FDA declines to review Moderna application for new flu vaccine | Trump administration
Regulators in the US will not review Moderna’s request to license a new and potentially more effective flu vaccine, even though the US Food and Drug Administration (FDA) had previously given the green light to the project. This decision is one that could have implications for all new and updated vaccines in the United States.
This is the Trump administration’s latest move against vaccines. In January, officials decided to completely stop recommending one-third of routine childhood vaccinations, including flu shots.
“This will likely deter industry from investing in future flu vaccines and make working with the U.S. FDA uncertain and problematic,” said Dorit Reiss, a law professor at UC Law San Francisco.
“They are refusing to study a new vaccine with more flexible technology, which creates a real risk that we may not have traditional vaccines next year.”
Messenger RNA, or mRNA, vaccines have shown the potential to be more effective in protecting against some diseases and can also be updated more quickly than traditional egg-based flu vaccines; This is an important consideration given that influenza evolves rapidly and can have pandemic potential.
FDA officials will not review evidence from clinical trials of Moderna’s new mRNA flu vaccine because the trials compared Moderna’s vaccine to existing standard flu vaccines rather than vaccines for high-risk individuals. letter It was signed by Vinay Prasad, director of the Center for Biological Evaluation and Research (CBER).
Prasad wrote that the FDA did not find the Moderna study “adequate and well-controlled” because comparing the new vaccine to the standard flu vaccine “does not reflect the best available standard of care.”
But Moderna compared its vaccine to the current high-dose flu vaccine administered to adults 65 and older; They compared the new vaccine to standard flu vaccines in adults under 65.
“High dosing is not the standard of care for people under 65,” Reiss said. “So their claims are also false.”
Researchers stated that the new vaccine provides better antibody responses than existing vaccines and there are no safety concerns. to create.
Another Moderna study, whose results have not yet been published, compared the new vaccine to standard flu vaccines in adults ages 50 and older.
FDA issues letter rejecting application; This means Moderna will not consider the license application until it provides more information. The letter did not specify what information was required. It is unusual for a refusal-to-file letter to be signed by the CBER director because these are typically decisions made by the review team.
No publicly available changes have been made to the rules and guidelines for conducting clinical trials on vaccines. But in a leaked internal email in November, Prasad said the FDA would “revise the annual flu vaccine framework,” including testing to show how well the vaccines work.
The U.S. Department of Health and Human Services (HHS) did not respond to questions about whether FDA rules have changed and whether the move represents a shift in policy toward approving flu vaccines for everyone, not just those at risk.
Stéphane Bancel, Moderna’s CEO, said in a statement that the decision “does not identify any safety or efficacy concerns” regarding the shot. “It should not be controversial to conduct a comprehensive review of an influenza vaccine rollout using an FDA-approved vaccine as a comparator in a study that was discussed and agreed upon with CBER before it began.”
Moderna requested a meeting with the FDA to discuss why the application was rejected.
“Combined with other steps, this demonstrates FDA’s intent to make it difficult to licensure vaccines for respiratory diseases without serious notice or consideration, and in ways that appear arbitrary,” Reiss said.
The license application is currently being reviewed in the European Union, Canada and Australia.
In January, HHS unilaterally changed its recommendation on influenza vaccination for children to recommend it only under “shared clinical decision-making”; This decision was made without consulting outside vaccine advisors, medical providers or the public.
