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

A committee of impartial Food and Drug Administration vaccine specialists are assessing the protection and efficacy of a COVID-19 vaccine made by American biotech company Novavax.

The panel will weigh whether or not to advocate the two-dose vaccine course to adults within the U.S. Later, the FDA will decide whether or not or not to authorize the pictures, which have already been authorized in 41 international locations exterior of the U.S. If cleared to be used within the U.S., the shot would be the fourth FDA-approved coronavirus vaccine on the market. Shots from Pfizer, Moderna and Johnson & Johnson have already been cleared to be used in adults within the U.S. for properly over a year. 

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

By now, roughly three-quarters of Americans are vaccinated, making it unclear if Novavax’s new instrument within the struggle towards COVID-19 will probably be in a position to discover a market.

Novavax’s shot is a protein vaccine, comparable to inoculations which have for years been used to stop hepatitis B, shingles and different ailments. Pfizer and Moderna’s mRNA vaccines, alternatively, give the physique genetic directions to make copies of the coronavirus’ outer coating, prompting the immune system to create antibodies towards the virus. 

Maryland-based Novavax has distributed greater than 40 million doses of its vaccine throughout Asia, Europe and elsewhere, and insists that its manufacturing challenges are historical past. The shot was developed in Novavax’s analysis lab however is produced by the Serum Institute of India.

Data from scientific trials is promising. The Novavax pictures have been discovered to be 90.4% efficient at stopping gentle, reasonable or extreme an infection with early variants of COVID-19. The vaccine was 100% efficient at stopping reasonable or extreme an infection in scientific trial individuals. 

In documents launched Friday, the FDA stated 6 out of roughly 40,000 trial individuals skilled a type of coronary heart irritation and decided that the instances “raise the concern for a causal association with the vaccine.”