US regulators will not review Moderna’s request to license a new, more effective flu shot, despite the US Food and Drug Administration (FDA) previously giving the project a green light – in a decision that could have implications for all new and updated vaccines in the US.
This is the latest move Trump administration Against vaccines. Officials decided in January to stop recommending one-third of routine childhood vaccinations altogether, including flu vaccines.
“This is likely to discourage industry from investing in future influenza vaccines and make working with the US FDA uncertain and problematic,” said Dorit Reiss, a law professor at UC Law San Francisco.
“They are refusing to review a new vaccine with more flexible technology, but will not have conventional vaccines next year while creating a real risk.”
Messenger RNA, or mRNA, vaccines have been shown to be more effective at protecting against certain illnesses, and they may be updated more quickly than traditional egg-based flu vaccines — as flu evolves quickly and may have pandemic potential.
FDA officials will not review evidence from Moderna’s clinical trials on the new mRNA flu shot because the trials compared Moderna’s shot to existing standard flu shots, not shots for high-risk people. letter Signed by Vinay Prasad, Director, Center for Biologics Evaluation and Research (CBER).
Prasad wrote that the FDA does not consider the modern trial “adequately and well-controlled” comparing the new shot to standard flu shots because it “does not reflect the best available standard of care.”
And Moderna compared their vaccine to an existing high-dose flu shot in adults 65 and older; Among adults under 65, they compared the new shot with standard flu vaccines.
“For those under 65, overdose is not the standard of care,” Rees said. “So their argument is also wrong.”
The new vaccine elicited better antibody responses than existing vaccines and showed no safety concerns, the researchers said found.
Another modern trial, the results of which have not yet been published, compared the new vaccine against standard flu shots in adults 50 and older.
The FDA has issued a denial-of-file letter, meaning it will not consider the licensing application until Moderna provides more information. The letter did not specify what information was required. It is unusual for the CBER Director to sign a refusal letter to file, as decisions are usually made by the review team.
There are no overt changes to the rules and guidelines on conducting clinical trials on vaccines. But in a Leaked In an internal email in November, Prasad said the FDA will “revise the annual flu vaccine framework,” including tests that show how well the vaccines work.
US Dept of health And Human Services (HHS) did not respond to questions about whether FDA rules have changed and whether the move represents a change in the way flu vaccines are approved for everyone, not just those at risk.
The decision “did not identify any safety or efficacy issues” with the shot, Moderna’s chief executive Stefan Bansel said in a statement. “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 is discussed and agreed upon with CBER prior to initiation.”
Moderna asked the FDA for a meeting to discuss why the application was denied.
“This, combined with other steps, demonstrates the FDA’s intent to make licensing vaccines for respiratory disease difficult without serious notice or scrutiny and in ways that appear arbitrary,” Reese said.
Licensing applications are already under review in the European Union, Canada and Australia.
In January, HHS unilaterally changed its recommendation for children’s flu shots, recommending it only under “shared clinical decision making” — a decision made without consulting outside vaccine consultants, medical providers or the public.
