The FDA says it will authorize Pfizer's COVID-19 vaccine, paving the way for people in the US to start getting shots as early as Monday
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The US Food and Drug Administration has said it intends to authorize Pfizer and BioNTech's COVID-19 vaccine.
It said Friday morning that it would "rapidly work toward finalization and issuance of an emergency-use authorization" for the shot. The COVID-19 vaccine would be the first to be authorized for use in the US.
The FDA said it had notified the drugmakers as well as the Centers for Disease Control and Prevention and the federal vaccine initiative known as Operation Warp Speed so they could "execute their plans for timely vaccine distribution."
The vaccine could be rolled out as early as Monday, Health and Human Services Secretary Alex Azar said on "Good Morning America" on Friday morning.
NEW: HHS Azar says FDA will proceed with emergency use authorization for Pfizer-BioNTech COVID-19 coronavirus vaccine and vaccinations could come as soon as Monday or Tuesday of next week. https://t.co/v1dsjMAvCK pic.twitter.com/48CGRJRTVs— Good Morning America (@GMA) December 11, 2020
"We could be seeing people getting vaccinated Monday, Tuesday of next week," Azar said.
The announcement follows an endorsement from an independent expert panel of more than 20 leading scientists and doctors, who reviewed data from a trial of Pfizer and BioNTech's vaccine on Thursday.
Operation Warp Speed leaders have previously said the plan is to ship 2.9 million doses of the vaccine within days.
The US hopes to vaccinate 100 million people by March: 20 million in December, 30 million in January, and 50 million more in February. Those projections depend on getting vaccines from Pfizer and from Moderna, a biotech company that also has a highly effective shot under FDA review.
Federal authorities are allocating vaccine doses to states and territories based on their adult populations, and each state will decide how to divvy up its supply. Earlier this month, a CDC advisory group recommended that healthcare workers and nursing-home residents be at the front of the line.
But a key COVID-19 advisor to President-elect Joe Biden has warned Americans to expect "hitches" in the rollout of Pfizer and BioNTech's vaccine.
"The biggest challenge is going to be both production and then getting it into people's arms," Dr. Atul Gawande said Thursday.
The UK began administering Pfizer and BioNTech's vaccine on Tuesday, making it the first nation in the West to roll out a COVID-19 vaccine. The next day, Canada became the second Western country to authorize the vaccine.