The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday.
[...]
In a release Tuesday, Moderna said the FDA did not identify any safety or efficacy concerns with the vaccine. Instead, it said the FDA took issue with the “comparator” in its clinical trial — the vaccine the company used as a benchmark to evaluate its own shot.
The FDA said the use of the standard flu shot as a comparator “does not reflect the best-available standard of care.” The standard flu shot is FDA-approved.
However, Moderna said that the agency’s stated reason is “inconsistent” with what regulators had told the company in 2024 and 2025.
“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Moderna CEO Stéphane Bancel said in the release, referring to the FDA’s Centers for Biologics Evaluation and Research, which reviews and approves vaccines, as well as other treatments such as gene therapies.
Moderna said last year that its mRNA flu shot was 26.6% more effective than the standard flu shot, based on a Phase 3 clinical trial.
[...]
Regulators in the European Union, Canada and Australia have accepted Moderna's mRNA flu vaccine application, the company said.
This "best available standard of care" comment is about the 65+ age group, for whom the FDA recommends high-dose vaccines like Fluzone HD (which contains four times the antigen of standard flu...
This "best available standard of care" comment is about the 65+ age group, for whom the FDA recommends high-dose vaccines like Fluzone HD (which contains four times the antigen of standard flu vaccines).
Vaccine and infectious disease experts, however, say the approach is misguided.
“It’s somewhat of a step backward,” said Dr. James Campbell, vice chair of the American Academy of Pediatrics Committee on Infectious Diseases. “We’ve had inactivated whole-virus vaccines for a very, very long time.”
The first whole-virus vaccine was developed in the late 1800s by Louis Pasteur, who made an early version of the rabies vaccine.
“It’s not innovative at all,” said Angela Rasmussen, a virologist at the University of Saskatchewan. “It’s actually ancient, sort of, by vaccine standards.”
I’m missing a lot of context here Doesn’t Moderna also have a regular flu shot on the market? Isn’t it some huge pharma company? Is Moderna American? I thought it was European but I forget? Is...
I’m missing a lot of context here
Doesn’t Moderna also have a regular flu shot on the market? Isn’t it some huge pharma company?
Is Moderna American? I thought it was European but I forget?
Is there any other mRNA based general flu shot available? Or is it all just specific to covid?
Does this just mean we’ll have the not-as-good flu shots now? What do other flu shot companies have to gain from this? Would Americans not just start to buy flu shots from other countries off the internet or something if the good ones aren’t available here?
Is the ultimate goal to make all the pro-government regulations people say the words “why don’t we just let the consumer decide” ?
Definitely not. We can barely get people to get annual flu vaccinations now, and they're free and everywhere. Only like 45% of Americans get vaccinated for the flu every year.
Would Americans not just start to buy flu shots from other countries off the internet or something if the good ones aren’t available here?
Definitely not. We can barely get people to get annual flu vaccinations now, and they're free and everywhere. Only like 45% of Americans get vaccinated for the flu every year.
To be fair my adhd ass just doesn't think about it. My prior employer would have a pharmacist come and administer it on site. For free. While I'm there. Fuck yeah I'll do that it's crazy easy....
To be fair my adhd ass just doesn't think about it.
My prior employer would have a pharmacist come and administer it on site. For free. While I'm there. Fuck yeah I'll do that it's crazy easy.
Having to set an appointment is already causing friction that between everything else in my life means I'm unlikely to do it.
Is that still the case? I know some collections of states are running their own medical groups to review and approve vaccines now, though I haven't kept up with their progress and how insurance...
Is that still the case? I know some collections of states are running their own medical groups to review and approve vaccines now, though I haven't kept up with their progress and how insurance companies are responding lately.
There's a difference between the recommended vaccine schedule and something not being FDA approved. A new vaccine (vs a drug being prescribed off label) won't be able to be sold in the US without...
There's a difference between the recommended vaccine schedule and something not being FDA approved. A new vaccine (vs a drug being prescribed off label) won't be able to be sold in the US without approval.
Three agency officials familiar with the matter told STAT that the team of career scientists was ready to review Moderna’s application, and that David Kaslow, the head of the vaccine office, wrote a detailed memo explaining why the FDA should embark on the review.
From the article:
[...]
[...]
This "best available standard of care" comment is about the 65+ age group, for whom the FDA recommends high-dose vaccines like Fluzone HD (which contains four times the antigen of standard flu vaccines).
Remember, it is time to "move beyond the limitations of mRNA", in favor of whole-virus vaccines.
Regarding whole-virus vaccines:
What if the vaccine was just like rawer and unprocessed, like milk? This is synergy.
I’m missing a lot of context here
Doesn’t Moderna also have a regular flu shot on the market? Isn’t it some huge pharma company?
Is Moderna American? I thought it was European but I forget?
Is there any other mRNA based general flu shot available? Or is it all just specific to covid?
Does this just mean we’ll have the not-as-good flu shots now? What do other flu shot companies have to gain from this? Would Americans not just start to buy flu shots from other countries off the internet or something if the good ones aren’t available here?
Is the ultimate goal to make all the pro-government regulations people say the words “why don’t we just let the consumer decide” ?
It's anti-mRNA propaganda as far as I can tell.
Definitely not. We can barely get people to get annual flu vaccinations now, and they're free and everywhere. Only like 45% of Americans get vaccinated for the flu every year.
To be fair my adhd ass just doesn't think about it.
My prior employer would have a pharmacist come and administer it on site. For free. While I'm there. Fuck yeah I'll do that it's crazy easy.
Having to set an appointment is already causing friction that between everything else in my life means I'm unlikely to do it.
I dont know what the goal of RFK's FDA is, but US insurance companies are way less likely to cover the cost of things not FDA approved.
Is that still the case? I know some collections of states are running their own medical groups to review and approve vaccines now, though I haven't kept up with their progress and how insurance companies are responding lately.
There's a difference between the recommended vaccine schedule and something not being FDA approved. A new vaccine (vs a drug being prescribed off label) won't be able to be sold in the US without approval.
People who are allergic to eggs can't take the standard flu shot. I wonder if the save is true of mRNA vaccines
They don't use eggs to make these vaccines so they shouldn't trigger any such allergies.
Prasad overruled FDA staff to reject Moderna’s flu vaccine application