Q: WHEN IS A "VACCINE" NOT A "VACCINE"

A: When it does not prevent infection or transmission of infection

As reported in Trial Site News on 26 April 2023:

“Recently, during the Food and Drug Administration (FDA) contemplated changes to the COVID-19 vaccine status, they elicited a commenting period. An organization called the Coalition Advocating for Adequately Labeled Medicines (CAALM) tracked by TrialSite filed a petition requesting that the agency update the COVID-19 vaccine product labeling –for both Pfizer and Moderna products—to reflect their actual safety and efficacy more accurately.” 

In response the FDA declared, “FDA authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission”. A “vaccine” can meet the EUA standard without any evidence that the vaccine prevents infection or transmission.

I have great respect for the contribution that Sasha Latypova is making to the COVID debate. She, like myself, once owned a Contract Research Organisation and worked as a consultant supplying clinical and regulatory support to multinational pharmaceutical companies.

CLICK HERE to listen to her interview on 15 April in Sweden about the lack of quality control of the gene-based mRNA so-called COVID “vaccines”.

There has been an enormous amount of independently generated data and expert opinion presented at various forums and online regarding this topic. The lack of application of Good Manufacturing Practice guidelines in the rush to bring the COVID “vaccines” to market appears to have resulted in many batches containing dangerous levels of contaminants including circular DNA called plasmids used in the manufacture of the mRNA by bacterial fermentation which could have considerable intergenerational genetic consequences yet to be determined.

However, there are other contaminants which are also of great concern and these include compounds called endotoxins which are lipopolysaccharides in the cell wall of Gram negative bacteria. These endotoxins appear to be responsible for the endotoxic shock cases reported in association with these injections. Endotoxins might be responsible for cases of immediate fatal toxicity. Spike protein takes days for the body to ramp up in production and it is reasonable to assume this is the probable cause of sub-acute or longer term toxicity.

In order to counter the speculation about poor batch to batch quality control of the “vaccines”, the TGA spin doctors have taken the highly unusual step of issuing a report of batch analyses in an attempt to quell concern and instil confidence in the safety of the injections.

You can view the report by CLICKING HERE.

To the untrained eye, this might impress…..it does not impress me. It shows no details of limits of specifications or actual results. We know that the unusually wide limits for mRNA content of the injections far exceeds those normally accepted by the pharmaceutical industry. But the endotoxin levels in these injections is critical also. What is being allowed in terms of endotoxin levels?

Many have reported a relatively high incidence of serious adverse events and death associated with about 7% of injection batches.

On endotoxins

I first met endotoxins many years ago when a US client of mine, Centocor, asked me to rush the registration of their new drug Centoxin in Australia. At the time, there was only a single clinical trial ongoing in the US for Centoxin which was used to counter the often fatal shock sometimes produced in association with antibiotic treatment of severe sepsis. In these cases, antibiotic treatment killed the invading bacteria in such large numbers that relatively large amounts of endotoxins were released from the walls of the dying bacteria and patients often died of successful antibiotic treatment.

This experience was part of my foundation of faith in the drug regulatory system because the Centoxin trial was stopped before it was scheduled to enrol the stipulated number of treated and placebo patients because it was obvious that Centoxin was saving lives and it was unethical to treat patients with septic shock with standard treatment and Centoxin placebo. The US FDA and The Australian TGA made a good call at the time. I compiled the application and it was approved in record time with only part of the trial completed and very little safety data.

Herein lies the moral……at the time Centoxin looked like it was effective and saving lives. The drug regulators saw this and acted quickly. However, I now understand Centoxin has been withdrawn from sale (like more than 100 other drugs approved since 1990) due to its toxicity.

When a drug is approved with limited safety data in a single clinical trial (like the COVID gene-based so-called “vaccines”, it is important to continually assess ongoing safety issues - I do not believe our TGA is doing this. These injections are associated with the highest incidence of reported serious adverse events and death of any pharmaceutical ever released in history yet in Australia they are still recommended for infants as young as 6 months of age without any credible or reliable evidence of benefit to risk.