To Meet Updated FDA Recommendations, Novavax Will Update Protein-Based COVID-19 Vaccine

Yesterday, the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended harmonizing the strain composition of COVID-19 primary series and booster vaccines.

The advisory committee’s 21-0 vote to unify vaccine doses means we will likely move away from monovalent COVID-19 vaccines, making bivalent shots, currently only available as a booster dose, the way of the future.

During the VRBPAC meeting, preeminent COVID-19 vaccine developers Pfizer-BioNTech, Moderna, and Novavax all presented data to demonstrate whether their respective vaccines retained efficacy against the emerging variants.

The only approved bivalent booster shots, mRNA vaccines from Pfizer-BioNTech and Moderna, contain strains from both the ancestral Wuhan virus and Omicron BA.4/BA.5. The Centers for Disease Control and Prevention (CDC) estimates the Omicron XBB.1.5 variant is now responsible for 61.3% of new infections in the US, meaning it is already time to start planning the next generation of updated COVID-19 vaccines.

This morning, Novavax announced plans to deliver an updated vaccine that will fulfill VRBPAC’s goal of harmonizing the viral strains in primary series and booster shots.

“Novavax is prepared to deliver an updated vaccine following FDA guidance on strain change,” said Silvia Taylor, executive vice president and chief communications officer of Novavax.

At the same time, Novavax argued that their existing protein-based COVID-19 vaccine, NVX-CoV2373, induces a broad immune response against current and genetic drift variant.

“Offering vaccine choices—and ensuring continuous access to those choices—must be at the center of any strategy to protect public health against COVID-19,” Taylor emphasized. “As expressed by several VRBPAC members, the Novavax protein-based COVID-19 vaccine plays an important role in protecting public health as part of a diverse portfolio.”