FDA Recommends COVID-19 Booster Doses Optimized for Omicron Variant

In a Thursday press release, the US Food and Drug Administration (FDA) recommended the inclusion of a SARS-CoV-2 Omicron component in COVID-19 vaccine booster doses.

The announcement comes after the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) one day earlier voted 90% “yes” to recommend that the fall and winter 2022 COVID-19 booster doses target the Omicron variant, which has been the predominant variant circulating in the US since December 2021.

“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,” stated Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, 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 U.S. beginning in fall 2022.”

After the VRBPAC meeting, the FDA advised vaccine manufacturers seeking to update their COVID-19 vaccines to develop modified shots that add an Omicron BA.4/5 spike protein component to the current vaccine composition to create a bivalent booster vaccine. The modified vaccines could potentially become available starting in early to mid-fall 2022, added Marks.

“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,” said Marks.

The agency also advised manufactures who have reported findings from clinical trials with modified vaccines containing an Omicron BA.1 component to submit the data to the FDA for evaluation before potential authorization of a modified vaccine with an Omicron BA.4/5 component. “Manufacturers will also be asked to begin clinical trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves,” continued Marks.

“In keeping with our commitment to transparency, the FDA will communicate future plans pertaining to the potential authorization or approval of COVID-19 vaccine booster doses with an omicron component,” concluded Marks.