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2021-05-13

ICAN (Informed Consent Action Network) yesterday published a legal update on its Sept 2018 FOIA request to the FDA to obtain copies of the clinical trials relied upon to license the varicella vaccine in 1995.

Yes, it has taken the best part of 30 months for the FDA to provide the necessary information, but that information has now been forthcoming.

"The FDA’s basis for licensing VARIVAX is incredible when considering that: (i) states mandate by law that millions of children receive VARIVAX every year; (ii) Merck cannot be sued for most injuries caused by this product under federal law; and (iii)  Merck’s sales of this product, alone or in combination with another of its products, was $2.275 billion in 2019.  But yet, the FDA licensed this product based on one fake “placebo” controlled trial, with only 956 children, and that reviewed safety for only around 2 months"

"The additional unredacted pages further support that, as explained in a prior legal update, this product should never have been licensed"

 

Whilst that may be so, would we not have heard about it by now if children had been damaged by this vaccine?

Well, maybe, or maybe not.

An accompanying legal update from ICAN confirms that they have also now written to the Secretary of Health and Human Services, the Director of the CDC, and the Commissioner of the FDA about an oft repeated issue: underreporting of adverse events to VAERS.  ICAN highlights Harvard’s findings that “fewer than 1% of vaccine adverse events are reported” and shows real life examples of precisely that for reports of anaphylaxis and deaths to VAERS.

VAERS (vaccine adverse events reporting system) is the system by by which feedback from vaccinations has been monitored in the USA for many years. If less than 1% of adverse events are being reported then clearly the system cannot be considered fit for purpose.

VAERS is also particularly critical in the context of the current Covid-19 vaccine roll-out.

We in the UK should note that the MHRA's yellow card reporting system is, like VAERS, a passive system dependent upon members of the public (including clinicians) to take the initiative in filing a report in the event of an adverse event. As many members of the public (including clinicians) may not be aware of the system, it must be considered probable that this system, like VAERS, is subject to a significant level of under-reporting.