Four German chemistry professors have sent a list of questions to BioNTech founder Ugur Sahin. They are concerned about a possibility of defective products.
The four 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; Martin Winkler, Professor Materials and Process Engineering at the Zurich University of Applied Sciences.
The professors sent a letter to Sahin, seen by the Berliner Zeitung. “We find the possibility of stabilising mRNA so that it can be used for vaccinations very exciting. We understand that this biotechnological innovation can open up very significant new possibilities in medical practice.”
They are “interested in both general public health and a successful chemical and pharmaceutical industry”, the professors said. But Matysik explained in an interview with the Berliner Zeitung: “As chemists, we don’t have the impression that this product can be used as a mass vaccine at the moment.”
A central question facing the researchers at BioNTech arises from an observation that there is something strange in the vials: “The vaccine is a white to grey-white dispersion. How does this significant colour difference come about; virtually all the substances used are colourless, so white would be expected. Where does the shade of grey come from? Are these impurities?”
Andreas Schnepf explained the problem: “It may well be that a pill, a liquid or a dispersion is coloured. But the colour grey, i.e. a ‘diluted black’, is hardly created in a process that would be expected. We need to know if it is an impurity. If a pill is not white, there is a suspicion that something has gone wrong. We need clarification from BioNTech on this.”
In their letter, the professors specifically ask: “How is a uniform product quality ensured, or rather how can you ensure that the mRNA to be packaged is present in the lipid nanoparticles and to what extent? How do you continue to control the concentration of mRNA active ingredient in each batch, and how do you control the concentration of active ingredient in the lipid nanoparticles relative to that outside the particles?”
A second issue of concern to the chemists is the “components used in the vaccine that are not approved for human medicine”. This concerns “the components ALC-0159 and ALC 0315 used to form the lipid nanoparticles”, which are “not directly approved for use on or in the human body”. The safety data sheet for ALC-0315 describes “that ALC-0315 irritates both eyes and skin or mucous membranes”. Schnepf sees a problem here: “If it can irritate the eyes or skin, what about the relationship to tissue? Here we need clarity.”
They added: “Are there any further planned or ongoing studies to determine the toxicological effects of the substances or their biological degradation?”
Finally, the scientists are concerned with reports of side effects. They are concerned because there are apparently different side effects with different batch numbers and wanted to know whether “the side effects are correlated with a small number of batch numbers”.
Specifically, they ask in their letter: “How can this circumstance be explained and what distinguishes these batches from the others, and are efforts underway to investigate this important aspect in more detail, especially with regard to quality assurance? Are there or are clinical studies planned to investigate the side effects and their causes as well as to increase the safety of the new Covid vaccines?”