Scientists: BioNTech’s responses on vaccine consistency and quality are unsatisfactory

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Four renownedscientist posed questions to BioNTech founder Uğur Şahin in an open letter dated January 20. Regarding the quality and safety as well as optical irritations of the highly acclaimed and used worldwide COVID-19 vaccine, Comirnaty®. According to an update of berlin newspaper However, they have yet to receive a direct response. The speakers are: Jörg Matysik, professor of analytical chemistry at the University of Leipzig; Gerald Dyker, professor of organic chemistry at the Ruhr University in 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. In the meantime, Dr. Tobias Unruh, professor of condensed matter physics at the Friedrich-Alexander-University of Erlangen-Nuremberg.

The critical quintet now receives partial answers, which however prove to be unsatisfactory. And still she had berlin newspaper the Ability and permission to document correspondence, including most recent dynamics. According to the report, responses from BioNTech’s press office led to further inquiries.

As of January 28, the company answered a number of questions berlin newspaper received after they forwarded the scientists’ letter to BioNTech’s press office. Three questions were answered by a company spokesperson and in the berlin newspaper published. In this article, scientists now react to these answers.

Regarding the issue of the existing gray discoloration of the dispersion, as a possibility of contamination of the vaccine, an assessment was requested as to whether there was a possible purity issue. The company replied:

“No. The perception of a color of the vaccine is described in the leaflet and is not an indication of possible contamination. The term “white to off-white dispersion” is a “technical term” used in the description of the products pharmaceuticals. In English, it is ‘white to off-white’. In German, this corresponds more to the term “off-white” or “creamy white” – and less to “grey”. Products containing nanoparticles are generally characterized by this property.

Turbidity would not affect the quality of the vaccine. On the contrary, “it comes only from the scattering of light on the lipid nanoparticles”. This was followed by a comparison with milk turbidity:

“A comparable effect also leads to the white color of the milk. Here, the impression of white milk is created by the scattering and reflection of light by fat globules in the surface layer.

However, the five scientists are not satisfied with the content and wording of the answer. For them, the information that can be found in the German-language supplement (“white to off-white”) remains “misleading” and “useless”. It is therefore still not understood if “the color is uniform, or if there are different shades between ‘white’ and ‘creamy white’, depending on the batch”. Referring to the comparative example with milk, the five scientists say:

“Modifies the particle size distribution of the dispersion (…) it would probably also change the color impression. Therefore, we assume that the BioNTech company would not recommend that doctors use a vaccine with a grayish tint. Certainly none of us would recommend drinking milk with a grayish tint either.

Asked about the procedure and the quality control of the mRNA method used, the company BioNTech replied that “the association of lipid nanoparticles and mRNA” had been “studied for several decades and documented in a large number of publications”. As proof, the reply refers to the publication “Reviews: Lipid nanoparticles for mRNA delivery” by Hou et al. (2021) in the Scientific Review Nature. Additionally, BioNTech writes:

“The quality of each batch is thoroughly tested by the manufacturer and, independently of it, also by the responsible federal authority. In Germany, it is the Paul Ehrlich Institute. The claim that the vaccine components are “not approved for direct use on or in the human body” has already been identified as misleading information in recent weeks.

The materials used in the vaccine are manufactured and tested according to the applicable quality requirements. “They are approved for use on or in humans as part of our COVID-19 vaccine,” BioNTech said.

In their reaction, however, the five scientists point out that “the use of mRNA as an active substance as well as the use of LNP dispersions as drug transport systems ‘has so far only been used in’ cancer therapy and the treatment of other serious illnesses”. and symptoms”. In the case of “less serious diseases”, however, the usage situation seems different, so that “side effects must continue to be considered more closely”. About the composition of the vaccine and the use of additives, the scientists write in the publication of their reaction:

“With respect to additives ALC-0159 and ALC-0315, the approval authority EMA has issued special obligations (specific obligations) as part of the conditional approval of the COVID-19 vaccine. These are also required when the request for an annual extension (Procedure No: EMEA /H/C/005735/R/0046) of conditional approval is still described as pending Why have these requirements not been met so far? now and what is the current status of the studies on these important requirements, which also include the additives ALC-0159 and ALC-0315?”

The third question BioNTech answered was that the professors wanted to know how the phenomenon of different side effects in different batches might occur. The question was:

“Are there any findings or have you done any studies on this?”

The company has made it clear that “no lot-specific reports of side effects are known at this time.” On the contrary, BioNTech regretted that “this claim was published without citing the source”. The pharmaceutical company in turn asked where this information came from. The reaction of the scientists was:

“We find this answer a little irritating. We got our information from the “How bad is my batch” website, which as noted here is based on data from the VAERS database. There is some accumulation of side effects with certain lot numbers. We just wanted to know if the data listed there is valid and if similar data is also collected by BioNTech in the context of pharmacovigilance according to batch numbers.

The data requested were therefore “collected as part of the ongoing clinical study III, in particular for the side effects already known, such as myocarditis. This side effect is also listed in the package insert,” according to the reaction in the article. Berlin newspaper. This in turn raises the following questions for scientists:

“Is this data also collected for Germany? Are there also batches here in which side effects occur more or less frequently? What investigations into the causes of the side effects are underway or planned? »

They would therefore appreciate if there was the possibility to have an overview or “access to the list of test parameters, including authorized deviations”. In addition, ask yourself the following questions:

“It would also be interesting to know how the additional quality control is carried out by the independent and officially controlled test laboratory and which test parameters are validated here. Are the 12 parameters of the test at the level of the active substance (mRNA) also validated by an independent control?

The final summary summarizes that the responses submitted by BioNTech so far raise more questions than they answer. “Urgent questions about the side effects of vaccines and their causes still remain unanswered,” laments the spokesperson. The five scientists also complain:

“Also, BioNTech has not yet answered our question regarding the snapshot (just after side effects of vaccination. Such side effects are certainly not related to the formation of the spike proteins, but are more likely to be attributed to a toxic or allergic reaction. In this regard, further ingredient investigations could be helpful. We therefore ask if such research is underway or planned to improve the safety of new mRNA vaccines.

So your conclusion is:

“In our opinion, critical questions and transparent answers are essential in due diligence, especially in such a case of only conditional approval, which nevertheless affects practically everyone.

An addition to the editorial team berlin newspaper The article reads: “We also sent the questions to the Paul Ehrlich Institute on January 26, but received no response from them by the evening of Monday February 1, other than an acknowledgment of automated receipt of our request.”

More on the subject – Thousands of damage caused by the corona vaccine in American soldiers? Doctors analyzed the Pentagon’s health database

Information:

The safety and effectiveness of corona vaccines are controversial issues. Many scientific, political and media experts consider them safe and effective because they largely prevent the risk of serious COVID-19 disease and the benefits of a corona vaccination outweigh the risks and side effects. The long-term side effects of vaccinations are generally not known. Risks such as the ADE (antibody-dependent enhancement) effect have so far not been observed with vaccine doses administered billions of times worldwide. Experts also rule out the possibility that gene sequences from mRNA vaccines, for example, are incorporated into human DNA. Statements from the World Health Organization (WHO) and the German Standing Committee on Immunization (STIKO) at the Robert Koch Institute (RKI) can be read here and here.

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