Quack backtracks on FDA mRNA vax attack
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The FDA has again changed its mind on Moderna’s application for approval of its mRNA flu vaccine.
Moderna, Inc. (NASDAQ:MRNA) today announced that, in response to a prior Refusal-to-File (RTF) letter, the Company engaged with the U.S. Food and Drug Administration (FDA) in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.
Following submission of the amended application, the FDA has accepted the biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, including adults 65 and older, for the 2026/2027 flu season.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
The AP News article notes that the FDA’s rejection is in line with the Undead Kennedy’s attacks on vaccines.
The Food and Drug Administration will consider whether to approve Moderna’s new flu vaccine after all, resolving a dispute that had blocked the company’s application for the first-of-its-kind shot.
Moderna announced the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology.
Did Moderna send President Rantsalot a sack of cash? Did a member of the administration who has not posed topless with Mid Rock remember that there’s a lot of overlap in the seniors/Republican voter Venn diagram? Did the head of the FDA realize that as a cancer specialist it is fucking stupid for him to object to vaccines?
It would be irresponsible not to speculate. Do so below.
People who post off-topic comments wish they were drinking milk in a hot tub with these two gents. [Update: Apparently that link doesn’t work. I’m not sure why anyone would want to see this, but here you go.]
