FDA advisory panel recommends EUA for Moderna COVID-19 vaccine

Dr. Michelle Chester inoculates Dr. Duroseau Yves with Pfizer's coronavirus vaccine on Monday at Long Island Jewish Medical Center Northwell Health in New York City. A vaccine by Moderna is expected to receive regulatory approval in the United States in the coming days. Photo by John Angelillo/UPI

Dec. 17 (UPI) — A Food and Drug Administration advisory committee voted Thursday to recommend the COVID-19 vaccine developed by Moderna for emergency use authorization.

The Vaccines and Related Biological Products Advisory Committee voted 20-0, with one abstention, to advise FDA Commissioner Dr. Stephen Hahn to issue an EUA for the vaccine. The vote came after a roughly 8-hour meeting of the committee to discuss the efficacy and potential side effects of the vaccine.

If the FDA issues the EUA, initial shipments could begin within days. The Centers for Disease Control and Prevention must also give its approval.

The FDA and CDC took the same steps to approve the vaccine developed by Pfizer and BioNTech last Friday and the first vaccinations were given to health workers on Monday.

There was one difference in the committee’s recommendations, though. The Pfizer-BioNTech vaccine was recommended for those 16 and older, while the Moderna vaccine was given the OK for those 18 and older.

On Tuesday, FDA researchers said in a 54-page review that the Moderna vaccine is safe and effective enough for emergency use in the United States and affirmed the company’s clinical trial results that showed the vaccine is 94% effective.

Moderna said last month its two-dose mRNA-1273 vaccine was tested among participants in a 30,000-volunteer clinical trial. The FDA review said the vaccine is highly protective for adults and prevents severe cases of the coronavirus disease.

Like Pfizer’s, Moderna’s is a new type “messenger RNA” vaccine that uses strands of genetic material from the coronavirus to activate the body’s immune system, rather than employing a whole, deactivated virus as traditional vaccines do.

The U.S. government has plans to purchase 200 million doses of the Moderna vaccine if it’s approved.


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