False and Misleading Efficacy Claims—What is the Motivation?

Dr. Rochelle Walensky Tweeting Counterfactuals with Intent

By Peter A. McCullough, MD, MPH

CDC Director, Rochelle Walensky, MD, MPH, for the record, continues to make false claims about the COVID-19 vaccine boosters with the apparent motivation of getting more Americans “fully vaccinated.”  This is in the backdrop of an 8.4% rate of Americans over age 5 taking one of them.[i] 

No matter how hard the internal pressure is at the CDC to get a “needle in every arm,” what would be such a strong motivation for Walensky to blatantly deceive Americans with such obvious counterfactual information?  She states “COVID-19 vaccines may not prevent every infection (as apparent in her personal case), but they do provide use important protection against severe illness, hospitalization, and death…”  

In order for that claim to be valid by US regulations, a COVID-19 vaccine would need to reduce the risk of adjudicated COVID-19 hospitalization and death as a primary endpoint in a prospective, double blind, randomized, placebo-controlled trial.  The benefit would need to be meaningful, e.g., ~20% relative risk reduction, and statistically significant, e.g., p<0.05. The conclusive study should have no significant threats to validity such as loss to follow-up.  There has been no pivotal randomized trial, and no one can claim COVID-19 vaccines reduce hospitalization and death.  The shortest section on the FDA Pfizer Fact Sheet is the “Benefits” section!  This is given with the consent form and makes no claims about severity, hospitalization, and death.[ii] 

She goes on to promote a two-month period between the last injection (presumably legacy mRNA) and the new bivalent vaccine.  This schedule has never been tested and demonstrated to be safe in human beings.  Even more shocking, the bivalent boosters which failed in animal studies to stop Omicron, have never been tested for safety or efficacy in human RCTs with clinical outcomes.  In academic medicine and the pharmaceutical regulatory community, the question is WHY does Walensky cross the line into making false claims, an illegal act for fully FDA approved and marketed drugs/vaccines?   Only senate or congressional hearings with direct questions will get the truth out of her.   Here are some possibilities:  1)  she is following orders from higher governmental authorities, 2) she knows the claims are false but truly believes the only way for vaccination to work is to keep everyone vaccinated on a continuous basis no matter what the costs, 3) she is in a form of a trance or psychological state driven by fear in herself and for humanity where COVID-19 vaccination has become like a talisman with special powers and cannot be challenged. Indeed, Walensky has never comprehensively discussed safety of COVID-19 vaccination, and she has not disclosed who should NOT take a COVID-19 vaccine.   So, the next time someone in your circles claims you or your loved one should take a COVID-19 vaccine to be “safe” or “protected” from serious outcomes, ask them to take a look at the consent fact sheet and read the tiny benefit section.

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[i] CDC COVID Tracker, Accessed November 9, 2022

[ii] VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT COMIRNATY (COVID-19 VACCINE, mRNA), THE PFIZER-BIONTECH COVID-19 VACCINE, AND THE PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS 12 YEARS OF AGE AND OLDER, August 22, 2022