Critical Debate on the Future of Healthcare

How Pharma Cooks the Books on Phase 4 Vaccine Safety Data

It's not just the Covid jabs, it is a decades long scam.

You may still be under the impression that safety trials for vaccines end with phase 3, collecting safety data on participants in the trials, months (or days, in the case of the mRNA jabs) after the vaccine has been administered. While that is in theory correct, there is an additional fourth phase, which aggregates data on side effects for years after the vaccine has been trialled. Real world data from potentially millions of patients. Here is how the CDC describes the process

Wow, that must most certainly identify any real side effects, you might think. Nothing could be further from the truth and a 2019 paper highlights just how pharma manipulates the collected Phase 4 data to preserve the safety narrative of their products.

First published in the BMJ, the paper is entitled Modernising vaccine surveillance systems to improve detection of rare or poorly defined adverse events. Authored by Rebecca E. Chandler, a research physician, Chandler argues that we need to modernise vaccine pharmacovigilance methods to restore public trust amid measles outbreaks and public concerns over the safety of vaccines.

“Before vaccines are licensed their efficacy has to be shown in clinical trials. The trials, however, are generally not powered to evaluate safety. Even phase III trials collect only limited safety data, mostly on common adverse events that occur shortly after vaccination such as local and systemic reactions related to the immunogenicity of the vaccine. As a result, when a new vaccine comes to market there is some uncertainty about its safety profile, specifically about rare events or those occurring a longer time after vaccination. Such effects cannot be detected until the vaccine is administered within large populations. That is the work of vaccine pharmacovigilance.”

doi: https://doi.org/10.1136/bmj.l2268

So now you may think it better to studiously avoid new vaccines for an extended period until safety has been proven? Right? Wrong. What you assume to be a process designed to protect you, is in actual fact a Pharma driven rubber stamp process for their vaccines’ safety profile. Covid vaccines were no different. Here is how the scam works. Pharma simply moves the goal posts and any new information emerging on adverse conditions NOT SEEN IN TRIALS is dismissed as coincidental.

Read that again, in case you failed to grasp it the first time. In plain English, if the adverse event was not picked up in the initial trial, it cannot (according to pharma) have anything to do with the vaccine in question. Don’t take my word for it, here it is in black and white.

In the new causality assessment, only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product–related-reactions. Reactions observed for the first time during post-marketing surveillance (Phase 4 clinical trial) are not considered as ‘consistent with causal association with vaccine’. All new serious adverse reactions are labelled as coincidental events ‘inconsistent with causal association,’ or ‘unclassifiable’ and the association with vaccine is not acknowledged. It has, in effect, made phase 4 trials redundant.”

Puliyel (2019) 

So imagine you’ve just administered billions of doses of Pfizer’s Covid Vaccine and a plethora of subsequent boosters. Pfizer can now revert to their original (and essentially farcical) clinical trial data and say, nope, this adverse event is not related to the vaccine because this does not appear in our clinic trial. Must be coincidental, mark it up as that, and let’s move on.

See how that works? Pharma have effectively turned a mechanism originally designed to protect the public against harm, into a validation tool for the safety of their product, when in reality, nothing could be further from the truth. Gaslighting patients suffering adverse events taken to a new level. This alone is not that shocking, given Pharma’s history of placing profit above human life. What is shocking is how they have managed to co-opt the whole system of reporting.

No one questions, everyone obeys, even when causality is blindingly obvious.

There is a strong and persistent tendency for vaccine and public health authorities to ignore, gloss over, and sometimes suppress reports of vaccine adverse effects. I shudder when I think of our experience with the whole cell pertussis vaccine before it was finally discontinued in the US in 1998. I think also of the role of injections—including vaccinations—in paralytic polio and, possibly, other polio-like diseases such as acute flaccid myelitis/AFM.

Allan S. Cunningham, Retired pediatrician (2019)

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Robert Turner
Robert Turnerhttps://foh.digital
Robert is co-founder and Editor Emeritus of Medika Life and a prolific author on all things health related. Currently heading up Editorial for FOH Digital, he is involved in numerous health-related startups that promote equitable and accessible care and is founder of Clinics IV Life, a non profit focused on providing maternal care to disadvantaged communities in Asia.

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