14.09.23 (5)
Emergency Authorization Granted without Emergency or Human Data
By Peter A. McCullough, MD, MPH
At this point, the American public and scientific community is flabbergasted at the complete regulatory malfeasance committed by US FDA VRBPAC and CDC panelists. As of September 12, 2023, the prior bivalent (original Wuhan /BA4/BA5 mRNA Code) has been retired and the new XBB.1.5 monovalent vaccines have been emergency use authorized. From the Pfizer core slides released today, there was a single experiment with 10 mice assigned to the prior BA4/BA5 bivalent and 10 assigned to the new XBB.1.5 monovalent vaccine. They were injected twice, 21 days apart. The new booster was authorized for a single 30 mcg shot in humans.
The pseudoviral antibody responses were greater for the new vaccine against the outgoing XBB.1.5 (3.1% of strains as of 9/2/23) and the incoming EG.5 (Eris) strain at 21.5%, but no information was given about and FL.1.5.1 which is growing at 14.5% in the US population.
There were no human studies presented in the core slides by Pfizer. It impossible to predict what would happen with a single human injection. Their last slide was a single ongoing clinical study of the new vaccine. There are two age groups, no randomization and no control group. There is zero chance to assess human safety or efficacy of the XBB.1.5 vaccine in sponsored studies.
The only thing that will stop ongoing scientific misconduct and regulatory malfeasance is public outrage and booster refusal. The vaccine companies are hauling in record profits, have not analyzed safety nor have they shown any interest in safer more effective products for testing in large-scale randomized double-blind placebo controlled trials. The Bio-Pharmaceutical Complex is completely off the rails! Coming next will be vaccines developed from computer generated mRNA genetic code with mathematical modeling of antibody response and no mice or human subjects at all.
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Thanks to petermcculloughmd.substack.com