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FDA advisory panel recommends emergency use approval of Novavax COVID vaccine

If fully cleared, would become 4th available in U.S.

An advisory panel to the U.S. Food and Drug Administration voted Tuesday to recommend an emergency use authorization for the COVID-19 vaccine developed by the Maryland-based biotechnology company Novavax.

The FDA's Vaccines and Related Biological Products Advisory Committee voted 21-0, with one abstention, to recommend the two-dose vaccine for adults.

If approved by FDA officials, the Novavax vaccine would become the fourth approved for use in the U.S. and the first with a more traditional vaccine composition including non-infectious pieces of coronavirus particles.

Phase three trials with roughly 30,000 adults in the U.S. and Mexico found that the vaccine was 90.4% effective at preventing contraction of the virus, according to Novavax officials.

"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," Novavax President and CEO Stanley Erck said.

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As of last Tuesday, 66.7% of U.S. residents have completed their initial vaccination series.

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FDA advisory panel recommends emergency use approval of Novavax COVID vaccine

If fully cleared, would become 4th available in U.S.

by Eli Walsh / BCN Foundation /

Uploaded: Sun, Jun 12, 2022, 4:31 pm

An advisory panel to the U.S. Food and Drug Administration voted Tuesday to recommend an emergency use authorization for the COVID-19 vaccine developed by the Maryland-based biotechnology company Novavax.

The FDA's Vaccines and Related Biological Products Advisory Committee voted 21-0, with one abstention, to recommend the two-dose vaccine for adults.

If approved by FDA officials, the Novavax vaccine would become the fourth approved for use in the U.S. and the first with a more traditional vaccine composition including non-infectious pieces of coronavirus particles.

Phase three trials with roughly 30,000 adults in the U.S. and Mexico found that the vaccine was 90.4% effective at preventing contraction of the virus, according to Novavax officials.

"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," Novavax President and CEO Stanley Erck said.

As of last Tuesday, 66.7% of U.S. residents have completed their initial vaccination series.

Comments

Parent and Voter
Registered user
Danville
on Jun 13, 2022 at 6:49 am
Parent and Voter, Danville
Registered user
on Jun 13, 2022 at 6:49 am

While I had gotten the earlier Moderna vaccine I personally would have liked the option of an alternative of a more traditional version vaccine such as the one Novavax offers. It would be helpful to get more details about the trial results so that everything is transparent.


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