The Food and Drug Administration could authorize Novavax’s 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 trial conducted in the UK when it submits its application 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 later,” he told CNBC’s “Closing Bell” in an interview.
That timeline could go back a month or two if the FDA decides to wait for data from U.S.-based trials, 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 collected by Johns Hopkins University . So far three vaccines have been authorized by Pfizer, Moderna and Johnson & Johnson.
In late January, Novavax published the results of the phase three tests in the UK, showing that the vaccine was globally effective at 89.3%, although slightly less effective against B.1.1.7, the strain discovered for 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 medically assisted adverse events occurred at low levels and were balanced between the vaccinated and placebo groups.”
Novavax has an agreement with the US government to supply 110 million doses. The company could complete those shipments by June or July, Erck said.
If the company’s vaccine is approved in the U.S., Erck said, it doesn’t care about demand, 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 of 200 million doses elsewhere.