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Novavax expects FDA clearance for Covid vaccine as early as May, CEO says


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

Novavax’s part three trial within the U.S. remains to be ongoing, with 30,000 individuals, Erck mentioned. The firm hopes the FDA will permit it to make use of knowledge from its medical trial performed within the U.Okay. when it recordsdata its emergency use software later this 12 months, he added.

U.Okay. well being regulators will seemingly evaluation the vaccine in April, adopted by the FDA “probably a month after that,” he informed CNBC’s “Closing Bell” in an interview.

That timeline may get pushed again by one or two months if the FDA chooses to attend for the U.S.-based trial knowledge, he mentioned.

Novavax is amongst a number of firms working to develop vaccines to combat the virus, which has contaminated greater than 114 million individuals worldwide and killed at the least 2.53 million as of Monday, in line with knowledge compiled by Johns Hopkins University. Three vaccines — from Pfizer, Moderna and Johnson & Johnson — have been licensed for use within the U.S. up to now.

In late January, Novavax launched outcomes from its part three trial knowledge within the U.Okay., displaying the vaccine was 89.3% efficient total, although barely much less efficient towards B.1.1.7, the pressure first found within the U.Okay., and B.1.351, the pressure first found in South Africa.

The firm mentioned the vaccine was nicely tolerated, including that “severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.”

Novavax has a take care of the U.S. authorities to produce 110 million doses. The firm may full these shipments round June or July, Erck mentioned.

If the corporate’s vaccine is accepted within the U.S., Erck mentioned, he is not nervous about demand for it, despite the fact that three vaccines are already being broadly distributed.

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



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