Paul Ehrlich Institute answers chemists

Five chemistry professors asked questions about the nature of BionTech’s Covod-19 vaccine (here) and sent them to the responsible authority, the Paul Ehrlich Institute (PEI) and the company. While the company answered some of the chemists’ questions (here), the PEI initially only sent an acknowledgment of receipt of the email.

The lawyer for the five chemistry professors received a message from the PEI on May 25, 2022, in which the authority informed the professors that they had now asked BionTech to help answer the questions.

Literally, the PEI writes:

“Dear Mrs. Dr. tubular,

We have received your letter of 04/29/22.

We have checked your application again. For the following two questions from your clients, we have started third-party participation in accordance with Section 8 IFG.

1. All details on the method of mRNA concentration determination and distribution in the final dosage form, the tolerance ranges for all quality tests (e.g. particle size, substance concentrations, color, mRNA in vitro expression and mRNA integrity).

2. Please let us know how and which control methods are used to assess the quality of the mRNA, ie how the identity of the mRNA species, the amount of truncated or faulty mRNA compared to the full mRNA is determined.

After feedback from the company and after checking the answer, you will receive a notification from us in which we also comment on your letter.

Kind regards

Paul Ehrlich Institute

Paul-Ehrlich-Str. 51-59

63225 Langen”

The five chemistry professors comment on the answer as follows:

“(1) The company (3 billion profits on 6 billion sales) produces mRNA injections that are paid for by taxpayers. Politicians not only excluded people from public life and imposed access bans on them who decided not to be treated with mRNA-containing drugs. In the field of nursing and in the armed forces, those affected are put under considerable pressure to have the injections administered, under threat of bans on their activities and fines or disciplinary sanctions. Not only are they threatened with losing their jobs and with it possibly the destruction of their economic existence, they also have to put up with the accusation that this behavior represents a refusal to obey orders (Bundeswehr) or an administrative offense (care). Against this background, in our opinion, a possible assertion of confidentiality interests against the public interest in disclosure is incomprehensible and also not justifiable. Here the company must ensure “trust through transparency”.

(2) In the brief reply of April 1, 2022, the PEI always referred to the EMA as “according to Regulation (EC) No. 726/2004, the authority responsible for carrying out the approval procedure.” We note that the short answer from the PEI of May 25, 2022 admits that the PEI has essential documents that can be used for close quality control – as this also corresponds to the legal mandate of the PEI.

(3) Since February 11, 2022, we have applied to the PEI for inspection of documents in accordance with the Freedom of Information Act (IFG § 1 Para. 1 S. 1). Unfortunately, the PEI still does not respond to our justified inquiries about further quality certificates, but only deals with a small part of our application. We regret this lack of transparency and reserve the right to take further steps.”

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