The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines

in the public interest. I have concerns about vaccines for profit.

There are schools of thought who believe our population is too big. In my view the issue is population and who gets to choose who lives who dies?

Paul Ralph Ehrlich (born May 29, 1932) is an American biologist, best known for his warnings about the consequences of population growth and limited resources.[2][3] He is the Bing Professor of Population Studies of the Department of Biology of Stanford University and president of Stanford’s Center for Conservation Biology.

Ehrlich became well known for his controversial 1968 book The Population Bomb, in which he famously stated that “[i]n the 1970s hundreds of millions of people will starve to death in spite of any crash programs embarked upon now.”[4][5] Among the solutions he suggested in that book was population control, including “various forms of coercion” such as eliminating “tax benefits for having additional children,”[6] to be used if voluntary methods were to fail. Ehrlich has been criticized for his opinions; for example, Ronald Bailey termed Ehrlich an “irrepressible doomster”.[7] Ehrlich has acknowledged that some of what he predicted has not occurred, but maintains that his predictions about disease and climate change were essentially correct and that human overpopulation is a major problem.[8

Wel­come

The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.

Entrance of the institute with head of Paul Ehrlich (Source: Morgenroth/Paul-Ehrlich-Institut)

Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute.

The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states (Länder)), and internationally (World Health Organisation, European Medicines Agency, European Commission, Council of Europe etc.).

Updated: 21.11.2019

(Prophylactic) vaccines are medicines that activate the immune system for the protection from infectious diseases.

Vaccines for Human (Source: Witthaya Prasongsin/Cultura/Getty Images)

In Germany, the Paul-Ehrlich-Institut (PEI) is responsible for vaccines and monitors their quality, efficacy, and safety.

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Coro­n­avirus SARS-CoV-2

Fundamental research, testing and research of viral vaccines, safety of biomedicines – these are tasks of the experts at the Paul-Ehrlich-Institut. In this section on the novel coronavirus Sars-CoV-2, you will find an overview of the facts and answers to questions on vaccine development against the virus.

Coronavirus Illustration (SARS-CoV-2) (Source: CDC/Alissa Eckert, MS; Dan Higgins, MAMS)

NEW | Audio Podcast of the German Federal Government on Vaccine Development with Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut, from 05.05.2020 (German only)

Coronavirus - Federal Government Podcast - Professor Klaus Cichutek on the progress in vaccines (Source: Bundespresseamt)

Coronavirus – Federal Government Podcast

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Professor Klaus Cichutek explains – Coronavirus vaccine

Professor Klaus Cichutek explains

Coronavirus vaccine (German only) (Source: Federal Ministry of Health)Video Player

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Professor Klaus Cichutek explains why a vaccine for combating the coronavirus is so urgently needed and how vaccine development works.

Press Briefing: Authorisation of the first clinical trial of a COVID-19 vaccine

Recording Press Briefing

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Recording Press Briefing

Part 2: Questions and Answers (German only)Video Player

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Alternative links (Youtube)
Recording Press Briefing 22 April 2020 – Part 1 (German only)
Recording Press Briefing 22 April 2020 – Part 2 (German only)Presentation | Prof. Dr. Klaus Cichutek, Paul-Ehrlich-Institut – Authorisation of the first clinical trial from the perspective of the regulator (22 April 2020)FAQ | Paul-Ehrlich-Institut Press Briefing (22 April 2020)Presentation | Professor Dr Ugur Sahin – BioNTech – BNT162 COVID-19 Vaccines: Development Programme (22 April 2020)

Where can I get information about a participation in the clinical trial of the COVID-19 vaccine?

In Germany, the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, authorises clinical trials of vaccines and approves the trials if the data situation is positive. The Paul-Ehrlich-Institut is not involved in the recruitment of study participants. This is the responsibility of the respective applicant, who has the relevant information (e.g. place of performance).

Audio Podcast of the Ärzte Zeitung on Vaccine Development with Professor Klaus Cichutek, President of the Paul-Ehrlich-Institut, from 17.03.2020 (German only)

Coronavirus

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The use of quotations / excerpts from this podcast is only possible with the approval of the Ärzte Zeitung.

Expert Video – In conversation with the virologist Professor Eberhard Hildt

Coronavirus

Expert Video with Professor Dr Eberhard Hildt, Virologist (in German)Video Player

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Background Information about the Novel Coronavirus – Facts and Figures

Download (As of: 06.03.2020)

Coronavirus and Safety of Biomedicines

How safe are blood, blood products and stem cell preparations in the context of SARS-CoV-2?

Based on experience with other coronavirus infections (SARS and MERS) and other viruses that lead to respiratory infections, the risk of transfusion-related transmission of SARS-CoV-2 is considered to be unfounded based on current knowledge. An examination of infected people with and without symptoms confirms this assessment. At the same time, if SARS-CoV-2 continues to spread, there is a risk of a shortage of blood components unless sufficient blood continues to be donated.

The haemotherapy directive, which defines the donor selection criteria, routinely stipulates the measurement of body temperature and an infection-related questioning of those who are willing to donate in order to exclude persons with febrile illnesses from blood donation. Therefore, people with symptoms of infection, even if they are minor, will in any case be deferred from donating blood.

Due to the current situation worldwide, the Paul-Ehrlich-Institut is cancelling the recommendation of 10th February 10th 2020, to defer especially returning travelers from China to donate blood, plasma or stem cells. The deferral periods due to other infectious agents such as malaria, chikungunya and WNV remain unchanged. In addition, the recommended deferral periods for SARS-CoV-2 at this time will be adapted according to the current state of knowledge. This means that people willing to donate are deferred for at least 4 weeks after complete recovery for their own protection in accordance with the requirements of the haemotherapy directive.

Persons with a direct contact to SARS-CoV-2 infected as well as to COVID-19 sufferers will be deferred for at least 2 weeks after the last contact. This recommendation is in line with the recommendations of the ECDC for donor selection and with the recommendation of the Robert Koch Institute (RKI) on home quarantine after contact with a COVID-19 patient.

Exceptions for medical personnel can be made under the responsibility of donor doctors. The donor selection criteria mentioned ensure that blood, plasma and stem cell products of high quality can be obtained.

In order to enable the supply of a sufficient amount of blood components even during the current SARS-CoV-2 pandemic, the PEI expressly points out that people willing to donate who had no contact with SARS-CoV-2 people and with no flu-like symptoms (fever, cough, difficulty breathing) should continue to donate blood.

As part of its responsibility, the Paul-Ehrlich-Institut is available to answer questions regarding safety issues as well as measures to ensure supply of blood, plasma and stem cell products.

The Paul-Ehrlich-Institut will inform the blood donation facilities and the public as soon as new findings regarding the SARS-CoV-2 endemic and blood safety are available.

How safe are tissue preparations in the context of SARS-CoV-2?

A transmission of respiratory viruses by implantation, transplantation, infusion or transfer of human cells or tissues has not yet been described. The potential for transmission of SARS-CoV-2 through tissue preparations is currently unknown.

No cases of transmission of SARS-CoV-2 via tissue preparations have been reported.

Clinical signs of infection in tissue donors are already being recorded as part of routine screening measures.

In principle, the eligibility for donation is assessed by a doctor (section 3 (1) and section 3 (2) TPG). Specific adjustments to donor screening and the donor eligibility-assessment process, including clinical evaluation and decision-making in specific cases, are at the discretion of the tissue establishment.

As there is currently no evidence that SARS-CoV-2 can be transmitted through the transplantation of tissue preparations, the PEI proposes the following precautionary measures:

  1. Exclusion of potential tissue donors upon contact with people with confirmed SARS-CoV-2 infection within 14 days before the donation
  2. Exclusion of potential tissue donors with confirmed SARS-CoV-2 infection within 14 days after completion of the recovery.

Contrary to the updated recommendations of the ECDC on donor selection from April 29, 2020, the recommendations of the PEI remain unchanged.

An obligatory screening test of deceased donors of tissue where no validated pathogen reduction method for enveloped viruses is used is currently not recommended due to the data available, analogous to the procedure for donating blood.
Tissue establishments can establish donor screening at any time that goes beyond the recommendations of the PEI.

Tissue preparations that undergo a validated pathogen reduction process for enveloped viruses are not affected by these precautionary risk-minimizing measures.

Further information on SARS-CoV-2 in relation to blood, blood products and stem cell preparations can be found in the publication by Corman et al, “SARS-CoV-2 asymptomatic and symptomatic patients and risk for transfusion transmission”. The Paul Ehrlich Institute press release “No virus detection in the blood of asymptomatic SARS-CoV-2 patients” and the SARS-Coronavirus 2 Announcement of the National Advisory Committee Blood (AK Blut) provides details on this.

The PEI continues to monitor the situation and will post updates as new information becomes available.

Updated: 14.05.2020