On December 9th, 2020, Pfizer and BioNTech announced that the European Medicines Agency (EMA) had fallen victim to a cyber attack and that documents related to development of their COVID-19 vaccine had been “unlawfully accessed.” The story was brought back to the forefront when it was revealed that the documents that had been accessed by the hackers were posted publicly online on January 12th, 2021. In an apparent effort to quell vaccine hesitancy, the EMA released an update stating that
“Whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created and additional titles were added by the perpetrators in a way which could undermine trust in vaccines.”
On January 12th, the day they were made public, I was able to get my hands on them (click here to download them). I posted about this on January 14th on my original Instagram account and shared my findings (ref. left/above, and please forgive my grammatical errors on the slides below…). The files consisted of official emails between EMA colleagues, Assessment Reports, Rolling Reviews, and official opinions on those reports and reviews, amongst other things. Nothing looked doctored, mislabeled, or spun in any way shape or form. Reading through the emails after sorting them in chronological order, I pieced together that there were some pretty large discrepancies between the commercial and clinical batches of mRNA integrity.
This is where it gets really interesting. There is a control process called “Chemistry Manufacturing and Controls” (CMC). This process is used to ensure that pharmaceutical and biopharmaceutical drug products are consistently effective, safe, and high quality for consumers. In the emails between the EMA, they detail out that there are “some issues on CMC to be sorted out” (ref. EMA Email 1). According to the CMC, there was “an important comparability issue with [Pfizer’s] vaccine that needs to be addressed prior to approval” (ref. EMA Email 3). The email goes on to explain that the CMC found “A significant difference in the %RNA integrity… between the clinical batches ( ~ 78% mRNA integrity)… and the proposed commercial batches (~ 55%)... [The] efficacy of the drug product is dependent on the expression of the delivered RNA.” The next email in the chain details that these differences in the level of mRNA integrity are of major concern.
Conclusions: a number of major concerns remain that impact the benefit/risk of the vaccine (efficacy/safety) most notably the comparability issue around % mRNA integrity.
(EMA Email 4)
Now for the kicker. In summation, the CMC caught an mRNA integrity difference between the clinical batches (those used on the interim trials in 2020) and the commercial batches (what are being mass produced and administered literally all over the world). As was stated, the mRNA integrity directly affects the efficacy and the drastic differences between the two batches was a cause for major concern that impacts “the benefit/risk of the vaccine (efficacy/safety).”
And there it is. The FDA admits that the CMC issue issue regarding the mRNA integrity would not need to be addressed at all (left/above). Why? Because under an Emergency Use Authorization, it isn’t necessary. Full FDA licensing and approval of Pfizer’s product would require addressing and correcting this issue, but not an EUA. A couple weeks after these leaks hit the web, Dr. Vanessa Schmidt-Kruger testified about this issue (amongst others) at the German Corona Extra-Parliamentary Inquiry Committee on January 30th. In March, the issue was finally addressed in a peer reviewed investigation by the British Medical Journal.
This issue concerning the mRNA integrity in Pfizer/BioNTech’s experimental vaccine needs to be addressed. The mass production of these products in facilities all over the United States presents an added complication to keeping the %mRNA consistent across all runs and batches of these products. Why wasn’t this issue, deemed as a cause of “major concern” pertaining to “risk/benefit of the vaccine (efficacy/safety), resolved? Why are these products being administered under the guise and justification of an EUA? Will it be addressed by the time this product receives full FDA licensing and approval? One can only hope.