FDA refuses to review Moderna's mRNA flu vaccine

The American pharmaceutical company Moderna announced that the United States Food and Drug Administration (FDA) has refused to review the application for authorization for its flu vaccine based on messenger RNA (mRNA) technology, the first of its kind developed by the company, AFP reports.

According to Moderna, the decision was communicated in a letter signed by Vinay Prasad, director of the FDA's vaccine regulatory committee. The official motivated the refusal by the fact that the clinical study conducted by the company was not "adequate and well-controlled" and that the product was not tested against the best performing flu vaccine available on the market. In the large clinical study, Moderna compared its experimental vaccine with Fluarix, a vaccine produced by the pharmaceutical group GSK.

• Moderna disputes decision: "there are no safety or efficacy concerns”

However, company representatives consider the decision unexpected and inconsistent with previous assessments by regulatory authorities. According to Moderna, the refusal is "inconsistent” with previous written communications with CBER - the FDA division responsible for biological products, including vaccines. The company's CEO, Stephane Bancel, stressed that the agency's letter did not mention any safety risks or efficacy concerns. He stated that a full analysis of the application would have been justified, especially given that the clinical trial had been previously discussed and approved by regulatory authorities.

• Tense political context around vaccines

The FDA's decision comes at a sensitive time, when the US administration has requested a review of the authorization procedures for certain vaccines, including influenza ones. The changes are linked to President Donald Trump's policy, and the development has raised concerns among the medical community about possible delays in approving innovative products. The situation is amplified by the skeptical positions towards vaccines of the US Secretary of Health, Robert F. Kennedy Jr., who reduced funding for research related to messenger RNA technology.

Despite the refusal in the US, Moderna said that regulatory agencies in the European Union, Canada and Australia have agreed to review the application for authorization for its mRNA flu vaccine. Messenger RNA technology became known globally after the success of the COVID-19 vaccines developed by Moderna and BioNTech-Pfizer, which generated billions of dollars in revenue and opened new directions in medical research.