The Food and Drug Administration first approved the use of a coronavirus vaccine in an emergency, a milestone in the fight against the pandemic that killed nearly 100,000 Americans.
“Today’s action follows an open and transparent review process that included input from independent science and public health experts and a thorough assessment by the agency’s career scientists to ensure this vaccine meets the FDA’s rigorous scientific standards for safety, efficacy and manufacturing quality that are required to support emergency approval, ”said FDA Administrator Stephen Hahn.
The vaccine is from Pfizer-BioNTech. They are part of a number of biomedical companies that have worked to develop a safe and effective vaccine.
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The FDA said that “the entirety of the available data provides strong evidence that the Pfizer-BioNTech COVID-19 vaccine can effectively prevent COVID-19. The data also shows that the known and potential benefits outweigh the known and potential risks and support the use of the vaccine in millions of people aged 16 and over, including healthy individuals. “
The federal government has planned to distribute 2.9 million doses of the vaccine within 24 hours of emergency approval, giving priority to frontline health workers and the elderly in long-term care facilities. The Pfizer vaccine is given in two doses three weeks apart.
Distribution of the vaccine to enough populations to eradicate the virus is expected to take months, possibly until mid-2021, as production ramped up and distribution and vaccination plans established. Dr. Moncef Slaoui, who heads Operation Warp Speed, the government’s project to accelerate vaccine development, said the US should have enough doses by the end of February to immunize 100 million Americans.
The FDA said the most commonly reported side effects were injection site pain, fatigue, headache, muscle pain, chills, joint pain, and fever. The agency said the side effects usually last for several days.
There are still unknowns about the effectiveness of the vaccine, e.g. B. how long it provides protection and whether it prevents person-to-person transmission. One challenge might be to convince a large section of the public to take the vaccine. A poll by the Pew Research Center last week found that 60% of Americans said they would definitely or likely take the vaccine. But 21% said they did not plan to get vaccinated.
However, the FDA said the vaccine had reached the threshold for distribution.
“Efforts to accelerate vaccine development have not compromised scientific standards or the integrity of our vaccine evaluation process,” Hahn said in a statement.
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