What the hell is wrong with FDA? Are they that corrupted and bought out by pharma that hospitalizations, deaths, MISC is so vanishingly low from COVID yet still want to boost (3rd dose) in 5-11 yr?
by Paul Alexander
The burden from severe diseases is near non-existent in children from COVID so wtf is wrong with FDA? even lower with OMICRION; why EUA and not BLA (full license)? this is no emergency so why EUA?
It is impossible, they just cannot do it, the FDA cannot give any sane sound reason why the 3rd dose is needed in 5-11 year olds and why EAU? Where is the EFF IN emergency? Where is the emergency in 5-11 year olds? Where is the data to show this? What Mr. FDA, is the evidence that you have to support this? When did you see this evidence for we certainly have not.
This is pure corruption and malfeasance by all involved. Where is the RCT? Why have you not done it? Is it because you know you will not be able to show any benefit? Why is there no bona fide clinical trial data to show benefit using hard objective patient-important outcomes such as death, severe disease, hospitalization? Not the bogus, soft unimportant ‘antibody’ level that are not a proper or even credible proxy for immune function/response.
Where is the EBM world in this? They would have savaged the bogus research by the pharma and the derelict behavior by the FDA already? Is EBM dead? Did they commit suicide over COVID? Is EBM also sold out to grant money? To the highest bidder? Shame on them. I know them all, shame on them. I schooled with them and researched with them.
And we are to ask, what really was the evidence for the initial 2 doses in this very low-risk age group? Was it even rigorous? Robust?
The EUA for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is based on FDA’s analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the October 2021 authorization of the Pfizer-BioNTech COVID-19 Vaccine primary series in this age group. Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose.
FDA authorizes Pfizer Covid booster for children 5 to 11 years old