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Pfizer Periodic Safety Update Report Confirms Batch Variability



Schmeling et al Respond to Criticism with Powerful Source of Internal Validity


By Peter A. McCullough, MD, MPH


As an epidemiologist I am in the business of determining scientific validity of published studies. The Schmeling analysis that demonstrated the batch or lots of Pfizer mRNA vaccines seemed to have very imbalanced side effect profiles was externally consistent with VAERS data presented by Senator Ron Johnson to the CDC. This has been the major explanation of why some are fine and others are injured or dead after COVID-19 vaccination. But, was there any confirmation of what Schmeling et al found?


In a reply to a letter to the editor, Schmeling et al reveal the Pfizer Periodic Safety Update as an source of internal validity.

“Finally, after publication of our report, we have become aware of the first Periodic Safety Update Report (PSUR) for the BNT162b2 vaccine covering the period 19 December, 2020 to 18 June 2021 that was submitted to the European Medicines Agency on 19 August 2021 by the market authorization holder (BioNTech).11 This PSUR appears to confirm a large variation in numbers of adverse events between different BNT162b2 batches and batches with the highest number of adverse events reported here were all those represented by the blue ‘high SAE’ trendline in the figure of our published study.”


Schmeling M, Manniche V, Hansen PR. Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine. Eur J Clin Invest. 2023 Dec;53(12):e14102. doi: 10.1111/eci.14102. Epub 2023 Oct 13. PMID: 37833825.


So it appears as if the “hot lot” theory is confirmed. This explains why some ~32% have virtually zero side effects and have little reason for concern. We only wish everyone could be in that group. All others have some reason for personal health vigilance for the emergency of vaccine-induced medical problems.


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Peter A. McCullough, MD, MPH


President, McCullough Foundation



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