“We do have a favorable vote,” Kathleen Hayes, the official who tallied the votes cast at the meeting, said in a live-stream of Thursday’s event held to determine if the vaccine jointly developed by Pfizer and Germany’s BioNTech was safe for use.
The advisory panel members were asked to consider the question: “Based on the totality of the scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 years of age or older?”
They overwhelmingly voted 17-4 in favor of the vaccine.
Earlier, during the meeting, the advisory panel requested data on severe allergic reactions to the vaccine.
The request came after two allergic reactions reported by UK health-care workers given the shots developed by Pfizer and BioNTech.
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency had also updated its guidance on Wednesday to advise people who have a history of “significant” allergic reactions to forgo the vaccine.
“I believe most of us are going to be revisiting some of these issues in about a week,” Arnold Monto, the epidemiologist who chaired Thursday’s panel meeting, said before concluding.
Pfizer did not immediately react to the FDA’s approval of its vaccine and bid to gather more data on the allergic reactions reported in Britain.
The Pfizer vaccine is the first immunization against the coronavirus greenlighted by the FDA, which is also considering for approval a similar shot developed by Moderna Inc.
The Pfizer vaccine is expected to be rolled out as soon as Friday to healthcare workers and long-term nursing home residents under a massive mobilization effort carried out by the US Army under the Trump administration “Operation Warp Speed” project.
People who get one of the two COVID-19 vaccines should get their second shot 21 or 28 days after the first one, according to the manufacturers.