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WASHINGTON (REUTERS) – A panel of outside advisers from the US Food and Drug Administration voted overwhelmingly on Thursday (December 10) to support the emergency use of Pfizer Inc.’s coronavirus vaccine, paving the way. for the agency to authorize the injection for a nation that has lost more than 285,000 lives to Covid-19.
The FDA is expected to clear the vaccine, developed with German partner BioNTech SE, for emergency use in the US in a few days. Distribution and inoculations are expected to begin almost immediately thereafter.
The committee voted 17 to 4 that the known benefits of the vaccine outweighed the risks of receiving the vaccine for people 16 and older, and one panel member abstained.
“This is a historic moment,” said Dr. Eric Dickson, CEO of UMass Memorial Health Care, who was not on the advisory panel, after the vote. He called the vaccine “the best solution to get us out of our current situation and help us save lives.”
Pfizer had asked for the two-dose vaccine to be approved for use in people ages 16 to 85. Several members of the advisory panel discussed whether 16- and 17-year-olds should be included in the recommendation because the risk to these people is low, and the evidence at trial was scant.
In the end, they voted on the issue raised by the FDA, which included 16-17 year olds.
“The final decision on whether to authorize the vaccine for emergency use will be made by career FDA officials,” the agency said in a statement.
The panel also discussed concerns raised by two reports of severe allergic reactions among vaccine recipients in Britain and what to advise pregnant women, who were excluded from the study. Women of childbearing age make up a large proportion of healthcare workers, who will be among the first to receive the vaccine.
The FDA said during the panel meeting that there was not enough data to support or contradict the use of the vaccine in pregnant women. The agency recommends that you make the decision on your own with the advice of your doctors.
Dr. Gregory Poland, a virologist at the Mayo Clinic in Rochester, Minn., Who previously served two terms on the FDA’s advisory panel, said he was surprised that the advisors did not issue more warnings about pregnant women, adding that Voting was otherwise as expected.
The consultants also spent much of the meeting discussing Pfizer’s plan to give volunteers who received a placebo in its trial the option to receive the vaccine when they are eligible to receive it based on recommendations set forth by state and local health officials.
Documents prepared by the FDA prior to the meeting did not point to any new safety or efficacy issues, raising optimism that the United States would soon follow Britain and Canada in licensing the vaccine.
Britain’s health regulator on Wednesday advised some people with a history of anaphylaxis, an overreaction of the body’s immune system related to drugs or food, to avoid receiving the vaccine.
FDA Commissioner Steven Hahn, before Thursday’s meeting, said the agency was carefully reviewing all data on Pfizer’s vaccine, including possible allergic reactions following the British warning.
He said the vaccine’s label would include details about who the vaccine was recommended to, and who should not receive it, if it is ultimately approved.
Pfizer and BioNTech said last month that a two-dose regimen of the vaccine was 95 percent effective in preventing Covid-19 disease, and detailed data published in agency documents showed that the vaccine began to show some protection. even before the volunteers received a second dose.
The papers also revealed safety data, including cases of Bell’s palsy among volunteers in the placebo and vaccine groups, although they said cases in the trial occurred at the same rate as in the general population. Other reactions included fever, fatigue, and chills.
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