U.S. FDA Considers Annual COVID-19 Vaccinations

The ongoing COVID-19 pandemic continues to present an extraordinary challenge to global health, complicated by rapidly evolving epidemiology, wrote the U.S. Food and Drug Administration (FDA) in a Briefing Document published today.

The Future Vaccination Regimens Addressing COVID-19 document was prepared for the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for January 26, 2023.

Excerpts from the Executive Overview are inserted below:

The complexities associated with the differences in composition and regimens of the currently authorized and approved COVID-19 vaccines in the U.S., the still incomplete understanding of SARS-CoV-2 immunology, and the absence of an established framework to inform periodic vaccine composition updates leave open scientific and policy questions regarding recommendations for simplifying the immunization schedule and updating the current COVID-19 vaccines for future vaccination campaigns.

The VRBPAC meeting will consider questions around simplifying the composition and immunization schedules of the authorized and approved COVID-19 vaccines, the process for determining the need for recommending a periodic update to COVID-19 vaccines, and the timing for implementation of such an update.

The only VRBPAC Voting Question is as follows: 

Simplification of current COVID-19 vaccine use: Does the committee recommend harmonizing the vaccine strain composition of primary series and booster doses in the U.S. to a single composition, e.g., the composition for all vaccines administered currently would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?

The VRBPAC Discussion Topics include, but are not limited to, the following:

• Immunization schedule: Please discuss and provide input on simplifying the immunization schedule to authorize or approve a two-dose series in certain young children, older adults, persons with compromised immunity and only one dose in all other individuals.
• Periodic update to COVID-19 vaccines: Vaccine composition: Please discuss and provide input on the consideration of periodic updates to COVID-19 vaccine composition, including the currently authorized or approved vaccines to be available for use in the U.S. in the fall of 2023.

The full, unedited document is available at this link.