The Food and Drug Administration may authorize Novavax’s Covid-19 vaccine for emergency use as early as May, the company’s CEO, Stanley Erck, told CNBC on Monday.
The Novavax phase three test in the U.S. is still in progress, with 30,000 participants, said Erck. The company expects the FDA to allow the use of data from its clinical trial conducted in the UK when it submits its application 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 after that,” he told CNBC’s “Closing Bell” in an interview.
That schedule could be postponed for a month or two if the FDA decides to wait for trial data based on the United States, 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 already been authorized for use in the United States.
In late January, Novavax released the results of its UK phase three trial data, showing that the vaccine was 89.3% effective overall, although slightly less effective against B.1.1.7, the strain discovered by the first time in the United Kingdom, and B.1.351, the strain first discovered in South Africa.
The company said the vaccine was well tolerated, adding that “serious, serious and physician-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 these shipments around June or July, said Erck.
If the company’s vaccine is approved in the United States, Erck said, he is not concerned about demand, although three vaccines are already being widely distributed.
“There is a great need for the vaccine in the United States and, you know, it is a big world,” he said, adding that the company has commitments for 200 million doses elsewhere.