The argument goes that the new shots vary so little from the older ones that they do not need to undergo any human clinical trials. This is the FDA's argument after it rubber-stamped the latest injections at warp speed.
FDA Commissioner Robert Califf and Center for Biologics Evaluation and Research Director Peter Marks indicated that the federal agency used the same process for approving the new boosters that it uses to approve new annual flu shots.
"This is the number one question people are asking," Califf said in a press conference.
Marks added that the FDA has "extensive experience in the past with strain changes made without clinical data based on the totality of available evidence." (Related: Moderna's own internal data shows that the shots are not effective against the Moronic subvariant of Chinese Germs.)
The duo held a virtual press conference to discuss the matter. The interactive Zoom feed allowed for the media – well, some of the media – to ask questions.
Just the News says it was given access only to a one-way version of the YouTube stream, which could only be watched and did not allow for questions to be asked.
Wake Forest University (WFU) in North Carolina, meanwhile, did not even wait for the livestream – or for the FDA's approval of the shot – before it started mandating it for students.
The Winston-Salem-based institution, which is part of the pharmaceutical-saturated "Triangle" region of central North Carolina, says its decision to mandate the all-new booster shots nearly a month before their actual approval was made "to strengthen our community's collective immunity."
Students and faculty who recently got the most prior booster are being forced along with everybody else to roll up their sleeves for the mystery injection, which was only tested on about eight mice before the FDA gave it the green light.
According to that really small animal study, Pfizer's injection "generated a 2.6-fold increase in neutralizing antibody levels" against BA.4/5 compared to the company's current booster.
Undefined "lab work" on Moderna's shot supposedly showed an eight-fold increase in the same neutralizing antibody levels, we are told.
U.S. Centers for Disease Control and Prevention (CDC) head Rochelle Walensky announced that the reason for the FDA's warp speed approval without human trials is that the federal government simply does not have the time to wait any longer for such things.
"We will be using what I would consider to be a potentially outdated vaccine" she said, referring to the current booster shots that are said to be ineffective against the latest subvariant of "Omicron," also known as Moronic in anagram form.
The goal seems to be to get as many of these things into people's arms before the midterm elections in November as possible. University of California San Francisco epidemiologist Vinay Prasad confirmed this in a tweet, writing:
"Walensky says we can't wait for human data, have to rely on mice ... This is y political appointees can't decide ... If u have election in Nov, u'd approve anything to lower cases right before the vote. Who cares about safety / severe dx ... FDA shd be firewalled."
Select Subcommittee on the Coronavirus Crisis Chair Jim Clyburn (D-S.C.), the person responsible for successfully pressuring the FDA into lowering its standards for covid injections being administered to children, issued a statement this week celebrating the FDA's warp speed approval of the new booster shot.
The latest Chinese Virus injection news can be found at ChemicalViolence.com.
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