by Brian Shilhavy
Editor, Health Impact News
In December of 2020, the European Medicines Agency (EMA) was allegedly the victim of a cyberattack as they were reviewing documents received from Pfizer regarding their mRNA COVID vaccine trials in preparation for issuing emergency use approval for the vaccine in Europe.
More than 40 megabytes of classified information was allegedly published on the dark web, and sent to several journalists, including The BMJ which just published a review of the leaked documents last week.
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.
And now there are now reports of entire school districts having to shut down and cancel classes because all the teachers and employees were injected at the same time and became so sick they could not go to work.
The corporate media has assured the public that these are “good” signs because it means the “vaccine is working.”
But my reply has been that before we consider “conspiracy theories” like speculating that some people are only getting a placebo, it is best to look at the more obvious, which is the possibility that some of the batches simply are duds, especially given the very low temperatures that the Pfizer shots are stored at, like 70 degrees F. below zero, and the meticulous procedures that are needed to thaw, mix, and store the doses.
It is just common sense that sometimes these procedures are going to be botched and mishandled. And now there are reports that in California and other places people are being recruited to administer the injections that have never done it before, like dentists, veterinarians, medical students, etc.
There is this illusion that the medical industry is comprised of very intelligent and capable people who work in the field of “science” and can almost do no wrong.
But the medical industry is made of fallible people, just like any other profession. Think of whatever industry you have your own experience with, and consider the vast range of competent people as opposed to incompetent people that work within that industry.
If it is an industry that typically requires a college degree, it is comprised of BOTH honor roll students and those who barely passed their classes getting by with the lowest grades possible to graduate. Or even worse, never really bothered to study anything at all, and instead bribed their way through college because they came from wealthy and influential families.
Every industry is comprised of honest and dishonest people. All of us who have worked in any kind of professional environment know that there are those who are trustworthy, and those who are not. There are those who are ethical, and those who are not.
The medical industry is no different, unless it is the fact that doctors and other medical researchers are worshipped and respected more among the public than most other industries, giving fuel to even MORE corruption than is present in most other industries.
So rather than conjecture that there is a plan to give the real “vaccine” to some while a placebo is given to others, I think this comment by the EMA is a much more plausible reason as to why some have very strong reactions to the injections, even to the point of dying, while others do not have any reactions at all:
EMA did acknowledge, however, that vaccine efficacy depends on the presence of suitable amounts of intact mRNA. In the case of the commercial batches that first raised alarm bells, the agency told The BMJ that the levels of truncated mRNA “and the amounts of a potential protein produced by the truncated mRNA would be too low to constitute a safety risk.”
EMA did not comment on how truncated mRNA might affect efficacy. (Emphasis mine.)
Dr. Meryl Nass, M.D. commented on The BMJ article with amazement that the public is so willingly accepting these shots without demanding to know more about them:
I had earlier read about the theft of documents from the European Medicines Agencies, and what they revealed about the Pfizer BioNTech vaccine’s mRNA manufacturing issues.
This article from the BMJ provides a bit of context, as well as explaining some of what we ought to know about these vaccines, but don’t.
I am flummoxed by the lack of interest shown by a public that wants its vaccines but doesn’t want to know anything about what is being injected into them and what the long-term effects will be?
Why aren’t citizens saying that of course they want to gain immunity, but demanding to know a lot more about these products before they are irretrievably vaccinated?
The EMA covid-19 data leak, and what it tells us about mRNA instability
Leaked documents show that some early commercial batches of Pfizer-BioNTech’s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari.
by Serena Tinari
As it conducted its analysis of the Pfizer-BioNTech covid-19 vaccine in December, the European Medicines Agency (EMA) was the victim of a cyberattack.
More than 40 megabytes of classified information from the agency’s review were published on the dark web, and several journalists—including from The BMJ—and academics worldwide were sent copies of the leaks.
They came from anonymous email accounts and most efforts to interact with the senders were unsuccessful. None of the senders revealed their identity, and the EMA says it is pursuing a criminal investigation.
The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production.
EMA scientists tasked with ensuring manufacturing quality—the chemistry, manufacturing, and control aspects of Pfizer’s submission to the EMA—worried about “truncated and modified mRNA species present in the finished product.”
Among the many files leaked to The BMJ, an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications.
EMA responded by filing two “major objections” with Pfizer, along with a host of other questions it wanted addressed.
The email identified “a significant difference in % RNA integrity/truncated species” between the clinical batches and proposed commercial batches—from around 78% to 55%. The root cause was unknown and the impact of this loss of RNA integrity on safety and efficacy of the vaccine was “yet to be defined,” the email said.
Ultimately, on 21 December, EMA authorised Pfizer-BioNTech’s vaccine. The agency’s public assessment report, a technical document published on its website, noted, “the quality of this medicinal product, submitted in the emergency context of the current (covid-19) pandemic, is considered to be sufficiently consistent and acceptable.”
It’s unclear how the agency’s concerns were satisfied. According to one of the leaked emails dated 25 November, positive news had come from an undisclosed source in the US: “The latest lots indicate that % intact RNA are back at around 70-75%, which leaves us cautiously optimistic that additional data could address the issue,” the email said.
A near miss?
It’s also unclear whether the events in November constitute a near miss in the commercial manufacturing of mRNA vaccines.
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 detail.
“The specification limit acceptance criteria are commercially confidential,” the agency said in an email.
The US Food and Drug Administration (FDA) directed The BMJ to read its guidance documents and its review of Pfizer’s vaccine, but none of these specify the percentage RNA the agency is requiring.
Asked to comment, the regulator pointed to Pfizer:
“information that you seek that is not addressed in the FDA Review Memorandum should be directed to Pfizer.”
In subsequent correspondence, FDA, EMA, and Canadian government department Health Canada all stated that specific information related to the acceptability criteria is confidential.
EMA did acknowledge, however, that vaccine efficacy depends on the presence of suitable amounts of intact mRNA.
In the case of the commercial batches that first raised alarm bells, the agency told The BMJ that the levels of truncated mRNA “and the amounts of a potential protein produced by the truncated mRNA would be too low to constitute a safety risk.”
EMA did not comment on how truncated mRNA might affect efficacy. The issue was satisfactorily addressed, the agency underlined, when further information was supplied by the manufacturer.
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.”
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