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Pushed Again

Novavax has again pushed back its timeline for seeking an Emergency Use Authorization from the US Food and Drug Administration for its SARS-CoV-2 vaccine, Reuters reports.

The company initially said it expected it could have regulatory authorization for its vaccine by May 2021, but in May said it would not be filing for regulatory authorization in the US, UK, and Europe until the third quarter of the year. According to Reuters, the company now says it expects to do so in the fourth quarter. Stanley Erck, the CEO of Novavax, tells Reuters that "[i]t's a matter of getting validation work done" on its manufacturing process.

According to the New York Times, the company has had problems ramping up its manufacturing process and has not yet established that it meets FDA standards. Until it does, the Times adds that Novavax, which won a $1.75 billion federal contract to develop its SARS-CoV-2 vaccine, would not receive US funds for manufacturing its vaccine. The company notes, according to the Times, that it would still receive funding for other aspects of its operation.

CNBC adds that Novavax is pursuing regulatory approval in India, Indonesia, and the Philippines and plans to apply for World Health Organization approval this month, which would allow the vaccine to be distributed via its global vaccine sharing initiatives.