COVID 10 Oliver 508

cdc.gov/coronavirus
COVID -19 Vaccine :
Considerations for Future Planning
Sara Oliver, MD, MSPH
ACIP MeetingFebruary 24, 202 3
Considerations for future planning
COVID -19 vaccines
COVID -19 vaccines:
Where we are now How do we
get there?COVID -19 vaccines:
Where we are going
Considerations for future planning
COVID -19 vaccines
COVID -19 vaccines:
Where we are now How do we
get there?COVID -19 vaccines:
Where we are going
Considerations for future planning
COVID -19 vaccines
COVID -19 vaccines:
Where we are now COVID -19 vaccines:
Where we are going  Where we are now :
Current recommendations
Vaccination rates
Hospitalization rates
How we get there :
How frequently should people get a COVID -19 vaccine?
Are there groups/populations who should have >1 vaccine per year? Goal :
Simple
recommendations
Current recommendations
https://www.cdc.gov/vaccines/covid -19/images/COVID19- vaccination -schedule -most -people.png
https://www.cdc.gov/vaccines/covid -19/images/COVID19- vaccination -schedule -immunocompromised.png

Coverage / Age (years) <2 2–4 5–11 12–17 18–24 24–49 50–64 >65
At least 1- dose† 7.6 10.3 39.7 71.9 81.9 85.2 95.0 95.0
Completed primary series 3.7 5.5 32.6 61.6 66.5 72.0 83.7 94.2
1st monovalent booster* - - 3.3 16.6 27.2 45.3 64.6
2nd monovalent booster * - - - - - - 10.6 25.3
Bivalent booster** 0.2 0.3 4.0 7.0 6.7 11.2 20.3 40.8
Unvaccinated 92.4 89.7 60.3 28.1 18.1 14.8 —†—†U.S. COVID-19 Vaccination Coverage (%) of Total Population by
Age Group — February 8, 2023
*Monovalent booster dose coverage as of August 26, 2022
** Bivalent booster coverage is independent of 1stand 2nddose monovalent coverage
†Note: Coverage is capped at 95%
Source: https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trends Updated February 10, 2023 6
U.S. COVID-19 vaccine uptake by age group,
August 2021 -January 2023
Source: IZ Data Lake 01,000,0002,000,0003,000,0004,000,0005,000,0006,000,0007,000,000
Primary Series, Ages 12-17 Primary Series, Adults Ages 18-49 Primary Series, Adults Ages 50-64 Primary Series,  Adults Ages 65+
Booster, Ages 12-17 Booster, Adults Ages 18-49 Booster, Adults Ages 50-64 Booster Adults Ages 65+Primary series authorization
1stbooster authorization
2ndbooster authorization Bivalent booster authorization Doses Administered
COVID-19 message fatigue challenges vaccine uptake
Recent studies reflect profound COVID- 1 9 message fatigue1, desire to end use of
mitigation2, and a common perception among adults that immunity is
sufficient without further boosters3
Barriers to vaccine access persist for some populations, i ncluding but not limited to:
–
––People living in rural areas
4
People experiencing homelessness5
People with disabilities6
•"If I can't get to it, it doesn't exist for me."
Despite improvements in vaccine equity after primary series vaccination, disparities i
n booster coverage have emerged7
1. Guan et al. Health Communication 2022: COVID -19 Message Fatigue: How Does It Predict Preventive Behavioral Intentions and What Types of Information are People Tired of
Hearing About? -PubMed (nih.gov) 2. CDC's State of Vaccine Confidence Insights Reports, Jan 26 2023: CDC’s State of Vaccine Confidence Insights Report 3. Sinclair et al. MMWR Jan
20 2023: MMWR, Reasons for Receiving or Not Receiving Bivalent COVID -19 Booster Vaccinations Among Adults —United States, November 1 –Dec ember 10, 2022 (cdc.gov)
4.Assessing barriers to access and equity for COVID -19 vaccination in the US -PMC (nih.gov) 5. McCosker et al. Vaccine May 2022: Strategies to improve vaccination rates in people
who are homeless. 6. Griffin -Blake et al. Barriers and facilitators of COVID -19 vaccine uptake among people with disabilities. P resentation to the COVID -19 Vaccine Innovation Team:
Feb 8 2023. 7. COVID -19 Vaccination Coverage, by Race and Ethnicity —National Immunization Survey Adult COVID Module, United States, December 2020– November 2021 |
MMWR (cdc.gov)
PI=Prediction Interval, VOC=Variants of Concern, VBM=Variants Being Monitored . https://covid.cdc.gov/covid -data- tracker/#variant -proportions Accessed Jan 20, 2023Trends in weighted variant proportion estimates & Nowcast
United States, November 6, 2022 –February 11, 2023
Collection date, week ending
Estimated Number of Reported COVID -19 Cases by Variant
Variant Proportions Scaled by Positive Nucleic Acid Amplification Test (NAAT) Counts
CDC COVID- 19 Lab Coordinating Unit Strain Surveillance and Emerging Variant Group. Data sources: https://covid.cdc.gov/covid- data-tracker/#variant -proportions and
https://covid.cdc.gov/covid- data-tracker/#trends_newtestresultsreported_7daytestingpositive_00
6M
04M
2MPositive tests / Proportion of viral lineages
Seroprevalenc e by Vaccine and Infection H istory Among
Adult U.S. Blood Donors, January –June 2022
Q1 = Jan.–Mar. 2022
Q2 = Apr.–Jun. 202243
35 35
254438615668 6730
3733
433136182417 2020 2225 2818 21 9 108 98 6 7 47 5
12 106 4
0%10%20%30%40%50%60%70%80%90%100%
Q1 Q2 Q1 Q2 Q1 Q2 Q1 Q2 Q1 Q2
Overall 18 to 49 50 to 64 65 to 74 75 and overSeroprevalence
Age (years) and quarterNo immunity
Infection only induced
immunity
Both vaccine and infectioninduced immunity
Vaccine only inducedimmunity
Source: https://covid.cdc.gov/covid- data-tracker/#nationwide -blood- donor -seroprevalence- 2022
Weekly population-based rates of COVID-19 -associated hospitalizations
by age group— COVID -NET, March 2020 –February 2023
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks.
Age Group
Monthly Age-Adjusted Rates of Lab- Confirmed Hospitalizations by Vaccination Status
among Adults Ages ≥18 Years —COVID- NET, January 2021–December 2022
0100200300400500600700Rate per 100,000 population
Month of Admission
Unvaccinated Primary series Primary series & ≥1 booster Primary series & ≥2 boosters Vaccinated, no bivalent booster Updated bivalent booster
Data are based on all hospitalizations regardless of reason for admission. Unvaccinated : No recorded doses of COVID -19 vaccine. Primary series ± ≥1 booster: Completed a primary series with or without ≥1
booster dose but did not receive an updated bivalent booster dose. Vaccinated, but no bivalent booster: Completed a primary series with or without ≥1 booster dose but did not receive an updated bivalent
booster dose. Updated bivalent booster : Received updated bivalent booster dose. Persons with partial or unknown vaccination status are excluded. See https://covid.cdc.gov/covid-data-tracker/#covidnet -
hospitalizations-vaccination for complete definitions of vaccination categories. In December 2022, compared to adults who
received an updated bivalent booster dose,
the monthly rates of hospitalization were
-16x higher among unvaccinated and
-2.6x higher in vaccinated adults without an updated booster dose
COVID- 19 vaccine
Where we are now
Current COVID- 19 vaccine recommendations are complex
Uptake of current bivalent vaccine is low
SARS -CoV-2 continues to evolve, but recent virus evolution has not led to large
population- level surges in cases or hospitalizations
Most adults have a prior infection, prior vaccination, or both
Hospitalization rates are highest older adults , but remain low among people who
have received a bivalent booster
Considerations for future planning
COVID -19 vaccines
COVID -19 vaccines:
Where we are now COVID -19 vaccines:
Where we are going
How we get there :
How frequently should people get a COVID -19 vaccine?
Are there groups/populations who should have >1 vaccine per year? Goal :
Simple
recommendations
How frequently should people get a COVID-19 vaccine?
Increases in COVID-19 cases (left) and hospitalizations (right) have occurred:
–During the winter months a nd/or
–Due to development of new i mmune escape variant
Cases from October 2021- February 2023 highlighted
https://covid.cdc.gov/covid -data-tracker/#trends_weeklycases_select_00 https://covid.cdc.gov/covid -data -tracker/#new -hospital -admissionsAdmissions from October 2021 – February 2023 highlighted
How frequently should people get a COVID-19 vaccine?
With monovalent COVID- 19 vaccines,
declines in VE noted over time
Likely impacted by both time since
vaccine dose and continued virus
evolution
Additional vaccine doses restored
protection lost over time
Continue to monitor impact of waning and virus evolution on VE for bivalent vaccines
VE = vaccine effectiveness
BA.2/BA.2.12.1 estimates: Link -Gelles et al. MMWR : https://www.cdc.gov/mmwr/volumes/71/wr/mm7129e1.htm
BA.4/BA.5 estimates: Link -Gelles et al. medRxiv : https://www.medrxiv.org/content/10.1101/2022.10.04.22280459v1 . Individuals with prior infections excluded. Adjusted for calendar time,
geographic region, age, sex, race, ethnicity, local virus circulation, respiratory or non -respiratory underlying medical conditi ons, and propensity to be vaccinated.

How frequently should people get a COVID-19 vaccine?
VE = vaccine effectiveness
CDC unpublished data. Updated from: Tenforde et al. MMWR December 16, 2022: https://www.cdc.gov/mmwr/volumes/71/wr/mm715152e1.htmTime since last dose impacts COVID- 19 vaccine effectiveness
–Relative VE of bivalent boosters (meaning the additional benefits of a bivalent booster) are higher
the longer it has been since the last monovalent dose
Safety is also likely improved with longer time between doses
–Myocarditis risk appears lower with longer time between doses
VISION: VE of bivalent
COVID -19 boosters against
hospitalizations among
adults aged ≥18 years –
VISION Network,
September –December 2022
How frequently should people get a COVID-19 vaccine?
Summary
Winter months and immune escape variants have impacted COVID- 19 epidemiology
–This past winter did not see same level of increases in cases/hospitalizations as previous winters
Time since last COVID- 19 vaccine dose may both increase the incremental benefits of a
COVID -19 vaccine, and decrease the risk of myocarditis
Vaccine protection likely declines over time
A plan for a fall booster dose could provide added protection, at a time when many
would be ~1 year from last dose
–Future epidemiology and SARS- CoV-2 virus evolution could help determine the need for
continued annual boosters
Are there populations who still need a primary series ?
Unvaccinated young children
While most adults have completed a primary series, most children ages 6 months –4  years
remain unvaccinated
For most older children, adolescents, and adults, future doses will be additional ‘boost’
a
fter prior infection, prior vaccination, or both
Young children will continue to age into the vaccine recommendations at 6 months and c
ould be SARS -CoV-2 naive
Some population of y oung children likely still need a ‘prime’ and ‘boost’ to optimize
immunity
Coverage / Age (years) <2 years 2–4 years
At least 1 -dose 7.6 10.3
Completed primary series 3.7 5.5
Unvaccinated 92.4 89.7
For parents with an unvaccinated or under -vaccinated child aged 6 –23 months, 38%
intend to get their child vaccinated in the next month, whereas 39.4% say they
‘definitely’ or ‘probably’ will not vaccinate their child and 23% are unsure
Additionally, 38% of parents of children ages 2 –4 years say they ‘definitely’ or
‘probably’ will get their child vaccinated in the next month, while 43.2% say they
‘definitely’ or ‘probably’ will not and 18.4% are unsure
Doctor’s offices and clinics were the most trusted place for parents to have their child
receive a COVID- 19 vaccine, as reported by 51.1% of parents of children aged 6 –23
months and 52.5% of parents of children aged 2 –4 yearsParental intent to get a COVID-19 vaccine for their child and
trusted places for children to receive a COVID-19 vaccine
CDC/University of Iowa/RAND survey. Unpublished data.
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks. Are there populations who still need a primary series ?
Unvaccinated young children
0510152025Rate per 100,000 population
Week Ending Date
6 months –<2 years 2–4 yearsPediatric hospitalization rates are higher among children 6 months to <2 years of a ge,
compared to children 2 –4 years of age
Weekly Population -Based Rates of COVID-19-Associated Hospitalizations among Children Ages 6 months -4 Years
—COVID -NET, March 2020– February 2023
63828993
0102030405060708090100
Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-DecSeroprevalence (%)
Month7585929799
0102030405060708090100
Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-DecSeroprevalence (%)
MonthPediatric SARS -CoV- 2 Infection- Induced and Combined (Vaccine -and Infection-
Induced) Seroprevalence from U.S. Commercial Laboratories —
March –December 2022
Source: https://covid.cdc.gov/covid- data-tracker/#pediatric -seroprevalence and unpublished data from CDCInfection -induced Combined
(vaccine- and infection -induced)

Are there populations who still need a primary series ?
Summary
Children ages <2 years have higher COVID- 1 9
hospitalization rates than older children
Children ages <4 years are less likely to have both
pr
ior infection and prior vaccination
Children have frequent visits to healthcare providers
The Work Group discussed continued primary series r
ecommendations for young children
Both ages 6  months- 2 years and ages 6 months-4
years were discussed without a clear consensus
https://www.healthychildren.org/English/family -life/health -management/Pages/Well- Child -Care-A- Check -Up-for-Success.aspx
Should older adults be recommended for >1 vaccine annually?
Hospitalization
r
ates are highest
among adults 65–74 years and
≥75 years of age
Age-Adjusted Rates of COVID -19-Associated Hospitalization by Vaccination Status and
Receipt of Booster Dose in Adults Ages ≥65 Years
COVID -NET, January 2021 –December 2022
CDC COVID Data Tracker. https://covid.cdc.gov/covid -data -tracker/#covidnet -hospitalizations -vaccination Accessed Feb 17, 2023In December 2022, adults ages ≥65 years
who received a bivalent booster had
12.8X lower risk of hospitalization for
COVID- 19 compared to unvaccinated
people and 2.5X lower risk of
hospitalization compared to those
vaccinated without a bivalent booster

Should older adults be recommended for >1 vaccine annually?
Immunity and vaccine
response is different in
older adults
Patterns of vaccine
effectiveness, including waning, may be different in older adults
Waning for bivalent VE against hospitalization, including among older adults, isn’t yet known
Unpublished CDC data. From ACIP presentation February 24, 2022ICATT: Relative VE of bivalent booster against symptomatic infection in
adults aged ≥ 18 years, December 1, 2022 –February 13, 2023

Should older adults be recommended for >1 vaccine annually?
Summary
Older adults have higher rates of hospitalization than younger adults
Rates of vaccination among older adults who have received a bivalent COVID- 19 v accine
booster dose remain low
The Work Group emphasized the importance of older adults being up to date on c urrent
recommendations, including receiving a bivalent booster
The Work Group discussed more frequent COVID- 19 vaccine doses for older adults, and
at this time felt the data were insufficient to determine a conclusion
Recommendations can be updated based on data in older adults including:
–Hospitalization rates of older adults who have received a bivalent booster
–Bivalent VE and patterns of waning for older adults
–SARS - CoV-2 virus evolution and possibility of future immune escape variants
Should people with immunocompromise be recommended for >1
vaccine annually?
Numerous studies have demonstrated that mRNA C OVID -19 vaccine effectiveness
among immunocompromised persons is lower than that of immunocompetent
persons, including within the period of Omicron predominance
This has been demonstrated across a range of immunocompromising conditions, and
i
s particularly notable for organ or stem cell transplant recipients
Among people with immunocompromise, recommendations prior to the bivalent boos
ter allowed for up to 5 monovalent doses of COVID-19 vaccine
Vaccine effectiveness studies are not yet sufficiently powered to evaluate e
ffectiveness of the bivalent booster among people with immunocompromise
Britton A, Embi PJ, Levy ME, et al. Effectiveness of COVID -19 mRNA Vaccines Against COVID -19– Associated Hospitalizations Among Immunocompromise d Adults During SARS -CoV-2 Omicron Predominance —VISION Network, 10 States,
December 2021 —August 2022. MMWR Morb Mortal Wkly Rep 2022;71:1335 –1342.
Embi PJ, Levy ME, and Patel P, et al. Effectiveness of COVID- 19 Vaccines at Preventing Emergency Department or Urgent Care Encounter s and Hospitalizations Among Immunocompromised Adults: an Observational Study of Real -World Data Across
10 US States from August—December 2021. Preprint. *Effectiveness of COVID-19 Vaccines at Preventing Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompromised Adults: An Observational Study of Real -
World Data Across 10 US States from August- December 2021 (medrxiv.org)
Ferdinands J M, Rao S, Dixon B E, Mitchell P K, DeSilva M B, Irving S Aetal.Waning of vaccine effectiveness against moderate and severe covid -19among adults in the US from the VISION network: test negative, case -control study BMJ 2022; 379 :e072141 doi:10.1136/bmj -2022-
072141
Should people with immunocompromise be recommended for >1
vaccine annually?
VISION: mRNA COVID- 19 VE for
hospitalizations among immunocompetent
versus immunocompromised adults
during Omicron predominance
(mid- Dec. 2021—Jul. 2022)
Figure: Ferdinands J M, Rao S,Dixon B E, Mitchell P K, DeSilva M B, Irving S Aet al. Waning of
vaccine effectiveness against moderate and severe covid -19 among adults in the US from the
VISION network: test negative, case- control study BMJ 2022 30
VE among immunocompromised
per
sons is lower than that of
immunocompetent persons at comparable time points after dose 2 and dose 3
VE wanes in both immunocompetent a
nd immunocompromised persons
Should people with immunocompromise be recommended for >1
vaccine annually?
Summary
Immunocompromised adults can have less robust immune response to COVID- 1 9
vaccines
Not currently any authorized prophylactic monoclonal antibody products for populations
a
t highest risk of COVID- 19
The Work Group discussed more frequent COVID- 19 vaccine doses for people with
immunocompromise, and at this time felt the data were insufficient to determine a conclusion
The Work Group acknowledged this population may continue to be more vulnerable to s
evere COVID- 19 and likely needs flexibility with COVID- 19 vaccine recommendations
Considerations for future planning
COVID -19 vaccines
COVID -19 vaccines:
Where we are now COVID -19 vaccines:
Where we are going  Goal :
Simple
recommendations
COVID -19 vaccines continue to be the most effective tool we have to prevent serious
illness, hospitalization and death from COVID -19
Goal of COVID- 19 vaccine program continues to be prevention of severe disease
–Prevention of post -COVID conditions, increased confidence in social interactions important
as well
Benefits of additional COVID- 19 vaccine booster doses vary by age, time since last
dose , and COVID- 19 incidence
A simplified, annual recommendation could help reduce vaccine and message fatigue
A COVID -19 vaccine framework that is similar to a well understood influenza vaccine
framework could be easy for COVID- 19 vaccine providers to implement, and for the
public to understand Considerations for future planning
COVID -19 vaccines
Simple recommendations are easier to communicate, which may improve uptake
–The Work Group was very supportive of simplified recommendations and planning for future
COVID -19 vaccines, which could include updated COVID -19 vaccines
Uncertainties remain for ideal timing and populations for future boosters, especially if new immune escape variants develop
The Work Group was supportive of a fall/annual COVID -19 vaccine program, with
flexibility to adjust based on new data, especially for populations at high risk
The Work Group will continue to review data to inform future deliberations:
–Vaccine effectiveness of bivalent COVID -19 vaccines over time
–Safety data of bivalent COVID-19 vaccines
–Cost effectiveness analyses
–COVID -19 epidemiology, including hospitalization rates among vaccinated and boosted persons
–SARS -CoV-2 genomic surveillance and virus evolution
–Data from vaccine manufacturers Work Group interpretation
Considerations for future planning
Monica Godfrey
Evelyn Twentyman
Danielle Moulia
Megan Wallace
Hannah Rosenblum
Lauren Roper
Katherine Fleming-Dutra
Ruth Link -Gelles
Amadea Britton
Sarah Meyer
Julianne Gee
Susan Goldstein
Mary Chamberland
Elisha HallValerie Morelli
JoEllen Wolicki
Heather Scobie
Sierra Scarbrough
Jefferson Jones
Aron Hall
Barbara Mahon
Data Analytics and Visualization Task Force
Coronavirus and other Respiratory Viruses Division
National Center for Immunization and Respiratory
DiseasesAcknowledgments
Question for ACIP
36Discussions about future COVID -19 vaccine recommendations are pre -decisional and
intended to inform planning and additional analyses.
What are ACIP's thoughts on a simplified framework for future COVID -19 vaccine
recommendations?
–What does ACIP think about children who may still need a primary series?
–What does ACIP think about future recommendations for older adults?
–What does ACIP think about future recommendations for people with
immunocompromising conditions ?
For more information, contact CDC
1-800- CDC- INFO (232- 4636)
TTY:  1 -888- 232- 6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Thank you

Summary: cdc.gov/coronavirus COVID -19 Vaccine :  Considerations for Future Planning Sara Oliver, MD, MSPH ACIP MeetingFebruary 24, 202 3 Considerations for future planning COVID -19 vaccines COVID -19 vaccines:  Where we are now How do we  get there?COVID -19 vaccines:  Where we are going   Considerations for future planning COVID -19 vaccines COVID -19 vaccines:  Where we are now How do we  get there?COVID -19 vaccines:  Where we are going   Considerations for future planning COVID -19 vaccines COVID…


acip charter

CHARTER

ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES

Advisory Committee’s Official Designation.

Advisory Committee on Immunization Practices (ACIP or Committee).

Authority.

The ACIP was established under Section 222 of the Public Health Service Act (42 U.S.C. §2l7a),
as amended.  The Committee is governed by the provisions of the Federal Advisory Committee
Act (FACA), Public Law 92-463 (5 U.S.C. § 1001 et seq.), as amended.

The ACIP has been given statutory roles under subsections 1928(c)(2)(B)(i) and 1928(e) of the
Social Security Act (42 U.S.C. § 1396s(c)(2)(B)(i) and 1396s(e)) and subsection 2713(a)(2) of
the Public Health Service Act (42 U.S.C. § 300gg-13(a)(2)).

Objective and Scope of Activities.

The Secretary, Department of Health and Human Services (HHS), and by delegation the
Director, Centers for Disease Control and Prevention (CDC), are authorized under Section 311
and Section 317 of the Public Health Service Act, [42 U.S.C. §243 and 42 U.S.C. §247b], as
amended, to assist states and their political subdivisions in the prevention and control of
communicable diseases; to advise the state s on matters relating to the preservation and
improvement of the public’s health; and to make gr ants to states and, in consultation with t he
state health authorities, to agencies and political  subdivisions of states to assist in meeting the
costs of communicable disease control programs.

Vaccines have played an important role in public health around the globe.  The Advisory
Committee on Immunization Practices (ACIP) prov ides recommendations to the CDC Director
on the use of vaccines and immunization program strategies to inform individuals, clinicians, and
broader public health efforts.  This committee convenes scientific and medical experts to provide
recommendations based on the best available evidence of vaccine risks and benefits, and
efficacy.
ACIP shall provide advice and guidance to the CDC Director regarding use of vaccines and
related agents for effective control of vaccine-preventable diseases and/or decreased
symptomatology in the civilian population of the United States and gaps in vaccine safety
research including adverse effects following v accination.  Recommendations made by ACIP are
initially reviewed by the CDC Director, and if adopted, become official CDC/HHS
recommendations, and may be published in the Morbidity and Mortality Weekly Report
(MMWR) .  The CDC Director informs the HHS Secretary, and Assistant Secretary for Health, of
immunization recommendations provided by the Committee.  Upon the licensure or
authorization of any vaccine or any new indicat ion for a vaccine, the Committee shall, as
appropriate, consider the use of the vaccine at its next regularly scheduled meeting.  If the
Committee does not make a recommendation at the Committee’s first regularly scheduled
meeting, the Committee shall provide an update on the status of such for the Committee’s
review.

Description of Duties.

The Committee shall provide advice for the control of diseases for which a vaccine is licensed or
authorized in the U.S.  The guidance will address use of vaccines and may include
recommendations for administration of immune globulin preparations and/or antimicrobial
therapy shown to be effective in controlling a di sease for which a vaccine is available.  Guidance
for use of unlicensed vaccines may be developed if circumstances warrant  and the Committee is
directed to develop such guidance by the CD C Director.  For each vaccine, the Committee
advises on population groups and/or circumstance s in which a vaccine or related agent is
recommended.  The Committee shall also provi de recommendations on contraindications and
precautions for use of the vaccine and related agents and provides information on recognized
adverse events.  The Committee also may provide  recommendations that a ddress the general use
of vaccines and immune globulin preparations as a class of biologic agents, use of specific
antibody products for prevention of infectious diseases, and special situations or populations that
may warrant modification of the routine recommendations.

The main tasks of the Committee can be or ganized into review and recommendations,
immunization schedules, and public health strategies.  ACIP shall review the latest scientific
evidence on vaccine safety, efficacy, and effect iveness to make recommendations on the routine
use of vaccines, including for specific populations such as pregnant women, elderly, and
immunocompromised individuals. Such review may include evaluation of pre- and post-
licensure data or if available, clinical tr ial data for vaccines under an Emergency Use
Authorization.  ACIP shall provide recommendations regarding revisions and updates to the
CDC immunization schedules for children, adoles cents, and adults, taking into account emerging
diseases, new vaccines, cumulative exposures to  vaccines and vaccine components, and changes
in disease epidemiology.  Furthermore, ACIP sh all advise on vaccination strategies that promote
optimal vaccine coverage, address health di sparities, and ensure equitable access to
immunizations across communities.

Committee deliberations on use of vaccines to control disease in the U.S. shall include
consideration of disease epidemiology and burden of  disease, vaccine risks and benefits, vaccine
efficacy and effectiveness, the quality of evidence reviewed, economic analyses, and
implementation issues.  The Committee may revise or withdraw their recommendation(s)
regarding a particular vaccine as new information on disease epidemiology, vaccine
effectiveness or safety, economic considerat ions, or other data become available.

Key responsibilities in developing committee r ecommendations can be organized into vaccine
recommendations, vaccine safety and monito ring, emerging vaccines and technology, global
health practices, and public engagement and tran sparency as part of ACIP public meetings.
ACIP shall be responsible for formulating recommendations for routine vaccination schedules
for different age groups and high-risk populations, advising on the use of vaccines in emergency
situations (such as during disease outbreaks or  public health emergencies), and reviewing
immunization practices (incl uding those related to vaccine storage, handling, and
administration).  ACIP shall also be responsible for reviewing data on vaccine safety and adverse
events, providing recommendations to enhance vacc ine safety surveillance systems, and advising
CDC on gaps in vaccine safety research; evaluatin g the risk/benefit profiles of vaccines based on
ongoing surveillance and new research findings; cons idering analysis of cumulative effects of
vaccines and their constituent components; engaging in re-analysis of vaccine safety and efficacy
as gaps are identified and new information be comes available; and evaluating the risks and
benefits of tailoring immunization practices to maximize benefits and reduce risks and take into
account variability in immune response for various populations.  Furthermore, ACIP shall be
responsible for considering on an ongoing basis th e safety, efficacy, and public health impact of
new vaccines, as well as novel vaccine platfo rms such as mRNA vaccines; and evaluating
vaccines for new diseases or variants of con cern, ensuring that recommendations adapt to new
scientific evidence and evolving disease landscapes.  ACIP shall also be responsible for
reviewing global initiatives; and reviewing v accination schedules by other countries and
international organizations.

ACIP shall employ a transparent, evidence-driven decision-making process in developing
recommendations.  The Committee shall review cl inical data, listen to expert presentations, and
consult with subject matter expert s to determine the benefits and risks of vaccines.  ACIP
decisions shall be based on rigorous scientific an alysis and deliberation, with the goal of
recommending immunization practi ces that protect and improve public health in the United
States.

In accordance with Section 1928 of the Social Security Act, ACIP also shall establish and
periodically review and, as appropriate, revise the list of vaccines for administration to children
and adolescents eligible to receive vaccines through the Vaccines for Children Program, along
with schedules regarding the appropriate dose and dosing interval, and contraindications to
administration of the pediatric vaccines.  The Se cretary, and as delegated by the CDC Director,
shall use the list established by ACIP for th e purpose of the purchase, delivery, and
administration of pediatric vaccines in the Vaccines for Children Program.

Further, under provisions of the Affordable Care Act (Section 2713 of the Public Health Service
Act, as amended), immunization r ecommendations of the Committee that have been adopted by
the Director of the Centers for Disease Control and Prevention must be covered by applicable
health plans.

Agency or Federal Officer Receiving the Advisory Committee’s Advice/Recommendations .

The Committee reports to the CDC Director.  Th e CDC Director informs the HHS Secretary and
the Assistant Secretary for Health, HHS, of immunization recommendations provided by the
Committee.

Support.
 Management and support services shall be provided by the CDC’s: Office of the Chief of Staff;
National Center for Immunization and Respirator y Diseases; National Center for Emerging and
Zoonotic Infectious Diseases; and National Center  for HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention as instructed by the CDC Director, to support ACIP-related activities.

Estimated Annual Operating Costs and Staff Years.
 Estimated annual costs for operating the Commit tee, including (i) Federal personnel (3) and
other Federal internal costs are $1,080,340; (ii)  proposed compensation and travel expense
payments for up to 19 members is $42,750; and (iii) reimbursable costs are $83,106.

Estimated Number and Frequency of Meetings.

Meetings will be held at the discretion of the ACIP DFO in consultation with the Chair.

Meetings shall be open to the public except as determined otherwise by the CDC Director or
other official, to whom the authority has been delegated, in accordance with the Government in
the Sunshine Act (5 U.S.C. § 552b(c)) and Section 10(d) of the FACA (5 U.S.C. § 1009(d)).
Notice of all meetings shall be given to the public.

Duration.

Continuing.

Termination.

Unless renewed by appropriate action, ACIP will te rminate 2 years from the date this charter is
filed.

Membership and Designation.
 The Committee consists of up to 19 voting members, who are Special Government Employees,
including the Chair and Vice Chair.

Members shall be selected from authorities who are knowledgeable in the fields of medicine,
vaccines, immunization practices, immunology, toxicology, pediatric neurodevelopment,
epidemiology, data science, statistical analysis, heal th economics, recovery from serious vaccine
injuries, or public health; have expertise in the use of vaccines or other immunobiologic agents in
clinical practice or preventive medicine, have expertise with clinical or laboratory vaccine
research, or have expertise in assessment of v accine safety and efficacy.  The Committee shall
include a person(s) knowledgeable about consumer  perspectives and/or social and community
aspects of immunization programs.  Members sh all be deemed Special Government Employees.

The Committee also shall consist of non-voting ex-officio members from the Health Resources
and Services Administration, the U.S. Food and Drug Administration, Centers for Medicare and
Medicaid Services, National Institutes of He alth, Indian Health Service, and the National
Vaccine Program at HHS or their designees.

If fewer than a quorum of ACIP members are eligible to vote due to absence or a financial or
other conflict of interest, the DFO, or designee, shall have the authority to temporarily designate
the ex-officio members as voting members.

There also shall be 33 non-voting liaison repr esentatives from the American Academy of Family
Physicians; American Academy of Pediatrics; American Academy of Physician Associates;
American College Health Association; American College of Nurse Midwives; American College
of Physicians; American Geriatrics Society; America’s Health Insurance Plans; American
Immunization Registry Association; American Medical Association; American Nurses
Association; American Osteopathic Association; American Pharmacists Association; Association
of Immunization Managers; Association of Americ an Physicians and Surgeons; Association for
Prevention Teaching and Research; Association of State and Territorial Health Officials;
Biotechnology Innovation Organization; Council of  State and Territorial Epidemiologists;
Canadian National Advisory Committee on Immu nization; Infectious Diseases Society of
America; Independent Medical Alliance;  Interna tional Society of Travel Medicine; Medical
Academy of Pediatrics and Special Needs; Nati onal Association of County and City Health
Officials; National Association of Pediatric Nurse Practitioners; National Foundation for
Infectious Diseases; National Medical Assoc iation; Pediatric Infectious Diseases Society;
Pharmaceutical Research and Manufacturers of America; Physicians for Informed Consent;
Society for Adolescent Health and Medicine; and Society for Healthcare Epidemiology of
America.  Liaisons shall be deemed representatives.

Members, including the Chair and Vice Chair, sh all be selected by the HHS Secretary and shall
be invited to serve for overlapping terms of up to four years, except that any member appointed
to fill a vacancy for an unexpired term shall be appointed for the remainder of that term.  A
member may serve 180 days after the expiration of that member’s term if a successor has not
taken office.

Subcommittees.

Subcommittees composed of members of the parent committee and other subject matter experts
may be established with the approval of the HH S Secretary.  The subcommittees must report
back to the parent committee and do not provide advice or work products directly to the agency.
The Department Committee Management Officer will be notified upon establishment of each
subcommittee and will be provided infor mation on its name, membership, function, and
estimated frequency of meetings.

Filing Date.

April 1, 2026

APPROVED:

_________________________  __________________________________
Date      Robert F. Kennedy, Jr.

 March 31, 2026

Summary: CHARTER     ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES       Advisory Committee’s Official Designation.     Advisory Committee on Immunization Practices (ACIP or Committee).     Authority.     The ACIP was established under Section 222 of the Public Health Service Act (42 U.S.C. §2l7a),  as amended.  The Committee is governed by the provisions of the Federal Advisory Committee  Act (FACA), Public Law 92-463 (5 U.S.C. § 1001 et seq.), as amended.     The ACIP has been given statutory roles…


economics studies guidance

ACIP Guidance for Health Economics Studies
Guidance for Health Economics Studies P resented to the Advisory Committee on
Immunization Practices (ACIP)
Prepared by
The ACIP Ad Hoc WG on Economic Analyses
(Members listed alphabetically)
Tracy Lieu, M.D., M.P.H.
Professor and Director, Center for Child Health  Care Studies Departme nt of Ambulatory Care
and Prevention
Harvard Pilgrim Health Care and Harvard Medical School
ACIP Member July 2004-June 2008
Martin I. Meltzer, M.S., Ph.D.
Senior Health Economist & Distinguished Consultant
CDC/NCPDCID/DEISS
Mark L. Messonnier, M.S., Ph.D.
Lead Economist
CDC/NCIRD/ISD
11/13/2007 Page 1 of 9

 ACIP Guidance for Health Economics Studies
Guidance for Health Economics Studies P resented to the Advisory Committee on
Immunization Practices (ACIP)
Rationale for this guidance
The Charter of the Advisory Committee on Immuni zation Practices (ACIP) states that, when
considering recommendations for use of a vaccine , ACIP members’ deliberations should include
consideration of vaccine efficacy as well as cost:b eneft and risk:benefit anal yses.  In recent years
there has been a trend toward an increasing numbe r of economic studies of vaccines presented as
evidence for the Committee to consider.  Precedent has been established by journals such as the
British Medical Journal  and Vaccine , in that they have adopted standards by which editors and
reviewers should consider the quality of subm itted economic studies. The Academy of Managed
Care Pharmacy also has adopted guidelines for economic data submitted in support of formulary
consideration. This Guidance has been developed to help ensure the quality of economic data
presented to the ACIP and its work groups (WG).
To ensure the value and consistency of economi c data presented to the ACIP, WG chairs are
advised to involve CDC economists from the inception of the WG.  Participation of CDC
economists can be facilitated by the National Cent er for Immunization and Respiratory Diseases
(NCIRD) lead economist, who can coordinate such involvement.
Objective of this guidance
It would be impossible to provide  a set of standards for methods, inputs and values for inputs that
would cover all the diverse vaccin e-related issues that the ACIP considers. The objective of this
guidance is to provide a framework for the desc ription and presentation of methods used to
examine the economics of a vaccine-related issue, such that the ACIP readily can understand the
science of the analyses.  To ensure that su ch standards have been  achieved, this guidance
specifically incorporates technical  review of any economic material s that are to be presented to
the ACIP.
GUIDANCE
Materials to be presented
All researchers (internal or exte rnal to CDC) wishing to presen t a health economics study (either
new or revised/updated) to the ACIP (or one of  its WGs) shall present the following material:
1) Document or report providing methods and results The document should provide a
detailed description of the methods and results.  The level of detail s hould be similar to that
provided in a manuscript that would be submitted to a peer-reviewed journal.  However, the
document should not be bound by journal restricti ons on length of the methods and results
sections. There is no need for a detailed intr oduction section. The discus sion section typically
would be shorter than that found in a published manuscript.  Additional details regarding the
content of this document are provided below.
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                ACIP Guidance for Health Economics Studies
2) Slide sets and other presenta tion materials (e.g., handouts ) The principles and template
for slides intended for presentation to the AC IP which outline the methods and results, are
provided in the “Guidance: format for presentation of slides” section. Additional details regarding slide content also are provided ( See attached set of “template slides.”)
Timeline for materials to be made available and review process
The report, slides, and ot her presentation material must be submitted to the relevant ACIP WG
chair and CDC lead staff person no later than 8 weeks before the ACIP general meeting or WG
meeting at which the analysis is proposed to be presented. Under  extraordinary circumstance, an
appeal can be made to the WG chair, the CDC lead staff person, and the NCIRD lead economist
to submit the report fewer than 8 weeks before th e ACIP meeting. In case of  such an appeal, the
lead economist will document the justification an d granting of exceptions in collaboration with
the WG chair and the CDC lead staff person.
The NCIRD lead economist (or designee) will work with the WG chair and CDC lead staff
person to identify reviewers for an anonymous peer  review.  Non-CDC revi ewers may be used if
a particular area of e xpertise is not available among CDC ec onomists.  Reviewers will consult
with relevant CDC subject-matter experts and return comments a nd questions in writing to the
NCIRD lead economist (or designee) at least 4 weeks in advance of the formal presentation.
These comments will be forwarded to the WG ch air and CDC lead staff person who will forward
them to the appropriate WG members and to th e researchers submitting the economic analysis.
This process will allow time for at least one round  of comments and revisions or responses prior
to the formal presentation.  Th e relevant WG chair, the CDC lead staff person, and the NCIRD
lead economist (or designee) will determine if revisions and responses are sufficient to allow
presentation. If differences persist, the WG chair and the CDC lead staff person, in conjunction
with all members of the WG, w ill decide if the information w ill be presented to the ACIP.
Reviewer comments also will be provided to th e WG and the ACIP to explain the differences
that may exist.
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 ACIP Guidance for Health Economics Studies
GUIDANCE: Content of document
A document describing the methods and results of a health economics study for consideration by
the ACIP will contain the follo wing sections and elements:
1) Affiliations
All authors shall incl ude their affiliations.
2) Statements of conflict or po tential conflicts of interest
A separate section listing any potenti al conflicts of interest shall be  included for each author.  If
there are no potential conflicts of  interest, a statement to that effect must be included (e.g.,
Author A: No conflicts of interest).
METHODS
3) Methods: the study question
The study question must be explicitly stated in detail (e.g., In this study, we  present results of a
cost-effectiveness analysis of routinely vacci nating age group XX  against Disease Y, using
vaccine Z, using three doses given once per year over three consecutive years.)
4) Methods: the perspective
The study must be conducted from the societal perspective unless strong justification is provided
for doing otherwise.
Other perspectives may be in cluded when relevant justif ication is provided for their
consideration. The study perspective(s) must be explicitly stated  (e.g., “The perspective used in this study is
societal.”)
5) Methods: intervention strategies
Intervention strategies must be clearly identifi ed and completely described.  A baseline strategy
must be included.
Authors must describe all releva nt interventions.  If the analys is does not include all possible
interventions, the authors sha ll provide the rationale for including or excluding them.  For
example, the authors of an analysis of vaccinati on of adults against pert ussis would discuss the
rationale for inclusion or exclusion of a select ive strategy of vaccinati ng care providers of young
infants.
6) Methods: time frame and analytic horizon
The time frame and analytic horizon for each stra tegy must be defined clearly, complete with
appropriate justification (e.g., “W e analyzed benefits and cost s over a ten year period.  The
analytic horizon was selected because availabl e data suggest that af ter XX years, vaccine-
11/13/2007 Page 4 of 9

 ACIP Guidance for Health Economics Studies
induced immunity may wane to the point where a large proportion of vaccinees would require a
booster dose to maintain adequa te levels of immunity.”).
7) Methods: the economic model
a) The analytic method used must be specified (e.g., cost-benefit, cost-e ffectiveness, or cost-
utility analysis).  The summary me asure must be defined/ identified.
b) The basic model used in the analysis must  be explained in the text without use of
mathematical notation. Authors may consider en hancing the written desc ription with a word
“equation”. If deemed necessary by the author s, an equation, or se t of equations, using
mathematical notation also can be provided in a technical appendix.
8) Methods: health outcomes of interest Health outcomes must be clearly identified (e.g., deaths, hospitalizati ons, outpatient visits,
quality adjusted life years).
Authors must ensure that health outcomes are re levant to the perspective.  Although almost any
health outcome may be relevant for a societal  perspective, some health outcomes may be
irrelevant for any additional perspectives.
9) Methods: inclusion of epidemiologic models
When an epidemiologic model is an integral part  of a health economics study to be presented to
the ACIP, the authors shall include a descripti on of the model.  The authors must include a
schematic diagram illustrating the model. Annotat ion in such a diagram must be done without
use of mathematical notation. Authors are directed to ensure that such schematic diagrams can be
readily understood without extensive reading of  the main text (i.e., can “stand alone”).
The authors must state the time step used in the epidemiologic model. “Time step” refers to the
time associated with the probabi lities used in the model. For example, if the authors use
probabilities of death per unit population per year, then the de facto  time step of such a model
would be one year. Probabilities, and time step, can be in almost any unit of time. The total
number of time steps must match the time fr ame of the economic model unless a specific
explanation is given.
Authors should note that it is insufficient mere ly to reference another source (e.g., reference a
previously published paper).
10) Methods: Inputs: values and sources
a) Probabilities: Values and sources must be  presented. Authors mu st make sure that
probabilities used in the analysis are “reasonable.”
b) Costs: Values and sources must be presen ted. The study shall differe ntiate between direct
medical, direct non-medical, indire ct (i.e., productivity), and in tangible costs (included when
relevant). The year of cost data also must be st ated.  Authors must make sure that included costs
are relevant to the stated perspective.
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 ACIP Guidance for Health Economics Studies
c) Other inputs:  Values and sources of any othe r inputs (e.g., Quality Adjusted Life Years) must
be presented.
Each value used in the model must  have at least one clearly identi fied source.  Values that are
assumed, or calculated (e.g., a resi dual probability), or the results of expert opinion shall be
identified as such. Authors are advised that the grea test clarity is often achieved by presenting all input values and
sources in tabular format.  Such tables must in clude sufficient footnotes to enable a reader to
readily understand the table without extensive reading of the main text (i.e., such tables must
“stand alone”).
11) Methods: discounting
All future costs and benefits shal l be discounted to present value.  This includes future health
outcomes (e.g., future lives saved must be discounted to present).
The discount rate used must be specified, and au thors must ensure that  the discount rate is
relevant to the stated perspective.
12) Methods: sensitivity analyses
The general goal of sensitivity an alyses is to demonstrate how conclusions might change with
changes in input values.
Sensitivity analyses, including appropriate thresh old analyses, shall be conducted and reported
on cost and incidence variables. The type of sensitivity analysis conduc ted must be described.
Authors are strongly encouraged to conduct sensitivity analyses that allow them to identify
which variables within the model are most influential in determining the overall results. The ranges and sources of the values used in the sensitivity analyses must be clearly reported.
Authors shall report values used in sensitivity an alyses in the same table in which they report
values of all inputs (see Point 10). Univariate sensitivity analyses (altering only one value at a time,  and keeping all other values
fixed at original values ) are unlikely to be considered adequa te. Authors shall present some form
of multivariate sensitivity analysis or an explan ation as to why such analysis is not presented.
Authors must use sensitivity analysis ranges that  are based on clinical ly relevant or policy
relevant cutoffs rather than those based on arbitr ary changes in input values (e.g., plus or minus
10% of initially used values). As a form of sensitivity analysis, in addition to presenting results that have been discounted to
present values (see Point 11), undiscounted costs and benefits may be presented.
13) Methods: independent replication
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 ACIP Guidance for Health Economics Studies
In general, information must be presented  that would allow a researcher, with sufficient interest
and relevant skills, to inde pendently replicate the study..
In order to meet such a standard, where necessa ry, authors may provide additional details in a
technical appendix.
RESULTS
14) Results: summary measures
Results that answer the study question must be identified. Th e summary economic measure(s)
that answers the study question must be presented.
The summary measure must be appropriat e for the perspective used in the study.
If deemed necessary, authors also may wish to present other results calculated during the
analysis, such as total number of cases averted.
15) Results: tables and graphs
All tables and graphs used to present result s must be readily understood without extensive
reading of the main text (i.e., such graphs and tables can “stand alone”). Authors must include
footnotes that will help a read er understand each table and graph.
Tables and graphs must add value to the report.  Graphs or tables that c ontain results not central
to the summary measure (see Point 16) ma y be included in a technical appendix.
Graphs shall be drawn using the standard guidelines for graphical representation of data.
Detailed guidelines can be found in texts such as Tufte (Tufte ER. The Visual Display of
Quantitative Information . Graphics Press, Cheshire Connect icut, 1983: pp. 197).  Examples of
such guidelines include:
1) Pie charts are almost always unacceptable.
2) Horizontal and vertical grid lines usually are not needed.
3) For line charts, typically only 4 lin es (variables) drawn per chart.
4) For column and bar charts, typically only 4 bars (variables) included per chart. Avoid
using “stacked” bars or columns (e.g., a column  that has several elements that add to
100%).
5) To allow easy printing and copying, graphs and figures should be drawn in gray-
scale. Color in graphs and figures should be used sparingly, if at all.
16) Results: sensitivity anal yses and influential variables
Authors shall present their sensit ivity analyses in a clearly id entified section, complete with
relevant tables and graphs.
Authors shall, whenever possible, present a list of “most influential” variables as identified
through sensitivity analysis (see Point 12).
DISCUSSION
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  ACIP Guidance for Health Economics Studies
17) Discussion: overall
The discussion section should be more limited than that typically found in a peer-reviewed
manuscript.
18) Discussion: limitations
Study limitations must be discussed.  Limitations shall include accuracy of any epidemiologic
model and input data (see Points 9 and 10).
Any implicit assumptions, such as an adequa te supply of vaccine, should be mentioned.
19) Discussion: relation to other relevant studies
Results must be discussed in relation to other similar studies if such studies are available.
20) Discussion: how results may change
There must be an explicit discussion, typically  drawing from the results of the sensitivity
analyses, of how results would change if ke y assumptions or valu es were to change.
21) Discussion: no policy implications Unless otherwise requested by the relevant WG ch air, the report must NOT include a discussion
of the policy implications of the results and limitations.  Because it is CDC’s and ACIP's
responsibility to make policy interpretations, such discussion will be deleted if included in the
document distributed for ACIP discussion, unless the WG chair specifically requests it be
included.
22) Details not addressed in this guidance
For further guidance regarding methods a nd results, researchers may follow the
recommendations described in the follo wing standard texts (or equivalent):
1) Prevention Effectiveness: A Guide to D ecision Analysis and Economic Evaluation, 2d . Ed.
Anne Haddix, Steven Teutsch, and Phaedra Cors o, editors. (New York:  Oxford University
Press, 2003)
2) Cost-Effectiveness in Health and Medicine.  Joanna Siegel, Louise Russell, Milton Weinstein,
and Marthe Gold, editors. (New York: Oxford University Press, 1996).
23) Additional information
1) Link to the Community Guide Economic Eval uation abstraction form  where all of the
important components of an EE analysis are pres ented.  The form has a quality rating of EEs at
the end. www.thecommunityguide.org/methods/econ-abs-form.pdf
2) Many standards for conducting economic eval uations are also on the CDC on-line Economic
Evaluation course. www.cdc.gov/owcd/EET/Preface/Preface.html
3) The Guide to Community Preventive Servi ces book, chapter 11 is titl ed “Interpreting and
Using Economic Evidence”.
11/13/2007 Page 8 of 9

  ACIP Guidance for Health Economics Studies
4) Detsky AS, Laupacis A. Relevance of cost-eff ectiveness analysis to clinicians and policy
makers. JAMA. 2007;298:221-4.
GUIDANCE: format for presentation of slides
Principles for presenting a health economics study to ACIP:
After the document has been peer-reviewed internally, and the WG chair and CDC lead staff
person have reviewed and discusse d the contents of the document a nd the relevant analysis, they
will decide whether to proceed with invi ting a presentation to the ACIP or WG.
It is realistic to assume that many ACIP members will not have had the opportunity to read the document.  Further, the ACIP general meetings (but not WG meetings) are open to the public.  Thus, the presenter of the health economics study should realize that most of the audience at the
presentation will not be aware of the study, and that the audience members have diverse
backgrounds. Further, especially fo r presentations at an ACIP gene ral meeting, it is likely that a
relatively short amount of time will be allotte d for the presentation, typically 20-30 minutes
including time for questions. A presentation made in the closed setting of a WG teleconference
or meeting may be longer and more detailed.
Template slides:
The attached set of template slides provides an outline of the type of slides and suggested layout
of each type of slide. The subj ect matter of the slides in the template is designed so that a
presenter can be assured of presenting the main f acts as they relate to the methods, results and
limitations of the study.
11/13/2007 Page 9 of 9

Summary: ACIP Guidance for Health Economics Studies  Guidance for Health Economics Studies P resented to the Advisory Committee on  Immunization Practices (ACIP)  Prepared by  The ACIP Ad Hoc WG on Economic Analyses  (Members listed alphabetically)  Tracy Lieu, M.D., M.P.H.  Professor and Director, Center for Child Health  Care Studies Departme nt of Ambulatory Care  and Prevention  Harvard Pilgrim Health Care and Harvard Medical School  ACIP Member July 2004-June 2008  Martin I. Meltzer, M.S., Ph.D. …


11 COVID Moulia 508

cdc.gov/coronavirus
Myocarditis and COVID- 19
Vaccine Intervals:
International Data and Policies
Danielle Moulia, MPH
ACIP MeetingFebruary 4, 2021
Discussion background and framework
Goal: Examine international data and policies on preferential
recommendations of an mRNA vaccine product or extended primary series
intervals as they relate to myocarditis and/or pericarditis*
Discussion framework
International data on risk of myocarditis by mRNA vaccine product, focusing on the highest risk group – young males post dose 2
International data on extended primary series interval: risk of myocarditis
and vaccine effectiveness
International policies and recommendations
* Myocarditis and/or pericarditis will be referred to generally as “myocarditis,” unless a specific study is being referenced.
International Data on Risk of Myocarditis
by mRNA Product
US:Summary of findings
VAERS : National, passive surveillance
Among males ages 18 –24 years , the myocarditis* reporting rate after a
second dose of Moderna was 40 per million
VSD: Nine integrated healthcare organizations, active surveillance
Among males ages 18 –39 years , the myocarditis/pericarditis** rate after a
second dose of Moderna was 1.5x (aRR‡: 1.5 [0.86–2.61]) than Pfizer
*As of January 13th, 2022; CDC case definition; 7 -day risk period; **As of January 15th, 2022; CDC case definition, 7 -day risk period
‡Adjusted for VSD site, age, sex, race/ethnicity, and calendar date
VAERS: Vaccine Adverse Events Reporting System VSD: Vaccine Safety Datalink
Source: Su J.  Myopericarditis following mRNA COVID -19 vaccination: Updates from the Vaccine Adverse Event Reporting System (VAERS). Sl ides presented to ACIP WG Dec 17, 2020.
Klein, N. Myocarditis Analyses in the Vaccine Safety Datalink: Rapid Cycle Analyses and “Head -to-Head” Product Comparisons. Slid es.
Canada: Summary of findings
Abraham et al . CAEFISS, passive and enhanced surveillance data
Among males ages 18 –29 years the myocarditis/pericarditis* reporting rate
after a second dose of Moderna ( 140 per million doses ) was ~5x(aRR‡: 4.73
[3.19–7.20]) higher than Pfizer ( 25 per million doses )
Buchan et al . Ontario, period of enhanced passive surveillance
Among males ages 18 –24 years, the myocarditis/pericarditis** reporting rate
after a second dose Moderna ( 300 per million doses ) was ~5xhigher than
Pfizer ( 59 per million doses )
*From December 1, 2020 to October 8,2021;  Myocarditis/pericarditis meeting level 1 -4 of the Brighton Collaboration case definiti on, 7 day risk period ** From December 14, 2020 to
September 4, 2021, myocarditis/pericarditis meeting level 1 -4 of the Brighton Collaboration case definition, study length risk period; ‡Poisson model conditioned by week
CAEFISS: Canadian Adverse Events Following Immunization Surveillance System
Source: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3988612 .Accessed 1/23/2022
https://www.medrxiv.org/content/10.1101/2021.12.02.21267156v1.article -metrics .Accessed 1/23/2022
United Kingdom: Summary of findings
Yellow Card reporting : Passive and active surveillance of adverse events
Among persons ages 18 –29 years , the myocarditis and pericarditis* reporting
rate after a second dose of Moderna ( 71 per million doses) was ~2.5x higher
than Pfizer (24 per million doses)
Patone et al: Self-controlled case series of myocarditis** hospitalizations in the
UK
Among males ages <40 years, additional events of myocarditis after a second
dose of Moderna ( 101 per million doses) was >8x than Pfizer (12 per million
doses )
*As of January 19, 2022, reports of suspected myocarditis and pericarditis associated with COVID -19 vaccines ; ** As of November 15, 2021, inpatient admission or death due to
primary and secondary ICD -10 of myocarditis, 28 day risk period
Source: https://www.gov.uk/government/publications/coronavirus -covid -19-vaccine -adverse -reactions/coronavirus -vaccine -summary -of-yellow -card -reporting#yellow- card -reports .
Accessed 1/22/2022.
Patone M. 2021 MedRxiv preprint. https://www.medrxiv.org/content/10.1101/2021.12.23.21268276v1.full.pdf . Accessed 1/22/2022.
Nordic Countries : Nordic cohort, myocarditis results
Presented to VaST on 1/10/2022
All residents ages 12 years and older in Denmark, Finland, Norway, and
Sweden (23.1M) from December 2020 –October 2022
Inpatient care for myocarditis and pericarditis
Within a 7 -day risk period after either dose, the rate ratio of myocarditis
for Moderna vaccine vs. an unvaccinated comparator was higher than
Pfizer vaccine vs. an unvaccinated comparator
–The highest rate ratios observed were among those receiving a
second dose of Moderna in a heterologous mRNA primary series
VaST: Vaccine Technical Advisory Workgroup
Source: Hovi et al., Slides not publicly available.
Denmark: SARS -CoV-2 vaccination and myocarditis or
myopericarditis: population -based cohort study
Design: Retrospective cohort
Period: October 2020 –October 2021
Population: 5M persons living in Denmark ages ≥12 years
Outcome: Hospital diagnosis of myocarditis or pericarditis, increased
troponin levels, and a hospital stay lasting >24 hours, 28 -day risk period
Adjusted using: Cox proportional hazard model with covariates for age,
sex, vaccine priority group, season, and clinical comorbidities
Source: Husby et al., SARS -CoV-2 vaccination and myocarditis or myopericarditis: population -based cohort study BMJ 2021; 375 :e068665 doi:10.1136/bmj -2021- 068665
Denmark: SARS -CoV-2 vaccination and myocarditis or
myopericarditis: population -based cohort study
Population Product Absolute Rate per
100,000 dosesaHR, Unvaccinated
Comparator
12–39 years Pfizer, after any dose 1.6 (1.0 to 2.6) 1.48 (0.74 to 2.98)
Moderna, after any dose 5.7 (3.3 to 9.3) 5.24 (2.47 to 11.12)
Males, ≥12
yearsPfizer, after any dose 1.5 (1.0 to 2.2) 0.82 (0.50 to 1.34)
Moderna, after any dose 6.3 (3.6 to 10.2) 3.22 (1.75 to 5.93)
Females, ≥12
yearsPfizer, after any dose 1.3 (0.8 to 1.9) 3.73 (1.82 to 7.65)
Moderna, after any dose 2.0 (0.7 to 4.8) 6.33 (2.11 to 18.96)
Males, 12 –39
yearsPfizer, post dose 2 1.8 (0.8 to 3.4)* 1.54 (0.62 to 3.81)*
Moderna, post dose 2 9.4 (5.0 to 16.0)* 9.80 (4.20 to 22.84) *
*conducted as part of a post hoc analysis
aHR: Adjusted hazards ratio. Adjusted for age, sex, vaccine priority group, season, and clinical comorbidities.
Source: Husby et al., SARS -CoV-2 vaccination and myocarditis or myopericarditis: population -based cohort study. BMJ 2021; 375: e068665 doi:10.1136/bmj -2021- 068665.
France and Germany : Summary of findings
Germany :National, passive surveillance
Among males ages 18 –29 years, the myocarditis/pericarditis*
reporting rate after any dose of Moderna ( 117 per million doses)
was >2x higher than Pfizer ( 47 per million doses )
France :Regional, enhanced passive surveillance
Among males ages 18 –24 years, the myocarditis** reporting rate
after a second dose of Moderna ( 139 per million doses) was ~3x
higher than Pfizer (43 per million doses )
*As of September 30, 2021; all reports post mRNA vaccination; **As of September 20, 2021; all reports post mRNA vaccine
Source: https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2021/Ausgaben/46_21.pdf . Accessed 1/23/2022.
https://www.omedit -auvergne -rhone -alpes.ars.sante.fr/index.php/system/files/2021 -10/ANSM_Rapport_CRPV_Moderna_22102021.pdf . Accessed 1/23/2022.
https://ansm.sante.fr/uploads/2021/10/22/20211021- covid -19-vaccins -pfizer -focus -1-2.pdf . Accessed 1/23/2022.
Myocarditis rate ratios (Moderna vs. Pfizer) country,
subgroup, and dose
Klein, USA, M 18 –39y, post dose 2₽Buchan, Canada -Ontario, M 18 –24y, post dose 2*
France, M 18– 24y, post dose 2*Abraham, Canada , M 18 –29y, post dose 2‡
Husby , Denmark, M 12 –39y, post dose 2*
Rate Ratio0 5 10 15 20
*Unadjusted rate ratio; ‡Adjusted with a Poisson model conditioned by calendar week of vaccine administration; ₽ Adjusted for VSD site, age, sex, race/ethnicity, and calendar date
Source . Husby et al., SARS -CoV-2 vaccination and myocarditis or myopericarditis: population -based cohort study. BMJ 2021; 375: e068665 doi:10.1136/bmj -2021- 068665
https://ansm.sante.fr/uploads/2021/10/22/20211021- covid -19-vaccins -pfizer -focus -1-2.pdf. Accessed 1/23/2022 .
Klein, N. Myocarditis Analyses in the Vaccine Safety Datalink: Rapid Cycle Analyses and “Head -to-Head” Product Comparisons. Slid es.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3988612 .Accessed 1/23/2022
https://www.medrxiv.org/content/10.1101/2021.12.02.21267156v1.article -metrics .Accessed 1/23/2022
Summary of findings: Myocarditis risk by mRNA product
Risk of myocarditis may be higher for Moderna than Pfizer vaccine
Limitations: observational data; rates not readily comparable due to
differences in:
–Case definition and risk interval length
–Subpopulations
–Case ascertainment
–Calendar time and vaccine implementation factors, including extended primary series intervals
A limited number of geographic locations are administering both Moderna and Pfizer and had data available.
International Data on Risk of Myocarditis
with an Extended Primary Series Interval
Ontario, Canada : Myocarditis/pericarditis by interval
Design: Retrospective, population- based cohort, using provincial vaccine registry
and passive vaccine safety surveillance
Period: December 14, 2020 to September 4, 2021
Population: Adults ages ≥18 years receiving dose 2 on or after June 1, 2021 in
Ontario; 19,740,741 doses of mRNA vaccines
Outcome: Myocarditis/pericarditis meeting level 1 –3 of the Brighton Collaboration
case definition
Analysis: Crude reporting rates; overall rate following dose 2 by product estimated
using Poisson regression, adjusted for dose 1 product and interval
–Dosing intervals : ≤30 days (≤4 weeks), 31 –55 days (5– 7 weeks), ≥56 days (≥8
weeks)
Source: Buchan S et al. Dec 2021, MedRxiv preprint.
Ontario, Canada: Reporting rate of myocarditis/pericarditis per million
doses among males ages 18 –24 years by vaccine product* and interval
Source: Buchan S et al. Dec 2021, MedRxiv preprint.
*Moderna -Pfizer not shown here because there were no reported events in males ages 18 –24 years; a smaller number of males in this age group received this schedule (n=8,853).020040060080010001200140016001800
≤4 weeks 5-7 weeks ≥8 weeks ≤4 weeks 5-7 weeks ≥8 weeks ≤4 weeks 5-7 weeks ≥8 weeks
Pfizer —Pfizer Moderna —Moderna Pfizer —ModernaRate (95% CI) per million doses
Males ages 18 -24 y n=235,819 n=93,616 n=85,893
Summary of data: Myocarditis risk with extended
primary series interval
Rates of myocarditis may be lower with extended primary
series interval
Reduced rates of myocarditis with extended interval were
observed with Moderna and Pfizer vaccines
Source : Buchan S. Dec 2021, MedRxiv preprint.
International Data on Vaccine Effectiveness
with an Extended Primary Series Interval
British Columbia and Quebec, Canada: Vaccine
effectiveness by primary series interval
Design: Test-negative case -control design to estimate vaccine effectiveness
Period: May 30 to October 2, 2021
Population: Community -dwelling adults ages ≥18 years in British Columbia (BC) and
Quebec, Canada; 1,235,447 specimens, including 44,673 test -positive cases and
2,460 hospitalizations
Outcome: Infections and hospitalizations due to SARS -CoV- 2, confirmed by RT -PCR
Analysis: Multivariable logistic regression to estimate odds ratios:
–Adjusted for age group (18 –49, 50– 69, 70– 79, ≥80 years); sex; epi week of the
analysis period (weeks 22 –39, categorical); and region of the province
–Dosing intervals: 3 –4 weeks, 5 –6 weeks, 7 –8 weeks, 9 –11 weeks, 12– 15 weeks,
16+ weeks
Source: Skowronski DM. 2021, MedRxiv preprint .
85 8591 91
8891 9193979998
959498
50556065707580859095100
0 2 4 6 8British Columbia
VE against infection VE against hospitalizationBritish Columbia and Quebec, Canada: Vaccine
effectiveness of any two doses of mRNA vaccines by
primary series interval
Source: Skowronski DM. 2021, MedRxiv preprint . 3–4w    5– 6w     7– 8w    9– 11w    12– 15w  ≥16w ≥7w
Time between dose 1 and dose 2 (weeks)Adjusted two dose VE (%: 95% CI)
VE against infection VE against Hospitalization798589 89 89908987979897969597
50556065707580859095100
0 1 2 3 4 5 6 7 8Quebec
3–4w    5– 6w     7– 8w    9– 11w    12– 15w  ≥16w ≥7w
Time between dose 1 and dose 2 (weeks)
England: Serological responses and vaccine
effectiveness by primary series interval
Design: Test-negative case -control design to estimate vaccine effectiveness
Period: October 2020 to June 2021
Population: Symptomatic adults ages ≥50 years attending community testing (n=308,764
unvaccinated persons; n=16,237 persons received Pfizer primary series vaccine); serological
responses of 421 immunocompetent adults ages 50 –89 years given two doses of Pfizer at
different intervals
Outcome: Testing SARS -CoV -2 positive by PCR through NHS, following COVID -19 compatible
symptoms; serological responses 14 –34 days post -dose 2
Analysis: Logistic regression to estimate odds ratios by vaccination status
–Adjusted for a week of onset, age group, gender, region, index of multiple deprivation, ethnicity,
health/social care worker, care home resident, flagged as clinically at extremely increased risk for COVID -
19 illness, and flagged as extended risk groups among adults ages <65 years
–Dosing intervals: 3 –4, 5–6, 7–8, 9–12 and > 12weeks
Source: Amirthalingam G. 2021, Nat Commun.
Pfizer vaccine
effectiveness against
symptomatic SARS -
CoV-2 infection was
higher with an extended interval (>6
weeks) compared to a
standard interval (3– 4
weeks) for all age groups.
Source: Amirthalingam G. 2021, Nat Commun.
Age:   ≥80 ≤Jan4  |         ≥80 >Jan 4        |             65 –79             |          50 –64
100%
90%
80%
70%
60%
50%
40%30%
20%
10%0%Post Dose 2 Vaccine Effectiveness (95% CI)
3-4              9- 12         | 3 -4                 9- 12  >12 | 3- 4        7- 8   9- 12  >12 |  3 -4  5- 6  7- 8  9- 12  >12
Interval between Dose 1 and 2 (weeks)England:
Pfizer vaccine
effectiveness by
primary series
interval
Summary: Immunogenicity with extended primary
series interval
Payne et al. (UK ): Among SARS- CoV- 2 infection naïve persons in an observational
cohort, serological responses were higher after an extended dosing interval (6 –14
week) compared to a standard interval (3 –4 week).
–Among persons with an extended interval, there were higher antibody and B
cell responses, as well as sustained B and T cell responses, compared to a
standard interval.
–An extended interval may promote efficient T cell expansion and long -term
memory cell persistence.
Amirthalingam et al. (England), Parry et al. (England), & Grunau et al (Canada):
Neutralizing antibody titers were higher following an e xtended dosing interval with
mRNA vaccine, compared to a standard interval.
Source: Payne R. 2021, Cell.; Amirthalingam G. 2021, Nat Commun.; Parry  H. 2022, Npj Vaccines.; Grunau B. 2022, Clin Inf Dis.
Summary of data: Vaccine effectiveness with extended
primary series interval
Extended primary series interval may improve immunogenicity and
vaccine effectiveness.
–Neutralizing antibody titers were higher following an e xtended dosing interval
(6–14 week) with mRNA vaccine, compared to a standard interval (3 –4 week). 1-4
–mRNA vaccine effectiveness against infection and hospitalization was 5 –10%
higher with an extended interval (7 –8 weeks vs. 3 –4 weeks). 5
Limitation: Data collected prior to Omicron surge
1 Payne R. 2021, Cell.
2Grunau B. 2022, Clin Infect Dis.
3 Amirthalingam G. 2021, Nat Commun
4Parry  H. 2022, Npj Vaccines
5Skowronski DM. 2021, MedRxiv preprint .
International Policies and
Recommendations
Canada
NACI strongly recommends a complete mRNA COVID- 19
vaccine series for persons ages ≥12 years.
–Ages 12 –29 years: Pfizer is preferred for the primary series.
–Ages 18 –20 years: Pfizer may be preferred for a booster.
mRNA vaccine productImmunization
scheduleMinimum
intervalAuthorized intervalOptimal interval
Pfizer -BioNTech
Comirnaty2-dose schedule 19 days 21 days 8 weeks
Moderna Spikevax 2-dose schedule 21 days 28 days 8 weeks
Source: National Advisory Committee on Immunization: Updated Guidance on the use of COVID- 19 Vaccines. (slides)
https://www.canada.ca/en/public -health/services/diseases/coronavirus -disease -covid -19/vaccines/safety- side-effects.html#myocardi tis-and-pericarditis . Accessed 1/23/2022
https://www.canada.ca/en/public -health/services/publications/healthy -living/canadian -immunization -guide -part-4-active -vaccines/p age-26-covid -19-vaccine.html#a5.4 . Accessed 2/1/2022.
United Kingdom
Preferential recommendation for Pfizer in persons ages 12–17
years
Interval : at least 8 weeks
–Ages 16–17 years, at higher risk*: at least 8 weeks
–Ages 16–17 years, not at high risk: 12 week
–Ages 12–15 years, higher risk of severe COVID- 19: at least 8 weeks
–Ages 12–15 years, contact of immunosuppressed person: 8 weeks
–Ages 12–15 years, not high risk, no contacts: 12 weeks
*In a recognized clinical risk group (see table 3) and those who work in health and social care should receive two doses of vac cine at an interval of at least eight weeks. This includes those
aged 16 to 17 years who expect to share living accommodation on most days (and therefore for whom continuing close contact is unavoidable) with individuals of any age who are
immunosuppressed
Source: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1045852/Greenbook- chapter -14a-11Jan22.pdf .   Accessed 1/22/2022
Nordic countries
Sweden : Pfizer is recommended for persons ages 12 –30 years over Moderna.
Interval : 3–4 weeks
Norway : Pfizer should be offered to persons ages 12 –30 years. Children and
adolescents ages 5 –15 years may receive 1 or 2 doses based on parents' decision;
persons ages ≥ 16 years should receive 2 doses
Interval : 3–12 weeks
–Persons ages 16 –18 years: 8– 12 weeks
–Children ages 5 –15 years with severe underlying conditions: 8 –12 weeks, but
can be adapted down to 3 weeks based on medical assessment
Source: https://www.fhi.no/en/id/vaccines/coronavirus -immunisation -programme/coronavirus -vaccine/#vaccination -of-children -and- adolescents . Accessed 1/22/2022
https://www.lakemedelsverket.se/en/coronavirus/covid -19-vaccine . Accessed 1/23/2022
https://thl.fi/en/web/infectious -diseases- and-vaccinations/what -s-new/coronavirus -covid -19-latest -updates/vaccines -and-coronavir us/getting -vaccinated -against -covid -19-how- why-and- when-
https://www.sst.dk/en/English/Corona -eng/Vaccination -against -covid -19/COVID -19-vaccines -in-Denmark
Nordic Countries
Finland : Boys and men ages 12 –30 years only offered Pfizer. Girls and
women ages >12 years are offered Pfizer or Moderna.
Interval : 6–12 weeks for persons ages ≥5 years
Denmark : Both Pfizer and Moderna vaccines are approved for persons
ages ≥12 years.
Interval : 3–6 weeks (median interval: 5 weeks)
Singapore and Taiwan
Singapore : Children under age 18 years should receive Pfizer vaccine.
Interval : At least 21 days; guidance notes myocarditis risk may decrease with
a longer interval, but encourages a second dose at 21 days due to Omicron
Taiwan : Both Pfizer and Moderna vaccines are approved for persons ages
≥12 years.
Interval : At least 12 weeks
Source: https://www.cdc.gov.tw/En/Bulletin/Detail/YPIDZwC4HjqBMtGi4jynHQ?typeid=158 . Accessed 1/31/22
https://www.moh.gov.sg/covid -19/vaccination/faqs ---children -related -vaccination -matters . Accessed 1/31/22
Australia
Both Pfizer and Moderna vaccines are approved for persons ages 12
years and older.
Interval : At least 3 weeks (Pfizer) or 4 weeks (Moderna)
–Children ages 5 –11 years (Pfizer): 8 weeks
•Can be shortened in special circumstances to a minimum of 3 weeks, such as in an outbreak response, prior to the initiation
of significant immunosuppression, or international travel
Source: https://www.health.gov.au/initiatives -and- programs/covid -19-vaccines/advice -for-providers/clinical- guidance/doses -and-administra tion. Accessed 1/30/2022.
https://www.health.gov.au/sites/default/files/documents/2021/12/atagi -recommendations -on-pfizer -covid -19-vaccine -use-in-children -aged -5-to-11-years_0.pdf . Accessed 1/30/2022.
France and Germany
France : HAS recommends persons under the age of 30 years be
given Pfizer over Moderna when available.
Interval : 6 weeks
Germany : STIKO recommends persons under the age of 30
years be given Pfizer over Moderna.
Interval : 3–6 weeks
HAS: Haute Autorité de Santé; STIKO: Standing Committee on Vaccination
Source: https://www.nitag -resource.org/sites/default/files/2021 -12/48_21.pdf . Accessed 1/23/2022.
https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2021/46/Art_03.html . Accessed 1/23/2022.
https://www.reuters.com/business/healthcare -pharmaceuticals/french -health- authority -advises -against -moderna -covid -19-vaccine -under -30s-2021- 11-09/. Accessed 1/23/2022.
Limitations
Not a systematic review; data are biased toward findings that influenced
national vaccine policy
Limited number of countries are administering both Moderna and Pfizer
Caution should be used when comparing myocarditis/pericarditis rates across studies as surveillance systems, case definitions and risk intervals,
subpopulation age ranges, and vaccine implementation differ substantially
National vaccine policies have evolved; some policies extending the primary
series interval evolved from implementation strategies to reach the most people with a first dose
Conclusion
Observational data suggest myocarditis/pericarditis may be associated with
–Moderna vs. Pfizer in persons ages 18 –29 years, especially males
–Shorter primary series interval
Several countries have implemented policies or recommendations to
lengthen the interval between doses (range: 6 -12 weeks) in the primary
series and/or preferentially recommend use of Pfizer among males and/or
persons aged <30 years, which may mitigate the risk of
myocarditis/pericarditis and improve vaccine effectiveness
Acknowledgements
Katie Curran
Sara Oliver
Megan Wallace
Monica Godfrey
Amy Blain
Amimah Asif
Sarah Mbaeyi
Evelyn Twentyman
Tara Jatloui
Susan Goldstein
Jack Gersten
Jefferson Jones
Eddie Shanley
Anthony FioreStephen Hadler
Valerie Morelli
JoEllen Wolicki
Elisha Hall
Erin Ricketts
Faisal Minhaj
Heather Scobie
VTF ACIP WG Team
ACIP COVID -19 Vaccines Work Group
Vaccine Task Force
Epi Task Force
Data Analytics and Visualization Task Force
Respiratory Viruses Branch
For more information, contact CDC
1-800- CDC- INFO (232- 4636)
TTY:  1 -888- 232- 6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Summary: cdc.gov/coronavirus Myocarditis and COVID- 19  Vaccine Intervals:  International Data and Policies Danielle Moulia, MPH ACIP MeetingFebruary 4, 2021 Discussion background and framework Goal: Examine international data and policies on preferential  recommendations of an mRNA vaccine product or extended primary series  intervals as they relate to myocarditis and/or pericarditis*  Discussion framework International data on risk of myocarditis by mRNA vaccine product, focusing on the highest…


04 COVID Kracalic 508

cdc.gov/coronavirusMyocarditis Outcomes Following mRNA
COVID -19 Vaccination
Preliminary Data: data are subject to change
Advisory Committee on Immunization Practices
February 4, 2022
Ian Kracalik PhD MPH
Vaccine Safety Team
CDC COVID-19 Vaccine Task Force
Disclaimer
The findings and conclusions in this report are those of the authors
and do not necessarily represent the official position of the Centers
for Disease Control and Prevention (CDC)
Mention of a product or company name is for identification purposes only does not constitute endorsement by CDC or FDA
2
Myocarditis following mRNA COVID -19 vaccination
Evidence from safety monitoring systems in multiple countries supports the
finding of an increased, but still rare, risk of myocarditis following mRNA COVID -
19 vaccination*
•Risk:
‒Highest in adolescents and young adults
‒Males > females
‒Following dose 2 > dose 1
•Onset within a few days of vaccination, mostly within a week
•Severity of cases varies; most who presented to medical care have responded
well to medications and rest
•Assessment of myocarditis health effects after COVID -19 vaccination in
progress 3 * https://www.who.int/news/item/09 -07-2021- gacvs -guidance -myocarditis -pericarditis -covid -19-mrna -vaccines
CDC enhanced surveillance for myocarditis outcomes after
mRNA COVID- 19 vaccination in Vaccine Adverse Event
Reporting System (VAERS) case reports*
4Purpose: Assess functional status and clinical outcomes among individuals
reported to have developed myocarditis after mRNA COVID -19 vaccination
Methods: A two -component survey conducted at least 90 days after the onset
of myocarditis symptoms
•Patient survey: Focused on 12 –29 years of age, ascertain functional status, clinical
symptoms, quality of life, and need for medication or other medical treatment
•Healthcare provider (e.g., cardiologist): Gather data on cardiac health and
functional status
Timeline: Data collection August 2021–January 2022
* https://www.cdc.gov/coronavirus/2019- ncov/vaccines/safety/myo -outcomes.html
Preliminary data from surveys of patients at least
90 days post myocarditis diagnosis
6Outreach focusing on myocarditis patients 12 –29 years of age
As of November 2021, VAERS had received ~989 reports of myocarditis or
myopericarditis after COVID -19 vaccination that met CDC case definition*
Of these, ~850 patient ages 12–29 years had reached 90 days post -myocarditis
diagnosis
•Of ~850 patients 90 days post diagnosis, 648 (81%) had a phone number listed
‒Of the ~648 patients who were called, ~360 (56%) completed the survey;
~270 (42%) were unreachable and 18 (3%) declined to participate
‒For the 360 patients interviewed, time from myocarditis onset to interview was 143 days (IQR: 131, 162)
* https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm
020406080100120
M F M F M F M F
12 to 14 15 to 19 20 to 24 25 to 29Number of patients
Sex and age group7Most patients diagnosed with myocarditis were young males
Median patient age was 18 years (IQR: 15 –22);
Of the 360 patients 90 days post myocarditis diagnosis, 86% (308) were male
17%
2%38%
6%21%
3%11%
2%Male patients
Female patients
8Race and ethnicity of myocarditis patients (N=360)
0 50 100 150 200 250
White,
 non-Hispanic
Hispanic
Asian,
 non-Hispanic
Black,
 non-Hispanic
Multi-racial,
 non-Hispanic
Other,
non Hispanic
American Indian orAlaskan Native,
non-HispanicNumber of patients
62%
20%
5%
4%
4%
3%
<1%
*4 patients did not provide a response
987% (314/360) received two doses of a COVID -19 vaccine
•Of those who received two doses, 98% (307/314) reported receiving
both doses before they were diagnosed with myocarditis
•9%(31/360) had a positive COVID -19 test before their
myocarditis diagnosisPrior to their myocarditis diagnosis, most patients received
two doses of a COVID- 19 vaccine
10Self reported previous medical history among patients with
myocarditis after mRNA COVID -19 vaccination (N=360)
60 (17%) had any condition
•11(3%) had an arrhythmia
•6(2%) had congenital heart disease
•6 (2%) had a history of myocarditis
•2(<1%) had Kawasaki disease
•1(<1%) had previous heart failure•32 (9%) had a history of asthma
•7 (2%) had an autoimmune disorder
•5(1%) genetic or chromosomal condition
•4 (1%) were immunosuppressed
•1 (<1%) had a history of Leukemia
•1(<1%) had type 1 diabetes
11Most patients with myocarditis after vaccination reported being
hospitalized at the time of myocarditis diagnosis (n=360)
92% (324) were hospitalized
•4% (13) were readmitted following myocarditis; 8 of 13 (62%) were
readmitted because of a concern with the heart
•20% (71) were prescribed medication for their heart as of their last
appointment with the provider
12Missed school or work within the 2 weeks prior to the date of
the interview reported among patients with myocarditis after
vaccination (N=360)
46 (8%) reported missing school
•Of these, 10 (37%) believed it was due to their myocarditis
19(5%) missed work
•Of these, 7 (37%) believed it was due to their myocarditis
Self-reported symptoms within 2 weeks prior to the date of the
interview among myocarditis patients (n=360)
•About half (49%)
reported
experiencing at
least 1 symptom in
the prior two
weeks
0 50 100 150 200 250 300noyesnoyesnoyesnoyesFatigue Palpitations SOB Chest pain
Number of patients 1378%
25%78%
22%
75%32%
68%
22%Shortness
of breathChest
pain
Palpitations
Fatigue
14EuroQol -5D-5L measurement of health status among patients
who developed myocarditis after vaccination (n=242)

Preliminary data from completed cardiologist or
other healthcare provider surveys
16Outreach to cardiologists or other healthcare providers
Of the 360/648 patients interviewed, ~346 (96%) listed contact information for a
cardiologist or other healthcare provider
•Of the 346 providers with contact information listed, 229 completed a survey
•An additional 151 providers completed surveys they had submitted for multiple
patients in VAERS or provided contact information via the VAERS report
•We were unable to contact 268 providers
•In total, 380 providers completed the survey with a median of 191 days (IQR: 170, 216) from patient myocarditis onset to date of provider survey
17The proportion of myocarditis patients cleared for physical
activity by their cardiologist or healthcare provider has increased (n=380)
At time of myocarditis diagnosis, 83% of patients
had restrictions on their physical activity
83%
Restricted
At time of provider survey, at least 90 days post
diagnosis, only 39% had restrictions
*25 (7%) were unsure39%
Restricted
050100150200250
Same cardiac status as
at the initial
myocarditis diagnosisImproved, but not
fully recoveredProbably fully
recovered, awaiting
additional informationFully recoveredNumber of PatientsBased on the cardiologists/healthcare provider assessment,
most patients appear to have fully or probably recovered from their myocarditis (n=380)
81% (309) of cardiologists or healthcare providers indicated the patient was
fully or probably recovered
Patient Recovery66%
15% 15%
1%
*8 providers were unsure 18
Proportion of myocarditis patients deemed to be fully or
probably recovered by their healthcare provider (n=309)
19
Results of the most recent cardiac function test (n=380)
53%
36%93%
77%
90%89%46%
64%
7%23%
10% 11%
050100150200250300350400
Troponin Cardiac MRI Echocardiogram Electrocardiogram Exercise stress test Ambulatory rhythm
monitoringNumber of patientsNormal or baseline Abnormal or elevated
20
121
68
231832
28
1 16383 592
53
17
920
030 14 3 514
020406080100120Late gadolinium enhancementInflamation or edemaWall motion abnormalitiesST segment elevationT wave abnormalitiesArrhythmiaConduction delays or blocksEctopic rhythymArrhythmiaOther cardiac concernOther non-cardiac concernArrhythmiaConduction delays or blocksEctopic rhythym
Cardiac MRI Electrocardiogram Exercise stress test Ambulatory rhythym
monitoringNumber of patientsAll patientsAbnormal findings from most recent cardiac function test
Patients fully or probably recovered
Overlap of abnormal findings among most recent cardiac
function tests
Troponin 51
EKG 26 22
Ambulatory rhythm 3 2 6
Exercise stress test 1 1 1 10
ECHO 9 7 31 20 060–80%
40–60%
20–40%
0–20%
22
Comparison of cardiac function tests at time of diagnosis and follow -up
14
127
239
248
57
75
36
340
4At �me of ini�al diagnosis At �me of follow -Up
68
79
233
253
17
174110
20
186
Number of myocardi�s pa�entsNumber of myocardi�s pa�ents
elevatedelevated
Comparison of cardiac function tests at time of diagnosis and follow -up
24Number of myocarditis patients Number of myocarditis patients 14
127
239At �me of ini�al diagnosis At �me of follow -Up
68
79
233

Comparison of cardiac function tests at time of diagnosis and follow -up
25248
57
75
253
17
110
At time of initial diagnosis At time of follow -upNumber of myocarditis patients Number of myocarditis patients
Comparison of cardiac function tests at time of diagnosis and follow -up
26At time of initial diagnosis At time of follow -up
36
340
4
174
20
186
elevatedelevatedNumber of myocarditis patients Number of myocarditis patients
Normal/Baseline function or absence of symptoms
Abnormal function or presence of symptoms
Unknown or no test results available
Patients deemed fully or probably fully recoveredPatients deemed not recovered
27Cardiac assessment and symptoms among patients deemed to be
recovered and not recovered from their myocarditis
Normal/Baseline function or absence of symptoms
Abnormal function or presence of symptoms
Unknown or no test results availablePatients deemed not recoveredCardiac assessment and symptoms among patients deemed to be
recovered and not recovered from their myocarditis
28Patients deemed fully or probably fully recovered
Normal/Baseline function or absence of symptoms
Abnormal function or presence of symptoms
Unknown or no test results availablePatients deemed not recovered
29Cardiac assessment and symptoms among patients deemed to be
recovered and not recovered from their myocarditis
Patients deemed fully or probably fully recovered
Summary
30At least 90 days after myocarditis diagnosis, most patients reported no impact
on their quality of life, and most did not report missing school or work
Only 13 (4%) were readmitted to the hospital
Most (81%) healthcare providers indicated the patient was probably fully or fully recovered
There did not appear to be a single test that was indicative of recovery
To our knowledge, there were no vaccine -associated myocarditis deaths in this
group
Ongoing efforts to continue patient follow- up and contact myocarditis patients
who were not yet recovered at time of survey
Surveys are being modified for children aged 5 -11 and follow -up to start in
February 2022
Acknowledgments
VAERS Team
•VAERS TTS abstraction team
•VAERS Myopericarditis abstraction team
•VAERS data team
Clinical Immunization Safety Assessment Project
COVID -19 Vaccine Task Force Data Monitoring and Reporting GroupThanks to the many people who made analysis of these data possible:
31
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The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Thank you!
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Summary: cdc.gov/coronavirusMyocarditis Outcomes Following mRNA  COVID -19 Vaccination Preliminary Data: data are subject to change Advisory Committee on Immunization Practices February 4, 2022 Ian Kracalik PhD MPH Vaccine Safety Team CDC COVID-19 Vaccine Task Force Disclaimer The findings and conclusions in this report are those of the authors  and do not necessarily represent the official position of the Centers  for Disease Control and Prevention (CDC) Mention of a product or company name is for…