This exact phrase ‘requires a sufficiently intact RNA molecule’ was used in the email from EMA staffer, Evdokia Korakianiti, which I included above, sent on November 23, 2020- now we likely know where Korakianiti referenced it from.
For the commercial batches (which were going to be rolled out across the globe) to have such a significantly lower level of mRNA integrity (intact RNA molecule) is greatly concerning given its intrinsic tie to the efficacy and potential safety of the product.
The next day Veronika Jekerle, Head of Pharmacy Quality Office, writes to Evdokia (see below).
The difference in the level of mRNA integrity was again noted as a major concern ‘shared by most member states’ and its ‘potential impact on safety.’ Jekerle highlights in bold, “An approval by the end of the year could potentially be possible, if these concerns + GMP will be resolved.”
This gives rise to the critical question- how were all these concerns resolved when CMA was granted only a few weeks later, on December 21? A possible way it was resolved is explained later in this report.
In contrast to the concerns of some of the other EMA officials, Marco Cavaleri writes around the same time in the following email (see below) that the mRNA content is not a major concern, according to the FDA- ‘the issue on the mRNA content not perceived as major.’ He also shockingly states, ‘unclear if GCP inspections ever done.’ This revelation is highly concerning given that GCP refers to Good Clinical Practise, which is ‘an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.’
What’s even more alarming is his following statement- ‘no major interest from FDA.’ This looks to reveal the regulatory agency’s apparent lack of concern or even interest on whether GCP inspections were completed, in the context of Pfizer’s clinical trials, which was relied on by the FDA to grant EUA for the Pfizer-BioNTech vaccine. In one of this author’s previous investigative reports for Trial Site News, we noted that the FDA only inspected 1% of Pfizer’s trial sites.
Further damming information is revealed (see screenshot below) when multiple regulatory agencies: Health Canada (HC), EMA, MHRA and FDA are all aware of the issue with % mRNA integrity, yet FDA and Health Canada make an unsubstantiated claim that ‘safety concerns associated. Are more of a theoretical concern.’
Health Canada then appears to contradict itself because its later described as showing particular concern about one region receiving ‘all the suboptimal material.’ Obviously, it didn’t want to be that region.
Shockingly, the end of the email reveals the ‘Applicant [Pfizer] has shared with FDA and us [EMA]/MHRA only today and issue with visible particles in the DP [drug product] appears to be lipid nanoparticle components.)’
This is highly concerning due to this significant issue being made known to the three key regulatory agencies on November 25, only a few weeks away before the EMA granted CMA and the FDA granted EUA for the Pfizer vaccine. Alarmingly, it was just days before the MHRA granted authorization in the UK on December 2, 2020. Veronika’s assumption that the ‘visible particles’ could be LNPs (lipid nanoparticles) is hard to accept given nanoparticles are not visible to the naked eye. Other anomalies were apparent, yet this was probably still a historical effort in terms of speed of vaccine development. It seems clear however some more time was needed.
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