Source: China State Council Information Office
The U.S. Food and Drug Administration (FDA) on Friday authorized American drugmaker Moderna’s COVID-19 vaccine for emergency use in the United States.
It is the second COVID-19 vaccine that has received FDA’s emergency use authorization (EUA) in the country, following the first one developed by American drugmaker Pfizer in partnership with German company BioNTech.
The EUA allows the Moderna COVID-19 vaccine to be distributed in the United States for use in individuals 18 years of age and older, said the FDA in a statement.
The FDA has determined that the Moderna COVID-19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna COVID-19 vaccine may be effective in preventing COVID-19, said the statement.
The data also show that the known and potential benefits outweigh the known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older, said the FDA.
Moderna’s COVID-19 vaccine is administered as a series of two doses, one month apart.
“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,” said FDA Commissioner Stephen Hahn in a statement.
The approval came a day after a key FDA advisory committee recommended authorizing the vaccine for emergency use.
The United States has recorded more than 17.41 million cases with over 313,000 related deaths as of Friday evening, according to the real-time count kept by Johns Hopkins University.