FDA Advisory Committee Backs Authorization of Novavax Covid Vaccine

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Novavax’s Covid vaccine cleared a hurdle toward authorization in the U.S. on Tuesday, with advisers to the Food and Drug Administration recommending advancing the vaccine.

If approved, the Novavax vaccine would become the fourth Covid vaccine authorized for use in the U.S. The three currently available are made by Moderna, Pfizer-BioNTech, and Johnson & Johnson.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted to advance the Novavax vaccine toward authorization, with 21 members voting in favor and one abstention. Committee members were asked if the benefits of two doses of the vaccine outweigh risks in adults over 18 years old.

The FDA must continue to inspect the vaccine’s manufacturing process for approval.

The Novavax vaccine is based on a traditional vaccine technology, using modified pieces of coronavirus to activate an immune response. Dr. Peter Marks, head of the FDA’s vaccine department, said that might help alleviate fears among Americans who haven’t received the Pfizer or Moderna vaccines, which are based on relatively newer mRNA technology.

“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 life-saving medical products is something that we feel we are compelled to do,” Marks told media outlets.

FDA documents noted that six cases of myocarditis and pericarditis occurred among roughly 40,000 volunteers in vaccine trials. Novavax said in a statement on June 3 that “we believe there is insufficient evidence to establish a causal relationship” between the vaccine and the types of heart inflammation.

The Novavax Covid vaccine has already been authorized in the European Union, Canada, Australia, and other nations.

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