FDA Issues Emergency Use Authorization for Second COVID-19 Vaccine

Doses will be arriving for use on individuals aged 18 years and older in the U.S. on Monday.
Loukia Papadopoulos

On Friday, the U.S. Food and Drug Administration issued an emergency use authorization for a second COVID-19 vaccine: the vaccine developed by Moderna Inc. and the National Institutes of Health (NIH). This new vaccine will soon be available for use in individuals 18 years of age and older.

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A world-first

This is the world's first authorization of the Moderna vaccine and will see doses arriving for use on Monday. The U.S. is currently recording more than 3,000 COVID-related deaths a day.

“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said in a statement FDA Commissioner Stephen M. Hahn, M.D.

“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA."

Of course, the second vaccine was held up to a review process just like the first one. And regulations mandate that, any future COVID-19 vaccine will be held to the same standards by FDA with "input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”

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Better than we dared to hope

The FDA revealed that the vaccine's potential benefits outweigh the known and potential risks. In addition, Moderna's vaccine is more convenient than Pfizer's since it doesn’t need to be stored at ultra-low temperatures. However, both treatments seem to be performing at very satisfactory levels.

The two work “better than we almost dared to hope,” NIH Director Dr. Francis Collins told The Associated Press. “Science is working here, science has done something amazing.” To date, COVID-19 has killed 1.7 million people worldwide, 312,000 of which were in the U.S. Hopefully, its impact will be gradually mitigated with these treatment options in place.

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