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FDA authorizes Novavax’s COVID-19 vaccine

After weeks of delay, the Food and Drug Administration has authorized emergency use of Novavax’s COVID-19 vaccine.

The Gaithersburg, Maryland-based company’s vaccine is the fourth one to be authorized for use in the U.S.

The Centers for Disease Control and Prevention still must recommend the Novavax vaccine before it can be used. The Biden administration said this week that it’s committed to buying 3.2 million doses of the vaccine — contingent on authorization by the FDA and recommendation by the CDC.

Novavax believes its protein-based vaccine will appeal to people who have been hesitant so far to get one of the mRNA vaccines. Novavax’s vaccine is based on traditional manufacturing methods used for decades.



“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur, such as hospitalization and death,” said the FDA’s commissioner, Dr. Robert Califf.

Novavax’s vaccine is already approved and in use in several other countries.

It is the latest chapter in what has been a long journey for Novavax. It was one of the original participants in the U.S government’s Operation Warp Speed, and received $1.6 billion in funding in early 2020 to develop and manufacture a COVID vaccine.

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