WASHINGTON (AP) — The U.S. has given the final go-ahead to the nation’s first COVID-19 vaccine, launching emergency vaccinations in a bid to end the pandemic.
Shots will begin in a few days after Friday’s decision by the Food and Drug Administration.
The FDA called the vaccine from Pfizer and its German partner BioNTech safe and strongly protective.
After the FDA approved the vaccine, President Donald Trump thanked the FDA and praised both Pfizer and Moderna in a video posted to his Twitter account.
But initial doses are scarce and rationed, with health workers and nursing home residents first in line.
According to the Associated Press, about 3 million doses of the vaccine are expected in the first shipments around the country, according to officials with Operation Warp Speed.
In a letter of authorization, the FDA said that in an ongoing trial of 44,000 people, the agency found the vaccine was safe and more than 90% effective in older adults.
In a press release, the FDA said participants in the trial complained of several side effects, which included pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever.
The FDA added that these side effects typically lasted several days, and people experienced the side effects after the second dose than after the first dose.
“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research in the press release.
Enough for the general population isn’t expected until spring, and experts urge people to mask up and keep their distance during a long, grim winter.
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” said FDA Commissioner Stephen M. Hahn, M.D. in the press release.
On Friday, the Centers for Disease Control and Prevention said they had moved up part of its COVID vaccine authorization meeting from Sunday to Saturday.