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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 company’s actions come after a final analysis of its 30,000-person late-stage trial show 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.

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.

Background: The U.S. government has agreed to pay up to $1.525 billion for 100 million doses of the vaccine, with an option to purchase another 400 million doses. The company has received about $2.5 billion overall from the government, with most of that money going to support the vaccine’s development.

Moderna has said it will have 20 million doses of vaccine available in the United States this year, and expects to produce 500 million to 1 billion doses in 2021.

What’s next: The FDA’s independent vaccine advisory group will meet on Dec. 17 to review the Moderna data. The agency is not obligated to follow the recommendations of the advisory panel, but it normally does. The FDA could decide whether to grant the emergency authorization soon after.

That would put Moderna just behind Pfizer and its German partner, BioNTech, who applied for emergency authorization of their vaccine earlier this month. The FDA advisory panel will discuss the Pfizer shot at a meeting on Dec. 10.

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