FDA declines to review Moderna application for new flu vaccine | Trump administration

US regulators will not consider Moderna’s application for approval of a new, potentially more effective flu vaccine – even though the US Food and Drug Administration (FDA) previously gave the project the green light – in a decision that could have implications for all new and updated vaccines in the US.

This is the latest action taken by the Trump administration against vaccines. In January, authorities decided to stop recommending a third of routine childhood vaccines altogether, including flu shots.

“This will likely discourage industry from investing in future flu vaccines and make collaboration with the U.S. FDA uncertain and problematic,” said Dorit Reiss, a law professor at UC Law San Francisco.

“They are refusing to consider a new vaccine with more flexible technology, while creating a real risk that we will not have traditional vaccines next year. »

Messenger RNA, or mRNA, vaccines have shown that they may be more effective in protecting against certain diseases, and they may also be updated more quickly than traditional egg-based flu vaccines — an important consideration since the flu is rapidly evolving and may have pandemic potential.

FDA officials will not review evidence from Moderna’s clinical trials of the new mRNA flu vaccine because the trials compared Moderna’s vaccine to existing standard flu vaccines, rather than vaccines intended for high-risk people, according to a letter signed by Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER).

The FDA does not consider the Moderna trial “adequate and well-controlled” because comparing the new vaccine to standard flu vaccines “does not reflect the best available standard of care,” Prasad wrote.

Still, Moderna compared its vaccine to an existing high-dose flu vaccine in adults aged 65 and older; In adults under 65, they compared the new vaccine to standard flu shots.

“For people under 65, the high dose is not the standard of care,” Reiss said. “Their argument is therefore also false. »

The new vaccine elicited better antibody responses than existing vaccines, and no safety concerns were observed, the researchers found.

Another Moderna trial, the results of which have not yet been published, compared the new vaccine to standard flu vaccines in adults aged 50 and older.

The FDA has issued a refusal to file letter, meaning it will not review the application for authorization until Moderna provides more information. The letter did not specify what information she would need. It is unusual for a refusal to file letter to be signed by the CBER Director, as these are typically decisions made by the review team.

There have been no public changes to the rules and guidelines for conducting vaccine clinical trials. But in a leaked internal email in November, Prasad said the FDA would “review the annual flu vaccine framework,” including tests demonstrating the vaccines’ effectiveness.

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 policy shift to approve flu vaccines for everyone, not just those at risk.

The decision “did not identify any safety or effectiveness concerns” with the vaccine, Stéphane Bancel, Moderna’s chief executive, said in a statement. “It should not be controversial to conduct a full review of an influenza vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed upon with CBER before commencing.”

Moderna has asked the FDA for a meeting to discuss why the application was denied.

“Combined with other measures, this shows the FDA’s intent to make it more difficult to approve respiratory disease vaccines, without notice or serious consideration, and in a manner that appears arbitrary,” Reiss said.

The license application is already under review in the European Union, Canada and Australia.

In January, HHS unilaterally changed its recommendation for the flu vaccine in children, recommending it only under “shared clinical decision-making” – a decision made without consulting outside immunization advisors, medical providers, or the public.