FDA review clears path for second coronavirus vaccine, this one developed by Moderna
Source: Washington Post
By 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 54-page document positions the Moderna vaccine to follow the same historic track as the Pfizer-BioNTech vaccine. After the FDA gave a positive review of the Pfizer-BioNTech vaccine exactly a week ago, the shots were endorsed by a panel of outside experts on Thursday and granted a green light by regulators a day later. The first doses were administered to health care workers on Monday. Much the same timeline is anticipated this week, given the similar results from Moderna’s vaccine and the fact that it relies on the same underlying technology. A gamble pays off in ‘spectacular success’: How the leading coronavirus vaccines made it to the finish line
Moderna’s vaccine will be reviewed Thursday by the same panel of independent experts at an all-day public meeting. The data they will consider echoes the evidence that led to a 17 to 4 vote to authorize the Pfizer-BioNTech vaccine, which was 95 percent effective. In addition, the two-shot Moderna regimen was particularly effective against severe disease. There were 30 cases of severe covid-19, the disease caused by the virus, in the trial, none of them in the group that got the vaccine. The Moderna vaccine worked well, regardless of age, race and gender. The adverse events associated were widespread, but short-lived, including fatigue, muscle aches and pain at the injection site.
In anticipation of its clearance, Gen. Gustave Perna, chief operating officer of the federal effort to develop and distribute vaccines, said Monday that the U.S. was preparing to ship almost 6 million doses of the Moderna vaccines to 3,285 locations in the first week. “It will be a very similar cadence that was executed this week with Pfizer,” Perna said, “where we’re hitting initial sites on Monday, follow on Tuesday and Wednesday.”
Read more: https://www.washingtonpost.com/health/2020/12/15/moderna-vaccine-found-safe-effective/
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