- WORLD NET DAILY - Art Moore - OCT 26, 2021 -
But members concede safety won't be known until it's administered
An FDA panel on Tuesday recommended emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 by a vote of 17-0, with one abstention.
However, during the hearing, many members, including the chairman, expressed concern about being given a "binary choice." They argued data indicate the risks outweigh the benefits for healthy children while those with underlying conditions who do face significant risks from contracting COVID-19 should have access to the vaccine.
The question before the panel, the Roster of the Vaccines and Related Biological Products Advisory Committee, was: "Based on the totality of the scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine when administered as a 2-dose series (10 ug each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age?"
FDA officials now will decide whether or not to accept the panel's recommendation, as soon as Tuesday night. If the FDA authorizes the vaccine, the process will move to a panel of the Centers for Disease Control and Prevention that will meet next Tuesday to discuss the same data.
President Biden's chief medical adviser, Dr. Anthony Fauci, said Sunday on ABC's "This Week" that if the CDC approves, it's likely that the vaccines "will be available for children from 5 to 11 within the first week or two of November."
Committee member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, expressed the concern of many members about "a side effect that we can't measure yet," referring to the heart inflammation condition called myocarditis.
But he concluded there was no other way forward.
"We're never going to learn about how safe the vaccine is unless we start giving it," he said. "That's just the way it goes."
Pfizer's briefing document, issued before the hearing, says on page 10 "the number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination."
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