U.S. FDA advisors vote 17-Four in favor of Pfizer’s COVID-19 vaccine approval
© Reuters. A vial of the Pfizer / BioNTech COVID-19 vaccine can be seen at the Royal Victoria Hospital in Belfast
By Manas Mishra and Julie Steenhuysen
(Reuters) – A group of outside advisors to the U.S. Food and Drug Administration voted overwhelmingly on Thursday to support the emergency use of Pfizer Inc (NYSE 🙂 coronavirus vaccine paves the way for the agency to approve the shot for a nation that has lost more than 285,000 lives to COVID-19.
It is generally expected that the FDA will approve the vaccine developed with German partner BioNTech SE (NASDAQ 🙂 within a few days for use in an emergency in the USA.
The committee voted 17-4 that the known benefits of the vaccine outweighed the risk of being shot for those aged 16 and over, with 1 member abstaining.
Pfizer has filed for approval of the two-dose vaccine for people aged 16 to 85 years. Several members of the advisory panel discussed whether 16- and 17-year-olds should be included in the recommendation, as the risk to these people is low and the evidence in the process was sparse.
In the end, they voted on the question asked by the FDA, which also included 16-17 year olds. The FDA usually follows the recommendations of its expert panels, but is not required to do so.
The panel also discussed concerns raised in two reports of serious allergic reactions among vaccine recipients in the UK, and spent much of the discussion with Pfizer’s plan to give volunteers a placebo in its study the option of receiving the vaccine If they are eligible for vaccination, get it under recommendations from state and local health authorities.
Documents prepared by the FDA prior to the meeting did not indicate any new safety or efficacy issues, raising optimism that the United States would soon follow the UK and Canada approving the vaccine.
The UK health authority on Wednesday advised some people with a history of anaphylaxis, an overreaction of the body’s immune system to drugs or food, not to get the vaccine.
FDA Commissioner Steven Hahn said ahead of Thursday’s meeting that the agency had carefully reviewed all data on the Pfizer vaccine, including possible allergic reactions following the UK warning.
He said the vaccine label would give details of who the vaccine was recommended for – and who shouldn’t be given it – when it is ultimately approved.
Pfizer and BioNTech said last month that a two-dose regimen of the vaccine was 95% effective in preventing disease from COVID-19, and detailed data released in the agency’s documents showed that the vaccine was showed some protection before the volunteers received a second dose.
The documents also revealed safety data, including cases of Bell’s palsy in volunteers in the placebo and vaccine groups, although cases in the study occurred at the same rate as in the general population. Other reactions were fever, tiredness and chills.
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