Moderna’s Influenza Vaccine Application Rejected by FDA
Moderna has revealed that the U.S. Food and Drug Administration (FDA) will not review its application for a new influenza vaccine utilizing mRNA technology.
On Tuesday, the company shared via a news release that, despite submitting a priority review voucher to expedite the evaluation process, it received a Request Rejected (RTF) letter for its experimental seasonal influenza vaccine, known as mRNA-1010.
The RTF letter, which was signed by Vinayak Prasad, MD, MPH, the director of the center, stated that the choice of an authorized standard-dose seasonal flu vaccine as a comparator in one of the trials was not considered “the best available standard of care.”
Moderna commented, “This letter is inconsistent with previous written communications from CBER to Moderna.”
The researchers pointed out that they had previously submitted a study protocol to the FDA’s Center for Biologics Evaluation and Research (CBER), which had approved the use of standard-dose influenza vaccines as comparators for Phase 3 trials but suggested that vaccines prioritized by the Advisory Committee on Immunization Practices (ACIP) for older adults should be considered.
Moderna argued that the FDA had not raised concerns about comparable vaccines in past regulatory reviews, making this recent decision quite unexpected.
Stéphane Bancel, CEO of Moderna, stated, “CBER’s decision, which found no concerns about the safety or efficacy of our products, does not advance our shared goal of increasing U.S. leadership in the development of innovative medicines. Conducting a comprehensive review of influenza vaccine applications using FDA-approved vaccines as comparators should not be controversial, and we hope to work with CBER to clarify the way forward quickly so that older Americans and those with underlying health conditions can access American-made innovations.”
In response to the RTF letter, Moderna has requested a Type A meeting with CBER, which are critical meetings designated for disputes and safety concerns related to significant regulatory “pathways,” aimed at resolving urgent issues hindering drug advancements.
Meanwhile, the Department of Health and Human Services (HHS) has decided to withdraw millions of dollars in funding for mRNA research. Secretary of Health Robert F. Kennedy Jr. justified this move by stating that current data indicates these vaccines are ineffective.
This shift in funding underscores the fundamental differences between vaccine platforms. Traditional vaccines usually work by introducing weaker or inactivated viruses or specific viral proteins to generate an immune response, while mRNA vaccines take a different approach. They deliver a piece of messenger RNA, which instructs the body’s cells to produce viral proteins temporarily, triggering antibodies’ production.
