MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP)

JULY 19, 2022

EXECUTIVE SUMMARY

CONTENTS

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

TUESDAY: JULY 19, 2022 ........................................................................................................................... 2

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

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

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

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

Session Introduction .............................................................................................................. 3

Epidemiology of COVID-19 & COVID-19 Vaccine Coverage ................................................ 3

Updates on Vaccine-Associated Myocarditis......................................................................... 7

Safety, Immunogenicity, and Efficacy of Novavax 2-Dose Primary Series in Adults ≥18 

Years of Age........................................................................................................................13

Public Comment ..................................................................................................................21

EtR Framework: Novavax COVID-19 Vaccine in Adults......................................................25

Interim Clinical Considerations: Novavax COVID-19 Vaccine.............................................36

Vote: Novavax COVID-19 Vaccine in Adults ≥18 Years of Age ..........................................40

CERTIFICATION.........................................................................................................................................44

ACIP MEMBERSHIP ROSTER...................................................................................................................45

ACRONYMS USED IN THIS DOCUMENT................................................................................................. 54
ACIP Meeting Summary July 19, 2022 

2 

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 July 19, 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; COVID-19 vaccine coverage; updates on vaccineassociated myocarditis; Novavax COVID-19 vaccine safety, immunogenicity, and efficacy in 

adults ages 18 years and older; Evidence to Recommendations (EtR) Framework: Novavax 

COVID-19 vaccine for adults ≥18 years of age; Clinical Considerations update; and a vote on

Novavax COVID-19 vaccine in adults ages 18 years and older. 

TUESDAY: JULY 19, 2022

WELCOME AND INTRODUCTIONS

Call to Order/Roll Call

Dr. Grace Lee (ACIP Chair) called to order and presided over the July 19, 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) 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 12:20 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-2022-0085. 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.

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 
ACIP Meeting Summary July 19, 2022 

3 

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

and nominations are currently being accepted for candidates to fill upcoming vacancies

on the ACIP practices. Detailed instructions for submission of names for potential candidates to 

serve as ACIP members are now available on the ACIP website. The deadline for applications 

for ACIP membership has been extended to August 15, 2022 for the 4-year year term beginning

in July 2023 at which time 6 positions will be filled, including a Consumer Representative 

position.

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 reported that in terms of trends in daily number of 

COVID-19 cases in the US from the start of the pandemic and July 14, 2022, there have been 

more than 89 million cases reported in the US.1 In total, there have been more than 1 million 

deaths due to COVID-19 reported in the US since the beginning of the pandemic.2 Depending

upon the data source, between 10.3% and 13.9%3 of all adults in the US have not received any 

vaccines. That translates to approximately 26 to 37 million US adults who have not yet received 

a COVID-19 vaccine. Among those who have received at least 1 dose, there are many 

individuals who need to complete the primary series and their booster, so they are not fully 

protected. Since ACIP last met, the COVID-19 Vaccines WG has reviewed data on the 

epidemiology of COVID-19 in adults; COVID-19 vaccine coverage in adults; the benefits of 

COVID-19 vaccination in adults; rare events of myocarditis following COVID-19 vaccination; and 

safety and the efficacy of the Novavax COVID-19 vaccine 2-dose primary series in adults ≥18 

years of age. In addition, the COVID-19 Vaccines WG developed its interpretation of the safety 

and efficacy of the Novavax COVID-19 vaccine primary vaccine series. 

Epidemiology of COVID-19 & COVID-19 Vaccine Coverage

Katherine E. Fleming-Dutra, MD (COVID-19 Epidemiology Task Force, CDC) reiterated that 

from the beginning of the pandemic through July 14, 2022, there have been more than 89 

million total recorded cases of COVID-19 in the US, and that the 7-day moving average was 

more than 120,000 cases per day at that time. The COVID-19 pandemic has disproportionately 

affected certain racial and ethnic communities. Hispanic/Latino persons, American Indian/ 

Alaska Native (AI/AN) persons, and persons of multiple/other races who are non-Hispanic have 

been disproportionately affected by COVID-19 infections.4 The Omicron variant is currently

predominant in the US. Through the week ending July 9th, Omicron has been over 99% 

predominant for many months. The BA.5 sub-lineage has comprised 65% of specimens and 

BA.4 has compromised 16.3%.5

1

 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed July 14, 2022 2

 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailydeaths Accessed July 13, 2022; Per National 

Center for Health Statistics Death Certificate Data: Total number of COVID-19 total deaths as of July 13, 2022, were 1,015,431. 

https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#AgeAndSex 3

 COVIDVaxView. Estimates produced by NORC at the University of Chicago using CDC’s National Immunization Survey-Adult 

COVID-19 Module (NIS-ACM). https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html. 

Accessed July 14, 2022 COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dosetotalpop. Accessed on July 13, 2022. 4

 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#demographics. Accessed July 11, 2022. 

5 https://covid.cdc.gov/covid-data-tracker/#variant-proportions. Accessed July 13, 2022 
ACIP Meeting Summary July 19, 2022 

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During the pandemic, there have been more than 4.9 million total hospital admissions for 

COVID-19. Focusing on the most recent time period, there has been an uptick in 

hospitalizations since April 2022. The vast majority (97.2%) of these admissions are occurring 

among adults 18 years of age and older. Higher hospitalization rates occur in the older age 

groups. Patients ≥70 years of age, 60-69 years of age, and 50-59 years of age have the highest 

admission rates, followed by other adult age groups. Importantly, recent increases in

hospitalization rates have been driven by older age groups, especially among patients ≥70 

years of age.6 Looking at COVID-19-associated hospitalization rates by race and ethnicity, 

COVID-NET provides more granular information on COVID-19-associated hospitalizations. 

Cumulative population-based rates of COVID-19-associated hospitalizations through June 25th

among persons of all ages by race and ethnicity show that AI/AN persons, Black persons, and 

Hispanic/Latino persons have been disproportionately affected by COVID-19-associated 

hospitalizations.7

In terms of mortality due to COVID-19 reported in the US since the beginning of the pandemic, 

tragically, there have been 1,018,578 deaths due to COVID-19 reported to CDC cumulatively in 

the US as of July 14, 2022.8 In terms of weekly trends in COVID-19-associated mortality rates 

by age group, data show that higher mortality rates are consistently observed in older age

groups and more than 99% of deaths occur in adults. The highest mortality rates occur among 

those ≥75 years of age, 65-74 years of age, and 50-64 years of age.9 Similar to hospitalization 

rates, there has been a recent increase in COVID-19 death rates among older age groups, 

especially among those ≥75 years of age. Looking at weekly COVID-19 mortality rates by race 

and ethnicity over the course of the pandemic, there has been a changing and complex 

relationship between race and ethnicity and mortality rates. Early in the pandemic, Black 

persons had the highest rate of death compared to persons of other race and ethnicities. AI/AN 

persons have been disproportionately affected throughout much of the pandemic. During the 

Omicron surge, Hispanic persons have had the highest rate of COVID-19 mortality.10 Race and 

ethnicity are risk markers for other underlying conditions that affect health, including 

socioeconomic status (SES), access to healthcare, and exposure to the virus related to 

occupation (e.g., frontline, essential, and critical infrastructure workers). 

Regarding COVID-19 disease trends by vaccination status as of June 2022, unvaccinated 

people ≥5 years of age had a 2.8 times higher risk of testing positive for COVID-19 compared to 

people vaccinated with at least a primary series.11 Looking at age adjusted rates of COVID-19-

associated hospitalizations by vaccination status in adults ≥18 years of age, hospitalizations for 

COVID-19 were higher among unvaccinated persons than among vaccinated persons. In May

2022, unvaccinated adults ≥18 years of age had a 3.5 times higher risk of COVID-19-associated 

hospitalization compared to people who completed a primary vaccine series and received at 

least one booster or additional dose.12 In terms of the age-adjusted rates of COVID-19-

associated deaths by vaccination status, unvaccinated people ≥12 years of age had higher 

mortality rates than people who received a primary series or a primary series and a booster 

dose. In May 2022, unvaccinated people ≥12 years of age had a 9 times higher risk of dying 

6

 Unified Hospital Dataset: https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions. Accessed July 13, 2022 

7

 COVID-NET: https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network. Accessed July 8, 2022 8

 Source: CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailydeaths. Accessed July 18, 2022; Per 

National Center for Health Statistics Death Certificate Data: Total number of COVID-19 total deaths as of July 13, 2022, were 

1,015,431; https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#AgeAndSex. Accessed July 18, 2022

9

 https://covid.cdc.gov/covid-data-tracker/#demographicsovertime and https://covid.cdc.gov/covid-data-tracker/#demographics. 

Accessed July 11, 2022. 

10 https://covid.cdc.gov/covid-data-tracker/#demographicsovertime. Accessed July 11, 2022. 11 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status. Accessed July 15, 2022 12 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination. Accessed July 11, 

2022
ACIP Meeting Summary July 19, 2022 

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from COVID-19 compared to people vaccinated with a primary series and a booster dose.13 The 

benefits of vaccination are more pronounced when the disease burden is high. With future 

COVID-19 surges, the unvaccinated will continue to bear the burden of disease.

It is important to note that monitoring rates of cases, hospitalizations, and deaths by vaccination 

status has limitations. These are not vaccine effectiveness (VE) studies. VE studies offer a more 

robust analyses as compared with surveillance and a better understanding of how well vaccines

are working in periods of high and low disease incidence.

In terms of opportunities to increase COVID-19 vaccination rates among US adults who have 

yet to receive a COVID-19 vaccine and thus would be eligible for a primary series with Novavax

vaccine should ACIP recommend this vaccine, trends over time by age group and the percent of 

people who have received at least one dose of COVID-19 vaccine show that vaccination

coverage is higher in older age groups. As of July 6, 2022, just over 20% of US adults 18

through 24 years of age, just under 20% of adults 25 through 39 years of age, and 13% of 

adults 40 through 49 years of age have yet to receive a COVID-19 vaccine.14 Data from CDC’s 

National Immunization Survey Adult COVID-19 Module (NIS-ACM) and vaccine administration 

data from COVID Data Tracker show the percent of US adults ≥ages 18 years of age who have 

not yet received a COVID-19 vaccine. The NIS-ACM conducted in May 2022 showed that 

13.9% of surveyed adults reported not yet receiving a COVID-19 vaccine versus 10.3% of the 

vaccine administration data in COVID Data Tracker. Using these data and Census data, it can 

be estimated that there are about 26 to 37 million US adults who have not yet received a 

COVID-19 vaccine.15

Data by race and ethnicity from May 2022 in the NIS-ACM show that 22% of persons of Other/ 

Multiple races, 20% of AI/AN persons, 14% of Hispanic persons, and 14% of White persons

have yet to receive a COVID-19 vaccine. Looking at the same data stratified by age group and 

race/ethnicity, higher proportions of younger adults 18 through 49 years of age remain 

unvaccinated than among older age groups. Among adults ages 18 through 49 years, people of 

Other/Multiple races who are non-Hispanic have the highest percentages remaining

unvaccinated, while Hispanic persons have the lowest percentages remaining unvaccinated. 

Among adults 50 through 64 years of age, people of Other/Multiple races who are non-Hispanic

have the highest percentages remaining unvaccinated and Black persons in this age group 

have the lowest proportion remaining unvaccinated. Very few adults ≥65 years of age remain 

unvaccinated. Looking at the same data by Metropolitan Statistical Area (MSA), a higher 

percentage of US adults living in rural areas remain unvaccinated as compared to those living in 

suburban or urban areas. Looking at the same data by income and poverty status, a higher 

percentage of US adults with incomes less than $75,000, particularly those living below poverty, 

remain unvaccinated compared to adults are higher incomes. Looking at these data by 

markers of access to healthcare, a higher percentage of US adults who do not have a regular 

primary care provider (PCP) remain unvaccinated compared to those who do and a higher

13 adults ages ≥50 years and immunocompromised individuals. CDC COVID Data Tracker. https://covid.cdc.gov/covid-datatracker/#rates-by-vaccine-status. Accessed July 15, 2022 14 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends. Accessed July 11, 2022. 

15 COVIDVaxView. Estimates produced by NORC at the University of Chicago using CDC’s National Immunization Survey-Adult 

COVID-19 Module (NIS-ACM). https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html. 

Accessed July 14, 2022 COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additionaldose-totalpop. Accessed on July 13, 2022. 
ACIP Meeting Summary July 19, 2022 

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percentage of those who do not have health insurance remain unvaccinated compared to those 

who have health insurance.16

In conclusion, as of July 14, 2022, more than 89 million COVID-19 cases and more than 1 

million COVID-19 deaths have occurred in the US. COVID-19 continues to cause new cases, 

hospitalizations, and deaths. COVID-19 has contributed to health inequities. AI/AN, Black, and 

Hispanic/Latino persons have been disproportionately affected by COVID-19-associated

hospitalizations and deaths. Vaccination is known to prevent COVID-19 cases, hospitalization, 

and deaths. However, about 26 to 37 million US adults have not yet received a COVID-19

vaccine. These adults will benefit from starting a COVID-19 vaccine primary series. 

Discussion Summary

Dr. Poehling emphasized the importance of the focus on unvaccinated persons, particularly in 

the context of the new vaccine being discussed. She asked whether there is any information

about how many people have been boosted once and twice, given that Omicron is circulating

and having a boost offers additional coverage.

Dr. Oliver indicated that these data had not been presented because the primary focus if this 

meeting was on Novavax, which is a primary series. The information on boosters doses is 

posted on the COVID Data Tracker. Among the population ≥65 years of age, 70% have 

received the first booster dose and 35% have received a second booster dose. There is 

definitely room for improvement, especially with the second booster dose in adults ≥50 years of 

age. 

Dr. Daley ask Dr. Fleming-Dutra to expand on the extent to which the disparities in terms of 

COVID-19 hospitalizations and deaths by race are a reflection of disparities in vaccination 

coverage versus other social determinants of health (SDOH), recognizing that there are 

surveillance data and that there are limitations to what can be concluded from them. 

Dr. Fleming-Dutra emphasized that this is a very important question. As noted, these data are 

based on surveillance. The cases are based on data reported to CDC on total cases, 

hospitalizations are based on COVID-NET data, and deaths come from the National Vital 

Statistics System (NVSS). While these sources reflect vaccination coverage, other SDOH and 

vaccine coverage are not included in this particular analysis.

Dr. Taylor from COVID-NET added one caveat for the hospitalization data is that the analysis by 

age adjusted rate ratios is cumulative, so it takes into account all hospitalizations that occurred 

from March 2020 through the period ending June 11, 2022. That includes a large portion of time 

when there was no effect of vaccination on hospitalization rates. This would make it difficult to 

dig much into the effect of vaccination on hospital rates.

Dr. Daley said if felt like perhaps qualitatively some of the disparities in vaccination coverage by 

race have lessened, but there are disparities by other important characteristics (e.g., SES, 

poverty, rurality, healthcare access, not having health insurance). These data made it seem like 

there had been at least some progress in disparities and coverage by race.

16 Source: COVIDVaxView. Estimates produced by NORC at the University of Chicago using CDC’s National Immunization SurveyAdult COVID-19 Module (NISACM). https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adults.html. 

Accessed July 14, 2022 
ACIP Meeting Summary July 19, 2022 

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Dr. King (NMA) pointed out that just because this is cumulative does not necessarily determine

the latest trends based on race, deaths, and hospitalizations in terms of what is occurring from a 

demographic standpoint among racial and ethnic populations.

Dr. Fleming-Dutra indicated that they would take this back to the various teams to conduct this 

analysis for the last year.

Dr. Lee emphasized that both the cumulative numbers and more recent numbers are helpful. 

While the cumulative data are incredibly helpful, in terms of supporting real-time decision 

making, having more recent real-time vaccination data would help support clinical and public 

health responses by increasing awareness of gaps and opportunities. 

Updates on Vaccine-Associated Myocarditis

Tom Shimabukuro, MD, MPH, MBA (CDC/NCEZID) provided an update vaccine-associated 

myocarditis, with a focus on classic myocarditis and myocarditis associated with mRNA COVID19 vaccination and an update on myocarditis following mRNA COVID-19 vaccination with a 

focus on people ≥18 years of age in the Vaccine Adverse Event Reporting System (VAERS) 

and the Vaccine Safety Datalink (VSD).

Classic myocarditis usually has an infectious cause, typically viral or presumed to be viral.

Although infection with a pathogen is frequently not identified. A pathogen is identified only 

about 40% of the time.17 It can be due to direct microbial infection of myocardial cells and/or 

ongoing inflammatory response, with or without clearance of the pathogen.18 Rarer causes 

include autoimmune, hypersensitivity, and giant cell myocarditis. The incidence in males is 

greater than females, starting after 5 years of age.19 It is common not to identify a pathogen or 

possible infectious etiology for myocarditis. Based on case series, where autopsy tissues were 

examined and tissue-based infectious disease testing was performed, a specific infectious 

cause was only identified in 13% to 36% of cases across age groups.20 For a case series where 

endomyocardial biopsy tissues were tested, viral nucleic acids were detected in heart tissues in 

approximately 38% of adults and children combined.21

In terms of the epidemiology of myocarditis in children and adults, after early childhood when 

genetic or congenital conditions are suspected to contribute to myocarditis, incidence is low and 

then begins to increase starting in adolescence. Incidence peaks in adolescence and gradually 

decreases with age. There is a striking male-to-female predominance, but that attenuates

around middle age.22 The following table compares the characteristics of myocarditis associated 

with mRNA COVID-19 vaccination and viral myocarditis: 

17 Bowles et al. J Am Coll Cardiol. 2003;42:466-72; Simpson et al. J Am Coll Cardiol; 2013;61:(10_Supplement) E1264; and Park et 

al. J Korean Med Sci. 2021;36:e232. 18 Caforio et al. Eur Heart J. 2013;34:2636-48, 2648a-2648d; Feldman et al. N Engl J Med. 2000;343:1388-98; and Guarner et al. 

Hum Pathol. 2007;38:1412-9 19 Arola et al. J Am Heart Assoc. 2017;6:e005306. 

20 Guarner et al. Hum Pathol. 2007;38:1412-9; Arola et al. J Am Heart Assoc. 2017;6:e005306; Weber et al. Arch Dis Child. 

2008;93:594-8; and Ilina et al. Pediatrics. 2011;128:e513-20. 21 Bowles et al. J Am Coll Cardiol. 2003;42:466-72 

22 Vasudeva et al. American J. Cardiology, 2021 (children); and Kyto et al. Heart. 2013 (adults)
ACIP Meeting Summary July 19, 2022 

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For vaccine-associated myocarditis, the inciting exposure is mRNA COVID-19 vaccination. 

Incidence is greater, following Dose 2 compared to Dose 1. For viral myocarditis, with 30% to 

60% having an asymptomatic viral course. For a vaccine-associated myocarditis, most cases 

are in adolescence and young adults, with more cases in males compared to females. For viral 

myocarditis, incidence is higher in males compared to females. Male incidence peaks in 

adolescence, and then gradually declines with age. For vaccine-associated myocarditis, 

symptom onset clusters within a few days after vaccination. Most of the vaccine-associated 

cases appear to occur within the week of vaccination. For viral myocarditis, onset is typically 1 

to 4 weeks after viral illness. In general, myocarditis associated with mRNA COVID-19

vaccination has been relatively clinically mild compared to viral myocarditis. There are VAERS

and VSD data to support these observations.

As a reminder, VAERS is the national spontaneous reporting system that is co-managed by 

CDC and FDA. As a passive surveillance system, VAERS accepts reports from anyone 

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

event. The key strengths of VAERS are that it can rapidly detect potential safety problems and 

can detect rare adverse events (AEs). The key limitation is that generally, cause and effect

cannot generally be determined from VAERS data alone.

In terms of US reports to VAERS of myocarditis after mRNA COVID-19 vaccination among 

people ≥18 years of age following a primary vaccine series and the first booster dose through 

the end of May 2022, there were 1,836 preliminary reports of myocarditis. Of these, 11 remain 

under review and 504 did not meet the CDC case definition.23 That leaves 1,321 reports of 

myocarditis that were verified to meet the case definition. To put that number in perspective, 

there were approximately 491.9 million primary series and first booster mRNA COVID-19

vaccine doses administered in the US among people ≥ages 18 years of age at that time

comprised of 213.3 million first doses, 185.1 million second doses, and 93.4 million first booster 

doses. 

23 CDC myocarditis case definition available at: https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm
ACIP Meeting Summary July 19, 2022 

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In terms of the time to onset for these case reports to VAERS among persons ≥18 years of age, 

reported cases tended to cluster within a few days of vaccination. The overwhelming majority 

occurring within 1 week of vaccination. Among the 1,321 reports of verified myocarditis

according to the CDC case definition among people ≥18 years of age, the median age where 

available was about 28 years (IQR: ages 21–42 years). Median time to symptom onset where 

available was 3 days (IQR: 2–5 days). A minority (19%) of reports had symptom onset 7 days

after vaccination. Most of these reports occurred after Dose 2 (n=962) and most of these reports 

occurred in males (n=960). In terms of VAERS reporting rates of myocarditis per 1 million doses 

administered, after mRNA COVID-19 vaccination in Days 0-7 and Days 8-21 post-vaccination, 

the risk both in males and females was concentrated in the Days 0-7 after vaccination. Elevated 

reporting rates were not seen with respect to background rates in the 8-21 days following

vaccination. Reporting rates were substantially higher in males compared to females and the 

highest reporting rates were observed following Dose 2, with reporting rates for boosters 

tending to fall in between the values for Dose 1 and Dose 2. The older age groups for males

were after 49 years of age, which was younger for females. Elevated reporting rates are not 

seen with respect to background rates. The differences in sex appear to attenuate.

CDC’s enhanced surveillance for myocarditis outcomes following mRNA COVID-19 vaccination 

in various case reports among people 12 through 29 years assesses functional status and 

clinical outcomes among individuals reported to have developed myocarditis after mRNA 

COVID-19 vaccination. It is a 2-component survey conducted at least 90 days after the onset of 

myocarditis symptoms that includes a patient survey and an HCP survey. Focusing on the main 

findings of the cardiologists or healthcare provider survey among those providing aftercare for 

these case patients, most patients (81.7%) were judged by their providers to have fully (66.6%) 

or probably fully (15.1%) recovered from their myocarditis. In terms of the key findings from the 

patient surveys at least 90 days after myocarditis diagnosis, most patients who were reached 

reported no impact on their quality of life and most did not report missing school or work. Of 

note, there was substantial heterogeneity in initial follow-up treatment and testing and there did 

not appear to be a single test that was indicative of recovery. The next steps are additional 

follow-up with patients who are not yet recovered at the time of the 90+ day survey and their 

HCP to further assess recovery status at 12 months.

24 Follow-up and evaluation of myocarditis 

cases in children 5 through 11 years of age is ongoing.

Now moving to the findings from the VSD. As a reminder, the VSD is CDC’s electronic health 

record (EHR)-based system that is used for surveillance and research and is a collaborative 

project between CDC and 9 integrated healthcare organizations around the US. VSD conducts 

Rapid Cycle Analysis (RCA), the aims of which are to: 1) monitor the safety of COVID-19

vaccines weekly using pre-specified outcomes; and 2) describe the uptake of COVID-19

vaccines over time among eligible VSD members overall and in strata by age, site, and 

race/ethnicity. This table delineates the VSD COVID-19 vaccine RCA pre-specified surveillance 

outcomes and the settings in which they are monitored: 

24 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myo-outcomes.html 
ACIP Meeting Summary July 19, 2022

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The primary VSD RCA analytic strategy is a vaccinated concurrent comparator analysis. This 

involves analyzing the number of outcomes observed in the risk interval after COVID-19

vaccination compared to the number expected. The expected was derived from “vaccinated 

concurrent comparators” who were in a comparison interval after COVID-19 vaccination. That is 

simply looking at rates in a risk interval in vaccinated individuals compared to rates in a

comparison interval in vaccinated individuals. The prespecified outcome of myocarditis/ 

pericarditis cases were verified using the CDC case definition. Comparisons were adjusted for 

age group, sex, race/ethnicity, VSD site, and calendar date.

In terms of mRNA COVID-19 vaccine doses administered in the VSD among people 18 through 

39 years of age by week, there was statistically significant clustering in the several days after 

vaccination. The overwhelming majority of these occurred within a week of vaccination, which is 

consistent with the data observed for VAERS reports. There were statistically significantly 

elevated rate ratios after Dose 2 and after a booster dose. Looking at product-specific findings,

there were elevated adjusted rate ratios after Dose 2 and the booster dose of Pfizer-BioNTech 

and after Dose 2 for Moderna. The event counts were substantially lower among females than 

for males, and the number of statistically significantly elevated adjusted rate ratios also were 

less for females. Females had a statistically significantly elevated adjusted rate ratio after Dose 

2 for the Moderna or Pfizer-BioNTech products. The adjusted rate ratios for males and females 

were statistically significant, but the excess cases in the risk period were substantially greater

for males. That is because the condition is much more common in males than in females. In the 

0 to 7 days following mRNA COVID-19 vaccination, the general findings in the VSD are that the 

incidence rates are substantially greater in males compared to females and in general, the 

incidence rates are highest after Dose 2. While there are some exceptions, the numbers are 

fairly small and point estimates may be unstable for those exceptions.
ACIP Meeting Summary July 19, 2022 

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Regarding verified myocarditis and pericarditis within 0 to 7 days of any primary series dose of 

mRNA COVID-19 vaccine by level of care and age group/product, most cases observed in the

VSD were hospitalized and had short lengths of stay. The median stay for either product was 1 

day, and all verified case patients were discharged home. Booster doses were very similar to 

the primary series in that most cases were admitted to the hospital, their length of stay was 

short at a median of 1 day, and they were discharged home.

In summary, the current evidence supports a causal association between mRNA COVID-19

vaccinations and myocarditis and pericarditis. Myocarditis is a rare event following vaccination.

CDC verified 1,321 cases in people ≥18 years of age after 491.9 million doses administered

in this age group in the US. Cases tend to cluster within the first week of vaccination. The risk is 

greatest in adolescents and young adults and is higher after Dose 2 compared to Dose 1 of the 

primary series. There is a higher in males compared to females. Some risk estimates for

females in the VSD are comparable to males, but case counts are small and excess risk in 

females is substantially lower than for males. The risk appears to decrease with age and the 

male-to-female predominance of cases attenuates with age. Reporting rates in VAERS are 

highest following Dose 2. Reporting rates following Dose 1 and the first booster dose tend to be 

lower. Incidence rates in the VSD of verified myocarditis and pericarditis 0 to 7 days following 

vaccination are generally highest following Dose 2. The available information suggests that

most persons with myocarditis after mRNA COVID-19 vaccination recover from myocarditis by 3 

to 8 months after diagnosis. 

Discussion Summary

Dr. King (NMA) inquired as to whether males who are athletes who engage in prolonged 

vigorous exercise after their vaccination could trigger the higher rate of myocarditis for males

compared to females since there are more male athletes than female athletes. Perhaps there 

should be a recommendation for teens and young adults not to undergo strenuous physical 

activity for perhaps a week after receiving vaccination. 

Dr. Shimabukuro indicated that this level of detail is not available from the surveillance

regarding association with physical activity. 

Dr. Oster added that this information has not been collected systematically, but having reviewed 

most of these charts and having taken care of some of these patients, the classic story is that it 

seems to appear out of nowhere (e.g., resting, sleeping, watching TV, attending church,

attending school, et cetera). While some cases have occurred with activity, onset in the vast 

majority has been at rest. Once diagnosed with evidence of cardiac inflammation, current 

guidelines are to restrain from competitive sports for about 3 months even though this cohort of 

young adults tends to recover sooner than in classic myocarditis. Males historically are more 

likely than females to get myocarditis, and there are a lot of different theories as to exactly why 

that could be. One of the most predominant theories is that testosterone levels are higher in 

males, and that can affect the receptors on the cardiac tissue that are at play here. At this time, 

there are no data to suggest that a recommendation should be made to limit activity following 

vaccination.

Dr. Sanchez inquired as to whether timing of doses could have an impact and if there are or 

would be data regarding the timing of booster doses and the occurrence of myocarditis.
ACIP Meeting Summary July 19, 2022

12

Dr. Shimabukuro indicated that there is good information that in the US during the period of this 

analysis, adherence to the primary series schedule was quite good. The timing of the booster 

dose may need further assessment. CDC has done a direct head-to-head comparison between 

the Pfizer and Moderna products and other groups have done comparisons as well. The 

findings from the recent VSD analysis, which was recently published in Vaccine, showed some 

evidence of an increased risk of myocarditis for Moderna compared to Pfizer. This did reach 

statistical significance in one of the sub-analysis CDC did. FDA did a similar analysis in their 

Biologics Effectiveness and Safety System (BEST) that did not detect an increased risk. There

are data from other countries that have looked at this as well. The general trend is that a modest 

increased risk has been observed for Moderna compared to Pfizer, but this has not been

consistent across all systems and analyses.

Dr. Poehling observed that because most adults adhered to the timing for the primary series, 

there would not be an opportunity to look at spreading the dose. He expressed her hope that for 

children, it would be possible to assess whether spreading the primary series 8 weeks apart 

would be feasible. She asked for clarification regarding whether this analysis was any booster 

dose or just the first booster and if it was just the first booster dose, whether there would be an 

opportunity to assess a second booster dose.

Dr. Shimabukuro said his understanding was that this analysis was limited to what they believe 

to be the first booster dose and looking at additional booster doses would be assessed in an 

additional analysis.

Dr. Klein added that these analyses were adjusted for time since the primary series and the 

booster doses.

Dr. Loehr reminded everyone that even though it is clear that there is a causal association with 

vaccination, it is important to remember that there is a higher risk of getting myocarditis and 

pericarditis from having COVID-19 disease.

Dr. Oster further elaborated on the risk of adverse cardiac outcomes with disease compared to 

vaccination, noting that data were presented previous and published in the Morbidity and 

Mortality Weekly Report (MMWR) showing that across all groups, the risk of the cardiac

manifestations of myocarditis and pericarditis is certainly higher after getting SARS-CoV-2 

versus having vaccines. Even in the highest risk group of adolescent and young adult males, 

the risk was 2 to 6 times greater of having significant heart involvement after getting COVID-19 

than after getting COVID-19 vaccine. COVID-19 is a serious disease that can have significant 

cardiac manifestations in a small but higher subset.

Dr. Daley pointed out that while they all would argue that it is very important to understand what 

is occurring, in the context of the day’s discussion, consideration needed to be given to how 

these data should help them think about myocarditis related to a new vaccine that is focused on 

spike protein but uses different technology. He asked Dr. Shimabukuro to remind them what the 

surveillance plans would be should ACIP vote to recommend the Novavax vaccine later in the 

day. He also requested that data from additional studies, if any, assessing the underlying

pathophysiology of vaccine-associated myocarditis be brought to the ACIP.
ACIP Meeting Summary July 19, 2022 

13

Dr. Shimabukuro said he would reach out to those doing the work and would be happy to return 

to describe any work assessing the underlying pathophysiology of vaccine-associated 

myocarditis. Regarding surveillance, myocarditis/pericarditis is an AE of special interest (AESI) 

for VAERS, so they will be specifically looking for reports suspicious of myocarditis and 

pericarditis and will review and follow-up on every report, including obtaining medical records 

and contacting healthcare providers to obtain sufficient information to apply the CDC case 

definition to verify reports. Enhanced surveillance for myocarditis and pericarditis after a 

Novavax will be conducted similar to what has been done for the mRNA vaccines. Surveillance 

for Novavax will be incorporated into the VSD RCA. How the RCA is done may depend on how 

much uptake there is and how much meaningful data are reported to VSD. There also is the 

Clinical Immunization Safety Assessment (CISA) that is available as a consult service for US

healthcare providers to receive a consultation on patients with complex AEs for Novavax or any 

other vaccines.

Safety, Immunogenicity, and Efficacy of Novavax 2-Dose Primary Series in Adults ≥18 

Years of Age

Filip Dubovsky, MD, MPH (Novavax, Inc.) Dr. Dubovsky presented on the safety, 

immunogenicity, and efficacy of Novavax COVID-19 vaccine, NVX-CoV2373, in adults ≥18 

years of age. He noted that their team provides an important new approach in the fight against 

COVID-19 and believes that supportive policy recommendations will improve vaccine availability 

and accessibility, with the ultimate goal of increasing vaccination rates in the US. NVX-CoV2373

is based on Novavax’s platform technology with its recombinant protein antigen formulated as a 

particle and Matrix-MTM adjuvant, which is a saponin-based adjuvant (SBA). SBAs are used in 

other approved vaccines. Adjuvant is important in helping the Novavax vaccine generate broad 

immune responses, including against variants.

This vaccine has key attributes that support increased access and ease of use. It is dispensed 

in a 10-dose vial and is a preservative-free, ready to use liquid suspension. It can be 

transported and stored at refrigerator temperatures, making it easy to ship, store, and 

administer. Each dose contains 5μg of antigen and 50μg of Matrix-MTM adjuvant. This vaccine is 

a 2-dose series administered 3 weeks apart with a 0.5 mL intramuscular (IM) injection using 

standard needles and syringes. The authorized indication in the US is for individuals ≥18 years 

of age. Currently, vaccination in the US is incomplete. Based on data from CDC from July 7, 

2022, 1 in 10 Americans have yet to receive a single dose of COVID-19 vaccines. The rates are 

even lower for a primary 2-dose series and boosters. Novavax believes a protein-based

alternative may help increase vaccine uptake in individuals who prefer a well-understood 

vaccine platform.

The NVX-CoV2373 clinical development program included 4 studies, which constitute the body 

of data used for global regulatory approval. This presentation focused on the Phase 3 studies, 

Study 301 (US/MX) and Study 302 (UK). Safety and efficacy were initially evaluated in Study 

302 in the UK (N = 15,187),25 which was followed by an even larger study in the US and Mexico 

to enable licensure from the US. As part of the US/Mexico Phase 3 study, effectiveness and 

clinical efficacy was studied in adolescents 12 through 17 years of age (N = 2,247),26 and these 

data are currently under review by the FDA.

25 Heath et al., NEJM, 2021; Toback et al., The Lancet Res Med, 2021 

26 Dunkle et al., NEJM, 2021
ACIP Meeting Summary July 19, 2022

14

To briefly summarize the Phase 3 results, VE against mild, moderate, or severe disease in both 

Phase 3 trials was 90%. Importantly, there was 100% protection against severe disease. These

trials were conducted when the virus had started to evolve rapidly. In fact, the majority of cases 

in both of these studies were attributed to variants of concern (VOC) or variants of interest

(VOI). High levels of efficacy were observed against these variants, which is a hallmark of the 

Novavax vaccine technology.

The US/Mexico Phase 3 study, Study 301, was conducted in the US population and the data 

from the study was the basis of authorization by the FDA. In Study 301, participants were 

randomized 2:1 to receive vaccine or a placebo. This was done in order to gather additional 

safety data on the vaccine from a larger number of participants. About 4 months after the initial 

vaccination period, the study remained blinded and crossed over to the opposite treatment arm. 

This was done so that all participants in the study could receive active vaccine. Participants are 

being followed 2 years following primary vaccination.

Demographics and baseline characteristics were well-balanced between the 2 arms. In both the 

NVX-CoV2373 and placebo arms, 13% of participants were ≥64 years of age. It is important to 

note that enrollment in older adults was somewhat limited. This is because COVID-19 vaccines 

became authorized and recommended for those ≥64 years of age while Novavax was enrolling. 

Black or African American participants made up 12% of the study population, 7% were 

American Indian, and 22% were Hispanic or Latino, which is representative of the overall US 

population. In line with one of the study goals, 95% of participants were considered at increased 

risk for COVID-19 either due to underlying medical conditions or their occupations.

The primary efficacy endpoint of the study was achieved with 90% protection from mild,

moderate, and severe disease. The lower bound was 84%. In fact, there were only 17 (0.1%)

mild cases in the 17,272 vaccine recipients compared to 79 (0.9%) cases in the 8,385 placebo 

recipients. As mentioned earlier, 100% protection was achieved against moderate or severe 

illness, an important secondary endpoint. This means that all the cases in the vaccine group 

were mild. The vaccine showed 93% (95% CI: 86, 97) efficacy against VOCs or VOI. The most 

commonly identified variants were Alpha, Iota, Epsilon, and Gamma with fewer cases being 

attributed to Beta, Delta, Kappa, and Eta. Again, all of the variant cases that did occur

in vaccine arm were mild in severity. Efficacy was 97% (95% CI: 74, 100) for isolates that would 

be considered more closely matched to the original vaccine strain. Efficacy against these strains 

was pre-specified as a key secondary endpoint of the study. The vaccine provided consistently

high levels of protection across all subgroups. Though the confidence intervals widened in the 

subgroups, the point estimates continued to support VE.

In conclusion of Study 301 efficacy, NVX-CoV2373 vaccine was highly efficacious in preventing 

COVID-19. Its efficacy was demonstrated against all the variants circulating during the study. 

The vaccine also provided complete protection for moderate or severe disease in adults. This 

vaccine demonstrated consistently high efficacy in adults across subgroups, including race, 

gender, and in individuals with medical comorbidities.

Now turning to safety. The total safety database includes approximately 50,000 people enrolled 

across 4 studies. This is a large database that provides confidence that this vaccine has a wellcharacterized safety profile that supports a positive benefit-risk and favorable reactogenicity 

profile across a diverse population.
ACIP Meeting Summary July 19, 2022

15

Beginning with a summary of solicited AEs collected through electronic diary entries for 7 days 

following each vaccination, there were fewer local events overall among those ≥65 years of age 

compared to younger adults 16 through 64 years of age. Pain and tenderness were the most 

commonly reported events. While many participants did not report reactogenicity events at all, 

those who did mostly reported events that were Grade 1 (mild) or Grade 2 (moderate) in 

severity. Grade 3 or higher events occurred at low rates. Overall, these events resolved quickly

with the median duration of 1 to 2 days. As expected, events occurred more frequently following 

the second dose and more participants in the vaccine group experienced these symptoms. Most 

events were mild or moderate in severity with low numbers of Grade 3 or higher events. The 

median duration was 1 to 2 days.

In terms of systemic reactogenicity, malaise, fatigue, muscle pain, and headache were most 

commonly reported. Once again, lower frequencies were reported in those ≥65 years of age. 

The vast majority of events reported were mild or moderate and resolved quickly with a median 

of duration of 1 to 2 days. Notably, the rates of fever are quite low in less than 1% of vaccinees.

Following the second does, while higher overall, most systemic events remain mild to moderate 

in severity. Grade 3 or higher events were uncommon with the median duration of 1 to 2 days.

Even after the second dose, a low proportion of participants reported fever. Overall, the 

frequency of unsolicited AE was comparable between vaccine and placebo groups, and severe 

adverse events (SAEs) were recorded in only 2 participants. Medically attended adverse events

(MAAEs) and potential immune-mediated medical conditions (PIMMC) were similar between 

groups. SAEs also were balanced between the vaccine and placebo groups. Death occurred at 

similar or low rates between treatment arms.

Given the importance of the topic of myocarditis/pericarditis, Dr. Dubovsky presented the

myocarditis/pericarditis data from the Novavax pooled safety database. As they learned through 

the investigations described earlier, natural events of myocarditis will occur in any sufficiently 

large database. In addition, young males are at higher risk for both vaccine-induced myocarditis

and other forms of myocarditis, which most often is caused by non-specific infections. COVID19 infections also can cause myocarditis. It is important to note that the Novavax studies were 

conducted largely during the time of heightened awareness for myocarditis. Overall in the 

placebo-controlled phase of the NVX-CoV2373 clinical development program, the rates of 

myocarditis were balanced between the vaccine and placebo arms at 0.007% (2 cases) for the 

vaccine arm and 0.005% (1 case) for the placebo arm. No pericarditis was reported. In Study 

301 (UK Phase 3 study), 1 case occurred in the active arm and 1 case occurred in the placebo 

arm. Of the 2 cases in vaccine recipients, one 67-year-old male also had concurrent severe 

COVID-19 infection after Dose 1. The other case from Study 302 occurred in a 19-year-old male 

3 days after the second dose of vaccine and occurred without a definitive alternative cause.

In the post-crossover portion of Study 301 and Study 302 during which all participants were

exposed to the vaccine, events of myocarditis or pericarditis occurred within expected 

background rates as determined by the European Medicines Agency (EMA) ‘vACcine Covid-19 

monitoring readinESS’ (ACCESS) study. This study was specifically designed to determine 

background rates of interest for COVID-19 vaccines. There were 3 reports of myocarditis or 

pericarditis, all of which had alternate possible infectious etiologies. A notable case occurred in 

a 16-year-old male 2 days after the second crossover dose of vaccine who had a viral illness 

diagnosed by a healthcare provider. A 20-year-old male had strep throat preceding the events 

of pericarditis. This was diagnosed by electrocardiogram (EKG) findings with a normal troponin 

level. A 28-year-old male had features of myocarditis and was diagnosed by an attending 

cardiologist with non-ST elevation myocardial infarction (NSTEMI).
ACIP Meeting Summary July 19, 2022

16

Novavax’s latest monthly Summary Safety Report (SSR) with post-authorization data includes 

more than 1 million doses administered and was submitted in July with the date of cutoff of June 

30, 2022. For a spontaneous report using a broad Standardised MedDRA Queries (SMQ)

search strategy, 68 potential reports were identified. As is typical for spontaneous reports, many 

have limited information. Out of the potential reports from this broad search, 17 met the Brighton

Collaboration definition of “definite” or “probable” myocarditis or pericarditis (1 definitive, 6 

probable myocarditis, 10 probable periocarditis). As a result of discussions with the FDA, the US 

label includes a warning that states that clinical trial data provide evidence for increased risk of 

myocarditis and pericarditis. Novavax is carefully monitoring its post-authorization data to 

understand the nature and magnitude of this risk. Additionally, they intend to follow-up each 

case with targeted questionnaires. These data are being communicated to all regulatory 

agencies in Novavax’s monthly SSRs. This close monitoring also will include post-authorization 

safety studies that cover large populations in administrative client databases and electronic 

health records (EHRs).

For the other events of interest, there were no reports of anaphylactic reactions or thrombosis 

with thrombocytopenia (TTS) in the Novavax integrated safety database. However, based on 2 

post-authorization reports of anaphylaxis, this labeling has been included in the NVX-CoV2373

label. There was also 1 case of neuropathy from UK Study 302 for which follow-up information

was received that meets the Brighton Collaboration definition of Guillain- Barré Syndrome

(GBS). Novavax will continue to monitor these carefully in all of its post-authorization 

surveillance activities.

Because pregnant women were excluded from all studies, there is limited information on 

pregnancy. For all women of childbearing potential, a negative urine pregnancy test was 

required during screening and prior to vaccinations. However, as in all Novavax studies with one 

follow-up, there were some reports of pregnancies. As of the 15th of March, a total of 147

pregnancies were reported across the entire clinical program. Of these pregnancies, 56 are

ongoing, 41 resulted in live births, 23 experienced miscarriages, 13 women elected

to have voluntary terminations, and one had an ectopic pregnancy. No fetal deaths or stillbirths

have been reported. Overall, these data do not indicate a potential risk for mother or fetus and 

are generally consistent with background rates. There are no specific restrictions for pregnant 

women in Novavax’s US or global labels. Novavax also has plans to conduct multiple postauthorization studies to assess additional safety and effectiveness data. They will be conducting 

2 effectiveness studies and 2 safety studies using administrative claims and health record 

databases. To characterize the safety profile in the post-marketing study, Study 405 is a global 

registry that will provide important data in pregnant women who receive Novavax COVID-19

vaccine.

In terms of the Novavax COVID-19 vaccine’s immune response against the Omicron variant, a 

multidimensional presentation of the immune responses for the US/Mexico Phase 3 study,

called antigenic cartography, explains the ability of the vaccine-induced antibody to recognize 

variant spike proteins. Antigenic cartography showed 100%seroconversion to all Omicron 

subvariants after 2 doses. The antigenic difference between the matched prototype strain and 

the Omicron subvariants is 7.9- to 11.8-fold different. After a single boost, the antigenic distance 

decreases for all of the Omicron variants, with BA.5 decreasing to just a 2.9-fold difference,

which can be considered a masked response. This phenomenon is believed to be driven by

broader recognition of new variants, which is further enhanced by the Matrix-MTM adjuvant. This 

analysis leads Novavax to believe that as people are immunized with additional doses of the 

NVX-CoV2373 recombinant spike protein vaccine, antigenic distance will be minimized, and a 

more universal response will be observed against variants. While it is unclear what variant will 
ACIP Meeting Summary July 19, 2022 

17

emerge after BA.5, boosting with the Novavax technology may be an attractive option as it 

provides high levels of antibody recognizing variants and a durable immune response.

Although it is not certain that variant-specific vaccine will provide significant clinical benefit, 

Novavax is evaluating a number of constructs in clinical studies. Novavax began a study in May 

2022 among adults 18 through 64 years of age who were previously vaccinated with mRNA

vaccine. This ongoing study will compare antibody responses between 5 arms: NVX-CoV2373, 

Monovalent Omicron BA.1, Bivalent Prototype + Omicron BA.1, Monovalent Omicron BA.5, and 

Bivalent Prototype + Omicron BA.5. This study will compare the variant-specific immune 

responses among the trial arms to support a data-driven decision by the utility of variant 

vaccines as it applies to the Novavax adjuvant recombinant protein technology. If it continues to 

be deemed desirable, the goal is to have variant vaccines available in the 4th quarter.

In summary, Novavax COVID-19 vaccine achieved high levels of efficacy in 2 large randomized 

controlled Phase 3 studies, including high efficacy against variants of concern and variants of 

interest. This vaccine is based on a platform that is well-understood. Recombinant vaccines

have been used globally for decades. This can be important, especially for those who are

vaccine-hesitant. The Matrix-MTM adjuvant is a natural SBA product. SBAs are used throughout 

the world. The data show that combining the Novavax SARS-CoV-2 spike protein with an 

immune enhancing adjuvant simulates a broad and robust immune response and provides a 

high level of clinical efficacy. Importantly, this vaccine is not highly reactogenic. This may be 

important for vaccine compliance, as boosting continues to be recommended. Novavax COVID19 vaccine presentation and storage support ease of use and wide access. Dr. Dubovsky 

expressed gratitude to the tens of thousands of people who volunteered for the Novavax clinical 

trial in the US and abroad, the healthcare providers, investigators, study personnel, and

partners. He stressed that their involvement is making a difference in the lives of people around 

the world.

Discussion Summary

Dr. Poehling asked what placebo formulation was used in the study and requested additional 

information about the case of neuropathy that met the GBS definition. 

Dr. Dubovsky indicated that the placebo formulation was normal saline. In terms of the GBS 

case, he noted that they have seen other cases of GBS in the post-authorization period.

Dr. Kim, Chief Safety Office at Novavax, added that the case of GBS occurred in the UK in 

Study 302 in a 65-year-old female. Over the course of a year, she experienced progressive 

motor and sensory deficits and had confirmatory laboratory testing. The case definition was met 

only recently when Novavax received follow-up information. There was some delay in reporting 

by the patient participant as the initial presentation was mild. She was being followed-up 

through the year, received additional testing, and the progressive nature of the motor and 

sensory deficits were confirmed. The initial symptoms presented as tingling and occurred within

about 9 days after the post-crossover Dose 1 and progressed over the next 9 months into

sensorimotor polyneuropathy that was confirmed by electromyographic (EMG) studies. The 

symptoms did improve after steroid treatment.

In response to a question about whether Novavax has data related to effectiveness against the 

Omicron variant, Dr. Dubovsky indicated that both efficacy studies were conducted before 

Omicron emerged. Therefore, they do not have any efficacy data that speaks to Omicron 

specifically. The data he showed with the antigenic cartography does have some information 
ACIP Meeting Summary July 19, 2022

18

about the Omicron variant, which showed that there was 100% seroconversion to all variants 

after a 2-dose priming series—including BA.5. The antigen distance narrowed with a 

subsequent dose.

Dr. Kotton noted that she is especially interested in protecting immunocompromised patients, 

but there does not appear to be a lot of data available with Novavax among persons who are 

immunocompromised. Australia recommended that it could be used as part of the 3-dose 

primary series in immunocompromised patients. She wondered whether he had data in that 

population and/or if it would be included in the study that began in May 2022 looking at Novavax 

after mRNA vaccine.

Dr. Dubovsky indicated that there is limited information about how the vaccine, especially 

multiple doses of vaccine, performs in people of various levels of immunocompromise. The US 

Phase 3 study includes some participants who are living with HIV. For the immune response in 

those who were HIV-negative versus those who were living with HIV, there was a small

diminishing in the overall titers in those living with HIV. This is the smallest dataset with only 9 

participants. For those who previously were exposed to COVID-19 and then were vaccinated, 

the priming with the 2-dose series provided very high titers well above that which is associated 

by protection in Phase 3 study. Novavax is conducting a study in South Africa that is evaluating 

people without HIV as well as more immunocompromised people living with HIV. This study is 

comparing a 3-dose versus a 2-dose series with various intervals to try to understand how 

better to use the Novavax vaccine in this population. In terms of CD4 counts, the participants in 

the data shown are very well-controlled. In the South Africa study, the population is 

heterogenous and includes people who are well-controlled and people who are less wellcontrolled.

Dr. Kotton emphasized that it is estimated that about 3% of the US population is

immunocompromised, are much more vulnerable to severe life-threatening infection, and are

less responsive to vaccination. She asked whether Novavax has work underway with non-HIV 

immunocompromised populations.

Dr. Dubovsky said their post-marketing studies are going to be able to address this quite well as 

very large studies are planned.

Dr. Sanchez expressed excitement with having another COVID-19 vaccine, particularly one that 

has a more traditional format. He requested definitions for mild, moderate, and severe; where 

hospitalization fit into the criteria for severe; whether there was routine testing for asymptomatic

infection; and given vaccine hesitancy, whether aborted fetal cells were used in the 

development of the Novavax COVID-19 vaccine.

Dr. Dubovsky indicated that they do have information on asymptomatic disease from following 

people who were anti-seroconverters or who were PCR-positive. No aborted fetal cells were 

used in the development of the Novavax COVID-19 vaccine. He called upon Dr. Dunkle who ran 

the study to speak to severity.

Dr. Dunkle, the physician who ran the study, confirmed that they did not use hospitalization as a 

criterion for severity. Most of the participants who were hospitalized for COVID-19 did not have 

their PCRs confirmed at the University of Washington and therefore were counted as SAEs due 

to the hospitalization. One succumbed to his disease but was not counted as an endpoint. In 

terms of asymptomatic infection, the best data come from the UK in Study 302 in which people 

were followed for up to 6 months. That is when their cases were collected. The median follow-
ACIP Meeting Summary July 19, 2022

19

up was 101 days in that study. Among people who either seroconverted or were PCR-positive, 

efficacy against any infection (symptomatic or asymptomatic) was 83% with a lower bound of 

75%.

Ms. Hayes (ACNM) requested further information about how women were discovered to be 

pregnant and when during their vaccine investigation trial experiences that they were pregnant.

Dr. Dubvosky noted that the data he presented were from the totality of data from the studies

Novavax started almost 2 years ago. These women are still under surveillance at this time. The 

vast majority of the pregnancies occurred at a distant time period after well after vaccines were 

administered. In these studies, they rely on women to them when they become pregnant and

they try to estimate when their last menstrual periods occurred. Without a systemic way to 

capture that, these data are incomplete. Recollection of last menses is incredibly unreliable

in most women.

In regard to a comment that the rate of miscarriages seemed very high, Dr. Dubovsky indicated 

that these rates are difficult to compare with the denominator. From their analysis, this seems to 

be within the reported norms. The problem is that people are much more likely to report when 

they have a poor outcome versus that they are just pregnant. Therefore, the denominator is 

probably incomplete. 

Dr. Kim confirmed this to be correct. Pregnancies were not systematically collected, which 

makes it difficult to interpret this kind of data and compare it to background rates. With the data 

they do have and a background rate of spontaneous abortions that is around 20% in the general 

population of spontaneous abortions, this finding is generally consistent with the background 

rates. 

Dr. Drees (SHEA) noted that it seems the best way to reach people who still do not have their 

primary series would be through individual practices when they are seeing their physician or 

provider for something else. These individuals may be less likely to seek out a vaccine at a 

pharmacy or a dedicated vaccination event. She worries that a provider may see only 1 or 2 of 

these individuals in a given day. Despite the fact that CDC and others have said that it is okay 

for providers to waste the remaining doses in a vial if they have the opportunity to vaccinate 1 

person, they are still somewhat reluctant to do that. While she was aware that Novavax was 

asked to provide this vaccine in multidose vials, she wondered whether there might be an 

opportunity in the US to provide single dose vials or if they would have to go back through the 

FDA regulatory process.

Dr. Dubovsky indicated that the format licensed in the US is a 10-dose vial. They have other 

formats that are licensed in other territories and by their partners. Novavax is working feverishly 

to get a lower format presentation that can be submitted to the regulators for approval in due 

course. They have some experience with this vaccine being made available alongside other 

vaccines in other countries. In certain countries, they have decent visibility into how the vaccine 

is being used. In Australia, they know that about 60% of vaccines being used are used as a 

primary series. That is in a country where people have a choice from among multiple vaccines

and are selecting the Novavax product specifically. The proportion is even higher in Korea. It is 

important to offer this as a choice for people as it gives them some control. It allows vaccinees,

physicians, healthcare, and the public health community to weigh the benefits and risks of which

vaccine to take.
ACIP Meeting Summary July 19, 2022

20

Dr. Eckert (ACOG) pointed out that the expected rate of miscarriages is 17% and that the study 

is well within what is expected. She asked whether any data are available on the Matrix-MTM 

adjuvant being used in other vaccines given to pregnant individual and data on gestational age

at birth and live births outcomes among women who were vaccinated.

Dr. Dubovsky replied that this vaccine has not been used in women who are pregnant

deliberately. Other saponin-based vaccines that are authorized globally are either used against 

shingles, which would be in an elderly population, or in children for malaria vaccines. A 

toxicology study showed no adverse impacts to either the infant or the new mothers. The 

amount of adjuvant is fairly low.

Dr. Kim added that in terms of gestational age at birth among women who have live births after 

receiving the vaccine, the reports were spontaneous and often have limited information. While 

they do their best to follow-up to get as much complete information as possible, a vast majority 

of these cases do not have gestational age. Study 301 collected pregnancy information and 

pregnancies are being followed. The cases that have resulted in live births have not been 

reported to have had been pre-term deliveries.

Dr. Duchin (IDSA) asked the potential for waning protection over time and the likely need for a 

booster dose of the Novavax COVID-19 vaccine.

Dr. Dubovsky indicated that data from the US/Australia Phase 1/Phase 2 study in terms of the 

immune responses against the prototype and against the BA.2 variant showed that at Day 35 

after the primary series, high titers were achieved that decayed over 6 months. This is the 

normal decay pattern associated with IgG. After a single boost at 6 months, higher titers were 

achieved that once again decayed over the following 6 months. Intervals between 6 months and 

12 months in the Phase 3 study were associated with protection. Consistent with the antigenic 

cartography, subsequent doses increase the immune response against even the quite distant 

strains. In terms of median duration in the context of efficacy, in the primary data there was a 

median of approximately 60 days of observation. In that range, they had to institute crossover. 

That terminated the ability to have continued placebo control follow-up. In countries where the 

vaccine has been used longer, they are just now at the 6-month timepoint. Where authorized, 

some countries have policy recommendations supporting boosting. To data, Novavax has not 

received information on waning efficacy because those data are still being collected.

Dr. Poehling asked about the median duration of follow-up for safety and for more discussion

about Grade 3 responses and if lymphadenopathy is a common finding. She clarified that she 

was trying to understand how long it took the Grade 3 symptoms to resolve and if they differed 

by local reactogenicity.

Dr. Dubovsky indicated that for the Novavax COVID-19 vaccine, safety follow-up was 

comparable between the vaccine and placebo groups, with a median duration of 92 days after 

Dose 1. Grade 3 or 4 symptoms did not necessarily last any longer. A relatively small proportion 

of people had solicited AEs that lasted longer than 7 days. Lymphadenopathy was not a 

common finding, but lymphadenopathy was not collected as a specified solicited AE.

Dr. Sanchez requested to hear more about SAEs in terms of the symptoms involved and 

whether these affected people’s normal daily lives and their ability to work.
ACIP Meeting Summary July 19, 2022 

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Dr. Kim indicated that SAEs were broken down into system organ class (SOC). They were 

balanced between the active and placebo arms. No patterns of concern were raised. Deaths 

infrequent at <0.1%, which is the range that would be expected in the general population. There 

were some cardiovascular deaths that occurred at about the same incidence between the 

placebo and treatment arms, as well as a scattering of causes of death (CODs) from events 

such as accidents, gunshot wounds, accidental overdose, et cetera. Novavax has an ongoing 

study that is trying to understand the impact of the vaccine on daily activities, such as work.

Dr. Daly requested more details about what is known about the safety of saponin as an adjuvant 

in other vaccines as well as what is known about VE against hospitalization and death either 

from Phase 3 trials or from post-authorization trials elsewhere in the world. 

Dr. Dubovsky responded that other versions of SBAs have been used extensively. Novavax has 

used it extensively in other kinds of development programs, including influenza for which they 

had a very nice Phase 3 study that ended a couple of years ago. It is being used in the malaria 

vaccine Novavax is associated with in Western Africa. In that study, the same dosage levels 

were taken down to children as young as 5 months of age, and it was thought to be tolerable. 

As far as the Novavax COVID-19 vaccine, their partners in India have taken the adult dose 

down into children as young as 2 years of age among whom it is thought to be tolerable with no 

safety signals detected to date. These are relatively small studies of just several hundred to 

several thousand individuals. The saponin story is that it has a 2-fold activity. It has a very short 

local reactivity where it induces cytokine and chemokine production and recruits antigenpresenting cells to the injection site. All of that resolves by 72 hours. There is slightly prolonged 

activity in the draining lymph nodes where there is increased antigen uptake presentation. It 

induces a polyfunctional CD4 immune response and high levels of neutralizing antibodies. This 

short duration is thought to be associated with the short duration of reactogenicity events

displayed. In terms of VE against hospitalization and death, in the placebo-controlled portion of 

the study, protection from hospitalization and death was 100%. The total count in the USMexico Phase 3 study was 6 hospitalizations including 1 death in the placebo group versus zero 

in the vaccine group. Post-authorization from elsewhere in the world are not yet available. 

However, prevention of severe disease has held up in all of Novavax’s studies in South Africa, 

the United Kingdom (UK), and the US.

Dr. Lee noted that it would be helpful to ACIP, particularly in the context of Omicron, to have an 

update on the post-authorization data when they become available. 

Public Comment

The floor was opened for public comment during the July 19, 2022 ACIP meeting at 12:35 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-2022-0085. Visit http://www.regulations.gov for access to the docket or to submit 

comments or read background documents and comments received.
ACIP Meeting Summary July 19, 2022

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Dr. Brian Dressen

Self

My name is Dr. Brian Dressen. I have extensive career experience thoroughly researching and 

assessing the degree of safety and efficacy of new products. I have no conflicts of interest and 

my words are my own. The clinical trials for Novavax reveal incidences of myo and pericarditis,

as well as neurological complications like GBS. Most marketing reports reveal that these

adverse reactions continue in the general population. Novavax, like Pfizer, Moderna, Johnson & 

Johnson, and AstraZeneca has been temporarily associated with a long COVID-like disabilities, 

cardiovascular issues, POTS, neurological disorders, neuropathies, and autoimmunity. A simple 

look at Australia and vaccine injury reports show Novavax is no different. The CDC and FDA are 

charged with ensuring the American public is provided with safe and effective vaccines—safe 

and effective. A publication in JAMA Internal Medicine last month examined the safety of mRNA 

vaccines in more than 433,000 people: 3.1% had Bell's palsy, paralysis, paresthesia, seizure, 

syncope, or vertigo; 2.7% experienced arrythmia; 3.4% had thrombocytopenia, anemia,

lymphopenia or neutropenia; 0.75% had a stroke; 0.6% had myocardial infarction; and over 8% 

of the dataset were diagnosed with at least one of the serious adverse events. Compared 

against previous vaccines, the COVID vaccines are far more dangerous. We are repeatedly

assured that serious complications are rare. The World Health Organization defines adverse 

events happening to 1 out of 100 persons or 1% taking a drug as common. This report shows 

that these reactions are common, not rare. You have failed at managing the pandemic. You 

have failed at ensuring safe and effective vaccines are available to the American people. We 

have learned that the CDC is not performing the required analysis of the pharmacovigilance

systems. This is the reason no safety signals are identified. The CDC is not looking for them. 

The COVID vaccines do not prevent infection or transmission and cause serious harms to some 

of those who take them. The continuation of the pandemic is evidence that the COVID products 

are not effective. Data have been presented today showing low expectation of protection for

current variants. My wife was severely injured by a single COVID vaccine dose in the clinical 

trial. Rather than report her reaction, the drug company dropped her from the trial and left her 

out of the report. We must do better. Those injured in a trial are a critical piece of vaccine safety 

data. They are being hidden, ignored, tossed aside, and forgotten. My wife’s family has changed 

forever. The clinical trial is also not appropriately evaluating the data. The FDA and CDC and 

the drug companies continue to deflect the persistent and repeated cries for help and

acknowledgement, leaving the injured as collateral damage. You have a very clear responsibility 

to appropriately assess the safety and risks of these vaccines. It is obvious that this is not 

happening. Serious questions regarding pregnancy, heart problems, Phase 3 reactions, missing 

work, and others have been raised today without answers. I ask, does this show that we can 

say they’re safe? Thank you.

Mrs. Aubrey Fick

Individual

Okay, 15 months ago I received 1 dose of the Pfizer vaccine, and my life has not been the same 

since. Within hours of receiving the vaccine, I developed neck spasms and a heavy feeling in

my head. Two weeks later, symptoms rapidly progressed. I developed internal vibrations in my 

brain, paresthesia, electrical shock sensations, tremors, neuropathy, vertigo, blurred vision,

heart palpitations, chest pains, tachycardia, and joint pain. It became difficult to walk, and 

sometimes my legs would suddenly stop working. Sleep was next to impossible. When I finally 

would fall asleep, my body would continue to jolt wide awake as though I had an electric shock, 

and I would be gasping for air. Each night I went to sleep, I feared my heart would stop, and I 

would not make it through the night. I went to the emergency room and was quickly dismissed
ACIP Meeting Summary July 19, 2022

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by the ER doctor who suggested that I had anxiety or acid reflux. I was advised to take Tums 

and sent on my way. I was utterly shocked. I knew then that I would be facing this battle alone

with no support from the medical community. To this day, I continue to suffer from a variety of 

neurological issues, particularly neuropathy and POTS symptoms. As a formerly healthy 35-

year-old woman, this experience has been traumatizing, and to watch the aftermath has been 

appalling. I experienced significant challenges in reporting to VAERS and Pfizer that have left 

me deeply concerned about the tracking and adverse events. I fervently scoured the internet 

and found social media groups with thousands of others suffering neurologically whose lives 

have been drastically altered. We are routinely silenced, labeled as misinformation, and met

with incredulous eyes. We are simply citizens of the United States of America that trusted that 

our government would provide aid and research in the event of adverse events. We need full 

acknowledgement and disclosure of neurological reactions from our federal agencies so that the 

medical communities can be made aware. We need robust large-scale research funding so that 

healthcare providers can be equipped with the necessary knowledge and possible treatment.

How is progress to be made if we simply have small research studies with 3 or 4 cases? Why 

were we affected? What about our bodies caused it to attack itself and our autonomic nervous 

system to stop functioning properly? Doctors should not have to fear repercussions from the

Medical Board in the event they come across a patient adversely impacted, and patients should 

not have to be gaslit in their nightmare. I urge you to assist in creating a dialogue where vaccine 

injury can be openly discussed. If this happened to your wife or your child, I trust that you would 

desire transparency with investigation and research funding. I trust that you would not want their 

stories censored. We must be compassionate and take urgent actions on all those suffering in 

the pandemic, irrespective of modality. We must be cognizant of using sweeping generalizations 

that the vaccines are safe and effective when clearly, for my body and thousands of others, it 

was toxic. Thank you for your time.

Ms. Ashley Scott

Policy and Outreach Coordinator

Blue Star Families (BSF)

My name is Ashley Scott. I am the Policy and Outreach Coordinator with Blue Star Family, a 

501(c)(3) organization that conducts IRB approved studies of the experience, perception, 

opinions, and beliefs of military and veteran expectant families with our partners at Syracuse 

University. Respondents to our April 2021 COVID Collaborative Pulse Check Poll indicated that 

having a choice in which vaccines to receive would increase their likelihood of receiving it. And 

this phenomenon is particularly prominent among Active Duty service members. When we

conducted the poll again in April of 2021, 66% of Active Duty respondents who were

unvaccinated and had no appointment scheduled reported that the opportunity to choose their 

vaccine would increase their likelihood of receiving a vaccine. The same was true for 43% of 

Active Duty spouses, 41% of veterans, and 48% of veteran spouses. And again, those are just 

of the respondents to our COVID Collaborative Pulse Check Poll. Based on these results, we 

believe it is possible that expanding vaccine choices could increase the likelihood of receiving 

the vaccine in military-connected populations. Thank you all for your time. 

Ms. Elizabeth ("Liz") Ditz

Vaccinate California

Thank you. Good morning committee members and those listening to today’s meeting. My 

name Liz Ditz. While I’m a member of Vaccinate California, today I’m speaking for myself. My 

date book tells me that I first expressed concern about this new pneumonia in the Far East 888

days ago. This committee has worked tirelessly over those days, and I appreciate the efforts 
ACIP Meeting Summary July 19, 2022

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you have made to make the decision factors public and transparent. I'm also an active member 

of a Facebook group, Vaccine Talk, an evidence-based discussion forum that has almost 

79,000 members worldwide. Some of the Vaccine Talk members are physicians who are all 

internists or other professions involved in vaccine safety. These experts have volunteered their 

time to educate other members. Today, I especially want to recognize 2 of them, Vincent 

Iannelli, MD who has developed a web resource, Vaxopedia, which addresses vaccine 

questions in a timely manner, and Nathan Boonstra, MD, who cohosts the podcast Vax Talk 

sponsored by Voices for Vaccine. At Vaccine Talk, one theme in the conversation about vaccine 

refusal, and vaccine hesitancy, and vaccine anxiety has been largely expressed for the

newness and to them the strangeness of the mRNA vaccine technology. Some of those folks 

previously said, “I’m not taking a COVID-19 vaccine yet” have also indicated that the vaccine 

discussed today, Novavax, would be acceptable. If Novavax is approved for use in the US, I am 

hoping the data will be gathered on the number of recipients who have previously refused

vaccines as opposed to those who had found the access difficulty to see if the hypothesis that 

having a choice makes a difference. Going forward in public health planning, planning on more 

robust and effective information platform, in my view, would reduce vaccine hesitancy. As you 

all know, there’s a large literature on how to address vaccine hesitancy, and I hope the

government can recruit and train community-level experts. Thank you again committee

members for your work.

Lindsay Burmeister

COVID Vaccine-Injured Individual

Founding Member of CVI/WA

I want to start by acknowledging to the committee that I attest I have no financial conflicts of 

interest. My name is Lindsay Burmeister, and I am COVID vaccine-injured. I have multiple 

neurological issues, including brain inflammation due to the Moderna vaccine that I received in 

March of 2021. In my quest for healing, I’ve come across communities of individuals with

debilitating neurological adverse reactions like mine. I am one of the founding members

of an independent non-partisan group of COVID Vaccine Injured in Washington State called 

CVI/WA. We have met with the offices of several members of Congress in our state and have 

done multiple media interviews in respected publications and medical journals. Due to the 

intentional suppression of our reaction by the CDC, FDA, and social media outlets, the injured 

are unable to find support and access essential medical care. There is no funding for research,

and there is no recovery plan or financial support available for us. As of July 2022, the CICP 

(Countermeasures Injury Compensation Program) has received almost 6,000 injury or death 

claims from the COVID vaccine products and has yet to pay out a dime. Both Britain and

Canada have started paying out COVID vaccine injury claims. Even Thailand has compensated 

over 14,000 people around $50 million to settle COVID vaccine injury claims. Again, by contrast, 

the US has paid out nothing. We were asked to protect others by getting this vaccine only to find 

out there is no support or protection for us in return. The total COVID vaccine injury is filed in 

the VAERS database as of June 2022 with 878,425 claims. And we know that only 1% to 10% 

of injuries are actually reported to that system. The claims are grossly underreported. And yet, 

this number continues to climb. More and more people know someone whose health has been

negatively impacted by the COVID vaccine products. And yet, you stay silent. This lack of

transparency is eroding the public’s trust in your agency. CDC, we need you to acknowledge us. 

Hear me when I say we need help. Without an acknowledgement from the CDC of our injuries, 

proof of causation cannot be met. And in many cases, doctors refuse to believe us or treat us.

The injured are losing their homes, their jobs, their insurance. They are going into massive debt, 

and in some cases, they’re losing their lives. We did our part. You assured us this was safe, and 
ACIP Meeting Summary July 19, 2022 

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we are suffering. It is time the government stepped up and put money and resources to this

effort. We are pleading for help. Thank you. 

Martha Nolan

HealthyWomen

Good afternoon. My name is Martha Noland, and I am speaking on behalf of HealthyWomen, 

the nation’s leading non-profit health information organization for women providing consumers 

and healthcare providers accurate evidence-based information about diseases and conditions, 

innovations in biomedical research, and changes in policy that impact the treatment and care 

women receive. We requested to speak today to encourage the committee to recommend 

usage of a protein-based vaccine against COVID-19 that was recently approved by FDA that 

would be administered as a 2-dose primary series given 3 weeks apart. Providers need more 

options to reach those who remain unvaccinated in our country while the pandemic continues.

COVID has been particularly devastating to Black and Latinx populations. While the disease is 

expected to reduce overall life expectancy by 2021 by just over a year, estimated reductions for 

Black and Latinx populations are 3 to 4 times more at risk than Whites. There are many reasons 

for vaccine hesitancy. As some have concerns or believe the massive misinformation efforts 

around using the mRNA technology and design and do not understand how they work. For 

those, perhaps the use of a more traditional protein-based vaccine designed similarly to the 

more well-known flu vaccine might overcome hesitancy. There are also millions of vulnerable 

Americans who have limited options for protection against COVID-19 and remain isolated and 

frustrated that they could be left on the sidelines while society continues to disregard safety 

protocol. I’m referring to the estimated 7 million immunocompromised individuals in the US for 

whom the stakes may be even higher than they were 2 years ago. We know that current

vaccines don’t work for everyone, and some are unable to take any of the options now offered.

And the risks to those who remain vulnerable to the severe disease, including COVID-19, is 

compounded today by the removal of mask requirements—the push to return to normal and 

ever-diminishing social distancing as caution by individuals. Organ transplant patients and those 

who rely on medications that suppress their immune systems do not feel protected. People 

living with conditions that compromise the strengths of their immune systems such as HIV, 

cancer, and many autoimmune diseases feel exposed. And many older American who manage 

their chronic conditions to multiple medications are now severe limited in their options for

treatment given the fear of drug interactions. We believe having a more traditional protein-based

COVID-19 vaccine option available would help overcome any of these issues. Additionally,

having a simpler storage method that could make the vaccine more widely distributed to rural 

and inner cities as well as healthcare practitioners who do not have ability to store refrigerated 

vaccines will create greater vaccine access to the US and around the world, particularly in areas 

that typically do not have equitable access to vaccines. We thank this committee for this tireless 

work and for diligently remaining at the forefront of dissolving threat to our health and wellbeing. 

Your work is critical in the fight against COVID-19, and we hope you will provide a

recommendation in favor of more vaccine options. Thank you.

EtR Framework: Novavax COVID-19 Vaccine in Adults

Evelyn Twentyman, MD, MPH (CDC/NCIRD) provided updates to the EtR Framework on as it 

pertains to the Novavax COVID-19 vaccine, adjuvanted as a primary series in adults ≥18 years

of age. Beginning with the mechanism of action of the Novavax COVID-19 vaccine, this is the 

first protein subunit COVID-19 vaccine authorized in the US. Pfizer-BioNTech and Moderna 

mRNA vaccines and the viral vector Janssen/J&J COVID-19 vaccine use genetic material
ACIP Meeting Summary July 19, 2022 

26

to encode a SARS-CoV-2 viral antigen and induce an immune response to that antigen. In 

contrast, adjuvanted protein subunit vaccines like the Novavax COVID-19 vaccine use the viral 

antigen without any genetic material and with an adjuvant added to help induce a strong

immune response. The Novavax COVID-19 vaccine includes a purified, full-length, and stable 

recombinant spike protein as the viral antigen and uses Matrix-MTM adjuvant to enhance the 

magnitude of the immune response to the spike protein. T-cells then recognize the spike protein

as a viral antigen and stimulate B-cells to produce neutralizing antibodies to this viral antigen

and help protect the vaccine recipient against COVID-19.

The policy question for this EtR Framework assessment was, “Should the Novavax COVID-19 

vaccine (2 doses, 5μg antigen + 50μg Matrix-MTM adjuvant, IM, 21 days apart) be

recommended for persons ages 18 years and older under an Emergency Use Authorization?” 

The PICO (population, intervention, comparison, outcomes) question considered the population

to be people ages 18 years and older. The intervention was a 2-dose primary series vaccination 

with Novavax COVID-19 vaccine with the doses given 21 days apart. The comparison was no 

vaccine. The outcomes of interest included symptomatic laboratory-confirmed COVID-19, 

hospitalization due to COVID-19, death due to COVID-19, asymptomatic infection, SAEs, and 

reactogenicity. The WG was guided by the EtR Framework domains of the public health 

problem, benefits and harms of the intervention, values, acceptability of the intervention to key 

stakeholders, feasibility of implementation, and the impact of the intervention on health equity.

In terms of the public health domain, the WG considered the magnitude of the COVID-19 public 

health problem and how COVID-19 vaccines in general are protecting people from this problem 

in terms of reducing the risk of cases, hospitalizations, and death due to COVID-19. COVID-19 

continues to pose a significant threat to public health in the US. As of July 14, 2022, there have 

been over 83 million cases of COVID-19 in the US.27 COVID-19 vaccines continue to mitigate

the burden of COVID-19 cases. In June 2022, unvaccinated people ≥5 years of age had a 2.8 

times higher risk of testing positive for COVID-19 compared to people vaccinated with at least 

the primary series.28 COVID-19-associated hospitalizations also continue and have been on the 

rise recently. The burden of COVID-19-associated hospitalization is significantly higher among 

adults ≥18 years of age compared to children ≤17 years of age.29 COVID-19 vaccines continue 

to reduce the risk of COVID-19-associated hospitalization for vaccine recipients. In May 2022, 

unvaccinated adults ≥18 years of age had a 3.5 times higher risk of COVID-19-associated 

hospitalizations compared with people who had completed their primary series and at least 1 

booster dose.30

Tragically, COVID-19 continues to kill. As of July 14, 2022, a total of 1,018,578 people had lost 

their lives to COVID-19 in the US.31 That is 1,018,578 too many. More than 99% of these people 

were ≥18 years of age—the population under consideration during this meeting. Fortunately,

COVID-19 vaccines continue to mitigate the risks of COVID-19 mortality for those who get 

vaccinated. In May 2022, unvaccinated people ≥5 years of age had a 6 times higher risk of 

dying from COVID-19 compared to people who had received a primary series. Unvaccinated 

people ≥12 years of age had a 9 times higher risk of dying from COVID-19 compared to those 

with a primary series completed and a booster dose.32 

27 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed July 14, 2022 28 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed July 15, 2022 29 Unified Hospital Dataset: https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions Accessed July 13, 2022 30 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination Accessed July 11, 2022 31 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailydeaths Accessed July 13, 2022; Per National 

Center for Health Statistics Death Certificate Data: Total number of COVID-19 total deaths as of July 13, 2022, were 1,015,431; 

https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm#AgeAndSex 32 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed July 15, 2022
ACIP Meeting Summary July 19, 2022 

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In terms of daily trends in doses of vaccine administered there fortunately has been outstanding 

success in getting hundreds of millions of COVID-19 vaccine doses administered across the US 

overall.33 There are still important opportunities to improve vaccination rates, particularly among 

people 18 through 49 years of age. In this group, less than 70% are fully vaccinated with a 

primary series, and less than 30% are up-to-date (UTD) with a COVID-19 booster vaccination.

Coverage does appear to improve with increasing age.34 This helps speak to the question 

raised earlier about who has received booster doses among those eligible. Certainly, being UTD 

is the most effective protection against COVID-19. The first step toward that is completing a 

primary series vaccination. Looking at these data by the percent of people with at least 1 dose 

of COVID-19 vaccine since these vaccines first became available, there is a struggle to 

complete vaccine coverage among the adult populations in particular.35 This illustrates 

opportunities to improve vaccine coverage.

To summarize the public health problem, COVID-19 continues to pose a significant health 

problem. COVID-19 vaccines continue to mitigate cases, hospitalizations, and deaths. However, 

not all people in the US have received the benefits that COVID-19 vaccines provide. In fact, 

about 26 to 37 million US adults have not yet received a single dose of a COVID-19 vaccine and 

would benefit from starting a primary series. In this context, the ACIP COVID-19 Vaccines WG

unanimously considered COVID-19 disease among adults ≥18 years of age to be of public 

health importance.

Moving now to the domain of benefits and harms, ACIP and CDC develop vaccine

recommendations using an explicit evidence-based method based on the GRADE approach 

(Grading of Recommendations, Assessments, Development, and Evaluation). One study 

provided the data used as GRADE evidence. This was the Novavax Phase 3 randomized 

controlled trial (RCT) otherwise known as Study 301. The data were obtained directly from the 

sponsor for the purposes of this analysis. These data did not include the 6 hospitalizations and 

1 death occurring in the placebo group. The data cutoff date was September 27, 2021,

with a median placebo-control follow-up at 2.5 months. Study enrollment and efficacy follow-up 

occurred during December 27, 2020 to September 27, 2021 and mainly when the Alpha variant

of SARS-CoV-2 was predominant. A total of 29,925 adults were randomized 2:1 to receive 

either the vaccine or placebo. The numbers of persons available for the analysis in the full 

analysis set that was used to assess SAEs included 19,963 vaccine recipients and 9,982 

placebo recipients. The per-protocol set included 17,272 vaccine recipients and 8,385 placebo

recipients. There was no immunologic or virologic evidence of prior SARS-CoV-2 infection and 

there were no major protocol deviations. 

Using the per-protocol population for all persons ≥18 years of age, there were 17 cases among 

the 17,272 persons in the vaccine arm and 79 among the 8,385 persons in the placebo arm, 

which resulted in a VE estimate of 89.6% (82.4%, 93.8%). This is the outcome that was used for 

GRADE. VE was at least 76% in those ≥65 years of age and those at risk due to the presence 

of a comorbidity. To provide support with data for effectiveness in persons ≥65 years of age in 

there were few events. An immunogenicity comparison between participants 50 through 64 

years of age demonstrated a VE of 90.7% (72.9%, 96.8%) in a post-hoc efficacy analysis

to those ≥65 years of age. The Day 35 neutralizing antibody GMT was slightly lower for persons 

≥65 years of age compared with those 15 through 64 years of age, with a GMT ratio of 0.91

(0.68, 1.2). The lower bound of the associated 95% confidence interval would have met FDA’s 

33 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-trends Accessed July 18, 2022 34 CDC COVID Data Tracker. COVID-19 Vaccinations in the United States. https://covid.cdc.gov/covid-datatracker/#vaccinations_vacc-total-admin-count-total Accessed July 18, 2022 35 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends Accessed July 18, 2022
ACIP Meeting Summary July 19, 2022

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usual success criterion for immunobridging non-inferiority of >0.67. VE of approximately 90% or 

higher was observed across racial and ethnic groups with the exception of Hispanic or Latino 

participants in whom VE was 75.7% with a confidence interval from 46% to 89.1% was 

observed.

In terms of the GRADE assessment for the outcome of symptomatic laboratory-confirmed 

COVID-19, the relative risk was 0.10 (0.06 to 0.18). The absolute risk demonstrated in the trial 

was 848 fewer cases per 100,000. In the past, there has been a heavier reliance on the relative 

effects because risk varied substantially from trial-to-trial. However, moving toward a longerterm vaccination strategy, absolute risks will be discussed more. For this outcome, there were 

no serious concerns in the certainty assessment, so the WG determined the certainty to be 

Type 1 (high certainty).

The second outcome for consideration was hospitalization for COVID-19. In addition to

hospitalization due to COVID-19, the protocol included a definition of severe illness due to 

COVID-19 per FDA guidance of aCOVID-19 case with ≥1 of following: clinical signs at rest 

indicative of severe systemic illness; respiratory failure; evidence of shock; significant acute 

renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; or death. This did 

not require hospitalization. For the outcome of severe COVID-19, there were no cases in the 

vaccine group and there were 4 in the placebo group for a VE of 100%. There were no 

hospitalizations for COVID-19 in either the vaccine or placebo groups of which the WG was 

aware, so the WG used a surrogate measure of severe COVID-19. Using this method, the 

relative risk was 0.05 (0.00 to 1.00) and absolute risk was 45 fewer cases per 100,000

with a 95% confidence interval from 48 fewer to 0 fewer. There was a serious concern for 

indirectness because severe COVID-19 is a surrogate outcome for hospitalization due to 

COVID-19. There was also serious concern for imprecision due to the small number of events.

The final evidence certainty was Type 3 (low certainty).

For the outcome of SAEs, there were 199 events among 19,735 participants in the vaccine 

group and 105 events in 9,847 events in the placebo group for a comparison of 1% 

experiencing SAEs in the vaccine group compared to 1.1% in the placebo group. In the vaccine 

arm, 5 participants experienced SAEs that were considered potentially related to vaccination.

Among these, FDA considered 1 event of angioedema as potentially related to vaccination. 

There was 1 event of myocarditis in a 67-year-old male with concomitant COVID-19 infection 28 

days after Dose 1, which was not considered related to vaccination but rather to COVID-19. 

Initial cases of myocarditis were observed after placebo crossover. For the GRADE assessment 

of the outcome of SAEs, the WG observed a relative risk of 0.92 (0.73 to 1.16). The absolute 

risk was 88 fewer SAEs per 100,000 with a confidence interval from 296 fewer to 175 more.

There were no serious concerns in the certainty assessment, so the final evidence certainty was 

Type 1 (high certainty).

For the outcome of severe reactogenicity, 16.3% of vaccine recipients experienced Grade 3 or 4 

local or systemic reactions after either dose compared to 4% in the placebo group. For the

GRADE assessment of this outcome, the relative risk of reactogenicity was 4.11 (3.70 to 4.57).

The absolute risk was 12,323 more per 100,000 (10,698 to 14,146). There were no serious 

concerns in the certainty assessment, and the evidence was determined to be Type 1 (high 

certainty).
ACIP Meeting Summary July 19, 2022 

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In summary of the GRADE analysis, Novavax COVID-19 vaccine is effective in preventing 

symptomatic COVID-19 during a period of Alpha variant predominance with an evidence 

certainty of Type 1 (high certainty). Severe COVID-19 was used as a surrogate for the outcome 

of hospitalization due to COVID-19. Novavax COVID-19 vaccine demonstrated efficacy

in preventing severe COVID-19, but the evidence certainty was Type 3 (low certainty). SAEs 

were balanced between the vaccine and placebo arms with an evidence certainty of Type 1

(high certainty). Severe reactions were more common among the vaccinated, with any Grade 3 

or higher reactogenicity reported in 16.3% of vaccinated versus 4% of placebo recipients. The 

evidence certainty for reactogenicity was Type 1 (high certainty). 

To consider additional information to assess VE and safety, the WG moved beyond the data 

considered through the GRADE to look at some additional evidence to inform their EtR 

Framework. With respect to efficacy, they included observations regarding circulating variants 

across the duration of a pandemic and observations of efficacy in the context of other variants.

Toward the strongest possible evaluation of safety, they looked at data pertaining to pre- and 

post-crossover vaccine recipients in Study 301 plus adolescent and booster expansions of 

Study 301 and all vaccine recipients across Novavax clinical trials globally including Studies 

301, 302, 501, and 101. To better understand myocarditis and/or pericarditis after Novavax, the 

WG considered a broader safety set and publicly available post-authorization data globally to 

allow for the experience of other countries with Novavax.

Some of the remaining questions about VE include VE in certain populations, VE against 

asymptomatic infection, and VE in the context of Omicron. Novavax VE in Study 301 was 

assessed in the period of predominance of the Alpha variant of SARS-CoV-2. Of 96 cases 

accrued in the primary efficacy analysis, pre-crossover from December 20, 2020 through 

September 27, 2021, there were 75 cases with sequence data as follows: 53% Alpha, 11% Iota, 

7% Epsilon, 4% Gamma, 3% Beta, 1% Delta, 1% Kappa, and 1% Zeta. It is important to explore 

why variant circulation might matter in the assessment of the benefits of a COVID-19 vaccine.

First, in neutralizing antibody studies assessing the immune response of people who received 

mRNA vaccines, study participants who completed their second dose of the mRNA vaccine

earlier mounted a weaker neutralizing antibody response against new variants as compared 

with Alpha. For Omicron, neutralizing titers were much lower compared with Alpha and 

ancestral strains.

Moving out of the laboratory and into real-world VE studies, VE from CDC’s VISION Network 

against hospitalizations for 2 doses of mRNA vaccines during the period of Alpha predominance 

was approximately 90% for both Pfizer-BioNTech and Moderna vaccines. Estimates during the 

Delta predominance period indicated combined 2-dose mRNA VE. However, there was a large 

drop in the period of Omicron BA.1 predominance down to just under 70%. There was another 

drop in the era of Omicron BA.2 and BA.2.12.1 to less than 60%.36 Returning to Novavax 

COVID-19 vaccine, 1 study investigated the efficacy of Novavax COVID-19 vaccine against the 

Beta (B.1.351) variant of SARS-CoV-2 in South Africa from 2020—2021. Among 2684 

participants seronegative at baseline, VE against symptomatic COVID-19 disease was 49.4% 

(6.1%, 72.8%). Among HIV negative participants who were seronegative at baseline, VE was 

60.1% (19.9%, 80.1%). Of 41 sequenced isolates, 38 (92.7%) were Beta variant. Post-hoc VE 

36 Alpha estimates for Pfizer-BioNTech and Moderna separately from: Thompson et al. NEJM

https://www.nejm.org/doi/full/10.1056/nejmoa2110362; Delta estimates for mRNA vaccines combined from: Thompson et al. 

MMWR https://www.cdc.gov/mmwr/volumes/71/wr/mm7104e3.htm; and Omicron estimates for mRNA vaccines combined from: 

Link-Gelles et al. MMWR https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e1.htm 
ACIP Meeting Summary July 19, 2022 

30

against the Beta variant was 51.0% (-0.6%, 76.2%).37 All this to say that the exact VE of the 

Novavax COVID-19 in the context of Omicron or future variants is unknown. 

Transitioning now to the broader safety dataset, there were several events of myocarditis and/or 

pericarditis with a possible relationship to vaccine detected over the expanded safety dataset of 

approximately 41,546 recipients ≥16 years of age. In addition, 1 event angioedema was 

identified in Study 301 and 1 event of GBS was identified in Study 302. To contextualize the 

events of myocarditis and/or pericarditis, intensive post-authorization COVID-19 vaccine

surveillance has identified a small risk of myocarditis associated with mRNA vaccination, 

particularly after a second dose in adolescent males and young men.38 COVID-19 disease itself 

is associated with risk of multiple serious cardiac outcomes, including myocarditis, pericarditis, 

stroke, acute coronary syndrome, myocardial infarction, heart failure, arrhythmia, and cardiac 

death.39

In this context, it is very clear that benefits of COVID-19 vaccine outweigh risks. The risk of 

cardiac complications is higher after COVID-19 than after mRNA COVID-19 vaccinations among 

males and females of all ages. Teen boys 12 through 17 years of age have a 2 to 6 times higher 

risk of cardiac complications after infection compared to after vaccination, and young men 18 

through 29 years of age have a 7 to 8 times higher risk of cardiac complications after infection 

compared to after vaccination. COVID-19 vaccine is the best way to protect against COVID-19

and rare cardiac complications.40

To briefly review what is known about myocarditis and/or pericarditis after mRNA vaccination 

from 2 of the platforms that make up the most intensive vaccine safety surveillance in US

history, VAERS reporting rates of myocarditis and/or pericarditis following mRNA vaccination by 

age group and sex show the highest reporting rate of 38.9 among males 18 through 24 years of 

age following Dose 2 within Days 0 to 7 after vaccination. VSD also demonstrated excess risk 

among young people following Dose 2. Now turning to what was observed in the Novavax 

clinical trials.41 In the total clinical safety database of over 40,000 vaccine recipients, 4 cases

myocarditis and/or pericarditis were identified as having a temporal relationship to vaccination 

and concern for a causal relationship to the vaccine. All 4 patients were hospitalized and all 4 

experienced complete clinical resolution. There were 3 additional cases identified across clinical 

trials, 2 in vaccine recipients and 1 in a placebo recipient, all of which had an alternative 

explanation for the etiology.

 

Myocarditis and pericarditis also have been identified in international post-marketing safety 

data. To date, over 744,000 doses42 of Novavax COVID-19 vaccine have been administered

post-authorization and/or approved in Australia, Canada, European Union, New Zealand, and

South Korea. These data were submitted by responses to FDA in advance of their consideration 

at the Vaccine and Related Blood Products Advisory Committee (VRBPAC) meeting on June 7, 

2022. Internationally, 35 unique reports including 36 unique myocarditis and/or pericarditis 

events have been identified. There were 29 cases of pericarditis and notably 5 of the individuals 

37 Shinde et al. Efficacy of NVX-CoV2372 COVID-19 vaccine against the B.1.351 variant. NEJM 2021; 384:1899-1909 38 Oster et al. JAMA. 2022;327(4):331-340. doi:10.1001/jama.2021.24110; 

39 2 Basu-Ray I, Almaddah Nk, Adeboye A, et al. Cardiac Manifestations Of Coronavirus (COVID-19) StatPearls Publishing; 2022 

Jan. https://www.ncbi.nlm.nih.gov/books/NBK556152/ 

40 Block JP, Boehmer TK, Forrest CB, et al. Cardiac Complications After SARS-CoV-2 Infection and mRNA COVID-19 Vaccination 

— PCORnet, United States, January 2021–January 2022. MMWR Morb Mortal Wkly Rep 2022;71:517-523. DOI: 

http://dx.doi.org/10.15585/mmwr.mm7114e1 41 FDA VRBPAC Briefing Document. June 7, 2022. https://www.fda.gov/media/158912/download 42 Lee L. FDA review of effectiveness and safety of Novavax COVID-19 vaccine in adults ≥18 years of age. June 7, 2022.

https://www.fda.gov/media/159004/download 
ACIP Meeting Summary July 19, 2022 

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with pericarditis had a history of pericarditis following mRNA vaccination. There also were 4 

cases of myocarditis, 2 cases of myopericarditis, and 1 case of carditis not otherwise specified.

The median known age of patients was 35 years, with 20 males and 15 females identified. This 

table summarizes what is known about myocarditis and pericarditis following Novavax COVID19 vaccine in clinical trials and post-vaccine data so far: 

An FDA EUA Fact Sheet for providers warning about myo/pericarditis reads, “Clinical trials data 

provide evidence for increased risks of myocarditis and pericarditis following administration of 

Novavax COVID-19 Vaccine, Adjuvanted.”43 The EUA Fact Sheet for recipients cautions 

recipients to tell vaccine providers about a history of myocarditis or pericarditis and also 

counsels what symptoms to watch for.44

To summarize the benefits and harms domain, Novavax COVID-19 vaccine had high efficacy in 

the setting of the Alpha variant (B.1.1.7) consistent with other authorized COVID-19 vaccines at 

that time. The efficacy with recent SARS-CoV-2 variants and future variants is unknown.

Reactogenicity reported after Novavax vaccine was similar to what has been reported for other 

COVID-19 vaccine primary series. There were reports of myocarditis and/or pericarditis after 

Novavax COVID-19 vaccine during clinical trials, and several cases are evident in early postauthorization data. Based on the available data, it is important to point out that VE or 

myocarditis rates for Novavax and mRNA COVID-19 vaccines cannot be directly compared. 

Post-authorization monitoring for both VE and safety will be important moving forward. Based 

on these data, the WG felt that the desirable anticipated effects of the Novavax COVID-19 

vaccine are large, the undesirable anticipated effects are small, and that the desirable effects 

outweigh the undesirable effects—favoring the intervention of Novavax COVID-19 vaccine. 

43 FDA. EUA Novavax HCP Fact Sheet. July 13, 2022. https://www.fda.gov/media/159897/download 44 FDA. EUA Novavax Fact Sheet for Recipients and Caregivers. https://www.fda.gov/media/159898/download 
ACIP Meeting Summary July 19, 2022

32

Now to discuss the domain of values, a survey was designed by the CDC, University of Iowa,

and RAND Corporation to assess vaccination intentions for protein-based COVID-19 vaccine 

with or without adjuvant among unvaccinated Americans. Data were collected from January 27-

February 2, 2022 with a sample size of 541 respondents. This presentation focused on the 

vaccination intention of protein-based COVID-19 vaccine with adjuvants, such as Novavax 

COVID-19 vaccine among unvaccinated adults. Among the unvaccinated respondents, 16% 

said that they probably or definitely would get an adjuvanted protein-based COVID-19 vaccine.

However, 52% of these unvaccinated respondents said that they probably or definitely would 

not get an adjuvanted protein-based COVID-19 vaccine. These results varied somewhat

by several demographic characteristics, but not by others. Vaccine intentions were significantly 

higher among men than among women, and vaccine intentions were significantly lower among 

non-Hispanic White adults than among non-Hispanic Black adults or among Hispanic adults.

Vaccine intentions did not vary by US region, metropolitan status, age, or education.

In another survey conducted June 18-23, 2022 among a representative sample of 1,788 

unvaccinated US adults, some unvaccinated adults were less adamantly against traditional 

vaccines than others. In other words, more long-standing platforms than others. Those in urban 

areas, adults under 35, and Black and Hispanic adults all were less likely than the average

unvaccinated American to say that they would skip a traditional protein-based vaccine. Given 

that few unvaccinated adults are interested in traditional protein-based COVID-19 vaccines, 

unvaccinated adults were asked if they would get a traditional protein-based COVID-19 vaccine 

if one were authorized for use in the US. The top concerns among unvaccinated adults who do 

not want a protein-based COVID-19 vaccine include side effects, followed by worries that the 

vaccine moved through clinical trials too fast, and/or a belief that the vaccine will not be

effective. The survey also detected a very interesting difference in beliefs about safety in 

protein-based vaccines versus mRNA vaccines. Among all adults, these assessments of safety 

were similar but interestingly, vaccinated adults seemed to more commonly express the belief 

that mRNA vaccines were safer while unvaccinated adults seemed to more commonly believe 

that protein subunit vaccines were safer.

To summarize values, when asked in early 2022, 16% of unvaccinated respondents probably

or definitely would get an adjuvanted protein-based COVID-19 vaccine like Novavax. However, 

52% of these unvaccinated respondents said that they probably or definitely would not. There 

were no significant differences by US region, metropolitan status, age group, or education,

but vaccination intentions were lower for females than males and lower for non-Hispanic White 

adults. Among unvaccinated adults, 77% said they would not get a traditional protein-based 

COVID-19 vaccine if one were authorized. Among unvaccinated adults, 28% said they view 

these traditional or more longstanding protein-based vaccines as safe compared with 17% who 

said mRNA shots or vaccines were safe. The WG felt that the desirable effects in terms

of their view within the target population were varied, that patient and caregiver views would 

vary, and that the valuation of this intervention varied. Additionally, the WG felt that there is 

probably important uncertainty or variability in this valuation.
ACIP Meeting Summary July 19, 2022 

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Moving to domain of acceptability, the most significant apparent influences upon an individual’s 

assessment of vaccine acceptability were assessed by a Kaiser Family Foundation (KFF)

survey.

45 Personal doctors were identified as the most trusted for COVID-19 vaccine 

information, with survey respondents’ own doctor most frequently ascribed a great deal or a fair 

amount of trust and pediatricians following next. CDC is investing in a variety of diverse 

partnerships to work to enhance the acceptability of vaccines across the nation, including 

investing in jurisdictions to launch new programs to enhance access, acceptance, and updates; 

in communities hard-hit by COVID-19; in health departments to address COVID-19 disparities; 

in community health organizations; and in partnership with the Federal Retail Pharmacy

Program to ensure vaccine access.46 Impressions from a jurisdictional partner listening session

with 26 jurisdictions present on July 7, 2022, most of the partners stated that they would order 

Novavax vaccine if it became available, expressed a high interest in support related to Novavax 

COVID-19 vaccine, and described highly varied intent of use including in private provider 

offices, pharmacies, local health departments, and all of the above.

To summarize the acceptability domain, the great majority of adults (85%) trust their own 

doctors to provide reliable information about COVID-19 vaccines. The CDC will continue to do 

everything the agency can to enhance vaccine acceptable, access, and uptake in communities 

disproportionately impacted by COVID-19 and elsewhere. As with other COVID-19 vaccines,

Novavax COVID-19 vaccine is likely to be acceptable to implementing partners. Overall, the WG

felt that the Novavax COVID-19 vaccine is probably acceptable to key stakeholders.

Turning now to feasibility, the WG considered standard known barriers to vaccine

implementation, including complexity of recommendations and communication thereof, vaccine 

storage and handling requirements, financial barriers, and supply barriers. The complexity of 

recommendations does not pertain to Novavax COVID-19 per se but instead applies to the 

complexity of the many vaccine recommendations it comes alongside as potentially the fourth 

approved COVID-19 vaccine in the US. The Novavax COVID-19 vaccine is supplied in a carton 

containing 10 multiple-dose vials with each vial containing 10 doses. This is stored in a 

refrigerator and does not need to be frozen. It has a beyond-use date of 6 hours after the first 

puncture and must be discarded shortly thereafter. This vaccine is preservative-free and does 

not require reconstitution or dilution. There is an interesting factor that pertains to the expiration 

date in that they are not on the labels. To find the expirations dates, partners must navigate to

www.Novavaxcovidvaccine.com. In the realm of financial barriers, COVID-19 vaccines continue 

to be provided to US populations free of charge. Health systems and/or health departments do

incur some costs for vaccine implementation, clinics, outreach, and education. In addition, 

financial hardship can arise if vaccine recipients have to take time off to receive the vaccine or 

afterwards if they experience post-vaccination reactogenicity that prevents them from working. 

In terms of supply barriers, the US has demonstrated that distribution of vaccine per se is

feasible to implement broadly. The purchase of Novavax COVID-19 vaccine thus far includes 

3.2 million doses with the intent to distribute following an ACIP recommendation, if indeed 

recommended. Some relative logistic advantages of Novavax vaccine include easy storage, 

familiar schedule, and easy preparation. The disadvantages in terms of feasibility might include 

that short seal beyond use date time and the need to discard after puncture. Additionally, there 

are no recommendations for unrefrigerated storage prior to puncture. The 10-dose packaging is 

45 KFF COVID-19 Vaccine Monitor (April 13-26, 2022). https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccinemonitor-april-2022/ Accessed July 7, 2022 46 CDC. COVID-19 Vaccine Equity for Racial and Ethnic Minority Groups. https://www.cdc.gov/coronavirus/2019-

ncov/community/health-equity/vaccine-equity.html Accessed July 7, 2022
ACIP Meeting Summary July 19, 2022

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currently only authorized for use as a primary series, which could lead to increased wastage. In 

addition, this is a new product for providers.

In summary of the feasibility domain, the Novavax COVID-19 vaccine would be the fourth 

COVID-19 vaccine with an EUA. All vaccines will continue to be provided free of charge. The 

US has demonstrated success in distributing about 600 million doses of COVID-19 vaccine 

across the country, which is excellent. There are some relative logistical advantages and a few 

disadvantages of Novavax vaccine as well. Overall, the WG felt that Novavax COVID-19 

vaccine would indeed be feasible to implement among adults ≥18 years of age as a primary 

series.

Turning now to the equity domain, the most severe COVID-19 outcomes have weighed more 

heavily on some populations than on others. These inequities are seen as a manifestation

of long-standing inequities and/or also contributors to continued and future inequities. Everyone 

needs to do everything possible to reduce health inequities. This is fundamental for those

working in public health and in clinical medicine. No single vaccine has the ability to overcome 

all disparities—not the vaccine under discussion during this meeting or any other single vaccine. 

There are several issues related to vaccine equity and health equity. It is critical to continue to 

investigate these persistent health inequities and do everything possible to resolve them, and it 

is important to underscore that any inequity in COVID-19 vaccine access or use has the 

potential to further exacerbate disparities in COVID-19’s impact. This table is a reminder of the 

powerful cumulative inequities and the higher risk of hospitalizations and deaths due to COVID19 among AI/AN persons, non-Hispanic persons, Black or African American non-Hispanic 

persons, and Hispanic or Latino persons as compared to White non-Hispanic persons:

Given the power of COVID-19 vaccines to reduce the risk of these severe outcomes, COVID-19 

vaccines represent a potential way to decrease these disparities over time. If distribution, 

access, acceptance, and uptake of COVID-19 vaccines is not inevitable, the intended effect of 

vaccines on these disparities may not be achieved. Thus far, inequities do persist and receipt of 

COVID-19 vaccine data from the NIS-ACM demonstrate that 22% of persons of Other/Multiple 

Races, 20% of persons who are AI/AN, 14% of the persons who are Hispanic, and 14% of 

persons who are White have yet to receive the COVID-19 vaccine. Data pertaining to other 

disparities also highlight that there is room to improve COVID-19 vaccination. Significantly more 
ACIP Meeting Summary July 19, 2022 

35

adults residing in a rural area have not received a COVID-19 vaccine compared to those 

residing in suburban or urban areas. Additionally, a higher percentage of adults with incomes 

less than $75,000 per year or living in poverty have not yet received a COVID-19 vaccine 

compared to adults with higher incomes. Other markers such as access to healthcare are still 

significant. A higher percentage of US adults who do not have a regular primary care provider or

health insurance have not received a COVID-19 vaccine compared to those with a regular 

provider and those who are insured. These disparities are important to note, particularly in the 

context of COVID-19 vaccines having been made available free of charge and without the need

for either primary care physicians or health insurance.

There may be more to learn about the barriers to COVID-19 vaccination in this space. The US 

Census Bureau Household Pulse Survey (HPS)47 shows that adults who had not received a 

single dose of the COVID vaccine tend to be younger, have lower levels of education 

attainment, are more likely to be non-white, are less likely to be married, are more likely to be 

economically disadvantaged, and are more likely to report a disability or a different ability than 

those who received at least 1 dose of COVID-19 vaccine. In an effort to make advancements 

toward vaccine equity for all, CDC launched the Partnering for Vaccine Equity program that is 

focused on increasing equity in adult immunization. Anyone who is interested in learning about 

these important efforts is invited to visit the Partnering for Vaccine Equity Vaccine Resource 

Hub to learn more and join CDC in these efforts.48

In summary of the equity domain, there are notable disparities in COVID-19 cases,

hospitalizations, and mortality rates by race and ethnicity. Vaccine status differs by age, level of 

education, race, and ethnicity. An additional COVID-19 vaccine utilizing traditional or 

longstanding vaccine technology will provide an additional option for unvaccinated individuals.

Improving vaccine equity requires continued efforts. National-, state-, local-, and communitylevel partners are focused on diverse endeavors to improve equity in adult immunizations 

among disproportionately affected populations. Overall, the WG felt that the impact of the

Novavax COVID-19 vaccine alone probably would have no impact on health equity.

To summarize the EtR Framework evaluation overall, the WG workgroup felt that COVID-19 is 

of public health importance and that anticipated desirable effects of the vaccine are large while 

anticipated undesirable effects are small. The WG felt that the balance of desirable and

undesirable effects favors the intervention. The certainty of evidence for critical outcomes 

ranged from high for prevention of symptomatic COVID-19 SAEs to low for prevention of 

hospitalization. The WG felt that the target population valuation of the Novavax COVID-19 

vaccine varies, with probably important uncertainty or variability. It was thought that the 

Novavax COVID-19 vaccine is probably acceptable to key stakeholders and it is feasible

to implement, but that the Novavax COVID-19 vaccine alone probably would have no impact on 

health equity.

The WG interpretation of the data presented thus far is as follows. The WG understands that the 

vaccine had high efficacy against symptomatic COVID-19 disease in the setting of Alpha 

predominance. Reports of myocarditis and/or pericarditis after Novavax COVID-19 vaccine are 

none during both clinical trial and early post-authorization data. Based on available data, the 

WG cannot directly compare VE or myocarditis rates for Novavax and mRNA vaccines, and that 

post-authorization monitoring for both VE and safety will be important. Vaccination remains the 

47 US Census Bureau Household Pulse Survey (HPS) United States Census Bureau. Who Are the Adults Not Vaccinated Against 

COVID? https://www.census.gov/library/stories/2021/12/who-are-the-adults-not-vaccinated-against-covid.html Accessed February 

24, 2022 48 https://vaccineresourcehub.org/ 
ACIP Meeting Summary July 19, 2022 

36

best way to protect against SARS-CoV-2 and the rare cardiac risks of COVID-19 disease. As 

always, the top priority remains vaccination of unvaccinated individuals. An additional COVID-19 

vaccine utilizing traditional or more longstanding vaccine technology will provide an additional 

option for unvaccinated individuals. Overall, the WG felt that the benefits of Novavax COVID-19 

vaccine outweigh risks. In the balance of consequences evaluated, the WG felt that the 

desirable consequences probably or clearly outweigh the undesirable consequences in most 

settings and recommended the intervention. 

Interim Clinical Considerations: Novavax COVID-19 Vaccine 

Dr. Elisha Hall (CDC/NCIRD) presented Interim Clinical Considerations for Novavax COVID-19 

vaccine. Novavax is authorized for people ≥18 years of age. People who are not moderately or 

severely immunocompromised should receive 2 primary doses separated by 3 to 8 weeks. 

People who are moderately or severely immunocompromised should receive 2 primary doses 

separated by 3 weeks. A third primary dose for people who are immunocompromised is not 

currently authorized. At this time, only the 2-dose primary series is authorized for both

populations. If and when a third dose is authorized, CDC could then add guidance to that effect.

Additionally, just like when other COVID-19 vaccines were first authorized for a primary series, 

only primary doses are authorized at this time. Neither a homologous or heterologous booster is 

authorized. It is expected that at some point in the future, people who choose this primary series 

would be able to get a booster when they need it. CDC provides clinical guidance for what FDA 

authorizes. Once authorized, these doses can be added to the COVID-19 vaccination schedule. 

In terms of a mixed primary series, COVID-19 vaccines are not interchangeable, including 

Novavax. The same vaccine product should be used for all doses in the primary series. If a 

mixed primary series is inadvertently administered, the series is considered completed and 

doses do not need to be repeated. This is considered to be an error and should be reported. As 

an exception to this rule, if a person starts but is unable to complete the primary series with the 

same COVID-19 vaccine due to a contraindication, any other non-contraindicated ageappropriate COVID-19 vaccine may be administered to complete the series at a minimum of 28 

days from the last dose. This would not need to be reported to VAERS because it is included in 

CDC’s guidance.

Existing co-administration guidance that applies to other COVID-19 vaccines also applies to 

Novavax vaccine. In general, COVID-19 vaccines may be administered without regard to timing 

of other vaccines and may be given on the same day or any time before or after. Routine

administration of all age-appropriate doses of vaccines simultaneously is recommended for 

people for whom no specific contraindications exist at the time of the healthcare visit. The only 

exception is that there are additional considerations for orthopoxvirus vaccines. When deciding

whether to co-administer another vaccine with Novavax vaccine, providers may consider

whether a person is behind or at risk of becoming behind on recommended vaccines, the 

likelihood of the person returning for another vaccination, the person’s risk of becoming infected 

with a vaccine-preventable disease, the person’s risk for severe disease if infected, and the 

reactogenicity profile of the vaccines. In terms of the exception to the co-administration 

guidance related to orthopoxvirus vaccination, there are 2 different scenarios because of the 

observed risk for myocarditis after receipt of ACAM2000, Moderna, Novavax, and Pfizer 

vaccines and the unknown risk for myocarditis after JYNNEOS vaccine. If a person receives an 

orthopoxvirus vaccine first, they might consider waiting 4 weeks before receiving Moderna, 

Novavax, or Pfizer COVID-19 vaccine. If a person instead receives Moderna, Novavax, or Pfizer 

first and are then recommended to receive an orthopoxvirus vaccine for prophylaxis in the 

setting of an outbreak, administration of the orthopoxvirus vaccine should not be delayed 
ACIP Meeting Summary July 19, 2022 

37

because of the recent receipt of one of the COVID-19 vaccines. This is because the benefit of 

administering an orthopoxvirus vaccine as soon as possible when indicated for prophylaxis 

outweighs the possible risk of myocarditis by administering them too close together.

Regarding preparation and administration of Novavax COVID-19 vaccine indicated for persons 

≥18 years of age, 1 dose contains 5μg of SARS-CoV-2 recombinant spike protein antigen + 

50μg Matrix-MTM adjuvant. The injection volume of 1 dose is 0.5 mL. The vaccine should not be 

diluted and contains 10 doses per volume. As with the other COVID-19 vaccines, it should be 

injected intramuscularly in the deltoid muscle for adults. The Novavax COVID-19 vaccine should 

be stored refrigerated between 2° to 8°C (36°to 46°F). It should be removed from refrigerated

storage only when ready to use. An unpunctured vial should not be stored at room temperature. 

Although some other COVID vaccines can be frozen, this one should not be frozen. Once 

punctured, the vial must be used within 6 hours. As Dr. Twentyman mentioned, the expiration

date is not printed on either the vial or the carton. Therefore, it is very important to use the 

Novavax expiry date checker tool to avoid administering expired vaccines.49

In terms of contraindications and precautions, the currently authorized or approved COVID-19 

vaccines are classified into 3 types: 1) mRNA vaccines, including Moderna and Pfizer-BioNTech

vaccines; 2) adenovirus vector, which includes only Janssen vaccine; and 3) protein subunit, 

which includes only Novavax. Contraindications include a history of a severe allergic reaction 

(e.g., anaphylaxis) after a previous dose or to a component Novavax COVID-19 vaccine, or a 

history of a known diagnosed allergy to a component of Novavax COVID-19 vaccine. The 

Clinical Considerations currently state that an allergy-related contraindication to one type of 

vaccine is a precaution to another. For Novavax COVID-19 vaccine, that language has been 

slightly modified to state that, “People with an allergy-related contraindication to one type of 

COVID-19 vaccine have either a contraindication or precaution to the other types of COVID-19 

vaccines.” The only contraindication is for people with a known allergy to polysorbate. This 

means they have a contraindication to both Novavax and Janssen vaccines, which contain 

polysorbate. In all other cases, an allergy-related contraindication to one type of COVID-19 

vaccine is a precaution to both of the other types.

The other changes to contraindications and precautions in the existing guidance apply only to 

Novavax COVID-19 vaccine and include the following:

 History of an immediate allergic reaction to any vaccine other than COVID-19 vaccine or 

to any injectable therapy

 History of a non-severe, immediate (onset less than 4 hours) allergic reaction after a 

dose of Novavax COVID-19 vaccine

 Moderate or severe acute illness, with or without fever

 History of MIS-C or MIS-A 

 History of myocarditis or pericarditis after a dose of an mRNA or Novavax COVID-19 

vaccine

49 https://www.novavaxcovidvaccine.com/ 
ACIP Meeting Summary July 19, 2022 

38

Myocarditis or pericarditis after a dose of an mRNA or Novavax vaccine is a precaution to a 

subsequent dose of any COVID-19 vaccine. Considerations for subsequent vaccination include 

whether the myocarditis or pericarditis was considered unrelated to mRNA or Novavax

vaccination, personal risk of severe acute COVID-19, and timing of immunomodulatory 

therapies. For people ≥18 years of age who choose to receive a subsequent COVID-19 vaccine, 

some experts advise using Janssen. People who choose Janssen should be informed of the risk 

of TTS. The highest risk is in females 30 through 49 years of age. Additionally, a history of 

myocarditis or pericarditis prior to COVID-19 vaccination is not a precaution. People with this 

history may receive any currently authorized or approved COVID-19 vaccine after the episode 

of myocarditis or pericarditis has resolved. Again, much of this guidance already has been in 

place for mRNA COVID-19 vaccines and is simply being extended to Novavax COVID-19 

vaccine.

There are no specific data on an extended interval between Dose 1 and Dose 2 of Novavax

COVID-19 vaccine. However, there is evidence of benefits of an extended interval in mRNA 

recipients. Some studies in adolescents and adults have shown that a small risk of myocarditis 

or pericarditis associated with mRNA COVID-19 vaccines might be reduced and peak antibody 

responses and VE might be increased. Therefore, an 8-week interval may be used between 

Doses 1 and Dose 2 to potentially reduce the risk of myocarditis or pericarditis. The 3-week 

interval is more appropriate for people who are moderately or severely immunocompromised, 

for people ≥65 years of age, and when protection needs to be achieved soonest, such as having 

another high-risk reason for severe disease or living, working, or traveling to an area with high 

COVID-19 community levels. The 8-week interval could be considered for the potential to

reduce myocarditis risk, especially in young adult males and for optimized VE. 

Discussion Summary (Twentyman & Hall) 

Dr. Twentyman briefly recapped what the “big picture” of the COVID-19 vaccine

recommendations would look like if the ACIP recommended the Novavax COVID-19 vaccine. 

For the primary series vaccinations, ACIP would recommend mRNA COVID-19 vaccines, 

Modern and Pfizer-BioNTech, and Novavax COVID-19 vaccine. For booster vaccination, mRNA 

vaccines would be recommended. Novavax COVID-19 vaccines are not currently authorized for

booster doses and no COVID-19 vaccines are currently authorized for booster dose use in 

Novavax COVID-19 vaccine primary series recipients. Just like when other COVID-19 vaccines 

were first authorized for a primary series, only primary doses are authorized at this time for the 

Novavax COVID-19 vaccine. Neither homologous nor heterologous boosters are authorized. It 

is expected that at some point in the future, people who choose this primary series would be 

able to get a booster when they need it. The Janssen COVID-19 vaccine should be used only in 

limited situations, which are described at length in the Interim Clinical Considerations.

Dr. Poehling said she was surprised that there is no expiration date on the vials and that 

providers would have to go to a website to check each and every vial to find out the expiration 

dates. She worries about the feasibility of doing that and the potential for error. She was not 

familiar with this approach for other vaccines.

Dr. Hall said that she does not think this is typical. This has come up with a QR code rather than 

having the date with one of the COVID-19 vaccines. CDC has a COVID-19 vaccine expiration 

date tracker to help aid with It is not as ideal as having the expiration on the vial, but it is 

available with CDC’s clinical education materials so that providers can look up the expiration 

and lots and write that down and note it on the carton immediately to help prevent vaccine 

administration errors. There is certainly a higher risk for administering expired vaccine. She 
ACIP Meeting Summary July 19, 2022

39

asked whether Novavax would like to comment about the label in terms of the reason for not 

including expiration dates.

Dr. Dubovsky indicted that the reason was strictly a logistical one. They are working toward 

providing labeling that is more complete.

Dr. Lee asked FDA colleagues to comment on whether this type of labeling is reviewed in 

advance of approval of a Biologics License Application (BLA), and if there are requirements for 

labeling and consistency across vaccines being used under an EUA. The last few vaccine 

approvals have gotten overly complex, so she wondered whether this might be an opportunity 

for improvement or if this is already in the works at FDA.

Dr. Rebecca Reindel from FDA acknowledged the concern and indicated that she would

doublecheck the specifics of each vaccine label or Fact Sheet to try to determine why 

information was or was not included. There may be specific considerations that inform that on a 

case-by-case basis. Working on the labeling to make it more consistent still would fall within the 

bounds of the regulations and what each specific fact sheet or label requires.

Dr. Kotton expressed appreciation that immunocompromised patients were included in the 

Clinical Considerations. However, based on all other vaccine data in immunocompromised 

patients, it would be anticipated that these patients would need more than 2 doses of vaccine

to engender significant protection. For now, the company did not include immunocompromised 

patients other than a very small subset of people living with HIV in their clinical trials. It is likely 

that these data will not be available for a while. It is disappointing that this estimated 3% of the 

US population who are vulnerable to severe life-threatening disease now have an option

for a vaccine, but it is likely to be less than fully protective. She expressed disappointment that 

this leaves providers in a situation where for the near foreseeable future, there will not be data 

to guide the ability to make a better decision for that population with this new vaccine.

Dr. Sanchez noted that he did not hear much about allergic reactions from Novavax in terms of 

adverse reactions, and he heard about the angioedema that possibly was related. In terms of 

the Clinical considerations, he did not hear anything about having to monitor individuals who

have received Novavax for 15 minutes or so after its receipt.

Dr. Kim indicated that Novavax looked broadly at possible allergic reactions, particularly

hypersensitivity reactions. There was a standard MedDRA query that was utilized for broad 

search that found a 0.77% incidence in Novavax COVID-19 vaccine recipients and a 0.57% 

incidence in the placebo arm. They were not serious and the most frequent were rash, urticaria, 

and contact dermatitis. There were no events of anaphylaxis reported in the clinical program.

For the single case of angioedema, there were some multiple confounding factors that were 

reported for that particular case. There were no other similar events observed in the clinical 

program or across the adjuvant program. This event occurred about 5 days after the first dose 

and resolved on the same day. There was no respiratory distress, and it was confounded by 

concomitant antibiotic use, concurrent infection, and a history of penicillin allergy.

Dr. Hall indicated that CDC’s guidance for the observation period has not changed. There are 

some minor edits to the language, but the meaning has not changed. Those with a history of 

anaphylaxis due to any cause should be observed for 30 minutes. Those with a history of an 

immediate allergic reaction of any severity to non-COVID-19 vaccines or injectable therapies, a 

history of non-severe immediate allergic reaction after a previous dose of the COVID-19 
ACIP Meeting Summary July 19, 2022 

40

vaccine, and people with a contraindication to a different type of COVID-19 vaccine that have a 

precaution to this one, and for all other people 15 minutes is the observation period. 

In terms of product mixing and matching, Dr. Sanchez pointed out that some places give only 

one type of vaccine. If someone receives Novavax and then only one of the mRNA vaccines is 

available for their second dose but the Novavax vaccine is not approved for booster dosing,

what booster dose should that person receive?

Dr. Twentyman responded that the fundamental principle is that homologous primary series

vaccines are recommended. If a mixed primary series is inadvertently administered, the primary 

series is considered completed and those doses do not have to be repeated. It is considered an 

error though. If someone did not intend to receive an mRNA vaccine at any point and that was 

why they were getting a Novavax series, they probably would not want to proceed

with another mRNA dose.

Dr. Romero added that CDC will issue a statement on this and recommendations in upcoming 

Clinical Guidance. 

Dr. Sanchez expressed disappointment in the myocarditis data. A lot has been said about this in 

terms of mRNA vaccines. Though the rates are not as large for the Novavax COVID-19 vaccine, 

they are still substantial. It seemed to occur equally between males and females, and he 

wondered whether there was any more information on this.

Dr. Twentyman responded that they take any and every event extremely seriously, including this 

one. The numbers that have been seen of myocarditis and/or pericarditis in clinical trials

and in post-marketing data globally are small. It was not clear that anything could be said about 

the balance between males and females yet, or that this risk is very well-characterized at this 

point. The data are not yet sufficient to feel confident about comparing the risk between mRNA

and Novavax COVID-19 vaccines. However, this further underscores the importance of the 

intensive vaccine safety surveillance efforts that are ongoing through VAERS and VSD and the 

work that supports those and other safety platforms. Much has been learned about the risk that 

COVID-19 disease itself poses to the human heart, and that these vaccines are protective

against those cardiac risks—even among those who are known to be at higher risk for these 

rare cardiac complications after mRNA vaccines. There is a lot more to learn and this will be 

evaluated closely. In the meantime, she encouraged everyone to complete the primary series.

Dr. Sanchez asked whether, if the Novavax COVID-19 vaccine was approved during this 

meeting, it would be added to v-safeSM. 

Dr. Shimabukuro indicated that any COVID-19 vaccines available can be included in v-safeSM

and a similar survey will be used as has been used with the other products.

Vote: Novavax COVID-19 Vaccine in Adults ≥18 Years of Age

Evelyn Twentyman, MD, MPH (CDC/NCIRD) presented the proposed recommendations for a 

Novavax COVID-19 vaccine in adults ≥18 years of age as follows:

“A two-dose Novavax COVID-19 vaccine, adjuvanted is recommended as a COVID-19 

vaccine primary series for persons ages 18 years and older under the EUA issued by 

FDA.” 
ACIP Meeting Summary July 19, 2022 

41

Discussion Summary

Dr. Long requested a clarification that did not need any word change in terms of the 

recommendation and vote, which looked straightforward. Instead, she offered a plea to hold the 

manufacturer to the fire to have an expiration date on the label. While she thought she heard 

Dubovsky from Novavax say that this will happen, she received a lot of feedback that the 2 

previous immunizations ACIP recommended had the wrong volume and wrong age. Having to 

understand the border—whether it is maroon, or brown, or whatever color—is not acceptable. 

This is cutting off a step, and in this case, with the probability that maybe 12% to 15% at most 

of the 10% of the population who are not immunized might choose this vaccine. There is no 

rush to have it without proper labeling to minimize risk. She expressed surprise that the FDA 

would authorize a vaccine without an expiration date, and she did not think ACIP should 

recommend it without an expiration date right on the vial. It is not acceptable to ask the poor, 

overworked, under-resourced administrators to go find a website and look it up for the particular 

vial in their hand. They are taught to look at the vial to confirm that they have the right age, the 

volume to administer, and the expiration date before drawing and administering the shot. ACIP 

is losing credibility with the people who have to administer these vaccines, so she would like

that caveat to be understood before this vaccine is provided for the US population.

Sandra Fryhofer (AMA) said that speaking as a practicing physician, she greatly understood Dr. 

Long’s comments. She explained that when her office had Moderna vaccine to administer, the

expiration dates were changing and increasing at unscheduled times. Her office received 

vaccine late on what they thought was the last day it could be administered, but it turned that 

Moderna had extended the expiration date. A moving expiration date is not new, but it is very 

confusing. It is even more confusing when the concentration of the vaccine is not on the vial.

Dr. Lee added that from an implementation standpoint, having a standard approach for how 

ACIP does this consistently across vaccine products would greatly ease implementation and 

barriers. Because everyone is worried about making errors, ACIP should make sure they are 

making it easier for people to do the right thing.

Motion/Vote: Novavax COVID-19 Vaccine in Adults ≥18 Years of Age

Dr. Loehr made a motion for ACIP to adopt the verbiage of the recommendation stating that, “A 

two-dose Novavax COVID-19 vaccine, adjuvanted is recommended as a COVID-19 vaccine 

primary series for persons ages 18 years and older under the EUA issued by FDA.” Dr. 

Poehling seconded the motion. No conflicts of interest (COIs) were declared. The motion carried

with 12 affirmative votes, 0 negative votes, and 0 abstentions. The disposition of the vote was 

as follows:

12 Favored: Bahta, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, Poehling, 

Sanchez, Talbot

 0 Opposed: N/A

 0 Abstained: N/A 
ACIP Meeting Summary July 19, 2022 

42

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. Talbot emphasized that they have been moving at warp speed as the Operation Warp 

Speed (OWS) name has said to make sure that vaccines are available for everyone, but ACIP 

will continue to look back and to determine what can be done better, such as labeling. Hopefully 

by the time they are talking about booster doses and immunocompromised doses for this 

vaccine, the labels will be updated.

Dr. Kotton expressed her hope that there would be an anticipated timeline for booster doses

for the late Summer and Fall. Some people have been asking whether they should be getting 

booster doses now when they are due or if they should wait. She is worried about that approach 

with BA.5 and thinks that a rough timeline that could be used for clinical decision-making would 

be useful for clinicians and vaccine recipients. She also encouraged further discussion during 

ACIP meetings about the monkeypox vaccine. There is a very active vaccine rollout, and as 

much information as possible would be very helpful. The presentations during the last meeting 

were useful and very welcomed by her colleagues. She also reiterated the importance of

additional methods of prevention. While there is a lot of discussion about immunization for 

people who are immunocompromised, monoclonal antibodies can be used for prevention as 

well. A minority of immunocompromised patients who would qualify for EVUSHELDTM have 

received even a first dose. There is now a recommendation for a second dose 6 months after 

the first dose. It seems key for the CDC to mention all methods of prevention, whether infection 

control vaccines or monoclonal antibodies. For clinicians listening for patients who are 

immunocompromised and their family members, she strongly requested consideration of 

EVUSHELDTM. It is effective in the setting of BA.5 and she has seen it be a significant game 

changer in combination with a full vaccine series for immunocompromised patients. 

Dr. Brooks noted that the primary target population for Novavax will be the 10% to 13% of those 

who are unvaccinated. Given that this is more or less the only indication right now, he 

understood the need to focus on that population, with the hope that perhaps this protein subunit 

vaccine will change them from being unvaccinated to vaccinated.

Dr. Lee emphasized that she is very positive about the Novavax COVID-19 vaccine and having 

a fourth option.

Dr. Sanchez said he was very positive about this vaccine, especially for those who are hesitant. 

A large population has voiced concern that this vaccine is made from aborted fetal tissue, which 

is not accurate and should eliminate some of that pushback. Physicians need some guidance 

about waiting for boosters until the Fall, given that there may be a bivalent COVID-19 vaccine 

available in the future. They cannot keep boosting every 3 months, but it seems there will be 

some urgency in FDA commenting on booster for those who are due a booster and those who 

receive the Novavax vaccine.

Dr. Kotton agreed, noting that people feel that they may be penalized if they get a booster now 

in the setting of raging BA.5 subvariant disease in that they think that their next booster may 

need to be significantly delayed. Increased transparency would help in terms of sharing more 

information about people receiving boosters now versus later. 
ACIP Meeting Summary July 19, 2022

43

Dr. Poehling highlighted that a lot has been learned throughout the pandemic and knowledge 

has evolved. At this point, the knowledge is that 3 doses of vaccine are really important.

Dr. Long emphasized that people will be thinking about boosters in August and September.

Millions of Americans are now at 6 months or more beyond their second boosters and they do 

not know what to tell people about whether to get the same vaccines that have been given 

previously, or to wait for an optimized booster that will be available.

In terms of equity, it is important to keep in mind that people of color, people who are living in 

poverty, homeless populations, et cetera often experience major access issues and cannot or 

will not go get another booster dose every 3 to 4 months. It is critical to know more about the 

bivalent booster as soon as possible in order to inform these individual.

Dr. Wharton expressed appreciation for the community’s engagement on the day’s issues. This 

has been an extraordinary couple of years, and unprecedented demands have been made on 

ACIP to repeatedly engage as recommendations have incrementally expanded for a number of 

vaccines that have been initially authorized by the FDA under EUA. The demands have been

extraordinary, and CDC is very grateful for the ACIP’s support in advising the agency on 

appropriate use of these products. The timeframe for additional boosters is not completely clear 

yet, but additional information will be shared with the COVID-19 Vaccine WG, full ACIP, and the 

public as it becomes available.
ACIP Meeting Summary July 19, 2022 

44

CERTIFICATION

Upon reviewing the foregoing version of the July 19, 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.
ACIP Meeting Summary July 19, 2022 

45

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 
ACIP Meeting Summary July 19, 2022

46

CINEAS, Sybil, MD, FAAP, FACP

Associate Professor of Medicine, Pediatrics, and Medical Science (Clinical)

The Warren Alpert Medical School of Brown University

Associate Program Director

Brown Combined Residency in Internal Medicine and Pediatrics

Providence, RI

Term: 7/28/2021 – 6/30/2025

DALEY, Matthew F, MD 

Senior Investigator 

Institute for Health Research, Kaiser Permanente Colorado 

Associate Professor of Pediatrics 

University of Colorado School of Medicine 

Aurora, CO 

Term: 1/4/2021 – 6/30/2024 

KOTTON, Camille Nelson, MD, FIDSA, FAST 

Clinical Director, Transplant and Immunocompromised Host Infectious Diseases 

Infectious Diseases Division, Massachusetts General Hospital 

Associate Professor of Medicine, Harvard Medical School 

Boston, MA 

Term: 12/23/2020 – 6/30/2024 

LOEHR, Jamie, MD, FAAFP

Owner, Cayuga Family Medicine

Ithaca, New York

Term: 7/26/2021 – 6/30/2025

LONG, Sarah S, MD 

Professor of Pediatrics 

Drexel University College of Medicine 

Section of Infectious Diseases 

St. Christopher’s Hospital for Children 

Philadelphia, Pennsylvania 

Term: 12/24/2020 – 6/30/2024 

MCNALLY, Veronica V, JD 

President and CEO Franny 

Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2022 

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 
ACIP Meeting Summary July 19, 2022 

47

SÁNCHEZ, Pablo J, MD 

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital Columbus, Ohio 

Term: 7/1/2019 – 6/30/2023 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University 

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 

EX OFFICIO MEMBERS 

 

Centers for Medicare and Medicaid Services (CMS) 

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification Centers 

for Medicare and Medicaid Services 

Baltimore, MD 

Food and Drug Administration (FDA) 

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications 

Office of Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD 

 

Health Resources and Services Administration (HRSA) 

GRIMES, Reed, MD, MPH 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

Indian Health Service (IHS) 

CLARK, Matthew, MD, FAAP, FACP

Physician

Chair, IHS National Pharmacy & Therapeutics Committee

Durango, CO
ACIP Meeting Summary July 19, 2022 

48

Office of Infectious Disease and HIV/AIDS Policy (OIDP)

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

 

National Institutes of Health (NIH) 

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) 

Bethesda, MD 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

 

American Academy of Pediatrics (AAP) 

MALDONADO, Yvonne, MD 

Senior Associate Dean for Faculty Development and Diversity 

Professor of Pediatrics and Health Research and Policy 

Chief, Division of Pediatric Infectious Diseases 

Stanford University School of Medicine 

Stanford, CA 

American Academy of Pediatrics (AAP) 

Red Book Editor

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine

Birmingham, AL 

 

American Academy of Physician Assistants (AAPA) 

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants 

Alexandria, VA 
ACIP Meeting Summary July 19, 2022

49

American College Health Association (ACHA) 

CHAI, Thevy S., MD 

Director of Medical Services 

Campus Health Services 

University of North Carolina at Chapel Hill Chapel Hill, 

NC 

American College Health Association (ACHA) (alternate) 

MCMULLEN, Sharon, RN, MPH, FACHA 

Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health 

Ithaca, NY 

American College of Nurse Midwives (ACNM) 

HAYES, Carol E., CNM, MN, MPH 

Lead Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast Atlanta, GA 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

In partnership with University of Rwanda and University of Illinois, Chicago 

American College of Obstetricians and Gynecologists (ACOG) 

ECKERT, Linda O, MD, FACOG 

Professor, Department of Obstetrics & Gynecology 

Adjunct Professor, Department of Global Health 

University of Washington 

Seattle, WA

American College of Physicians (ACP) 

GOLDMAN, Jason M, MD, FACP 

Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic University, Boca 

Raton, Florida 

Private Practice 

Coral Springs, FL 

American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics Geriatrics 

Division Chief 

Duke University and Durham VA Medical Centers 

Durham, NC 

America’s Health Insurance Plans (AHIP) 

GLUCKMAN, Robert A, MD, MACP 

Chief Medical Officer, Providence Health Plans 

Beaverton, OR 
ACIP Meeting Summary July 19, 2022

50

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA

Washington, DC 

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA) 

RITTLE, Charles (Chad), DNP, MPH, RN Assistant 

Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA) 

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA) 

HOGUE, Michael D., PharmD, FAPhA, FNAP

Dean and Professor of Loma Linda University School of Pharmacy

Director, Center for Interprofessional Education & Practice

Loma Linda, CA

Association of Immunization Managers (AIM) 

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health

Bismarck, ND 

Association for Prevention Teaching and Research (APTR) 

ZIMMERMAN, Richard, MD, MPH

Professor

University of Pittsburgh School of Medicine

Department of Family Medicine and Clinical Epidemiology

Pittsburgh, PA

Association of State and Territorial Health Officials (ASTHO) 

SHAH, Nirav D, MD, JD 

Director

Maine Center for Disease Control and Prevention

Augusta, ME 
ACIP Meeting Summary July 19, 2022

51

Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

Council of State and Territorial Epidemiologists (CSTE) (alternate) 

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

Canadian National Advisory Committee on Immunization (NACI) 

DEEKS, Shelley, MD, MHSc, FRCPC, FAFPHM

Deputy Chief Medical Officer of Health, Department of Health and Wellness, Nova Scotia

Associate Professor, Dalla Lana School of Public Health, University of Toronto

Chair, National Advisory Committee on Immunization

Halifax, Nova Scotia

Infectious Diseases Society of America (IDSA) 

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 

International Society for Travel Medicine (ISTM) 

BARNETT, Elizabeth D, MD Professor of 

Pediatrics 

Boston University School of Medicine 

Boston, MA 

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 
ACIP Meeting Summary July 19, 2022

52

National Association of County and City Health Officials (NACCHO) (alternate)

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease

Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine 

Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health

Seattle, WA 

National Association of Pediatric Nurse Practitioners (NAPNAP) 

STINCHFIELD, Patricia A, RN, MS, CPNP 

Director 

Infectious Disease/Immunology/Infection Control

Children's Hospitals and Clinics of Minnesota 

St. Paul, MN 

National Foundation for Infectious Diseases (NFID) 

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

National Foundation for Infectious Diseases (NFID) (alternate)

DALTON, Marla, PE, CAE 

Executive Director & CEO 

National Foundation for Infectious Diseases (NFID) 

Bethesda, MD 

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD Professor and Chair 

University of Medicine and Dentistry of New Jersey Robert Wood 

Johnson Medical School 

New Brunswick, NJ 

Pediatric Infectious Diseases Society (PIDS) 

O’LEARY, Sean, MD, MPH 

Associate Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

Pediatric Infectious Diseases Society (PIDS) (alternate)

SAWYER, Mark H, MD 

Professor of Clinical Pediatrics 

University of California, San Diego School of Medicine 

San Diego, CA 
ACIP Meeting Summary July 19, 2022

53

Pharmaceutical Research and Manufacturers of America (PhRMA) 

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur 

Swiftwater, PA 

Society for Adolescent Health and Medicine (SAHM) 

MIDDLEMAN, Amy B, MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center

Oklahoma City, OK 

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine 

Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA
ACIP Meeting Summary July 19, 2022 

54

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 

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 

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

EHR Electronic Health Records 

EMA European Medicines Agency 

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

HHS (Department of) Health and Human Services

HIV Human Immunodeficiency Virus 
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HRSA Health Resources and Services Administration 

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IM Intramuscular 

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 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAPNAP National Association of Pediatric Nurse Practitioners 

NCIRD National Center for Immunization and Respiratory Diseases 

NFID National Foundation for Infectious Diseases 

NIH National Institutes of Health

NIS-ACM National Immunization Survey Adult COVID-19 Module 

NMA National Medical Association 

NSTEMI Non-ST Elevation Myocardial Infarction 

NVSS National Vital Statistics System

OWS Operation Warp Speed 

PCP Primary Care Provider/Practitioner

PEP Post-Exposure Prophylaxis 

PHAC Public Health Agency Canada 

PIDS Pediatric Infectious Disease Society 

PIMMC Potential Immune-Mediated Medical Condition 

RCA Rapid Cycle Analysis

RCT Randomized Controlled Trial

RR Relative Risk

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SBAs Saponin-Based Adjuvant 

SDOH Social Determinants of Health 

SES Socioeconomic Status 

SHEA Society for Healthcare Epidemiology of America 

SMQ Standardised MedDRA Queries 

SOC System Organ Class 

SSR Summary Safety Report 

TTS Thrombotic Thrombocytopenia Syndrome 

UK United Kingdom

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 
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VRBPAC Vaccine and Related Blood Products Advisory Committee 

VSD Vaccine Safety Datalink

WG Work Group