How % mRNA integrity was apparently resolved
The discrepancy between batches appears to have may been resolved when it’s mentioned that the ‘latest lots [received by the FDA] indicate the % intact RNA are back around 70-75%.’
However, in a leaked report of a meeting with Pfizer and the EMA on November 26, 2020, a day after Veronika’s email, it shockingly reveals that the RNA integrity specification was revised down to >=50% for drug product shelf life, significantly lower than the minimum threshold of 70% that Acuitas Therapeutics had stipulated and the average 78% of the clinical batches. Was this the EMA’s (and potentially FDA/MHRA/HC) way of ‘resolving’ the issue to ensure ‘an approval by the end of the year’?
Mention is made of ‘uncertainties about consistency of product quality and hence uncertainty as regards product safety and efficacy of the commercial product.’ Yet, it’s baffling how lowering the RNA integrity specification would remedy that major objection.
In another slide the artifact states, ‘Truncated [shortened] and modified RNA species should be regarded as product- related impurities.’ This confirms that these shortened mRNA species which lowered the level of %mRNA integrity were classed as impurities. Another alarming concern arising from these impurities is flagged ‘the possibility of translated proteins other than intended spike protein (S1 S2) resulted from truncated and/or modified mRNA species should be addressed.’ (See screenshot below)
The evidence in this report confirms that regulatory bodies like the FDA, MHRA, EMA and Health Canada knew of the differences in batches, regarding % mRNA integrity and because of that the effect on ‘safety and efficacy’ was unknown. The leaked Pfizer/EMA meeting report raises material concerns assuming the issue was resolved by simply lowering the RNA integrity specification. In other words, perhaps it was never resolved.
A particular website that has drawn a lot of attention recently, which speaks to the difference between batches is howbadismybatch.com. It’s a comprehensive database with analysis on ‘batch codes and associated deaths, disabilities and illnesses for Covid 19 Vaccines.’ By entering a batch number of any of the Covid-19 vaccines, it tells you the frequency of adverse events reported associated with that batch.
I spoke with Sasha Latypova, who has run clinical trials for over 25 years and owns her own biotech company, to ask her expert opinion on the leaked documents. She said, “The lack of mRNA integrity and presence of uncharacterized fragments of RNA in batches of Pfizer's product was identified as a "Major Objection" - a formal regulatory red flag, deemed a product impurity and would have been a showstopper in any normal drug approval process. At a minimum, it required an additional "bridging" clinical trial to evaluate the clinical effects which would have taken months to design and conduct properly. Panic overruled scientific integrity, and an arbitrarily lowered batch acceptance standard was adopted for the sake of meeting a politically motivated deadline. To date, this issue remains unresolved and could be the underlying cause for the enormous variation in the rates of adverse events and deaths observed for different manufacturing batch numbers in the CDC VAERS and other databases.’
Latypova made an apt reference to the fate of the Titanic, by drawing a comparison in the way regulatory bodies conducted their ‘warp speed’ process of authorising the Covid-19 vaccines. The Titanic's captain, Edward J. Smith, was aiming to better the crossing time of another vessel, which meant the ship was travelling way too fast, in waters known to have ice. This set it on a fatal collision with an iceberg and the rest is history.
In light of the evidence included in this report and the fact that the Pfizer-BioNTech Covid-19 vaccine is one of the most lucrative products in history (last year Pfizer made $37 billion in sales with predictions for 2022 being $32 billion), this author strives to open a discussion with some vital questions which must be addressed by the regulatory agencies involved, Pfizer and those in the scientific/medical community:
What are the safety and efficacy implications of a significantly lowered mRNA integrity (arising from truncated and modified mRNA) in the commercial batches of this vaccine?
Exactly what are the visible particles observed in the DP (drug product) that Pfizer shared last minute with the EMA, FDA and MHRA and what are its safety and efficacy implications?
Answers to these questions are of major public importance.
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https://www.trialsitenews.com/a/what-the-leaked-ema-emails-docs-reveal-major-concerns-with-pfizer-c-19-vaccine-batch-integrity-and-the-race-to-authorise-cdda0ba2
https://archive.ph/sQYoE