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

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 despatched a missive to Moderna refusing to review its new shot, saying its application did not comprise satisfactory research – leaving the company’s president, Dr. Stephen Hoge, in “complete shock.”

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 FDA’s top vaccine official.

Moderna’s flu vaccine will probably be reviewed by the FDA. Rawf8 – inventory.adobe.com

The security company’s reversal follows The Post’s editorial warning that blocking the last stage of approval for the vaccine might in the end kill “hundreds, maybe thousands, of senior citizens.”

Moderna proposed a cut up application to speed alongside the review, looking for full approval for adults aged 50 to 64 and accelerated approval for those 65 and older – contingent on conducting a research among older adults after the vaccine’s release.

The FDA has set an August deadline to resolve whether or not to approve the new vaccine, according to Moderna. If accredited, seniors will probably be in a position to roll up their sleeves for the new jab in time for the 2026-2027 flu season.

“We appreciate the FDA’s engagement… and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel said in a press release Wednesday. 

The new flu vaccine makes use of messenger RNA technology, also referred to as mRNA, which is the same methodology utilized in COVID vaccines.

Though widely considered as protected by medical professionals, Health Secretary Robert F. Kennedy Jr. has railed against mRNA pictures – claiming they pose “more risks than benefits.”

Last week, the FDA despatched a missive to Moderna refusing to review its new shot. REUTERS

Under his lead, the FDA has terminated almost $500 million in federal funding for mRNA vaccine development – impacting initiatives at firms like Moderna and Pfizer.

“The rules of the game being changed after the game has been played…will make it very hard to invest in making new medicines and cures in this country,” Moderna’s Hoge told The Post.

Moderna spent “north of a billion” {dollars} on the scientific trial, which concerned more than 40,000 people, according to a company spokesperson. It obtained a $750 million funding from Blackstone for the research.

But the FDA’s letter “actually just said, ‘We’re not even going to open it,’” Hoge told The Post.

Prasad had signed the letter refusing to review Moderna’s vaccine application regardless of an objection from the second-highest ranking vaccine scientist at the company.

In the observe, Prasad cited issues that the management vaccine utilized in the research was not the best attainable possibility.

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