Novavax expects FDA approval in May


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

Novavax’s Phase 3 trial in the US with 30,000 participants is ongoing, Erck said. The company hopes the FDA will allow it to use data from its UK clinical trial when it files its emergency use application later this year, he added.

The UK health authorities are likely to review the vaccine in April, followed by the FDA “probably a month after,” he said in an interview with CNBC’s “Closing Bell”.

That schedule could be postponed for a month or two while the FDA waits for the U.S. trial dates, he said.

Novavax is among several companies working to develop vaccines against the virus, which on Monday infected more than 114 million people worldwide and killed at least 2.53 million people, according to Johns Hopkins University. Three vaccines – from Pfizer, Moderna, and Johnson & Johnson – have so far been approved for use in the United States.

In late January, Novavax released results of its Phase 3 trial data in the UK, showing that the vaccine was 89.3% overall effective, despite being used against B.1.1.7, the strain first discovered in the UK, and B.1.351 was a little less effective. the tribe first discovered in South Africa.

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

Novavax has signed a contract with the US government to supply 110 million cans. The company could complete those shipments in June or July, Erck said.

If the company’s vaccine is approved in the US, it doesn’t worry about demand, even though three vaccines are already widely available.

“The US has a huge need for vaccines and it’s a big world,” he said, adding the company has commitments for 200 million doses elsewhere.



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