Something Shifting?
This is interesting. On December 14, TechnoFog noted the FDA gave approval to vaccine boosters amid 16 and 17-year-olds without consulting the medical advisory panel on safety and efficacy of the policy shift {SEE HERE}.
As correctly noted at the time, “This is the FDA making a cost/benefit calculation without knowing the costs or benefits. It doesn’t know the real risks, because it didn’t study the potential for adverse reactions in kids aged 16 – 17 years,” yet, the FDA did it anyway.
The issue is actually quite alarming considering there are multiple studies showing that specific age group, especially young males, were negatively impacted by vaccine created heart damage. Then again, adverse vaccine outcomes may have been the reason why the FDA never wanted to convene a medical advisory board before giving the approval for a vaccine booster to the group most at risk for the adverse outcome.
Regardless of FDA motive, the Washington Post is now following-up on the issue pointed out by Techno Fog and calling out the Biden administration for having the FDA ignore medical community advice:
(WaPo) […] Before last month, the standard practice was for the agencies to convene standing outside advisory committees, whose members inspect the relevant data, debate it and vote. That did not happen in these cases, meaning that the costs and benefits of these policy moves, from a medical perspective, were not fully aired publicly and discussed in advance.
One of us is the former deputy director of the FDA’s Office of Vaccines Research and Review; the other is a former acting chief scientist at the FDA. We believe that much is lost when decisions like these are made without consulting outside experts — whatever one believes about the merits of the policies in question.
At this point in the pandemic, the world faces a host of new questions related to vaccines and boosting. The recommendations of experts on the outside advisory committees are needed more than ever — so the scientific community can understand the empirical bases for decisions, and so the public can be assured that science, not politics, is driving vaccine policy.
In each of the recent decisions we’ve mentioned, at least some experts would probably have voiced opposition (based on earlier scientific debates and votes the two committees had taken, which supported different conclusions). That these experts were not given a chance to make their cases could hurt the credibility of these agencies. (read more)
Ultimately, what both Techno Fog and the Washington Post are now noting is a background of politics, not science, driving the medical policy of the Biden administration.
We can only imagine the media and public reaction to a Trump administration if they ever attempted the same type of policy and ignored medical advice.
The issues here compound when you realize the same FDA is going to push a third dose of Pfizer vaccine into children aged 2 to 5-years-old. The pharmaceutical scientists are now claiming the dosage of the vaccine was not strong enough for the kids, so they need to inject them with even more vaccine to avoid a virus that is non-threatening to them.
New York Times – A low dose of the Pfizer-BioNTech coronavirus vaccine did not produce a potent immune response in children aged 2 to just under 5 years of age, the companies announced on Friday, a discouraging setback that threatens to keep the vaccine from younger children.
[…] In a conference call with investors and analysts on Friday, Kathrin Jansen, Pfizer’s head of vaccine research, said the company planned to seek authorization for a “three-dose series” in children, instead of the originally planned two doses. If the revised strategy works, “we would have a consistent three-dose vaccine approach for all ages,” she said. (read more)
Interesting…. “investors and analysts“. Go figure.
