Novavax expects FDA clearance for Covid vaccine as early as May, CEO sayshttps://www.cnbc.com/2021/03/01/covid-vaccine-novavax-expects-fda-clearance-for-covid-vaccine-as-early-as-mayThe 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 U.S. 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 U.K. when it files its emergency use application later this year, he added.
In late January, Novavax released results from its phase three trial data in the U.K., showing the vaccine was 89.3% effective overall, though slightly less effective against B.1.1.7, the strain first discovered in the U.K., and B.1.351, the strain first discovered in South Africa.
The company said the vaccine was well tolerated, adding that “severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.”
U.K. health regulators will likely review the vaccine in April, followed by the FDA “probably a month after that,” he told CNBC’s “Closing Bell” in an interview.
