FDA panel confirms Moderna vaccine safety; EUA expected Friday

The FDA's vaccine advisory committee confirmed that Moderna's COVID-19 vaccine is safe and highly effective, according to data released Dec. 15. 

The committee is set to meet Dec. 17 to discuss and vote on whether  the FDA should authorize the vaccine candidate for emergency use. The agency intends to authorize the vaccine Dec. 18, people familiar with the plans told The New York Times. That would give Americans access to the vaccine as soon as Dec. 21. The FDA has said about 6 million doses would be distributed immediately upon authorization, according to the Times

The committee's review of Moderna's clinical trial data confirmed that that vaccine was 94.1 percent effective in a trial of 30,000 people. Mild side effects including fever, headache and fatigue were reported. 

There weren't any significant differences in how effective the vaccine was in people based on race, gender, or whether they were healthy or at risk of severe COVID-19 because of conditions such as obesity and diabetes, according to the Times. For people ages 65 and older, the vaccine showed about 86.4 percent efficacy.

Moderna's vaccine also produced more evidence that it can prevent serious cases of COVID-19, the Times reported. In the trial, 30 people developed severe COVID-19, all of which were in the placebo group. 

The drugmaker is requesting authorization for its vaccine for people ages 18 and up. Pfizer's vaccine was authorized for those as young as 16 because it tested the vaccine candidate in more young people. 

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