FDA Advisers Recommend Authorization Of A 4th COVID Vaccine

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend Novavax’s two-dose dose COVID-19 vaccine for adults on Tuesday (June 7). The vaccine could be distributed by the end of the week.

The Novavax vaccine uses decades-old technology that has been previously used to create vaccines against hepatitis B and HPV. The company said that clinical trial data showed its vaccine was 90% effective at preventing COVID-19 and 100% effective at preventing severe illness.

While the test results were compiled before the Omicron variant emerged, Novavax’s Chief Medical Officer, Dr. Filip Dubovsky, said the pharmaceutical company is confident the vaccine will provide protection against that variant and others that may develop.

“It’s factual that we don’t have efficacy data against omicron, what we do have is a technology that we think generates a broad immune response, demonstrated against a broad array of variants,” Dubosvky told the advisory committee.

If the vaccine is granted an emergency use authorization, Novavax said it will request the FDA to authorize a booster shot as well.

If the FDA and CDC sign off on the vaccine, it will be the fourth one available in the United States.

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