Novavax awaits FDA approval from May

The Food and Drug Administration may authorize Novavax’s Covid-19 vaccine for emergency use starting in May, company CEO Stanley Erck told CNBC on Monday.

Novavax’s phase three trial in the United States is still ongoing, with 30,000 participants, Erck said. The company hopes that the FDA will allow it to use data from its clinical trial conducted in the UK when it submits its request for emergency use later this year, he added.

UK 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 schedule could be delayed by a month or two if the FDA chooses to wait for trial data in the US, he said.

Novavax is among several companies working to develop vaccines to combat 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 the University. Johns Hopkins. So far, three vaccines, from Pfizer, Moderna, and Johnson & Johnson, have been licensed for use in the United States.

In late January, Novavax published the results of its phase three trial data in the UK, showing that the vaccine was 89.3% effective overall, although slightly less effective against B.1.1.7, the strain first discovered in the UK, and B.1.351, the strain first discovered in South Africa.

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

Novavax has an agreement with the United States 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 US, Erck said, he is not concerned about demand, even though three vaccines are already being widely distributed.

“There is a great need for the vaccine in the United States and, you know, it’s a big world,” he said, adding that the company has commitments for 200 million doses elsewhere.


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