The Food and Drug Administration could authorize the Novavax 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 United States is still ongoing, with 30,000 participants, Erck said. The company hopes the FDA will allow it to use data from its clinical trials in the UK when it applies for emergency use later this year, he added.
UK health regulators are likely to review the vaccine in April, followed by the FDA “probably a month later,” he told CNBC’s Closing Bell in an interview.
That timeline could be pushed back a month or two if the FDA chooses to wait for U.S. study data, he said.
Novavax is one of 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 since Monday, according to data compiled by Johns Hopkins University. Three vaccines – from Pfizer, Moderna and Johnson & Johnson – have been approved for use in the United States so far.
At the end of January, Novavax published the results of the third phase studies in the UK, which show that the vaccine was generally 89.3% effective, although slightly more effective against B.1.1.7, the strain first discovered in Great Britain and B.1.351, the strain first discovered in South Africa.
The company said the vaccine was well tolerated, adding that “severe, serious and healthcare-related adverse events occurred at low levels and were balanced between the vaccine and placebo groups.”
Novavax has an agreement with the US government to provide 110 million doses. The company could complete these shipments around June or July, Erck said.
If the company’s vaccine is approved in the United States, Erck said, he is not worried about its application, even though three vaccines are already widely distributed.
“There’s a lot of 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.