Dr. Gerald Dyker, Professor of Organic Chemistry at the Ruhr University Bochum, and Dr. Jörg Matysik, Professor of Analytical Chemistry at the University of Leipzig, … recently appeared on the Punkt.Preradovic online programme of the German journalist Milena Preradovic to discuss batch variability.
Their starting point was the recent Danish study showing enormous variation in the adverse events associated with different batches of the Pfizer-BioNTech vaccine …:
It shows that the batches used in Denmark, which are represented by the points in the graph, essentially break down into three groups.
Green — normal doses, 60%:
The ‘green batches’ clustered around the green line have a moderate or moderately-high level of adverse events associated with them. … It represents the batch that was the used the most in Denmark, with somewhat over 800,000 doses having been administered. …
Blue — something wrong, very dangerous doses, 5%:
There are then the ‘blue batches’ clustered around the blue line, which are obviously associated with an extraordinarily high level of adverse events. As Dyker notes, no more than 80,000 doses of any of the blue batches were administered in Denmark — suggesting that these especially bad batches may perhaps have been quietly pulled from the market by public health authorities. …
Eight thousand out of 80,000 doses would give a reporting rate of one suspected adverse event for every 10 doses — and Dyker notes that some of the blue batches are indeed associated with a reporting rate of as high as one suspected adverse event for every six doses! …
Yellow — placebos, 30%
Finally, we have the ‘yellow batches’ clustered around the yellow line, which, as can be seen above, barely gets off the x-axis. …
Dyker notes that they include batches comprising some 200,000 administered doses which are associated with literally zero suspected adverse events.
As Dyker puts it, “malicious” observers might note that “this is how placebos would look”.
And malicious observers might be right. For Dyker and Matysik compared the batch numbers contained in the Danish study with publicly available information on the batches approved for release, and they made the startling discovery that almost none of the harmless batches, unlike the very-bad and not-so-bad batches, appear to have been subject to any quality-control testing at all.
Unbeknownst to most observers, it is precisely the German regulatory agency, the Paul Ehrlich Institute (PEI), which is, in principle, responsible for quality control of all the Pfizer-BioNTech vaccine supply in the EU. (The institute is named after the German immunologist and Nobel Prize winner Paul Ehrlich, not, of course, the Stanford biology professor of the same name.) …
Dyker and Matysik found that the PEI had tested and approved for release all the very bad ‘blue’ batches, the overwhelming majority of the not-so-bad ‘green’ batches, but almost none of the harmless ‘yellow’ batches -– as if the PEI knew in advance that these batches were unproblematic.
There have been a lot of unconfirmed suspicions and accounts that the Pfizer vaccine harm was mainly confined to some batches, pointing to manufacturing flaws. It would certainly account for the uneven effectiveness and harms from the vaccine.