FDA reverses decision not to review Moderna’s new flu vaccine

The Food and Drug Administration has reversed its decision not to review a new flu vaccine from Moderna, the pharmaceutical company said Wednesday.

Last week, the FDA sent a missive to Moderna refusing to review its new shot, saying its application did not contain adequate research – leaving the company’s president Dr. Stephen Hoge in “complete shock.”

Moderna’s flu vaccine will not be reviewed by the FDA. Rawf8 – stock.adobe.com

In an exclusive interview with The Post, Hoge said he was “completely surprised and honestly pretty confused” after receiving the letter from Dr. Vinay Prasad.

The safety agency’s reversal follows The Post’s editorial warning that blocking the last stage of approval for the vaccine could ultimately kill “hundreds, maybe thousands, of senior citizens.”

The FDA will not review Moderna’s new flu vaccine. REUTERS

Moderna proposed a split application to speed along the review, seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older – contingent on conducting a study among older adults after the vaccine’s release.

The FDA has set an August deadline to decide whether to approve the new vaccine, according to Moderna. If approved, seniors will be able to roll up their sleeves for the new jab in time for the 2026-2027 flu season.