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Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
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Next Steps for the COVID- 19 Vaccine Program
Lakshmi Panagiotakopoulos, MD, MPH
ACIP MeetingFebruary 28, 2024
Can we improve the current COVID- 19
vaccine policy timeline?
mRNA updated (2023 –2024 Formula) vaccines were authorized or
approved on September 11, 2023
ACIP met September 12, 2023 to review the available evidence for
updated COVID -19 vaccines (monovalent, XBB.1.5 component)
ACIP recommended updated COVID -19 vaccines as authorized under EUA
or approved by BLA in persons aged ≥6 months:
–Moderna COVID -19 vaccine in persons ≥6 months
–Pfizer- BioNTech COVID -19 vaccine in persons ≥6 months
–Novavax COVID- 19 vaccine in persons ≥ 12 years*COVID- 19 Vaccine Policy Decision – Fall 2023
3ACIP: Advisory Committee on Immunization Practices | EUA: Emergency Use Authorization | BLA: Biologics License Application
*Novavax authorized for use on October 3, 2023
Timeline: Fall 2023 COVID -19 Vaccine Recommendation
September 12
ACIP Vote and CDC
Recommendation
for the Updated
2023 -2024 COVID -
19 Vaccine
September 15
Updated
Interim Clinical
Considerations
on the Use of
COVID -19
Vaccines PostedSeptember 19
COCA Call on
Recommendations
for Influenza,
COVID -19, and RSV
Vaccines for Older
Adults
September 27
Immunization
scheduled
updatedOctober 3
Novavax
Updated 2023-
2024 COVID -
19 vaccine
authorized
October 10
MMWR on Use
of Updated
2023 –2024
COVID -19
Vaccines
ACIP: Advisory Committee on Immunization Practices | CDC: Centers for Disease Control and Prevention | COCA: Clinician Outreach and Communication Activity |
MMWR: Morbidity and Mortality Weekly Report
https://www.cdc.gov/vaccines/covid -19/clinical- considerations/covid -19-vaccines -us.html | https://www.cdc.gov/mmwr/volumes/72/wr/mm7242e1.htm 4
COVID -19 related hospitalizations had already begun to increase before
the ACIP vote on use of the updated (2023 -2024) COVID -19 vaccine
Weekly COVID -19 new hospital admissions – National Healthcare Safety Network (NHSN), United States, June 2023 – January 2024
https://covid.cdc.gov/covid -data -tracker/#trends_weeklyhospitaladmissions_select_00
ACIP Vote and CDC
Recommendation
5
Uncertainty around recommendations made planning for state and local vaccine
programs challenging
Vaccine orders had to be placed prior to knowing groups for whom vaccine would be recommended
Stakeholder presentations, provider toolkits, and webpages all had to be updated after recommendation was made, limiting available window for communication of recommendation prior to the respiratory virus season
There were reports of issues with vaccine access, including among those at highest risk of severe illnessWhat happened after the Fall updated (2023 -2024) COVID -
19 vaccine policy vote?
6
Less lead time for planning (e.g., staffing, scheduling, EHR prompts)
A new recommendation may occur during a surge in COVID -19 associated
hospitalizations and may not provide enough time for distribution, partner
engagement, preparation of healthcare providers and facilities, and uptake to mitigate the rise in disease
May limit ability to coordinate messaging surrounding the fall/winter respiratory virus season and promote importance of COVID -19 vaccination in communications
Likely limit ability to plan vaccination clinics with COVID -19, flu, and/or RSV vaccine in
settings such as long -term care facilities, communities, workplaces, and schools
EHR: Electronic health recordPotential impacts of continuing with a Fall vote for the
2024 -2025 COVID -19 vaccine
7
8Annual seasonal influenza vaccine timeline
Feb March April July May June Aug Sep Oct Nov Dec
WHO Vaccine
Composition
RecommendationsFDA VRBPAC
MeetingACIP votes on
proposed
recommendations
FDA issues sBLAsJan
Manufacturers distribute vaccine
Providers administer vaccine
WHO : World Health Organization | FDA: Food and Drug Administration | VRBPAC : Vaccines and Related Biologic Products Advisory Committee | ACIP : Advisory Committee on
Immunization Practices | CDC: Centers for Disease Control and Prevention | sBLAs : Supplemental Biologics License Applications CDC/ACIP
recommendations
published
Current Time Frame for Updated COVID -19 Vaccine Availability
Dec. Jan. Feb. Mar. Apr. May Jun. Jul. Aug. Sep. Oct. Nov. Dec.Year -round genetic and phenotypic characterization
WHO TAG -CO-VAC
Recommendation •Timing of TAG- CO-VAC recommendations and regulatory review for 2022 and 2023 shown
Vaccine manufacturing etc.
Vaccine distribution & administrationIdentify vaccine
candidates
Produce
antisera to
candidatesAnalyze neutralization of
recent virusesFDA
VRBPAC FDA license approval
Current timing for the vaccine strain composition is challenging for the manufacture and
distribution of vaccine early in the Fall
Slide for discussion purposes. Information is approximated and exact timelines for manufacturing are inferred.
WHO : World Health Organization | TAG -CO- VAC: Technical Advisory Group on Covid -19 Vaccine Composition | FDA : Food and Drug Administration | VRBPAC : Vaccines and
Related Biologic Products Advisory Committee | ACIP : Advisory Committee on Immunization PracticesACIP Rec.
9
Dec. Jan. Feb. Mar. Apr. May Jun. Jul. Aug. Sep. Oct. Nov. Dec.ACIP Rec. Revised Time Frame for 2024 -2025 COVID -19 Vaccine Availability
Year -round genetic and phenotypic characterization
Vaccine manufacturing etc.
Vaccine distribution & administrationIdentify vaccine
candidates
Produce
antisera to
candidatesAnalyze neutralization of
recent viruses
FDA
VRBPACFDA license approval
Proposed changes: WHO -TAG-CO-VAC mid -late April (exact date to be determined), FDA VRBPAC in May, ACIP in JuneWHO TAG -CO-VAC
Recommendation?
Slide for discussion purposes. Information is approximated and exact timelines for manufacturing are inferred.
WHO : World Health Organization | TAG -CO- VAC: Technical Advisory Group on Covid -19 Vaccine Composition | FDA : Food and Drug Administration | VRBPAC : Vaccines and
Related Biologic Products Advisory Committee | ACIP : Advisory Committee on Immunization Practices
Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement - 05/16/2024 | FDA10
ACIP meeting in June to review evidence for 2024 -2025 COVID -19 vaccine
recommendations, including:
–WHO and FDA antigen selections
–Manufacturer studies and immunogenicity data
–Cumulative effectiveness and safety data
–Epidemiology from current and prior years
–Uptake from current and prior years
–Cost effectiveness
ACIP vote on 2024 -2025 COVID -19 vaccine recommendations in June
2024 -2025 Formula will become available as regulatory actions are taken
by FDA and vaccines are distributed by manufacturersProposed COVID- 19 Vaccine Policy plan - 2024
ACIP : Advisory Committee on Immunization Practices | WHO : World Health Organization | FDA : Food and Drug Administration 11
Pros and Cons of a June COVID -19
vaccine policy decision
Enables early planning across entirety of healthcare delivery system
•National, state and local public health departments
•Large and small practices, other venues for vaccine delivery (e.g., pharmacies)
Allows time for clear communication of recommendations
Provides vaccine sites with earlier information on which to base ordering decisions
Vaccines potentially available immediately following FDA authorization or approval
Alignment with influenza vaccine recommendations
Decrease number of emergency ACIP meetingsPros of a June COVID- 19 vaccine policy decision
13FDA : Food and Drug Administration | ACIP : Advisory Committee on Immunization Practices
–Epidemiology and strain changes
•Minor changes: unlikely to impact recommendation
•Major changes: may require subsequent emergency action
–Updated vaccine antigen changes do not require new human data
•Manufacturers provide pre- clinical immunogenicity for VRBPAC antigen selection
•Additional clinical trial data beyond that presented at VRBPAC may not be
available before ACIP votes (both for June and September)
•Reliance on large body of cumulative effectiveness and safety data
–Consistent temporal patterns of COVID -19 not yet established
•While this is true, we have four years worth of epidemiologic data to predict a peak in the winter 2024- 2025Potential cons of a June COVID -19 policy decision
VRBPAC : Vaccines and Related Biologic Products Advisory Committee | ACIP : Advisory Committee on Immunization Practices 14
We have more than four years worth of data on COVID -19 and three years worth of
data on COVID -19 vaccines
We have a well- established precedent from influenza vaccine recommendations
–Virus evolves rapidly and updates to vaccine antigens are needed
It is unlikely there will be more data between June and September to influence
updated COVID- 19 vaccine policy decision
Increased lead time will ease implementation challenges for vaccine providers
Increased lead time can also allow for clearer messaging in provider and patient educational materialsTakeaways
15
Important to separate policy question/decision from timing of decision
Work group members were in favor of moving decision to June, and
discussed many ways that this could ease implementation challenges,
including clearer communication of vaccine policy and increase lead
time for clinicians
Work group members emphasized that communication surrounding a
recommendation prior to updated vaccine availability, as done routinely
for influenza vaccine, will be importantWork Group Interpretation
16
Megan Wallace
Mary Chamberland
Kevin Chatham -Stephens
Matthew Daley
Katherine Fleming -Dutra
Monica Godfrey
Susan Goldstein
Lisa Grohskopf
Aron Hall
Elisha Hall
Sarah MeyerDanielle Moulia
Evelyn Twentyman
David Wentworth
JoEllen Wolicki
ACIP COVID -19 Work Group
Immunization Services Division
Immunization Safety Office
Coronavirus and Other Respiratory
Viruses Division
National Center for Immunization and Respiratory Diseases Acknowledgements
17
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.
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.