Novavax COVID-19 shot could be cleared for U.S. use by May: CEO
Novavax Inc's COVID-19 vaccine could be cleared for use in the United States as soon as May if U.S. regulators authorize it based on data from the company's British trial, which could be completed "in the coming weeks," its chief executive said on Monday.
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Novavax Inc's COVID-19 vaccine could be cleared for use in the United States as soon as May if U.S. regulators authorize it based on data from the company's British trial, which could be completed "in the coming weeks," its chief executive said on Monday.
However, Chief Executive Stanley Erck added that talks with the U.S. Food and Drug Administration are ongoing and the agency may require Novavax to submit data from its U.S. trial, which could take an additional two months to complete, pushing back U.S. clearance to mid-summer.
Preliminary data from its UK trial released in January showed the vaccine to be around 96% effective against the original version of the coronavirus and around 86% effective against the now widely circulating variant first discovered in Britain.
Novavax can already manufacture its shots at scale and will be able to have tens of millions of doses stockpiled and ready to ship in the United States when it receives authorization, Erck said.
"It will be substantial - in the many tens of millions or a hundred million," Erck said in an interview.
Novavax's vaccine is a two-dose regimen like Pfizer's and Moderna's, but is easier to ship as it can be stored at refrigerator temperatures, rather than frozen.