Tuesday, August 24, 2021

FDA admits that neither VAERS nor its many other pharmacovigilance systems are functional, nor will VAERS be in the future

FDA made an extraordinary admission in its letter to BioNTech yesterday, to justify failing to find safety "signals" better know as serious, common vaccine-induced injuries and deaths.  So it asked the fox to please guard the henhouse instead.  Pretty please Mr. Pfizer, would you look into myocarditis and other serious problems for us?  We are not capable...

Guess FDA thought few would be able to parse its bureaucratize, discussed here and in the prior 5 posts.  See page 6 of the document linked above:  

"We have determined that an analysis of spontaneous postmarketing adverse events [VAERS reports] reported under section 505(k)(1) of the FDCA [Federal Food, Drug and Cosmetic Act] will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. 

Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks."

Let's parse this some more.  VAERS, with about 13,000 deaths reported this year, and about 500,000 adverse events reported this year, is somehow unable to be analyzed to discover what it was established by Congress to discover:  serious vaccine-induced adverse events.  Reporting to VAERS since the vaccines became available is unprecedented.  For example, about 8,000 cumulative deaths were reported to the system during its entire 30 year existence.  Yet in 2021, over 12,000 deaths have reported following Covid vaccinations alone.

We already know from Israeli data, and US data presented to CDC's advisory committee on June 23, that the rate of reported cases of myocarditis in vaccinated teenage boys aged 12-17 is at least 25 times greater than expected, and is 50 times greater than the reported rate in vaccinated males over 65. 

But analysis of VAERS by CDC and FDA, who jointly manage it, cannot properly assess this risk?  Even though Congress requires them to do so?

Equally as shocking, FDA can apparently see into the future, and any hopes that it will soon fix its analytic conundrum have been dashed.  FDA can already state that VAERS analysis will not be sufficient to assess known myocarditis risks.

What about all the other databases that Steve Anderson, PhD, head of the Office of Biostatistics and Epidemiology, told us in October he would be using to evaluate vaccine safety?  I posted screenshots showing databases encompassing over 300 million people that Anderson said FDA would access to evaluate the safety of Covid vaccines.  After all, this system is required by Congress to function, and if it doesn't, FDA is breaking the law:

"the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks."

So there you have it.  FDA is required by law to properly use and maintain massive databases for the evaluation of vaccine safety.  Yet it says neither is working. But no matter, FDA issued a license for the Comirnaty vaccine anyway yesterday.


Anonymous said...

Dr. Nass, please run for governor of Maine!

Anonymous said...

Bobby and Meryl 2024

Unknown said...

I am a contractor and know little of the inner workings of the big pharma/medical establishment in the US/world. I don't understand how the people who run these organizations are able to get by with virtually no accountability? This situation on VAERS is either gross incompetence at best or outright collusion and ethical fraud. MS news is now openly saying as a "non-vaxxed" citizen I am willfully killing my innocent (compliant) fellow citizens. https://www.msn.com/en-us/health/medical/he-survived-two-tours-in-afghanistan-but-died-from-a-treatable-illness-because-hospitals-were-overcrowded-with-unvaxxed-covid-patients/ar-AANP8NY?ocid=entnewsntp . My comment is what recourse does the truth have?