EUA granted by FDA (Marks & CDC support) & this is the sub-optimal shocking data used to grant EUA: ‘Monovalent XBB.1.5 Pfizer BNT162b2 COVID-19 Vaccine, ACIP Presentation September 12, 2023

McCullough strikes DEEP into enemy territory hitting targets: i)no control group 2)study based on 20 mice (like bivalent BA4/5 iii)antibody titers iv)no human data v)short follow-up vi)no safety study
Once again, we have the FDA and Marks etc. outdoing themselves for recklessness and harms to the US population. They have approved a booster with a spike that will mismatch the dominant sub-variant (s) (XBB.1.5 vaccine spike for EG.5 and/or BA.2.86 and/or FL.1.5.1 spike antigen etc. and this will drive viral immune escape, the vaccinee becoming infected, re-infected, original antigenic sin (immune imprinting, recall antibodies) and drive natural selective pressure and thus more infectious variants to emerge. The CDC, NIH, FDA etc. know full well what they are doing and that once you vaccinate into the teeth (midst) of ongoing viral circulation e.g. EG.5 circulates and they will vaccinate with XBB.1.5 booster, with a vaccine that is non-sterilizing, non-neutralizing (does not stop infection, replication, or transmission), then the selective pressure on the infectiousness and virulence of the virus will drive more variants to emerge. This can be catastrophic for mankind if a lethal variant is generated/selected.
IMO, these malfeasants are deliberately harming the US population and by extension, the world. Where is the safety data with this new XBB.1.5 booster? Where is the human data? Where is the control group? Why did they not assess patient-important outcomes, even in mice? Not antibody levels. To compare XBB.1.5 to BA.4 and BA.5 is a joke. Where are the long duration, large sample sized comparative effectiveness research via randomized controlled clinical trials? Placebo controlled. Where? Has the FDA and its regulators gone literally insane? Is this really ‘The Insane Age’? Is the next step authorization of vaccine based ONLY on in silico modelling?
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-12/10-COVID-Modjarrad-508.pdf?utm_source=substack&utm_medium=email

Alexander COVID News-Dr. Paul Elias Alexander’s Newsletter is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

There is NO COVID emergency (ended May 11th 2023 by Biden) so why did the FDA, Dr. Peter Marks, CDC etc. move to approve emergency use authorization (EUA) for the ‘mismatched’ XBB.1.5 omicron booster?

Dr. Paul Alexander
·
Sep 12

Something stinks to high heavens! Alexander COVID News-Dr. Paul Elias Alexander’s Newsletter is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

Read full story

Courageous Discourse™ with Dr. Peter McCullough & John Leake

BREAKING–Pfizer XBB.1.5 Monovalent Vaccine Tested in 20 Mice, No Control Group, and No Humans

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 …
Read more
10 hours ago · 280 likes · 46 comments · Peter McCullough, MD

BREAKING–Pfizer XBB.1.5 Monovalent Vaccine Tested in 20 Mice, No Control Group, and No Humans

Emergency Authorization Granted without Emergency or Human Data

Start McCullough here, excellent scholarship:
‘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.’

Alexander COVID News-Dr. Paul Elias Alexander’s Newsletter is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

Go to Dr Alexancer on Substack
Author: Dr. Paul Alexander