The pharmaceutical group Moderna announced on Tuesday that the U.S. Food and Drug Administration (FDA) had refused to consider an application for authorization for its first flu vaccine based on messenger RNA (mRNA) technology.
This decision comes as the FDA has requested a review of the authorization procedures for certain vaccines, particularly against the flu, changes proposed by President Donald Trump that are worrying the medical community.
According to Moderna, an American laboratory, the head of vaccine regulation at the FDA, Vinay Prasad, wrote in a letter that Moderna's clinical trial was not "adequate and well controlled," and that the experimental vaccine had not been tested against the best product available on the market.
In a large-scale clinical trial, Moderna compared its new product to Fluarix, a flu vaccine from the pharmaceutical group GSK.
Moderna believes this rejection is "inconsistent with previous written communications" with the FDA branch that regulates biological products, including vaccines, known by the acronym CBER.
This decision "has not identified any safety or efficacy issues concerning our product" and "does not contribute to our common goal of strengthening American leadership in the development of innovative medicines," complained Moderna CEO Stéphane Bancel in a statement.
"It should not be controversial to conduct a full review of an application for authorization of a flu vaccine using as a comparator an FDA-approved vaccine, in a study discussed and approved by the CBER before its launch," he added.
According to Moderna, the FDA's letter of refusal identified no safety risks or efficacy issues with the mRNA vaccine, which regulators in the European Union, Canada, and Australia have already agreed to review.
Moderna and its competitor and compatriot BioNTech-Pfizer were the first laboratories to market Covid-19 vaccines using messenger RNA technology, which earned them billions of dollars.
While Donald Trump had described mRNA as a "modern-day miracle" during his first term, his tone has changed since returning to power. His Secretary of Health and Human Services, Robert F. Kennedy, a longtime vaccine skeptic, notably cut funding for messenger RNA research.
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