The questions relate to coloring, lipid nanoparticles, and “components not approved for human medicine.”
27 Jan 2022 12:44 pm
Four renowned scientists write a letter to BioNTech founder Uğur Şahin. They want more information from the biotechnology company’s CEO about the Comirnaty® vaccine he is developing. The questions relate, among other things, to the coloring and lipid nanoparticles.
The Berlin newspaper reported in an article from January 26, 2022 about the request of four renowned scientists who have been intensively dealing with the active substance since the approval of the vaccine Comirnaty® from BioNTech. The scientists are Jörg Matysik, Professor of Analytical Chemistry at the University of Leipzig; Gerald Dyker, Professor of Organic Chemistry at the Ruhr University Bochum; Andreas Schnepf, Professor of Inorganic Chemistry at the University of Tübingen and Martin Winkler, Professor of Materials and Process Engineering at the Zurich University of Applied Sciences.
Based on their analyzes and assessments, the four scientists decided to send the BioNTech founder a letter in which they addressed their concerns and the resulting questions to Şahin. The letter is available to the Berliner Zeitung. According to the article, the scientists would not oppose the novel mRNA technology used in the active substance Comirnaty® and would not be closed to its development: “We find the possibility of stabilizing mRNA in such a way that it can be used for vaccinations very exciting . We understand that this biotechnological innovation can open up very important new possibilities in medical practice,” says the statement from the letter that has now become known.
With the mRNA technologist, BioNTech would research, develop and use a very promising but also a very complex technology. This could be used successfully in cancer therapy in the future, but with the vaccine against COVID-19, in her opinion, the situation should be viewed more differentiated. The letter to Şahin is quoted as follows:
“As chemists, we don’t have the impression that this product can currently be used as a mass vaccine.”
Based on this assessment, urgent questions would therefore arise. The first key uncertainty would be information in the summary of the product characteristics, i.e. the information on the package insert for the Comirnaty® product. The original leaflet contains the note: “The vaccine is a white to off-white dispersion”. The four scientists asked the formulated question in the letter to the BioNTech director:
“How does this significant color difference come about; almost all substances used are colorless, so white would be expected. Where does the gray tone come from? Are these impurities?”
Andreas Schnepf, who works at the University of Tübingen, explains the reasons for the question in the article in the Berliner Zeitung:
“It’s possible that a pill, a liquid or a dispersion is colored. But the color grey, i.e. a ‘diluted black’, hardly ever arises in a process that would have been expected. We have to know whether it’s about It’s a contamination. A pill that isn’t white suggests something went wrong. We need clarification on this from BioNTech.”
Schnepf and another author of the letter, Jörg Matysik, also explained in the article that they are aware of the great difficulties of quality control in mRNA technology. The scientists are therefore “very interested” in hearing from BioNTech which methods of quality assurance the company would use: “We have discussed with colleagues and so far have not been able to find any starting points on how to improve the quality of mRNA technology for such a large volume of a product.” The next question to Şahin is therefore in the original letter:
“How is a consistent product quality ensured, or how can you ensure that and to what extent the mRNA to be packaged is present in the lipid nanoparticles? How is the concentration of mRNA active substance in the individual batches controlled and how the concentration of Active ingredient in the lipid nanoparticles in relation to that outside the particles?”
The four scientists also deal with the problem of the physical degradation of components and substances that are processed, used and contained in the vaccine active ingredient. These included the “components ALC-0159 and ALC 0315”, which in turn are required for the formation of lipid nanoparticles, an essential component of mRNA technology. in one safety data sheet Regarding ALC-0315, it can be read “that ALC-0315 irritates both the eyes and the skin or mucous membranes”. Professor Schnepf sees a problem in this respect: “If it can irritate the eyes or the skin, how does it relate to the tissue from? We need clarity here,” said the scientist, according to the Berliner Zeitung. Another question from the letter in the original quote:
“Are there currently ongoing or planned studies to localize the whereabouts of the substances, which are only used as additives, after use? Are there further planned or ongoing studies to determine the toxicological effects of the substances or their biological degradation products?”
The letter also addresses the issue of potential side effects. The four authors are concerned because there are “apparently different side effects with different batch numbers”. The researchers believe it is possible that the high production pressure could lead to different results in individual batches, which, however, is “not tolerable”, says Professor Schnepf and comments: “It really shouldn’t be, because all cans have to contain the same thing being.” The question to Şahin in the cover letter reads:
“How can this circumstance be explained and what distinguishes these batches from the others, and are efforts being made to examine this important aspect more closely, especially with regard to quality assurance? Are there or are planned clinical studies to investigate the side effects and their investigate causes and increase the safety of the new COVID vaccines?”
Finally, the Berliner Zeitung quotes from the letter: “Some side effects occur quickly after vaccination, and much faster than one would expect if this were linked to the formation of the spike protein. A toxic or allergic reaction would be more likely here Question what could be narrowed down by further investigations into the ingredients.” The question is therefore: “whether such investigations are ongoing or planned”:
“All in all, you have to focus much more on the problem of side effects and also involve doctors, who have to advise the patients, in this discussion.”
According to the Berliner Zeitung, Professor Schnepf’s assessment of the subject of compulsory vaccination is as follows: “For a law on compulsory vaccination, the Bundestag, but also every individual who is vaccinated, needs a sound basis of knowledge in order to make an informed, personal decision With the information currently available from BioNTech, this data basis is not yet available with regard to the COVID-19 vaccines.”
In addition to the letter from the four scientists in the Berliner Zeitung and their concerns and questions about the novel mRNA technology, the reference to an article by SWR from November 19, 2019 that sheds light on the topic of new vaccine technologies. In the article, in which Uğur Şahin also has a say, it says at the end: “Now the new vaccine is being tested in clinical studies on humans. The scientists hope for approval in five to six years”.