The Food and Drug Administration (FDA) would probably grant emergency use authorization (EUA) to Novavax’s coronavirus vaccine as early as Wednesday, Politico reports quoting two people familiar with the matter.
In a time when White House officials stress the importance of vaccination and boosters to prevent severe disease, the White House Covid response coordinator Ashish Jha encouraged in a press briefing on Tuesday all Americans to get vaccinated if they haven’t already due to the BA.5 rise across the country.
The regulatory clearance would offer a fourth, two-dose protein-based option to adults as a primary immunization series, which may appeal to people skeptical of messenger RNA vaccines developed by Pfizer-BioNTech and Moderna or who are allergic to components of those jabs.
Maryland-based Novavax still needs to complete a final round of quality testing for its vaccine over the next several days.
Although there are cautions that the plan could still change and the FDA declined to comment on the matter, the Biden administration purchased 3.2 million doses of the vaccine earlier this week in anticipation of the FDA and CDC authorization for the jab.
The Trump administration preordered 110 million doses of the vaccine in 2020 – investing $1.6 billion in the process – which was considered among the most promising Covid vaccines at the time, but Novavax struggled for months to meet US regulatory standards and ran into a series of production issues.
Despite launching its initial shots in the US several steps behind the other vaccine manufacturers, which are working on reformulated vaccine boosters that better target the mutating virus, Novavax jab is still promising with the latest data of its two Phase 3 clinical trials showing high levels of protection with an overall efficacy of 90% at preventing Covid-19 infections and 100 percent effective at preventing severe disease and hospitalizations.
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