COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Issues EUA for Second COVID-19 Vaccine

FDA maze of regulations

Moderna COVID-19 vaccine becomes second vaccine of its kind to receive FDA authorization

The US Food and Drug Administration (FDA) announced Dec. 18, 2020, the issuance of a second emergency use authorization (EUA) for a COVID-19 vaccine. This EUA was granted to Moderna for its Moderna COVID-19 Vaccine. This is the second EUA to be granted for a COVID-19 vaccine, and it allows for use of the vaccine in individuals 18 years and older.

“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,” FDA Commissioner Stephen M. Hahn, MD, said. “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. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”

The Moderna vaccine and the Pfizer vaccine are the only two COVID-19 vaccines to currently have EUAs; however, other vaccine candidates continue to produce promising results.

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