When it comes to the CONvid-19 and the experimental medical treatment of an injectable mRNA medical device, one sometimes feels as though they are swimming against the current in a sea of insanity. The circle of friends and family who are opting to take this injection, despite the months of research into CONvid-19 and these experimental injectable mRNA medical devices, appears to increase, leaving one to operate in a “going against the grain” fashion. But, as the research into all of this continues, the information uncovered cements the position these experimental treatments are unsafe and extremely dangerous for administration.
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On March 10, 2021, The BMJ published an article describing the cyberattack on the European Medicines Agency (EMA) where leaked classified documents exposed that early commercial batches of Pfizer-BioNTech’s mRNA injectable medical device had lower levels than expected of “intact mRNA” and questions arose regarding the “stability” of the mRNA injection.
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.
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.
With mRNA medical treatment being “new”, how does anyone know what is “sufficiently consistent and acceptable”? How does anyone provide proper informed consent when there is evidence of problems with stability being withheld from medical professionals and the public?
The BMJ did not provide any of the documentation “hacked” from the EMA for review; therefore, the report is being taken as accurate.
The EMA reported that some of the information leaked appeared to be “doctored”; however, this information offers the medical community and researchers an opportunity to evaluate the complexities of quality assurance regarding the new mRNA technology experimental injections. This would include “everything from the quantification and integrity of mRNA and carrier lipids to measuring the distribution of particle sizes and encapsulation efficiency” as well as mRNA stability – the most important and critical variable to this technology. But, this has received little if any attention. Not only is this relevant to Pfizer-BioNTech’s device, it is relevant to Moderna, CureVac and others. From what is known, mRNA is unstable, making stability a top priority to this technology.
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The BMJ continued:
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.
If there are no specific regulatory guidance for mRNA based injections, who knows what is considered “stable” and/or safe? Moreover, who knows what happens to the lipid nanoparticles encasing this technology? How cold does it have to be to stop instability and degradation since this is identified as a problem with current methods? Unsurprisingly, the pharmaceutical manufacturers appear “resistant” to full disclosure.
Despite attempts by the BMJ to ascertain from Moderna, Pfizer BioNTech and Curevac, as well as regulators, what percentage of mRNA integrity was considered acceptable for these injections, none offered a response. UK regulators at The Medicines and Health Care Products Regulatory Agency acknowledged a lack of a specific percentage of mRNA integrity but declined to comment further. In an email statement, the UK agency stated, “The specification limit acceptance criteria are commercially confidential”. Why is that confidential when it is extremely relevant to transparency, safety and stability?
The US Food and Drug Administration, when confronted with similar inquiries, directed the BMJ to read its guidance documents and the review of the Pfizer “vaccine”. However, none have specified the mRNA percentage the agency requires. When pressed further, the FDA regulator pointed to Pfizer saying, “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.” It sounds eerily like a “run around” to avoid stating that no one knows.
Here is what the BMJ subsequently discovered.
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.
Health Canada told The BMJ that Pfizer had conducted investigations into the root cause of reduced integrity in the commercial vaccine batches, and “changes were made in their processes to ensure that the integrity was improved and brought in line with what was seen for clinical trial batches.” Health Canada said the three agencies subsequently determined that “there was no concern with the RNA integrity or any other product specifications.”
Correspondence in the leaked documents suggests that FDA, Health Canada, and EMA were aligned on clinically qualified specifications of percentage mRNA integrity. Health Canada has confirmed to The BMJ that regulators “have worked together to align those requirements,” but all agencies declined to share with The BMJ any specifics on grounds that such information was commercially sensitive.
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. Pfizer stressed: “Each batch of vaccines is tested by the official medicinal control laboratory—the Paul Ehrlich Institute in Germany—before final product release. As a result, the quality of all vaccine doses that are placed on the market in Europe has been double tested to ensure compliance with the specifications agreed upon with the regulatory authorities.”
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.”
CureVac, whose mRNA vaccine was submitted for EMA’s “rolling review” in February, told The BMJ that “it is too soon to give details.”
Professor Crommelin informed the BMJ “For small, low molecular weight products, the active pharmaceutical ingredient integrity is typically close to 100%.” The shortage of information on mRNA integrity may suggest a lack of certainty among regulators and the manufacturers on how to assess evidence completely with this new experimental technology.
Supposedly, the fragility issue (stability) with mRNA was resolved by encapsulating the mRNA into “nanocarriers made of polymers, lipids, or inorganic materials.” Moderna, Pfizer BioNTech, and the Imperial College London chose lipid nanoparticles as the nanocarrier for the mRNA in their experimental injections. However, this has produced another unknown – biodistribution of the lipid nanoparticles. In other words, where do these go or how are they distributed into the human tissues after injection? JW Ulm, a gene therapy specialist, raised this concern stating it is an unknown that could have implications for the safety of the injection.
Ulm told The BMJ: “Pfizer-BioNTech and Moderna did a remarkable job of rapidly scaling up manufacturing of such a novel system in swift fashion, which is genuinely a landmark technological achievement. However, pharmacokinetic studies, with independent laboratory confirmation, are essential to ascertain potential cytotoxicity and macroscopic toxicity, especially given the likelihood of booster injections over months or years, since the tissue trafficking patterns of the mRNA vaccine payload will determine which cells and tissues are killed by cytotoxic T-cells in each round.” Given the variation in LNP formulations, it is unclear how relevant previous animal experiments are to answering this question.
None of the manufacturers contacted by BMJ would address Ulm’s concerns.
Daan J.A. Crommelin, along with authors Thomas J. Anchordoquy, David B. Volkin, Wim Jiskoot, and Enrico Mastrobattista, addressed these issues in an NIH website publication, “Addressing the Cold Reality of mRNA Vaccine Stability.” In the abstract, the authors stated, “We conclude that systematic approaches to identify the key physicochemical degradation mechanism(s) of formulated mRNA vaccine candidates are currently lacking. Rational design of optimally stabilized mRNA vaccine formulations during storage, transport, and administration at refrigerated or ambient temperatures should thus have top priority in the pharmaceutical development community.” It appears these authors found the review of the literature on “the pharmaceutical stability of mRNA vaccine candidates, including attempts to improve their stability, analytical techniques to monitor their stability, and regulatory guidelines covering product characterization and storage stability”, lacking the needed information.
The historical account included in the study cited the importance of complete, intact mRNA molecules as essential to the potency of a “vaccine”. It was noted that even minor degradation reactions anywhere along an mRNA strand can “severely slow or stop proper translation performance of that strand” resulting in the formation of an incomplete antigen. Most importantly, the authors claimed that historically, the nature, quality and supplier of excipients, as well as the design of the formulation manufacturing process, could affect the “pharmaceutical stability of formulated mRNA vaccine candidates in terms of chemical stability of the mRNA/excipients as well as the colloidal stability of their complexes.”
According to the authors, the delivery mechanism or nanocarrier, a critical component, is just as important in consistent quality. Yet, the literature is lacking this information in order to complete a thorough investigative analysis. The authors conclude these stability, storage and quality issues need to be addressed.
Despite all of this lack of critical information, health agency regulators in Europe, the US, and Canada have authorized these injections for emergency use without asking the “right” questions.
Wouldn’t you want to know what affects degraded mRNA could have inside your body? What does the body do with lipid or polymer nanocarriers encapsulating the mRNA? Does these truncated mRNA strands and/or nanocarriers cause “unintended” consequences? How does this affect safety? How could this irreparably damage the human genome?
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With the questions of mRNA stability unanswered, and the lack of acceptable integrity percentage of mRNA in the adjuvant being presented to the public, one could assume there are more risks involved than what is being told to the public. Remember, this technology is unable to be “switched off” once it enters the body. It begs the question as to whether the incredible number and severity of side effects are directly proportional to the percent of degraded mRNA in the injection and the body’s processing of these nanocarriers encapsulating the mRNA. This would be in addition to the genome altering consequences that intact mRNA strands and degraded mRNA strands are causing in the recipient. Since Pfizer-BioNTech, Moderna, and CureVac are not being forthcoming with information and the regulatory agencies appear to be willing to accept some form of explanation, no matter how unsound from those entities, it becomes more critical for everyone to do their own research or read the research that others have conducted.
This is another point in this new experimental technology that should be revealed to the individual contemplating receiving this injection. The administrator of the injection should disclose the experimental nature of this injection along with these problems with instability and storage for proper informed consent. But, bet you ten dollars to a dime those who are administering this injections are engaged in thinking this is just another “vaccine” without investigating further. This means they are responsible for not obtaining proper informed consent and can be held liable in a court of law for their malpractice.
Based on everything known about these injections and in light of these unknowns, it should be enough to conclude these injections should be ceased for EUA and these unknowns could be contributing to the multitude and varied adverse reactions/injuries to the public in addition to the altering of the human genome, which has not been disclosed to the public. Moreover, without full disclosure, those who administer the mRNA injections cannot obtain proper informed consent to relieve them of engaging in medical malpractice.
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