Coronavirus: Novavax applies for FDA emergency use authorization for COVID-19 vaccine

Novavax announced it formally applied for an emergency use authorization for its COVID-19 vaccine in the United States.

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If approved, the Novavax vaccine could be the first COVID-19 vaccine available in the United States based on proteins, instead of mRNA. According to a news release announcing the application, the Novavax vaccine uses the coronavirus spike protein to enhance the body’s immune response and create antibodies. The “protein subunit” technology is the same technology that has been used for decades in making other routine vaccines, CBS News reported.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” said Stanley Erck, president and CEO of Novavax, in a statement.

Most adults in the United States have been vaccinated against COVID-19 with mRNA vaccines developed by Moderna or Pfizer and BioNTech, CBS News reported.

In a Phase 3 clinical trial, Novavax’s COVID-19 vaccine was 90% effective, as we reported in June. The company told The New York Times its vaccine can generate an immune response against the Omicron variant, but it’s unknown how strong the protection is.

The vaccine can be stored at normal refrigeration temperatures and has a shelf life of about nine months, CNN reported. If the FDA approves the emergency authorization, the company told CNN they would have the first 100 million doses ready to ship. The vaccine is two doses, given three weeks apart.

Both the FDA and the Centers for Disease Control and Prevention must approve the vaccine before they can be given in the United States, CBS News reported. The shot has already received regulatory approval in Australia and South Korea, and has been greenlighted by the World Health Organization.

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