FDA approves Novavax COVID-19 shot but with unusual restrictions

WASHINGTON – The Food and Drug Administration has issued a long-awaited support of Novavax’s COVID-19 vaccine but with antithetic restrictions.

Novavax makes the nation’s lone accepted protein-based coronavirus vaccine – and until present it had exigency authorization from FDA for usage successful anyone 12 and older.

But precocious Friday, the FDA granted the institution afloat support for its vaccine for usage lone successful adults 65 and older – oregon those 12 to 64 who person astatine slightest 1 wellness occupation that puts them astatine accrued hazard from COVID-19.

Vaccines made by Novavax’s competitors Pfizer and Moderna already are afloat licensed for usage successful anyone 12 and older, and besides are authorized for usage successful children arsenic young arsenic 6 months.

Next month, influential advisers to the Centers for Disease Control and Prevention were acceptable to statement if yearly COVID vaccines inactive should beryllium recommended for everyone oregon lone definite radical astatine higher risk. The Novavax determination suggests the Trump medication whitethorn already person decided however to proceed successful beforehand of that meeting.

Novavax main enforcement John C. Jacobs welcomed the licensure.

“Market probe and U.S. CDC statistic bespeak that older individuals and those with underlying conditions are the populations astir apt to question retired COVID-19 vaccination seasonally. This important milestone demonstrates our committedness to these populations and is simply a important measurement towards availability of our protein-based vaccine option,” helium said.

In its Friday support letter, the FDA didn’t explicate the restrictions though they bespeak skepticism astir vaccines from Health Secretary Robert F. Kennedy Jr. and different Trump officials.

Novavax primitively showed its vaccine was harmless and effectual successful a 30,000-person objective trial. The FDA had been connected way to assistance Novavax afloat support – without restrictions -- by its April 1 people date, according to 2 radical with nonstop cognition of the concern who spoke connected information of anonymity to sermon confidential bureau matters.

Novavax aboriginal announced the FDA alternatively was asking it to tally an further proceedings aft approval, which is highly unusual. FDA did bid respective further trials to beryllium completed successful the adjacent fewer years, immoderate examining whether the vaccine mightiness beryllium associated with immoderate bosom conditions. Another required survey indispensable measure the benefits of continuing vaccination successful 50- to 64-year-olds who don’t person wellness problems that summation their hazard from COVID-19.

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