Regulatory Novavax seals FDA green light for protein-centered COVID injection

Novavax seals FDA green light for protein-centered COVID injection


Novavax’s new vaccine for corona virus will soon hit the United States market as it received the go-ahead from Food and Drug Administration late on Wednesday. The vaccine is to be administered as a shot and is based on protein. It is United States’ fourth pandemic-catering vaccine following Moderna, Johnson & Johnson and Pfizer.

Novavax is a biotechnology organization that works to develop vaccines for serious diseases like Ebola and other influenza. It aims to make a change globally by developing and delivering state-of-the-art vaccines to needful patients around the globe. The current stock price of Novavax is just under $70 per share. The company was founded 35 years ago in 1987 and is headquartered in Gaithersburg, Maryland in the United States. It has over 10 items in its pipeline and delivering different vaccine doses that go over 2B in number annually. 

FDA authorized Novavax vaccine for adult, and this emergency use authorization is mainly to avoid COVID-19 that is triggered by SARS-CoV-2, in adults over the age of 18. According to John Trizzino, Chief Commercial Officer, Chief Business Officer and EVP of Novavax, the company intends to file an application for full biologics license by the end of 2022, hoping it would be the last vaccine for COVID that would be given the emergency green light.

Like many companies, Novavax also had to be creative with how it markets their product after entering the second half of the third year of the pandemic. The company marketed the traditional vaccine shot as an additional option for children and vaccine cynics among others who might have steered clear of the mRNA offerings that gained popularity in the United States.

Robert Califf, M.D., FDA Commissioner stated, “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

Peter Marks (M.D., Ph.D), director of FDA’s Center for Biologics Evaluation and Research added that the company’s vaccine shot offers another option for adults while adding another vaccine to the United States’ supply against COVID-19 virus

This FDA approval was given after reviewing the data from the company’s late-stage study in the United States and Mexico that was ongoing. The results from the protein-derived vaccine were promising, showing 90.4% effectiveness for all 3 severity levels of COVID-19; mild, moderate and severe.

The study was done on a total of 25,500 subjects. Out of these 8,300 were given placebos while the other 17,200 were recipients of the protein-based vaccine shot. Result was seventeen cases of the virus from the vaccine group while the other group saw 79.

The vaccine group also saw zero reported cases of severe or even moderate COVID-19 while the placebo group had reported four severe cases and nine moderate cases among the participants.

A subset that included participants over the age of 65 was also examined. The Novavax shot in the subset revealed an efficacy of nearly 79%. However, Food and Drug Administration notified that the company’s trial took place before the delta and omicron variants took North America by storm.

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