According to the chief executive of US vaccine developer Novavax Inc, Stanley Erck, the company's COVID-19 vaccine could be cleared for use in the US as soon as May 2021, Reuters news agency reported on Tuesday.
This clearance is possible if US regulators authorise the COVID-19 based on data from the company's British trial, which could be completed "in the coming weeks."
However, Erck added that talks with the US Food and Drug Administration are ongoing and the agency may require Novavax to submit data from its US trial, which could take an additional two months to complete, pushing back US clearance to mid-summer.
Reportedly, preliminary data from Novavax's UK trial, released in January 2021, showed the vaccine to be around 96% effective against the original version of COVID-19 and around 86% effective against the now widely circulating UK COVID-19 virus variant.
In an interview, Erck was quoted as saying: "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 authorisation", adding that Novavax had promised to deliver 110 million doses to the US government by the end of the third quarter and that could happen as early as July 2021.
The research chief of Novavax, Gregory Glenn, said that Novavax's vaccine production plants should all be fully functional by April 2021.
"In April, May, June, we should be finishing filling and finishing product in advance of regulatory approvals," Glenn said.
Novavax's COVID-19 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, Reuters added.
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