FDA won't consider a new mRNA vaccine for flu despite the technology's life-saving promise
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FDA won't consider a new mRNA vaccine for flu despite the technology's life-saving promise
"The vaccine uses mRNA to inoculate the recipientthe 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 U.S. Food and Drug Administration refused to consider Moderna's mRNA influenza vaccine. The vaccine uses messenger RNA to instruct cells to produce a viral protein and elicit an immune response, using the same platform as the Moderna and Pfizer COVID-19 vaccines. Moderna stated that the FDA's refusal did not cite safety or efficacy concerns but pointed to complaints about the company's clinical studies, referencing a letter from CBER director Vinay Prasad. A virologist, Angie Rasmussen, noted the trial proceeded with FDA blessing and argued that regulatory decisions should follow a systematic, transparent, advisory-informed review.
Read at www.scientificamerican.com
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