FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

FDA issued a recommendation on June 30, 2022 to COVID-19 vaccine manufacturers that indicated that they should include an Omicron subvariant BA.4/5 component in their vaccines. This move follows the recommendation of the Vaccines and Related Biological Products Advisory Committee, an independent advisory board that met publicly to discuss the necessity of this course of action ahead of an anticipated COVID-19 surge in fall and winter.

According to an agency press release, the official recommendation states that vaccine manufacturers intending to update their COVID-19 vaccines should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition. The goal behind this is to create bivalent booster vaccines that can potentially be used by early-to-mid fall 2022. FDA also noted that it is not advising changes to primary vaccine series because they have been shown to provide a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2.

“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,” said FDA in the release. “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 [United States] beginning in fall 2022.”