Washington: The United States has approved Moderna's COVID-19 vaccine, paving the way for the release of millions of doses.
It is now the second vaccine to get approval.
US President Donald Trump tweeted: " Congratulations, the Moderna vaccine is now available!"
Congratulations, the Moderna vaccine is now available!— Donald J. Trump (@realDonaldTrump) December 19, 2020
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older, read the statement issued by U.S. Food and Drug Administration.
“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 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," Hahn said.
"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," said Stephen M. Hahn.
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.
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.
In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.
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