Novavax delays until 3rd quarter timelines for COVID-19 vaccine regulatory filings

Novavax delays timelines for COVID-19 vaccine regulatory filings, production Novavax Inc (NVAX.O) on Monday again delayed its timeline for ramping up COVID-19 vaccine production and said it now does not expect to seek regulatory authorization for the shot in the United States, Britain and Europe until the third quarter of 2021, sending its shares tumbling. Carl O'donnell Reuters

Novavax Inc (NVAX.O) on Monday again delayed its timeline for ramping up COVID-19 vaccine production and said it now does not expect to seek regulatory authorization for the shot in the United States, Britain and Europe until the third quarter of 2021, sending its shares tumbling.

The Maryland-based company has repeatedly pushed back production forecasts and has struggled to access raw materials and equipment needed to make its vaccine. Novavax shares fell more than 9% in extended trading after closing nearly 9% lower on Monday.

Novavax said it does not expect to hit its production target of 150 million shots per month until the fourth quarter of 2021, later than its previous forecast of sometime in the third quarter. It had also previously said it could see U.S. regulatory authorization as soon as May. read more

But on a call to discuss first-quarter results, Chief Executive Stanley Erck said major manufacturing hurdles have been cleared and that all of its facilities can now produce COVID-19 vaccine at commercial scale.

He said Novavax currently has about 30 million to 40 million doses on the shelves and its factories are making more each week.

While vaccine demand is declining in the United States, the Novavax shot is expected to play an important role in global inoculation efforts. Many countries such as India and much of South America still have low vaccination rates and are desperate for supplies. ...