Late in the evening on Dec. 11, the U.S. Food and Drug Administration (FDA) authorized the first COVID-19 vaccine for use in the country. The emergency use authorization means that doses of the vaccine—made by Pfizer/BioNTech—can be shipped at any time; certain Americans could be vaccinated as soon as next week.
In a statement, FDA commissioner Dr. Stephen Hahn said “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.” In the same press release, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, noted that “efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process.”
The authorization for the two-dose vaccine comes a day after an FDA advisory committee voted 17-4 (with one abstention) to greenlight the vaccine after reviewing data on the shot’s safety and efficacy.
“We have received the great news that the FDA has authorized the emergency use of our COVID-19 vaccine for people 16 or older,” Albert Bourla, Pfizer Chairman and CEO, said in a Dec. 11 video statement announcing the authorization. Bourla said the company is ready to begin shipping doses “immediately” throughout the U.S. from its three manufacturing facilities in Andover, Mass.; Kalamazoo, Mich.; and St. Louis, Mo. The vaccine has already received approval in the UK and health officials began vaccinating people there on Dec. 8; it has also been approved in Canada, where the first shots are expected next week.
”It is a wonderful feeling because for the first time outside of clinical trials, we see something that was developed in our lab that could reach people and could change that vaccinated person’s life,” Ugur Sahin, co-founder of BioNTech, tells TIME. “The understanding that it will make a difference to many, many, many people and all of their families is an extremely powerful and energizing feeling.”