Moderna to seek emergency FDA authorization for coronavirus vaccine

Moderna will file Monday for an emergency authorization of its coronavirus vaccine from the Food and Drug Administration, becoming the second company to do so.

The vaccine developer said it would simultaneously ask the European Medicines Agency for conditional approval.

The FDA filing would clear the way for the vaccine to be authorized for use in the United States within weeks. Moderna's application relies on a final analysis of its 30,000-person late-stage trial that showed the vaccine to have 94.1 percent efficacy, on par with the 94.5 percent reported in a preliminary analysis. The vaccine worked consistently for different ages, races, ethnicities and genders, and the side effects were mild, Moderna said.

President Donald Trump tweeted his support of the vaccine on Monday, hours after the company's announcement.

"Moderna now applying for Emergency Vaccine Approval.. @US_FDA MUST ACT QUICKLY!!!" he wrote. "'Operation Warp Speed has been a great modern day miracle.'”

New information: The final analysis was based on 196 cases of Covid-19 reported among the study participants. The vast majority — 185 — occurred in people who got a placebo, compared to just 11 among people who got the vaccine.

All 30 severe cases took place in the placebo group, and one participant in the placebo group died of the virus, Moderna said.

The most common side effects included pain at the vaccine injection site, fatigue, muscle and joint pain, headache and redness. The side effects were worse after the second of two doses of the vaccine, which are normally given four weeks apart.