It’s been both sad and horrifying to watch our public health institutions be dismantled — as science is ignored and development programs are shut down — a trajectory that will lead to preventable illness and death. This pattern has been unfolding for some time.
In at least a temporary reprieve, however, the FDA has reversed course on Moderna’s flu vaccine. The agency initially cited trial design concerns in refusing to review the application but agreed to move forward after discussions with the company. Perhaps the significant public criticism had an impact.
Moderna says the FDA will consider its new flu shot after resolving a public dispute
The Food and Drug Administration will consider whether to approve Moderna’s new flu vaccine after all, resolving a dispute that had blocked the company’s application for the first-of-its-kind shot.
Moderna announced the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology.
The dispute centered over a 40,000-person clinical trial that concluded Moderna’s new vaccine was more effective in adults age 50 and older than one of the standard flu shots used today. In the FDA’s rare “refusal to file” letter, vaccine director Dr. Vinay Prasad faulted the trial for not including another brand specifically recommended for people 65 and older.
U.S. rejection of new mRNA flu vaccine ‘sends chills,’ epidemiologist says
Amna Nawaz, Courtney Norris and Bridget Craig, PBS
The U.S. Food and Drug Administration announced recently that it will not review Moderna’s mRNA flu vaccine, despite late-stage trials showing it was safe and effective. The rejection has many in and outside the industry concerned about the Trump administration’s approach to vaccine development and recommendations. Amna Nawaz discussed more with Michael Osterholm.
Transcript:
Amna Nawaz:
The U.S. Food and Drug Administration announced recently it will not review Moderna’s mRNA flu vaccine despite late-stage trials showing it was safe and effective.
The rejection of the experimental flu application, at least for now, has many in and outside the industry concerned about the Trump administration’s approach to vaccine development and recommendations. It’s the latest move that reflects Health Secretary Robert F. Kennedy Jr.’s criticism of mRNA technology, which was used by Moderna and Pfizer to combat the coronavirus.
Michael Osterholm is the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, and he joins me now.
