The Food and Drug Administration gave emergency use authorization for the first time to a coronavirus vaccine, a milestone in the fight against the pandemic that has resulted in the deaths of nearly 300,000 Americans.
“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 administrator Stephen Hahn.
The vaccine comes from Pfizer-BioNTech. They have been among a number of biomedical firms that have been racing to develop a vaccine that is safe and effective.
The FDA said that “the totality of the available data provides clear evidence that Pfizer-BioNTech Covid-19 Vaccine may be effective in preventing Covid-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals.”
The federal government has been planning to distribute 2.9 million doses of the vaccine within 24 hours of emergency authorization, with the priority being given to front-line healthcare workers and the elderly in longterm care facilities. The Pfizer vaccine is administered in two doses, three weeks apart.
The distribution of the vaccine to enough of the population to eradicate the virus is expected to take months, perhaps into the middle of 2021, as production ramps up and distribution and inoculation plans are put in place. Dr. Moncef Slaoui, who is leading Operation Warp Speed, the administration’s project to accelerate vaccine development, has said that by the end of February, the U.S. should have enough doses to immunize 100 million Americans.
The FDA said that the most commonly reported side effects were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever. The agency said that the side effects typically last several days.
There are still unknowns about the effectiveness of the vaccine, such as how long it will provide protection and whether it will prevent transmission from person to person. A challenge may be to convince a large swath of the public to take the vaccine. A Pew Research Center poll last week showed that 60% of Americans said that they would definitely or probably take the vaccine. But 21% said that they did not intend to get vaccinated.
But the FDA said that the vaccine met the threshold for distribution.
“Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process,” Hahn said in a statement.