No Safety Data Behind US FDA’s Approval of a Fourth Injection for COVID-19

by | Apr 2, 2022 |

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The US regulatory agencies, the CDC and FDA, are supposed to require evidence of efficacy and safety prior to the recommendation or approval of drugs and vaccines, and other biologics. This evidence is supposed to form the basis of the regulatory agencies’ position on pharmaceutical products to insure that US citizens have access to effective options for medicine, which they can choose to adopt or not based on a formal process of informed consent.

Last week, the US FDA approved a fourth COVID-19 vaccine dose (aka “second booster” using a single, small study from Israel.

A few shocking facts about the study:

>  It was not peer-reviewed. It was published on an NIH pre-print server ⏤ something called “Research Square”.

>  It was not a small study. It was an itsy, bitsy, teeny-weeny study (154 patients) that lasted only 40 days.

>  It was a retrospective study, not a prospective randomized clinical trial.

>  It is a single, non-replicated study.

>  The authors adjusted for risk factors associated with COVID-19 deaths. This is like adjusting for risk factors of dying from cancer in a chemotherapy trial.

>  The study itself nevertheless generalizes to “the elderly population” and the “older adult population” after adjusting for risk covariates, a logical flaw called translational failure. Their study results are restricted to people without the risk of death from COVID-19.

The study’s authors warned that their study had a serious limitation, specifically that the study did not examine the safety of the fourth dose. They wrote: “An important drawback of this study is the absence of safety data, as it was out of the scope of this short-term study. Future studies will be needed to assess the safety of the second booster administration.”

I have other technical concerns over the authors’ use of censoring data, adjusting for coexisting illnesses, and other issues that I’ll save for another time.

All of this information is published on the preprint server. The FDA’s inexplicable position on reliance on such a huge recommendation of hundreds of millions of additional medical procedures on such paltry data is indefensible.

Dr. Peter Marks and everyone who rubber-stamped the fourth dose of COVID-19 for people over 50 should resign.

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Dr. James Lyons-Weiler is a biomedical research scientist dedicated to reducing human pain and suffering through knowledge. He conducts research in the public interest via The Institute for Pure and Applied Knowledge (http://ipaknowledge.org) and educates the public via live, online courses at IPAK-EDU LLC (http://ipak-edu.org). He has published numerous peer-reviewed research studies on usafe proteins and toxic levels of aluminum in vaccines. He serves as Editor-in-Chief of the open-access peer-reviewed journal Science, Public Health Policy & the Law and hosts the podcast Unbreaking Science and writes the substack, Popular Rationalism.
Dr. Lyons-Weiler’s Substack newsletter, Popular Rationalism, is available via free subscription.

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Ella Willis
Ella Willis
1 month ago

muy,bhntny

Neil Rivalland
Neil Rivalland
1 month ago

The covid-19 vaccine is none other than an experimental scientific procedure due to only nine months given to measure its safety and efficacy in clinical trials and then its immediate administration for inoculation of the public. Even though a medical emergency warranted the vaccines administration to the public, the vaccine developers have to date not released any safety data to determine the ingredients contained in the contents of the vaccine. Due to this, no informed concent can be given to and received from a vaccine recipient because no specifications to determine the vaccines safety exist from the vaccine developers. Therefore, hindsight alone should reveal that the vaccine is not safe for everyone and should not be marketed as a “one fits all” solution. Now, if coercion to take the vaccine is applied to anyone it nonetheless violates the Nuremberg Code which is there to protect us from medical experimentation.

Last edited 1 month ago by Neil Rivalland

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