Novavax will finally get its day with the FDA

 A Food and Drug Administration advisory committee has put Gaithersburg, Maryland-based Novavax’s COVID-19 vaccine on its June 7 agenda.

The Vaccines and Related Biological Products Advisory Panel includes independent physicians and scientists who make recommendations about vaccine authorization to the FDA, which most often follows those recommendations.

Novavax submitted its vaccine for FDA approval Dec. 31, 2021. Its COVID-19 vaccine is already approved or in use by several other countries in Asia and Europe.

If approved for use in the U.S., it would make Novavax a latecomer to the COVID vaccine arsenal, though its vaccine is different from the mRNA vaccines supplied by Pfizer and Moderna.

The Novavax vaccine is a more traditional protein-based vaccine that can also be stored at much higher refrigeration temperatures. Novavax has also said that because it is a traditional-type vaccine, some hesitant to get the mRNA vaccines might be more willing to take it.

“We continue to hear from physicians, healthcare organizations and consumers who are anxiously awaiting another vaccine option. We believe our vaccine, built on a well-understood protein-based vaccine platform, can play a part in fulfilling this need,” Novavax CEO Stanley Erck said in a statement Friday.

Novavax was among early participants in the federal government’s Operation Warp Speed, receiving $1.6 billion in 2020 to develop and manufacture a COVID vaccine.

In February, Novavax published research supporting its vaccine as effective in teens. It has also been testing a combination COVID and influenza vaccine.

https://wtop.com/business-finance/2022/04/novavax-will-finally-get-its-day-with-the-fda/