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Covid 19News ArticleCovid vaccinesPfizer Covid19 VaccineModerna Covid 19 Vaccinehttps://vaccineimpact.com/2021/leaked-pfizer-documents-reveal-only-55-of-some-covid-vaccine-samples-had-rna-intact-prior-to-european-approval-exposing-huge-quality-control-issues/?fbclid=IwAR0UMkok3xAFec9LCyo9b4P4qcHwneoInWfCidCGuc1QiuQsnzHayO4T9F8- March 14, 2021
One of the key issues revealed in the leaked documents, according to The BMJ, was that European regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. Some batches were as low as only 55% intact.
This raises an interesting question, as I have had some people ask me how it is that we have reported so many deaths and injuries following the mRNA vaccines, when in their personal network of families and friends they know people who have received the mRNA “vaccines” with seemingly no adverse reactions at all.
Some have posed the question as to whether or not some people were getting placebos. After all, the corporate media has gone out of their way to warn people that the side effects of these novel new experimental “vaccines” are very serious, especially after the second dose.
EMA says the leaked information was partially doctored, explaining in a statement 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.”
But the documents offer the broader medical community a chance to reflect on the complexities of quality assurance for novel mRNA vaccines, which include everything from the quantification and integrity of mRNA and carrier lipids to measuring the distribution of particle sizes and encapsulation efficiency.
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.
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.
RNA instability is one of the biggest hurdles for researchers developing nucleic acid based vaccines. It is the primary reason for the technology’s stringent cold chain requirements and has been addressed by encapsulating the mRNA in lipid nanoparticles.
“The complete, intact mRNA molecule is essential to its potency as a vaccine,” professor of biopharmaceutics Daan J.A. Crommelin and colleagues wrote in a review article in The Journal of Pharmaceutical Sciences late last year.
“Even a minor degradation reaction, anywhere along a mRNA strand, can severely slow or stop proper translation performance of that strand and thus result in the incomplete expression of the target antigen.”
Crommelin and colleagues note that specific regulatory guidance for mRNA based vaccines has yet to be developed, and The BMJ’s attempts to clarify current standards were unsuccessful.
Transparency and confidentiality
The BMJ asked Pfizer, Moderna, and CureVac, as well as several regulators, what percentage mRNA integrity they consider acceptable for vaccines against covid-19. None offered any specifics.
The Medicines and Healthcare products Regulatory Agency, the UK’s medicines regulator, acknowledged the lack of a specified percentage RNA integrity, but declined to provide further details.
“The specification limit acceptance criteria are commercially confidential,” the agency said in an email.
Pfizer also declined to comment on what percentage mRNA integrity it is aiming for, nor would it address questions about the cause of the unexpectedly low percentage mRNA integrity in certain batches, leaving open the question of whether it could happen again.
Moderna’s chief corporate affairs officer Ray Jordan declined to respond to any of The BMJ’s questions, stating: “At this point, Moderna will not be offering additional commentary on these topics.”