FDA’s Catastrophic Safety and Quality Oversight Failures on COVID Vaccines

Since its inception in 1934, The Food and Drug Administration (FDA) has had regulations to oversee drug and medical products manufacturing processes and quality control to protect the public from unsafe products.

Recent research revelations from career pharma insider whistleblowers, Alexandra Latypova and Hedley Rees, provide chilling information on catastrophic safety and manufacturing oversight failures for the still experimental COVID-19 injections that are linked to the skyrocketing deaths and complications happening to people around the world.  Dr. Michael Yeadon, former Pfizer Chief Scientist Worldwide for Respiratory Pharmacology, has reported that Pfizer documents showed the FDA knew of the deadly risks.

Making the mRNA for the product is a complex, multistage process. Each step entails potential errors that can be amplified at later stages. Scaling up any process is problematic. Making millions of doses required scaling up at breakneck speed. One batch may contain up to 900 liters; problems were encountered at 37 liters, and it appears nothing has been done to resolve them.

Theoretically, every vial of vaccine is supposed to have uniform content. But

independent analysis reveals more than 10,000% variability in potency from batch to batch. Other violations of safety and quality control include the following:

Not a single vial tested had ingredients or doses that conformed to FDA labeling requirements.

·         Some vials contained NO mRNA, others contained massive doses far exceeding the stated amounts. Is this a cause of “sudden death” soon after vaccination?

·         Some vials contain high concentrations of DNA and protein impurities in quantities far exceeding the allowed limits specified by the manufacturer. Numerous other contaminants have been described.

·         Some batch numbers of Pfizer and Moderna are associated with more than 5000 adverse event reports in the CDC’s Vaccine Adverse Event Reporting System (VAERS). Yet other batch numbers show zero to only a small number of adverse events. Such variance should not be happening if consistency and quality manufacturing standards were followed.

·         Almost all vials examined contain high contamination levels of various metals that are toxic to the human body. 

Additionally, frozen vaccines are delivered to vaccination centers in an UNFINISHED state. This means multi-step “finishing” procedures have to be carried out on sites that are not equipped or qualified to do such procedures safely and properly.

Any of these problems should have stopped production lines. Shockingly, the normal Good Manufacturing Practices (GMP) standards and pharmacovigilance oversight have been flagrantly ignored by all of the COVID injection manufacturers. The U.S. and European oversight agencies (FDA, EMA) have turned a blind eye to the fact that GMP standards are not being followed. This is unprecedented in the history of the FDA and is an outrageous violation of public trust.

The implausible scale of Pfizer mRNA manufacturing, based on documents received from Freedom of Information Act (FOIA) requests, suggests to experts that Pfizer is either combining batches, diluting to an unprecedented degree, relabeling older products, or something even more fraudulent. There simply is no way with the current production capacity to reach that scale of production and maintain reliable safety or quality.

Another stunning revelation from pharma insider Hedley Rees from the UK is that “over a period of 40 years, Big Pharma has outsourced every physical activity it possibly could, until it has lost its ability to develop new drugs—drug development, manufacture, and distribution is now in the hands of third party organizations.”

In his INSIDE PHARMA article, “The One Thing Big Pharma Can’t Outsource—Culpability,” Rees explains: “Outsourcing manufacture can work so long as the development process and control are in the hands of the developer and the developer allows detailed instructions and specifications to be handed down to contractors and suppliers.” However, Big Pharma has lost control, and out-sourcing has brought it to the brink of failure, he states. “The only way to deliver blockbuster revenues in an acceptable timescale was to cheat. To deceive and falsify in the most cynical way possible, hang the consequences.”

Disregarding the many questions raised about the safety of the mRNA technology itself, the dangerous violations of regulatory oversight of manufacturing and distribution revealed by courageous whistleblowers should alone halt the program.

Your shot may contain virtually no active ingredient—perhaps helping to explain the apparent lack of efficacy. Or it may contain a massive overdose—perhaps explaining the high frequency of “sudden death syndrome.” You have no way to know which you get when you take “the jab” or get a “booster.”

For those who suffer adverse side effects and prolonged complications of the experimental COVID shots, there are integrated treatment approaches to help patients restore health. Combinations of anti-inflammatory and anti-coagulant prescription medications, nutraceuticals, vitamins and minerals, and lifestyle strategies help alleviate inflammation, micro-blood clotting, oxidative stress, and immune system damage.

COVID injection manufacturers—Pfizer, Moderna, Johnson and Johnson, and AstraZeneca—should all be held accountable for their negligence, but we must not stop there. Americans and people around that world must hold our taxpayer-funded regulatory agencies accountable for their gross failures to protect a trusting public.