FDA committee approves Novavax’s late COVID-19 vaccine

A panel of independent vaccine experts from the Food and Drug Administration has voted to advance a COVID-19[feminine] vaccine made by The American biotechnology company Novavax.

After an hour-long meeting on Tuesday, the FDA’s Vaccines and Related Biologicals Advisory Committee voted that the health benefits of the Novavax two-dose vaccine outweighed the risks for adults in the United States. United. The committee voted 21 to 0, with one abstention.

The FDA could decide as early as this week to issue “emergency use authorization” for the injections, which have already been approved in 41 countries outside the United States.

If cleared for use in the United States, the vaccine will be the fourth FDA-approved coronavirus vaccine on the market. Photos of Pfizer, Modern and Johnson & Johnson have already been cleared for use in adults in the United States for over a year.

Novavax shares, which have fallen 67% this year, rose slightly in morning trading on Wall Street. The company filed an initial emergency use authorization application in late January, late, after encountering manufacturing hurdles.

Right now, about three-quarters of Americans are vaccinated, so it’s unclear whether Novavax’s new tool in the fight against COVID-19 will be able to find a market.

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

“The positive recommendation from the advisory committee recognizes the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology,” said Novavax CEO Stanley C. Erck, in a statement. “We heard at today’s VRBPAC meeting the strong support for our vaccine from physicians, healthcare organizations and consumers who are eagerly awaiting a protein-based vaccine option. We look forward to looking forward to the FDA’s decision.”

“Very serious” problem

FDA vaccine chief Dr. Peter Marks told The Associated Press that another vaccine option in the United States could inspire at least some resisters to consider rolling up their sleeves.

“We have a vaccination problem that is very serious in the United States,” Marks said. “Anything we can do to make it easier for people to accept these potentially life-saving products is something we feel compelled to do.”

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

Data from clinical trials are promising. Novavax injections have been shown to be 90.4% effective in preventing mild, moderate or severe infection with early variants of COVID-19. The vaccine was 100% effective in preventing moderate to severe infection in clinical trial participants.

In documents released Friday, the FDA said 6 of the approximately 40,000 trial participants suffered from some form of heart inflammation and determined that the cases “raise concern of a causal association with the vaccine.” “.

— The Associated Press contributed to this report.

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