An outside advisory panel voted overwhelmingly to recommend the Food and Drug Administration (FDA) authorize a COVID-19 vaccine made by Novavax for use in adults, a move that could lead to adding a fourth vaccine to the U.S. arsenal.
The FDA’s vaccine advisory panel voted 21-0, with one abstention. The FDA does not have to follow the panel’s recommendation, though it often does.
Novavax’s two-dose vaccine was about 90 percent effective at preventing mild, moderate and severe COVID-19 during clinical trials. But critically, the trials were conducted before the omicron variant and panel members expressed concern about whether the efficacy would hold up against the current variants.
Novavax’s vaccine could appeal to people who have been reluctant to receive one of the mRNA vaccines, as it was manufactured using a fundamentally different process.
“We do have a problem with vaccine uptake that is very serious in the United States, and anything we can do to get people more comfortable to be able to accept these potentially lifesaving medical products is something that we feel we are compelled to do,” said Peter Marks, the FDA’s top vaccine regulator.
But winning over even a small number of eligible people who haven’t yet been vaccinated could be a difficult task and it’s not clear how much success the company will find. The U.S. is not short on doses from any of the Pfizer-BioNTech or Moderna vaccines that have been available for more than a year.
The Maryland-based Novavax secured a $1.8 billion contract from the Trump administration’s Operation Warp Speed early in the pandemic to scale up research and purchase up to 100 million doses.
