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.1The 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. 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.

Source: CNN January 27, 2023 21:38 UTC