"Confidence that this Vaccine is Safe"

Post #1131

A report in The Defender, put out by Children’s Health Defense, quoted health officials making a remark in ‘late April/early May’ of 2021 about the Janssen (Johnson & Johnson) COVID shot:

But FDA was using a certain method for detecting disproportionate adverse event (AE) reporting called Empirical Bayesian Geometric Mean (EBGM) and — very specifically — FDA was on the lookout for 5th percentile (EB05) values above 2.0.

But by 17 Apr 2021, this exact metric was throwing a Safety Signal regarding Pulmonary embolism (PE) reports to VAERS. Pulmonary embolism (blood clot lodged in lung artery) is a serious adverse event that can kill you — and the FDA’s official metric was sounding an alarm about it when they claimed confidence of safety.

The EBGM is a measure of center when using a Multi-item Gamma Poisson Shrinker (MGPS) algorithm. From an article that tracked EBGM along with the lower (EB05) boundary (bottom of blue-shaded area in graph below), you can tell that that EB05 value was sitting above 2.0 (even above 4.0!) for Pfizer shots during Week 7 (February) of 2021:

[click to enlarge]

And the data supplement for the study just above shows that, for Janssen (Johnson & Johnson), the EB05 values were at least as bad or worse:

[click to enlarge]

EB05 values — the detection method that FDA uses (highlighted orange in column I)— were above 2.0 from 17 Apr 2021 to 4 Sep 2021. Using the cell counts given (yellow- and green-highlighted), I verified the Reporting Odds Ratio (ROR) along with the 90% lower bound of the ROR (cell B31). PE reports were 7.8x more likely to be Janssen.

If FDA’s own critical threshold is being violated, then how could they sit there claiming confidence that the Janssen vaccine was safe? When checking for the PE reporting rate per million doses of Janssen, it was an astonishing 35 reports per million doses. That’s 3 times higher than the average for all serious AE reports.

Someone apparently did not get the memo regarding an elephant being in the room.

Reference

[article in The Defender] — https://childrenshealthdefense.org/defender/emails-chd-foia-government-covid-vaccine-injury-reports/

[Standard Operating Procedures for VAERS data mining] — https://childrenshealthdefense.org/wp-content/uploads/VAERS-SOP.pdf

[report showing Pfizer throwing a prolonged “official FDA Safety Signal” (EB05 > 2.0) for pulmonary embolism by Week 7 of 2021] — Harpaz R, DuMouchel W, Van Manen R, Nip A, Bright S, Szarfman A, Tonning J, Lerch M. Signaling COVID-19 Vaccine Adverse Events. Drug Saf. 2022 Jul;45(7):765-780. doi: 10.1007/s40264-022-01186-z. Epub 2022 Jun 23. PMID: 35737293; PMCID: PMC9219360. https://pmc.ncbi.nlm.nih.gov/articles/PMC9219360/

[18.99 million US doses of Janssen doled out]

[672 US reports of PE to VAERS from Janssen]