Moderna requests Emergency FDA approval for its COVID-19 vaccine


According to The New York Times, Moderna requested Emergency FDA approval for its COVID-19 vaccine. The company said that if the vaccine is authorized, Americans could begin receiving doses as early as December 21.

Moderna, the American drug development company, declared that it applied to the Food and Drug Administration for authorization of its vaccine for emergency use. The company’s satisfactory statement brings hope to the U.S health crisis, due to the upsurge in the number of cases, according to The New York Times. The announcement also comes as the US looks to approve Pfizer’s vaccine in coming days (USA Today).

The company revealed that its COVID-19 vaccine proved to be 94.1 percent effective, according to complete data from an extensive study, which also confirms the earlier evaluations. The vaccine was developed in association with government researchers from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases.

The study, which included 30,000 people, showed that the final data has met the scientific criteria required to determine whether the vaccine is successful. The new data also corresponds with an analysis of interim data, which was released November 16th, that found the vaccine to be 94.5 effective. The study also showed that the vaccine is 100 percent effective in preventing severe diseases triggered by COVID-19.

After Pfizer, Moderna is the second vaccine developer to apply for emergency use authorization. According to Stephane Bancel, the chief executive of Moderna, the company is on track to produce 20 million doses by the end of December, and from 500 million to a billion in 2021, where each person requires two doses administered one month apart. The vaccine developed by Pfizer also requires two doses per person. According to The New York Times, the first shots of the two vaccines are likely to go to the frontline workers, including health care workers, police officers, employees, and residents in nursing homes.



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