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Moderna to Seek FDA Approval for COVID Vaccine

coronavirus vaccine

Nov. 30, 2020 -- Moderna will ask the FDA on Monday for emergency use authorization (EUA) for its coronavirus vaccine, the pharmaceutical company said in a news release.

Moderna says it expects the FDA’s Vaccines and Related Biological Products Advisory Committee to review the vaccine Dec. 17. If the committee approves the EUA, the vaccine will be shipped to distribution points across the country right away and given to high-priority groups set by the CDC, such as front-line health care workers.

The first vaccine shots could be given to people as early as Dec. 21, said Moderna CEO Stéphane Bancel, according to The New York Times.

In the news release, Moderna said its vaccine had proven to be 94.1% effective, and 100% effective in severe cases of COVID-19.

Of the 30,000 people in the Moderna clinical trial, about half got the vaccine and half got a placebo. In the placebo group, 185 people contracted the coronavirus, with 30 becoming severely ill and one dying, the news release said. In the vaccine group, 11 people got the coronavirus and none became severely ill.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” Bancel said in the news release. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death.”

Pfizer became the first company to apply for an EUA for its COVID-19 vaccine on Nov. 20. The FDA is expected to consider the Pfizer vaccine in a Dec. 10 meeting. Pfizer says its vaccine has a 95% efficacy.

Moderna and Pfizer both use two shots of messenger RNA to create an immune response against the coronavirus. The shots are given about 2 weeks apart.

Moderna expects to have 20 million doses of the vaccine available in the United States by the end of 2020 and remain on track to produce 500 million to 1 billion doses globally in 2021, the news release said.

The company says “efficacy was consistent across age, race and ethnicity, and gender demographics.” Of the 196 participants who got COVID, 33 were older than 65, and 42 came from diverse communities.

Moderna will also apply for a conditional marketing authorization with the European Medicines Agency (EMA).

WebMD Health News Brief

Sources

Moderna: "Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization."

The New York Times: “Moderna will apply for emergency F.D.A. vaccine approval and says first injections could begin by Dec. 21.”

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