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.”
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.
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.”
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.
“We appreciate the FDA’s engagement… and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel said in a statement Wednesday.
The new flu vaccine uses messenger RNA technology, also known as mRNA, which is the same method used in COVID vaccines.
Though widely viewed as safe by medical professionals, Health Secretary Robert F. Kennedy Jr. has railed against mRNA shots – claiming they pose “more risks than benefits.”
Under his lead, the FDA has terminated nearly $500 million in federal funding for mRNA vaccine development – impacting projects at companies 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 clinical trial, which involved more than 40,000 people, according to a company spokesperson. It received a $750 million investment from Blackstone for the study.
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 in spite of an objection from the second-highest ranking vaccine scientist at the agency.
In the note, Prasad cited concerns that the control vaccine used in the study was not the best possible option.
