Recommendations from the unanimous vote must be adopted by the FDA and CDC.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously voted to recommend replacing the previously authorized COVID-19 vaccination regimen with the bivalent version of the vaccine for those who are receiving a primary COVID-19 vaccine.1
The FDA is expected to sign off on the VRBPAC recommendation, according to several news sources. Both the FDA and CDC must adopt this recommendation before implementation.
This change in vaccination guidance makes the COVID-19 vaccines more akin to a yearly flu shot, a “major shift in strategy despite a long list of questions about how to best protect against a still rapidly mutating virus,” noted the Associated Press.2
The bivalent vaccine, reformulated by both Pfizer-BioNTech and Moderna, protects against the BA.4 and BA.5 Omicron subvariants. More recent evidence indicates that this bivalent formulation also protects against death and severe disease associated with the XBB.1 variant currently dominating cases in the United States.
Vaccine manufacturer Novavax also participated in the VRBPAC meeting, during which the company shared data demonstrating that their COVID-19 vaccine, adjuvanted (NVX-CoV2372)—currently available under an FDA emergency use authorization in individuals aged 12 and older—when used as a booster "induces a broad functional immune response, including against forward drift variants."3 The company is prepared to deliver an updated vaccine to reflect the new FDA guidance.
According to CNN,4 the VRBPAC vote is one part of a larger FDA plan to both simplify and improve the way COVID-19 vaccines are administered. A proposed plan would convene VRBPAC advisers yearly to evaluate whether the COVID-19 vaccine should be updated to reflect currently circulating viral strains.
For most Americans, the FDA noted, a once-yearly COVID booster should be sufficient. However, additional questions around young children and immunocompromised adults were raised—and must be answered with more data.
This story will be updated as it continues to develop.