The FDA refused to review Moderna's application for a mRNA-based flu vaccine. The refusal is based upon which vaccine Moderna should have used as their control. IIRC Moderna stated that they worked with the FDA in their choice. At
In the Pipeline medicinal chemist Derek Lowe wrote, "Stat reported today that Prasad overruled others at the agency, who were ready to begin the review, although HHS denies that this was the case. Of course they do. But Prasad signed the rejection letter personally, which is also something I’ve never heard of before, so draw your own conclusions...And let’s get real here: this application is being denied, personally by Vinay Prasad and against the recommendation of the FDA’s remaining experts, because he and the rest of the Trump administration are
hostile to vaccines in general and to
mRNA technology in particular. I don’t see how anyone can look at the statements and actions of the political appointees (from RFK Jr. on down) and come away with any other impression. We are deliberately walking away from the most advanced form of one of the most effective public health measures available to the human race, and instead we are
investigated older technologies that happen to involve the administration’s friends. Meanwhile, mRNA therapies are under investigation - in more advanced parts of the world - for far more than vaccines, including various types of cancer. But we, on the other hand, seem to be
plowing money into ivermectin (of all things) for that purpose."
CIDRAP also covered this story. "Vaccine companies generally work with clear, well-established expectations of the kinds of studies considered acceptable by the FDA, Peter Hotez, MD, PhD, of Baylor College of Medicine, tells CIDRAP News. “There was a commitment,” he said, adding that to “string Moderna along and all of a sudden say, nope, we’re not going to even review it” risks undermining confidence in FDA processes. The decision, Hotez warned, could “have an immediate chilling effect on the vaccine industry.” Vaccine makers may start to reassess whether to invest in US-based vaccine development if regulatory expectations shift late in the process. The FDA "changed their mind," about whether Moderna could use a standard-dose flu shot in the trial, Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said, "which is really not fair.""
