FDA Changes Mind, Will Review Moderna’s Flu Shot
Vinay Prasad, the head of the FDA’s vaccine and biologics division, initially refused to review the vaccine because of an inadequate clinical trial.
The U.S. Food and Drug Administration (FDA) reversed course and will review Moderna’s flu vaccine.
Vinay Prasad, the head of the FDA’s vaccine and biologics division, initially refused to review the vaccine because of an inadequate clinical trial.
On Wednesday morning, Moderna announced the FDA’s change of heart:
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.”
Last week, Moderna disclosed the refusal, pointing out that Prasad took issue with the company’s “choice of a licensed standard-dose seasonal influenza vaccine comparator.”
Pasad told Moderna that “the lack of an ‘adequate and well-controlled’ study with a comparator arm that ‘does not reflect the best-available standard of care.'”
A comparator in clinical trials is also called a control. Those who receive the comparator are known as the control group.
A company can use an investigational or approved medicine, a placebo, a different procedure, or an intervention as a comparator.
Moderna countered that the FDA’s guidance and regulations for an annual flu vaccine do not state that using a comparator reflects the “best-available standard of care.”
Moderna cited 21 C.F.R. § 314.126 (Adequate and well-controlled studies).
A quick search for the word “comparator” did not yield results.
Prasad’s letter also “did not identify any specific safety or efficacy concerns regarding” the vaccine.
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Comments
I’d rather independent scientists ( uuhh not you bill nye) evaluate the drugs and submit the info to the government to be held on file and if something goes awry the company gets taken to court ( which happens sometimes..anyways)
but instead of having government hogs who write the laws and are paid off (somewhat?) legally
the gov can prosecute w/o a conflict of interest
Ok, but why do you believe an independent scientist can’t be bought off as well? I agree that the government is inefficient and often flawed, but I would rather do the unsexy hard work of restoring quality of our institutions than hand it off to another corrupt or easily corruptable entity and say it automatically has to be better because it is not the government.
Sorry Moderna but while I think the mRNA technique shows promise I’m not convinced it’s safe especially relative to the older technologies which have been available for and used for years. I will not be consuming your vaccines for the available future.
When did they start allowing a “comparator” other than a placebo?
The Siri-Glimstad report (https://www.hsgac.senate.gov/wp-content/uploads/Siri-Testimony.pdf) was shocking to me. It says most vaxxes scheduled for infants/children were tested in trials that didn’t use actual placebos, using instead “comparators” that were bioactive (incl. other vaccines and “placebos” that contained adjuvants and other chemicals – i.e., not just saline solutions). One used a comparator that was another vaccine, which itself had been tested in a trial that used a vaccine as a comparator, which in turn had been tested in a trial that used an experimental vaccine as a comparator!
why not?
maybe no to a placebo b/c they actually wanted more of a “real life” scenario?
or do you think the comparator is not worthy?
thanks
Few, if any. test the endpoint of whether they prevent the targeted disease. They are tested to see if they generate an immune response. I think this is pretty weak evidence of safety and efficacy.
Yes, sadly this is the whole “joke” of vaccine safety. I don’t believe there is one vax that is or was actually tested against a true placebo. And even with that, the regulators have this bizarre thought that they actually can’t – why?- because it would be depriving the child of a needed vaccine. So a newer one may be tested against an older similar one. What happens if that one had some long standing problem, like the old DPT did. All the better for the trial because the older one had too many bad side effects. The new one has the same amount or maybe a few less (if they happen to observe for only a week, which happens) so of course the new one is now deemed better/safer. This has been going on for a long time and many are really waking up to the deception – ergo, less trust in the vaccines
No more jabs of any kind for me. Wouldn’t be prudent at this juncture!