The U.S. Food and Drug Administration gave emergency use authorization on Friday for Moderna’s COVID-19 vaccination, the second company approved to distribute vaccines to combat the pandemic.
The recommendation, announced in a news release Friday evening, comes one day after an FDA advisory panel recommended the vaccine, and a week after the agency approved an EUA of the vaccine from Pfizer and BioNTech.
“The emergency use authorization allows the vaccine to be distributed in the U.S for use in individuals 18 years and older,” the FDA tweeted.
The EUA for Moderna’s vaccine was granted after the recommendation by the FDA’s Vaccines and Related Biological Products Advisory Committee on Thursday. The recommendation, which passed with 20 yes votes and one approval, means the Moderna vaccine could be used as early as next week. The panel voted that the benefits of the highly effective Modern vaccine outweighed its risks for people individuals 18 years of age and older.
However, before the vaccines can be shipped, a U.S. Centers for Disease Control and Prevention immunization advisory committee must vote to recommend the vaccine and CDC Director Robert Redfield must sign off on the recommendation.
“I’ve never been more hopeful that we will eventually turn the corner on this pandemic,” Richard Besser, former acting director of the Centers for Disease Control and Prevention and current president of the Robert Wood Johnson Foundation, told NBC News.
“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 said in the release. “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited time frame 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.”
Anthony S. Fauci, the nation’s top infectious disease expert, called the approval two vaccines “an historic moment.”
“This to me is a triumph of multiyear investment in biomedical research that culminated in something that was not only done in record time, in the sense of never before has anybody even imagined you would get vaccines to people in less than a year from the time that the sequence was made known,” Fauci told The New York Times. “This is an example of government working. It worked really well,” he added.
Moderna, based in Cambridge, Massachusetts, now will be ready to distribute approximately 5.9 million doses of its vaccine around the country. Shipping could begin as soon as Sunday, with deliveries on Monday, the Times reported.
Cox Media Group