Approval of the Moderna vaccine gives the US a second option in the fight against COVID-19.
The US Food and Drug Administration on Friday granted emergency use authorization for
Moderna’s COVID-19 coronavirus vaccine candidate, mRNA-1273.
This move paves the way for wide distribution.
In a press release, FDA Commissioner Stephen M. Hahn, MD, said the move is a positive for a public numb to the COVID-19 pandemic.
“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,” he said in the statement. “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 s
upport emergency use authorization that the American people have come to expect from the FDA.”
Hahn added that FDA standards and review processes, which are the same the administration 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.
In the release, the FDA noted that the Moderna vaccine showed an efficacy of 94.1 percent with 100 percent efficacy against severe COVID-19 and low frequency of serious adverse events.
Moderna officials have indicated that the company expect to have 20 million doses available by the end of the year and a further 500 million to one billion doses in 2021.
Moderna now joins Pfizer and BioNTech in supplying the drugs to the U.S. government.