Moderna Requests FDA and EUA Approval for its COVID-19 Vaccine Candidate

On Monday, Moderna requested EUA and FDA approval for its COVID-19 vaccine. The pharmaceutical company claims that its candidate is 94.1% successful against the coronavirus.

According to the FDA's vaccine advisory committee, Dr. Paul Offit, this is “amazing data."

On Saturday, the chief medical officer of Modena, Dr. Tal Zaks, stated that "it was the first time I allowed myself to cry," as now they have "a full expectation to change the course of this pandemic."

On November 20, the pharmaceutical company Pfizer also applied for COVID-19 vaccine approval, with results similar to Modena’s. The FDA will review both candidates later this month.

According to the National Institute of Allergy and Infectious Diseases Director, Dr. Anthony Fauci, the first vaccinations will be distributed "towards the latter part of December".

After releasing its Phase 3 clinical data on Monday, Moderna will seek the European Medicines Agency’s approval as well. By the end of this year, the company plans to manufacture nearly 20 million doses of its vaccine in the US and distribute up to 1 billion worldwide in 2021.

If the vaccine is authorized by the FDA, the US Centers for Disease Control and Prevention advisory committee should decide who will be vaccinated first. In all probability, the first individuals to take the shot will be healthcare staffers.