FDA: Booster Against New Subvariants Coming This Fall

Via press release from the FDA:



As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19.

Following a thorough discussion on June 28, 2022, an overwhelming majority of the advisory committee voted in favor of including a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022.

Following the vote, and striving to use the best available scientific evidence, we have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022.

As we expect this coming year to be a transitional period when this modified booster vaccine may be introduced, we have not advised manufacturers to change the vaccine for primary vaccination, since a primary series with the FDA-authorized and approved COVID-19 vaccines provides a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2.