 admissions that appeared in the 

panhandle. This is possibly even more accented in rural areas. I have witnessed here [unclear]. 

To give you numbers, we only have yet to reach 50% of the population in the panhandle who 

have received 2 doses. We only have 20% with 1 booster dose. But [unclear] when it comes to 

cases, stressed healthcare system, [unclear] in the pandemic. It is unlikely due to vaccine 

shortages. In fact [inaudible] have been very successful in [unclear]. If the committee and CDC 

can improve the communication outreach to the public with clear, accessible information across 

the board, but also [unclear] behind vaccination rates, 

as the vaccine [unclear] have been very successful in seeing that and [unclear] this preparation 

it will be clearly appreciated. Thank you. 

Booster Doses of Moderna COVID-19 Vaccines in Adults, Adolescents, & Children 

Jacqueline Miller, MD (Moderna) presented data on Omicron booster-containing doses of 

Moderna COVID-19 vaccines in adults, adolescents, and children. For the Fall US booster 

campaign, Moderna is producing a 50 μg bivalent vaccine containing 25 μg of mRNA encoding 

the original strain by protein sequence and 25 μg encoding the sequence for the spike protein of 

BA.4/BA.5. The indication is for a single 50 μg booster administered at least 2 months after 

either completion of the primary series or receipt of a booster dose of any authorized or 

approved monovalent COVID-19 vaccine. 

Although mRNA-1273 protects against variants of concern, especially in the case of severe 

35, 36 disease, the purpose of adding mRNA encoding variant sequences to the booster doses is 

to improve the immunogenicity against Omicron lineages, which have remained dominant for 

the past 8 months; induce a broader cross-neutralization response to other potential variants of 

concern; and extend the duration of protection. Data consistently show the ability of these 

bivalent variant vaccines to address these goals. 

As the virus has continued to evolve, Moderna has evaluated 3 monovalent and 4 bivalent 

vaccine candidates designed to address variants of concern. More than 7,000 adults have 

received a booster dose of one of these vaccine candidates. Critical data are primarily available 

for the Beta (mRNA-1273.211) and Omicron BA.1 (mRNA-1273.214) vaccines. The BA.4/BA.5 

bivalent (mRNA-1273.222) vaccine was in a clinical trial that completed enrollment the previous 

week. Data are anticipated to be available at the end of the year. 

35 FDA Briefing Document for June 26, 2022 VRBPAC Meeting 36 WHO Interim Statement on the Composition of Current COVID-19 Vaccines (June 17, 2022) 

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ACIP Meeting Summary September 1, 2022 

To review the available clinical data for the bivalent SARS-CoV-2 vaccines targeting variants of 

concern, currently available clinical data includes safety, immunogenicity, and 6-month 

antibodies persistence data from 300 participants who received the Beta-containing bivalent 

vaccines. Median follow up in these subjects was 245 days after the third dose booster. 

After the fourth dose, safety and immunogenicity data are available in 437 participants who 

received the Omicron BA.1-containing vaccine who were followed for a median of 43 days. 

These clinical data form the basis of Moderna’s submission for bivalent boosters. There were 

also pending data from the 512 participants who were recently vaccinated with the Omicron 

BA.4/BA.5-containing vaccine. This trial completed enrollments the previous week and the data 

are expected later this year.37 

The demographic data from the study of the BA.1 bivalent vaccine were compared to the 

mRNA-1273 fourth dose control group. Third doses in these groups were given approximately 8 

months after completion of the primary series and the fourth dose was administered 

approximately 4.5 months after the third. About one quarter of the participants had evidence 

of prior SARS-CoV-2 infection at the pre-booster time point. Comparing the fourth dose BA.1 

Omicron-containing bivalent booster to post-dose 2 with mRNA-1273 post-dose 3 mRNA-1273, 

the solicited local adverse reactions included injection site pain, erythema, swelling, and axillary 

swelling and tenderness. The reported rates after Dose 2, 3, and 4 were at least similar or lower 

than mRNA-1273 second and third doses in the bivalent Omicron BA.1-containing fourth 

dose vaccine. Importantly, there were no Grade 4 events reported after the BA.1 booster. 

Looking at the same 3 groups in terms of the systemic solicited symptoms, both the frequency 

and severity of the solicited systemic reactions were observed to be lower after a bivalent fourth 

dose booster and after mRNA-1273 administered as a second or third dose. Once again, no 

Grade 4 reactions were reported after the BA.1-containing booster. In terms unsolicited AEs 

that were reported within 28 days after vaccination, rates of each category of AE were similar 

between the mRNA-1273 and BA.1 bivalent vaccine group. Among the 3 SAEs reported, cases 

of prostate cancer and traumatic fracture were reported in the BA.1 group and a single case of 

spinal osteoarthritis was reported in the mRNA-1273 group. None of these SAEs were 

considered by the investigators to be vaccine-related, and there were no cases of myoor pericarditis reported in either group. 

Regarding the immunogenicity analyses that were used in this study to infer effectiveness, the 

primary objectives of the study were to demonstrate the superiority of the BA.1-containing 

vaccine over mRNA-1273 in terms of neutralizing antibody responses to BA.1 and to 

demonstrate the non-inferiority of the bivalent vaccine to mRNA-1273 in terms of the original 

strain neutralizing antibody titers. For the BA.1 superiority hypotheses, there were 2 criteria to 

assess success. The first was that the BA.1 GMT ratio had to have a 97.5% confidence interval 

lower bound which exceeded 1.0. The actual ratio was 1.75 with a lower bound of 1.49, so this 

criterion was met. The second criterion was that the lower bound of the 97.5 confidence interval 

around the group difference seroresponse rate would exceed minus 10%. This was also met 

with a point estimate of 1.5% and a lower bound of minus 1.1%. In terms of the non-inferiority 

hypotheses to the immune responses against the original strain, the lower bound of the 97.5% 

confidence interval had to be greater than 0.67. This was met with a point estimate of 1.22 and 

a lower bound of 1.08. For the group difference in seroresponse rate, the lower bound had to be 

37 Chalkias et al. Research Square 2022, doi: 10.21203/rs.3.rs-1555201/v1; in press Nat Med; Chalkias et al. medRxiv 2022, doi: 

10.1101/2022.06.24.22276703; in press New Engl J Med 

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ACIP Meeting Summary September 1, 2022 

greater than -10%. This was also met as the response rate in both groups for 100%. Therefore, 

the study met the primary objective to demonstrate superiority in terms of BA.1 antibody titers 

and non-inferiority in terms of original strain neutralizing antibody titers. 

Importantly, the primary hypotheses were evaluated in subjects who had no evidence of prior 

infection. It is known that, at this moment in time, many vaccinated individuals have experienced 

SARS-CoV-2 infection. They comprised about a quarter of the participants in this particular 

study. In terms of the GMTs and the fold rises to BA.1 in all participants, regardless of previous 

SARS-CoV-2 infection, both the mRNA-1273 groups and the Omicron BA.1-containing bivalent 

vaccine, even the subjects with evidence of prior infection were observed to have substantially 

higher pre-vaccination titers derived benefits from the BA.1 bivalent vaccine, with a 4-fold rise in 

post-vaccination titers to Omicron BA.1. This exceeds the 2.5-fold rise observed in the mRNA1273 group and led to a GMC ratio of 1.9 and a lower bound of the 95% confidence interval of 

1.50. 

In terms of improved antibody titers the Omicron sublineages, the major objective is developing 

the bivalent vaccines. Regarding the antibody titers to BA.1 and the original strain, 

stratified by age group 18 to <65 years and greater than or equal to ≥65 years of age, postvaccination, the BA.1 bivalent vaccine was consistently immunogenic to both the original and 

BA.1 strain in subjects ≥65 years of age who are at increased risk for the severe complications 

of COVID-19. The observed antibody titers against the BA.1 variant of concern were higher with 

the bivalent vaccines compared to mRNA-1273, regardless of age stratum. Antibody titers to the 

original and BA.1 strain also were analyzed in subjects stratified by age. With both strains 

evaluated, the BA.1 bivalent vaccine was consistently immunogenic across age groups. The 

induction of cross-protection to other Omicron sublineages was another major objective 

for the development of the bivalent booster vaccine. 

The ability of antibody titers induced by BA.1 bivalent vaccine and mRNA-1273 to crossneutralize BA.4/BA.5 was analyzed, stratified by evidence of prior infection. Both vaccines 

demonstrated an increase in GMT to BA.4/BA.5, which showed evidence of crossneutralization. The higher antibody titers induced with a BA.1 booster offers a reason to 

anticipate that the BA.4/BA.5 bivalent vaccine will lead to improved antibody titers. The antibody 

titers also were stratified to BA.4/BA.5 by evidence of prior infection and age group. As 

observed with the BA.1 antibodies, the bivalent vaccine consistently induced numerically higher 

titers against BA.4/BA.5 across age strata, which indicates that those adults ≥65 years of age 

will also benefit from cross-protection conferred by the bivalent vaccine. Bivalent vaccines also 

were also developed to induce better cross-protection to strains which are not included in the 

vaccine. Looking at antibody titers and relative GMC ratios in terms of binding antibodies for the 

BA.1 bivalent vaccine compared to mRNA-1273 at 28 days post-vaccination, for all variants 

studies (Alpha, Beta, Delta, and Gamma), binding antibody titers were significantly higher 

with the BA.1 bivalent vaccine as compared to mRNA-1273. Recognizing that neutralizing 

antibody data also are important with this vaccine, Moderna is in the process of generating 

those data and will share them when available. 

Data also were analyzed with respect to antibody persistence, which is another important 

consideration for the bivalent vaccine. Data from the individuals who received the Betacontaining variant vaccines were compared to mRNA-1273 comparing a third dose to a third 

dose at Day 29 and then Day 181 or 6 months after vaccination. For the original strains with 

D614G and the Beta, Omicron, and Delta variants, the GMT ratio for the Beta strain was 

consistently higher than 1.0. Importantly, the GMC ratios increased even further to the original 

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ACIP Meeting Summary September 1, 2022 

strains, Beta and Omicron BA.1, at 6 months after vaccination, which suggests that the bivalent 

boosters may improve longer term cross-neutralizing antibody durability. 

Moving to specific data which have been generated with the BA.4/BA.5 bivalent vaccine, Dr. 

Miller presented the non-clinical data in mice that supported Moderna’s EUA submissions.38 

The BA.4/5 bivalent vaccine was evaluated in a murine animal model expressing a human 

ACE2 receptor. These mice previously were primed with mRNA-1273 and then were boosted 

approximately 31 weeks later with the BA.4/BA.5-containing bivalent vaccine, BA.1 bivalent 

vaccine, and mRNA 1273 with a sham vaccination. The two bivalent vaccines both induced 

statistically significantly higher antibody titers against the Omicron sublineages as compared to 

mRNA-1273. These mice were then challenged with 104 platforming units of a BA.5 strain 4 

weeks after the booster dose was given. As Moderna has consistently observed, results from its 

murine challenge studies correlated with observations in human clinical trials. These data are 

supportive of the immunogenicity of the BA.4/BA.5-containing bivalent vaccine. 

Moderna is generating data with booster doses in the pediatric population. Its submissions of 

booster data generated in children 12−17 and 6−11 years of age are currently ongoing to the 

FDA. The original pediatric studies were extended to evaluate booster studies of mRNA-1273 in 

these populations. Similar to adults where the booster is administered at half the dose of the 

primary series, adolescents received a booster of 50 g after a 100 g primary series. Children 

6−11 years of age received a 25 g booster after a primary series of 50 g. Moderna expects to 

complete these submissions by mid-September. In the youngest age stratum of children 6 

months−5 years of age, Moderna is evaluating a primary series with a bivalent BA.1-containing 

vaccines and booster doses with both mRNA-1273 and the BA.1 bivalent vaccine. Results from 

this trial should be available by the end of the year. They also are exploring ways to evaluate 

primary series and boosters with the BA.4/BA.5 vaccine. 

In summary, the bivalent booster vaccines have been generally well-tolerated in individuals ≥18 

years of age. Local and systemic reactogenicity are generally similar to or lower than that 

observed with Dose 2 and Dose 3 of mRNA-1273. No new safety concerns have been observed 

in Moderna’s booster vaccine studies. The prespecified immunogenicity objectives, 

which align with FDA guidance for the licensure of bivalent booster vaccines, were met for 

superiority to BA.1 and non-inferiority to the original strain. There were significantly higher 

antibody titers to BA.4/BA.5 with the BA.1 bivalent vaccine, and binding antibody titers were 

also higher than mRNA-1273 against more distant variants of concerns. Higher immune 

responses also were observed in individuals ≥65 years of age who are at the highest risk 

for the complications of severe COVID-19 disease. Moderna’s Beta-containing bivalent vaccines 

demonstrated improved durability of neutralizing antibodies compared to mRNA-1273 at 6 

months after vaccination. Preclinical data for the BA.4/BA.5-containing bivalent vaccine in mice 

is supportive of VE. This is being verified in an ongoing clinical trial. The bivalent BA.4/BA.5 

vaccine will be presented in a 2.5 mL vial. It is intended to have a 0.5 mL administration for 

adults ≥18 years of age. As Moderna is reducing the number of doses in the multi-dose vial, 

they are working toward the future looking for single syringe presentation. 

38 Scheaffer et al, manuscript under preparation 

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ACIP Meeting Summary September 1, 2022 

Discussion Summary 

Dr. Brook noted that in the presentation, Dr. Miller showed viral particles in the respiratory, 

upper respiratory, and lungs of the mice. In the clinical studies for the other age groups and with 

no booster, he asked whether they measured viral particles in the respiratory tract and if this 

was going to be considered a correlate of VE in adults. 

Dr. Miller indicated that the investigators conduct challenge studies in the mouse model prior to 

initiating the first clinical trials with mRNA-1273 and saw evidence that the vaccine is capable 

of inducing antibodies that can neutralize virus and protect against infection in the various areas 

of the respiratory tract. Ultimately, the best data come from human clinical trials. As they 

switched from the BA.1 variant vaccine that Moderna initially prepared to discuss at the 

VRBPAC meeting in June over the summer to the BA.4/BA.5-containing vaccine, they have 

been able to manufacture doses and conduct the clinical trials in the mice more quickly than 

they have been able to execute the human clinical trial. Data further supporting the BA.4/BA.5 

will come from the clinical trial for which enrollment just completed, which they will present later 

this year. The Beta-containing variants and the BA.1-containing variant vaccines both performed 

in a similar way, demonstrating superior antibody titers to the variant of concern as compared to 

mRNA-1273 and noninferiority to the original strain. Moderna believes that the consistency of 

the clinical results are the basis on which they are licensing or authorizing the vaccine. 

Dr. Edwards, Moderna, added that he has led the research for SARS-CoV-2 vaccines for the 

last 2.5 years. In terms of the animal studies performed over the course of the development of 

the original vaccine and in the evaluation of the bivalent vaccines is what was represented as a 

common measurement that Moderna performs in animal studies. That includes mouse, 

hamster, and non-human primate (NHP) studies. It is a good measurement to indicate the level 

of protection that is provided for the different vaccine regimens. Unfortunately, it is not 

something that can be performed clinically due to constraints around certain types of sampling 

that they could perform within clinical studies. That is why they have relied on either efficacy 

measurements or post-clinical observations in order to establish efficacy. 

Dr. Cineas asked whether there are data on breakthrough clinical cases in the BA.1 group 

versus mRNA-1273 or whether there has not been enough follow-up time for those data. 

Dr. Miller indicated that they do not yet have those data for the BA.4/BA.5-containing vaccine. 

Because they have the median of 43 days of follow-up after BA.1, they do have those data. 

There are disease incidence rates in the mRNA-1273 groups versus the BA.1-containing 

vaccine groups that were followed and compared. They were followed both for subjects with no 

evidence of prior infection and subjects with evidence of prior infection. In the BA.1 bivalent 

group, the incidence rate was 2.5%. In the mRNA-1273 group, the rate was 2.4%. 

Referring to Slide 18, Ms. Bahta recalled that Dr. Miller mentioned “significantly higher. To her, it 

appeared that the confidence intervals were overlapping. 

Dr. Miller indicated that the GMRs were shown in the top bar immediately below the name of the 

variant of concern (VOC), followed by a 95% confidence interval. Those 95% confidence 

intervals are all above the value of 1.0. These are the between group comparisons that were 

performed in an exploratory fashion to look at comparisons between groups. They do need to 

be interpreted conservatively because the multiplicity adjustments are made for the primary 

endpoints of the trial. Moderna feels that these data are indicative that they may expect to see 

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ACIP Meeting Summary September 1, 2022 

higher neutralizing antibody titers as they have seen for the Beta-containing vaccine at 28 days 

after vaccination and higher GMRs and tighter confidence intervals after 6 months. 

Dr. Sanchez emphasized that these vaccines are needed to cover other barriers. Referring to 

Slide 25, he asked whether the studies planned in children 6 months−5 years of age also will be 

with the BA.1 vaccine. 

Dr. Miller confirmed that those studies are also with the BA.1 vaccine, but they also have been 

requested to conduct clinical trial work with the BA.4/BA.5 vaccine. They are currently in the 

process of figuring out the best way to do that in the pediatric population. The strategy all along 

has been to generate data as quickly as possible to enable implementation of a vaccination 

program before the Fall/Winter cold and influenza season by bracketing investigations of the 

bivalent vaccine in adults, particularly in the oldest adults ≥65, and then in the youngest children 

6 months−5 years of age to provide a view of the antibody titers at both of the extremes of age. 

Moderna is extending the Kaiser effectiveness study that they have talked about a number of 

times with ACIP to look at the BA.4/B.5. That protocol is being extended down to 6 months of 

age into booster doses for the pediatric population. That may be the best evidence with which 

they will be able to demonstrate in the future. 

Dr. Sanchez expressed concern about the data presented in humans on the BA.1 vaccine. 

While it certainly looks very promising and he understood the constant shift of variants, the 

studies with BA.4/BA.5 are ongoing in humans. He wondered whether that was premature. 

Dr. Miller reiterated that the clinical data Moderna prepared for the Fall campaign was assuming 

predominance of the BA.1 strain for Omicron. That is why they have analyze the BA.4/BA.5 

neutralizing capability of the BA.1 vaccine, because the 2 Omicron sublineages are obviously 

related. There is about a 4-mutation difference between them as opposed to about a 35-

mutation difference between the original strain and the BA.1 Omicron vaccine. They will 

continue to generate the BA.4/BA.5-containing data. Moderna anticipates that just as the Betacontaining variants and the BA.1-containing various bivalent data were consistent with each 

other, both in terms of safety and the patterns of immunogenicity, there will be improved 

immunogenicity to VOCs both for the sequence in the vaccine but also across other variants of 

concern as compared to the original strain. In the safety data and the reducing reactogenicity 

profile that they see after subsequent doses have been consistent between both of the bivalent 

formulations study. She thinks continuing to study BA.4/BA.5 is the best they can do to be able 

to be ready for the Fall cold and winter influenza season with a vaccine that best matches the 

current circulating strain. The data look excellent for the BA.1 variant. 

Dr. Poehling observed that in clinical studies, the longest follow-up at 245 days would be with 

the Beta variant bivalent vaccine. One of the major questions regards the extent to which 

waning is seen. She asked whether clinical data are available on the waning with the Beta 

variant over the 245 days. 

Dr. Miller said the reason Moderna has data from the Beta variants is because the Beta variant 

emerged in Fall of 2020, so they have had longer to follow those subjects than with the BA.1-

containing variant, which emerged around Thanksgiving of 2021. In all cases, the antibody titers 

with the Beta bivalent-containing vaccine are numerically higher than what is seen with an 

mRNA-1273 vaccine. The distance between the 2 actually increases at the 6-month time point 

and Moderna believes that there is a biologic basis for this. That is actually why they advocated 

fairly strongly for the bivalent composition. When the mRNA in a bivalent formulation is 

delivered to the cell, the mRNA for the original strain spike sequence and for whatever bivalent33 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary September 1, 2022 

containing sequences are delivered to the cell, which means that the ribosomes are translating 

in the same cell strands of both the original and the variant of concerns, these amino acid 

chains still naturally assemble into trimers. Moderna has been working with the University of 

Washington and has been able to demonstrate in a publication that they are in the process of 

submitting, that heterotrimers are actually formed. What that means is that unlike with the 

original 1273 where the original 3-spike sequence is the only one available, they have 

sequences from both the original strain and the variant of concerns. This actually leads to more 

open confirmation and exposure of additional antigens. They believe that t is exposure to those 

additional antigens that leads to the improved antibody persistence, not only against the variant 

of concern but against the original strain and other variants as well. 

Dr. Kotton noted that about the 3% of the US population is estimated to be 

immunocompromised. She asked whether they were included in any of these cohorts and if 

there are further data or plans for studying that population, which has been exceptionally 

vulnerable to COVID-19. 

Dr. Miller reported that they have conducted a separate Moderna-sponsored clinical trial in 

patients with solid organ transplants and also supported a collaborator in a clinical trial 

investigating booster doses in patients with solid tumors and hematologic cancers. In both 

cases, they have been able to observe that the vaccine is immunogenic and lead to additional 

immune responses. In the cancer population, they studied 3 doses. In the transplant population, 

they studied up to 4 doses. Those data are actually going to form part of the basis of Moderna’s

supplemental BLA (sBLA) for booster dose full licensure as opposed to EUA authorization. They 

are actively working on that submission now in order by the end of the year to prepare for the 

2023 season. 

Dr. Kotton indicated that having access to those data would help to better inform patients as to 

what the best plan would be for them. 

Dr. Miller indicated that the data in cancer patients already has been published and they will 

share that publication with the committee. The data from the solid organ transplant patients also 

can be shared with the committee. 

Ms. McNally indicated that as the Consumer Representative for ACIP, she wanted to try to distill 

down an issue for the public in terms of the extent, if any, to which Moderna’s research and 

development process differed in the creation of the bivalent vaccine from the original vaccine. 

Dr. Miller indicated that the original vaccine was part of a clinical development program that 

included the Phase 1, 2, and 3 clinical trials. Moderna views the bivalent vaccines as extensions 

of the SARS-CoV-2 virus much like the influenza vaccine is changed every year as the influenza 

virus evolves. Instead of a full efficacy trial each year as is done with influenza vaccines, they 

are measuring immune responses and inferring effectiveness, because they have observed that 

immune responses correlate with protection against disease. Those are data that Moderna has 

published in conjunction with the NIH recently in Science. Moving forward, as they have done 

with influenza vaccines, they will continue to evaluate the clinical data, compare those immune 

responses, and show the consistency to the original clinical trial. 

Dr. Loehr recognized that these are animal studies for the BA.4/BA.5 variants and agreed that in 

the future, there are likely to be more variants that should be treated in the same way as 

influenza variants if there is evidence that the pattern seems to flow smoothly and new variants 

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ACIP Meeting Summary September 1, 2022 

can be used every year. After thinking about it, he was comfortable even though there are only 

animal data and there are no human data supporting the BA.4/BA.5 variants booster. 

Dr. Duchin, NACCHO, recalled Dr. Miller stating that the mouse study data accurately predicted 

what is known now through human data for the mRNA-1273 variant and requested that she say 

more about that to help people understand the relevance of the mouse data and how it is has 

been a useful and accurate predictor of what is seen in humans. 

Dr. Miller said the value of this particular murine model is that the animals express the human 

ACE2 receptor. The reason that is important is that the ACE2 receptor in humans is actually the 

port of entry into human cells by this virus. By using an animal that is expressing that same 

protein, it is possible to see the impact of the biology the vaccine has on the animal that would 

be susceptible to infection in the same way a human would be. 

Dr. Edwards, Moderna, added that Moderna has 2.5 years of experience with these animal 

models and how they do correlate to human immune responses. They have seen very good 

correlation between effective doses and effective bivalent vaccines between mice, NHP, and 

humans to this point. One particularly relevant point is that in these animal studies, they 

measure the impact of variants on neutralizing titers. F-or example, a BA.1 neutralizing titer in a 

mouse vaccinated with 1273 is many-fold reduced versus the original strain. They see the same 

thing recapitulated when assessing human sera. Both from an immunogenicity standpoint and 

an impact of variants standpoint, these animal models have translated very well. 

Dr. Sanchez asked about studies in pregnancy and, to get an idea of how the vaccine is 

formulated, whether the 2 different mRNA strains are encoding the different spike protein and it 

is just 1 strand that codes both and if the ultimate protein crosses the placenta. 

Dr. Miller reported that Moderna is conducting a safety follow-up study in pregnant women. 

There is a registry in which the study is currently ongoing through which approximately 800 

pregnancies overall will be examined. In terms of the regarding mRNA sequences, there are 2 

distinct mRNA sequences. The first sequence is the original sequence that was in mRNA-1273. 

It encodes for the full-length spike protein from the original Wuhan strain. The second sequence 

includes the sequence from a BA.4/BA.5. It is important to note that the spike protein sequence 

is identical from BA.4/BA.5, which is why if is referred to it as a BA.4/5 sequence. Those 2 are 

individual sequences on lipid nanoparticles. More than 1 lipid nanoparticle is able to enter the 

cell, which is how both mRNA sequences are able to be translated inside the same cell. In 

terms of transfer across the placenta, Moderna has conducted developmental and reproductive 

toxicology studies with mRNA-1273 as well as other vaccines in its pipeline and they do not see 

that the pregnancy or fetus is impacted by vaccination. 

Dr. Edwards, Moderna, added that the mRNAs that are included are co-formulated in the same 

lipid nanoparticles and then delivered to the same cells. Further, they also introduced to both 

mRNAs the 2 proline mutations that stabilize the conformation of the spike protein into the 

prefusion conformation. In terms of pregnancy, they have evidence from animal studies that 

there is placental transfer of both IgG and to a limited degree IgA. That also includes maternal 

transfer via breast milk. In terms of the protein that is generated by the mRNA and whether that 

crosses the placenta, Moderna has done developmental and reproductive toxicity studies. 

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ACIP Meeting Summary September 1, 2022 

Dr. Miller added that this protein has been engineered to be cell surface expressed, so it is not a 

protein that is secreted in the same way that a subunit protein might be injected and flowing 

freely. It is mRNA that is entering the cells, and then the protein itself is cell surface expressed. 

It is not secreted protein. 

Referring to Slide 7, Dr. Lee noted that the interval between the third and the fourth dose looks 

like the average is 4.5 months, but the lower range is around 3 months. The lower bound of 

approval is 2 months from the last prior dose or the last dose and he wondered whether there 

are any safety data for that 2- to 3-month window. 

Dr. Miller indicated that Moderna is generating data with respect to the 2-month window in 

collaboration with the National Institutes of Health (NIH). The data available now comes from 

previous collaborations with the NIH in the 3-month window. The 2-month window was 

requested of them based on the desire to make boosters available prior to potential increases in 

infection rates. 

Doran Fink, FDA, confirmed that this was correct. There are no clinical trial data or significant 

real-world data with a booster dose at a 2-month interval. However, there are data with booster 

dose intervals ranging from 3 through 6, 7, and 8 months or longer for vaccine reactogenicity 

that do not seem to show a difference in the level of reactogenicity compared to the interval. 

One specific concern about the interval is the risk of vaccine-associated myocarditis that has 

been observed most prominently following the second primary series dose and also a first 

booster dose in certain populations. They do not have data one way or another that would 

suggest that a risk of myocarditis would be higher or lower following an interval of 2 months as 

opposed to 3 months. Frankly, any clinical trials of the size that FDA is able to look at for 

considering the authorization of these booster doses would not be adequately powered to look 

at the myocarditis anyway. They do have experience, as the committee knows, with the risk 

of myocarditis relative to the primary series interval between first and second doses. Those data 

indicate that the risk when the primary series doses are separated by at least 2 months appears 

to be lower than when the primary series doses are administered closer together and there is no 

further reduced risk with interval longer than 2 months. Based on the totality of evidence that 

FDA has, and also considering the timeliness of making this booster dose available to 

individuals who may have received their last vaccination more recently, those considerations 

underlie FDA’s decision to authorize these bivalent boosters with a minimum interval of at least 

2 months. He stressed that FDA understands that most people who would be eligible for these 

second boosters will have received their last COVID-19 vaccination well beyond 2 months 

previously. Therefore, there is a relatively small fraction of individuals who might be considering 

getting one of these bivalent boosters at an interval of close to 2 months. 

Dr. Lee recalled that a question was raised during the last ACIP meeting and earlier in this 

meeting regarding the VAERS AE reporting regarding potential administration errors and the 

concern that the committee has had with regard to labeling. She requested further information 

about single dose syringes in terms of whether there are any plans to modify or make the 

labeling clearer to minimize the risk of administration errors going forward. 

Dr. Miller indicated that it is the intent to get to product-specific presentation for each individual 

presentation. 

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ACIP Meeting Summary September 1, 2022 

Dr. Mustafa, Moderna, added that it is in Moderna’s forecast to move to a specific presentation 

by age. As they move out of the pandemic configuration, they have this as part of their longrange strategic planning for having specific use presentations. 

Dr. Lee emphasized that it would be helpful for ACIP to hear a clear plan from both 

manufacturers regarding the timing for when changes would occur to the labeling. There are 

many administration errors that seem disproportionate to what has been seen with other 

vaccines or with the adult vaccines. She feels strongly that anything that can be done to support 

implementation by providers, public health, and pharmacists would be extremely helpful 

in the delivery of these vaccines and getting them to the children who need them. 

Pfizer-BioNTech COVID-19 Omicron-Modified Bivalent Vaccine 

Kena Swanson, PhD (Pfizer) presented immunogenicity and safety data today for PfizerBioNTech’s bivalent Omicron-modified variant vaccine. She emphasized that throughout the 

pandemic, SARS-CoV-2 variant epidemiology has been rapidly changing. In particular, there 

has been the emergence of the more antigenically distinct Omicron variants of concerns with 

demonstrated increased transmissibility and evidence for partial immune escape. With that in 

mind, the focus of this discussion was on the bivalent vaccines that include an Omicron 

BA.4/BA.5 component to address COVID-19 due not only to the Omicron sublineages, but also 

due to potential subsequent variants of concern. 

Over the past 2-plus years, Pfizer-BioNTech has gained substantial clinical experience with 

variant modifying vaccines across different age groups. This was first evaluated early in the 

pandemic when the Beta variant of concern was of particular interest when it initially emerged. 

Pfizer-BioNTech evaluated a monovalent form of the Beta variant-modified vaccine in 

individuals 18−55 years of age, both as a primary series and as a third and fourth dose booster. 

More recently, they have subsequently evaluated the Omicron BA.1 variant-modified vaccine 

both as a monovalent formulation in adults 18−55 years of age as primary series and fourth 

dose booster and a bivalent formulation in adults ≥55 years of age. Pfizer also has an ongoing 

study of the bivalent BA.1 vaccine in adults 18−55 years of age. Throughout the clinical 

evaluation of each of these vaccines, the pre-clinical data also generated with these same 

formulations have reliably predicted responses in humans. That is across the Omicron BA.1 

both monovalent and bivalent data. In terms of the focus of the day’s discussion being Omicron 

BA.4/BA.5 bivalent vaccine, Pfizer has an ongoing clinical study evaluating this vaccine in 

individuals 12−55 years of age and >55 years of age. Dr. Swanson described some of the preclinical data that has shown some evidence which it is anticipated will be translated to 

observations in humans as in the prior pre-clinical evaluation of variant-modified vaccines. 

In terms of immunogenicity data with Pfizer-BioNTech Omicron BA.1-containing variant 

vaccines, C4591031 Substudy D included approximately 1,420 participants 18−55 years of age 

in which a primary titer series of the monovalent Omicron BA.1-containing vaccine was 

evaluated at a 30 μg dose level. These participants had no evidence of prior SARS-CoV-2 

infection. Looking at serum neutralizing titers 1 month after the second dose of a primary series 

of the monovalent Omicron BA.1 vaccine compared to the USA Washington 2020 and Delta 

strains, a very Omicron-specific neutralizing response was observed with a monovalent 

Omicron BA.1 vaccine in naïve individuals. Looking at pre-clinical data, the same monovalent 

Omicron BA.1-containing vaccine was evaluated at the same dose regimen at Day 0 and Day 

21 in naïve mice. This was at a dose level of 0.5 μg. Again, there was a very Omicron-specific 

response. In addition, neutralization was evaluated against not only the reference strain, but 

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ACIP Meeting Summary September 1, 2022 

also Beta and Delta. The original ancestral strain spike combined with the Omicron BA.1 spike 

elicits a more balanced immune response across the different variants of concerns, including 

the reference strain in this preclinical study. This provides some evidence to support that 

bivalent vaccine will provide a better and broader immune response compared to a monovalent 

approach in a naïve background. 

Study C4591031 Substudy E evaluated the bivalent Omicron BA.1-containing vaccine among 

approximately 1920 participants >55 years of age who received either the bivalent Omicron 

BA.1-containing vaccine administered as a 30 μg fourth dose or the or the prototype vaccine 

administered as a 30 μg fourth dose. Dose 4 was administered at a median of 6.3 months from 

Dose 3. One goal was to understand the Omicron BA.1 neutralizing antibody response as part 

of the evaluation of the superiority criteria that needed to be met in order to demonstrate a 

substantial improvement in the Omicron BA.1 neutralizing response with the bivalent vaccine 

compared to the prototype. In order to meet superiority criteria, the GMR of the neutralizing 

response in the bivalent vaccine had to be >1.0 to meet simple superiority criteria for the lower 

bound of the 95% confidence interval. Superiority was met with a lower bound of 1.17 and a 

GMR of 1.56. Looking at the Omicron BA.1 neutralization response but instead of GMR now 

evaluating seroresponse rate, the seroresponse noninferiority criterion that needed to be met 

was a lower bound of the 95% confidence interval for the percentage difference in response 

rates between the bivalent vaccine group and the prototype vaccine group being > -5. The lower 

bound of the confidence intervals for the bivalent vaccine was > -5, which had a lower bound of 

4.0. Therefore, noninferiority was met for the seroresponse rates. 

Now looking at before vaccination and 1-month post-dose, a substantial increase was observed 

in Omicron BA.1 neutralization activity in the bivalent vaccine-containing group compared to the 

prototype. The geometric mean fold rise (GMFR) from before vaccination and 1-month postfourth dose was 9.12 for the bivalent vaccine compared to 5.8 for the prototype. Moving beyond 

the Omicron BA.1 neutralizing response also was important in the bivalent composition, which 

also includes the original ancestral sites to demonstrate noninferiority of the reference strain 

neutralizing response, used a validated SARS-CoV-2 neutralization assay. In this case for 

noninferiority criteria, the lower bound the 95% confidence intervals GMR between the bivalent 

and the prototype vaccine was required to be >0.67. The GMR was 0.99 with a lower bound of 

0.82, so the noninferiority criterion was met. 

To summarize the safety data, the reactogenicity profile of the bivalent Omicron BA.1-containing 

vaccines given as a fourth dose was compared to the prototype vaccine given as a fourth dose 

in this same study in participants >55 years of age. The reactogenicity profile was very similar 

between the variant-modified vaccine compared to the prototype vaccine. There also are data 

showing similar trends in the original data variants modified vaccine studies and with the 

monovalent Omicron BA.1-containing vaccines. Over time, there has been the emergence of 

the BA.4 variant and now the dominance of the BA.5 variant. These 2 sublineages include the 

same spike antigen. The neutralization activity was evaluated with the prototype vaccine group 

preceding the fourth dose and the Omicron BA.1-containing vaccines at the fourth dose, which 

showed a nice increase in the Omicron neutralizing response. In this subset analysis, 

neutralization of BA.4/5 was observed. However, this was reduced compared to the BA.1 

variant, which was why Pfizer subsequently went on to evaluate a BA.4/BA.5-containing bivalent 

vaccine. Looking at the booster settings of the Omicron BA.1 monovalent and bivalent vaccines 

in mice that have received 2 prior doses of the original BNT162 V2 vaccines, similar trends were 

observed. There were improved Omicron neutralizing responses in the Omicron-containing 

vaccine groups and reduced neutralization activity against the BA.4/BA.5 variants. This is a nice 

translation of preclinical to clinical data. 

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ACIP Meeting Summary September 1, 2022 

In terms of the BA.4/BA.5 monovalent and bivalent vaccine compositions that were evaluated as 

a booster dose, again looking at a third dose in mice that previously received 2 doses of the 

BNT162b2 vaccine, the neutralization data were 7 days post-third dose. This analysis evaluated 

neutralization activity against the ancestral strain, which in this case was Wuhan 21, compared 

to the Omicron sublineages BA.1, BA.2, BA.2.12.1, and BA.4/BA.55. The key takeaway for this 

analysis was that there was a more balanced immune response against the Omicron 

sublineages with the 4/5 containing vaccines, including substantial increases in the matched 

strains of BA.4/BA.5 compared to the Omicron BA.1 monovalent and the prototype vaccine. 

Following this initial evaluation in mice, a follow-on study was performed to confirm these 

results. This confirmatory study showed that Omicron BA.4/BA.5 monovalent and bivalent 

boosters in mice substantially increased Omicron neutralization responses to all omicron 

variants, including BA.4/BA.5. 

To summarize the Omicron BA.4/BA.5-modified variant vaccine, Pfizer-BioNTech has shown 

that the reactogenicity profile of the various vaccines that have been evaluated clinically (Beta, 

Omicron BA.1) are similar overall to the prototype BNT162b2 vaccine. Alpha and Delta also 

were evaluated in prior clinical studies. In each of these studies, the reactogenicity profile has 

been similar to the prototype vaccine, BNT162b2. The evaluation of the Omicron BA.1-

containing vaccines, both monovalent and bivalent, demonstrated superiority for the Omicron 

BA.1 GMR, non-inferiority for the seroresponse, and non-inferiority for the reference strain 

GMR. Across the evaluation of variant-modified vaccines to date, pre-clinical immunogenicity 

data have reliably predicted observations in humans. Including the latest Omicron BA.4/BA.5 

modified variant of vaccine booster in mice improved neutralizing responses across Omicron 

sublineages. Collectively, similar trends are anticipated in the ongoing BA.4/BA.5 bivalent 

clinical study. An EUA has been granted for use of the bivalent Omicron BA.4/BA.5 variantmodified vaccine at the 30 μg dose level as a booster dose for eligible populations ≥12 years of 

age. There will be further clinical evaluation of a BA.4/BA.5 bivalent vaccine in pediatric 

populations. 

Discussion Summary 

Ms. McNally said that as the ACIP’s Consumer Representative, she wanted to ask Dr. Swanson 

the same question shed asked Dr. Miller regarding the extent to which Pfizer’s research and 

development process differed in the creation of this vaccine from the original vaccine. 

Dr. Swanson responded that it is important to note that from the first modified vaccine that Pfizer 

evaluated, the Beta monovalent, through the current Omicron BA.4/BA.5, the only change has 

been in the variant-specific sequence changes in the mRNA itself. All of the processes for 

making the mRNA drug substance and formulating it into the lipid nanoparticle follow the exact 

process as has been used throughout generation of the COVID-19 vaccine, the BNT162b2. 

Dr. Poehling asked whether Pfizer has any long-term data among its variant studies in humans 

on what is known about the persistence or the waning of the immune response. 

Dr. Swanson indicated that Pfizer has on-going follow-up to assess the duration of the antibody 

response in their clinical studies. They are still following out to a later time point of 6 months and 

beyond. The data they currently have available on persistence would be in a subset of 

participants who received 3 doses of the BNT162b2 prototype vaccine. They evaluated activity 

against the reference strains and the Omicron BA.1 variant of concern at the time. This was 

before BA.4/BA.5 emerged. Similar antibody decay rates are seen between the reference strain 

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ACIP Meeting Summary September 1, 2022 

and Omicron BA.1 at least out to 5 months after Dose 3. Pfizer is continuing to follow the overall 

kinetics with more subjects and more time. 

Dr. Kotton asked what work is underway for immunocompromised patients and what information 

might inform decision-making for this vulnerable population. 

Dr. Swanson indicated that Pfizer is conducting a study on immune compromised individuals. 

To date, the enrollment rate has not been as expected. While vaccination in this population is 

generally recommended, there are no data at this point specific to that study in the 

immunocompromised group. 

Dr. Kitchin added that with broad recommendations in most countries for immunocompromised 

persons to be vaccinated in the face of the threat of SARS-CoV-2, it still has been difficult to 

enroll individuals into clinical trials. Therefore, they do not have data yet in that population. They 

do not currently have any ongoing studies of administration of the bivalent BA.4/BA.5 vaccine in 

immunocompromised individuals. 

Dr. Kotton emphasized that this makes it challenging for ACIP to think about how to best couch 

its recommendations, so she encouraged studies in this highly vulnerable population. 

Dr. Sanchez said his comments would be similar for Pfizer as for Moderna in terms of the 

packaging of this vaccine and studies on pregnancy. Referring to Slide 17, he asked about the 

monovalent versus bivalent presentation of the variant vaccine in terms of immunogenicity, 

potentially generating lower antibody neutralization titers, and the potential for more rapid 

decay. 

Dr. Swanson indicated that in the clinical study among individuals >55 years of age, monovalent 

Omicron BA.1 versus bivalent Omicron BA.1 was evaluated. There was a trend for slightly 

higher Omicron BA.1 neutralizing responses in the monovalent vaccine group compared to the 

bivalent group. While she did not think it could be speculated as to whether that difference was 

clinically meaningful, similar trends are being seen preclinically, with slightly higher strain 

matched responses with monovalent versus bivalent presentation with the BA.1-containing and 

the BA.4/5-containing vaccines. She referred back to the primary series immunogenicity data 

that showed clear benefit of having that bivalent composition. The goal is to ensure that they are 

solving for the current circulating variants, but also anticipating potential future variants by 

applying that bivalent approach. In term of whether there is a statistically significant decrease in 

titers when the monovalent and BA.4/5 are combined, Dr. Swanson said did not think so and 

recalled that the confidence intervals were overlapping. In terms of pregnancy, they have an 

ongoing study within pregnant women. They have run into similar challenges with enrollment, 

given that the vaccine was made available for this group. 

Dr. Kitchin added that the data analyses are still ongoing in the study conducted in pregnant 

women, which is following the pregnant women and their infants. That study originated with the 

original vaccine, but Pfizer will be generating data from that study despite the difficulties in 

enrollment. 

Dr. Daley asked what Pfizer’s specific plans are concerning presentation of any pediatric 

products to minimize dose administration errors and what the timeline would be for those plans. 

Dr. Swanson recalled that there also was a similar question regarding the current rollout of the 

BA.4/BA.5 for persons ≥12 years of age and older. 

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ACIP Meeting Summary September 1, 2022 

Referring to Slide 38 from the back-up slides, Dr. Levine indicated that the bivalent Omicroncontaining vaccine will retain the gray cap as per the original vaccine. The reason for this is that 

the Omicron-containing bivalent vaccine is essentially the same drug product and contains the 

same formulation as the original vaccine, albeit it contains the different strain much like the 

influenza vaccine. The gray cap is a visual indication that the product is the same dose, requires 

the same storage conditions, and has the same handling requirements as the original cap 

presentation. There is differentiation between the original primary series vaccine for the original 

vaccine and the BA-4/BA.5-containing bivalent vaccines through the label. 

Dr. Lee pointed out that when they get to the Clinical Considerations, it would be clearer why 

they were asking these questions. The dilution/no dilution, colors of the cap, accuracy of 

expiration data, et cetera have be somewhat overwhelming. It was not clear whether the μg 

dosing was 30/30 or 15/15 for the Omicron components. Having the information on dosing 

would be incredibly helpful. 

Dr. Kitchin or Levine indicated that the labeling on expiration date has been changed. While this 

has been flagged as a potential mislabeling, that was not the case. Pfizer was labeling the 

product conservatively with the information that was available at the time to try and make sure 

that they have the product available to patients as soon as possible. And as soon as they got 

the information to update the label and the approval that allowed for that update, that was done 

so as quickly as possible. 

Dr. Deeks (NACI) noted that with respect to the various studies, it looked like the monovalent 

Beta and Omicron went down to age 18 and the bivalent studies went to >55 years of age and 

requested clarification on whether the bivalent BA.4/BA.5 had not been studied in anyone 12−17 

years of age as the age group for whom there is an authorization. 

Referring to Slide 4, Dr. Swanson indicated that it was correct that the bivalent Omicron BA.1 

data presented during this session and that are currently available are in individuals >55 years 

of age. Within that same study, they have enrolled and will be generating additional data on 

participants 18−55 years of age with the BA.1 bivalent-containing vaccine. For the BA.4/5, they 

have stratified the clinical studies to ensure they have a sufficient numbers of individuals 12−17 

years of age, 18−55 years of age, and those >55 years of age for receiving the BA.4/5 bivalent 

as a fourth dose booster. 

Dr. Anderson (PIDS) expressed gratitude to both manufacturers for what sounded like efforts to 

move clinical trials of the bivalent vaccine into children of all ages, the data from which everyone 

anxiously awaits. 

Dr. Long emphasized that there are not many data upon which to make confident decisions. For 

the bivalent BA.4/5 vaccine, there are no human antibody data even over a very short period of 

time. While they had heard that many doses have been purported to lengthen the antibody 

response, they had not seen sufficient data on adding something new such as BA.4/5 and in 

whom this vaccine might be used. She asked for clarification about whether they were seeing all 

of the human clinical data on BA.4/5. 

Dr. Swanson indicated that they have extensive data on the prototype vaccine for which they 

have seen very consistent responses through the third dose against both the ancestral strain 

and different variants of concern, including Omicron. The BA.4/5 bivalent study is ongoing, so 

they do not yet have specific clinical data for that bivalent vaccine composition. However, the 

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ACIP Meeting Summary September 1, 2022 

Omicron lineage has been the most antigenically distance variant of concern to date for SARSCoV-2 throughout the SARS-CoV-2 pandemic. When a much more antigenically distinct spike is 

combined with the original ancestral spike, the more distant there is in the following of the 

diversity of antigen-specific memory B cells over time. The anticipation would be that combining 

something so distant would result in some chance of improving upon not only memory B cells 

recognizing epitopes that are shared between the ancestral and the BA.4/5, but also potentially 

specific to BA.4/5—so a broadening of the protective immunity. They will generate the data. 

That is within the realm across different disease areas, including influenza, where that could be 

an anticipation in the data that they will see. They have seen in the preclinical studies a 

maturation of the neutralizing antibody response. In terms of the initial data with a third dose 

booster of the BA.4/5, the data they had to include in this presentation were 7 days post-Dose 3. 

They also have gone on to look at 1 month with the BA.1-containing bivalent vaccine and are 

now generating data for the BA.4/5 bivalent. They do see nice continual increases in the 

neutralizing antibody response against either the BA.1 or BA.4/5 over time, so she thinks there 

is some opportunity that that they may see some expansion in the breadth of protection. 

Dr. Long asked whether there was anticipation of when they would be asking for authorization 

for boosters of the bivalent in children 5−11 years of age. 

Dr. Gruber indicated that Pfizer anticipates providing data from the existing study, the 

BNT162b2 booster data in children 5−11 years of age, about cross-reactive immune response 

against BA.1 and BA.4/5 and anticipate that they would file for submission sometime in the first 

part of October. As Dr. Swanson said, they are working with their FDA partners to identify the 

best way to move forward into the younger age groups with appropriate trials and getting data 

as quickly as possible so that they could further extend the potential for the bivalent BA.4/5 and 

original containing vaccines as soon as possible. 

EtR Framework: Bivalent COVID-19 Vaccine Booster Doses 

Sara Oliver, MD, MSPH (CDC/NCIRD) provided updates to the EtR Framework on bivalent 

COVID-19 vaccine booster doses. As a reminder, the EtR Framework is a structure for 

describing the totality of the information considered in moving from evidence to ACIP 

recommendations. While they have walked through numerous EtRs to date, it has been difficult 

to answer a single question to highlight the impact of the intervention on health equity. For the 

last several months, a subset of the COVID-19 ACIP WG engaged in a critical review of the 

Equity Domain and gathered extensive input and feedback through consultation with health 

equity experts and other partners, such as the National Medical Association (NMA) and the 

Office of Minority Health and Health Equity (OMHHE). Throughout this process, it has become 

clear that consideration of equity is integral to every aspect of the production, study, 

authorization, and recommendation of COVID-19 vaccines. The need for a systematic reliable, 

and action-oriented review of evidence toward enhanced equity also was made clear, but 

structural problems require structural solutions. The adjustment of the structure is required 

for meaningful change, and an adjustment of the EtR framework to enable systematic, reliable 

review of evidence toward actionable recommendations to enhance equity may help facilitate 

meaningful change. Therefore, at least for this presentation, the WG proposed a change to the 

equity domain. Now as a consideration across each other EtR domain, the WG recommends 

the systematic, reliable inclusion of data to speak to the equity considerations in each domain to 

demonstrate the data and encourage actions needed to enhance equity as relevant to each 

domain. 

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ACIP Meeting Summary September 1, 2022 

Therefore, for this presentation, the voting question on equity was removed and attention to 

equity was enhanced across all of the other domains as shown here: 

This will be an iterative process that will require feedback from ACIP and others and the process 

will continue for future EtRs. 

Given that EUAs were issued for the bivalent Pfizer vaccine in those ≥12 years of age and the 

bivalent Moderna vaccine for those ≥18 years of age and there would be votes for these specific 

vaccines and age groups, the question for this EtR Framework analysis was, “Does ACIP 

support the use of updated (bivalent) COVID-19 vaccine booster doses for those individual in 

age groups already currently recommended to receive a COVID-19 vaccine booster?” The 

current recommendations are that people 5−49 years of age are recommended for 3 doses and 

those ≥50 years of age are recommended for 4 doses. The overall future proposed 

recommendation would for individuals recommended for a primary series and a bivalent booster 

dose, regardless of the previous booster doses given. Age and vaccines for this will be as 

authorized by FDA and recommended by ACIP and CDC. This is not necessarily the 

recommendation for this meeting, but is where it is envisioned that the future of the program 

would be going. While they would hear from Dr. Hill later in the day regarding the details for the 

schedule, Dr. Oliver wanted to orient everyone to the broader discussion they hoped to have 

during this session. 

Beginning with the first EtR domain of the Public Health problem, over 94 million COVID-19 

cases had been reported to CDC through August 29, 2022.39 Hospitalization rates peaked for all 

age groups during last winter’s Omicron wave. Since April 2022, hospitalization rates in older 

age groups have increased relative to the other age groups.40 In June, unvaccinated adults had 

4.6 times higher COVID-associated hospitalization rates compared to those who were 

vaccinated with at least 1 booster.41 Also in June, unvaccinated people ≥5 years of age had 8 

times higher COVID-associated death rates compared to those with at least 1 booster dose.42 

In June 2022, people ≥50 years of age with 2 booster doses had a 14 times lower risk of dying 

from COVID-19 compared to unvaccinated individuals and a 3 times lower risk of dying from 

COVID-19 than people with 1 booster dose.43 

39 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed August 30, 2022 40 COVID-NET; https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html Accessed August 26, 2022 41 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination Accessed August 3, 

2022 

42 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed August 24, 2022 43 https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccinbooine-status Accessed August 24, 2022 

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ACIP Meeting Summary September 1, 2022 

Moving to vaccination data and trends in the cumulative percentage of the US population 

vaccinated with a primary series by age group, persons ≥65 years of age had the highest 

coverage at 92%. Coverage decreased as age decreased, with the lowest coverage among 

children 5−11 years at 3%. Individuals 6−5 years of age are also recommended to receive a 

vaccine but were not included in these data. In terms of coverage for first booster doses by age 

group, the highest coverage was among those ≥65 years of age at 65% and the lowest 

coverage was among children 5−11 years of age at 13%. Looking at trends in coverage for 

second booster doses by age group, the highest coverage was among persons ≥65 years of 

age, but only 41% overall had completed a second booster.44 

In terms of the equity question for this domain regarding whether the problem impacts all 

populations equally, the case rate was higher among the large metro classification and the 

death rate was higher in the rural population in the recent Omicron surge.

45 Looking at weekly 

cases by race and ethnicity throughout the pandemic, cases have been higher among racial and 

ethnic minority populations.46 In terms of COVID-19 hospitalizations by race and ethnicity, 

hospitalizations were higher among racial and ethnic minority populations, although this was 

more pronounced earlier in the pandemic.47 For COVID-19-associated deaths, mortality rates 

have been higher throughout the pandemic among racial and ethnic minority populations and 

were more pronounced earlier in the pandemic. Recent mortality rates show less evidence of 

these disparities.48 

In summary of the public health domain, over 94 million COVID-19 cases have been reported in 

the US as of August 2022. Since April 2022, hospitalization rates in older age groups have 

increased relative to other age groups. In addition, during Omicron predominance in June 2022, 

unvaccinated adults ≥18 years of age 4.6 times higher hospitalization rates compared with 

those who received at least 1 booster, and unvaccinated individuals ≥5 years of age and older 

had an 8t times higher death rate. Vaccination rates are much higher among older adults 

relative to other ages groups. People of racial and ethnic minority groups have been 

disproportionately burdened by COVID-19 illness, hospitalization, and death. Therefore, the WG 

felt that COVID-19 is of public health importance—especially among populations recommended 

to receive a booster. 

Turning to the domain of benefits and harms and beginning with a summary of the available 

clinical trial data, there are data from the Moderna bivalent booster clinical trial with BA.1 

and Pfizer BioNTech bivalent booster clinical trial data with BA.1 (–BNT162b2+BNT162b2 Omi: 

30 μg bivalent: 15 μg ancestral + 15 μg BA.1). There are no international data yet available for 

bivalent boosters and there are no clinical trial data for bivalent boosters with BA.4/5 available to 

date. 

44 CDC Immunization Data Lake. Accessed 8/22/22; First and second boosters do not include Texas for all ages or Idaho for ages 

<18 45 CDC COVID Data Tracker. Trends in COVID-19 Cases and Deaths in the United States, by County-level Population Factors. 

https://covid.cdc.gov/covid-data-tracker/#pop-factors_7daynewcases Accessed August 25, 2022 46 CDC COVID Data Tracker. COVID-19 Weekly Cases and Deaths per 100,000 Population by Age, Race/Ethnicity, and Sex. 

https://covid.cdc.gov/covid-data-tracker/#demographicsovertime Accessed August 25, 2022 

47 CDC COVID Data Tracker. COVID-NET Laboratory-confirmed COVID-19 hospitalizations. https://covid.cdc.gov/covid-datatracker/#covidnet-hospitalization-network Accessed August 25, 2022 48 Source: https://data.cdc.gov/NCHS/Provisional-Weekly-Deaths-by-Region-Race-Age/tpcp-uiv5 (National Vital Statistics System 

provisional death certificate data) 

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ACIP Meeting Summary September 1, 2022 

In the Moderna Phase 2/3 trial, persons were given a 50 μg bivalent boost of mRNA-1273.214 

that included 25 μg of the ancestral Wuhan-Hu-1 strain and 25 μg of the Omicron B.1.1.529 

spike as a second booster vaccine (P205 Part G) compared to 50 μg mRNA-1273 (ancestral) as 

a second booster vaccine (P205 Part F). The trial participants were adults ≥18 years of age. A 

total of 437 participants received a bivalent booster and 377 received an mRNA-1273 ancestral 

booster. The dosing interval from the first booster to the bivalent booster was 136 days and 

from first booster to second ancestral booster was 134 days. The median follow up was 43 to 57 

days. Immunogenicity was assessed by the antibody response on Day 29 after the study 

vaccination. Based on the GMRs, comparing the antibody response in participants that received 

the bivalent booster to those who received the monovalent ancestral vaccine, the bivalent 

vaccine met superiority criteria for both Omicron and ancestral SARS-CoV-2 antibodies. The 

superiority criteria also were met in participants with or without evidence of infection on Day 29, 

with the highest GMTs observed in those with prior infection.49 

Local reactogenicity with the Moderna bivalent booster (mRNA-1273.214) as a 4th dose was 

similar to the second and third doses of the ancestral Moderna vaccine. The most commonly 

reported Grade 3 local reaction was redness. Systemic adverse reactions with the bivalent 

vaccine were lower than systemic reactions from second and third doses and the ancestral 

vaccine, and the most commonly reported systemic adverse reaction was fatigue. No Grade 4 

events were reported in the trial. There were no SAEs assessed as related to the vaccine. 

There were 2 participants who experienced 2 SAEs, a prostate cancer diagnosis and a 

traumatic fracture, within 28 days of the booster dose. There were no deaths or adverse events 

of special interest (AESI), including myocarditis or pericarditis. In the bivalent booster group, all 

severe events included reactogenicity events (fatigue, chills, arthralgia, headache) and 1 patient 

reported lymphadenopathy (axillary/cervical). 

Moving to the Pfizer BioNTech bivalent booster clinical trial with BA.1 (C4591031), individuals 

received a fourth dose of a 30 μg bivalent vaccine comprised of BNT162b2 ancestral and 

BNT162b2 Omi BA.1 and were compared to those who received a fourth dose of 30 μg of the 

BNT162b2 ancestral monovalent vaccine. The study evaluated safety and immunogenicity 

among participants ≥55 years of age. A total of 305 participants received the bivalent Omicron 

vaccine BNT162b2 Omi (BA.1) and 305 received monovalent BNT162b2 ancestral vaccine. The 

dosing interval from the first booster to the second booster was 6.3 months and the median 

follow-up was 1.7 to 1.8 months. Immunogenicity was assessed by the antibody response 1 

month after the study vaccination. Based on the GMRs, comparing the antibody response in 

participants who received the bivalent booster to those who received the monovalent ancestral 

vaccine, the bivalent vaccine met superiority criteria for Omicron antibodies and non-inferiority 

criteria for ancestral SARS-CoV-2 antibodies. 

In participant ≥55 years of age, local and systemic reactogenicity with the Pfizer bivalent 

vaccine were similar to the prototype vaccine. Fever >38.9 °C to 40.0 °C was reported by 4 

participants in the vaccine group. No fevers >40.0 °C were reported. For persons 18–55 years 

of age, monovalent Omicron-modified vaccine (30 μg dose) showed similar reaction as 

prototype vaccine. No bivalent reactogenicity data were available in this age group. No AEs 

were assessed as related to the vaccine. There were no life-threatening AEs or deaths reported 

by participants. There were no cases of anaphylaxis, hypersensitivity, myocarditis, pericarditis, 

appendicitis, or other AESIs. In the bivalent booster group, all severe events included 

reactogenicity events such as fatigue, chills, arthralgia, and headache. Some mild to moderate 

events of lymphadenopathy also were reported. 

49 https://www.medrxiv.org/content/10.1101/2022.06.24.22276703v1.full.pdf 

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ACIP Meeting Summary September 1, 2022 

To summarize the clinical trial data, a bivalent booster dose of both Moderna and Pfizer COVID19 vaccines increased the immune response in those who had completed a primary series 

and a previous booster. Compared with ancestral booster dose, the bivalent booster doses 

demonstrated a superior response to Omicron and either a superior or non-inferior response to 

the ancestral strain. The bivalent booster doses had a similar reactogenicity profile to the 

primary series and to an ancestral booster dose. It should be noted that the data from the 

clinical trials are limited in size, age, and bivalent booster type. 

In terms of other considerations, the risk of myocarditis following a bivalent booster dose is 

unknown. There are limited data from second booster doses of the current COVID-19 vaccines 

as its recommended only for adults ≥50 years of age. Therefore, Dr. Oliver reviewed the risk of 

myocarditis following a second dose in the primary series and the first booster dose by age 

group and sex. She showed the tables shared earlier by Dr. Shimabukuro earlier of the VAERS 

reporting rates of verified myocarditis per 1 million mRNA COVID-19 vaccinations (PfizerBioNTech and Moderna combined) for Days 0–7 post-vaccination; VSD incidence rates of 

verified myocarditis/pericarditis in the 0–7 days after Pfizer-BioNTech vaccination in people 

ages 12–39 years for Dose 2 and a first booster dose and the same data following a primary 

series and booster dose after Moderna vaccination; and the myocarditis/pericarditis crude 

reporting rates per million doses administered following COVID-19 mRNA vaccines from the 

Ontario, Canada50 surveillance data showing that across all ages, the rates of myocarditis were 

lower after a booster dose than after Dose 2 of the primary series. Based on CDC enhanced 

surveillance for myocarditis outcomes following mRNA COVID-19 vaccination in VAERS case 

reports among individuals 5–29 years of age at least 90 days after the myocarditis diagnosis,51 

most patients who were reached reported no impact on their quality of life and most did not 

report missing school or work. Among the 226 patients whose providers completed the follow-up 

surveys, most HCP (80.1%) indicated that patients were fully recovered or probably fully 

recovered. 

In summary of myocarditis and pericarditis, the risk of myocarditis has been identified after 

COVID-19 vaccine. This risk is rare and primarily observed in adolescent and young adult 

males. Among the VAERS data, the reporting rates of myocarditis are lower after a booster 

dose compared to the primary series. Among VSD data, the incidence following Dose 2 of a 

primary series and a booster dose are similar, but the case counts are small. Surveillance data 

from Canada indicate that the risk of myocarditis or pericarditis following the first booster dose 

appears lower than the risk following the second dose of the primary series. This was observed 

for both Pfizer and Moderna products across all age groups.52 Most individuals with myocarditis 

and pericarditis had fully recovered at follow-up. Based on data from pre-Omicron estimates, the 

risk of adverse cardiac outcomes were 1.8 to 5.6 times higher after SARS-CoV-2 infection than 

after mRNA COVID-19 vaccination among males 12−17 years of age.

53 An interval of 8 weeks 

between vaccine doses may further lower the myocarditis risk. 

50 https://www.publichealthontario.ca/-/media/Documents/nCoV/epi/covid-19-aefi-report.pdf?sc_lang=en 51 As previously presented to ACIP: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-COVIDShimabukuro-508.pdf 52 Public Health Agency of Canada. NACI: Recommendations on the use of bivalent Omicron-containing mRNA COVID-19 

vaccines. Sept 1, 2022 

53 DOI: http://dx.doi.org/10.15585/mmwr.mm7114e1 

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ACIP Meeting Summary September 1, 2022 

As a reminder, VaST closely reviews data from US safety monitoring systems and other 

sources. Through August 2022, VaST held 64 teleconference meetings. This is their 

interpretation of the safety data, with a special focus on myocarditis. They felt that for v-safeSM, 

the reactions and health impacts were not higher after a booster dose than after a primary 

series Dose 2. For VAERS, there were no additional concerns and myocarditis reporting rates 

were lower after a booster dose than a primary series. For VSD, there were few myocarditis 

or pericarditis cases after a booster dose, and the risk estimates were imprecise. The risk after 

booster doses appeared similar compared to the risk after the primary series Dose 2. VaST also 

reviewed additional vaccination data in pregnancy, for which no safety concerns were identified 

from any of the systems that have data on primary series and the first booster dose. VaST will 

continue to closely review the safety data, including data after a bivalent vaccine booster once 

these are available. 

To better understand the impact of a fall booster rollout, data were reviewed from projects in the 

COVID-19 Scenario Modelling Hub, which is a multi-team effort aimed at creating and modelling 

planned scenarios for the mid- to long-term COVID-19 situation. There are typically 5 to 10 

submissions per scenario round at the national level, and results are ensembled and 

summarized by the Hub. Rounds 14 and 15 were planning scenarios projecting COVID-19 

burdens through mid-2023 under different booster policies. In Round 14, the VE with the 

bivalent boosters was assumed to be 80% against symptomatic disease with non-immune 

escape strains. The scenario included a targeted booster campaign in persons ≥50 years of age 

versus influenza vaccine-like uptake in person ≥18 years of age. The model also looked at no 

variant versus a Fall “variant X” with 40% immune escape and 20% increased severity. Round 

15 was a rapid round aimed to update Round 14 and consider booster dose time. The same VE 

and variant assumptions were used as in Round 14 but the scenario assumed booster 

recommendations with influenza-like uptake in persons ≥18 years of age starting in September 

2022 versus starting in November 2022.

54 

The Round 14 national ensemble projection intervals showed that regardless of the presence of 

a new variant, influenza vaccine-like uptake in individuals ≥18 years of age would lead to over a 

20% reduction in hospitalizations and over a 15% reduction in deaths versus a recommendation 

for individuals ≥50 years of age.

55 The Round 15 national projection intervals showed that 

absent a new variant, boosters to individuals ≥18 years of age in September could prevent 

over 100,000 more hospitalizations56 and nearly 10,000 more deaths57 compared to a booster 

rollout in November. 

Immune tolerance and concerns for COVID-19 vaccine booster doses have been discussed 

before. As a reminder, immune tolerance is the concern that giving additional doses of COVID19 vaccine would lead to lower antibody levels or a failure to restore antibody levels to what was 

seen after a previous dose or T-cell exhaustion. However, data have not been seen at this point 

to suggest that this is occurring. Bivalent vaccine is able to improve vaccine titers in individuals 

without prior infection and also provided a robust boost in antibody titers for individuals with prior 

infection. High antibody titers were seen for bivalent vaccine prior to SARS-CoV. High antibody 

titers seen for this bivalent vaccine plus prior infection could lead to slower waning and 

prolonged protection against COVID-19 and severe disease.58 

54 https://data.cdc.gov/Flu-Vaccinations/Influenza-Vaccination-Coverage-for-All-Ages-6-Mont/vh 55 https://covid19scenariomodelinghub.org/ 56 95% Confidence Interval: 21,000-251,000 57 95% Confidence Interval: 500-19,000 58 Chalkia et al, medRxiv 2022, doi 10.1101/2022.06.24.22276703; In press New Engl J Med 

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ACIP Meeting Summary September 1, 2022 

Imprinting previously also was discussed previously. Imprinting, sometimes known as the 

“original antigenic sin” is the concern that the initial exposure to one virus strain primes B-cell 

memory and limits the development of memory B-cells and neutralizing antibodies against new 

strains. However, data suggest an improved diverse response attained with bivalent vaccines. 

Antibody titers to all SARS-CoV-2 variants tested were higher with the bivalent vaccine 

compared to the monovalent ancestral vaccine.59 

Earlier in the day, they heard from Dr. Thornburg about antigenic cartography or ways to map 

out the antibody responses. Antigenic cartography uses 2D and 3D maps to visualize how 

closely related the antibody responses are for different viruses. Antibody landscapes are 

another form of cartography that evaluate the diversity of the immune response. A flat 

landscape is better as it indicates that the response to all viruses or variants are similar. When 

the sheet of paper or the landscape is sloped, it means that the responses were very skewed 

to one particular variant. A study done by the NIH looked at antibody responses on Day 15 after 

giving a variety of vaccines, including several different bivalent vaccines. For the Day 15 

antibody response, and especially for those with a history of prior infection, the bivalent 

vaccines with a prototype + Omicron composition provided the most robust response that was 

diverse and similar across the different variants.60 

In terms of Omicron itself and the differences between BA.1 and BA.4/5, the clinical data from 

the bivalent vaccines are obtained primarily using BA.1. Compared to the ancestral virus, which 

was circulating in early 2020 and is what is currently in the monovalent vaccines, all Omicron 

sub-lineages have shared mutations highlighted in this graphic by the black arrow: 

Many of these mutations are in the receptor binding domain highlighted in the box with RBD. 

The receptor binding domain, as the name implies, is the primary binding site for antibodies. 

These mutations contribute to decreased neutralization and increased transmissibility for the 

omicron sub-lineages. Any vaccine that uses any Omicron subvariant would include all of these 

mutations.61 

59 https://www.biorxiv.org/content/10.1101/2022.02.03.479037v1.full.pdf; and https://assets.researchsquare.com/files/rs1555201/v1_covered.pdf?c=1650045900 60 https://www.medrxiv.org/content/10.1101/2022.07.12.22277336v1.full.pdf 61 Evolution of the SARS‐CoV‐2 omicron variants BA.1 to BA.5: Implications for immune escape and transmission – Shrestha 

Reviews in Medical Virology - Wiley Online Library 

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ACIP Meeting Summary September 1, 2022 

Regarding the differences between BA.1 and BA.4/BA.5 specifically, the reason there are 2 

numbers is that because BA.4 and BA.5 are 2 different Omicron sub-lineages, but the spike 

protein for each, which is the focus of the vaccine, is identical. When talking about what is in the 

vaccine, the spike protein is for both BA.4 and BA.5, but it is still just a single sequence, not 2 

different ones. Looking at this graphic, the bar at the top is for BA.1 and the bar at the bottom is 

BA.4/BA.5: 

The numbers and letters seen are areas where they different from the main virus of comparison. 

The text on the bottom right lists all of the differences between BA.4 and BA.5. The figure 

highlights where several of these are with the red arrows. There are differences overall, but they 

fundamentally are not a completely new or different virus. They actually share most of the same 

genetic code except the highlighted red differences.62 

The world is in a different position now than in 2020 or 2021. Especially with the recent Omicron 

surges for the past year, many people also have had a SARS-CoV-2 infection. This impacted 

the antigenic landscapes and raises the consideration of COVID-19 vaccination with and without 

prior SARS-CoV-2 infection. The study from Qatar looking at VE with 2 or 3 doses of mRNA 

vaccines with or without prior infection showed that individuals who had 3 doses of vaccine and 

a prior infection were the most protected, with a VE of nearly 80%. The effectiveness of prior 

infection alone was around 50%.63 The risk of reinfection fundamentally changed during the 

Omicron surge as well. Another study looked at EHRs in the US and assessed the risk of 

reinfection through the calendar months. As the US went into the Omicron surge, the risk of 

reinfection increased significantly.

64 

Given that the discussion for this meeting was focused primarily on bivalent mRNA vaccines 

and ACIP was being asked to consider the broader program as well, Dr. Oliver provided 

information on non-mRNA boosters. At this time, the published data are limited. The study 

looked at a handful of individuals who received a Novavax primary series and a booster 

compared to those who received original monovalent mRNA vaccines. Although no data were 

available to compare what this would look like with the updated bivalent vaccines, the 

responses overall were fairly similar to what was seen with the monovalent mRNA vaccines. 

Notably, this was only with 4 or 5 individuals in the Novavax group.65 Another RTC assessed 

third dose boosters given 10−12 weeks after an initial course of the Pfizer-BioNTech COVID-19 

62 SARS-CoV-2 variants ~ ViralZone (expasy.org) 63 Altarawneh HN, Chemaitelly M, Ayoub HH, et.al. Effects of Previous Infection and Vaccination on Symptomatic Omicron 

Infections. N Engl J Med 2022; 387:21-34 64 Individuals with recent prior SARS-CoV-2 infection are at reduced risk of Omicron infection and associated hospitalization 

(medrxiv.org) 65 DOI: 10.1126/science.abq020 

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ACIP Meeting Summary September 1, 2022 

primary series. All booster doses resulted in an increase in anti-spike IgG concentration, but the 

third dose of the mRNA vaccines resulted in GMCs that were about 3 times higher than those 

observed in the Novavax booster recipients. All boosters in the study showed acceptable side 

effect profiles.66 

In terms of the equity question for this domain pertaining to whether the desirable and 

undesirable anticipated effects are demonstrated across all populations equally, this language 

was very specifically chosen to assess the following: 

Are the desirable and undesirable anticipated effects Are the desirable and undesirable effects equally demonstrated 

demonstrated across all populations? across all populations? 

• Were persons of all races and ethnicities included in clinical • Were desirable and undesirable effects examined by 

trials or observations? population group? 

• Do the demographics of study populations reflect • Are there any desirable or undesirable effects which appear 

demographics of the US population? more frequently in one or more population groups? 

• Are there specific population groups for which the burden of 

the public health problem or benefit of the intervention is of 

particular concern? 

− If so, are these population groups represented in clinical 

trials or observations? 

For all future EtRs, the WG commits to evaluating the benefit-risk data through this lens as well. 

The demographic make-up of the Moderna clinical trial for the bivalent vaccines consisted of a 

smaller percentage of Hispanic and Latino participants than make up the US Census data. 

Likewise, the trial was comprised of a larger proportion of White participants within the US 

population.67 Similarly, the Pfizer trial had less racial and ethnic diversity than the US 

population. Additionally, because the trial was conducted in persons >55 years of age, the 

median age of the trial participants was much higher than what is seen in the US population. 

In terms of the results by race and ethnicity, the Moderna vaccine bivalent vaccine 

demonstrated that Omicron BA.1 and original strain neutralizing antibodies after the fourth dose 

were comparable across racial groups. In the Pfizer BioNTech trial, subgroups of participants 

>55 years of age in the safety population generally had similar AE profiles from study 

vaccination to 1 month post-dose across various vaccine groups when evaluated by subgroups 

of sex, race, and ethnicity. Overall, there were no meaningful differences between the 

subgroups for the Omicron variant or the original strain. However, it should be noted that in both 

trials the subgroups of race and ethnicity included a limited number of participants, so the 

results should be interpreted with caution. 

To summarize the data available overall to inform the recommendations in terms of the benefits 

and harms, there is experience from using the COVID-19 vaccine mRNA platforms for nearly 2 

years and over 600 million doses in the US alone. There are extensive VE studies as well as 

robust post-authorization safety data across multiple platforms. Clinical human data from 

bivalent COVID-19 vaccines are available in over 1,700 persons. This includes data on bivalent 

vaccines with both Beta and Omicron variants from manufacturers and NIH studies. Over 1,400 

individuals received a bivalent vaccine with the Omicron component specifically. While there are 

subtle differences in mutations between the BA.1 and BA.4/BA.5 spike protein sequences, it is 

not anticipated that any differences would be seen in the safety or reactogenicity of the vaccines 

based on these limited mutations. The overall composition of the vaccine as well as the total 

antigenic load are the same as the current booster doses. Data from the antigenic cartography 

and antibody studies and modeling data also were reviewed. 

66 DOI: https://doi.org/10.1016/S0140-6736(21)02717-3 67 https://www.medrxiv.org/content/10.1101/2022.06.24.22276703v1.full.pdf; US Census Bureau QuickFacts: United States 

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ACIP Meeting Summary September 1, 2022 

In terms of what is known, COVID-19 vaccines have a high degree of safety. Rare events of 

myocarditis have been seen after the mRNA vaccines in post-authorization studies, and cases 

of myocarditis have been attributed to the vaccine in the Novavax clinical trials. COVID-19 

vaccines also provide high levels of protection against severe disease. Initially, the COVID-19 

vaccines also provided high levels of protection against infection and transmission. However, as 

the virus evolved, more rapid waning of protection was noted against asymptomatic and milder 

disease. COVID-19 booster doses further increase protection against severe disease. Bivalent 

COVID-19 vaccines expand the immune response after vaccination. Vaccines that contain 

Omicron will improve the antibody response to Omicron. Bivalent vaccines appear to provide a 

more diverse response overall, which may improve the immune response to future variants as 

well. 

However, it also is important to acknowledge what is not known. The rates of myocarditis after 

bivalent COVID-19 vaccines are not known. It is unlikely that the inclusion of Omicron would 

increase myocarditis rates. Age and sex of the individual are likely contributing factors to 

development of myocarditis after vaccine. The interval since the previous dose and total dose 

may be related. However, it is unlikely that the inclusion of Omicron would have an impact. The 

incremental increase in VE is unknown. Antibody titers to currently circulating variants were 

higher after bivalent booster dose than with the current monovalent booster. However, most of 

the data to inform recommendations were from that BA.1 bivalent vaccine. The incremental 

benefit of going from BA.1 to BA.4/BA.5 are unknown. The duration of protection for these 

vaccines also is unknown. However, antibody titers after bivalent vaccine and prior infection 

were robust. This combination of prior infection and the bivalent vaccine may prolong the 

duration of protection, which could decrease the need for frequent boosters. However, as with 

all vaccines, the duration of protection may vary by age and immune status. 

To summarize the balance of benefits and risks for these bivalent vaccines, Moderna and Pfizer 

BioNTech bivalent vaccines increase the immune response for those who have completed a 

primary series and a previous booster. Similar reactogenicity profiles were seen with the primary 

series and ancestral booster dose. Myocarditis risk following a bivalent booster dose is 

unknown, but is anticipated to have a similar risk to what is seen after monovalent vaccine 

booster doses. Modelling projects that more hospitalizations and deaths would be averted when 

booster doses are recommended broadly for persons ≥18 years of age compared to only 

persons ≥50 years of age and when the booster campaign would begin in September compared 

to November. The benefits and harms for the US population are best assessed when clinical 

trial and study populations are optimally representative of the US population. The WG felt that 

the substantial desirable anticipated effects were moderate, the undesirable anticipated effects 

were small, and the balance favors the intervention. 

Moving to the values domain, survey data from an online survey conducted in partnership with 

the CDC and the University of Iowa68 conducted recently over the month of August showed that 

72% of eligible respondents said that they definitely or probably would get an updated booster 

that protects against Omicron. Among people who said that they were unsure about getting a 

booster, people felt that they have enough protection from their prior dose or that the booster 

may not be effective. When asked why people would get a booster, preventing them from 

spreading to others and preventing severe disease were the most common responses. Moving 

into the Fall, implementation of a COVID-19 booster program will overlap with the influenza 

vaccination season as well. When survey recipients were asked if they would be willing to get 

68 CDC and University of Iowa/RAND survey, August 2022, unpublished 

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ACIP Meeting Summary September 1, 2022 

an influenza shot and the updated COVID-19 at the same time, 63% of individuals were 

extremely or somewhat willing to receive them together. 

Regarding the equity question for this domain regarding whether there is important variability in 

how patients or populations value the outcome, booster uptake has remained relatively steady, 

with those groups with higher initial vaccine uptake also more likely to have received their 

booster dose. This means that older adults, college graduates, and those with higher incomes 

remain the most likely to be both vaccinated with a primary series and booster.

69 There is 

notable difference in the vaccinated versus the vaccinated with the primary series versus 

boosted status among adults of Hispanic or Latino ethnicity. Despite a high vaccine uptake, 

around a third of the adults who say that they have completed a primary series have not yet 

received a first booster. In terms of why people have not received a booster, shown by race and 

ethnicity, a higher proportion of vaccinated adults without a booster of Hispanic ethnicity felt that 

they have enough protection from prior infection or may have had side effects from previous 

doses or could be worried about missing work from the symptoms post-vaccine. 

In summary of the value domain, 72% survey respondents reported that they were likely to 

receive an updated booster, with the prevention of spread to others (46.2%) and a change in 

case severity (38%) appearing to lead as the main reasons why they would want to get an 

updated booster. Nearly two-thirds of adults were willing to receive a COVID-19 vaccine and an 

influenza shot at the same time. However, receipt of a booster to date demonstrates persistent 

vaccine inequity. Adults of older age, those with college degrees, and those with higher incomes 

remain most likely to be vaccinated with a primary series and booster. Notably, about a third of 

adults of Hispanic or Latino ethnicity have not yet received a booster despite completion of a 

primary series. The WG felt that the target population felt that the desirable effects were 

moderate relative to undesirable effects. However, there is probably important uncertainty or 

variability. 

The domain of acceptability can be considered through the lens of acceptability of the COVID19 vaccination program overall. Over 800 million doses have been delivered to date. Over 90% 

of the population has received at least 1 dose and over 223 million individuals have completed a 

primary series. There is a broad network of COVID-19 vaccine providers, including critical 

pharmacy providers, federal partners, and jurisdictional providers.70 For the equity question for 

this domain regarding whether the intervention is equally acceptable across all populations, 

Asian, American Indian, and Alaskan Native, Native Hawaiian, or other Pacific Islander 

populations have the highest percentage among those who are fully vaccinated or have 

completed a primary series, whereas the Black populations have the lowest vaccination 

to date. As it pertains to booster vaccination trends by race and ethnicity, multi-racial and Asian 

populations have the highest percent among those who received their first booster dose, and 

second booster dose receipt is higher again among multi-racial populations relative to other 

racial and ethnic groups.71 There also have been disparities by population for those who have 

completed a primary series by county and urbanicity, with those enlarged metropolitan areas 

having a higher vaccination rate than those in rural populations.72 Vaccination rates vary by 

69 The survey was conducted July 7 – 17, 2022, online and by telephone among a nationally representative sample of 1,847 U.S. 

adults. KFF COVID-19 Vaccine Monitor: July 2022. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccinemonitor-july-2022/ Accessed August 9, 2022 70 Source: Data pulled from CDC COVID Data Tracker as of 08/17/22 1200 71 CDC COVID Data Tracker. Trends in Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United 

States. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends Accessed August 31, 2022 72 CDC COVID Data Tracker. COVID-19 Vaccination Equity. https://covid.cdc.gov/covid-data-tracker/#vaccination-equity Accessed 

August 31, 2022 

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ACIP Meeting Summary September 1, 2022 

race, ethnicity, and disability status.73 As shown before, a provider’s recommendation remains 

very important to COVID-19 vaccine acceptance. This importance appears highest among 

individuals who are over 65 years of age, Black, retired or with incomes under $30,000. This 

indicates that the potential for healthcare providers to increase the acceptability of these 

bivalent vaccines through communications with their providers. 

To summarize acceptability, over 800 million does doses of COVID-19 vaccines have been 

delivered across a wide network of vaccine providers. However, significant disparities and 

completion of the primary series and receipt of booster doses still persist by race and ethnicity, 

urbanicity, and differences in abilities including vision, hearing, mobility, and cognition. However, 

it is important to note that the detection of the disparities does not necessarily explain the 

disparities. Differences in acceptability can be what contributes to the disparities, but through 

listening sessions when revising the equity domain, they heard caution against explaining all 

disparities as vaccine hesitancy or low acceptability when other drivers also may be present. 

Differences in access may contribute to these disparities as many others may as well. 

Identifying and understanding these and other drivers in equity is a critical step toward closing 

these equity gaps and there is further work to do here. In the meantime, healthcare provider 

recommendations are important and continue to appear to increase the acceptability of COVID19 vaccination, particularly among adults who are Black, over the age of 65, retired, and of 

lower income. The WG felt that the vaccine is probably acceptable to key stakeholders. 

Moving to feasibility, looking at trends in completed primary series and first boosters for persons 

5−11 years of age, 12−17 years of age, 18−49 years of age, for most individuals ages 5−49 

years of age, it has been 6 months or more since their last COVID-19 vaccine dose. While many 

persons 50−64 years of age and ≥65 years of age have received a second booster in the past 6 

months, comparatively few have received a dose in the past 8 weeks. Overall, the numbers 

have declined with each of the booster recommendations. In September, based on the total 

number of persons eligible, which includes those who have completed a primary series 

but not received a COVID-19 vaccine in the past 2 months consistent with the language in the 

EUA is almost 210 million individuals. The number ineligible, which would be those who had a 

vaccine dose in the past 2 months, is less than 5 million.74 

Overall, the US Government has purchased approximately 171 million bivalent mRNA vaccine 

booster doses for the Fall and beyond, with the options to purchase additional doses as needed. 

Based on this, there will be a sufficient and finite supply of these vaccines. Limited supply 

settings are not anticipated overall. However, jurisdictions have been given considerations for 

selecting sites to receive the initial doses based on ability to rapidly use the vaccine. These 

considerations were in the Operational Planning Guide75 provided to jurisdictions, including 

location and access to a range of populations to ensure equitable distributions; ability the reach 

those at highest risk of COVID-19; ability to handle the large product shipments; and ability to 

administer the vaccines. Overall, the bivalent vaccines have the same storage and handling 

parameters as the monovalent vaccines that they are used to handling. However, both 

manufacturers’ bivalent vaccines will have gray label borders but different injection volumes. 

The monovalent and bivalent labels for the Pfizer vaccine have identical cap and label colors. 

73 CDC COVID Data Tracker. COVID-19 Vaccination among People with Disabilities. https://covid.cdc.gov/covid-datatracker/#vaccinations-disability-status Accessed August 25, 2022 74 Source: CDC IZDL; Accessed 8/22/22; First boosters does not include Texas for all ages or Idaho for ages <18 75 CDC Fall Vaccination Operational Planning Guide – Information for the Fall Vaccine Campaign, Including Upcoming Bivalent 

COVID-19 Vaccine Booster Doses. https://www.cdc.gov/vaccines/covid-19/downloads/CDC-Fall-Vaccination-OperationalPlanning-Guide.pdf Accessed August 19, 2022 

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ACIP Meeting Summary September 1, 2022 

For Moderna, the bivalent vaccine will be distinct from the adult monovalent dose but may look 

similar to the product for ages 6−11 years. 

In terms of the equity question for this domain regarding whether it is feasible to implement 

across all populations, the WG looked at data from the CDC COVID Data Tacker76 

demonstrating persistent racial and ethnic disparities and receipt of the first booster among 

those who are eligible. The WG previously reviewed the survey data demonstrating that about a 

third of adults of Hispanic or Latino ethnicity have completed a primary series but not received a 

booster. Based on the Data Tracker, persons ≥12 years of age who are eligible for a first 

booster, over half of those of Hispanic or Latino ethnicity had not received it. In fact, more than 

half of eligible populations among American Indian, Alaskan Native, Black, Native Hawaiian, 

and Pacific Island populations also have not received their first booster. 

In summary, use of the bivalent COVID-19 vaccines appears feasible but with some important 

limitations. Over 200 million people will be eligible for these bivalent vaccines. Most are at least 

6 months out from their last COVID-19 vaccine does. CDC has provided an Operational 

Planning Guide for jurisdictions preparation, and there will be a sufficient but finite supply of 

these bivalent vaccines. Some aspects of these vaccines will be easy for implementation, but 

vials and labeling may require additional education. Importantly, significant racial and ethnic 

disparities persist in receipt of a booster, suggesting that the intervention may not be equally 

feasible to implement across all populations. The WG felt that the updated bivalent vaccines are 

probably feasible to implement. 

Regarding the domain of resource use, a study by Abhishek Pandey et al77 evaluated COVID19 attributable disease and direct medical costs that could be averted by a booster program 

under 2 potential scenarios. Looking at coverage similar to influenza vaccination rates and what 

would result if broader coverage of 80% was achieved, this study estimated that an early Fall 

booster vaccination program that reaches coverage similar to the 2020-2021 influenza season 

could prevent up to approximately $62 billion in direct medical costs, which would further 

increase with broader coverage of the vaccines. This is not yet published in a peer-reviewed 

publication or a model that CDC has conducted, but it includes data of possible estimates of a 

cost-benefit scenario using their model estimates. 

Then for the equity question for this domain regarding whether the intervention is a reasonable 

and efficient allocation of resources across all population, cost-effectiveness data are not yet 

available for most demographic subgroups. However, 1 study78 was available for older adults 

that looked at the cost-effectiveness of the first booster dose of the Pfizer BioNTech vaccine 

administered 6 months after the second dose among adults ≥65 years of age from a healthcare 

system perspective. Compared to a 2-dose primary series but without a booster, the booster 

strategy in 100,000 older adults resulted in a net monetary benefit of over $3 million and a gain 

of 3.7 quality adjusted life years over 180 days. Noting that the cost-effectiveness of the 

boosters is highly sensitive to the population incidence of COVID-19 and the VE, the study 

estimated that offering COVID-19 boosters to adults ≥65 years of age in the US was likely to be 

cost effective. 

76 CDC COVID Data Tracker. Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States. 

https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic Accessed August 27, 2022 77 Abhishek Pandey et al., “How Many Lives Could a Fall COVID-19 Booster Campaign Save in the United States?,” To the Point

(blog), Commonwealth Fund, July 26, 2022. https://doi.org/10.26099/rc8x-dx51 78 https://doi.org/10.1016/j.ijid.2022.03.029 

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ACIP Meeting Summary September 1, 2022 

To summarize the domain of resource use, a fall vaccination campaign that expands eligibility 

for boosters and moves more aggressively to reach people could avert a surge of 

hospitalizations and deaths that would result in substantial savings and direct medical costs. 

The WG felt that the bivalent vaccines probably were a reasonable and efficient allocation of 

resources. 

The current Moderna vaccine includes 50μg of the ancestral strain. For the current monovalent 

Pfizer vaccine, there are 30μg of the ancestral strain. The updated bivalent Moderna vaccine 

contains 25μg of the ancestral strain and 25μg of the spike protein from Omicron BA.4/BA.5. 

The updated Pfizer bivalent vaccine contains 15μg of ancestral and 15μg of BA.4/BA.5. Overall, 

the bivalent vaccines have the same total antigen amount as the monovalent vaccines, but with 

the additional Omicron composition. 

To summarize, the data presented in EtR show that the current monovalent COVID-19 vaccines 

have dramatically reduced COVID-19 hospitalizations and deaths. However, as the virus has 

evolved, there have been declines in neutralizing antibodies and VE, and there has been more 

rapid waning from the vaccines. Inclusion of a second SARS-CoV-2 variant in the vaccine 

broadens the antibody response. Omicron-specific bivalent vaccines were studied in over 1,400 

individuals. Omicron-specific bivalent vaccine resulted in higher antibody titers for Omicron 

variants, higher titers for other SARS-CoV-2 variants, and titers that were as high or higher for 

ancestral SARS-CoV-2. Broad uptake of the COVID-19 vaccine booster doses early this Fall 

could prevent over 100,000 hospitalizations compared to a later or more limited rollout and may 

even save billions of dollars of direct medical costs. 

COVID-19 Pre-Exposure Prophylaxis Guidance 

Evelyn Twentyman, MD, MPH (CDC/NCIRD) reviewed COVID-19 pre-exposure prophylaxis 

(PrEP) guidance, pointing out that this simplification of recommendations is a great opportunity 

to look closely at the spectrum of resources available to protect people with moderate to severe 

immunocompromise. Therefore, in addition to the potential new recommendation to receive an 

updated bivalent booster, Dr. Twentyman reviewed existing recommendations for PrEP, which 

can be used in complement COVID-19 vaccines to protect the immunocompromised population. 

PrEP refers to a medication that is given before exposure to an infectious disease to protect an 

individual against that disease. The PrEP, EvusheldTM, is recommended for those ≥12 years of 

age who weigh at least 40 kilograms or 88 pounds with moderate to severe immunocompromise 

due to a medical condition or receipt of certain immunosuppressing treatments. Examples of 

such medical conditions or treatments are included in the EvusheldTM EUA Fact Sheets on 

CDC’s website79 and are similar to those previously leading to eligibility for multiple boosters. 

EvusheldTM is also recommended to be given to those who are unable to receive COVID-19 

vaccines due to a history of severe adverse reaction to a COVID-19 vaccine or one of its 

components. 

Tixagevimab/Cilgavimab (EvusheldTM) is a combination of 2 long-acting human monoclonal 

antibodies derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. 

The FDA issued an EUA for use of EvusheldTM for PrEP in December 2021, revised the EUA to 

increase the dose to 300 mg of each monoclonal antibody in February of 2022, and revised the 

Fact Sheet for Healthcare Providers80 to recommend EvusheldTM be administered every 6 

months in June 2022. EvusheldTM must be prescribed by a healthcare provider. Doses can be 

79 Evusheld Healthcare Providers FS 06292022 (fda.gov); Image: ASPR Webinar: What is Evusheld? https://aspr.hhs.gov/COVID19/Therapeutics/Products/Evusheld/Pages/default.aspx 80 https://www.fda.gov/media/154701/download 

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ACIP Meeting Summary September 1, 2022 

found through the US Government Therapeutic Locator Tool on the Administration for Strategic 

Preparedness & Response’s (ASPR’s) website.

81 As of August, there is also a new ordering 

pathway available through the HHS Health Partner Order Portal (HPOP)

82 such that in addition 

to the larger orders available through the HPOP distribution process, providers who are not 

participating in that process can now order up to 3 doses through the Small Volume Orders 

portal.83 

Use of EvusheldTM is evidence-based. In an RCT,84 EvusheldTM had efficacy for the prevention 

of COVID-19. In multiple other studies,

85 including real-world data, EvusheldTM was observed to 

have efficacy against severe COVID-19 outcomes including during this period of Omicron 

variant predominance. Additionally, in vitro studies show that EvusheldTM is predicted to work 

against BA.4/BA.5. Despite the protection that EvusheldTM can provide, most people who are 

immunocompromised in the US have not actually received EvusheldTM. Among the almost 7 

million individuals with immunocompromise, only about 5% have actually received doses of 

EvusheldTM. This is not an issue of supply. Current EvusheldTM supply far exceeds demand. 

More than 390,000 doses are already distributed and available for use today.86 EvusheldTM is 

distributed by the USG at no cost to participants, although some locations of administration may 

have an associated administration fee. 

In terms of how use of monoclonal antibodies for PrEP can complement receipt of COVID-19 

vaccines for optimal protection of those with immunocompromise, after any dose of COVID-19 

vaccine, an individual should wait 2 weeks before receiving EvusheldTM. After EvusheldTM

receipt, there is no minimum interval to the next COVID-19 vaccine either within a primary 

series or if receiving a booster dose. EvusheldTM is recommended to be administered every 6 

months and individuals should consult with their physician for a prescription. CDC is in the 

process of updating several webpages to make this information more widely available. Updated 

content for healthcare providers will include descriptions of patient eligibility and detailed 

EvusheldTM administration guidance, as well as those links to options for ordering EvusheldTM. 

Updated content for the general public will include additional information about how to know if 

someone is eligible for EvusheldTM, as well as the dose finder mentioned earlier. Updated 

language within the Interim Clinical Considerations for use of authorized and approved COVID19 vaccines will clearly describe how use of EvusheldTM complements COVID-19 vaccination to 

optimally protect people with moderate to severe immunocompromise. 

Interim Clinical Considerations for COVID-19 Vaccines: Bivalent Boosters 

Dr. Elisha Hall (CDC/NCIRD) presented anticipated updates to the Interim Clinical 

Considerations for COVID-19 vaccine bivalent booster doses, contingent on a recommendation 

for these vaccines. August 31, 2022, Moderna and Pfizer bivalent vaccines were authorized. 

The Moderna bivalent vaccine was authorized for use in people ≥18 years of age and the Pfizer 

bivalent vaccine was authorized for use in people ≥12 years of age. These vaccines were 

81 https://covid-19-therapeutics-locator-dhhs.hub.arcgis.com/ 82 https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Pages/important-update-27July2022.aspx 83 https://app.smartsheet.com/b/form/21e4312a2985457f982bb2738cf82744 84 Levin et al, Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19, New England Journal of Medicine, 

2022 85 a) Tixagevimab/Cilgavimab for Prevention of COVID-19 during the Omicron Surge: Retrospective Analysis of National VA 

Electronic Data | medRxiv; b) Serum neutralization of SARS-CoV-2 Omicron sublineages BA.1 and BA.2 in patients receiving 

monoclonal antibodies | Nature Medicine; c) Al Jurdi et al., American Journal of Transplantation;June 2022; d) Association 

between AZD7442 (tixagevimab-cilgavimab) administration and SARS-CoV-2 infection, hospitalization and mortality | Clinical 

Infectious Diseases | Oxford Academic (oup.com); and e) Takashita E, et al, Efficacy of Antibodies and Antiviral Drugs against 

Omicron BA.2.12.1, BA.4, and BA.5 Subvariants. N Engl J Med. 2022 86 Data source: HHS-Tiberius: https://aspr.hhs.gov/COVID-19/Therapeutics/orders/Pages/default.aspx 

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ACIP Meeting Summary September 1, 2022 

authorized for use as a single booster dose administered at least 2 months after either 

completion of primary vaccination with any authorized or approved monovalent COVID-19 

vaccine or receipt of the most recent booster dose with any authorized or approved monovalent 

COVID-19 vaccine. Along with the authoritarian of bivalent vaccines for persons ≥12 years of 

age, monovalent mRNA COVID-19 vaccines are no longer authorized as booster doses for 

individuals ≥12 years of age. This means that monovalent booster doses can no longer be given 

to people ≥12 years of age, even if the person had not previously received a monovalent 

booster dose. 

Everyone ≥12 years of age is recommended to receive 1 age-appropriate bivalent mRNA 

booster dose after completion of any FDA-approved or FDA-authorized monovalent primary 

series or last monovalent booster does. This means that people cannot get a bivalent booster 

without first completing a primary series. Homologous and heterologous boosters are allowed 

as long as they are age appropriate, meaning only Pfizer bivalent can be given to people 12−17 

years of age. Either Moderna or Pfizer bivalent can be given to people ≥18 years of age. There 

is no preference. At this time, there are no changes to schedules for children 6 months−11 

years of age. Again, the bivalent booster recommendation replaces previous booster 

recommendations for people ≥12 years of age. This means that everyone ≥5 years of age who 

are eligible for a booster dose will now be eligible for only 1 booster dose. People 5−11 years of 

age who received Pfizer are eligible for 1 monovalent booster dose currently, and people ≥12 

years of age may are eligible for 1 bivalent booster dose. 

In terms of the Fall booster reset, the proposed recommendations are simplified. There is a 

change in the way they vaccines are thought about from dose counting monovalent boosters to 

1 bivalent booster for everyone eligible. This table reinforces that regardless of whether 

someone had 0, 1, or 2 monovalent boosters, 1 bivalent booster is now recommended: 

Since some people may already have had 3, 4, or even 5 doses for those who are 

immunocompromised and had a second booster already, it is important to emphasize that total 

number of doses will no longer be looked at. In terms of the COVID-19 vaccination schedule for 

people who are not moderately or severely immunocompromised, people ≥12 years of age who 

have completed at least the primary series and are 2 months out from the last dose should not 

be denied a bivalent booster dose based on the number of total doses the person has received. 

Regarding the COVID-19 vaccination schedule for people who are moderately or severely 

immunocompromised, people ≥12 years of age are recommended to receive a primary series of 

either Moderna, Novavax, or Pfizer. This would be followed by an age-appropriate bivalent 

booster dose at least 2 months or 8 weeks after completion of the primary series or most recent 

monovalent booster. The bivalent booster is now recommended regardless of how many 

previous monovalent boosters were received. In certain limited situations, Janssen can be used 

followed by bivalent booster at least 2 months later. 

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ACIP Meeting Summary September 1, 2022 

For people who are moderately or severely immunocompromised, the primary series will remain 

the same. Moderna, Novavax, or Pfizer is recommended. For Moderna and Pfizer, this is 3 

doses. For Novavax, this is 2 doses. The bivalent recommendation is the same for everyone, 

with 1 bivalent booster dose at least 2 months after completion of the primary series or most 

recent previous monovalent booster does. Again, Janssen is only used in limited situations for 

those ≥18 years of age. Those who got a Janssen primary dose should get an additional mRNA 

followed by a bivalent booster. 

In terms of the specifics on timing considerations for bivalent boosters, the current timing 

guidance for vaccination in persons with current or prior SARS-CoV-2 infection also applies to 

bivalent boosters. If a person has current or has had a prior SARS-CoV-2 infection, at a 

minimum, vaccination should be deferred at least until recovery from acute illness and criteria to 

discontinue isolation have been met. In addition, people who recently had SARS-CoV-2 

infection may consider delaying vaccination longer by 3 months from symptom onset or positive 

test if infection was symptomatic. Individual factors such as risk of COVID-19 severe disease, 

community-level, or characteristics of the predominant strain should be taken into account when 

determining whether to delay getting a COVID-19 vaccine after infection. 

With new bivalent vaccines, co-administration guidance has not changed. Routine 

administration of all age-appropriate doses of vaccines simultaneously is recommended as best 

practice for people for whom no specific contraindications exist at the time of the healthcare 

visit. Of note, orthopoxvirus vaccine does not follow the same routine guidance, and further 

information on that very specific situation can be found in CDC’s Interim Clinical Considerations. 

Extensive experience with non-COVID-19 vaccines has demonstrated that immunogenicity 

and adverse event profiles are generally similar when vaccines are administered simultaneously 

as when they are administered along. Therefore, providers should offer all vaccines for which a 

person is eligible at the same visit. 

With both influenza and COVID-19 vaccine campaigns, a lot of questions have been received 

about co-administration of these vaccines specifically. Providers should offer influenza and 

COVID-19 vaccines at the same visit, if eligible. This includes adjuvanted or high-dose influenza 

vaccines, but the recommendation in this case is to administer in separate limbs. With both 

influenza and SARS-CoV-2 circulating, getting both vaccines is important for prevention of 

severe disease, hospitalization, and death. Getting both vaccines at the same visit increases the 

chance that a person will be up-to-date with their vaccination. Studies looking at coadministration have shown that immunogenicity is similar between those who received coadministered COVID-19 vaccine and seasonal influenza vaccine and those who received these 

vaccines separately. Approximately 9.4% (~92,000) of v-safe TM participants reported 

simultaneous vaccination with an mRNA COVID-19 vaccine and seasonal influenza vaccine, 

and 8.7% (~454,000) of persons enrolled in the VSD received simultaneous vaccination with a 

COVID-19 booster and seasonal influenza vaccine during the 2021-2022 influenza season. To 

summarize reactogenicity of co-administered COVID-19 vaccine and seasonal influenza 

vaccine to date, the following chart shows the percent difference in participants reporting 

reactogenicity between COVID-19 and influenza vaccine versus COVID-19 alone: 

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ACIP Meeting Summary September 1, 2022 

Generally, COVID-19 vaccines administered with seasonal influenza vaccine showed similar or 

only slightly higher reactogenicity and no specific safety concerns were identified. 

In terms of best practices for multiple injections, it is recommended to label each syringe with 

the name and dosage of the vaccine, lot number, initials of preparer, and beyond use time if 

applicable. Each vaccine should be administered in a different injection site and injection sites 

should be separated by one inch or more. The COVID-19 vaccine and vaccines that may be 

more likely to cause a local reaction, such as adjuvanted or high-dose influenza vaccine and 

COVID-19 vaccine, should be administered in different limbs if possible. 

Regarding the look of the bivalent products the monovalent and bivalent cap and border label 

colors will be identical for the Pfizer product, both of which are gray. Most characteristics are the 

same in that they are authorized for persons ≥12 years of age at 30 micrograms. The injection 

volume is 0.3 mL. Dilution is not required for these specific products, although other Pfizer 

products require dilution and they have the same beyond use of 12 hours and the same storage 

requirements. The monovalent is primary series and the bivalent is booster doses. The 

monovalent and bivalent labels are almost identical aside from the name being different. It is 

important to be aware of the potential for errors. CDC will have education on strategies to 

prevent administration errors to try to reduce errors. 

For Moderna, Dr. Hall highlighted 2 different vials in comparison to the bivalent, the one for the 

older age group (≥12 years of age) and the one with the most similar appearance (6−11 years of 

age). The first monovalent product authorized for persons ≥12 years of age and is fairly visually 

distinct from the bivalent product authorized for ages ≥18 years of age. The monovalent is in a 

red-capped vial with a light blue labeled border color and is now only authorized for primary 

doses. Comparatively, the bivalent product for booster doses in people ≥18 years of age is in a 

vial with a dark blue cap and a gray labeled border. The injection volume, beyond use date of 12 

hours, and storage requirements are the same. The labels for the 2 products just highlighted are 

much more visually distinct. The bivalent booster is clearly labeled “BOOSTER DOSES ONLY”

in all caps, and there are different colors on these labels. The vial that looks the most similar is 

actually the monovalent product authorized for primary doses in people 6−11 years of age. This 

vial also uses a dark blue cap, and the visual distinction is the purple label border. Of note, the 

monovalent vial authorized for primary doses in ages 6−11 years is not authorized for booster 

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ACIP Meeting Summary September 1, 2022 

doses. The main distinction is the name of the vaccine and the color of the border, and the 

background for the booster dose is only text and is purple. 

CDC continues to encourage people to stay up-to-date with their COVID-19 vaccines. Staying 

up-to-date keeps people current with the COVID-19 vaccine recommendations. With new 

recommendations, people are up-to-date if they have completed a primary series and received 

the most recent booster dose recommended for them by CDC. 

COVID-19 Vaccines WG Interpretation 

Sara Oliver, MD, MSPH (CDC/NCIRD) summarized the overall WG interpretations. As Dr. 

Daley mentioned at the beginning of the day, the WG has met frequently over the course of the 

last several months to review data that would inform these recommendations. In addition, the 

WG has had broad policy discussions around the use of the updated bivalent COVID-19 

vaccines for people in age groups currently recommended for booster doses. As a reminder, 

based on the current FDA authorizations, the current recommendations would be for PfizerBioNTech COVID-19 vaccine bivalent for individuals ≥12 years and older and the Moderna 

vaccine bivalent for individuals ≥18 years of age. However, it is expected that additional 

authoritarians for other ages and vaccines may follow over the next several weeks to months. 

The WG discussed that the current population recommended for these boosters is very 

heterogenous. Many in the US have had Omicron infection over the past 9 months. In addition, 

individuals recommended for the bivalent COVID-19 booster doses may have previously 

received a primary series and only 1 booster dose, while the population ≥50 years of age who 

are immunocompromised may have received a primary series and 2 booster doses. The WG 

also noted that the balance of benefits and risks for individuals may vary by age, by previous 

receipt of booster, or by recent SARS-CoV-2 infection. There are uncertainties around the 

incremental benefit for some individuals including those with recent infection or recurrent 

vaccine receipt. 

The WG also discussed recommendations in the setting of prior infection. COVID-19 vaccines 

are recommended even for those who have had prior infection. Rates of reinfection increased 

during Omicron period. Bivalent COVID-19 vaccines in the setting of prior SARS-CoV-2 

infection, sometimes called “hybrid immunity,” results in the highest antibody titers. 

Encouragingly, these high and diverse titers may result in a longer duration of protection and 

increased need for frequent COVID-19 vaccine booster doses. Studies have shown that 

increased time between infection and vaccination may result in an improved immune response 

to vaccination. Those with recent SARS-CoV-2 infection may consider delaying the vaccine 

does by 3 months from symptom onset or a positive test. 

The WG also discussed that time since most recent vaccine dose may be more important 

than total cumulative number of doses. They also fully acknowledged that there will be a time 

of transition as the recommendations move from counting dose number to optimal timing 

of the vaccination campaigns. They know clearly and have learned for the last 2 years that 

vaccine recommendations that are simple and easy to communicate are important. The WG 

also discussed that if SARS-CoV-2 becomes seasonal virus, and annual vaccine program could 

be an effective strategy for the future. All of this highlights that there is a distinct effort to simplify 

vaccine recommendations through a transition to what could be a more sustainable and longterm COVID vaccination program. 

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ACIP Meeting Summary September 1, 2022 

To highlight the new framework for the equity data used during this session, a key important 

part of the discussion through equity is that equity is not a yes/no question but requires 

considerations for implementation. Discussions among the WG also identified several of these 

implementation considerations, some of which have been discussed already such as ensuring 

supply, ordering, and provider readiness through an equitable distribution of the vaccine. 

Communications is also integral for equitable implementation, creating COVID communication 

plans that understand existing data around attitudes and perceptions for COVID vaccines and 

adjusts actions accordingly, leveraging trusted partners to deliver the vaccines as well as 

trusted messengers to communicate with a broad population. 

The WG reviewed the totality of the data presented throughout this session. As a reminder, this 

was the summary of the WG judgements for EtR: 

As the WG reviewed the totality of the data presented and acknowledged uncertainties around 

aspects of the data, they felt that the desirable consequences probably or clearly outweighed 

the undesirable consequences. The WG proposed to ACIP to recommend the intervention. With 

that in mind, the WG posed the following question to ACIP: 

Should the updated or bivalent vaccines be recommended for persons already 

recommended to receive a vaccine booster dose broadly, very specifically pointing out 

the votes for today would be for the Moderna vaccine in persons ≥18 and over and the 

Pfizer vaccine in persons ≥12 years of age and over? 

The WG also asked for ACIP feedback on and overall updated recommendation strategy that is 

more in line with traditional ACIP recommendations and a broad summary of the program. CDC 

will review any additional data to consider expansion of age groups recommended for bivalent 

COVID-19 vaccines. Future recommendations would necessarily follow updates to the EUAs 

issued by FDA. 

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ACIP Meeting Summary September 1, 2022 

Vote #1: Pfizer-BioNTech COVID-19 Bivalent Vaccine in Individuals ≥12 Years of Age 

Sara Oliver, MD, MSPH (CDC/NCIRD) presented the proposed recommendations for a PfizerBioNTech COVID-19 bivalent vaccine in individuals ≥12 years of age as follows: 

A single booster dose of bivalent Pfizer-BioNTech COVID-19 vaccine is recommended 

for individuals ages 12 years and older at least 2 months after receipt of a primary 

series or prior monovalent booster dose, under the EUA issued by FDA. 

ACIP repeals its previous recommendations for administration of monovalent PfizerBioNTech COVID-19 vaccine boosters for persons ages 12 years and older. 

Motion/Vote #1: Pfizer-BioNTech COVID-19 

Bivalent Booster Vaccine in Individuals ≥12 Years of Age 

Dr. Poehling made a motion for ACIP to adopt the verbiage of the recommendation stating that, 

“A single booster dose of bivalent Pfizer-BioNTech COVID-19 vaccine is recommended for 

individuals ages 12 years and older at least 2 months after receipt of a primary series or prior 

monovalent booster dose, under the EUA issued by FDA. ACIP repeals its previous 

recommendations for administration of monovalent Pfizer-BioNTech COVID-19 vaccine 

boosters for persons ages 12 years and older.” Ms. McNally seconded the motion. No conflicts 

of interest (COIs) were declared. The motion carried with 13 affirmative votes, 1 negative vote, 

and 0 abstentions. The disposition of the vote was as follows: 

13 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Talbot 

1 Opposed: Sanchez 

0 Abstained: N/A 

Vote #2: Moderna COVID-19 Bivalent Vaccine in Individuals ≥18 Years of Age 

Sara Oliver, MD, MSPH (CDC/NCIRD) presented the proposed recommendations for Moderna 

COVID-19 bivalent vaccine in individuals ≥18 years of age as follows: 

A single booster dose of bivalent Moderna COVID-19 vaccine is recommended for 

individuals ages 18 years and older at least 2 months after receipt of a primary series or 

prior monovalent booster dose, under the EUA issued by FDA. 

ACIP repeals its previous recommendations for administration of monovalent Moderna 

COVID-19 vaccine boosters for persons ages 18 years and older. 

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ACIP Meeting Summary September 1, 2022 

Motion/Vote #2: Moderna COVID-19 Bivalent Vaccine in Individuals ≥18 Years of Age 

Dr. Poehling made a motion for ACIP to adopt the verbiage of the recommendation stating that, 

“A single booster dose of bivalent Moderna COVID-19 vaccine is recommended for individuals 

ages 18 years and older at least 2 months after receipt of a primary series or prior monovalent 

booster dose, under the EUA issued by FDA. ACIP repeals its previous recommendations for 

administration of monovalent Moderna COVID-19 vaccine boosters for persons ages 18 years 

and older. No conflicts of interest (COIs) were declared. The motion carried with 13 affirmative 

votes, 1 negative vote, and 0 abstentions. The disposition of the vote was as follows: 

13 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Talbot 

1 Opposed: Sanchez 

0 Abstained: N/A 

Discussion Summary 

Subsequent to the vote, Dr. Lee invited ACIP members to make a statement about the rationale 

for their vote and/or to share any additional general comments: 

Dr. Long said that as a clinician making a decision for individuals, she would be on Dr. 

Sanchez’s side. She makes this decision for most people, considering and hoping that the 

advantages will outweigh any risks that are not yet anticipated. 

Dr. Sanchez explained that he voted “no” because he feels that human data are needed and are 

very important. This is a new vaccine and a new platform. There is a lot of vaccine hesitancy 

already. While human data are needed, he thinks the vaccine will have similar safety as already 

seen with the previous vaccines with mRNA. He personally is of the age group that is at higher 

risk and is almost sure that he will take the vaccine. However, he feels that this vote was 

premature without having seen human data. 

Dr. Poehling said she thought this was a huge step forward in simplifying the recommendations 

and hopefully enhancing coverage. It does put a lot of pressure on the distribution of the vaccine 

because of switching from bivalent to monovalent for boosters among people ≥12 years of age. 

Her sincere hope is that this will be expedient and not impair access for all who want the 

bivalent vaccine. 

Dr. Brooks expressed appreciation for Dr. Oliver’s synopsis of the EtR Framework showing the 

beauty of how important that is and the addition of equity on each of the line items, because the 

WG struggled with equity. The only reason he voted “yes” was because of thinking about how 

influenza vaccines are handled on a yearly basis. While they have data, it is based on the last 

vaccine. 

Dr. Oliver confirmed that all of the discussion and deliberation will be captured in the Clinical 

Considerations to make sure that it fully reflects the diverse opinions of this committee in the 

vote. 

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ACIP Meeting Summary September 1, 2022 

Dr. Lee expressed appreciation for all of the input throughout the day on the booster 

recommendations and the move toward. Like one of the members mentioned earlier, they might 

not be “out of the woods yet” but she remains optimistic as this becomes a solution that is one 

that can be sustained. If anything changes substantively about the benefit-risk balance or if 

there are any new safety considerations, she assured everyone that the ACIP most certainly 

would meet. She assured members of the public that the ACIP and CDC systems and teams 

continue close monitoring. She recognized and acknowledged the uncertainty, but expressed 

her hope that despite that, hopefully this recommendation will make a huge impact in the ability 

to continue to weather the pandemic together. 

Dr. Wharton thanked the ACIP, speakers, and public for sticking with them throughout the day 

for this very long meeting. This is a big step forward for simplification and hopefully in moving 

toward something that is a more normal set of vaccine recommendations and a cadence of 

changes to recommendations. The hope is for simplicity and less frequent changes going 

forward. As a reminder, this meeting originally was scheduled for 2 days. However, given that all 

of ACIP’s business for this meeting was completed, adjournment at this time ended the meeting 

and the ACIP would not reconvene the next day. 

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ACIP Meeting Summary September 1, 2022 

CERTIFICATION 

Upon reviewing the foregoing version of the September 1, 2022 ACIP meeting minutes, Dr. 

Grace Lee, ACIP Chair, certified that to the best of her knowledge, they are accurate and 

complete. Her original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC. 

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ACIP Meeting Summary September 1, 2022 

ACIP MEMBERSHIP ROSTER 

CHAIR 

LEE, Grace M, MD, MPH 

Associate Chief Medical Officer for Practice Innovation 

Lucile Packard Children’s Hospital

Professor of Pediatrics, Stanford University School of Medicine 

Stanford, CA 

Term: 8/4/2021 – 6/30/2023 

EXECUTIVE SECRETARY 

WHARTON, Melinda, MD, MPH 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

Atlanta, GA 

MEMBERS 

BAHTA, Lynn, RN, MPH, CPH 

Immunization Program Clinical Consultant 

Infectious Disease, Epidemiology, Prevention & Control Division 

Minnesota Department of Health 

Saint Paul, Minnesota 

Term: 7/1/2019 – 6/30/2023 

BELL, Beth P, MD, MPH 

Clinical Professor 

Department of Global Health, School of Public Health 

University of Washington 

Seattle, WA 

Term: 7/1/2019 – 6/30/2023 

BROOKS, Oliver, MD, FAAP 

Chief Medical Officer 

Watts HealthCare Corporation 

Los Angeles, CA 

Past President, National Medical Association 

Term: 7/26/2021 – 6/30/2025 

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 

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ACIP Meeting Summary September 1, 2022 

CINEAS, Sybil, MD, FAAP, FACP 

Associate Professor of Medicine, Pediatrics, and Medical Science (Clinical) 

The Warren Alpert Medical School of Brown University 

Associate Program Director 

Brown Combined Residency in Internal Medicine and Pediatrics 

Providence, RI 

Term: 7/28/2021 – 6/30/2025 

DALEY, Matthew F, MD 

Senior Investigator 

Institute for Health Research, Kaiser Permanente Colorado 

Associate Professor of Pediatrics 

University of Colorado School of Medicine 

Aurora, CO 

Term: 1/4/2021 – 6/30/2024 

KOTTON, Camille Nelson, MD, FIDSA, FAST 

Clinical Director, Transplant and Immunocompromised Host Infectious Diseases 

Infectious Diseases Division, Massachusetts General Hospital 

Associate Professor of Medicine, Harvard Medical School 

Boston, MA 

Term: 12/23/2020 – 6/30/2024 

LOEHR, Jamie, MD, FAAFP 

Owner, Cayuga Family Medicine 

Ithaca, New York 

Term: 7/26/2021 – 6/30/2025 

LONG, Sarah S, MD 

Professor of Pediatrics 

Drexel University College of Medicine 

Section of Infectious Diseases 

St. Christopher’s Hospital for Children 

Philadelphia, Pennsylvania 

Term: 12/24/2020 – 6/30/2024 

MCNALLY, Veronica V, JD 

President and CEO Franny 

Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2023 

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 

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ACIP Meeting Summary September 1, 2022 

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 

SHAH, Nirav D, MD, JD 

Director 

Maine Center for Disease Control and Prevention 

Augusta, ME 

Term: 9/26/2022 – 6/30/2026 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University 

Nashville, TN 

Term: 10/29/2018 – 6/30/2023 

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) 

GRIMES, Reed, MD, MPH 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

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ACIP Meeting Summary September 1, 2022 

Indian Health Service (IHS) 

CLARK, Matthew, MD, FAAP, FACP 

Physician 

Chair, IHS National Pharmacy & Therapeutics Committee 

Durango, CO 

Office of Infectious Disease and HIV/AIDS Policy (OIDP) 

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

National Institutes of Health (NIH) 

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) 

Bethesda, MD 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP) 

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

American Academy of Pediatrics (AAP) 

O’LEARY, Sean, MD, MPH

Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

American Academy of Pediatrics (AAP) 

Red Book Editor 

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine 

Birmingham, AL 

American Academy of Physician Assistants (AAPA) 

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants 

Alexandria, VA 

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ACIP Meeting Summary September 1, 2022 

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 

70 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary September 1, 2022 

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA 

Washington, DC 

American Medical Association (AMA) 

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA) 

RITTLE, Charles (Chad), DNP, MPH, RN Assistant 

Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA) 

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA) 

HOGUE, Michael D., PharmD, FAPhA, FNAP 

Dean and Professor of Loma Linda University School of Pharmacy 

Director, Center for Interprofessional Education & Practice 

Loma Linda, CA 

Association of Immunization Managers (AIM) 

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health 

Bismarck, ND 

Association for Prevention Teaching and Research (APTR) 

ZIMMERMAN, Richard, MD, MPH 

Professor 

University of Pittsburgh School of Medicine 

Department of Family Medicine and Clinical Epidemiology 

Pittsburgh, PA 

Association of State and Territorial Health Officials (ASTHO) 

TBA 

Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

71 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary September 1, 2022 

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

Council of State and Territorial Epidemiologists (CSTE) (alternate) 

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

Canadian National Advisory Committee on Immunization (NACI) 

DEEKS, Shelley, MD, MHSc, FRCPC, FAFPHM 

Deputy Chief Medical Officer of Health, Department of Health and Wellness, Nova Scotia 

Associate Professor, Dalla Lana School of Public Health, University of Toronto 

Chair, National Advisory Committee on Immunization 

Halifax, Nova Scotia 

Infectious Diseases Society of America (IDSA) 

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 

International Society for Travel Medicine (ISTM) 

BARNETT, Elizabeth D, MD Professor of 

Pediatrics 

Boston University School of Medicine 

Boston, MA 

National Association of County and City Health Officials (NACCHO) 

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

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 

72 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary September 1, 2022 

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) 

ANDERSON, Evan, MD 

Professor of Pediatrics and Medicine 

Pediatric and Adult Infectious Diseases 

Children’s Healthcare of Atlanta and Emory University Hospital

Emory University School of Medicine 

Atlanta, GA 

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 

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 

73 
 

 

 

 

 

 

 

ACIP Meeting Summary September 1, 2022 

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 

74 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary September 1, 2022 

ACRONYMS USED IN THIS DOCUMENT 

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices 

ACOG American College of Obstetricians and Gynecologists 

ACP American College of Physicians 

AE Adverse Event 

AESI Adverse Event of Special Interest 

AHIP America’s Health Insurance Plans

AI/AN American Indian/Alaskan Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association 

AOA American Osteopathic Association 

APhA American Pharmacists Association 

AR Adverse Reaction 

ASPR Administration for Strategic Preparedness & Response 

ASTHO Association of State and Territorial Health Officers 

BEST Biologics Effectiveness and Safety System 

BLA Biologics License Application 

CDC Centers for Disease Control and Prevention 

CISA Clinical Immunization Safety Assessment 

CLI COVID-like illness 

CMS Center for Medicare and Medicaid Services 

COD Cause of Death 

COI Conflict of Interest 

CSTE Council of State and Territorial Epidemiologists 

CVD Cardiovascular Disease 

DFO Designated Federal Official 

DoD Department of Defense 

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs 

ECG/EKG Electrocardiogram 

ED Emergency Department 

EHR Electronic Health Records 

EMR Electronic Medical Record 

ET Eastern Time 

EtR Evidence to Recommendation 

EUA Emergency Use Authorization 

FDA Food and Drug Administration 

GBS Guillain- Barré Syndrome 

GMT Geometric Mean Titers 

GRADE Grading of Recommendations, Assessment, Development and Evaluation 

HCP Healthcare Personnel / Providers 

HCW Healthcare Workers 

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ACIP Meeting Summary September 1, 2022 

HHS (Department of) Health and Human Services 

HIV Human Immunodeficiency Virus 

HRSA Health Resources and Services Administration 

ICATT Increasing Community Access to Testing 

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IM Intramuscular 

IVY Influenza and Other Viruses in the Acutely Ill 

J&J Johnson & Johnson 

KFF Kaiser Family Foundation 

LTCF Long-Term Care Facilities 

MAAE Medically Attended Adverse Event 

MedDRA Medical Dictionary for Regulatory Activities 

MMWR Morbidity and Mortality Weekly Report 

MSA Metropolitan Statistical Area 

NAAT Nucleic Acid Amplification Tests 

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 

NCIRD National Center for Immunization and Respiratory Diseases 

NEJM New England Journal of Medicine 

NFID National Foundation for Infectious Diseases 

NHP Non-Human Primate 

NIH National Institutes of Health 

NIS-ACM National Immunization Survey Adult COVID-19 Module 

NMA National Medical Association 

NVSS National Vital Statistics System 

PCP Primary Care Provider/Practitioner 

PCR Polymerase Chain Reaction 

PHAC Public Health Agency Canada 

PIDS Pediatric Infectious Disease Society 

PrEP Pre-exposure Prophylaxis 

RCA Rapid Cycle Analysis 

RCT Randomized Controlled Trial 

RR Relative Risk 

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SDOH Social Determinants of Health 

SES Socioeconomic Status 

S-Gene Spike Gene 

SHEA Society for Healthcare Epidemiology of America 

SMQ Standardised MedDRA Queries 

SOC System Organ Class 

SSR Summary Safety Report 

SVI Social Vulnerability Index 

TTS Thrombotic Thrombocytopenia Syndrome 

UC Urgent Care 

UK United Kingdom 

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ACIP Meeting Summary September 1, 2022 

US United States 

USG United States Government 

UTD Up-To-Date 

VA (US Department of) Veteran’s Affairs

VAERS Vaccine Adverse Event Reporting System 

VE Vaccine Efficacy 

VE Vaccine Effectiveness 

VOC Variants of Concern 

VRBPAC Vaccine and Related Blood Products Advisory Committee 

VSD Vaccine Safety Datalink 

WG Work Group 

77