Last week, the FDA went around normal committee practices to approve booster shots for children.
It is a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board... FDA is quietly doing this because their experts previously voted it down, voicing concerns about medical harms. @POTUS @DrWoodcockFDAhttps://t.co/tFk3jRkzg5
— Marty Makary MD, MPH (@MartyMakary) January 2, 2022
FDA PLEASE STOP: nyt reporting @fda is about to authorize boosters for 12-15 yr-olds WITHOUT convening their VRBPAC expert advisory committee. We are in uncharted territory.
— Marty Makary MD, MPH (@MartyMakary) December 30, 2021
Who's calling the shots @US_FDA?? Experts (standard process) or The White House?https://t.co/tFk3jRkzg5
During a briefing with reporters at the White House Wednesday, CDC Director Rochelle Walensky touted the approval.
"This week, FDA made several vaccine authorizations, and CDC followed these authorizations by making additional vaccine recommendations," Walensky said.
"First, CDC authorized – FDA authorized and CDC recommended shortening the window in which people who received the Pfizer COVID-19 vaccine can get a booster dose from six months to five months," she continued. "Second, FDA authorized and CDC recommended that children ages 5 to 11 who are moderately or severely immunocompromised should get an additional primary shot of the Pfizer COVID-19 vaccine 28 days after their second shot to provide them additional protection."
Dr. Anthony Fauci also touted the approvals.
"The Pfizer-BioNTech is now authorized and recommended for children from 5 to 17. Children from 12 to 17 can get a booster. The FDA authorized 12 to 15," Fauci said.
Walensky was then asked why the FDA panel wasn't convened before the booster was approved. She responded by saying 'there's so much action happening right now" and that "these are unprecedented times."
"I wanted to ask about the FDA's recommendations that have come out since November and seemingly happening without consulting the panel of independent experts that were consulted for approvals on the vaccines themselves. Has there been a policy change or sort of a shift away from standard practice when it comes to recommendations for boosters versus the process that everyone went through for the vaccine itself?" Fox News correspondent Jacqui Heinrich asked.
"So, obviously, these are unprecedented times where there's so much action happening right now with regard to vaccination. And given those unprecedented times, we've convened our Advisory Committee on Immunization Practices more than ever before. We had a meeting prior to, the week prior to Christmas, and we are now having a meeting today, so the week after New Year’s," Walensky responded. "And I am in regular touch, in regular touch with these experts to ensure that they are confident as to the discussions that they feel like need to be had as we're making decisions about vaccination for the country."
Meanwhile, doctors outside of the federal, bureaucratic and political system have been warning about the health risks to young people that come with vaccination vs natural infection from Wuhan coronavirus.
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