FDA authorizes Pfizer's COVID-19 vaccine for emergency use
Vaccinations could start as soon as next week.
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"The FDA's authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic," said FDA Commissioner Stephen M. Hahn.
"Today's action," Hahn continued, "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."
Pfizer, which developed the vaccine with German partner BioNTech, said last month the vaccine demonstrated 95% effectiveness in clinical trials.
Given that there are more than 330 million people in the US, not everyone will immediately be able to get the vaccine, which is given in two doses. Health care workers will be prioritized, as well as people at higher risk of infection due to age, underlying conditions or profession. Pfizer has said it expects to produce up to 50 million vaccine doses in 2020 and 1.3 billion in 2021.
Earlier on Friday, Secretary of Health and Human Services Alex Azar said his agency would work with Pfizer to get the vaccine shipped out.
"We could be seeing people getting vaccinated Monday or Tuesday of next week," Azar said on Good Morning America.
The vaccine is administered as a series of two doses, three weeks apart.
The first cases of COVID-19 were reported in China a year ago this month. By March, a pandemic was in full force. According to the Johns Hopkins coronavirus dashboard, more than 69 million cases have been confirmed worldwide and nearly 1.6 million people have died of COVID-19 as of Thursday.
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