FDA Endorses Moderna's COVID-19 Vaccine for Emergency Use
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From the Left
FDA review clears path for second coronavirus vaccine, this one developed by ModernaBy the end of the week, the United States could have two coronavirus vaccines.
A vaccine candidate developed by biotechnology company Moderna appears poised for regulatory clearance after a detailed data review by Food and Drug Administration scientists confirmed the two-shot regimen was 94 percent effective in a clinical trial and carried no serious safety concerns.
The FDA is likely to authorize the vaccine as soon as Friday, according to a person with knowledge of the situation who spoke on the condition of anonymity because they were not authorized to...
From the Center
FDA staff endorses emergency use of Moderna’s Covid vaccine in a critical step toward approvalThe staff of the Food and Drug Administration on Tuesday endorsed the emergency use of Moderna’s coronavirus vaccine, a critical step forward in winning formal clearance to be administered to the public as early as next week.
The staff report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which meets Thursday to review Moderna’s request for emergency use authorization.
The group of outside medical advisors recommended Pfizer’s vaccine for emergency use last Thursday, and the FDA approved it the next day. The committee is expected...
From the Right
FDA finds Moderna coronavirus vaccine is effective and safeThe Food and Drug Administration released data showing that Moderna's COVID-19 vaccine is safe and effective.
The FDA's review, which was published on Tuesday, confirmed Moderna’s previous assessment that its vaccine had an efficacy rate of 94.1% in a trial of 30,000 people. It noted that potential side effects of the vaccine include fever, headache, and fatigue but added that those unintended effects were not dangerous.
The vaccine's high efficacy was documented after two doses of the vaccine were administered 28 days apart.
The data release is another step for...
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