As reported by the Berliner Zeitung, five professors of chemistry and physics from German universities have released an open letter directed at the German control authority at the Paul-Ehrlich-Institut (PEI), expressing doubts about the quality control of the German COVID vaccine. After previously engaging in a fruitless exchange with the pharmaceutical company BioNTech, in which the chemists had formulated a series of questions regarding their vaccine, they have now made their concerns public.
While the authors of the open letter stress that they are convinced that “mRNA-based medications open a new and very promising avenue for treating cancer,” they argue that such medications should only be used “when their advantages are proven to outweigh their disadvantages based on valid and sufficiently extensive studies.”
Specifically with regards to BioNTech’s vaccine Comirnaty, the authors express “significant concerns” over some of the vaccine’s handling protocols. It is discouraged, for example, to shake the medication after the prescribed dilution, after which it may only be used within six hours. For them, this indicates a “rather immature formula of the medication.”
Prior to their open letter, the professors had formulated questions to BioNTech twice; both attempts went unanswered. Only recently, through a belated, indirect response printed for public consumption within the pages of the Berliner Zeitung, were the scientists’ concerns acknowledged, albeit still unanswered. In contrast to BioNTech’s circuitous reply, the scientists have received multiple reports by the public of adverse vaccine effects.
Since you, the control authority, have granted the Corona–vaccine another conditional approval, we want to share with you our extraordinarily great concern as colleagues, that this new type of vaccine is potentially NOT advantageous to the health of the German population. This applies even more if it came to a limited or general vaccination mandate in Germany.
Some of the most pressing issues involve the presence of the components ALC–0159 and ALC–0315, which are used to create lipid nanoparticles (LNP). Since there are no “universal standards” for the usage of these components and the widespread use of LNPs in healthy people is new, they consider an “irrefutable proof of safety” to be essential before exposing large parts of a healthy society to this treatment. The authors ask the PEI for a list of studies proving the safety of the LNP dispersions, as well as defining the standards for usage of said lipids in the vaccine by BioNTech.
Peculiar to the ALC–0315 component is its ability to irritate the eyes and mucous membrane and cause cancer. The presence of this component in the vaccine was particularly alarming, since, as the chemists explained, even when they need to handle it in a laboratory, they use protective measures to prevent contact:
We would strongly urge employees in our chemical laboratories to handle this substance under strict observance of appropriate safety measures (e.g. facemask, lab coat, gloves, lab glasses). But now it is being injected directly into the body!
Another issue presented in the open letter pertains to quality control. World-wide cases of impurities in batches of vaccines had been reported, including the observation of black particles found in bottles of the Moderna vaccine in Japan (explained as the products of defective machinery). Because the impurities entered the vaccine during production, the scientists have requested transparent communication regarding production control: of batches, methods, standard operating procedures—the full protocol of quality control measures taken by the PEI.
Also relevant to quality control are issues of the color of the vaccine solution. The official description describes it as being “a white to off-white dispersion,” but when asked why some solutions were gray, and whether the gray color could be due to impurities, BioNTech answered that the vaccine wasn’t gray, but “broken white to cream-white,” a response that “severely misinforms the doctors performing vaccinations,” according to the letter.
The letter reaches beyond the solution and handling of the vaccine to address the numerous, unaccounted for adverse effects reports. The scientists have asked whether any research into the source of these side effects is being made in light of the “growing number of reports” claiming that side effects might be correlated to low-quality batches of vaccines. They also condemn the now common practice of physicians who are “reluctant to report negative side effects of the vaccine.”
The letter appeared in the Berliner Zeitung on February 16th and has not been answered by the time of the writing of this article.