FDA grants emergency authorization to Novavax COVID vaccine

Amber CoakleyJuly 14, 2022

FILE – In this image provided by the Serum Institute of India, vials of freshly manufactured Novavax COVID-19 vaccines wait to be labeled in 2022, in Pune, India. The U.S. is getting another COVID-19 vaccine choice as the Food and Drug Administration on Wednesday, July 13, 2022, cleared Novavax shots for adults. (Serum Institute of India for Novavax via AP)

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UPDATED 7:37 AM PT – Thursday, July 14, 2022

The FDA authorized Novavax’s two-dose COVID-19 vaccine for adults over the age of 18. According to reports, officials approved the company’s vaccine clinical trial data, which suggested it was 90 percent effective at preventing a COVID infections.

This came after multiple delays due to concerns about Novavax’s new manufacturing process. The CEO of the company, Stanley Erck, commented on the news during a recent press conference.

“So the FDA has given us an emergency use authorization and that’s to authorize our vaccine to be used for a two-dose regimen in in primary vaccinations for all adults over 18 years old,” he expalined. “Our expectation with conversations with the FDA is that will then be expanded to include adolescents, will include booster doses, as they review the data that they already have in hand.”

The Novavax COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use as a primary series to prevent COVID-19 in individuals 18+. [🧵2 of 2]
— Novavax (@Novavax) July 13, 2022

Meanwhile, the CDC will have to sign off on the vaccine before it is made available. This comes after the FDA approved a second booster shot of either the Moderna or Pfizer COVID-19 vaccines for the elderly and immunocompromised people back in March.

The Biden administration’s COVID-19 response team recently announced its new strategy in tackling the latest coronavirus subvariant. On Tuesday, the White House outlined its mitigation plan for the BA.4 and BA.5 subvariants of the virus.

Today, the Biden-Harris Administration announced its strategy to manage the BA.5 Omicron subvariant ⁠– ensuring Americans continue to have easy and convenient access to vaccines, treatments, tests, and other tools that protect against and treat COVID-19. https://t.co/Z0zhIpIcro

— The White House (@WhiteHouse) July 12, 2022

The outline includes changes and convenient access to vaccines, boosters and treatments while providing Americans with patient awareness and increasing protection to the immunocompromised. According to the White House, the subvariants are responsible for the majority of new cases sweeping the nation.