Nothing surprising here ....
FDA won’t consider a new mRNA vaccine for flu despite the technology’s life-saving promise
The U.S.’s drug safety agency declined to review a next-gen flu vaccine that uses the same tech as the coronavirus shots
By Jackie Flynn Mogensen edited by Claire Cameron
The U.S. Food and Drug Administration is refusing to consider a new mRNA flu vaccine made by Moderna, the company
revealed in a statement on Tuesday.
The vaccine uses mRNA to inoculate the recipient—the same technology used in the Moderna and Pfizer coronavirus vaccines. The way these vaccines work is by delivering a copy of messenger RNA, which acts like a blueprint for cells to make proteins. In the vaccines’ case, the mRNA carries the instructions the body’s cells need to make a protein that can trigger an immune response to the targeted virus.
The FDA’s decision didn’t identify safety or efficacy concerns, according to Moderna. It was based on complaints about the studies Moderna conducted to assess the vaccine, the company said, citing a letter signed by Center for Biologics Evaluation and Research (CBER) director Vinay Prasad.
“This was a clinical trial performed with the FDA’s blessing,” says Angie Rasmussen, a virologist at the University of Saskatchewan. “The top U.S. vaccine regulator should make decisions based on ....
MORE>