A day after an advisory panel recommended the use of the Moderna COVID-19 vaccine, the US Food and Drug Administration (FDA) Friday approved it as the second vaccine to fight the pandemic.
“The emergency use authorization allows the Moderna COVID-19 vaccine to be distributed in the US for use in individuals 18 years of age and older,” said the agency in a statement.
The panel on Thursday voted 20-0 with one abstention, paving the way for a final green light from the FDA for use of the vaccine.
Moderna is the second coronavirus vaccine in the US after Pfizer/BioNTech’s vaccine, which was authorized by the FDA last week.
The pandemic has recently resulted in vast numbers of COVID-19-related hospitalizations and deaths in the country.
“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 the health agency’s Commissioner Stephen Hahn.
Moderna vaccine is administered as a series of two doses, one month apart, according to the agency.
On Tuesday, an FDA report said the Moderna vaccine is 94.5% efficient with “no specific safety concerns identified that would preclude” issuance of emergency use authorization.
“The vaccine elicited increased local and systemic adverse reactions as compared to those in the placebo arm, usually lasting a few days,” the report said.
A New York healthcare worker received the first dose of the Pfizer/BioNTech vaccine on Monday.
As of Friday evening, the country’s coronavirus-related deaths exceed 312,000, and over 17.4 million cases have been registered so far, according to a running tally by the US-based Johns Hopkins Coronavirus Resources Center.
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