The Food and Drug Administration (FDA) has approved Novavax’s Covid-19 vaccine, called Nuvaxovid, but with certain restrictions. The FDA decision came last Friday about six weeks after the agency had set its own deadline for approval. While the FDA has now granted Novavax full approval for its vaccine, the agency limits who can get the shot.
The vaccine will only be available for people 65 and older, or for people between 12 and 64 with an underlying medical condition that puts them at greater risk if they contract the virus. That would include conditions like cancer, diabetes, asthma, and or obesity.
The Gaithersburg-based company had sought government approval for years. It began distributing its vaccine under Emergency Use Authorization in July 2022 for anyone 12 or older.
The new government approval will limit Novavax’s ability to distribute its Covid-19 vaccine to healthy people under 65.
Novavax is a traditional, protein-based vaccine while its two counterparts, Moderna and Pfizer-BioNTech use mRNA technology. Moderna and Pfizer both received full government approval in 2022.
Company Reaction
Novavax President and CEO John Jacobs welcomed the FDA’s decision and addressed the new restrictions.
“Market research and the Centers for Disease Control and Prevention (CDC) statistics indicate older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally,” Jacobs said in a statement.
“This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option,” he added.
The government’s full approval of Novavax’s Covid-19 vaccine will trigger a $175 million payment from the global healthcare company, Sanofi.
FDA Advisory Panel Meets This Week
Novavax expects to be ready to deliver its 2025-2026 Covid-19 vaccine in the fall in partnership with Sanofi. However, Novavax like other approved vaccine providers, still need to hear recommendations for future Covid-19 vaccines from an FDA advisory committee. That committee will meet on Thursday, May 22 and will provide guidance to the vaccine makers on how to proceed.
FDA Requires Novavax Conduct New Testing
Meantime, the FDA’s approval will require Novavax to conduct new testing. Initial approval was based on Novavax’s completion of its Phase 3 trial. Now, the FDA is asking Novavax to conduct a new Phase 4 trial of people between 50 and 64 not at high risk of developing complications from Covid-19. Novavax says it is working with Sanofi to determine the cost of this new trial. It is unclear how long the new trial will take to complete.
