"Pharmacovigilance and Biostatistics" for vaccines at FDA: 7 of 18 positions are vacant. And desperately [not] seeking Myocarditis.
Is this the excuse for not looking at all their databases on COVID vaccine safety? Who is looking at the info on over 100 million Americans allegedly collected to assure vaccine safety?
Excerpts from a substack I wrote in December 2021:
And here is a more recent FDA list of the databases FDA claims it is using to assess COVID vaccine safety, in addition to VAERS, which FDA and CDC jointly share:
There was another system FDA promised to use to evaluate vaccine safety: PRISM. But we have heard nothing from PRISM regarding COVID vaccines, or anything else, lately. PRISM has disappeared.
Myocarditis is the most obvious COVID vaccine-associated severe adverse event. It usually happens within 4 days of the second shot. It is most common in young males. It has been reported many thousands of times to VAERS. Understanding it ought to be a slam dunk.
On August 23, 2021, FDA had the temerity to write to BioNTech that its [FDA's] capabilities were inadequate to assess myocarditis, so BioNTech would have to do it for them. Here is what FDA wrote about its inability to use VAERS and its many other databases to assess the myocarditis risk:
As noted above, the FDA acknowledges that “We have determined that an analysis of spontaneous post-marketing adverse events reported under section 505(k)(1) of the FDCA [in other words, analyzing VAERS--Nass] 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 [in other words, FDA's many other databases that cost the taxpayer $zillions are also inadequate--Nass] is not sufficient to assess these serious risks.”
NOT SUFFICIENT???? Is this a joke? All this data, plus software, plus a team of analysts, and FDA says it can't assess the risk of myocarditis, despite identifying thousands of cases?
Unsaid, but implied, is that if FDA is incapable of understanding thousands of reported cases of myocarditis, it cannot or will not study the other serious adverse events that have been reported in conjunction with COVID vaccines.
VAERS has operated for 30 years, collecting reports of vaccine adverse events. It averaged under 100 cases of myocarditis reported yearly until this year. Through November 2021, CDC reports it received 1949 reports of myocarditis and pericarditis, just in those under 30. CDC didn't say what the total number of reports for all ages was.
Somehow, FDA and CDC don't seem at all perturbed that the acknowledged reporting rate of myocarditis is over 20 times the average during the past 30 years. Why not?
CDC has been even more shady in its analyses of safety than FDA, if that is even possible. Below, Nancy Messonier, then head of Immunizations and Respiratory Diseases at CDC, presented this list of databases that CDC would be using in the evaluation of COVID vaccine safety, on December 10, 2020. Apart from the V-safe database (which CDC stopped talking about last January, after it revealed that 1-3% of vaccine recipients required a doctor visit to deal with side effects—and has now cancelled for COVID vaccines) the Vaccine Safety Datalink (VSD) (which somehow can't find any problems, not even myocarditis) and the VAERS database, all the other databases CDC promised to study have been MIA.
NIH, whose job has never been to issue treatment guidelines, but instead to perform and fund research, suddenly took over the treatment guidelines for COVID early in 2020. It formed a committee of internal and eternal "experts" to make up the guidelines. How were they chosen? That is not clear, but what is clear is that 16 of these so-called experts had current or recent financial entanglements with Gilead, the maker of remdesivir. NIH and the US Army also owned pieces of remdesivir. A number of the experts had financial dealings with Merck. While NIH is the single biggest funder of medical research in the world, I cannot recall seeing a single study it funded on the safety of COVID vaccines. Yet somehow vaccines are its number one recommendation.
It is not clear whether the NIH's guidelines committee is functional. The NIH has been sued to learn whether a vote was even taken by the committee regarding its ivermectin guidelines, which fly in the face of the evidence on ivermectin. And no one has answered the big question: how was NIH somehow authorized to issue treatment guidelines in the first place?
Here is what has obviously occurred. All these agencies were told they had to keep quiet on vaccine problems (and perhaps problems of other COVID treatments), and they had to fiddle with their data or their analytic methods, or both, to get the required results. And there was to be NO BAD NEWS, no matter what. And no good news regarding generic treatments.
As we have seen, the so-called scientists and physicians working as bureaucrats in these agencies all caved, sucked it up, did the dirty work, kept their jobs, and betrayed their oaths and the trust of the people of the USA and the world.
Here is one example of their gross perfidy:
Rochelle Walensky, MD, MPH
#COVID19 vaccines are safe for children 5-11. They have undergone the most comprehensive & intense safety monitoring system in U.S. history. To date, no serious safety concerns have been identified. Vaccination is the best way to protect children from COVID-19. Dec. 10
Yet here is what her own agency found 6 months ago:
And in Hong Kong, health authorities found one case of myocarditis in every 2700 boys aged 12-17 after their second shot. Apparently CDC Director Walensky thinks that is safe. Is she really a doctor?
It is important to call out the criminals. I hope everyone knows HHS gave the CDC Director's husband's company a $5 million dollar contract in taxpayer money, with options for $12 million more, presumably if she behaves herself... at our expense.
And here is a May 2023 BMJ opinion piece that could not be more apt:
When will Americans and those we elected say enough is enough?