US refuses application for new mRNA flu vaccine
The US Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel-winning mRNA technology.
The news came after the FDA contacted Surgeon General Robert F. Kennedy Jr. It’s the latest sign of his administration’s increasing scrutiny of vaccines, especially those using mRNA technology, which he criticized before and after he became the nation’s top health official.
Moderna received a “refuse to file” letter from the FDA objecting to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu vaccines used today.
That trial concluded that the new vaccine was slightly more effective than the standard vaccine in adults aged 50 and over.
The letter from FDA vaccine director Dr Vinay Prasad said the agency did not consider the application to be an “adequate and well-controlled trial” because it did not compare the new vaccine to “the best standard of care available in the United States at the time of the study.”
Prasad’s letter pointed to some recommendations that FDA officials gave to Moderna in 2024 under the Biden administration, but which Moderna did not follow.
According to Moderna, this feedback stated that it was acceptable to use the standard dose of flu vaccine chosen by the company, but that another brand, specifically recommended for the elderly in the study, would be preferred for anyone aged 65 and over.
Still, Moderna said the FDA allowed the study to proceed as originally planned.
The company said it also shared with the FDA additional data from a separate trial comparing the new vaccine to a licensed high-dose vaccine used for seniors.
Moderna CEO Stephane Bancel said in a statement Tuesday that the FDA “did not identify any safety or efficacy concerns regarding our product” and “does not advance our shared goal of increasing America’s leadership in developing innovative medicines.”
It is rare for the FDA to refuse to submit an application, especially for a new vaccine; This requires companies and FDA staff to engage in discussions for months or years.
Moderna requested an urgent meeting with the FDA and noted that it had applied for the vaccine to be approved in Europe, Canada and Australia.
Last year, FDA officials working under Kennedy rolled back recommendations on COVID-19 vaccines, added extra warnings to two leading COVID vaccines made with mRNA technology, and removed criticism of the administration’s approach from the FDA advisory panel.
Kennedy announced last year that his department would cancel more than US$500 million ($707 million) in contracts and funding for the development of vaccines using mRNA.
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