FDA Grants Emergency Use Authorization for Pfizer Vaccine
Administration on Friday granted an emergency use authorization for the coronavirus vaccine developed by Pfizer and BioNTech, marking a major milestone in the pandemic that has claimed close to 300,000 American lives.
“It is nothing short of a medical miracle to have FDA authorization of a vaccine for COVID-19 just over 11 months since the virus was made known to the world,” Health and Human Services Secretary Alex Azar said in a statement.
The highly-anticipated approval allows vaccine shipments to begin. However, shots cannot be administered until a Centers for Disease Control and Prevention advisory committee votes Saturday on whether to recommend the vaccine for the public and if certain groups of people should not receive the shot. CDC Director Robert Redfield would then need to sign off on the committee’s recommendation.
Azar on Friday said that the first vaccinations could start Monday or Tuesday. Britain, Bahrain, Canada, Saudi Arabia and Mexico have also approved the vaccine.
FDA Commissioner Stephen Hahn was reportedly pressured by the White House to issue the emergency use authorization on Friday, with White House chief of staff Mark Meadows telling him to submit his resignation if the agency does not make the decision by the end of the day.
President Donald Trump has repeatedly expressed frustration over the regulatory process. He took to Twitter on Friday to criticize the FDA, calling it a “big, old, slow turtle” and urging Hahn to “get the dam vaccines out NOW.”
Over the next 24 hours, 2.9 million doses of the vaccine will be shipped across the country, according to Gustave Perna, the chief operations officer for Operation Warp Speed. An equal number of shots will be reserved to guarantee a second dose is available for the individual roughly three weeks later.
Government officials have said they expect to have enough vaccines to inject 20 million people this month and 100 million – nearly a third of the U.S. population – by the end of February. Officials have said that everyone who wants a vaccine could get one by June.
A CDC advisory committee earlier this month recommended that the first available vaccines go to health care workers and nursing homes.
The vaccines will be shipped to “wherever the governors have told us they want it to go,” according to Azar.
Despite the promising development, the U.S. is expected to see hundreds of thousands more deaths from the virus before the vaccine is widely available in the spring. Health officials have warned that the vaccine rollout won’t immediately impact the outbreak and urged citizens to continue following mitigation measures like wearing a mask and social distancing.
An emergency use authorization “is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic,” according to the FDA. A full approval for a vaccine typically requires six months of safety data collection.