Document text
Clinical Considerations for the use of 2024 -2025
COVID -19 Vaccines in the United States
Lakshmi Panagiotakopoulos, MD, MPH
COVID -19 ACIP Work Group co -lead
Advisory Committee on Immunization Practices Meeting
October 23, 2024National Center for Immunizations and Respiratory Diseases
•On June 27, 2024, ACIP recommended 2024 -2025 COVID -19 vaccination for
everyone ages 6 months and older
•On August 22, 2024, FDA approved and authorized Moderna and Pfizer -
BioNTech 2024 -2025 COVID -19 vaccines
•On August 30, 2024, FDA authorized Novavax 2024 -2025 COVID -19 vaccine
•The Interim Clinical Considerations for Use of COVID -19 vaccines webpage
was updated with detailed recommendations
•A Policy Note outlining the recommendations was published in the
MMWR on September 10, 2024Current 2024 -2025 COVID -19 vaccine
recommendations
https://www.cdc.gov/vaccines/covid -19/clinical -considerations/covid -19-vaccines -us.html
https://www.cdc.gov/mmwr/volumes/73/wr/mm7337e2.htm
ACIP: Advisory Committee on Immunization Practices | FDA: Food and Drug Administration | MMWR: Morbidity and Mortality Weekly Report 2
•Use of 2024- 2025 COVID -19 vaccine: Routine schedule
-Proposed recommendations for a second dose in adults ages 65
years and older
•Use of 2024- 2025 COVID -19vaccine: People with moderate or severe
immunocompromise
-Proposed recommendations for use of additional dose(s) in people
with moderate or severe immunocompromise
•Updates to clinical considerations Outline
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Routine schedule
People without moderate or severe immunocompromise
•All doses should be homologous (i.e., from the same manufacturer) Current recommendations for children ages 6 months – 4 years
Doses recommended:
Initial series of 2 Moderna vaccine doses OR 3 Pfizer-
BioNTech vaccine doses
At least 1 dose of 2024– 2025 COVID -19 vaccine, as part of
or in addition to initial series
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•2024– 2025 COVID -19 vaccine dose is recommended at least 2 months after receipt of the
last COVID -19 vaccine dose
•mRNA COVID -19 vaccines authorized or approved for ages 6 months and older and
Novavax COVID -19 vaccine authorized for ages 12 years and older
•People who are previously unvaccinated for COVID -19 and are receiving Novavax should
complete a 2 -dose initial seriesCurrent recommendations for people ages 5 years and older
Doses recommended:
•1 dose of 2024- 2025 COVID -19 vaccine
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•2024– 2025 COVID -19 vaccine dose is recommended at least 2 months after receipt of the
last COVID -19 vaccine dose
•mRNA COVID -19 vaccines authorized or approved for ages 6 months and older and
Novavax COVID -19 vaccine authorized for ages 12 years and older
•People who are previously unvaccinated for COVID -19 and are receiving Novavax should
complete a 2 -dose initial seriesProposed recommendations for people ages 5 – 64 years
Doses recommended:
•1 dose of 2024- 2025 COVID -19 vaccine
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Proposed recommendations for adults ages 65 years and older
•If previously unvaccinated and receiving Novavax, 2 doses are recommended as
initial vaccination series followed by a third dose of any age -appropriate 2024- 2025
COVID -19 vaccine 6 months (minimum interval 2 months) after second dose.
8Doses recommended:
•2 doses of 2024- 2025 COVID -19 vaccine
•Recommended interval 6 months (minimum interval 2 months)
Recommendations for people with
moderate or severe immunocompromise
Current recommendations for people ages 6 months and older
who are moderately or severely immunocompromised
Doses recommended:
Initial COVID -19 vaccine series*
At least 1 2024– 2025 COVID -19 vaccine dose
May receive 1 additional 2024 -2025 COVID -19
vaccine dose with option for further additional
doses of 2024- 2025 COVID -19 vaccine**
*Series of 3 homologous mRNA COVID -19 vaccine doses or 2 Novavax COVID -19 vaccine doses (if ages 12 years and older); includes revaccination after
hematopoietic cell transplant and CAR -T-cell, or B -cell- depleting therapies.
**Further additional dose(s) may be administered, informed by the clinical judgement of a healthcare provider and personal prefe rence and
circumstances. Further additional doses should be administered at least 2 months after the last 2024 -2025 COVID -19 vaccine dose.
For more information, see https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim- considerations -us.html#immunocompromised .
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Proposed recommendations for people ages 6 months and
older who are moderately or severely immunocompromised
Doses recommended:
Initial COVID -19 vaccine series*
At least 2 2024– 2025 COVID -19 vaccine doses**
Recommended interval 6 months (minimum interval 2 months)
Additional 2024 -2025 COVID -19 vaccine doses under
shared clinical decision making***
*Series of 3 homologous mRNA COVID -19 vaccine doses or 2 Novavax COVID -19 vaccine doses (if ages 12 years and older); includes revaccination after
hematopoietic cell transplant and CAR -T-cell, or B -cell- depleting therapies.
**One 2024- 2025 COVID -19 vaccine dose may be received as part of the initial vaccination series and at least one of the two doses should be received 6
months (minimum interval 2 months) after completion of the initial series.
***Additional doses should be administered at least 2 months after the last 2024 -2025 COVID -19 vaccine dose.
For more information, see https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim- considerations -us.html#immunocompromised .
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Updates to Clinical Considerations
•Age transitions
•Interchangeability of COVID -19 vaccines
•COVID -19 vaccination and prior SARS -CoV -2 infectionClinical considerations
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•CDC recommends that people receive the age -appropriate vaccine product
and dosage based on their age on the day of vaccination.
•If a person moves to an older age group between vaccine doses, they
should receive the vaccine product and dosage for the older age group. For children who transition from age 4 years to age 5 years and children who are moderately or severely immunocompromised and transition from age 11 years to age 12 years, the option to administer a lower dosage is no longer authorized.Transitioning from a younger to older age group
https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim -considerations -us.html#age -transitions 14
•COVID -19 vaccine doses from the same manufacturer should be
administered whenever recommended. In the following circumstances, an
age-appropriate COVID -19 vaccine from a different manufacturer may be
administered:
-Same vaccine not available at the vaccination site at the time of the clinic visit
-Previous dose unknown
-Person would otherwise not receive a recommended vaccine dose
-Person starts but unable to complete a vaccination series with the same COVID- 19
vaccine due to a contraindication
A Vaccine Adverse Event Reporting System (VAERS) report is not indicated in these
circumstances.Interim Clinical Considerations on interchangeability of
COVID- 19 vaccines
15 https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim -considerations -us.html#Interchangeability
•People ages 12 years and older who are initiating vaccination with
Novavax COVID -19 Vaccine (i.e., previously unvaccinated) and
receive a first dose of Novavax should complete the 2 -dose initial
vaccination series with Novavax vaccine.
•However, if more than 8 weeks have elapsed since receipt of the
first dose of Novavax, any 2024– 2025 COVID -19 vaccine (i.e.,
Moderna, Novavax, or Pfizer -BioNTech) may be administered.Additional guidance: Interim Clinical Considerations on
interchangeability of COVID- 19 vaccines – Novavax*
16 https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim -considerations -us.html#Interchangeability *For people who are not moderately or severely immunocompromised
•COVID -19 vaccination is recommended for everyone ages 6 months and
older, regardless of prior symptomatic or asymptomatic SARS -CoV -2
infection, including people with Long COVID.
•People who recently had SARS -CoV -2 infection may consider delaying a
COVID -19 vaccine dose by 3 months from symptom onset or positive test
(if infection was asymptomatic).
•Individual factors such as risk of severe COVID -19 and current indicators of
community transmission should be taken into account when determining
whether to delay getting a COVID -19 vaccination after infection.Reminder: COVID -19 vaccine and prior SARS -CoV-2
infection
https://www.cdc.gov/vaccines/covid -19/clinical -considerations/interim -considerations -us.html#infection 17
Summary
•Children ages 6 months –4 years
-Unvaccinated: Should receive a multidose initial series with a 2024 –2025 mRNA
vaccine
-Previously completed an initial series: Should receive 1 dose of a 2024 –2025
mRNA vaccine from the same manufacturer as the initial series
•People ages 5 –64 years:
-Should receive 1 dose of an age- appropriate 2024 -2025 COVID -19 vaccine*
•People ages 65 years and older:
-Should receive 2 doses of any 2024 –2025 COVID -19 vaccine, spaced 6 months
apart (minimum interval 2 months)**Overview of the COVID -19 vaccination schedule:
Routine vaccination
*People ages 12 -64 years who are unvaccinated and receive the 2024 -2025 Novavax COVID -19 vaccine for initial vaccination should receive 2 doses of 2024- 2025 Novavax COVID -19 vaccine.
**People ages 65 years and older who are unvaccinated and receive Novavax COVID -19 Vaccine for initial vaccination should receiv e 2 doses of 2024– 2025 Novavax COVID -19 vaccine followed by a
third dose of any 2024 –2025 COVID -19 vaccine dose 6 months after the second dose (minimum interval 2 months). 19
•Unvaccinated:
-Should receive a multidose vaccination series with an age -appropriate 2024– 2025
vaccine and receive 1 2024– 2025 dose 6 months after completing the initial series
(minimum interval 2 months)
•Previously completed an initial series:
-Should receive 2 doses of an age -appropriate 2024– 2025 COVID -19 vaccine,
spaced 6 months apart (minimum interval 2 months)
•May receive additional age -appropriate 2024 –2025 COVID -19 vaccine
doses under shared clinical decision -makingOverview of the COVID -19 vaccination schedule:
Moderate or severe immunocompromise
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•Interim Clinical Considerations for Use of COVID -19 Vaccines in the United
States webpage continues to be rapidly updated to reflect the most recent
COVID -19 vaccine guidance
•COVID -19 vaccine recommendations have moved towards simplicity and
the standard language used for the ACIP routine immunization schedules
and General Best Practices
•Recommendations for use of additional doses in older adults and people
with moderate or severe immunocompromise will be updated following the October 2024 ACIP meeting votesSummary
https://www.cdc.gov/vaccines/covid -19/clinical -considerations/covid -19-vaccines -us.html 21
•Mary Chamberland
•Katherine Fleming -Dutra
•Susan Goldstein
•Elisha Hall
•Lauren Roper
•JoEllen Wolicki •Coronavirus and other Respiratory
Viruses Division
•Immunization Safety Office
•Immunization Services Division
•National Center for Immunization and
Respiratory Diseases
•ACIP COVID -19 Work GroupAcknowledgements
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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.