An analysis of leaked documents containing early clinical trial results for the Pfizer-BioNTech COVID-19 vaccine shows that “regulators had major concerns” over the integrity of the mRNA in it shortly before its approval for release to the public.
According to The BMJ, the documents were obtained through a cyberattack on the European Medicines Agency (EMA), after which they were leaked to various media, including BMJ reporters. The BMJ examined the documents and determined that EMA scientists tasked with ensuring manufacturing quality of the vaccine were concerned that “truncated and modified mRNA species” were “present in the finished product.”
One drawback of the documents was that they were “partially doctored” emails that came from multiple users. However, The BMJ determined that what was in there was enough to cause a discussion on how the vaccine came to be approved. Points in the review include:
- Specific regulatory guidance for mRNA-based vaccines do not exist
- Intact mRNA molecule is essential to the vaccine’s potency
- It’s unclear how the vaccine came to be approved on the heels of findings that the mRNA integrity might be compromised
“Of particular concern is RNA instability, one of the most important variables relevant to all mRNA vaccines that has thus far received scant attention in the clinical community,” The BMJ said. “It is an issue relevant not just to Pfizer-BioNTech’s vaccine but also to those produced by Moderna, CureVac, and others, as well as a ‘second generation’ mRNA vaccine being pursued by Imperial College London.”
SOURCE: The BMJ March 10, 2021