The Constant Covid Vaccine Manufacturing Quality Problems

Executive Summary

• The covid vaccines have had horrendous quality problems and differences in quality between batches.
• This story has barely been covered.

Introduction

It has been presented that there are no quality problems with various batches of covid vaccines, and this is incorrect. Moreover, mRNA vaccines were always challenging to manufacture and store to make them safe.

Our References for This Article

To see our references for this article and related Brightwork articles, visit this link.

Problems With Manufacturing Vaccine Quality – Released Through a Computer Hack or Leak

The public was never told about the covid vaccine manufacturing quality only became public knowledge because of a computer hack or leak. This previously hidden information shows severe problems with the vaccine manufacturing process.

This is covered in the following quotation.

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. – BMJ

Curiously, those who provide accurate information being hidden by the public at an agency funded by the public are being investigated for criminal prosecution. Would this information have ever been published and known if not for the hack?

The European Medicine Agency serves a function analogous to the US FDA. The leaked documents show something pharmaceutical companies and perhaps the EMA do not want anyone to know, as explained in the following quotation.

EMA Hid Concerns About the Covid Vaccines Quality From the Public?

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.” – BMJ

Note that none of these issues with quality was communicated to the public. The EMA actively deceived the public on this topic.

Clearing The Low Bar of Quality Control by the EMA

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.

Is there a program to actively monitor the batch quality performed by a regulatory body, or is it entirely left up to the vaccine manufacturer? How does anyone taking the vaccine know what they are getting?

EMA Changes Focus From The Actual Content of the Emails

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.”3

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,4 as well as a “second generation” mRNA vaccine being pursued by Imperial College London.5

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 (box).

“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.”

Vaccine Manufacturers Have No Integrity Specifications

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.

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.

In subsequent correspondence, FDA, EMA, and Canadian government department Health Canada all stated that specific information related to the acceptability criteria is confidential.

A 2% intact mRNA level in the batch of vaccines would be acceptable, as there is no standard that any manufacturer can point to.

This means that the standards by which the vaccines are being held are lower than those for paint manufacturing. Any paint manufacturer can provide acceptable tolerances under which a batch of paint is within quality specifications.

However, notice the reality of the effectiveness of vaccines and the topic of intact mRNA, which is explained in this quote from The Defender.

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 (below).

“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.”

Interesting. It appears that even a minor degradation reaction anywhere along the mRNA strand can render the vaccines far less effective.

Pfizer Also Has No Idea About Batch Specifications or At Least Refuses to Share This Information

Pfizer does not want any manufacturing specification used against it so that it can make anything, and no one can say that the vaccines it makes don’t meet quality standards. This is explained in the following quotation from BMJ.

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.”

Yes, Pfizer won’t answer any specifics on the correct level or active mRNA, but Pfizer will provide a blanket PR statement that they are “safe and effective.”

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,10 told The BMJ that “it is too soon to give details.”

Yes, they will not release any information that could expose how they do not have a standard they are trying to meet, which can then be used against them. The vaccines are “safe and effective.” The public should not be asking questions and does not deserve answers. Take the immunization and shut up — or be restricted in what you can do in society, where you can travel, what jobs you can hold, etc…

More Than Just Efficiency Issues…Safety Issues

The problem with manufacturing quality control goes beyond the effectiveness of the vaccines. Some bad batches of vaccines were not made to the specification of the vaccine formula but made it through a quality inspection and were injected into people anyway. This is explained in the following quotation from Rights and Freedoms.

An investigation of data found in the USA’s Vaccine Adverse Event Reporting System (VAERS) has revealed that extremely high numbers of adverse reactions and deaths have been reported against specific lot numbers of the Covid-19 vaccines several times, meaning deadly batches of the experimental injections have now been identified.

But what’s perhaps more concerning is that the “deadly” lots were distributed widely across the United States whilst other “benign” lots were sent to just a few locations.

Shockingly we can also see from the data that 30 lots of Pfizer vaccine had between 1,000 and 1,499 adverse event reports per lot, another 20 lots had between 1,500 and 1,999 adverse event reports per lot, and another 23 lots had between 2,000 and 2,499 adverse event reports per lot.

This suggests that there were a small quantity of dangerous batches of the Pfizer Covid-19 vaccine and a large quantity of seemingly harmless (at least in the short term) batches of the Pfizer Covid-19 vaccine.

The same can be seen for the Moderna Covid-19 vaccine. Ninety-five-percent of the lots of Moderna vaccine had zero death reports made against them. Meaning the 2,603 deaths were associated with just 5% of the lots of Moderna vaccine.

Thirteen lot numbers were associated with 41-60 deaths each, 2 lot numbers were associated with 61-80 deaths each and 1 lot number was associated with 81-100 deaths.

The following quotes from Mike Whitney describe more problems with vaccine batches.

I just couldn’t imagine that there could be a such a huge discrepancy between vaccines that are supposed to be identical. Now we see that they’re not identical, not even close. The differences are humongous and deadly. Which brings us to our next question: Is it intentional? If these lots are responsible for most of the vaccine-generated deaths on VAERS, and if there is up-to “1,000 to 1” difference in adverse events between these and the other batches; then we need to know whether or not this was done deliberately or not. So, is it all a big mistake or are we looking at premeditated murder?

More Specifics on Manufacturing Quality Problems

The following quote is from the article How Do We Navigate Uncertainty In These Perilous Times?

Quality Issue #1: Metal Particles and Glass Shards

Physical contaminants—Japan pulled 1.63M vials of Moderna’s vaccine after visible metal particles were found in them and when examining vaccine vials, Ryan Cole found glass shards in the vaccines. Both of these suggest the production of the vaccines was rushed to the point basic quality control steps were not taken.

Quality Issue #2: Degraded mRNA Fragments

•mRNA integrity—Leaked files from Europe’s FDA demonstrated that the drug regulators were aware much of the mRNA in the vaccines were mRNA fragments rather than the complete vaccine sequence. This suggests that the vaccine mRNA was poorly produced.

Quality Issue #3: Temperature Control Issues

Temperature control—Once the vaccines hit the market, the interest in ultra-freezing them rapidly waned and before long was largely forgotten. Similarly, more and more we observed vaccines being left out on a table all day long at vaccination sites. This again suggested people were receiving different vaccine doses as some contained mRNA which had more significantly broken down.

Quality Issue #4: Dissimilar Lots

Hot-lot distribution—In Europe, lots were found to be more toxic in Belgium (the vaccine production site for Europe). This suggested that the closer to the time of production a vaccine was injected, the more harmful it was (whereas later on much of the mRNA had time to break down and make less spike protein in the body)

Quality Issue #5: Degradation of the Vaccines

This was also demonstrated by data repeatedly showing mRNA vaccines in Sweden repeatedly and rapidly became less dangerous the further from their production time that they were injected.

Becuase the vaccines did not work and were 100% side effects, the best thing would be to have gotten a degraded and old vaccine.

Quality Issue #6: A “Hodgepodge of Vaccines”

Vaccine production—when Ryan Cole did a recorded examination of the vaccines with Del Bigtree they found:

We looked at all the different vaccines and I think one of the conclusions we came away with is that it’s just a hodgepodge..there were vaccines that seems as though there were no particles within them, almost nothing there it was almost like a saline shot and then there were Pfizer’s that were just packed with them and you just get the sense that the manufacturing of this is totally inconsistent…some were more concentrated and some were less.

This suggests that there was either very poor mixing when the vaccines were packaged (leading to some having lots of the lipid nanoparticles and others none) or that the vaccine manufacturers were unable to produce enough vaccine to meet the existing orders and switched to packing placebo vials to meet their contracted orders.

Again, everyone should pray that they got the fake vaccines. Fake vaccines allowed you to comply with mandates, but to escape the side effects of the vaccines. Fake vaccines may have been what was given to Joe Biden to make it look like he took the vaccine but do not have the side effects for the president.

In short, from the start, I was relatively sure the vaccine doses were not the same (based on the observations I made) but I couldn’t explain why and hence considered a lot of hypotheses (e.g., different mRNA doses were being done as a large scale experiment). Now that the dust has settled, I believe the most likely explanation was simply poor manufacturing, which is by far the most benign explanation as it suggests many were spared from the severe consequences of these vaccines (as they received “duds”).

How the EMA Works For Pharmaceutical Companies and Is Paid For By Them

The EMA sees its customers as pharmaceutical companies, not the public. This is explained in the article How Pharmaceutical Companies control both The FDA And The European Medicine Agency.

Conclusion

These vaccines present a significant danger to the public. These vaccines have enormous quality problems that make them unsafe, and the quality assurance of the vaccines is, according to the FDA, “a secret,” as is covered in the article How The FDA’s Emergency Use Authorization Testing Protocols For Covid Vaccines Are Secret.

Not only were the vaccines completely ineffective against COVID-19, but they also came with significant safety issues, meaning every person vaccinated degraded their health. Now, the health authorities, MDs, and establishment media deny the many health complications caused by vaccines.

This site covers what people can do to mitigate the damage caused by vaccines in their bodies.

Addressing the Damage

One of the best ways to address the damage caused by the covid vaccines is with Ivermectin. This is the reason I began taking Ivermectin -- before investigating all the other health benefits of the drug. Now, I take Ivermectin for many reasons.

• We have Ivermectin dosage calculators based on research studies and for all the different uses of Ivermectin.
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• We also cover the broader problems with dosage calculation in medicine at the article The Problem With Dosage Calculation in Medicine, as this is an issue much larger than for one drug. 

About Our Ivermecting Testing Program and Recommended Ivermectin Source of Supply

• We performed pharmaceutical testing on Ivermectin to find a lower-cost version that also matched Merck's original Ivermectin in bioequivalence.
• You can read about the details of our Ivermectin testing in this article, Our Ivermectin Bioequivalence Testing.
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