The company announced on Tuesday that the U.S. Food and Drug Administration is declining to take into account the application of Moderna to manufacture a new flu vaccine produced using Nobel Prize-winning mRNA technology.
The news is the most recent indicator of intensified scrutiny of vaccines by the FDA under Health Secretary Robert F. Kennedy Jr., especially vaccines based on mRNA technology, which he has criticized before and after becoming the nation’s top health official.
Moderna was sent what is known as a “refusal-to-file” letter, in which the FDA complained that it was conducting a 40,000-person clinical trial that compared a new vaccine to one of the standard flu shots used today.
Such a trial ended up in the fact that the new vaccine was a little better in adults 50 and above compared to the standard shot.
The letter from the FDA vaccine Director, Dr. Vinay Prasad, stated that the agency does not consider the application to contain an “adequate and well-controlled trial” as it didn’t compare the new shot to “the best-available standard of care in the United States at the time of the study.”
In his letter, Prasad indicated certain recommendations that FDA officials had offered Moderna in 2024, during the Biden administration, which the latter did not adhere to.
Moderna cites that feedback, which it claimed made it acceptable to use the standard-dose flu shot that the company had settled on, but another brand that was specifically suggested for seniors would be preferred in the study by anyone over 65 years old.
Therefore, Moderna remarked, the FDA did accept the ability to continue the study as planned. The company added that it had also provided the FDA with additional data based on another trial of the new vaccine against an approved high-dose vaccine that was used in seniors.
Moderna CEO Stephane Bancel added in a statement that the FDA “did not identify any safety or efficacy concerns with our product” and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines.”
FDA hardly ever refuses to accept an application, especially in the case of a new vaccine, where the companies and the FDA workforce have months or years of discussions. Moderna has also requested an urgent meeting with the FDA, and it has also submitted an application to approve the vaccine in Europe, Canada, and Australia.
FDA officials under Kennedy in the previous year have reversed their recommendations regarding COVID-19 vaccinations, added additional warnings to the two most popular COVID vaccines, which are created through mRNA technology, and expelled critics of the administration strategy from an FDA advisory board.
Kennedy had announced last year that his department would cancel over 500 million in contracts and funding related to the development of vaccines using mRNA.
Over the decades, the FDA has been permitting vaccine manufacturers to update their annual flu vaccines rapidly to match the newest strains by demonstrating that the vaccines can produce an immune response in patients.
That is a much more effective way than conducting long-term studies that would monitor whether patients get the flu and how they are doing. Prasad had once, in an internal memo last year, stated that the streamlined method would no longer be allowed, and then many more than a dozen past FDA commissioners had written an editorial admonishing the statements.
