Novavax expects FDA clearance as early as May

by Buzz Street Times

The Food and Drug Administration could authorize Novavax‘s Covid-19 vaccine for emergency use as early as May, the company’s CEO, Stanley Erck, told CNBC on Monday.

Novavax’s phase three trial in the U.S. is still ongoing, with 30,000 participants, Erck said. The company hopes the FDA will allow it to use data from its clinical trial conducted in the U.K. when it files its emergency use application later this year, he added.

U.K. health regulators will likely review the vaccine in April, followed by the FDA “probably a month after that,” he told CNBC’s “Closing Bell” in an interview.

That timeline could get pushed back by one or two months if the FDA chooses to wait for the U.S.-based trial data, he said.

Novavax is among several companies working to develop vaccines to fight the virus, which has infected more than 114 million people worldwide and killed at least 2.53 million as of Monday, according to data compiled by Johns Hopkins University. Three vaccines — from Pfizer, Moderna and Johnson & Johnson — have been authorized for use in the U.S. so far.

In late January, Novavax released results from its phase three trial data in the U.K., showing the vaccine was 89.3% effective overall, though slightly less effective against B.1.1.7, the strain first discovered in the U.K., and B.1.351, the strain first discovered in South Africa.

The company said the vaccine was well tolerated, adding that “severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.”

Novavax has a deal with the U.S. government to supply 110 million doses. The company could complete those shipments around June or July, Erck said.

If the company’s vaccine is approved in the U.S., Erck said, he isn’t worried about demand for it, even though three vaccines are already being widely distributed.

“There’s plenty of need for the vaccine in the U.S. and, you know, it’s a big world,” he said, adding the company has commitments for 200 million doses elsewhere.

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