of clinical trial data released Tuesday, the U.S. Food and Drug Administration has endorsed Moderna’s application for emergency use authorization for its Covid-19 vaccine, finding it to be safe and 94% effective at preventing disease, paving the way for a formal approval later this week when the regulator’s vaccine panel meets. Key Facts
The regulator’s analysis broadly supports Moderna’s announcements at the end of its clinical trials, though it does note a decreased effectiveness, 86% as opposed to 94%, in people 65 and over. said that the vaccine has a “favorable safety profile” with “no specific safety concerns,” though side effects are common, with many experiencing fatigue and headaches after injection.
The analysis will be used on Thursday by the Vaccines and Related Biological Products Advisory Committee, who will meet to discuss emergency authorization. While the endorsement of FDA scientists does not mean the vaccine will be authorized for use in the U.S., it does influence the committee making that decision, which is due to meet Thursday. If authorized, Moderna’s vaccine will be the second Covid-19 vaccine to be approved for emergency use in the U.S.
JermutusLutz It usually takes 4-5 year's to determine if a vaccine is safe for use on human subject's. But the FDA is approving this in 4 weeks? Why hasn't HCQ been touted these last 10 month's?.it's been proven for over 80 year's with a 98% efficacy rate!!