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Moderna Has Submitted Its Coronavirus Vaccine For Emergency Approval From The FDA

If approved, the vaccine could become the second shot to become available in the US by December.

Posted on November 30, 2020, at 8:32 a.m. ET

Nurphoto / Getty Images

The drug company Moderna announced that it would be submitting its coronavirus vaccine for emergency approval from the FDA on Monday, following clinical trial data showing its shots are very effective at preventing cases of COVID-19.

Once submitted, Moderna's will be the second coronavirus vaccine on its way to emergency approval from the US health agency. Pfizer submitted its vaccine for approval earlier this month.

Moderna's application to the FDA will be based on 196 cases of COVID-19 reported in its clinical trial of 30,000 people. One hundred eighty-five of the people who got sick had gotten a placebo shot, indicating that the vaccine was 94.1% effective. All 30 cases of severe COVID-19 were in the placebo group, and one person in the group died of the disease.

These promising results are in line with preliminary data the drug company announced earlier this month. No serious side effects have been reported.

If approved, both Pfizer and Moderna's vaccines could start being administered in the US as early as December. The FDA's emergency approval meeting for Pfizer's vaccine is scheduled for Dec. 10, while Moderna said it expects its to take place on Dec. 17. How long it will take for the health agency to approve a vaccine is unclear: Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, has said it could take days to weeks. Once approved, Operation Warp Speed Chief Operating Officer Gen. Gus Perna said last week that they will be able to start shipping vaccines across the country within 24 hours.

The CDC has outlined a three-phase vaccine distribution plan that recommends that each state first give vaccines to healthcare workers. Older people, essential workers, and people with underlying health problems are next in line. Mass vaccination is expected to begin across the US by April.

The hopeful news comes as the US health crisis continues to rapidly worsen. The US recorded more than 4 million COVID-19 cases and over 25,000 deaths in November alone, hospitals across the country are overwhelmed, and public health officials are warning that there will be an even bigger spike following the Thanksgiving holiday. More than 266,000 Americans have died of COVID-19 so far, part of the nearly 1.5 million people across the globe who have died of the disease.

By the end of 2020, Moderna said it expects to have 20 million doses of its vaccine available in the US and hopes to manufacture 500 million to 1 billion doses globally in 2021.

The Moderna and Pfizer vaccines are both part of a new class of messenger RNA (mRNA) gene vaccines that have yet to be approved for use in people. They carry genes instructing human cells to make viral proteins, triggering the body's immune response.

A BuzzFeed News investigation, in partnership with the International Consortium of Investigative Journalists, based on thousands of documents the government didn't want you to see.