FDA to decide fate of Novavax’s late-to-the-game COVID-19 vaccine


A committee of independent Food and Drug Administration vaccine experts are assessing the safety and efficacy of a COVID-19 vaccine made by American biotech company Novavax.

The panel will weigh whether to recommend the two-dose vaccine course to adults in the U.S. Later, the FDA will decide whether or not to authorize the shots, which have already been approved in 41 countries outside of the U.S. If cleared for use in the U.S., the shot will be the fourth FDA-approved coronavirus vaccine on the market. Shots from Pfizer, Moderna and Johnson & Johnson have already been cleared for use in adults in the U.S. for well over a year. 

Novavax shares, which have fallen 67% this year, edged up in morning trade on Wall Street. The company first filed for emergency use authorization in late January, behind schedule, after running into manufacturing hurdles.

By now, roughly three-quarters of Americans are vaccinated, making it unclear if Novavax’s new tool in the fight against COVID-19 will be able to find a market.

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Novavax’s shot is a protein vaccine, similar to inoculations that have for years been used to prevent hepatitis B, shingles and other diseases. Pfizer and Moderna’s mRNA vaccines, on the other hand, give the body genetic instructions to make copies of the coronavirus’ outer coating, prompting the immune system to create antibodies against the virus. 

Maryland-based Novavax has distributed more than 40 million doses of its vaccine across Asia, Europe and elsewhere, and insists that its manufacturing challenges are history. The shot was developed in Novavax’s research lab but is produced by the Serum Institute of India.

Data from clinical trials is promising. The Novavax shots were found to be 90.4% effective at preventing mild, moderate or severe infection with early variants of COVID-19. The vaccine was 100% effective at preventing moderate or severe infection in clinical trial participants. 

In documents released Friday, the FDA said 6 out of roughly 40,000 trial participants experienced a form of heart inflammation and determined that the cases “raise the concern for a causal association with the vaccine.” 

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