FDA Advisors Back Novavax’s Covid Vaccine, Clearing Way for Authorization
T he Food and Drug Administration’s vaccines advisory panel backed Novavax’s long-delayed Covid-19 vaccine, saying the benefits outweighed the risks.
The panel voted Tuesday 21 to zero in favor of the proposition that the vaccine’s benefits outweighed its risks, with one abstention. The panel, however, expressed disappointment that more data was not available on the vaccine’s efficacy against more recent variants of the virus.
It’s now up to the FDA to decide whether to authorize the vaccine on an emergency basis.
All signs point to the FDA giving the vaccine the nod. In comments made early in Tuesday’s meeting, the director of the FDA’s Center for Biologics Evaluation and Leadership, Dr. Peter Marks, said that there is a significant need for a Covid-19 vaccine in the U.S. not based on a messenger RNA approach.
“Having a protein-based alternative may be more comfortable for some, in terms of their acceptance of vaccine,” Marks said, referring to the more traditional vaccine modality that Novavax (ticker: NVAX) used. “We do have a problem with vaccine uptake that is very serious in the United States, and anything that we can do to get people more comfortable to be able to accept these potentially lifesaving medical products is something we feel we are compelled to do.”
Trading in Novavax shares was halted Tuesday in anticipation of the vote. This year, shares are down more than 65%. The stock fell 20% on Friday after documents released by the FDA in advance of the meeting raised concerns that FDA staff were opposed to the drug’s authorization. Those concerns appear to have been baseless, though Novavax’s ride during the meeting wasn’t without its bumps.
Novavax first presented promising efficacy data on its Covid-19 vaccine in early 2021. Delays have plagued the company. While billions of Covid-19 shots have been administered around the globe, Novavax says that 744,000 doses of its vaccine have been administered as of the end of April.
At the Tuesday meeting, the FDA presented an analysis showing that the Novavax vaccine demonstrated 90.4% efficacy in participants over aged 18. Collection of data for the study, however, ended in September, before the emergence of the Omicron variant.
“It’s a little hard to draw any conclusions as to how it would perform against Omicron,” said Dr. Ofer Levy, a temporary voting member of the committee and a professor at the Harvard Medical School, at the meeting.
— Sabrina Escobar contributed to this article