CEO Stanley Erck said Novavax's COVID-19 vaccine could be cleared in the US as soon as May if the FDA authorizes it based on data from the company's UK trial, which could be completed as soon as April, as reported in NASDAQ.
He added that talks with the FDA are ongoing and the agency may require that Novavax submit data from its US trial, which could take another two months to read out and push back US clearance to mid-summer.
An early data readout in January from its UK trial showed the vaccine to be around 96% effective against the original version of SARS-CoV-2 and roughly 86% effective against the now widely circulating variant first discovered in the UK.
According to Erck, 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 US when it receives authorization.
"It will be substantial - in the many tens of millions or a hundred million," Erck said in an interview. Novavax had promised to deliver 110 million doses to the US government by the end of the third quarter. That could happen as early as July, Erck said.
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