The Food and Drug Administration will hold a meeting of its Vaccines and Related Biological Products Advisory Committee next month to evaluate Moderna’s investigational mRNA flu vaccine. The session, scheduled for June 18 according to a Federal Register notice posted on May 22, will focus on the safety and efficacy of Moderna’s MFLUSIVA for adults aged 50 years and older.
This review comes after controversy earlier this year when the FDA initially declined to accept Moderna's application for review. In February, the agency issued a refusal-to-file letter citing concerns that the pivotal trial used a control group that "does not reflect the best-available standard of care." Andrew Nixon, spokesperson for the agency, said at that time: “The FDA rejected Moderna’s application for filing because the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy.”
The decision drew significant criticism from within the industry. Reports indicated that Department of Health and Human Services officials had to defend former Center for Biologics Evaluation and Research Director Vinay Prasad publicly. Then–FDA Commissioner Marty Makary was also called into President Donald Trump’s office regarding concerns over how vaccine issues were being handled.
Following discussions between Moderna and the FDA, regulators agreed to accept an amended application. The new submission seeks regular approval for adults ages 50–64 years old, as well as accelerated approval for those aged 65 years or older. A final decision is expected in August.
In recent months there have been several high-level departures at both CBER (Center for Biologics Evaluation and Research) and CDER (Center for Drug Evaluation and Research), including Prasad himself, Acting CBER Director Katherine Szarama, Acting CDER Director Tracy Beth Høeg, along with other senior staff members such as chief of staff and chief AI officer. Since President Trump took office there have now been six different leaders each at CBER and CDER.
Observers are watching closely as leadership changes continue across major health agencies while key regulatory decisions like this one move forward.
