Good afternoon,
FDA’s Intergovernmental Affairs staff (IGA) wants to let you know that the meeting materials for the Tuesday, June 28, 2022 meeting of FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) are now available. At that meeting, the Committee will discuss whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified, and if so, which strain(s) should be selected for Fall 2022.
This meeting is a follow-up to the April 6, 2022 VRBPAC meeting that discussed general considerations for future COVID-19 vaccine booster doses and the strain composition of COVID-19 vaccines to further meet public health needs.
On Tuesday the 28th, the VRBPAC will consider information from presentations discussing:
- current data on the evolution of SARS-CoV-2 variants, effectiveness of currently available COVID-19 vaccines, and modeling predictions for the potential future evolution of the COVID-19 pandemic;
- recently-released recommendations from the World Health Organization (WHO) on updates to the composition of COVID-19 vaccines;
- immunogenicity data from clinical studies evaluating COVID-19 vaccines with various strain compositions; and
- FDA’s perspective on the considerations for strain composition modifications of COVID-19 vaccines.
Following these presentations, the VRBPAC will be asked to discuss several questions regarding authorization of modified COVID-19 vaccines, and to vote on a recommendation for the COVID-19 vaccine strain composition to be used for booster doses.
Detailed information about Tuesday’s meeting, including a link to the livestream of the meeting and the agenda, roster, briefing documents, and discussion questions, is available here. The public docket for this meeting is FDA-2022-N-0905.
We hope this information is helpful to you. If you have any questions, please feel free to contact me or FDA's Intergovernmental Affairs Team at iga@fda.hhs.gov.
Respectfully,
Ruth
Ruth G. Watson, J.D.
Intergovernmental Affairs Specialist (on detail)
Intergovernmental Affairs (IGA)
Office of the Commissioner/OPLIA U.S. Food and Drug Administration
Mobile: 301 219-4162
Office: 301-796-8927
Ruth.Watson@FDA.HHS.gov
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