MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP) 

JUNE 21-23, 2023 

MEETING SUMMARY 

CONTENTS 

WEDNESDAY: JUNE 21, 2023 .................................................................................................................... 3 

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

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

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

RESPIRATORY SYNCYTIAL VIRUS VACCINES: ADULT ..................................................... 4 

Brief Summary .................................................................................................................... 4 

Vote #1: RSV Vaccines for Adults ≥65 Years of Age (Amendment) .................................... 5 

Vote #2: RSV Vaccines for Adults 60─65 Years of Age ...................................................... 6 

POLIO VACCINE.................................................................................................................... 6 

Introduction......................................................................................................................... 6 

Recommendations for Adult Polio Vaccination.................................................................... 7 

Vote #1: Polio Vaccination Unvaccinated and Incompletely Vaccinated Adults ..................16 

Vote #2: Polio Vaccination Unvaccinated and Incompletely Vaccinated Adults ..................17 

INFLUENZA VACCINE ..........................................................................................................17 

Introduction........................................................................................................................17 

WG Considerations and Proposed Recommendations.......................................................17 

VFC Resolution..................................................................................................................29 

Vote #1: Influenza Vaccination Recommendation ..............................................................31 

Vote #2: Influenza Vaccination MMWR Recommendations and Reports ...........................31 

Vote #3: Influenza Vaccine VFC Resolution.......................................................................32 

PUBLIC COMMENTS............................................................................................................32 

Overview............................................................................................................................32 

Public Comment.................................................................................................................32 

THURSDAY: JUNE 22, 2023......................................................................................................................37 

AGENCY UPDATES..............................................................................................................37 

Centers for Disease Control and Prevention ......................................................................37 

Centers for Medicare and Medicaid Services .....................................................................38 

Food and Drug Administration............................................................................................39 
Health Resources and Services Administration..................................................................39 

Indian Health Service.........................................................................................................40 

National Institutes of Health ...............................................................................................40 

Office of Infectious Disease and HIV/AIDS Policy ..............................................................41 

PNEUMOCOCCAL VACCINES .............................................................................................41 

Introduction........................................................................................................................41 

Vote #1: Routine PCV Use for All Children aged <24 Months ............................................42 

Vote #2: Catch-Up PCV Doses for Children Aged 24–71 Months with an Incomplete PCV 

Vaccination Status .............................................................................................................43 

Vote #3: Children Aged 2–18 Years with Any Risk Condition Who Have Completed Their 

Recommended PCV Doses Before Age 6 Years................................................................43 

Vote #4: Children Aged 6–18 Years with Any Risk Condition Who Have Not Received Any 

Dose of PCV ......................................................................................................................44 

Vote #5: VFC Resolution....................................................................................................44 

DENGUE VACCINE...............................................................................................................45 

Brief Summary ...................................................................................................................45 

CHIKUNGUNYA VACCINE....................................................................................................45 

Brief Summary ...................................................................................................................45 

RESPIRATORY SYNCYTIAL VIRUS VACCINES: PEDIATRIC/MATERNAL.........................45 

Brief Summary ...................................................................................................................45 

PUBLIC COMMENTS............................................................................................................46 

FRIDAY: JUNE 23, 2023.............................................................................................................................51 

MPOX VACCINES.................................................................................................................51 

Brief Summary ...................................................................................................................51 

MENINGOCOCCAL VACCINES............................................................................................51 

Brief Summary ...................................................................................................................51 

VACCINE SAFETY................................................................................................................51 

Brief Summary ...................................................................................................................51 

COVID-19 VACCINES...........................................................................................................51 

Brief Summary ...................................................................................................................51 

CERTIFICATION.........................................................................................................................................53 

ACIP MEMBERSHIP ROSTER ..................................................................................................................54 

ACRONYMS USED IN THIS DOCUMENT.................................................................................................63 

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WEDNESDAY: JUNE 21, 2023 

WELCOME AND INTRODUCTIONS 

Call to Order/Roll Call 

Dr. Grace Lee (ACIP Chair) called to order and presided over the June 21-23, 2023 Advisory 

Committee on Immunization Practices (ACIP) meeting. Dr. Lee conducted a roll call each day, 

which established that a quorum was present. A list of Members, Ex Officios, and Liaison 

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

following conflicts of interest (COIs) were identified: 

 Dr. Camile Kotton is involved in a clinical trial for Takeda for an investigational antiviral agent 

for cytomegalovirus (CMV) that does not involve vaccine. 

Announcements 

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

meeting were available on the ACIP website and were made available through a ShareLinkTM 

file for ACIP Voting, Ex Officios, and Liaisons Members. The ACIP is, at its heart, a public body. 

Engagement with the public and transparency in all of its processes are vital to the committee’s 

work. She indicated that there would be 2 oral public comment sessions during this meeting, 

which were scheduled for 4:15 Eastern Time (ET) on June 21, 2023 and 4:50 pm on June 22, 

2023 ET. To create a fair and more efficient process, individuals interested in making an oral 

comment were asked to submit a request online in advance of the meeting. Priority is given to 

these advance requests. If more people make requests 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 may submit 

written comments via https://www.regulations.gov using Docket Number ID CDC-2023-0035. 

Information on the written public comment process, including 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 while serving on the 

committee, CDC may issue 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 those 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/she abstains on all votes 

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

Applications are being solicited for applications and nominations of candidates to fill upcoming 

ACIP vacancies. Detailed instructions for submission of names of potential candidates to serve 

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

August 1, 2023 for the 4-year terms beginning July 2024. 

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RESPIRATORY SYNCYTIAL VIRUS VACCINES: ADULT 

Brief Summary 

During the RSV session, Dr. Alejandra Gurtman (Pfizer) presented Pfizer data on season 2 

safety and efficacy and on co-administration with influenza vaccine. Dr. Leonard Friedland 

(GSK) presented GSK season 2 safety and efficacy and co-administration with influenza 

vaccine. Dr. David Hutton (University of Michigan) presented updated cost-effectiveness of the 

Pfizer and GSK vaccines, known as the main CDC model. Dr. Ismael Ortega Sanchez 

(CDC/NCIRD) provided a comparison of cost-effectiveness results of the main CDC model and 

each manufacturer model (e.g., Pfizer and GSK). Dr. Michael Melgar (CDC/NCIRD) presented 

the updated EtR Framework including GRADE (Grading of Recommendation Assessment, 

Development and Evaluation) and clinical considerations for the Pfizer and GSK vaccines. The 

following language was proposed for votes: 

 Vote #1: Adults 65 years of age and older are recommended to receive a single dose of 

RSV vaccine. 

 Vote #2: Individual adults aged 60─64 years may receive a single dose of RSV vaccine, 

using shared clinical decision-making based on risk assessment. 

Discussion Points for Clarification Prior to the Vote 

Dr. Loehr made a motion to approve the first vote as stated, “Adults 65 years of age and older 

are recommended to receive a single dose of RSV vaccine.” Dr. Brooks seconded the motion. 

Dr. Loehr made a motion to approve the second vote with a revision to state, “Individual adults 

aged 60─64 years may receive a single dose of RSV vaccine, using shared clinical decisionmaking. Dr. Poehling seconded the motion. 

Dr. Sanchez made a motion to amend the first vote to “Adults 65 years and older may receive a 

single dose of RSV vaccine using shared clinical decision-making.” Dr. Long seconded the 

motion. 

Dr. Kotton, as the WG Chair, reminded the ACIP members that the WG for people 65 years of 

age and over thought that there was moderate data for desirable anticipated effects, that the 

undesirable anticipated effects were low, and the majority opinion was that the WG favored the 

intervention. The WG spent many months, virtually every week in recent times, reviewing a 

large amount of data and research that went into the original proposed vote language. Although 

they were having an amazing, interesting, and vigorous conversation at this time, she 

suggested that the members contemplate that slides 46, 47, 48, and 49 reflected what the WG 

spent time doing rather than perhaps changing opinions now. She also emphasized that along 

with others, she had major concerns about cost, and thought the companies who make these 

vaccines are beholden to share cost with the ACIP. She personally found it upsetting that GSK 

virtually doubled the cost of vaccine in recent times and wondered what the future holds. 

Following the public comments and prior to the vote, Dr. Wharton indicated that they heard back 

from their colleague at the Center for Medicare and Medicaid Services (CMS), Mary Beth 

Hansen, regarding questions the ACIP raised earlier who indicated that should the older adult 

RSV vaccine be recommended by ACIP, coverage would be through Part D for Medicare 

beneficiaries. 

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Dr. Leonard Friedland (GSK) clarified that the rationale for the price range reviewed during this 

session and for which the ACIP requested additional information on pricing, the price range 

reviewed reflected AREXVY’s efficacy over 2 full RSV seasons, which resulted in better costeffectiveness versus GSK’s previously submitted analyses. The original price range was based 

on clinical data over 1 season only. To aid in the committee’s decision-making, GSK could 

confirm that the price of its RSV vaccine would fall within a narrow range of $200 to $295. This 

reflects the totality of the GSK data reviewed earlier concluding that AREXVY provides durable 

efficacy for at least 2 full seasons in the 60 and over population, including in those with 

underlying comorbidities and across advancing age. This reinforces GSK’s confidence in 

AREXVY’s potential to make a significant public health impact. The price of AREXVY will be 

based on cost-effectiveness analyses to ensure efficient allocation of resources. 

Donna Altenpohl (Pfizer) indicated that as was stated earlier in the day, to support the costeffectiveness analyses as part of the US CDC’s EtR framework, Pfizer provided CDC a price 

range of $180 to $270. Pfizer has been consistent with its price range since they first provided 

their cost-effectiveness analyses early this year. According to the CDC cost-effectiveness model 

shared during this session, even at the highest end of the Pfizer range of $270, the Pfizer RSV 

vaccine would have a cost per quality-adjusted life year (QALY) of under $180,000. This is not a 

guarantee, as Pfizer is in the midst of competitive price negotiations and has not set its list price. 

Regarding a question that arose about reports of 2 possible cases of acute disseminated 

encephalomyelitis (ADEM) related to RSV vaccines, Dr. James Sejvar (CDC) said that it 

appeared that there was some equating of ADEM with Guillain-Barré Syndrome (GBS). He 

clarified that although both are inflammatory neurologic diseases, GBS and ADEM are 

fundamentally different diseases. Although they can see sporadic cases of ADEM in the setting 

of prior vaccination within the 42-day window, association of causality is sometimes hard to 

establish. The other point about the 2 cases in question, for the data presented about the RSV 

vaccines, these were preliminary diagnoses of ADEM without the diagnostic testing that 

neurologists would like to see to substantiate a diagnosis. Apparently, these 2 cases were 

based upon clinical observations only without substantiating neuroimaging or cerebrospinal fluid 

tests. It is difficult, if not impossible, to come to a definitive diagnosis of ADEM in the absence of 

confirmatory neuroimaging or cerebrospinal fluid (CSF) studies. 

Dr. Lee reminded everyone that based on the rules of order, the ACIP would first vote on the 

amended Vote #1. If it passed, this would be the recommendation. If not, they would return to 

the original vote. 

Vote #1: RSV Vaccines for Adults ≥65 Years of Age (Amendment) 

Dr. Lee (ACIP Chair) showed the proposed vote language following the public comment period. 

The vote was combined with the RSV session for ease of reading: 

Adults 65 years of age and older may receive a single dose of RSV vaccine, using 

shared clinical decision-making. 

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Motion/Vote #1: RSV Vaccines for Adults ≥65 Years of Age (Amendment)

Dr. Poeling made a motion to approve the recommendation as stated, which Dr. Talbot 

seconded. No COIs were declared. The amended motion carried with 10 affirmative votes, 4 

negative votes, and 0 abstentions. The disposition of the vote was as follows: 

10 Favored: Bahta, Bell, Cineas, Daley, Lee, Loehr, Long, McNally, Poehling, Sanchez 

4 Opposed: Brooks, Chen, Kotton, Lee, Talbot 

0 Abstained: N/A 

Vote #2: RSV Vaccines for Adults 60─65 Years of Age 

Dr. Lee (ACIP Chair) showed the proposed vote language following the public comment period. 

The vote was combined with the RSV session for ease of reading: 

Individual adults aged 60–64 years may receive a single dose of RSV vaccine, using 

shared clinical decision-making based on risk assessment. 

Motion/Vote #2: RSV Vaccines for Adults 60─65 Years of Age

Dr. Poeling made a motion to approve the recommendation as stated, which Dr. Talbot 

seconded. No COIs were declared. The motion carried with 14 affirmative votes, 0 negative 

votes, and 1 abstention. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Sanchez 

0 Opposed: N/A 

1 Abstained: Talbot N/A 

POLIO VACCINE 

Introduction 

Oliver Brooks, MD, FAAP introduced the Polio Vaccination WG, which was formed 

approximately a year ago. The WG’s Terms of Reference (TOR) are to consider the following 

policy topics under consideration: 

1. Whether more specific guidance on adult vaccination, including use of adult booster doses, 

can be provided in the context of circulating poliovirus. 

2. Whether adults who are immunocompromised should be recommended an additional adult 

booster of a polio-containing vaccine. 

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3. Whether fractional doses of IPV (fIPV), as prequalified by WHO, should meet polio 

vaccination requirements, including for people immigrating to the United States. 

4. Consider criteria under which novel Oral Polio Vaccine type 2 (nOPV2) might be used in 

areas with outbreaks or persistent circulation of poliovirus. 

During this session, the WG presented on TOR #1 for the WG’s consideration, deliberation, and 

vote. 

Recommendations for Adult Polio Vaccination 

Sarah Kidd, MD, MPH (CDC/NCIRD) presented on behalf of the Polio Vaccination WG, 

indicating that the 2 main objectives for this session were to: 1) summarize the WG’s 

deliberations on adult polio vaccination specifically for recommendations for unvaccinated and 

incompletely vaccinated adults and recommendations for booster doses of IPV; and 2) present 

the WG’s proposed language for an ACIP vote. She presented the WG’s deliberations using the 

ACIP EtR Framework with the standard domains of: Public Health Problem, Benefits & Harms, 

Values, Acceptability, Resource Use, Equity, and Feasibility. As background, the most recent 

ACIP statement on adult polio vaccination was published in 2000, and it contains some 

ambiguous and outdated language. The 2000 statement is as follows: 

2000 Recommendations for Inactivated Polio Vaccine (IPV) Vaccination of Adults1 

 Vaccination is recommended for certain adults who are at greater risk for exposure to 

polioviruses than the general population 

 Unvaccinated adults who are at increased risk of exposure should receive a primary 

vaccination series with IPV 

 Adults who have had a primary series of oral polio vaccine (OPV) or IPV and who are at 

increased risk of exposure can receive another dose of IPV 

Multiple problems and questions about the recommendations came to light last year when a 

New York polo paralytic case was identified. First, the 2000 statement focuses almost 

exclusively on adults at increased risk of poliovirus exposure. It was unclear how increased risk 

should be defined in a setting of circulating vaccine-derived poliovirus (cVDPV) in the US. In 

addition, there was no clear guidance for unvaccinated adults who were not known to be at 

increased risk of exposure, and there was uncertainty about vaccinated adults and when and if 

a booster was advised. With that in mind, the first policy question the WG addressed was as 

follows: 

Policy Question #1

Should completion of a primary polio vaccination series with IPV be recommended for 

unvaccinated and incompletely vaccinated adults in the US? 

The population of interest was unvaccinated and incompletely vaccinated US adults (with tOPV 

or IPV) US adults aged ≥18 years. The intervention was completion of a primary vaccination 

series with IPV. The comparison group was no vaccination or partial series completion. The 

most important outcomes of interest were prevention of paralytic poliomyelitis; serologic 

1 https://www.cdc.gov/mmwr/preview/mmwrhtml/rr4905a1.htm 

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immunity to polioviruses Types 1, 2, and 3; SAEs following vaccination; and indirect effects 

(e.g., community transmission and impact on health systems). The current definition of fully 

vaccinated, an adult is conserved fully vaccinated if they have received the following:2 

 A primary series of at least ≥3 doses of tOPV or IPV in any combination administered ≥4

weeks apart

AND 

 The last dose in the series was given on or after the 4th birthday

AND 

 The last dose in the series was given ≥6 months after the previous dose

In terms of the Public Health Domain, poliovirus infection can cause poliomyelitis and lifelong 

paralysis. Paralytic disease occurs in fewer than 1% of infections, with the exact frequency 

varying by serotype. Non-paralytic clinical illness occurs in approximately 25%, including 1%– 

5% with aseptic meningitis. Most (75%) poliovirus infections are asymptomatic. The incidence of 

paralytic polio decreased rapidly in the US after introduction of the Salk IPV in 1955, quickly 

followed by the Sabin OPV in 1961. The Sabin OPV vaccine was used for routine childhood 

immunization in the US for decades. In 1997, an enhanced-potency IPV was introduced as part 

of a sequential schedule with IPV followed by OPV. In 2000, the US moved to an IPV-only 

schedule, and IPV has been the only polio vaccine recommended in the US since that time. 

Wild-type poliovirus Type 1 (WPV1) and cVDPV are still circulating in certain parts of the world. 

This map shows the distribution of the almost 700 paralytic polio cases that have been identified 

in the last 12 months (note that environmental detections from wastewater are not shown in this 

map:

3 

2 https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5830a3.htm 

3 https://polioeradication.org/polio-today/polio-now/ 

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A case of paralytic polio caused by vaccine-derived poliovirus Type 2 (VDPV2) was confirmed in 

an unvaccinated young adult from Rockland County, New York in July last year. Genetic 

sequencing has indicated a linkage to polioviruses collected in wastewater in Israel, the UK, and 

Canada. Of note, Rockland County has reported overall low vaccine coverage for over 20 years. 

In Summer 2022, just 60% of children under age 2 had received 3 doses of IPV. Zip code level 

coverage was as low as 37% in some areas. Fortunately, no additional paralytic cases have 

been identified. Poliovirus related to the case was detected in wastewater in several other New 

York counties and New York City. Retrospective testing detected poliovirus in the area as early 

as April 2022, indicating circulating and asymptomatic infections in the area at least since that 

time. Related virus continued to consistently be detected in wastewater until the beginning of 

November of last year. Only 2 samples have been positive for poliovirus since November 1st, 

with the most recent being collected on February 22nd in Rockland County. Samples collected in 

the last 15 weeks all have been negative. 

Looking at the pattern of wastewater detections in each affected county by week, there was just 

one paralytic polio case identified. But the presence of that case and the pattern of wastewater 

detections indicate that there were likely at least 1,000 to 2,000 mostly asymptomatic infections 

in the area. Circulating poliovirus poses a risk of paralytic polio to those who do not have 

immunity. In the US, most people are protected from paralytic polio because they have been 

vaccinated. National Salk IPV vaccination campaigns in the late 1950s targeted all persons up 

to 40 years of age. In terms National US Immunization Survey (USIS) data4 for Salk IPV 

vaccination coverage by September 1961 by age and race, campaign coverage was highest 

among children 5─14 years of age in 1961. This would be birth years 1947─1956. Also of note, 

estimates of coverage were higher among whites than non-whites in all age groups. In 

comparison to children and adolescents, coverage was lower in adults ≥20 years of age. Not 

many adults ≥40 years of age were vaccinated in the campaigns. 

After that USIS household survey, subsequent surveys focused on coverage among preschoolaged children.5 It is important to note that data from 3 different national surveys for 3-dose polio 

vaccination coverage among children used different methodologies and have different 

limitations. The USIS was based on parental recall and is thought to underestimate actual 

coverage by as much as 20% when compared to actual vaccination records. In contrast, the 

National Immunization Survey (NIS) data, come from actual vaccination records. While 

coverage levels, especially in the 1970s and 1980s, might be cause for concern. 

It is interesting to contrast those coverage data with serosurveys that indicate that a large 

majority of Americans have protective antibodies to poliovirus. In a National Health and Nutrition 

Examination Survey (NHANES) survey conducted in 2009─2010,6 seroprevalence varied by 

poliovirus serotype but was high in all the age groups studied. Seroprevalence for Type 3 was 

consistently the lowest but remained high even in the oldest age group. Of note, there were 

some small differences in seropositivity by race ethnicity group, but none of these were 

statistically significant among the younger age groups. Among older adults, differences by race 

and ethnicity generally were not statistically significant with a few exceptions where Mexican4 Morris, Public Health Reports 1964 

5 Sources: Simpson et al, AJPM 2001 Forty years and four surveys: How does our measuring measure up? – ScienceDirect. CDC, 

MMWR 2001 National, State, and Urban Area Vaccination Coverage Levels Among Children Aged 19--35 Months --- United 

States, 2000 (cdc.gov). CDC, MMWR 2006 National, State, and Urban Area Vaccination Coverage Among Children Aged 19--35 

Months --- United States, 2005 (cdc.gov). CDC, MMWR 2011 National and State Vaccination Coverage Among Children Aged 19--

35 Months --- United States, 2010 (cdc.gov). Hill et al, MMWR 2016 Vaccination Coverage Among Children Aged 19–35 Months — 

United States, 2015 | MMWR (cdc.gov). Hill et al, MMWR 2018 Vaccination Coverage Among Children Aged 19–35 Months — 

United States, 2017 | MMWR (cdc.gov). 

6 Wallace et al, BMC Public Health 2016 

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American adults had slightly lower seroprevalence of Type 2 antibodies compared to nonHispanic Blacks in those 20─39 years of age and compared to non-Hispanic Whites in 

individuals 40─49 years of age. They also had lower levels of Type 3 antibodies compared to 

non-Hispanic Whites in individuals 40─49 years of age. Unfortunately, there are no 

seroprevalence data for older age groups by race and ethnicity. 

To summarize the problem, the US remains at risk of poliovirus importations as long as there is 

ongoing transmission of poliovirus globally. Data indicate that most US adults have serologic 

immunity to polioviruses Type 1, 2, and 3. However, unvaccinated and incompletely vaccinated 

adults remain susceptible to paralytic polio if exposed to poliovirus. In response to the question 

for the EtR domain, the WG agreed that paralytic polio is a problem of public health importance. 

Regarding the Benefits and Harms domain, the effectiveness of enhanced-potency IPV has 

been established. The presence of detectable neutralizing antibodies is an accepted correlative 

protection against paralytic disease. However, immunity against paralytic disease can be 

present even in the absence of detectable antibodies. Studies of serologic immunogenicity 

among infants and children show that 70% to 100% are seropositive after 2 IPV doses and 88% 

to 100% are seropositive after 3 doses. There are limited data on VE against paralytic polio, but 

estimates range from 36% to 89% for 1 dose and 89% to 98% for 2 doses. However, because 

this is a routine childhood vaccine, there is a paucity of data for previously unvaccinated adults 

who receive a primary series.7 

In addition to serologic immunity, which protects against severe disease and paralysis, it also 

important to consider mucosal immunity and the potential effect of IPV on transmission. IPV 

does not decrease the proportion of people who will shed poliovirus when exposed. Multiple 

studies have shown that there is no significant difference between IPV and unvaccinated 

individuals in terms of the odds of shedding. However, several studies indicate that IPV may 

reduce the quantity and perhaps duration of shedding. Although a recent modeling study 

indicated no impact of IPV. There are fewer data on nasopharyngeal immunity following IPV, but 

data from 2 studies suggest that rates of nasopharyngeal shedding are similar and low at 0% to 

4% among both OPV and IPV vaccinees.8 

The safety of IPV also is well-established and IPV is well-tolerated. Local reactions at the 

injection site were reported during clinical trials and up to a third reported erythema, induration, 

or tenderness at the injection site. Combining IPV with other vaccines has not been associated 

with increased frequency or severity of reported AEs, compared to when the other vaccines are 

administered alone. No SAEs have been causally associated with the use of the current 

formulation of IPV.9 In a paper that looked at 2000─2012 data from VAERS during a period 

when more than 250 million IPV doses were distributed during 2000-2012, 41,792 AEs were 

submitted for IPV-containing vaccines. Most of these were non-serious and 95% were among 

persons less than 7 years of age. Most events were associated with IPV that was co 

administered with other vaccines and standalone IPV accounted for just 0.5% of reports.10 It is 

important to remember that VAERS is a passive reporting system cannot assess causal 

associations between vaccination and AEs. However, the lack of a signal in VAERS after 

decades of IPV use is reassuring. 

7 Vidor et al review, PIDJ 1997. Stoeckel et al, Rev Infect Dis 1984. CDC, MMWR 1988. John, Rev Med Virol 1993. 

8 Hird and Grassly meta-analysis, PLoS Pathogens 2012. Kok et al, Bulletin of WHO 1992. Onorato et al, JID 1991. Brouwer et al, J 

R Soc Interface 2022. 

9 : Sanofi Pasteur Package Insert - IPOL (fda.gov) . Vidor et al, PIDJ 1997. Murdin et al, Vaccine 1996. Wattigney et al, Pediatrics 

2001. IOM 1994. 

10 Iqbal et al, Lancet ID 2015. 

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For the ErR domain of Benefits and Harms, the WG interpretation was that taking into account 

both the individual- and population-level effects, the desirable anticipated effects of completing a 

polio vaccination series are large, the undesirable anticipated effects are minimal, and the 

anticipated benefits of completing a primary polio vaccination series outweigh the anticipated 

harms. 

In terms of the Values domain, an Annenberg Science Knowledge (ASK) survey11 was 

conducted in October 2022 that included questions about polio, so there are some data about 

what the general public thinks about polio recently. In this survey, 59% of people said it would 

be “extremely bad” to have polio and an additional 26% said it would be “very bad” to have 

polio. This was a higher proportion of the population than for other diseases surveyed, including 

long-COVID, Mpox, or measles. There is evidence that the general public values polio 

prevention, at least at the individual level. In addition, 85% of respondents said that they were 

likely to recommend that an eligible person in their household get vaccinated with the polio 

vaccine, indicating relatively high acceptability of the vaccine among the general public. 

However, when thinking about the values of the specific population in question, unvaccinated or 

incompletely vaccinated adults, it is likely that this is a heterogeneous group that consists of 

persons whose family chose for them to not be vaccinated as children and persons who missed 

opportunities to be vaccinated as children. There is a lack of data on how these populations 

currently perceive their risk of paralytic polio and how they perceive the anticipated positive 

versus negative effects of polio vaccination. Additional acceptability considerations include the 

pros that the context of global polio eradication efforts and the prevention of paralytic polio have 

been a public health priority for decades. In practice, there currently are many competing 

priorities for clinicians and local public health departments. The cons are competing priorities for 

clinicians and local public health departments and uncertainty about eligibility for vaccination 

and the true level of risk to adults in the US also could undermine acceptability. 

The WG thought that whether the target population of unvaccinated or incompletely vaccinated 

adults feel that the described effects of vaccination are large relative to the undesirable effects 

likely varies because of the heterogeneity of this group. The WG also felt that there is probably 

important uncertainty or variability in the values of the target population. In contrast, for 

acceptability of key stakeholders overall, the WG felt that providing a primary series to 

unvaccinated or incompletely vaccinated adult was probably acceptable to key stakeholders. 

Moving to the Feasibility domain, there currently is just one US-licensed manufacturer of 

standalone IPV (e.g., Sanofi). There are 3 US-licensed manufacturers of combination vaccines 

that include IPV (e.g., Sanofi, Merck, GSK). However, these combination vaccines are currently 

not indicated for adults. The potential demand for IPV is difficult to quantify. There are no data 

on the number of adults who know they are unvaccinated or incompletely vaccinated, so it is 

difficult to quantify potential demand. In practice, it is possible to learn from New York’s 

experience last summer. New York State and New York City did not experience any significant 

IPV supply issues despite identification of a polio case, persistent wastewater detections in the 

area, national media attention and calls, and a concerted effort by the health department to 

vaccinate unvaccinated persons, including adults. 

11 https://www.annenbergpublicpolicycenter.org/what-u-s-adults-know-and-believe-about-polio-and-the-bivalent-covid-booster/ 

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Other resource and feasibility considerations include issues with access. Adult medicine offices 

typically do not stock IPV, so access to vaccination sites that do stock IPV could be a barrier to 

implementation. Also, there are concerns about the potential effects on health systems and their 

vaccine screening and patient recall algorithms. However, the WG felt that these concerns could 

be mitigated with clear guidance for who is eligible for vaccination with these recommendations. 

The WG talked at length about the feasibility of implementing risk-based recommendations, 

particularly if risk of exposure in the population changes over time. Overall, the WG felt that 

vaccination of adults who are known or suspected to be unvaccinated or incompletely 

vaccinated was probably or was a reasonable and efficient allocation of resources. They also 

felt that it was probably feasible to implement. 

For the Equity domain, there are different rates of childhood vaccination and poliovirus immunity 

in different communities. Having an opportunity to receive catch-up polio vaccination as an adult 

likely increases equity. There are no known differences in VE among immunocompetent 

persons in the US setting. Assuring equitable access to vaccination sites with IPV will be an 

important consideration for implementation. Overall, the WG felt that providing polio vaccination 

for adults known or suspected to be unvaccinated or incompletely vaccinated probably would 

increase equity. 

For the overall balance of consequences, taking into account all of the EtR domains just 

presented, the WG considered 2 different populations of unvaccinated adults. For unvaccinated 

and incompletely vaccinated adults known to be at increased risk of poliovirus exposure, the 

WG’s judgment was that the desirable consequences clearly outweigh undesirable 

consequences in both settings. For unvaccinated and incompletely vaccinated adults who are 

not specifically known to be at increased risk of poliovirus exposure, the WG’s judgement was 

that desirable consequences probably outweigh undesirable consequences in most settings. 

Most of the WG’s deliberations focused on whether the recommendations for unvaccinated 

adults should be a risk-based recommendation or a uniform recommendation for all 

unvaccinated adults. Currently, situations that are considered to put adults at increased risk of 

poliovirus exposure include international travelers, laboratory and healthcare workers, and 

healthcare workers or other caregivers. In addition, unvaccinated or incompletely vaccinated 

adults whose children will be receiving an OPV and unvaccinated adults or incompletely 

vaccinated adults who are living or working in a community where poliovirus is circulating are 

considered to be at increased risk of exposure and vaccine is recommended. It became clear to 

the WG that most of these situations pose risk at the individual level and there would be an 

opportunity to anticipate the risk and vaccinate prior to the potential exposure. A situation for 

unvaccinated and incompletely vaccinated adults in a community where poliovirus is circulating 

was different. The situation affects an entire population, and the community already is at 

increased risk at the time the risk is recognized. This means there potentially would be missed 

opportunities for vaccination prior to exposure if the recommendation remains solely a riskbased recommendation. 

Additional challenges with the current risk-based recommendation came to light in 2022 when 

CDC, New York City, and state health departments received numerous questions about which 

adults were at increased risk of exposure. For instance, in which of these counties with 

wastewater detections or adjacent to wastewater detections are unvaccinated adults considered 

at increased risk of exposure? Are counties with a single wastewater detection of poliovirus 

considered to be at increased risk of exposure? When are unvaccinated adults in these counties 

no longer at increased risk of exposure? Are unvaccinated adults traveling to these counties at 

increased risk of exposure? As wastewater surveillance becomes more common, it is possible 

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that other jurisdictions might experience sporadic detections of poliovirus in their wastewater. 

These are the types of challenges that arise when trying to implement a risk-based 

recommendation. 

With these factors in mind, the pros of a uniform recommendation are that it allows 

unvaccinated adults and their healthcare providers to take advantage of opportunities to get 

vaccinated before they are at increased risk of exposure. It also brings adult polio vaccination 

policy closer in line with other routine childhood vaccines such as MMR and varicella vaccines. 

It is a less complicated policy to communicate, understand, and implement in that the 

recommendation does not change based on the latest wastewater data. The cons are that most 

adults in the US still have a low risk of poliovirus exposure and paralytic polio and most adults 

received their primary polio vaccination series as children. Another other con is that demand for 

IPV potentially could exceed supply, particularly if a large number of adults without 

documentation of polio vaccination status were to assume that they were not vaccinated. 

However, the WG felt that this issue could be mitigated by providing guidance for this group in 

the clinical considerations. 

Ultimately, the majority of the WG supported a uniform recommendation. However, a substantial 

minority favored the current risk-based recommendation with the addition of language 

specifically addressing unvaccinated adults who are not known to be at increased risk of 

exposure. The proposed recommendation language and important Clinical Considerations 

follow: 

Proposed Language for Policy Question #1 

Adults who are known or suspected to be unvaccinated or incompletely vaccinated against polio 

should complete a primary vaccination series with IPV. 

Important Context to Be Included in Clinical Considerations

In general, unless there are specific reasons to believe they were not vaccinated, most adults 

who were born and raised in the United States can assume they were vaccinated against polio 

as children. Polio vaccination has been part of the routine childhood immunization schedule for 

decades and is still part of the routine childhood immunization schedule. Adults who received 

any childhood vaccines almost certainly were vaccinated for polio. 

The second policy question addressed by the WG was as follows: 

Policy Question #2

Should a booster IPV dose be recommended for adults at increased risk of poliovirus exposure 

who have previously completed a primary polio vaccination series? 

The specific population being considered was US adults ≥18 years if age who are at increased 

risk of poliovirus exposure who have also completed a primary polio vaccination series with 

trivalent OPV, IPV, or a combination of both. The intervention was a booster dose of IPV and 

the comparison group was adults who competed a primary series, but did not receive a booster 

dose. Again, the main outcomes of interest were: prevention of paralytic polio; serologic 

immunity to poliovirus Types 1, 2, and 3; SAEs following vaccination; and indirect effects (e.g., 

community transmission and impact on health systems. The 2000 booster statement follows:12 

12 CDC MMWR 1977; CDC MMWR 1986 

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2000 Statement 

Adults who have had a primary series of OPV or IPV and who are at increased risk [of 

exposure to poliovirus] can receive another dose of IPV. Available data do not indicate 

the need for more than a single lifetime booster dose with IPV for adults. 

In terms of the rationale, this has been a long-standing recommendation since tOPV was used 

in routine immunization. However, the actual need for a supplementary dose has not been 

established. It has been thought that “there is value in assuring protection against infection with 

wild polioviruses when exposure can reasonably be expected.” (1977 ACIP Statement). Of note, 

there were at least 2 reported cases of paralytic polio in adult travelers who had completed a 

primary series with Salk IPV and/or tOPV. However, further details on these cases are not 

available and it is unknown whether a booster dose would have prevented these cases. 

The 2000 guidance was complicated in 2014 when CDC issued interim guidance in response to 

new WHO Polio International Health Regulations (IHR) Emergency Committee Temporary 

Recommendations. The WHO recommendations were for travelers who were departing 

countries with poliovirus circulation in order to prevent exportation. They applied to residents 

and travelers who were staying in the country for more than 4 weeks. If implemented by a 

country, proof of polio vaccination (IPV or tOPV) within the last 12 months could be required 

prior to leaving the country. This recommendation or a similar recommendation is still included 

in the most recent polio IHR statement. In response to this new WHO recommendation in 2014, 

which differed from ACIP recommendations, CDC published interim guidance in 2014 that 

stated:

13 

“Adults who have completed a routine series of polio vaccine are considered to have 

lifelong immunity to poliovirus but data are lacking. As a precaution, persons aged ≥18

years who are traveling to areas where there has been WPV circulation in the last 12 

months and who have received a routine series with either IPV or OPV in childhood 

should receive another dose of IPV before departure. For adults, available data do not 

indicate the need for more than a single lifetime booster dose with IPV.” 

It is unclear whether previously vaccinated adults need an IPV booster for protection. Results 

from the NHANES serosurvey showed that seroprevalence of neutralizing antibodies were high 

for all 3 serotypes and in all age groups studied.14 There are no data on the comparative VE of 

a primary series plus booster compared to a primary series alone, but serologic studies in adults 

with heterogeneous pre-booster vaccination histories and heterogeneous seropositivity have 

shown that 98% to 100% are seropositive 1 month after receiving an IPV-containing booster. 

One study also followed up trial participants 10 years later and 98% to 100% were still 

seropositive at that time.15 In terms of the safety of IPV, combining IPV with other vaccines has 

not been associated with increased frequency or severity of reported adverse reactions 

compared to when other vaccines are administered alone, and no SAEs have been causally 

associated with the current formulation of IPV.16 

13 Wallace MMWR 2014; Statement of the thirty-fifth Polio IHR Emergency Committee (who.int) 14 Wallace et al, BMC Public Health 2016 15 Sources: Broderick et al, Vaccine 2015; Domenicus et al, Vaccine 2014; Fukushima et al, Vaccines 2022; Grimprel et al, Vaccine 

2005; Kovac et al, Vaccine 2015; Larnaudie et al, Human Vaccines 2010; Zimmermann et al, Vaccine 2013. 16 Sources: Sanofi Pasteur Package Insert - IPOL (fda.gov) . Vidor et al, PIDJ 1997. Murdin et al, Vaccine 1996. Wattigney et al, 

Pediatrics 2001. IOM 1994. 

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For the EtR domain of Benefits and Harms, the WG determined that for adults at increased risk 

of exposure, the desirable anticipated effects of receiving an IPV booster were small to 

moderate, the undesirable effects were minimal, and the anticipated benefits outweighed the 

anticipated harms. 

Considering target population values, the results of that ASK survey conducted in 2022 showed 

the majority of adults surveyed thought that having polio would be “extremely bad” or “very bad” 

and that 85% said they were likely to recommend that someone in their household get 

vaccinated against polio if they were eligible. 

In terms of the Value domain, the WG thought that the target population, meaning previously 

vaccinated adults who were at increased risk of exposure, probably felt that the desirable effects 

of a booster were large compared to the undesirable effects. However, this was split with a 

significant portion of the WG also saying that they did not know based on the limited data 

available. The WG thought there probably was not important uncertainty or variability in terms of 

target population values. 

When considering acceptability, feasibility, and resources for IPV boosters, the WG noted that 

the current recommendation that adults who have had a primary series of OPV or IPV and who 

are at increased risk of exposure to poliovirus can receive another dose of IPV, that this 

recommendation is long-standing, and it is generally considered accepted and feasible. 

However, if the at increased risk of exposure group were to be expanded, for instance to include 

previously vaccinated adults in certain US areas with poliovirus circulation, feasibility might be 

affected in the future. Again, the experience of New York State and New York City in 2022 is 

helpful in that even in the context of a polio case and media attention, IPV supply was not a 

significant issue. 

The WG agreed that providing a booster IPV dose to adults at increased risk of exposure 

“probably” is or “is” acceptable to key stakeholders, “probably” is a reasonable and efficient 

allocation of resources, and “probably” or “is” feasible to implement. 

To address the Equity EtR domain, there are no known differences in response to a primary 

series or need for a booster by socioeconomic group in the US setting. No groups or settings 

are known to be disadvantaged by the current recommendation. However, the WG thought that 

there is a potential for increased equity by boosting immunity in persons at increased risk of 

exposure, especially persons with potential occupational exposures to poliovirus. On that basis, 

the WG thought that boosters for those at increased risk of exposure “probably” would result in 

increased equity. 

For the overall WG judgment, taking into account all of the EtR domains, the WG thought the 

desirable consequences of an IPV booster probably outweigh the undesirable consequences in 

most settings for previously vaccinated adults who are at increased risk of poliovirus exposure. 

The majority of the WG agreed with the current ACIP recommendation for adult boosters and 

recommended a vote to reaffirm this language. This recommendation is risk-based and based 

on shared clinical decision-making, and the proposed language includes some slight evidence 

to modernize the language compared to the 2000 statement. 

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Proposed Language for Policy Question #1 

Adults who have received a primary series of tIPV or OPV in any combination and who are at 

increased risk of poliovirus exposure may receive another dose of IPV. Available data do not 

indicate the need for more than a single lifetime booster dose with IPV for adults. 

Clinical Considerations 

Situations that put adults at increased risk of poliovirus exposure include: 

 Travelers who are going to countries where polio is epidemic or endemic (For additional 

information, see Polio: For Travelers). 

 Laboratory and healthcare workers who handle specimens that might contain 

polioviruses. 

 Healthcare workers or other caregivers who have close contact with a person who could 

be infected with poliovirus. 

Vote #1: Polio Vaccination Unvaccinated and Incompletely Vaccinated Adults 

Sarah Kidd, MD, MPH (CDC/NCIRD) displayed and read the proposed vote language following 

the public comment period. The vote was combined with the Polio Vaccine session for ease of 

reading: 

Adults (aged ≥18 years) who are known or suspected to be unvaccinated or

incompletely vaccinated against polio should complete a primary vaccination series with 

IPV. 

Important Context to Be Included in Clinical Considerations: 

In general, unless there are specific reasons to believe they were not vaccinated, most adults who were born and raised 

in the United States can assume they were vaccinated against polio as children. Polio vaccination has been part of the 

routine childhood immunization schedule for decades and is still part of the routine childhood immunization schedule. 

Adults who received any childhood vaccines almost certainly were vaccinated for polio. 

Motion/Vote #1: Adult Polio Vaccination 

Dr. Poeling made a motion to approve the recommendation as stated, which Dr. Talbot 

seconded. No COIs were declared. The motion carried with 14 affirmative votes, 0 negative 

votes, and 0 abstentions. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

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Vote #2: Polio Vaccination Unvaccinated and Incompletely Vaccinated Adults 

Sarah Kidd, MD, MPH (CDC/NCIRD) displayed and read the proposed vote language following 

the public comment period. The vote was combined with the Polio Vaccine session for ease of 

reading: 

Adults who have received a primary series of tIPV or OPV in any combination and who 

are at increased risk of poliovirus exposure may receive another dose of IPV. Available 

data do not indicate the need for more than a single lifetime booster dose with IPV for 

adults. 

Motion/Vote #2: Adult Polio Vaccination 

Dr. Poeling made a motion to approve the recommendation as stated, which Dr. Cineas 

seconded. No COIs were declared. The motion carried with 14 affirmative votes, 0 negative 

votes, and 0 abstentions. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

INFLUENZA VACCINE 

Introduction 

H. Keipp Talbot, MD, MPH (ACIP, WG Chair) reported that recent WG activities have included 

preparation of the proposed 2023-2024 Influenza Statement and discussion of the safety of 

influenza vaccination of persons with egg allergy. She indicated that this session would include 

presentations focused on influenza vaccination of persons with egg allergy, including: 1) 

Background, WG Considerations, and an EtR Framework Discussion; and 2) Proposed 

recommendations for the 2023-24 influenza season. 

WG Considerations and Proposed Recommendations 

Lisa Grohskopf MD, MPH (CDC/NCIRD) presented the EtR discussion and WG considerations 

for influenza vaccination of persons with egg allergy, particularly those with a history of severe 

allergic reaction to egg. Beginning with some background, egg allergy is a relatively common 

food allergy affecting approximately 1% to 3% of children by 3 years of age.17 It resolves for 

many during later childhood and adolescence. In one study, 68% have developed a tolerance 

by 16 years of age.

18 Reactions range from mild to life-threatening. Diagnosis is generally done 

by a clear history of immediate allergic reactions to egg or egg-containing foods, as well as skin 

prick testing (SPT) or estimation of egg-specific IgE levels.19 Of the 9 influenza vaccines that 

are currently available in the US, 7 are produced through the propagation of viruses in 

17 Eggesbo M et al. Allergy 2001;56(5):403-411; and Erlewyn-Lajeunesse M et al. BMJ 2009;339:b3680 18 Savage JH et al. J Allergy Clin Immunol 2007;120(6):1413-7 19 Eggesbo M et al. Allergy 2001;56(5):403-411 

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embryonated eggs. These vaccines can and generally do contain residual amounts of egg 

proteins (e.g., ovalbumin). For 5 of the 7 egg-based vaccines, the egg ovalbumin content is 

listed in the package insert and is generally low, under about 1 mcg/dose. For 2 of the 7 eggbased vaccines, ovalbumin is not listed. There are 2 egg-free vaccines, Flucelvax Quadrivalent, 

which is a cell culture-based inactivated vaccine (ccIIV4), and Flublok Quadrivalent. While these 

2 vaccines are considered egg-free, only Flucelvax Quadrivalent is approved for children <18 

years of age. 

ACIP currently recommends,

20 and has for a number of years, that all persons with egg allergies 

should receive influenza vaccine and that it is not necessary to receive an egg-free vaccine. Any 

influenza vaccine that is otherwise appropriate for the person’s age and health status can be 

used (i.e., any IIV4, RIV4, or LAIV4). For those who have a history of severe allergic reaction to 

egg, and for the purposes of the ACIP guidance, this is defined as follows: 

“If a vaccine other than ccIIV4 or RIV4 is used, the selected vaccine should be 

administered in an inpatient or outpatient medical setting, including but not necessarily 

limited to hospitals, clinics, health departments, and physician offices. Vaccine 

administration should be supervised by a health care provider who is able to recognize 

and manage severe allergic reactions.” 

No specific post-vaccination observation period is recommended. The primary focus of this 

session concerned the language pertaining to severe allergic reaction in terms of whether this 

additional recommendation no longer needs to be made for people with severe egg allergy. 

Some of the reasoning behind this has to do with guidance from other professional 

organizations. The recommendations of the Joint Task Force (JTF) of the American Academy of 

Asthma, Allergy & Immunology and the American College of Asthma, Allergy & Immunology 

(Joint Task Force AAAAI/ACAAI) differ from the ACIP and American Academy of Pediatrics 

(AAP) recommendations. Since the 2016-2017 season, AAP has recommended no additional 

measures for persons with egg allergy.21 The AAP 2022-2023 Influenza Prevention and Control 

Guidance states that “Children with egg allergy can receive any influenza vaccine without any 

additional precautions beyond those recommended for all vaccines.”22 The Technical Report 

that accompanies the recommendations indicates that measures such as the use of specific 

vaccines, observation periods, or restricting vaccination to specific medical settings and 

screening for egg allergy are not warranted and constitute a barrier to vaccination.

23 The 

AAAAI/ACAAI similarly state that, “No special precautions beyond those recommended for the 

administration of any vaccine to any patient are necessary for administration of influenza 

vaccine to egg-allergic individuals.”24 

Severe allergic reactions to vaccines overall are uncommon and anaphylaxis is rare, but given 

their potential seriousness, preparation for such reactions is recommended when administering 

any vaccine to any recipient. The General Best Practices Guidelines for Immunization in the 

chapter entitled “Managing Adverse Reactions” notes that allergic reactions are uncommon, and 

anaphylaxis following vaccines is rare, but also notes that vaccination settings should be 

prepared for potential serious reactions, noting that epinephrine and equipment for managing 

20 CDC/ACIP. MMWR Recomm Rep 2022;71(No. RR-1):1–28 21 Recommendations for Prevention and Control of Influenza in Children, 2016–2017 | Pediatrics | American Academy of Pediatrics 

(aap.org) 22 Recommendations for Prevention and Control of Influenza in Children, 2022–2023 | Pediatrics | American Academy of Pediatrics 

(aap.org) 23 AAP. Technical Report for the 2022-23 Recommendations for the Prevention and Control of Influenza in Children, 2022-23 24 Greenhawt M et al. Ann Allergy Asthma Immunol 2018;120:49-52 

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airways should be available for immediate use.25 As a last piece of background, there are 

several past approaches to influenza vaccination of persons with egg allergy that are not 

currently recommended, including the following: 

 Vaccine skin testing prior to vaccination:26 

− Skin prick and/or intradermal testing with dilution of vaccine 

− If positive, vaccination deferred or administered via alternative dosing protocol 

 Graded administration of vaccine:27 

− Incrementally increasing volumes, often in 5 to 6 steps, sometimes with dilutions 

in early steps 

− 0.05 mL of 1:100 dilution→0.05 mL of 1:10 dilution→0.05 mL→0.1 mL→ 0.15 

mL→0.2 mL, with observation periods after each dose (e.g., 15 minutes)

− In the literature, these also are referred to “desensitization protocols” 

 Split dosing of vaccine:28 

− Most commonly 10% of dose volume→observation period→remaining 90% of

dose volume, often with additional observation after final dose. 

The policy question the WG addressed for this analysis regarded whether to no longer 

recommend additional safety measures for persons with egg allergy of any severity, beyond 

what is recommended for any other persons presenting for influenza vaccination. In the 

discussion that follows, the proposed intervention was to no longer make the recommendation 

regarding vaccination setting for those with a history of severe allergic reaction to egg. With that 

background in mind, Dr. Grohskopf summarized the WG’s discussion of the EtR Framework. 

Beginning with the Public Health Importance domain regarding whether vaccination of eggallergic persons is an issue of public health importance, influenza vaccination is important and 

recommended for all persons 6 months and older. Come individuals are at increased risk of 

severe illness due to influenza and some egg-allergic individuals might fall into this category. 

For example, egg allergy is more common in younger age groups, sometimes resolves as 

children get older, and frequently co-exists with asthma. In one cross-sectional survey of 38,408 

children,

29 asthma prevalence was higher among children with egg allergy (46.5%) than with the 

other 8 most common food allergies (33.2%). Younger children and people with asthma are 

groups that are recognized as being at increased risk for severe influenza illness and are 

populations for which barriers to vaccination might be more consequential. 

In the WG discussion, a number of points were raised related primarily to potential increased 

risks for some people with egg allergy in terms of how consequential the potential barriers may 

be or if they even exist. On the one hand, current recommendations might be a real or 

perceived barrier to vaccination (e.g., by promoting hesitancy based on safety concerns, or 

providing a reason to decline vaccination). This could be detrimental to egg allergy persons who 

are at increased risk of severe influenza. No data specifically examining or confirming that the 

current recommendations as they stand are an actual barrier, but the existence of a real or 

perceived barrier is plausible. Conversely, some WG members raised the point that current 

recommendations might be less of a barrier now than they were previously since the cell 

25 Kroger AT et al. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html 26 Bierman CW et al. J Infect Dis 1977;136:S652-S655; and Miller JR et al. J Allergy Clin Immunol 1983;71:568-173 27 Murphy KR et al. J Pediatr 1985;106(6):931-933 28 James JM et al. J Pediatr 1998;133:624-628 29 Samady W, Warren C, Wang J, et al. Egg allergy in US children. J Allergy Clin Immunol Pract. 2020;8(9):3066-73 

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culture-based egg-free vaccine, Flucelvax Quadrivalent, is currently approved for individuals ≥6

months of age. Until relatively recently, it was only for 4 years and older. Now it goes to the 

youngest age group that probably has the highest prevalence of egg allergy. However, it is 

important to consider that there is only 2 vaccine that is egg-free that is licensed for children <18 

years of age compared with 4 other vaccines that are egg-based. In polling on this question, 

95% of the WG responded either “yes” or “probably yes” vaccination of egg-allergic individuals 

is an issue of public health importance, with only 6% of the total responding “probably no.” 

For the second domain of Benefits and Harms, a systematic literature view was conducted, and 

a GRADE analysis was performed. There was somewhat of a disconnect because it seemed 

unlikely that data would be found directly addressing the question of whether having the 

additional recommendation was consequential. Therefore, the review focused on the safety of 

influenza vaccine in this population, addressing the question, “Does the available evidence 

concerning the safety of influenza vaccine in persons with a history of egg allergy favor routine 

vaccination without additional safety measures, regardless of severity of previous allergic 

reaction to egg?” Because all egg allergy individuals are currently recommended to get 

influenza vaccine and they were are not looking at the question of whether to vaccinate or 

whether to choose specific vaccines, this review focused solely on harms and did not include 

review of efficacy or effectiveness data. 

In terms of the PICO question, the population was persons of any age with a history of allergy to 

eggs, or who had an allergic reaction to influenza vaccine believed to be secondary to egg 

allergy. The interventions included any influenza vaccine. The comparators of interest included 

placebo, non-egg-based influenza vaccine, non-influenza control vaccines, no vaccine, or no 

comparator. Within 4 hours of vaccination, the critical outcomes of death, anaphylaxis meeting 

Brighton Criteria Levels 1─3, anaphylaxis otherwise classified, and allergic symptoms requiring 

hospitalization. The 2 anaphylaxis outcomes were combined. Important outcomes included 

allergic reaction symptoms requiring outpatient or emergency department (ED) medical 

attention. This category included instances that were described as being treated with 

medications, without explicit mention of whether there was outpatient or ED care. The second 

important outcome was allergic reaction including cardiovascular symptoms, respiratory 

symptoms, angioedema, or generalized urticaria. The basis for inclusion of this set of reactions 

was that they fall short of anaphylaxis, but nonetheless might be considered worrisome. 

The systematic review yielded a total of 47 reports describing 52 studies. There was only 1 

randomized study, which was a comparison of full-dose with the 10%/90% split dosing of 

vaccine. There was 1 VAERS report summary. The remainder were retrospective and 

prospective cohort studies and case series and 2 involved only recombinant vaccine, which is 

egg-free. Of interest none of the studies included a relevant comparison group (e.g., an 

alternative intervention such as no intervention or a different vaccine, an egg-free vaccine, or no 

vaccine). In general, these studies administered vaccine to a population of individuals with egg 

allergy and then followed them for reactions. Of the reports, 14 were abstracts only, with no 

related paper found and relatively limited information. All of the papers, reports, and studies 

were reviewed descriptively. However, 28 reports encompassing 31 studies were included in the 

GRADE analysis. The studies included in GRADE were of egg-based seasonal and monovalent 

pandemic vaccines only and included full- or split-dose administration. Those 2 administration 

methods were combined in the data because after consultation with an allergist, it was 

determined that these 2 administration routes were similar from the point of view of risk of an 

adverse reaction. For the randomized study that compared full- versus split-dose, those 2 

experimental groups were combined, and this study was treated as a cohort study. Data with 

unknown or unclear vaccine type, unspecified administration protocols, that used a graded 

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protocol of ≥3 steps to administer vaccine, or which had an unknown or unclear denominator 

were excluded. Since there were no comparators, the data were summarized as frequencies. 

This table summarize frequency of the events that occurred by vaccine type for persons with 

egg allergies of all severities, with the results stratified these results by Seasonal IIVs*, 

Monovalent IIVs*, and live-attenuated influenza vaccine (LAIV): 

*Includes several papers for which vaccine type not explicitly stated, but presumed based upon season, study location, and/or use of graded/split 

dosing. Seasonal IIV data include one paper describing a virosomal vaccine. 

†One study reported 6 instances of reactions including “wheezing, eczema exacerbation, or hives on chest”, but not specifying number with each 

symptom. If assumed that all six included wheezing, frequency would be 11/1591=0.7% 

All of the LAIV work was with seasonal vaccine. The seasonal IIV group included one virosomal 

vaccine, which was not available in the US. It was a study from Europe. GRADE and evidence 

certainty for every vaccine and outcome were assessed separately. However, the results were 

all the same. Therefore, only one column was included for space considerations. Certainty 

levels were very low across the board. With regard to the event frequencies, the included 

papers reported no occurrences of the three critical outcomes death, anaphylaxis, or 

hospitalization across vaccine type. For reactions requiring outpatient or ED attention, 

frequencies were 0.2% for seasonal IIV, 1.5% for monovalent IIV, and 0% for LAIV. 

Instances that involved treatment with symptomatic medications were included, which was the 

majority of these. There were only 2 that referred explicitly to transfer to an ED. For reactions 

including cardiovascular symptoms, respiratory symptoms, angioedema, or generalized 

urticaria, the frequencies were 0.3% for seasonal IIV, 0.6% for monovalent IIV, and 0.8% for 

LAIV. Again, certainty across the board was very low. These studies generally were all 

observational studies, so they started with a certainty of low, so downgrading even for one 

characteristic would bring the certainty to very low. This work overall was downgraded mainly 

for methodological quality and for imprecision. Because these data reflected data for people 

with egg allergy of all severities and not just those who had a history of anaphylaxis to egg, it 

also was downgraded for indirectness. 

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This table summarize frequency of the events that occurred by vaccine type for a subset of 

persons with anaphylaxis to eggs, with the results stratified these results by Seasonal IIVs*, 

Monovalent IIVs*, and live-attenuated influenza vaccine (LAIV): 

*Includes several papers for which vaccine type not explicitly stated, but presumed to be IIV based upon season, study location, and/or use of 

graded/split dosing. 

This subset of individuals in these studies were found to have reported a history of anaphylaxis 

to egg. Since the policy question focuses on people who have a history of severe egg allergy, 

this group was important to the WG and they were hoping to find as much as possible and the 

data were stratified where possible. Overall, the numbers are lower. Some studies did not 

include people with severe egg allergy, did not mention whether people with severe egg allergy 

were included, did not state the numbers of these people in the study, or did not report the 

findings specifically for that subgroup. They might have reported reactions, but then did not go 

on to say whether they occurred or how many of them occurred in people with anaphylaxis to 

egg. There were no events for any of the outcomes of interest for any vaccine type in this 

subset. This is likely due, at least in part, to small sample sizes. Certainty for these outcomes 

was rated as very low for each vaccine type as well, with downgrading primarily for 

methodological quality and imprecision. 

To summarizes, the certainty of evidence for the 3 critical and 2 important outcomes of interest 

was very low for all 3 vaccine types. While studies without denominator data and those for 

which the vaccine was unclear were not included in the GRADE analysis, one particular report 

bears noting in this discussion. This was a report of Brighton Level 1 anaphylaxis that occurred 

in a person with “possible” egg allergy within 30 minutes of receiving monovalent vaccine. It was 

reported in a paper summarizing VAERS reports of AEs to monovalent pandemic vaccine 

during the 2009-2010 season.30 The information presented on the case in this paper is limited 

and it is unclear from the way it is described whether the recipient was documented to be egg 

allergic. It is referred to as a case of “possible” egg allergy. The reactions were included in the 

counts in the GRADE evidence profiles because there was not a defined denominator, given 

that these were VAERS data. While the paper states that approximately 127 million doses of 

influenza vaccine were distributed that season; however, the number of doses that were actually 

administered is unknown. Other reactions among egg-allergic persons reported in this paper 

included 2 described as respiratory hypersensitivity and 1 as a sensation of throat closure. 

30 Halsey NA, et al. Vaccine. 2013 Dec 9;31(51):6107-12. doi: 10.1016/j.vaccine.2013.09.066. Epub 2013 Oct 8. PMID: 24120547. 

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The papers related to egg-free vaccine discuss reactions following recombinant influenza 

vaccine were from Woo, et al 2015 and 2017. These are summaries of VAERS reports following 

administration of recombinant influenza vaccine. They include reports of serious allergic 

reactions following RIV, some of which occurred among persons with egg allergy. RIV is egg-, 

gelatin-, antibiotic-, and preservative-free. Because RIV is an egg-free vaccine, these reactions 

cannot be assumed to be a manifestation of egg allergy. However, this literature brings up a 

couple of points that probably are important. One that the authors note is that the occurrence of 

such reactions might reflect an underlying predisposition to atopy among egg-allergic 

individuals. Also, it highlights the importance of thinking about the unpredictability of severe 

allergic reactions and the importance of being prepared in all vaccination settings for all 

recipients and with all vaccines. 

There are a number of limitations to this review and the literature retrieved, which were 

discussed within the WG. These were observational data with no comparator groups meeting 

criteria. Not only are the data observational, but also most of the cohort studies essentially were 

case series because there was no comparator group. It is important to note that about 4 studies 

included a comparator group of non-egg-allergic people, but that was not the kind of comparator 

group that was going to provide the information needed. Some of the data were available only 

from abstracts, which had relatively limited details compared with the paper. Many of the 

papers, particularly the older papers, employed skin testing with egg proteins and/or vaccine 

prior to deciding to vaccinate or deciding how to vaccinate (e.g., full- versus split-dose). 

Therefore, it is possible that there could have been some kind of selection bias caused by that 

procedure. There is considerable variability in the level of detail in which outcomes are 

described, particularly in abstracts for which descriptions are scant. Even among the full papers 

there is variability in the level of detail. 

It is probably reasonable to assume that serious reactions, such as death or anaphylaxis, are 

more likely to be reported than less serious ones. Even among less serious ones, there was 

some variability. Most studies had a follow-up period for delayed reactions to be reported by 

parents or caregivers, perhaps 24 to 72 hours after discharge from the vaccination setting, but it 

is easy to see how some of these reactions might not be described as well and instances of 

outpatient care or hospitalizations might be missed. The observation time post-vaccination 

varied and often was not reported for the delayed reactions. While the WG was trying to be 

conservative with the 4-hour window after vaccination, observation times ranged between 30 

minutes and 2 hours across the board. Even authors who reported delayed vaccinations often 

did not report the elapsed time post-vaccination, which made the data difficult to use. Ovalbumin 

content was not reported or was unknown in most instances. Some authors did report it, relying 

on either the package insert or having the vaccine assayed themselves. In most instances 

where noted, it was under 1 microgram per dose and substantially less in some cases. In 

particular, the monovalent vaccine ArepanrixTM was used in some of the studies. ArepanrixTM has 

as unusually low ovalbumin content as did the virosomal vaccine, which was in one of the 

studies. It is difficult to know how this compares with current vaccines, since the package inserts 

for current vaccines express this information as an upper limit. A number of papers have shown 

that the quantity of ovalbumin can vary from lot-to-lot. Finally, and perhaps most important, data 

specifically for people with anaphylaxis to egg were very limited. Not all studies specified 

included them and some did not include them. Where they were included, the data were not 

always reported specifically for that population. 

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In terms of egg allergy and anaphylaxis reports after IIVs in VAERS between 2017─2022, 

colleagues in the Immunization Services Office (ISO) did a brief review of VAERS reports for 

egg allergy and anaphylaxis for the 2017─2022 period. In the review of VAERS reports, there 

were 178 anaphylaxis reports after IIVs, 18 of which were reported to have an egg allergy. 

Clinical review of these reports revealed 7 reports of anaphylaxis and egg allergy(4 among 

children, 3 among adults), all of which occurred in the 2017─2018 season. There were 4 

Brighton Level 1, 1 Brighton Level 3, and 2 that did not meet Brighton. Associated influenza 

included Fluarix Quad in 2 instances, Fluzone Quadrivalent in 2 instances, Fluvirin Trivalent in 1 

instance, Flucelvax Quadrivalent in 1 instance, and Flublok Quadrivalent in 1 instance. It is 

difficult to assess whether the reaction was due to egg protein in these instances due to limited 

laboratory data. 

With regard to the question of benefits and harms, because this review focused solely on safety 

literature, only 1 of the benefits and harms questions was addressed. For the question of how 

substantial the undesirable anticipated effects are, 83% of respondents (N=18) selected either 

“small” at 44%, or “minimal” at 39%. There was 1 vote (6%) for “moderate” and 11% selected 

“varies.” 

Moving to the Values domain and the question regarding whether the target population feels 

that the desirable effects are large relative to the undesirable effects, no direct evidence was 

found to support any conclusions. It was raised that a change in the recommendations might be 

reassuring to some who have wanted to be vaccinated but were hesitant or perceived it to be 

unsafe. It also was raised that it might be a source of concern for some people, with 1 WG 

member expressing that the change might be viewed unfavorably if it was perceived as a 

tradeoff between safety versus increasing coverage and reducing missed opportunities to 

vaccinate. For this question, there was not a majority opinion for any single answer, but half of 

respondents responded indicated “Don't Know” probably reflecting lack of information to inform 

this particular question. There was considerable dispersion among the other options, although 

none selected “No.” Regarding whether there is important uncertainty about or variability in how 

much people value the main outcomes, no direct evidence was found to support conclusions 

here. Presumably, greater value might be attached to the more serious outcomes, such as 

death, anaphylaxis, and hospitalization, which were the critical outcomes. But again, no data 

were found to support this. For the values question whether there is important uncertainty about, 

or variability in, how much people value the main outcomes, there was a clearer majority of 

responses, with 67% indicating that they felt that there was “probably not important uncertainty 

or variability” in how people value the main outcomes. However, 28% selected that there is 

“probably important uncertainty or variability.” 

Regarding the Acceptability domain, no direct evidence was found from stakeholders. However, 

there was some information that speaks indirectly to the possibility of acceptability. Some 

information speaking for acceptability includes the fact that several US professional societies 

(AAP, AAAAI, ACAAI) already recommend that no special measures, screening, observation 

periods, selection of specific vaccines, or specific vaccination settings are needed for those with 

egg allergy. A potential factor against acceptability is that as of 2022─2023, packaged inserts 

for egg-based vaccines continue to carry a contraindication for severe hypersensitivity reactions 

to any vaccine components which for egg includes egg-based vaccines. This could cause 

confusion among providers and consumers. However, this is a contraindication that has been in 

place for quite some time and ACIP has recommended influenza vaccination for a number of 

seasons with any appropriate vaccine, including egg-based vaccines for people with egg allergy 

regardless of severity to reaction to egg. Therefore, there is probably not an a priori reason to 

assume that a change in recommendations would affect acceptability substantially. In further 

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discussion with the WG, considerations regarding acceptability included the idea that alignment 

of recommendations among public health organizations and professional societies facilitates 

consistent messaging to providers and patients. However, some expressed the concern that 

some settings might not be prepared to manage severe reactions, even though the guidelines 

state that preparation should be in place, and further that acceptability could be severely 

negatively impacted if the anaphylaxis occurs in a setting unprepared to manage it—particularly 

if there is a bad outcome. The same WG member raised the importance of stressing that every 

setting must be prepared to manage anaphylaxis or should not be administering any vaccine to 

any recipient. Finally, there was concern for potential liability issues. With regard to whether a 

change in recommendations would be acceptable, 44% of 18 respondents indicated “Yes” while 

56% indicated “Probably Yes,” with no responses in the negative. 

For the Resource Use domain, following consultation with the NCIRD Health Economist, no 

economic analysis was conducted for this review. One reason was that the target population is 

small. There also is lack of data for some factors that would be important in constructing the 

needed assumptions for an economic model. For example, there is not a reliable estimate on 

the proportion of those with egg allergy who have had severe reactions to egg. The proportion 

of individuals with egg allergy by age, particularly in older age groups, is uncertain. Importantly, 

there is little information on the proportion of persons with egg allergy who are receiving eggbased versus egg-free vaccines. Finally, the primary emphasis of this review was on safety 

rather than cost. While the intervention discussed here is not really one that has to do with the 

vaccines per se and the WG did not discuss whether to recommend some vaccines over others, 

the point was raised that a change in recommendations with regard to setting could lead to 

influenza vaccination of egg-allergic persons being achieved in a more widespread manner in 

more settings, and that could lead to a change in the balance of use of egg-free versus eggbased vaccines in this population. With that in mind, the WG examined cost data. While average 

wholesale cost data were not available, some information was obtained from CMS payment 

allowances and the VFC. This table reflects these data, rounded to the nearest dollar:

31 

Overall, CMS payment allowances and VFC costs are higher for the egg-free vaccines that are 

approved for children. In particular for both the multi-dose and preservative the single-dose 

formulations of Flucelvax Quadrivalent, the egg-free subculture based vaccine costs are about 9 

to 11 dollars higher than the average corresponding presentation for the egg-based inactivated 

vaccines. 

31 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-drugs/McrPartBDrugAvgSalesPrice/VaccinesPricing; and CDC 

Vaccine Price List (Private sector cost per dose) 

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The WG considerations around the issue of resource use included that removing existing 

restrictions possibly could result in a more efficient allocation of resources if the data suggests 

no or minimal increase in AEs. Conversely, a change in recommendations and lower cost of 

egg-based vaccines might lead to their increased use, which might be associated with 

increased cost if there is increase in reactions that require medical attention. With regard to 

whether the intervention is a reasonable and efficient allocation of resources, of 18 respondents, 

1 was excluded who selected 2 options. Of the 17 remaining, 76% responded “Yes” and 24% 

responded “Probably Yes.” 

Regarding the Equity domain, no direct evidence was identified that would affect conclusions in 

this particular population of egg-allergic individuals. However, some indirect evidence 

concerning the risk of some populations to severe influenza illness and the prevalence of egg 

allergy are raised here as potential indirect lines of evidence. For example, some racial and 

ethnic groups are at increased risk of severe influenza illness, highlighting the importance of 

influenza vaccination. One paper recently reported that influenza-associated hospitalization and 

ICU admission rates were higher among Black, Hispanic, and AI/AN children under 4 years of 

age compared with white children.32 Additionally, some studies indicate that some groups are 

more likely to have food allergies. For example, Black children were disproportionately 

represented among children with egg allergy in one series.

33 If current recommendations are a 

real or perceived barrier to vaccination, the intervention potentially could improve equity with 

regard to risk of severe influenza illness in this population. 

Issues related to trust in the healthcare system were raised by a couple of WG members as 

potentially negative impacts. Again, this is not about recommending egg-based versus non-eggbased vaccines. Instead, this point brings together the issues of cost, equity, and trust. The 

proposed recommendation focuses on language related to vaccination setting. People with eggallergy are currently recommended to receive any vaccine that is otherwise appropriate, even if 

it is egg-based. However, a change in recommendations might mean that the vaccination 

occurs more widely in more settings than previously. Perhaps with increased use of egg-based 

influenza vaccines rather than egg-free vaccines in some settings could be influenced by their 

relative cost. The fact that egg-based vaccines are less expensive might reinforce the belief that 

vaccination providers do not care to use the necessary resources to provide a potentially safer 

vaccine. With regard to impact on health equity, the WG responses were dispersed. This 

possibly reflects uncertainty given the lack of specific data. However, 50% of the 18 

respondents expressed that equity would be “Probably Increased.” 

For the last domain of Feasibility, a number of considerations were raised. Considerations 

favoring feasibility are that the proposed change is a simplification of the previous 

recommendation. It involves removal of an extra recommendation for 1 subgroup, and it makes 

the recommendations for vaccination of egg-allergy persons uniform regardless of severity and 

basically similar to the recommendations for vaccination of any person against influenza. It also 

does not specify particular vaccines and does not change recommendations for emergency 

equipment and resources in vaccination settings. As noted, the General Best Practices already 

indicate that equipment and medicines to manage potential severe allergic reactions should be 

available in all vaccination settings.34 A consideration against feasibility is that there might be 

some vaccination settings that are not already prepared to manage severe allergic reactions, 

and such settings would need to address these needs. Again, all settings already are 

recommended to be prepared for severe allergic reactions when administering any vaccine to 

32 O’Halloran et al JAMA Netw Open. 2021 Aug 2;4(8):e2121880 33 Samady W et al. J Allergy Clin Immunol Pract. 2020 Oct;8(9):3066-3073.e6. doi: 10.1016/j.jaip.2020.04.058 34 Kroger AT et al. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html 

26 
 

 

 

 

 

 

 

 

 

 

 

any recipient. With regard to whether the intervention is feasible, 89% of the 18 respondents 

answered “Yes” and 11% answered “Probably Yes.” 

In terms of the balance of consequences and sufficiency of information, 61% of the 18 

respondents indicated that the “Desirable consequences clearly outweigh undesirable 

consequences in most settings” and 39% responded that the “Desirable consequences probably 

outweigh undesirable consequences in most settings.” With regard to whether there is sufficient 

information to move forward with a vaccination, 100% of the 18 respondents answered “Yes” 

and 0% responded “No.” 

Influenza Vaccine Safety Update and Proposed Recommendations for the 2023-2024 

Influenza Season 

Lisa Grohskopf MD, MPH (CDC/NCIRD) presented a brief influenza vaccine safety update and 

the proposed recommendations for the votes. Approximately 173 million doses of influenza 

vaccines were distributed in the US for the 2022-2023 season.35 In VAERS, which is comanaged by CDC and FDA, no new safety concerns were identified for influenza vaccines. In 

the VSD, which is a collaboration between CDC and 9 integrated healthcare organizations 

within the VSD, approximately 5.5 million doses of influenza vaccine were distributed for the 

season. No new safety concerns were identified in influenza vaccine monitoring.36 However, a 

statistical signal for ischemic stroke after Pfizer-BioNTech Bivalent mRNA COVID-19 vaccine in 

persons ≥65 years of age that was detected in a VSD analysis for COVID-19 vaccine safety 

monitoring.

37 Post-signal analyses in VSD found an elevated rate ratio for ischemic stroke after 

simultaneous vaccination with Pfizer-BioNTech Bivalent mRNA COVID-19 vaccine and highdose or adjuvanted influenza vaccine, which has attenuated over time. Separate analyses did 

not detect elevated rate ratios for ischemic stroke after influenza vaccine administered without 

bivalent mRNA COVID-19 vaccine. 

To provide an overview of the proposed recommendations for 2023-2024, vaccination of all 

persons ≥6 months of age who do not have contraindications continues to be recommended. 

Additionally, no changes were proposed for the recommendations regarding timing of 

vaccination compared to the past season. Proposed changes include the updated US influenza 

vaccine composition for 2023-2024 and proposed changes to the recommendations for 

vaccination of persons with egg allergy. As noted, the timing of vaccination recommendations 

are unchanged from last season. Because this information is important for programs in terms of 

planning their influenza vaccine campaigns for the upcoming season, Dr. Grohskopf reviewed 

them briefly. The overarching recommendation is that for most persons who need only 1 dose of 

influenza vaccine for the season, vaccination ideally should be offered during September or 

October. The reason that is the case and not earlier is because of concerns about waning of 

immunity during the season. However, vaccination among vaccinated persons should continue 

after October and throughout the season as long as influenza viruses are circulating and 

unexpired vaccine is available. Vaccination during July and August are not recommended for 

most groups due to concerns for waning immunity. Considerations for July and August 

vaccination are noted for adults, children, and pregnant persons. 

35 Weekly Flu Vaccination Dashboard | FluVaxView | Seasonal Influenza (Flu) | CDC 36 Outcomes monitored in VSD: acute disseminated encephalomyelitis, anaphylaxis, Bell’s Palsy, encephalitis, Guillain-Barré 

syndrome, seizures, transverse myelitis 37 Shimabukuro T, ACIP presentation on April 19, 2023 mRNA COVID-19 bivalent booster vaccine safety update (cdc.gov) 

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For most adults, particularly adults ≥65 years of age, and for pregnant persons in the first or 

second trimester, vaccination during July and August should be avoided unless there is concern 

that vaccination later in the season might not be possible (e.g., concern that an opportunity to 

vaccinate at all might be missed). This is because, particularly for adults ≥65 years of age, there 

is a concern about waning immunity over the course of the season that has been documented in 

all age groups but appears to be the most pronounced among older adults. There are 2 

recommendations for children. Children who require 2 doses who are ≥6 months─8 years of 

age who have an unclear or unknown influenza vaccination history or who have not received a 

lifetime total of 2 doses should receive their first dose as soon as possible, including during July 

and August if vaccine is available, to allow for the second dose that is to be administered 4 

weeks later to be given ideally by the end of October. For children who require only 1 dose, 

vaccination during July and August can be considered. This is because waning has been 

documented in all age groups, although there are less data currently for children. Moreover, 

school-aged children commonly present to HCP in the late summer months for preschool 

physicals, which presents a vaccination opportunity that should be considered if that child is not 

expected to be seen again prior to the season. For pregnant people in the third trimester, 

vaccination during July and August can be considered because vaccination might reduce risk 

for influenza illness in their infants during the first months after birth when they are too young to 

receive influenza vaccine. This has been documented in a number of studies. 

In terms of the US influenza vaccine composition for 2023-2024, there is only 1 proposed 

change that comes from the FDA. FDA’s VRBPAC met in early March as usual to select the 

recommended composition for the next season.38 All vaccines available expected to be 

available in the US for the next season will be quadrivalent. The 2023-2024 composition 

includes updated influenza A(H1N1)pdm09 components for both egg-based and non-egg-based 

vaccines. Interestingly, this has caused some confusion and questions because the 

A(H1N1)pdm09 components last year also were an influenza A/Victoria and an influenza 

A/Wisconsin, but they were different with slightly different numbers in their taxonomy. The 

components for the H3N2 and both B viruses are the same as last season. All US-licensed 

influenza vaccines will include hemagglutinin derived from the following: 

 An influenza A/Victoria/4897/2022 (H1N1)pdm09-like virus (egg-based vaccines) 

An influenza A/Wisconsin/67/2022 (H1N1)pdm09-like virus (cell and recombinant vaccines) 

 An influenza A/Darwin/9/2021 (H3N2)-like virus (egg-based vaccines) 

An influenza A/Darwin/6/2021 (H3N2)-like virus (cell and recombinant vaccines) 

 An influenza B/Austria/1359417/2021-like virus (B/Victoria lineage) 

 An influenza B/Phuket/3073/2013-like virus (B/Yamagata lineage) 

38 https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisorycommittee-march-7-2023-meeting-announcement 

28 
 

 

 

 

 

 

 

The proposed recommendation language for vaccination of persons with egg allergy was 

drafted for the ACIP’s consideration and editing as appropriate: 

 All persons aged ≥6 months with egg allergy should receive influenza vaccine unless a

contraindication exists. Any influenza vaccine that is otherwise appropriate for the recipient’s

age and health status can be used (egg based or non-egg based).

 Egg allergy in and of itself necessitates no additional safety measures for influenza

vaccination beyond those recommended for any recipient of any vaccine, regardless of

severity of previous reaction to egg.

 Severe and life-threatening reactions to vaccines can rarely occur with any vaccine and in

any vaccine recipient, regardless of allergy history. Providers are reminded that all vaccines

should be administered in settings in which personnel and equipment needed for rapid

recognition and treatment of acute hypersensitivity reactions are available. All vaccination

providers should be familiar with their office emergency plan and be certified in

cardiopulmonary resuscitation.

VFC Resolution 

Jeanne Santoli, MD, MPH (CDC/NCIRD) indicated that the purpose of this resolution was to: 1) 

update the product table in the IIV component of the resolution; 2) revise the eligible groups 

section in the LAIV component of the resolution; and 3) add/update the links in the 

contraindications and precautions section of both components of the resolution. The eligible 

groups are all children 6 months─18 years of age. There are no changes to the vaccine 

schedule and recommended dosage intervals are as follows: 

 6 months through 8 years: 1 or 2 doses, as noted in the current ACIP recommendations

 9 through 18 years: 1 dose

 Minimum age: 6 months

 Minimum interval between dose 1 and dose 2 (where applicable): 4 weeks

This table lists the currently approved IIVs in the VFC program, including the age indication for 

each vaccine, with the only change being removal of a product that is no longer available in the 

US: 

29 
 

 

 

 

 

 

Recommended Dosage Refer to product package inserts available at: 

https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states 

For the contraindications and precautions, some guidance was removed about the use of 

vaccine in egg-allergic individuals that was thought to be potentially confusing. Instead, a link 

was added to the details about the contraindications and precautions. 

Contraindications: 

1. For egg-based IIV: History of severe allergic reaction (e.g., anaphylaxis) to any component 

of the vaccine (other than egg) or after previous dose of any influenza vaccine. 

2. For cell culture-based IIV: History of severe allergic reaction (e.g., anaphylaxis) to cell 

culture-based IIV or any component of the vaccine. 

Precautions: 

1. Moderate or severe acute illness with or without fever 

2. GBS within 6 weeks following a previous dose of influenza vaccine 

3. For cell culture-based IIV only: History of severe allergic reaction to any other influenza 

vaccine. 

Details of contraindications and precautions can be found at Prevention and Control of 

Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on 

Immunization Practices — United States, 2022–23 Influenza Season | MMWR (cdc.gov). 

For the LAIV section, the eligible groups were reworded to remove reference to potential 

precautions for vaccination and instead indicate that the eligible groups are non-pregnant 

children and adolescents aged 2 through 18 years. The recommended vaccination schedule 

and dosing intervals were unchanged: 

 2 years through 8 years: 1 or 2 doses, as noted in the current ACIP recommendations 

 9 through 18 years: 1 dose 

 Minimum Age: 2 years 

 Minimum interval between dose 1 and dose 2 (where applicable): 4 weeks 

The dosage and contraindications and precautions section was unchanged except for an update 

to the link in this section to match the latest published statement. The statement regarding 

updates based on published documents did not change from the following: 

[If an ACIP recommendation regarding influenza vaccination is published within 6 months 

following this resolution, the relevant language above (except in the eligible groups sections) 

will be replaced with the language in the recommendation and incorporated by reference to the 

URL]. 

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Vote #1: Influenza Vaccination Recommendation 

Dr. Lee (ACIP Chair) displayed and read the proposed vote language following the public 

comment period. The vote was combined with the Influenza Vaccine session for ease of 

reading: 

All persons ages ≥6 months with egg allergy should receive influenza vaccine. Any

influenza vaccine (egg based or non-egg based) that is otherwise appropriate for the 

recipient’s age and health status can be used. 

Motion/Vote #1: Influenza Vaccination Recommendation 

Dr. Poeling made a motion to approve the recommendation as stated, which Ms. Bahta 

seconded. No COIs were declared. The motion carried with 14 affirmative votes, 0 negative 

votes, and 0 abstentions. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

Vote #2: Influenza Vaccination MMWR Recommendations and Reports 

Dr. Lee (ACIP Chair) displayed and read the proposed vote language following the public 

comment period. The vote was combined with the Influenza Vaccine session for ease of 

reading: 

Affirm the updated MMWR Recommendation and Reports, “Prevention and Control of 

Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on 

Immunization Practices—United States, 2023-24 Season.” 

Motion/Vote #2: Influenza Vaccination MMWR Recommendations and Reports 

Dr. Poeling made a motion to approve the recommendation as stated, which Dr. Daley 

seconded. No COIs were declared. The motion carried with 14 affirmative votes, 0 negative 

votes, and 0 abstentions. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

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Vote #3: Influenza Vaccine VFC Resolution 

Dr. Lee (ACIP Chair) displayed and read the proposed vote language following the public 

comment period. The vote was combined with the Influenza Vaccine session for ease of 

reading: 

Approve the Vaccines for Children (VFC) resolution for influenza vaccines. 

Motion/Vote #3: Influenza Vaccine VFC Resolution 

Dr. Poeling made a motion to approve the recommendation as stated, which Dr. Daley 

seconded. No COIs were declared. The motion carried with 14 affirmative votes, 0 negative 

votes, and 0 abstentions. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

PUBLIC COMMENTS 

Overview 

The floor was opened for public comment on June 21, 2023 at 4:15 PM ET. Given that many 

more individuals registered to make oral public comments than could be accommodated during 

this meeting, selection was made randomly via a lottery. Dr. Lee provided a gentle reminder that 

the ACIP appreciates diverse viewpoints that are respectful in nature and issue-focused rather 

than comments directed at individuals. 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 Number ID CDC-2023-0035. Visit 

http://www.regulations.gov for access to the docket or to submit comments or read background 

documents and comments received. The public comment session occurred prior to the votes, 

but the votes were connected back with their respective sessions for ease of reading. 

Public Comment 

Lindsay Clarke, JD

Senior Vice President 

Health Education and Advocacy

Alliance for Aging Research 

Good afternoon and thank you to the committee for this opportunity to comment. My name is 

Lindsay Clarke. I am the Senior Vice President of Health Education and Advocacy at the 

Alliance for Aging Research. One of the educational campaigns that I lead at the Alliance is the 

“Our Best Shot” campaign. Over the years, this campaign has produced dozens of educational 

resources focused on raising awareness about the importance of vaccines in older adults, how 

32 
 

 

 

 

 

 

 

 

 

 

 

 

 

they work, which ones are recommended by this committee, how the Medicare program covers 

vaccines, and more. The resources have included a focus on influenza, pneumonia, shingles, 

and COVID. In this past year, we’ve produced educational films on RSV in older adults, 

emphasizing to viewers that RSV is not just a pediatric disease. While we know that older adults 

are especially vulnerable to serious complications from RSV, we also know that adults ages 60 

to 64 living with asthma, congestive heart failure, COPD are all at high risk for RSV related 

hospitalizations and deaths. Additionally, studies from the CDC and others presented at the 

ReSViNET conference in January demonstrate that a higher proportion of adults ages 60 to 64 

who were hospitalized and/or experienced severe outcomes due to RSV were Black, Hispanic, 

or American Indian/Alaskan Natives. These racial and ethnic defenses are critical to consider 

when determining age recommendations for the new RSV vaccines. Earlier and higher rates of 

asthma, congestive heart failure, or COPD in communities of color due to structural racism led 

to earlier RSV onset and higher risk of hospitalization, severe outcomes, including deaths, and 

must be considered as part of the age recommendations. Once the recommendations are 

determined, we urge publication in the MMWR without delay. While respiratory surges are no 

longer limited to the traditional cold and flu season, we know that the surges of influenza, 

COVID, pneumonia, RSV, and other respiratory illnesses continue to flood and overwhelm our 

healthcare system in the fall and winter months. Being able to start administering these 

vaccines for the fall season will undoubtedly save lives. Lastly, we urge the federal government 

to make sure that the safety of co-administering multiple vaccines like RSV, influenza, COVID, 

and pneumonia is clearly communicated. We know from our education and outreach that 

misinformation about the safety of receiving multiple vaccines at once persists and clear 

communication from the FDA, CDC, and other agencies is critical in the distribution of reliable 

and trustworthy information on vaccination and specifically on co-administration. We are excited 

about the new RSV vaccines, and while general awareness and prevention will remain a priority 

for the Alliance, we look forward to being able to encourage older adults and all adults at high 

risk to receive an RSV vaccine to protect themselves and their loved ones. Thank you again for 

this opportunity to comment. 

Erica DeWald 

Chief Communication Officer 

Vaccinate Your Family 

Thank you and good afternoon. I am the Chief Communication Officer at Vaccinate Your Family, 

an organization you will hear about from my colleague, Serese Marotta, in just one moment. 

Thank you for the opportunity to comment. I wanted to thank the ACIP voting members and 

liaisons for all of their hard work in recent years. While many in the general public first became 

aware of ACIP during the pandemic, our organization has held the ACIP in the highest regard 

for decades. Our policies specifically stipulate that Vaccinate Your Family follow the 

recommendations of this committee. This week’s meeting showcases the depth and the breadth 

of the work you do. ACIP serves a critical role in ensuring the safety and efficacy of our vaccine 

schedule in the US. As independent experts, your review of the available data presents an 

unbiased view of how best to protect people in this country. Science and the data it creates 

should always lead the way on vaccination recommendations. As you consider votes on 

pneumococcal and RSV vaccines as well as the reformulation of the COVID-19 vaccines, 

Vaccinate Your Family urges you to continue to consider the available data. Too often in recent 

years, politics have attempted to replace science. The ACIP has remained firm in their 

commitment to follow the data. We hope others will in turn continue to follow the ACIP and 

respect their independent review of the safety and effectiveness of new and existing vaccines. 

Thank you again for the opportunity to comment. 

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Serese Marotta 

Director of Advocacy and Education

Vaccinate Your Family 

Good afternoon. Hello, I’m Serese Marotta, Director of Advocacy and Education at Vaccinate 

Your Family. On behalf of Vaccinate Your Family, thank you for the opportunity to comment 

today. Established 30 years ago, Vaccinate Your Family works to protect people of all ages from 

vaccine-preventable diseases through advocacy, education, and policy. As evidenced by the 

COVID-19 pandemic, there is still much work to do to improve health equity and this is a priority 

for our organization. While we recognize that ACIP is discussing several important topics this 

week, my comments will focus primarily on respiratory syncytial virus, also known as RSV. Our 

organization is pleased that the committee will be considering recommendations for RSV 

vaccines for older adults, and we sincerely appreciate the robust discussions this morning. RSV 

infections in older adults result in 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths 

every year in the United States. Recent studies found that the economic burden of RSV 

infections on healthcare systems was substantial, with RSV hospitalizations resulting in a 

national direct cost burden of $1.5 to $4.0 billion dollars for adults greater than 60 years old. 

Given the public health and economic burdens of RSV on older adults in the US, it is imperative 

that we have preventive measures like vaccines available as early as possible to help protect 

older adults from this disease. RSV can also be serious for infants and young children. Every 

year in the US, 58,000 to 80,000 children younger than 5 years old are hospitalized with RSV, 

and an estimated 100 to 300 children younger than 5 lose their lives to it. RSV not only causes 

a significant public health burden for young children, but also it creates a serious economic 

burden for families. According to a recent national survey, more than 2/3 of parents said that 

RSV caused a financial burden or crisis to their family. RSV has disproportionate impacts on 

Black and Hispanic/Latino infants as well as those on Medicaid, which is why it is so important 

that we have equitable access to preventive measures, including tools like monoclonal 

antibodies and maternal vaccinations. The past ‘22─’23 seasons saw a resurgence of RSV, 

along with other respiratory diseases like flu and COVID, resulting in a triple-demic that puts 

serious strains on our healthcare systems. We urge ACIP to follow the science and, if possible, 

provide timely recommendations prior to the start of the next RSV season this Fall. This means 

the inclusion of passive immunizations in the VFC program and the timely publication of the 

MMWR. 

Martha Nolan, JD 

Senior Policy Advisor

HealthyWomen 

Good afternoon. My name is Martha Nolan. I am the Senior Policy Advisor for HealthyWomen, 

an advocacy organization committed to educating women so they can make informed health 

choices, advocate for themselves, and prioritize their health and wellness. For thousands of 

women across the country, we are a trusted source for credible, up-to-date information relevant 

to their mental and physical well-being and we believe a critical aspect of business preventive 

care. We understand the vital role that vaccines play in protecting against severe disease and 

are a strong proponent of ensuring that women and their families have the information they 

need to make informed decisions about their vaccine options. Last year’s unexpected influx of 

RSV cases, on top of the already active flu, COVID, and pneumonia season, presented a stark 

reminder of why continued innovation in vaccines is so necessary. At the time, many adults 

were learning about the risk of RSV for older Americans for the first time, and there were no 

vaccines available to protect themselves. We know that on average, as many as 160,000 adults 

65 and older are hospitalized for RSV, and up to 10,000 older adults die each year from the 

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virus. These numbers do not capture the many more Americans who may not require 

hospitalization but suffer at home from this illness. Given the considerable increase in 

respiratory threats facing the older population over these past few years, the need for preventive 

tools to defend against them cannot be overstated. It is also worth noting that the majority of 

care is provided by women, with 1 in 4 women reporting being caregivers and over a 1/3 of 

these women reporting that they are caring for a parent and a parent in-law, according to the 

CDC. Caregiving is a challenging and demanding responsibility and involves spending an 

extensive amount of time with those caring more and can put older Americans at greater risk of 

contracting a virus like RSV given the intergenerational aspect of a woman’s caregiving roles. 

That is why we are so encouraged to be here today speaking about not just 1 but 2 FDAapproved vaccines for this virus after decades of having no protection. This is truly an important 

step forward and we are eager to share this committee’s recommendations with our 

communities, so that all those who are eligible can benefit from this critical protection. 

HealthyWomen is grateful for this committee’s work to ensure that these new protections are 

made available to those most vulnerable to serious illness and death. We ask that you provide 

as clear and simple guidance as possible on who should consider receiving these vaccines 

because, as you know, that is not the final step before older Americans can access these 

vaccines. So, in order to ensure everyone who is eligible for the need of protection has broad 

and equitable access to the vaccine before the start of yet another respiratory season this Fall, 

we ask for the process for publishing this guidance to be done in a timely and straightforward 

manner to ensure potential timely coverage by CMS. HealthyWomen appreciates the 

opportunity to address this important issue and we look forward to communicating the CDC’s 

guidance to our communities so that everyone who is eligible for the vaccines understands the 

value they play in protecting their long-term well-being. Thank you. 

Michael Hoerger, PhD, MSCR

Clinical Health Psychologist

Health Scientist and Health Strategist

Runs a Health Science PhD Program 

Thank you all for your service during this difficult time. I’m Mike Hoerger. I run a Health Science 

PhD program in the Deep South. I’m a Clinical Health Psychologist, Health Scientist, and Health 

Strategist. I’m also in the sandwich generation with 3 young children at home and older relatives 

nearby. I have a few comments about COVID. We know from national wastewater data that 

SARS-CoV-2 transmission is lower now than during 75% of the pandemic, of course, higher 

than 25% of the pandemic. But during this time of lower transmission, it’s important for 

organizations and families to hopefully catch their breath and reflect on their COVID strategy. I 

appreciate how receptive you all were to oral comments last time. I have a few strategic 

suggestions about COVID vaccines. First, transparency. I think we need more transparency and 

balanced framing. We need to be clear on vaccine efficacy, while also acknowledging that 

benefits wane substantially after 2 to 4 months, not annually, and they do less to protect against 

long COVID than we might hope, with cumulative risk increasing upon each reinfection. My 

family is highly vaccinated, and we would get more today if possible, but we need to avoid 

overpromising on any particular tool. Second, agility. We need faster COVID vaccine updates 

based on emerging variants so we’re skating to where the puck is going, not to where it was 

months ago. We need to open up Novavax to all Americans 6 months and older, regardless of 

vaccine history or ability to pay. We desperately need next-generation vaccines that 

substantially reduce transmission. Third, we need a multi-layered strategy. SARS-CoV-2 viral 

and aerosol particles linger in the air like smoke, infect people when inhaled, and can cause 

severe damage to multiple organ systems. In addition to vaccines, we need to emphasize the 

use of high quality, well-fitting masks. Some of the best N95s are now only .09 cents each and 

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are readily available. We also need to emphasize the importance of air cleaning through 

ventilation and filtration, particularly given the forthcoming ASHRAE building standards. Babies 

under 6 months cannot mask or get COVID vaccines, so we need safe spaces in healthcare 

and at vaccination sites. A year ago, my twins were newborns and we had to navigate through a 

large health system to receive recommended medical care. We passed 70 clinicians who were 

unmasked. That’s extremely dangerous. We need masks in health and in dental care, 

particularly for patients who must be unmasked at times for care. Finally, we need to do more 

on outreach and education. Nationally, uptake of the bivalent booster has been lower than we 

would hope, and particularly so in my part of the country in the Deep South, often even among 

older adults. We needed to reach out to the community, retail pharmacy chains, and clinicians. 

Again, I appreciate you all working hard during the ongoing pandemic, particularly when you 

and your families may be dealing with illness, trauma, moral distress, bereavement, and other 

stressors. The work you are doing is very important. Thank you for your time. 

Ms. Sarah Berry

Independent Pro-Vaccine Advocate 

42believer 

Hello, CDC ACIP members. Thank you for your attention today. My name is Sarah Berry, also 

known as 42believer online. I am an independent pro-vaccine advocate who splits my time 

between gathering critical information on anti-vaxxers for numerous journalists and volunteering 

my time with pro-vaccine individuals and groups. One of them is Safe Communities Coalition, a 

nonprofit focused on educating legislators about vaccine policy issues, although there are many 

more that I like to talk to when possible. My purpose in giving a comment today is to talk about 

the stifling of innovation when anti-vaccine talking points embed themselves in the mainstream. 

We see this in low uptake for flu vaccines, which aside from the HPV vaccine, were the most 

commonly attacked vaccine prior to the pandemic. Some people, even those who I know 

personally, have hesitations about the necessity of the flu shot. So, how do we reach the 

average person about the flu vaccine? I have one talking point I use when speaking to friends 

who are genuinely hesitant about the flu vaccine, which is to bring up a sadly not unheard of but 

very serious consequence to flu infection, quadruple amputation. I recently, very recently, just 

yesterday, had a conversation with 2 friends about this and even shared pictures showing 

children as young as 5 needing this kind of intervention and they were absolutely shocked. Their 

faces said everything. I think we’ve gotten too used to seeing influenza trivialized, partially 

because of COVID, partially because of anti-vaxxers prior to COVID, but many people do suffer 

or die from flu every year. We can save some of them by being more upfront about the dangers 

of not vaccinating against flu. Prior to the pandemic, anti-vaxxers also used fear about the flu 

vaccine to push a bill in my home state that would have banned flu vaccine requirements in 

healthcare facilities. The thorough discussions around all future vaccines that have been 

discussed today are eventually going to be stifled by the overtaking of anti-vaccine viewpoints, 

both on a legislative level and a cultural one. As you all might have seen the fantastic Dr. Hotez, 

who researches new vaccines without relying on typical pharmaceutical funding that antivaxxers hate so much, has faced attempts at having his innovation stifled by simply calling out 

the influence of anti-vaccine talking points in our culture. This is my takeaway. We need to be 

more specific. We need to be specific about what happens when people don’t vaccinate. We 

need to show people examples and videos and feature these people, so they know that this is a 

real potential outcome, and we need more people like Dr. Hotez being specific about why antivaccine grifters should not be trusted. I’ve been following this topic since 2017. If you need help 

with that, please reach out at 42believer@gmail.com. Thank you for your time. 

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Kelly Moore, MD, MPH

Chief Executive Officer 

Good afternoon. I'm Dr. Kelly Moore, the CEO of Immunize.org and a former ACIP member. 

Immunize.org is a 32-year-old national nonprofit that supports implementation of ACIP 

recommendations and advocates for health policies that remove barriers to immunization. It’s 

great to be at the threshold of having immunizations recommended to mitigate the under-valued 

burden of RSV disease in older adults and soon, hopefully, in infants. After today’s vote, though, 

please continue public updates to the ACIP early and often on effectiveness and safety. We 

need evidence of the impact of these vaccines on the frail elderly in long-term care and 

elsewhere among the 80 plus population. In addition, as noted, the inflammatory neurologic 

disease cases observed are, for now, an uninterpretable signal—maybe something, maybe not. 

Either way, confidence in implementation will be helped by regular updates as you learn more. 

As an aside, it is notable to me that the debate between shared clinical decision-making and 

routine recommendation seems to weigh more than usual on Medicare logistics and less on the 

interpretation of efficacy and safety data, and also that today’s decision must be made without 

the final prices. That issue at least seems fixable. After today’s votes comes the need to 

address RSV in infants. We’ll have to work fast to make a difference for babies this fall, and I 

urge the committee and the CDC to make decisions concerning maternal vaccination and infant 

immunization as soon as feasible and to publish an MMWR without delay. Timing is going to be 

a crunch. In addition, we want affordable infant RSV protection to be within the reach of every 

family. To that end, if judged an effective use of resources by ACIP, we encourage you to vote 

to include the new long-acting monoclonal antibodies, or mAbs, in the VFC program so 

newborns are not denied access due to a family’s inability to pay. Thank you to those working to 

update our regulatory policy making payment processes to support the use of passive 

immunization for population health. Experts like Vanderbilt’s Jim Crowe tell me that long acting 

mAbs could be the quickest tool to make to protect the population from the next pandemic virus, 

beating vaccines by months. In light of that, now is a great time to standardize the process to 

evaluate, approve, and recommend passive immunizations with population-wide application and 

to establish the expectation that they, like active vaccinations, should be affordably accessible 

to all in the interest of public health. Thank you for all your hard work today. I miss you. 

THURSDAY: JUNE 22, 2023 

AGENCY UPDATES 

Centers for Disease Control and Prevention 

José R. Romero, MD noted that throughout this meeting, the ACIP would receive the most 

current and comprehensive information on many of CDC’s efforts, so he would keep his CDC 

updates brief and only share high-level updates on COVID-19, influenza, measles, and efforts to 

maintain childhood vaccination coverage. COVID-19 remains a key public health priority. 

COVID-19 hospitalizations and deaths continue to decline from the seasonal peak of January 

2023. These peaks were far lower than those seen during the 2 previous winters. CDC provides 

weekly updates on COVID-19 vaccine distribution and administration on the CDC COVID-19 

Tracker website. As of June 11, 2023, greater than 56 million individuals have received an 

updated bivalent COVID-19 vaccine dose. Since the recommendation of the Pfizer-BioNTech 

COVID-19 vaccine for children aged 5─11 years, greater than 9 million individuals aged 5─11 

years have completed the primary series. While most Americans continue to pay nothing out-ofpocket for COVID-19 vaccine due to their insurance coverage, 25 million uninsured American 

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adults are at risk of losing access to affordable vaccines for COVID-19 and treatments when 

these transition to the commercial marketplace. In April 2023, HHS announced the Bridge 

Access Program for COVID-19 vaccines and treatment. This public-private partnership provides 

under- and un-insured adults with access to COVID-19 vaccines and treatments at no cost from 

Fall 2023 to the end of 2024. Turning now to seasonal influenza, following a moderately severe 

influenza season that peaked earlier than usual in late fall and early winter, influenza 

vaccination provided substantial protection this season. CDC again partnered with the Ad 

Council and the American Medical Association (AMA) for their annual “Get My Flu Shot” 

Campaign. The campaign encouraged the American public, with an emphasis on Black and 

Hispanic audiences, to get vaccinated against the influenza for the season 2022-2023. Planning 

for a new campaign for the 2023-2024 season is underway. With regard to avian influenza, the 

currently circulating influenza A(H5) viruses remains low. However, CDC and others remain 

very vigilant for this. An A(H5) candidate vaccine was developed by CDC and made available to 

vaccine manufacturers in early 2022. CDC continues to work with international, national, state 

and local partners to detect H5, and to prevent transmission through enhanced surveillance and 

guidance for people who may be exposed to infected birds. CDC continues to analyze viral 

sequence data for genetic markers associated with greater disease severity, more efficient 

infectivity, transmissibility to humans, reduced susceptibility to antiviral drugs, and impact on 

candidate vaccines and diagnostics. With regard to measles, with declines in measles 

vaccination rates globally during the COVID-19 pandemic, measles outbreaks are occurring in 

all World Health Organization regions. The United States has seen an increase in measles 

cases from 49 in 2021 to 121 in 2022. All have occurred among children who are not fully 

vaccinated, including the outbreaks in Minnesota and Ohio. Jurisdictions at highest risk for 

measles continue to be those contained communities with persistently low vaccination coverage 

and importations from locations with measles outbreaks. In terms of CDC’s current efforts to 

maintain childhood vaccination coverage, the agency launched the “Let’s Rise Campaign” to 

address pandemic-related declines in routine immunizations and equip partners and health care 

providers with actionable strategies, resources, and data to support getting all Americans back 

on schedule with their routine immunizations. More information about “Let’s Rise” and access to 

routine immunization resources and data can be found on CDC’s website. 

Centers for Medicare and Medicaid Services 

Mary Beth Hance reported that a CMS continues to emphasize the importance of routine 

pediatric immunizations. One way they have done this is through the Connecting Kids to 

Coverage National Campaign, which provides materials that can be used or rebranded to 

outreach grantees and a variety of partners who include government agencies, community 

organizations, health care providers, schools, and others. There are many tools available 

related to vaccines on the Connecting Kids to Coverage National Campaign. In addition, a 

Back-to-School webinar was held on Tuesday of this week that emphasized, among other 

things, the importance of immunizations and of getting caught up on immunizations before 

school. Shifting to follow-up from the previous day’s adult RSV vaccines conversation, Ms. 

Hance confirmed from her colleagues on the Medicare side of CMS that if this vaccine is 

recommended, it will be included in Part D of the Medicare Program. 

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Food and Drug Administration 

David Kaslow, MD reported that since the February 2023 ACIP meeting, 2 RSV vaccines with 

proposed indications for use in adults 60 years of age and older were reviewed by Vaccines and 

Related Biological Products Advisory Committee (VRBPAC), which subsequently approved both 

in May 2023. In addition, VRBPAC also met to review an RSV vaccine with the proposed 

indication for the prevention of lower respiratory tract disease and severe lower respiratory tract 

disease caused by RSV in infants from birth through 6 months of age by active immunization of 

pregnant individuals. Also reviewed by ACIP the previous day were VRBPAC’s 

recommendations in March on the selection of strains to be included in the influenza virus 

vaccines for the 2023-2024 influenza season. In April, FDA amended the Emergency Use 

Authorizations (EUAs) of the 2 COVID-19 bivalent mRNA vaccines to simplify the vaccination 

schedule for most individuals and to authorize the current bivalent vaccine containing original 

and Omicron BA.4 and BA.5 strains for all doses administered to individuals 6 months of age 

and older. A week ago, VRBPAC met to discuss and make recommendations on the selection 

of strains to be included in the periodic updated COVID-19 vaccines for the 2023-2024 

vaccination campaign. The committee unanimously voted to update the vaccine composition to 

a monovalent COVID-19 vaccine with an Omicron XBB lineage and expressed a preference for 

the XBB.1.5 sublineage. On June 16, 2023, FDA advised manufacturers who will be updating 

their COVID-19 vaccines that they should develop a vaccine with a monovalent XBB.1.5 

composition for the 2023-2024 formula of COVID-19 vaccines in the US. In April 2023, FDA cohosted with Biomedical Advanced Research and Development Authority (BARDA) a workshop 

on recombinant protein-based COVID-19 vaccines to review and discuss overcoming 

challenges faced by recombinant protein vaccine platforms in timely strain updates and 

pandemic readiness. Highlighted in that workshop was the timely availability of additional 

updated COVID-19 vaccines beyond the current nucleic acid-based vaccines approved for use 

at the onset of periodic vaccination campaigns. A number of regulatory actions are anticipated 

in the coming months. As reflected in the current ACIP meeting agenda, the magnitude of the 

current submissions under review is unprecedented. On behalf of FDA’s Office 

of Vaccines Research and Review (OVRR) and Center for Biologics Evaluation and Research 

(CBER), Dr. Kaslow thanked the ACIP and the many ACIP WGs for their partnership in the work 

on this very large portfolio vaccine and vaccine candidates. 

Health Resources and Services Administration 

CDR Reed Grimes, MD, MPH reported that the National Vaccine Injury Compensation 

Program (VIPC) continues to process a high volume of claims in Fiscal Year 2023. As of June 

1, 2023, petitioners have filed 747 claims with the VICP and $119.6 million has been awarded, 

including awards to petitioners for their attorney fees and costs. In addition, the VICP is 

working on a backlog of 1,363 claims alleging vaccine injury. More data about the VICP can 

be obtained at www.hrsa.gov/vaccinetackcompensation/data/index.html. As of June 1, 2023, 

11,806 claims alleging injuries or death from COVID-19 countermeasures have been filed with 

the Countermeasures Injury Compensation Program (CICP), including 8,372 claims alleging 

injuries from COVID-19 vaccines. CICP has rendered decisions on 919 COVID-19 claims. Of 

the countermeasures claims, 25 have been determined medically eligible for compensation, 

20 claims are pending a review of the eligible expenses, 4 have been compensated, and 1 did 

not have eligible expenses for reimbursement. A total of 894 COVID-19 countermeasure 

claims have been denied compensation because of various reasons. More information about 

the CICP can be found at www.hrsa.gov/CICP. 

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Indian Health Service 

Matthew Clark, MD, FAAP, FACP reported that the IHS continues to prioritize access, 

quality, and equity in vaccine distribution and administration for American Indian and Alaska 

Native tribal communities served by the IHS system of care. Following expiration of the Public 

Health Emergency (PHE), the IHS has remained committed to its efforts to promote COVID19 vaccination in all age groups in every region. They are currently implementing a national 

vaccine strategy for the tribal communities served by IHS federal, tribal, and urban Indian 

organization programs. The E3 Vaccine Strategy is designed to promote access for every 

patient at every encounter to every recommended vaccine when appropriate. This includes all 

ACIP-recommended vaccines in all age groups. Working in collaboration with key 

stakeholders, especially its tribal and urban Indian organization partners, IHS is committed to 

improving general vaccination rates in tribal communities. The E3 Operational Plan includes a 

bottom-up approach to encourage innovation, incentivize effort, and recognize success 

drawing on the adaptability of the IHS’s comprehensive health care system to cross-pollinate 

federal, tribal, and urban Indian programs using best practices developed in Indian country for 

Indian country. Following rollout of the E3 Champions Pilot Program in Spring 2023, Dr. Clark 

said he was pleased to report that over 2 dozen federal, tribal, and urban Indian programs 

have applied for and received designation as an IHS E3 Champion Pilot site. IHS looks 

forward to continued collaboration with its tribal, urban, and federal partners to ensure access 

to safe and effective vaccines and to reduce morbidity and mortality from vaccine-preventable 

illness across the age spectrum for American Indian and Alaska Native people served by the 

IHS. 

National Institutes of Health 

John Beigel, MD reported that the NIH continues to support basic and clinical research to 

improve human health. A large part of what the NIH does is centered around new and better 

vaccines, for which he highlighted a few studies and other updates that may be of interest to 

ACIP. For COVID-19, although currently available vaccines are highly effective at preventing 

severe disease, infection and death, there is significant interest in mucosal vaccines that could 

potentially reduce transmission of the virus and/or asymptomatic disease. In November, the 

National Institute of Allergy and Infectious Diseases (NIAID) co-hosted a workshop on the 

science of developing mucosal vaccines for SARS-CoV-2. The workshop highlighted what is 

known, gaps in the field, and a potential path forward. A link to the manuscript that summarizes 

the workshop will be provided in the written comments. Related to the need for advancing next 

generation vaccines, Project NextGen was announced in May 2023. Project NextGen is a 

coordinated effort through which NIAID and BARDA will work with the private sector to advance 

a pipeline of new innovative vaccines into clinical trials. NIAID’s efforts are going to focus on a 

structured program evaluating multiple next-generation COVID-19 vaccines in Phase 1 and 

Phase 2 clinical trials. A link will be provided in the written comments, but it can also be found 

just by searching “NIAID Project NextGen.” Shifting to tuberculosis (TB), a clinical trial testing a 

freeze-dried, temperature-stable TB vaccine was found to be safe and effective in simulated 

antibodies, as well as the cellular immune response. A non-stable temperature form had 

previously been studied, but this is the first time any subunit TB vaccine in a temperature-stable 

form has been evaluated, which is critical in terms of thinking about how to roll out a TB vaccine. 

For influenza, a clinical trial of an experimental mRNA universal influenza vaccine developed by 

NIAID’s Vaccine Research Center (VRC) began enrolling volunteers at Duke. This is the first 

investigational universal influenza vaccine candidate tested by the Collaborative Influenza 

Vaccine Innovation Center (CIVIC) Program, which is a program to advance more durable, 

broadly protective and longer lasting influenza vaccines. The approval of RSV vaccines marks 

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an important step toward protecting the nation from this serious respiratory disease. It is 

important to highlight that that accomplishment is a result of decades of scientific discovery and 

research funded by the NIH and many other groups. The development of effective vaccines 

takes time. It is a series of incremental discoveries and steps, but good science is fundamental 

to getting effective vaccines like the ACIP voted on the previous day. For HIV, May 18, 2023 

marked 26th anniversary of HIV Vaccine Awareness Day. An effective, safe, long-lasting HIV 

vaccine remains crucial for ending the HIV pandemic worldwide. However, HIV continues to 

pose a formidable challenge to vaccine development due to its ability to mutate rapidly and 

heighten reservoirs that the immune system cannot reach. The NIH applauds efforts of the 

global community of scientists, advocates, study participants, and funders enabling 

unprecedented levels of innovation and adaptation in pursuit of a highly effective HIV vaccine. 

There are several other updates and links for which he referred listeners to the written 

comments. 

Office of Infectious Disease and HIV/AIDS Policy 

CDR Valeria Marshall, MPH, PMP reported that in the National Vaccine Program, housed 

within the Office of Infectious Disease and HIV/AIDS Policy (OIDP), is working on the progress 

report for the “Vaccines Federal Implementation Plan” and will work with federal agencies over 

the summer to provide their progress across goals and strategies. The National Vaccine 

Advisory Committee (NVAC) convened on June 16-17, 2023. In an effort to be responsive to 

emerging challenges and immunization, select agenda topics included preparing for the 

potential approval of passive immunization products, restoring vaccination rates in the postpandemic period, and addressing clinician fatigue. The committee updated their progress on 2 

ongoing charges, including the charge on vaccine innovations and vaccine safety. 

PNEUMOCOCCAL VACCINES 

Introduction 

Katherine A. Poehling, MD, MPH (ACIP WG Chair) reminded everyone that pneumococcal 

vaccines currently recommended for use in the US include PCV13 and PCV20 for adults. 

PCV13 and PCV15 are recommended for children. PPSV3 has a risk-based recommendation 

for children. PPSV3 is recommended for adults who previously received PCV13 or PCV15, but 

not for those receiving PCV2020. The goal is to move forward with fewer differences. As a 

reminder, all children under 2 years of age have the same pneumococcal vaccine 

recommendation for 3 primary series and a booster, often known as the 3 + 1 schedule. The 

primary series doses are administered at 2, 4, and 6 months and the booster is given at 12 to 15 

months later. Currently, either PCV13 or PCV15 can be given to US children. Children with 

certain underlying conditions are recommended to receive PPSV23. Children with chronic 

medical conditions (CMC), cerebrospinal fluid (CSF) leak, and cochlear implants are 

recommended to receive PPSV23 ≥8 weeks after the conjugate vaccine. Children with 

immunocompromising conditions are recommended to receive PPSV23 ≥8 weeks after the 

conjugate vaccine. Then ≥5 years later, a second dose of PPSV23 is recommended. Children 

6─8 years of age with CMC can receive PPSV23 if they did not receive pneumococcal 

conjugate vaccine. Of note, CMC includes chronic heart disease (CHD), chronic lung disease 

(CLD),and diabetes mellitus (DM). 

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An extended indication for PCV20 use among children was approved on April 27, 2023. 

Pediatric PCV15 use was approved in June 2022. Both PCV15 and PCV20 were approved 

based on safety and immunogenicity data compared with PCV13. There are no direct PCV15 vs 

PCV20 comparisons. Unknown clinical implications include numerically lower antibody 

responses vs PCV13 and numerically higher antibody response against serotype 3 in PCV15 vs 

PCV13. 

With all of this in mind, the WG considered the following policy questions: 

 Should PCV20 be recommended as an option for pneumococcal conjugate vaccination 

according to currently recommended dosing and schedules for US children aged <2 years? 

 Should PCV20 without PPSV23 be recommended as an option for pneumococcal 

vaccination for US children aged 2─18 years of age with underlying medical conditions that 

increase the risk of pneumococcal disease? 

Presentations during this session focused on and economic analysis and public health impact of 

PCV20 use in children presented by Dr. Charles Stoecker (Tulane University); a comparison of 

cost-effectiveness analyses on PCV20 use in children by Dr. Ayabina Diepreye (CDC/NCIRD); 

a summary of the WG’s interpretation on EtR and policy options presented by Dr. Miwako 

Kobayashi (CDC/NCIRD); the VFC Resolution presented by Dr. Jeanne Santoli (CDC/NCIRD); 

and the following 5 votes: 

Vote #1: Routine PCV Use for All Children aged <24 Months 

Miwako Kobayashi, MD, MPH (CDC/NCIRD) displayed and read the proposed vote language 

following the public comment period. The vote was combined with the Pneumococcal Vaccine 

Session for ease of reading: 

Use of either PCV15 or PCV20 is recommended for all children aged 2–23 months 

according to currently recommended PCV dosing and schedules. 

Motion/Vote #1: Routine PCV Use for All Children aged <24 Months 

Dr. Cineas made a motion to approve the recommendation as stated, which Ms. Bahta 

seconded. No COIs were declared. The motion carried with 14 affirmative votes, 0 negative 

votes, and 0 abstentions. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

42 
 

 

 

 

 

 

 

 

 

Vote #2: Catch-Up PCV Doses for Children Aged 24–71 Months with an Incomplete PCV 

Vaccination Status 

Miwako Kobayashi, MD, MPH (CDC/NCIRD) displayed and read the proposed vote language 

following the public comment period. The vote was combined with the Pneumococcal Vaccine 

Session for ease of reading: 

For children with an incomplete PCV vaccination status, use of either PCV15 or PCV20 

according to currently recommended PCV dosing and schedules for: 

• Healthy children aged 24─59 months 

• Children with specific risk conditions* aged 24─71 months 

*Risk conditions include: cerebrospinal fluid leak; chronic heart disease; chronic kidney disease (excluding maintenance 

dialysis and nephrotic syndrome, which are included in immunocompromising conditions); chronic liver disease; chronic 

lung disease (including moderate persistent or severe persistent asthma); cochlear implant; diabetes mellitus; 

immunocompromising conditions (on maintenance dialysis or with nephrotic syndrome; congenital or acquired asplenia or 

splenic dysfunction; congenital or acquired immunodeficiencies; diseases and conditions treated with immunosuppressive 

drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, Hodgkin disease, and solid organ 

transplant; HIV infection; and sickle cell disease and other hemoglobinopathies). 

Motion/Vote #2: Catch-Up PCV Doses for Children Aged 

24–71 Months with an Incomplete PCV Vaccination Status 

Dr. Daley made a motion to approve the recommendation as stated, which Dr. Long seconded. 

No COIs were declared. The motion carried with 14 affirmative votes, 0 negative votes, and 0 

abstentions. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

Vote #3: Children Aged 2–18 Years with Any Risk Condition Who Have Completed Their 

Recommended PCV Doses Before Age 6 Years 

Miwako Kobayashi, MD, MPH (CDC/NCIRD) displayed and read the proposed vote language 

following the public comment period. The vote was combined with the Pneumococcal Vaccine 

Session for ease of reading: 

For children aged 2–18 years with any risk condition who have received all 

recommended doses before age 6 years: 

• Using ≥1 dose of PCV20: No additional doses of any pneumococcal vaccine are

indicated. This recommendation may be updated as additional data become 

available. 

• Using PCV13 or PCV15 (no PCV20): A dose of PCV20 or PPSV23 using 

previously recommended doses and schedule is recommended. 

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Motion/Vote #3: Children Aged 2–18 Years with Any Risk Condition

Who Have Completed Their Recommended PCV Doses Before Age 6 Years 

Dr. Long made a motion to approve the recommendation as stated, which Ms. Bahta seconded. 

No COIs were declared. The motion carried with 14 affirmative votes, 0 negative votes, and 0 

abstentions. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

Vote #4: Children Aged 6–18 Years with Any Risk Condition Who Have Not Received Any 

Dose of PCV 

Miwako Kobayashi, MD, MPH (CDC/NCIRD) displayed and read the proposed vote language 

following the public comment period. The vote was combined with the Pneumococcal Vaccine 

Session for ease of reading: 

For children aged 6–18 years with any risk condition who have not received any dose of 

PCV13, PCV15, or PCV20, a single dose of PCV15 or PCV20 is recommended at least 

8 weeks after the most recent dose of pneumococcal vaccine. When PCV15 is used, it 

should be followed by a dose of PPSV23 at least 8 weeks later if not previously given. 

Motion/Vote #4: Children Aged 6–18 Years with Any

Risk Condition Who Have Not Received Any Dose of PCV 

Dr. Sánchez made a motion to approve the recommendation as stated, which Dr. Daley 

seconded. No COIs were declared. The motion carried with 14 affirmative votes, 0 negative 

votes, and 0 abstentions. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

Vote #5: VFC Resolution 

Jeanne Santoli, MD, MPH (CDC/NCIRD) displayed and read the proposed vote language 

following the public comment period. The vote was combined with the Pneumococcal Vaccine 

Session for ease of reading: 

Approve the Vaccines for Children (VFC) resolution for pneumococcal pneumonia. 

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Motion/Vote #5: VFC Resolution 

Ms. Bahta made a motion to approve the recommendation as stated, which Dr. Sánchez 

seconded. No COIs were declared. The motion carried with 14 affirmative votes, 0 negative 

votes, and 0 abstentions. The disposition of the vote was as follows: 

14 Favored: Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally, 

Poehling, Dr. Sánchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

DENGUE VACCINE 

Brief Summary 

The Dengue Vaccines schedule included a session introduction by Dr. Wilbur Chen (ACIP, WG 

Chair); introduction of policy questions for TAK-003 by Dr. Alfonso Hernandez (CDC/NCEZID); 

presentation of a cost-effectiveness analysis and the health impacts of routine vaccination with 

TAK-003 dengue vaccine in Puerto Rico by Dr. Guido Espana (University of Notre Dame); a 

summary of two economic models for dengue vaccine TAK-003 use in Puerto Rico by Dr. 

RajReni Kaul (CDC/NCIRD); and a presentation of the partial EtR framework for TAK-003 by Dr. 

Joshua Wong (CDC/NCEZID). No votes were taken on this topic during this meeting. 

CHIKUNGUNYA VACCINE 

Brief Summary 

The Chikungunya Vaccine session included a session introduction by Dr. Beth Bell (ACIP, WG 

Chair); a presentation on the value of chikungunya vaccine to US travelers and providers by Ms. 

Nicole Lindsey (CDC/NCEZID); and presentations on chikungunya virus infection among 

laboratory workers, a large chikungunya outbreak in Paraguay, and WG plans and timelines by 

Dr. Susan Hills (CDC/NCEZID). No votes were taken on this topic during this meeting. 

RESPIRATORY SYNCYTIAL VIRUS VACCINES: PEDIATRIC/MATERNAL 

Brief Summary 

The Respiratory Syncytial Virus Vaccines: Pediatric/Maternal session included a session 

introduction by Dr. Sarah Long (ACIP, WG Chair); a presentation on an economic analysis of 

RSVpreF in pediatric populations by Dr. David Hutton (University of Michigan); a presentation 

on the EtR of Pfizer maternal RSV vaccine by Dr. Katherine Fleming-Dutra (CDC/NCIRD); a 

presentation on an economic analysis of the combined use of nirsevimab and maternal 

RSVpreF vaccine by Dr. David Hutton (University of Michigan); and a presentation on clinical 

considerations for RSV maternal vaccine and nirsevimab by Dr. Jefferson Jones (CDC, NCIRD). 

No votes were taken on this topic during this meeting. 

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PUBLIC COMMENTS 

The floor was opened for public comment on June 22, 2023 at 4:50 PM ET. Given that many 

more individuals registered to make oral public comments than could be accommodated during 

this meeting, selection was made randomly via a lottery. Dr. Lee provided a gentle reminder that 

the ACIP appreciates diverse viewpoints that are respectful in nature and issue-focused rather 

than comments directed at individuals. 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 Number ID CDC-2023-0035. Visit 

http://www.regulations.gov for access to the docket or to submit comments or read background 

documents and comments received. The public comment session occurred prior to the votes, 

but the votes were connected back with their respective sessions for ease of reading. 

Mr. Joaquín Beltrán

Biden/Harris 2020 Regional Director

Small Retail Investor of Novavax Vaccine 

Thank you for having me. Full transparency, I was a Biden/Harris 2020 Regional Director and 

currently am a small retail investor of Novavax vaccine’s ongoing availability, vaccinated with 2 

Pfizers, 1 Novavax, and never had COVID. My name is Joaquín Beltrán. Today I am calling on 

the CDC to fulfill its specific mission to control and prevent disease. Here are the specific 

actions to take: 1) make Novavax’s updated XBB.1.5 booster available upon manufacturing 

completion; 2) update booster guidelines for equal access and allow for multiple boosters to 

improve protection; 3) expand Novavax access to everyone 6 months and up; 4) bring back 

mask requirements in healthcare savings; and 5) bring back testing and data. Here are some 

stories on why these actions are important. My friend Robbie, who has been suffering from longCOVID for years, her mother was recently in the hospital for a non-COVID issue. She acquired 

COVID in the hospital and died from that very infection—a tragic and preventable death. My 

grandma and my dad, who both have long COVID, my grandma for whom I am a caregiver— 

they have been experiencing long-COVID after their infections. Both have circulation issues and 

their quality of life has not been the same. Other friends, in trying to protect themselves, many 

have had to lie or go out of state, or the country even, to obtain a Novavax vaccine because of 

current language in the guidelines, specifically the line that reads, “but have not previously 

received a COVID-19 booster and if they cannot or will not receive mRNA vaccines.” This 

language should be removed immediately. Other friends have lost all sources of income due to 

disability and others are currently in this very moment being evicted from their homes because 

of long-COVID. These stories are not unique to people I know. Millions are suffering and going 

through this suffering from long-COVID and through this financial hardship. Moreover, hospitals 

are collapsing from shortages, from thousands of healthcare workers who have died from 

COVID, many more who have become disabled, and from increased overall morbidity in the 

population from the CDC’s de facto mass reinfection policy that creates cumulative risk— 

cumulative risk of heart attacks, stroke, brain damage, Type 1 diabetes in children, immune 

dysregulation, and much more. I am urging the CDC to take immediate action to protect our 

families and communities by: 1) making Novavax’s updated XBB.1.5. booster available upon 

manufacturing completion; 2) updating booster guidelines for equal access and allow for 

multiple boosters to improve protection; 3) expanding Novavax access to everyone 6 months 

and older; 4) bringing back mask requirements in healthcare settings; and 5) bringing back 

testing and data. Thank you so much for your time. 

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Dorit Reiss, JD, PhD 

Professor of Law 

University of California San Francisco 

Hello, my name is Dorit Reiss. I am a Professor of Law at UC San Francisco. Thank you for the 

opportunity to again comment to the committee. I have 3 points to make first following the 

committee’s careful critical discussion of RSV vaccines both yesterday and today, the 

penetrating question about the data, and the thoughtful way of the discussion. Frist, I’d like to 

thank both the committee and the WGs for their extensive work on this. This meeting always 

shows the extensive data and work behind every vaccine decision, with reams of information 

provided, though you have to boil it down to relatively short presentation. More than ever, I think 

this meeting shows us how hard it is to make decisions when you don’t have full information, 

which you rarely do, but this is a little more extreme than usual. It’s exactly in this situation 

where we need the expert input of a committee like ACIP even more than when the data is 

clear. I’d like to reinforce the committee members’ comments that we need data before the 

committee gets to a vote, but I would like to finish by reminding the committee and CDC on this 

point that the vaccine-recommended under “shared clinical decision-making” may be treated by 

doctors as less important and not recommended. I hope that any materials sent out will remind 

doctors of the risk of the diseases and vaccines they’re recommending for in this way and set 

out clearly that at least a discussion of the vaccine is recommended. The shared clinical 

decision-making shouldn’t be “don’t talk about it,” but should be “at least talk about it.” Second, 

since we discussed dengue and chikungunya vaccine today, and following yesterday’s 

discussion of the reemergence of polio, I want to use those to remind everyone of the 

importance of covering these diseases and looking for the safety of the citizens of our territories 

as much as of the states, and generally, the importance of addressing so-called neglected 

tropical diseases, which are not really tropical, including by funding and promoting vaccination 

against them. Thank you for highlighting the larger burden of these outbreaks both in deaths 

and in other ways they are harming, and of course, in this age of climate change and travel, 

diseases don’t stay. They will be coming beyond their borders, and we need to look at them for 

more selfish reasons as well. A bit off topic, this is a chance to remind everyone of the 

importance of protecting our vaccine scientists from harassment. To build on this last point, I 

want to remind people that although anti-vaccine harassment has always been part of the reality 

of people responding to this information, as several of our scientists can testify, it’s been going 

more extreme, more virulent, and the volume has grown. Although CDC and ACIP have an 

important role in providing good information, they’re not going to be in the front of line of 

debunking. But I hope CDC makes sure that its scientists and ACIP experts have the support 

and protection they need to do the job safely and with resources and answers when harassed, 

and I would encourage other institutions to support scientists to speak up as well. Thank you. 

Patricia Neuenschwander, PNP 

Pediatric Nurse Practitioner 

Good evening. I would love to stand before you and commend this committee on their rigorous 

evaluation of high-quality studies used to make recommendations, but I can’t. I am a nurse who 

was a defender of vaccine safety and efficacy, a nurse who dutifully vaccinated her children and 

herself, confidently trusting that the CDC recommendations were based on a rigorous 

evaluation of high-quality studies. I now know that was a lie. I sat yesterday listening to Dr. 

Talbot express her legitimate concerns over the RSV studies. When those concerns were not 

addressed, she did not vote “no.” She abstained. This is not scientific discourse. It is a pressure 

cooker for experts in the field to vote unanimously for anything that is put forward giving the 

illusion of consensus. I want to focus the remainder of my comments specifically on the 

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inadequate RSV vaccine science used yesterday and that is being used today with pregnant 

women. They did not study the people who would potentially benefit—people over 75, nursing 

home patients, patients with the usual amount of comorbid conditions, or the immune 

compromised. Applying the questionable data from one healthy group to another group that has 

far more risk and yet not studied, is scientifically unsound. Immunogenicity trials are inadequate. 

There are no established immune correlates of protection. We know nothing about additional 

doses or the coadministration with vaccines other than a small number who received a flu 

vaccine. The factual evidence presented from the GRADE evaluations did not show benefit with 

hospitalization, severe illness, or death, probably because the population used was healthy. We 

will never know now, but I’m sure that you will use suboptimal, biased observational studies in 

the future to try and show it does. The actual science shows that it may reduce hospitalization 

for RSV illness, but the effect is very uncertain and a very low-evidence type. It may impact 

severe RSV illness requiring supplemental oxygen and other support, but the effect is very 

uncertain and a very low-evidence type. Yet you’ll tell providers and the American people that it 

prevents severe disease and hospitalizations. These issues are not unique to the RSV vaccine 

trials. I have watched again and again as ACIP gave blanket approvals to COVID vaccines and 

boosters with equally questionable data. This is why you have anti-vaxxers. You are losing 

credibility and trust with frontline healthcare workers, and you have lost credibility and trust with 

the majority of Americans because you are allowing junk science and industry influence to 

determine your decisions. The CDC has settled too long for data that is poor, inadequate, or no 

data. It’s time to modernize, demand rigorous science, embrace transparency, and engage in 

free and open debate or the entire vaccine program will die. Thank you. 

David Wiseman, PhD 

Research Bioscientist 

Synechion, Inc. 

Thank you very much. Please see our written remarks. FDA has just advised developing 

XBB.1.5 COVID monovalents. This strategy seems destined to fail with the currently low death 

rate despite the 17% bivalent uptake. Do people agree with Dr. Offit that chasing variants is a 

losing game? Already 3 months after introduction, the bivalents were alarmingly evaded by XBB 

according to Wang and other studies omitted from FDA’s January brief. Cleveland Clinic noted 

that they were not alone in finding a possible association with more vax doses and higher risk of 

COVID, and last week, that COVID risk is lower in out-of-date than up-to-date adults. CDC 

interprets otherwise, but their data echoes others with rapid waning to negative [unclear] 

suggesting immune compromise. Rouzine in Nature and FDA’s brief suggest vaccination 

influences evolution and natural selection of escaped variants. Recall Dr. Long’s comments in 

January 22 that “repeated whack-a-mole boosting was unsustainable.” Let’s chase safety, not 

variants. Temporal associations between vax coverage and all-cause mortality persist. Why did 

it take until March for myocarditis to appear in Janssen’s factsheet and CDC and FDA to report 

this potential safety concern in the Wu paper? We flagged this signal to ACIP in late 2021. Why 

can’t they find a stroke signal outside of VSD when it appears in CDC’s VAERS FOIA release in 

January? That same release shows cancer signals, but still no cancer genotoxic or mutagenicity 

studies, and yet the National Cancer Institute shows reverse transcription is possible. NIH 

showed message and spike into the nucleus. Episomal transmission does not need integration. 

FDA’s Dr. Peden writes “DNA can be oncogenic.” There are reports of possibly replicationcompetent residual plasmid template DNA with antibiotic-resistance and undisclosed SV40 

promoter sequences at levels above guidelines, suggesting adulteration. Excluding these gene 

therapies from guidance does not change biology or safety concerns. FDA extrapolates further 

the chasm between EUA “may be effective” and the regular safe and effective standards. The 

bivalents yield novel heterotrimers with untested tox and likely misbranding. Dr. Sanchez’s 

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question last year about spike kinetics remains unanswered, with no FDA insistence for these 

studies. Lipid nanoparticles widely distribute, spike persists for up to 4 months, mRNA up to 28 

days. If you can’t say where and for how long these gene therapies induce spike production, 

you shouldn’t be asking people to vax. Dr. Fauci, in Cell, writes “vaccines have never effectively 

controlled these sorts of vaccines, and are not expected to do so.” Dr. Marks, in JAMA, 

questions incrementally modifying variant-specific vaccines. Regulate these products as gene 

therapies, no free passes to poorly understood platforms. Thank you very much. 

Mr. Burton Eller 

Executive Director of Advocacy 

National Grange 

My name is Burton Eller. I’m the Executive Director of Advocacy for the National Grange. 

Founded in 1867, the Grange is the oldest national organization advocating for Americans living 

in rural and small-town America. Our mission is to work together to support and advance the 

safety, health, economic security, and well-being of those who have chosen a rural way of life. 

We are here today to continue our effort to highlight the vulnerability of our communities to 

respiratory diseases, and to share our support for ensuring that older Americans most 

vulnerable to RSV have access to the newly FDA-approved vaccines before the start of the 

respiratory season. As you may know, rural Americans face an elevated risk of serious illnesses 

from respiratory diseases. These are due to a number of factors, including the fact that rural 

Americans are less likely to have health insurance and have less access to healthcare as more 

and more rural hospitals are closing their doors. A lack of reliable broadband also limits rural 

Americans’ ability to access healthcare services. Additionally, rural areas have a higher 

percentage of Americans aged 65 and older versus urban areas. While the COVID-19 

pandemic, in ways, helped shine light on the positive aspects of living outside of cities, the 

resulting migration of urban residents to rural areas has also put an added strain on our already 

limited resources. As we saw more adults suffering from RSV last fall and winter, it was almost 

reminiscent of the beginning of the COVID pandemic. News outlets throughout the country were 

once again reporting the challenges that remaining rural hospitals faced as they tried to cope 

with the influx of patients needing care, with no space to offer them. Fortunately, with longawaited development and approval of an RSV vaccine, we have the tools to protect ourselves. 

We thank the committee for your thoughtful consideration of who would be the best served by 

these vaccines, but we are concerned that these vote for the shared clinical decision-making 

may create a rather disproportionate impact on rural seniors. Rural providers are stretched thin, 

and their patients tend to be older and sicker. In urban areas, there are 31 physicians for every 

10,000 people, compared to just 13 physicians in rural areas, and there are fewer clinical 

facilities like clinics and pharmacies. While we believe every American should have the choice 

of whether to receive a vaccine, we also want to ensure equitable access to the information of 

what vaccines are available and why they are so important. For rural seniors who do not have 

easy access to their clinician, any extra step, we fear, could reduce the likelihood that these 

patients will gain access to these protections. Regardless, we are encouraged by those aged 60 

years and older who will have the opportunity to consider a protection against RSV, and hope 

the recommendations are reconsidered in the future as we have more data to indicate whether 

these most vulnerable communities are truly and adequately being served. Thank you. 

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Miss Elizabeth Ditz 

Potential RSV Vaccine Recipient 

My name is Liz Ditz and I live in San Mateo County, California. Thank you all and to the 

committee for the time and expertise that you donate to the nation to improve public health. I’m 

especially grateful to Dr. Camille Nelson Kotton this morning for sharing on Twitter the key 

benefits of the RSV vaccine. I am speaking as a potential RSV vaccine recipient. I’m over 65 

and have other risk factors for infection with RSV. I am grateful that the committee voted to 

approve the vaccine, and I’m disappointed that the recommendation is that my age cohort “may” 

get the vaccine with shared decision-making rather than we “should” get the vaccine. Here’s 

why. I’ve been an advocate for vaccines in my community, both in-person and online, for over 

20 years. Until relatively recently, I had no idea that RSV was a significant health risk for people 

over 60. I thought it was only a risk for infants, especially those born prematurely. It’s hard to 

sell a health intervention like a vaccine if the intended recipient has no idea that the disease 

prevented is a risk for the recipient. Most people in my age cohort that I know were eager to get 

the Shingrix vaccine because the suffering caused by shingles is common knowledge. Most 

people in my age cohort that I know have been vaccinated against pneumococcal disease 

because of the significant drop in quality of life and hospitalization for pneumonia is common 

knowledge. Most people in my age cohort that I know do take an annual flu vaccine because a 

risk of flu in our age group is common knowledge. And yes, many in my age cohort do get their 

flu vaccines and others through vaccine clinics or pharmacies. In other words, the vaccine 

recipient drives the decision to get the vaccine—not a physician or other healthcare provider. 

We are in a dangerous era where influential sources are blatantly anti-science. What is the plan 

to explain to older Americans that this is a disease that does not just kill, but significantly impairs 

their quality of life? After an ICU stay and hospitalization, it takes a while to return to pre-illness 

baseline quality of life, independence, and mobility. Because these vaccines will be covered 

under Medicare Part D and thus administered in pharmacies rather than physicians’ offices, 

what is the plan to educate not just the vaccine-giving pharmacists, but all client-facing 

pharmacy staff have to educate elders? I appreciate that the committee voted for “may” rather 

than “shall” because of a lack of data. What is the plan to collect post-approval data, especially 

in the 80-and-over age cohort? What’s the plan for this committee to reconsider this data and to 

change “may” to “shall?” Again, thank you all for your hard work, and I hope that this vaccine will 

be reconsidered soon. 

Shinsuke Yamamoto 

Member, Protect Our Future 

Hi, thank you. My name is Shin Yamamoto. I’m a husband, father of 2 kids ages 3 and 9, and a 

member of the group Protect Our Future, a nonprofit advocating for equitable healthcare and 

COVID-19 vaccine access for children of all ages. We’ve led a fairly cautious lifestyle since 

March 2020 between waiting for vaccinations for all of us and trying to reduce adverse 

outcomes for my wife, who is now on B-cell depletion therapy for her relapsing and remitting 

multiple sclerosis. Considering the problems of autoimmune disease and other chronic illnesses 

in this country, I don’t think we’re an isolated case. Many like us have had to make hard choices 

and accept an elevated level of risk that comes with reintegrating into society. I support and 

welcome the updated COVID-19 vaccine boosters coming from various manufacturers. I would, 

however, like to see simultaneous availability across all ages, which we have not had up to now. 

This is the most equitable option and one that will ultimately help those of us most at risk who 

still have to balance our health and the daily lives of our families. Accessibility for pediatric 

vaccines has been an issue, and I would like to see that addressed as well. Finding a vaccine 

for your kids should not be as difficult as finding a popular Christmas toy in stock. The same 

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thought applies for any vaccination for RSV, which was a cause for so many sick kids in 2022. 

That is all. Thank you. 

FRIDAY: JUNE 23, 2023 

MPOX VACCINES 

Brief Summary 

The Mpox Vaccines session included a session introduction by Dr. Pablo Sanchez (ACIP, WG 

Chair); updates from the 2022/2023 US Mpox Outbreak: Epidemiology, Vaccine Safety, and 

Vaccine Effectiveness by Dr. Faisal Minhaj (CDC/NCEZID); and presentations on clinical 

guidance for the use of JYNNEOS during Mpox outbreaks and considerations for long-term 

protection against Mpox by Dr. Agam Rao (CDC/NCEZID). No votes were taken on this topic 

during this meeting. 

MENINGOCOCCAL VACCINES 

Brief Summary 

The Meningococcal Vaccines Session included a session introduction by Dr. Kathy Poehling 

(ACIP, WG Chair); a presentation on a cost-effectiveness analysis by Dr. Ismael OrtegaSanchez (CDC/NCIRD); and presentations on GRADE/EtR and a summary and WG 

considerations by Dr. Sam Crowe (CDC/NCIRD). No votes were taken on this topic during this 

meeting. 

VACCINE SAFETY 

Brief Summary 

The Vaccine Safety Session included a presentation of the background on the CDC 

Immunization Safety Office (ISO) and ISO efforts to evaluate studying the safety of the 

childhood immunization schedule by Dr. Tom Shimabukuro (CDC/NCEZID); a presentation on 

the childhood immunization schedule and safety from studies in the Vaccine Safety Datalink 

(VSD) by Dr. Matthew Daley (Kaiser Permanente Colorado); and a presentation on the 

preliminary evaluation of aluminum content in childhood vaccines and the risk of asthma in a 

Danish nationwide cohort by Dr. Anders Hviid (Statens Serum Institut, Copenhagen, Denmark). 

No votes were taken on this topic during this meeting. 

COVID-19 VACCINES 

Brief Summary 

The COVID-19 Vaccines Session included a session introduction by Dr. Matthew Daley (ACIP 

WG Chair); a presentation of updates to COVID-19 epidemiology and vaccine effectiveness 

(VE) by Dr. Fiona Havers (CDC/NCIRD), Dr. Romeo Galang (CDC/NCCDPHP), and Dr. Ruth 

Link-Gelles (CDC/NCIRD); a presentation on infection-induced and hybrid immunity by Dr. 

51 
Jefferson Jones (CDC/NCIRD); and a summary and presentation of WG considerations by Dr. 

Megan Wallace (CDC/NCIRD. No votes were taken on this topic during this meeting. 

52 
CERTIFICATION 

Upon reviewing the foregoing version of the June 21-23, 2023 ACIP meeting minutes, Dr. Grace 

Lee, ACIP Chair, certified that to the best of her knowledge, they are accurate and complete. 

Her original, signed certification is on file with the Management Analysis and Services Office 

(MASO) of CDC. 

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ACIP 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 

CHEN, Wilbur H, MD, MS, FACP, FIDSA 

Professor of Medicine 

Center for Vaccine Development and Global Health 

University of Maryland School of Medicine 

Baltimore, MD 

Term: 12/23/2020 – 6/30/2024 

DALEY, Matthew F, MD 

Senior Investigator 

Institute for Health Research, Kaiser Permanente Colorado 

Associate Professor of Pediatrics 

University of Colorado School of Medicine 

Aurora, CO 

Term: 1/4/2021 – 6/30/2024 

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 

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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 

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 

55 
 

 

 

 

 

 

 

 

 

 

 

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)

TBD 

Health Resources and Services Administration (HRSA)

GRIMES, Reed, MD, MPH 

CDR, USPHS 

Director, Division of Injury Compensation Programs 

Health Systems Bureau 

Health Resources and Services Administration 

Rockville, MD 

Indian Health Service (IHS)

CLARK, Matthew, MD, FAAP, FACP 

Physician 

Chair, IHS National Pharmacy & Therapeutics Committee 

Durango, CO 

Office of Infectious Disease and HIV/AIDS Policy (OIDP)

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

National Institutes of Health (NIH) 

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) 

Bethesda, MD 

56 
 

 

 

 

 

 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

American Academy of Pediatrics (AAP)

O’LEARY, Sean, MD, MPH 

Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

American Academy of Pediatrics (AAP) 

Red Book Editor 

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine 

Birmingham, AL 

American Academy of Physician Assistants (AAPA)

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants 

Alexandria, VA 

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) 

LEE, Sara, MD 

Assistant Vice President of University Health and Counseling Services 

Chief Health Officer 

Case Western Reserve University 

Cleveland, OH 

57 
 

 

 

 

 

 

 

 

 

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) 

GRUBB, Jessica, MD 

Medical Director, Infectious Diseases 

Elevance Health Companies/Carelon 

Charleston, SC 

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA 

Washington, DC 

American Immunization Registry Association (AIRA) (alternate) 

LONDO, Courtnay, MA 

Senior Program Manager 

Washington, DC 

58 
 

 

 

 

 

 

 

 

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)

GOODE, Jean-Venable “Kelly” R., PharmD, BCPS, FAPhA, FCCP 

Professor and Director, PGY1 Community-Based Pharmacy Residency Program 

School of Pharmacy, Virginia Commonwealth University 

Richmond, VA 

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)

JUTHANI, Manisha, MD 

Commissioner 

Connecticut Department of Public Health 

Hartford, CT 

Biotechnology Industry Organization (BIO)

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

59 
 

 

 

 

 

 

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 

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)

DUCHIN, Jeffrey, MD 

Health Officer, 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 

Infectious Diseases Society of America (IDSA) (alternate)

MCAULEY, James B., DTM&H, MD, MPH 

Clinical Director 

Whiteriver Indian Hospital 

Whiteriver, AZ 

International Society for Travel Medicine (ISTM)

BARNETT, Elizabeth D, MD Professor of 

Pediatrics 

Boston University School of Medicine 

Boston, MA 

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

National Association of County and City Health Officials (NACCHO) (alternate) 

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease 

Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine 

Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health 

Seattle, WA 

60 
 

 

 

 

 

 

 

 

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 Association of Pediatric Nurse Practitioners (NAPNAP) (alternate) 

DESHON, Dana, DNP, APRN, CPNP-PC 

Order of Saint Francis Medical Group 

Morton Pediatrics 

Morton, IL 

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) 

PAULSEN, Grant, MD 

Associate Professor of Pediatrics 

Pediatric Infectious Diseases 

Cincinnati Children’s Hospital Medical Center 

Cincinnati, OH 

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 

61 
 

 

 

 

 

 

 

 

 

 

 

Pediatric Infectious Diseases Society (PIDS) (alternate)

Shannon A. Ross, MD, MSPH 

Professor of Pediatrics 

University of Alabama at Birmingham 

School of Medicine 

Birmingham, AL 

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)

MEHROTRA, Preeti, MD, MPH 

Senior Medical Director 

Infection Control/Hospital Epidemiology 

Beth Israel Deaconess Medical Center 

Adult and Pediatric Infectious Diseases 

Harvard Medical School 

Boston, MA 

Society for Healthcare Epidemiology of America (SHEA) (Alternate)

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 

62 
63 

 

ACRONYMS USED IN THIS DOCUMENT

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics 

ABCs Active Bacterial Core Surveillance System 

ACA Affordable Care Act 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices 

ACOG American College of Obstetricians and Gynecologists 

ACP American College of Physicians 

ADE Antibody-Dependent Enhancement 

ADHD Attention Deficit Hyperactivity Disorder 

AE Adverse Event 

AESI Adverse Event of Special Interest 

AHIP America’s Health Insurance Plans 

AI/AN American Indian/Alaskan Native 

AIDP Acute Inflammatory Demyelinating Polyneuropathy 

aIIV Adjuvanted Influenza Vaccine 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association 

AMETHST American Transformative HIV Study 

AMIS American Men’s Internet Survey 

AOA American Osteopathic Association 

AOM Acute Otitis Media 

APhA American Pharmacists Association 

AR Adverse Reaction 

ARI Acute Respiratory Illness 

ASPR Administration for Strategic Preparedness and Response 

ASTHO Association of State and Territorial Health Officers 

AUC Area Under the Curve 

BARDA Biomedical Advanced Research and Development Authority 

BEST System Biologics Effectiveness and Safety System 

BLA Biologics License Application 

CBER Center for Biologics Evaluation and Research 

CBO Community-Based Organization 

ccIIV4 Cell-Culture Based Vaccine 

CDC Centers for Disease Control and Prevention 

CHD Chronic Heart Disease 

CHIKV Chikungunya Virus 

CHIP Children’s Health Insurance Program 

CICP Countermeasures Injury Compensation Program 

CISA Clinical Immunization Safety Assessment Project 

CLD Chronic Lung Disease 

CLI COVID-Like Illness 

CMC Chronic Medical Conditions 

CMS Center for Medicare and Medicaid Services 
 

 

CMV Cytomegalovirus 

COI Conflict of Interest 

CONUS Continental United States 

COPD Chronic Obstructive Pulmonary Disease 

COVID-NET Coronavirus Disease 2019 (COVID-19) Hospitalization Surveillance Network 

CSF Cerebrospinal Fluid 

CSTE Council of State and Territorial Epidemiologists 

CVD Cardiovascular Disease 

cVDPV2 Circulating Vaccine-Derived Poliovirus Type 2 

DCAC Dengue Case Adjudication Committee 

DENV Dengue Virus 

DFO Designated Federal Official 

DM diabetes mellitus 

DoD Department of Defense 

DSMB Data Safety Monitoring Board 

DUA Data Use Agreement 

DVA Department of Veterans Affairs 

eCRF Electronic Case Report Form 

ED Emergency Department 

EIND Emergency Investigational New Drug 

EMA European Medicines Agency 

EMDS Enhanced Meningococcal Disease Surveillance 

EMR Electronic Medical Record 

ET Eastern Time 

EtR Evidence to Recommendation 

EU European Union 

EUA Emergency Use Authorization 

FAERS FDA Adverse Event Reporting System 

FAS Freely Associated States 

FDA Food and Drug Administration 

FluSurv-NET Influenza Hospitalization Surveillance Network 

FQHC Federally Qualified Health Centers 

FRN Federal Register Notice 

FRPP Federal Retail Pharmacy Program 

GACVS Global Advisory Committee on Vaccine Safety 

GBS Guillain-Barré Syndrome 

GDP Gross Domestic Product 

GISAID Global Initiative on Sharing All Influenza Data 

GMC Geometric Mean Concentrations 

GMT Geometric Mean Titers 

GPEI Global Polio Eradication Initiative 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

HCP Healthcare Personnel / Providers 

HD-IV High-Dose Influenza Vaccine 

HHS (Department of) Health and Human Services 

HIV Human Immunodeficiency Virus 

HRSA Health Resources and Services Administration 

HSCT Hematopoietic Stem Cell Transplant 

HZ Herpes Zoster 

64 
 

 

 

 

IC Immunocompromising Conditions 

ICERs Incremental Cost Effectiveness Ratios 

ICU Intensive Care Unit 

IDMC Independent Data Monitoring Committee 

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IIS Immunization and Infectious Diseases 

IIS Immunization Information System 

IIV Inactivated Influenza Vaccine 

ILINet Influenza-like Illness Surveillance Network 

IM Intramuscular 

IMD Invasive Meningococcal Disease 

IPD Invasive Pneumococcal Disease 

IPV Inactivated Polio Vaccine 

IRA Inflation Reduction Act of 2022 

ISD Immunization Services Division 

IV Intravenous 

IVIG Intravenous Immune Globulin 

IVWG Federal Interagency Vaccine Workgroup 

IVY Investigating Respiratory Viruses in the Acutely Ill 

LGBTQ+ Lesbian, Gay, Bisexual, Transgender, Queer or Questioning, or Other 

LRTD Lower Respiratory Tract Disease 

LRTI Lower Respiratory Tract Illness 

LTCF Long-Term Care Facilities 

MAAEs Medically Attended Adverse Events 

MACDP Metropolitan Atlanta Congenital Defects Program 

MATISSE Maternal Immunization Study for Safety and Efficacy 

MELODY Prevention of Medically Attended Lower Respiratory Tract Infection Due to 

Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants 

MFS Miller Fisher Syndrome 

MICH Maternal, Infant, and Child Health 

MIS-C Multisystem Inflammatory Syndrome in Children 

MMWR Morbidity and Mortality Weekly Report 

MoH Ministry of Health 

MSM Men Who Have Sex with Men 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada 

NAMCS National Ambulatory Medical Care Survey 

NAPNAP National Association of Pediatric Nurse Practitioners 

NBP Nonbacteremic Pneumonia 

NCCDPHP National Center for Chronic Disease Prevention and Health Promotion 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCHS National Center of Health Statistics 

NCIRD National Center for Immunization and Respiratory Diseases 

NDC National Drug Code 

NDCMC Newly Diagnosed Chronic Medical Conditions 

NFID National Foundation for Infectious Diseases 

NHANES National Health and Nutrition Examination Survey 

NHP Non-Human Primate 

65 
 

NHSN National Healthcare Safety Network 

NIAID National Institute of Allergy and Infectious Diseases 

NICU Neonatal Intensive Care Unit 

NIH National Institutes of Health 

NIS National Immunization Survey 

NMA National Medical Association 

NNDSS National Notifiable Diseases Surveillance System 

nOPV2 Novel Oral Polio Vaccine, Type 2 

NP Nasopharyngeal 

NREVSS National Respiratory and Enteric Virus Surveillance System 

NSSP National Syndromic Surveillance Program 

NSTEMI Non-ST-Elevation Myocardial Infarction 

NVAC National Vaccine Advisory Committee 

NVPO National Vaccine Program Office 

NVSN New Vaccine Surveillance Network 

NVSS National Vital Statistics System 

NYS New York State 

OASH Office of the Assistant Secretary for Health 

ODPHP Office of Disease Prevention and Health Promotion 

OGC Office of General Council 

OIDP Office of Infectious Disease and HIV/AIDS Policy 

OP Oropharyngeal 

OPA Opsonophagocytic Activity 

OPV Oral Polio Vaccine 

PCP Primary Care Provider/Practitioner 

PCR Polymerase Chain Reaction 

PCV Pneumococcal Conjugate Vaccines 

PEP Post-Exposure Prophylaxis 

PFFS Private Fee-For-Service 

PHAC Public Health Agency Canada 

PHE Public Health Emergency 

PHEIC Public Health Emergency of International Concern 

PICO Population, Intervention, Comparison, Outcomes 

PIDS Pediatric Infectious Disease Society 

PK Pharmacokinetics 

POTS Postural Orthostatic Tachycardia Syndrome 

PPSV23 Pneumococcal Polysaccharide Vaccine 

PPV Positive Predictive Value 

PR Puerto Rico 

PrEP Pre-Exposure Prophylaxis 

QALY Quality-Adjusted Life Year 

QIV Quadrivalent Inactivated Influenza 

RCA Rapid Cycle Analysis 

RCT Randomized Controlled Trial 

RESP-NET Respiratory Virus Hospitalization Surveillance Network 

RSV-NET Respiratory Syncytial Virus Hospitalization Surveillance Network 

SAB Spontaneous Abortion 

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

66 
SD-IIV Standard-Dose Unadjuvanted Influenza Vaccines 

SES Socioeconomic Status 

SHEA Society for Healthcare Epidemiology of America 

SME Subject Matter Expert 

SMFM Society for Maternal-Fetal Medicine 

SNF Skilled Nursing Facilities 

STIs Sexually Transmitted Infections 

SVD Sudan Virus Disease 

TIA Transient Ischemic Attack 

TOR Terms of Reference 

UK United Kingdom 

US United States 

USG United States Government 

USVI US Virgin Islands 

VAERS Vaccine Adverse Event Reporting System 

VDPV Vaccine-Derived Poliovirus 

VE Vaccine Efficacy 

VE Vaccine Effectiveness 

VEPP Vaccine Equity Pilot Program 

VFC Vaccines For Children 

VFIP Vaccines Federal Implementation Plan 

VICP National Vaccine Injury Compensation Program 

VNSP Vaccines National Strategic Plan 

VRBPAC Vaccines and Related Biological Products Advisory Committee 

VSD Vaccine Safety Datalink 

VZV Varicella-Zoster Virus 

WG Work Group 

WGS Whole Genome Sequencing 

WHO World Health Organization 

WPV Wild Poliovirus 

ZIKV Zika Virus 

67