COVID

Moderna seeks full authorization of COVID-19 vaccine

The vaccine is 93% effective through six months after the second dose, according to the company.

Moderna – which already had Emergency Use Authorization from the U.S. FDA – has finished applying for full authorization. AP Photo/Sunday Alamba

By Mia McCarthy

1 minute to read

Moderna, a local biotechnology company, finished its submission for a Biologics License Application to the United States Food and Drug Administration for a full authorization of their COVID-19 vaccine.

“This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company’s history,” said Chief Executive Officer of Moderna, Stéphane Bancel in a statement.

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Moderna — a Cambridge-based company — reported their final submission included clinical data from their vaccine study’s third phase. Over 30,000 people in the United States took part.

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The Moderna COVID-19 vaccine has been approved under an Emergency Use Authorization for those over the age of 18 in the United States. The vaccine is 93% effective through six months after the second dose, according to the company.

Moderna has also sought approval from the FDA for emergency use of the vaccine for adolescents over the age of 12.

This announcement comes two days after the Pfizer COVID-19 vaccine gained full FDA approval.

Bancel also thanked the Moderna team for their dedication, the FDA for their help with the submission, and the Institute of Allergy and Infectious Diseases, National Institutes of Health, and Biomedical Advanced Research and Development Authority for their partnership in the study.

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