Covid19: FDA issues emergency use authorization for Pfizer vaccine


The US Food and Drug Administration has authorized Pfizer and BioNTech’s coronavirus vaccine for emergency use in the United States.

A Pfizer spokesperson confirmed to CNN on Friday that an emergency use authorization had been granted, following the recommendation of the FDA’s Vaccines and Related Biological Products Advisory Committee.

On Saturday the CDC’s Advisory Committee on Immunization Practices (ACIP) is scheduled to meet and vote on recommending the vaccine.

Before people outside of clinical trials can get the first US coronavirus vaccine, two government agencies need to give the go ahead — and it looks like one will do that in the coming hours.

Key players in the vaccine decision process have been told to expect the US Food and Drug Administration to issue an emergency use authorization for Pfizer/BioNTech’s vaccine by Saturday, according to a federal government source close to the situation.

The EUA would allow shipping to begin, but shots still can’t be administered until the CDC’s Advisory Committee on Immunization Practices (ACIP) meets and recommends the vaccine.

Dr. Amanda Cohn of the ACIP said that she expects the FDA to issue the emergency use authorization by 10 a.m. Saturday.

“We do anticipate that it is likely,” she said.If the FDA decision comes after that time, then the AICP meeting will probably take place Sunday.

Cohn’s comments come a day after a panel advising the FDA recommended the agency grant an emergency use authorization for the vaccine. They also come as the FDA commissioner was told to green light the vaccine Friday or resign, according to an administration official and a source familiar with the situation.

Once the FDA authorizes vaccine use, Operation Warp Speed — the federal government’s initiative to develop a vaccine — can start distributing the vaccine to states.

Health and Human Services Secretary Alex Azar told ABC that the FDA would work with Pfizer to get the vaccine shipped “so we could be seeing people get vaccinated Monday, Tuesday of next week.”

Governors are prioritizing who would get the vaccines first in their states. Healthcare workers and the most vulnerable, including residents of long-term care facilities, are expected to be first in line.

States will receive shipments of Pfizer’s vaccine once a week to begin with after the shots are rolled out, Operation Warp Speed Chief Adviser Moncef Slaoui said.

The number of vaccines will increase “week-on-week” because manufacturing will ramp up, Slaoui said. 

Governors will be notified a week in advance how many doses to expect, he said.