June 30, 2022
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a virtual meeting on June 28, 2022, to publicly discuss whether a change to the current vaccine strain composition of COVID-19 vaccine booster doses is necessary for the 2022 fall and winter seasons.
A majority of the committee voted in favor of including a SARS-CoV-2 Omicron component in COVID-19 vaccines that would be used for booster doses in the U.S. beginning in fall 2022. In consideration of the committee’s vote and the discussion that took place about the specific SARS-CoV-2 variant to include, and considering the totality of the available evidence, FDA has advised vaccine manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an Omicron BA.4/5 component to their current vaccine compositions to create two component (bivalent) booster vaccines.
We expect this coming year, when these modified booster vaccines will be introduced, to be a transitional period. Therefore, we have not advised manufacturers to change the vaccine for primary vaccination, since a primary series with this vaccine provides a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2.