US FDA clears Novavax COVID vaccine for adults


July 13 (Reuters) – The U.S. Food and Drug Administration on Wednesday cleared the use of Novavax Inc’s (NVAX.O) COVID-19 vaccine, paving the way for a vaccine whose more traditional technology has sparked hope for wider acceptance among vaccine skeptics.

Novavax shares rose 1.3% to $70.89 after its two-dose vaccine became the fourth COVID vaccine to be licensed for use in adults in the United States.

The US Centers for Disease Control and Prevention (CDC) still needs to approve the vaccine for use before it can be made available to people.

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A group of CDC vaccine advisers is scheduled to meet on Tuesday, but the agenda has not yet been released.

Earlier this week, the US government said it had obtained 3.2 million doses of the Novavax vaccine, which it plans to release once the company completes quality testing in the coming weeks.

More than two-thirds of the US population have been fully vaccinated with injections from Moderna Inc (MRNA.O), Pfizer-BioNTech or Johnson & Johnson (JNJ.N).

U.S. health officials hope people who opted out of Pfizer and Moderna’s vaccine, which are based on breakthrough messenger RNA (mRNA) technology, will instead opt for the protein-based vaccine. Novavax.

The vaccine, already approved in Europe, is based on technology that has been used for decades to fight diseases such as hepatitis B and influenza.

“Today’s clearance provides adults in the United States who have not yet received a COVID-19 vaccine another option that meets FDA’s rigorous standards,” said FDA Commissioner Robert Califf, in a statement.

In Europe, however, demand for the vaccine has not been significantly high, with around 242,000 vaccine doses administered since its launch in December, prompting Novavax to focus more on low-income countries.

The company’s initial application for U.S. authorization of the vaccine was delayed nearly a year due to development and production issues, making it a late entrant into the domestic COVID vaccine market.

Novavax has forecast between $4 billion and $5 billion in sales this year. Analysts expect sales at the lower end of this range, according to Refinitiv.

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Reporting by Manas Mishra and Mrinalika Roy in Bengaluru; Editing by Vinay Dwivedi and Devika Syamnath

Our standards: The Thomson Reuters Trust Principles.


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