Peter Marks' Safety Signal Slow-walk

Post #1287

CHD’s Defender recently reported on the Senate Hearing investigating a suspected cover-up, or a slow-walk, regarding what FDA and CDC knew about harms from COVID shots, and what they were telling the public about harms from COVID shots. Senator Ron Johnson has a link to an opening statement containing this bullet:

On May 27, 2021, three days after the meeting where FDA and CDC officials acknowledged the safety signal for myopericarditis, FDA’s then-Director of the Center for Biologics Evaluation and Research, Peter Marks, wrote to Walensky and Woodcock and appeared to raise concerns about even posting “clinical considerations” about myocarditis.12 He wrote “I need to ask for your patience with me. We still have concerns here if myocarditis and pericarditis have not actually signaled.”13

Notice how it was the end of May in 2021, and Peter Marks was waffling back-and-forth about whether there really is a safety signal present for COVID shots. But CDC promised to employ the data-mining surveillance method of the Proportional Reporting Ratio (PRR), which can be strengthened by reporting it’s 5th Percentile.

Here are 1,287 VAERS reports of myocarditis after COVID shots in males of age 16-24:

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And here are the 21,922 adverse event reports for the same time and for the same group:

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The myocarditis reports represent a “proportion” of the total reports, but we need to compare it to a baseline for non-COVID vaccines:

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That’s 81 total reports of myocarditis which came in for this group for the years from 2008-2019. And here are the total of 9,056 adverse event reports over the same time-window:

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Alright, now we have a baseline in the proportion of all adverse event reports comprised by myocarditis reports, and here is what it looks like when you perform CDC’s official analysis on the data. The color coded cells help you see what gets divided by what in order to get a PRR, and a PRR over 2.0 is a Safety Signal:

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As you can see in cell D6, an April Safety Signal was thrown because the PRR was over 2.0. While CDC did not announce that it would also form a confidence interval around the PRR in order to limit the number of false signals coming in, I went ahead and formed it, anyway. Cell G7 shows that even the 5th Percentile PRR was still above 1.8.

But by May 2021, there is no question (at all) that there is a Safety Signal — because even the lower bound of the PRR is well above 2.0. In fact, even if you only look at the running tallies of myocarditis reports and all reports — using cumulative numbers only — you still reach a situation in May 2021 with a definite Safety Signal.

Reference

[online search tool for VAERS] — https://medalerts.org/vaersdb/index.php