An FDA vaccine advisory committee recommended future COVID-19 vaccine boosters should include a SARS-CoV-2 omicron BA.4/5 component for boosters beginning in fall 2022. The recommendation from the Vaccines and Related Biological Products Advisory Committee was based on concerns that SARS-CoV-2 has evolved significantly, with recent surges around the world associated with the rapid spread of highly transmissible variants such as omicron, the agency said.

The agency has advised manufacturers to develop bivalent boosters targeting omicron BA.4/5, but has not advised them to change the vaccine for primary vaccination, the FDA noted, “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.”

“Currently available vaccines have helped reduce the most serious outcomes (hospitalization and death) caused by COVID-19, but results from post-authorization observational studies have shown that effectiveness of primary vaccination wanes over time against certain variants, including omicron. And while initial booster doses have helped restore protection against severe disease and hospitalization associated with omicron, studies have also indicated waning effectiveness of first booster doses over time.

“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 Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research. “Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any potential authorization of a modified vaccine containing 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.”

The FDA has been planning for the possibility that vaccines would need to be modified to address circulating variants and previously provided guidance to industry on how to do so efficiently. As has been the case with all COVID-19 vaccines throughout the pandemic, the agency will evaluate all relevant data to inform the safety, effectiveness and manufacturing quality of modified vaccines under consideration for authorization or approval to ensure that they meet the FDA’s standards.