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

Azar
US Health and Human Services Secretary Alex Azar.
  • The Food and Drug Administration (FDA) said Friday it would "rapidly work toward" issuing an emergency use authorization for Pfizer and BioNTech's COVID-19 vaccine.
  • It would be the first vaccine authorized for use in the US.
  • The first shots of Pfizer's and BioNTech's vaccine could be given out as early as next Monday or Tuesday, Alex Azar, secretary of the US Health and Human Services Department, said.
  • The US aims to vaccinate 100 million people by March, including 2.9 million doses of Pfizer's shot within days of its authorization.
  • Visit Business Insider's homepage for more stories.

The US Food and Drug Administration (FDA) has said it intends to authorize Pfizer and BioNTech's COVID-19 vaccine.

It "will rapidly work toward finalization and issuance of an emergency use authorization" for Pfizer's shot, it said Friday morning. The vaccine would be the first to be authorized for use in the US.

It had notified the drugmakers, as well as the US Centers for Disease Control and Prevention (CDC) and Operation Warp Speed so they can "execute their plans for timely vaccine distribution," it said.

The vaccine could be rolled out as early as Monday or Tuesday, Alex Azar, the secretary of the US Health and Human Services Department (HHS), said on Good Morning America (GMA) Friday morning.

"We could be seeing people getting vaccinated Monday, Tuesday of next week," Azar told GMA.

 

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 the Pfizer vaccine on Thursday.

Operation Warp Speed leaders have previously said the plan is to ship 2.9 million doses of Pfizer's shot within days.

The US aims to vaccinate 100 million people for free 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 potential 'hitches' in the rollout of Pfizer'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'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 country to authorize the vaccine.

This is a developing story.

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