CAMBRIDGE- Americans will receive the second COVID-19 vaccine.
On Friday, the commissioner of the U.S. Food and Drug Administration, Stephen Hahn allowed emergency authorization to a vaccine made by Moderna, a week later granting similar approval to the vaccine made by Pfizer and its German partner, BioNTech.
He is “authorizing” instead of approving the vaccine because lengthy research is required to meet the full standards for approval, which the authorities don’t want to wait for in the time of public health emergency.
The quick decision to authorize the vaccine was possible because the agency “burst through regulatory red tape,” Stephen said in a press conference. “We worked swiftly based on the urgency of this pandemic.”
The declaration makes the U.S. the first country to approve two Coronavirus vaccines that show “compelling and clear efficacy”- director of the Center for Biologics Evaluation and Research, Dr Peter Marks said during the press conference on Friday. He added it is “another achievement as we work to end the Coronavirus pandemic.”
The approval comes a day after the U.S. reported 17 million cases of Coronavirus and an independent authorization committee revised the data from human trials of Moderna’s vaccine, declaring its benefits outweighed its risks. Following a trial that included 30,000 volunteers, the vaccine protected more than 95% of people from active disease, without causing major health problems.
Trucks will begin distributing the vaccine this week, with the 5.9 million shots already manufactured are expected to be given out on Tuesday.
It’s an outstanding achievement for the 10-year-old Cambridge biotech company that had never brought a new product to market.
But it will take time to distribute the vaccine across the country and the whole world, achieving the 75% protection- from both natural diseases and vaccination- that experts say will be required to stop widespread infections.