Latest News – 12 September 2024
Latest News – 12 September 2024
Quick Links – Answers to most Frequently Asked Questions
Reporting Suspected Cases of Adverse Events
In the interest of monitoring the safety of vaccines and biomedicines, we ask you to report suspected cases of adverse events online. The Paul-Ehrlich-Institut provides a form for this purpose at www.nebenwirkungen.bund.de. After submitting a report, you will receive a confirmation of receipt and a specific PEI number. However, this number is not used for personal contact with the vaccinated person or their relatives.
The Paul-Ehrlich-Institut requires suspected case reports for signal detection – i.e. for identifying possible, previously unknown vaccine risks. The Paul-Ehrlich-Institut cannot offer individual vaccination advice, as it is not a clinical institution. If you suspect you have experienced an adverse event or vaccination complication, please contact your attending physician for clarification and treatment.
Online Reporting of Side Effects (German only)
Explanatory Videos: How the Safety of Medicinal Products Is Monitored – The Spontaneous Reporting System
Data on suspected Adverse Drug Reactions
Responsibilities for the Recognition of Vaccine Damage
According to section 24 of the Social Code (Sozialgesetzbuch, SGB) XIV, vaccination damage is understood to mean damage to one's health that exceeds the usual extent of a vaccination reaction. Section 5 of the SGB XIV regulates the degrees of damage and stipulates that temporary health conditions lasting up to six months are not to be considered as damage.
If a vaccinated person or their relatives suspect that they have suffered vaccination damage after a publicly recommended vaccination, they can submit an application for relief under the Federal War Victims Relief Act (Bundesversorgungsgesetz) in accordance with section 24 of the Social Code (SGB) XIV in conjunction with section 4 of the Social Code XIV. The application for compensation must be submitted to the Social Welfare Office in the federal state in whose territory the vaccination was carried out in accordance with section 113 subsection 5 of the SGB XIV. The Paul-Ehrlich-Institut is not responsible for processing recognition procedures for vaccination damages.
Reporting the suspicion of a vaccine side effect or vaccine complication within the meaning of section 6 of the Infection Protection Act (Infektionsschutzgesetz, IfSG) – i.e. the suspicion of damage beyond the usual extent of a vaccination reaction – to the Paul-Ehrlich-Institut does not constitute an application for recognition of vaccine damage. Submitting a report is separate from the application and serves to detect early indications of possible signals of serious side effects in order to initiate any necessary risk prevention measures.
Access to Infectious Disease Advice and Information for Doctors
The STAKOB (Permanent Working Group of Competence and Treatment Centres for high consequence infectious diseases), based at the RKI, offers individual infectiological advice for doctors in cooperation with the DGI (German Society for Infectious Diseases).
Infectiology Advice Network for Physicians – An offer from STAKOB and DGI (German only)
How we process your enquiry?
How we process your enquiry?
anfragen@pei.de: This is the email address for health care professionals and individuals who wish to communicate with the Paul-Ehrlich-Institut.
Please send your enquiry either by a direct email or by using our contact form. Before sending an enquiry, please kindly check our website to find out whether it contains extensive information to answer your question.
( www.pei.de/faq-en, www.pei.de/coronavirus).
We may not be able to answer all email personally, since we are currently receiving a very high number of enquiries. For this reason, we are processing received emails using a special procedure to meet the currently extremely high amount of information needed by the health care professionals and the public to our best possible knowledge and ability:
- FAQ
We view all incoming emails to check whether we already provide information on our website. If not, we will answer your enquiry personally. We will either send the answer to you directly or extend our information content on our website as soon as possible.
www.pei.de/faq-en
As a matter of course, we will answer urgent questions within the responsibility of the Paul-Ehrlich-Institut with priority. - Quick links
You can use our so-called quick links to obtain quick access to the most frequently asked questions. The information contained on this link is updated by us regularly.
www.pei.de/quick-links-enquiries Focusing on tasks
Please understand that we will be unable to provide personal answers to questions, as a standard procedure, if they are NOT within the direct sphere of responsibility of the Paul-Ehrlich-Institut.
These include:
- Vaccination recommendations
In Germany, the organisation which makes recommendations on vaccinations is the Standing Vaccination Committee (Ständige Impfkommission, STIKO) at the Robert Koch-Institut. The STIKO extensively justifies its recommendations and provides them online:
Vaccination recommendation by STIKO
- Personal vaccination advice for citizens
The Paul-Ehrlich-Institut is not a medical facility. Thus, we are unable to provide advice on vaccinations which goes beyond the assessment of reported suspected cases of adverse effects. If you require personalised advice on vaccinations, please always consult your treating doctor. - Recommendations on diagnoses and treatments
Many factors are important for medical advice and a diagnosis. These can only be taken into account appropriately through personal contact between the patient and the doctor. For this reason, please seek advice from your treating doctor with regard to such questions. Please also refrain from sending us your personal patient data.
Sphere of responsibility of the Paul-Ehrlich-Institut related to vaccinations with COVID-19 vaccines
In its role as the Federal Institute for Vaccines and Biomedicines, the Paul-Ehrlich-Institut is responsible for the authorisation of clinical trials in Germany as well as pharmacovigilance – the documentation and assessment of possible adverse effects of COVID-19 vaccines, including those recorded during the post-marketing authorisation period. We actively contribute to the marketing authorisation of vaccines at a European level in the various bodies of the European Medicines Agency (EMA). In addition, we provide medicines developers with advice on regulatory affairs (scientific advice) and perform official batch release tests on COVID-19 vaccines.
Contact
Contact
Due to the coronavirus pandemic, the volume of requests has multiplied, so that we can only answer requests to a limited extent. In order to still serve as many request as possible, we are continuously expanding our range of information on the website. Please therefore check whether we have already prepared an answer on our website for your individual request:
Thank you for your understanding!
Important Note - Requests for medical (vaccination) advice
The Paul Ehrlich Institut is not a clinical institution and therefore cannot offer individual vaccination advice, except information regarding the evaluation of reported suspected cases of side effects.
Also, recommendations for diagnosis and therapy are not possible, because many factors are important for appropriate medical advice, which can only be adequately considered in the personal contact between doctor and patient.
Please contact your attending physician with these questions.
PEI Headquarter
PEI Headquarter
Paul-Ehrlich-Institut
Federal Institute for Vaccines and Biomedicines
Paul-Ehrlich-Str. 51-59
63225 Langen
GERMANY
Phone: +49 6103 77 0
Email: pei@pei.de
Contact Persons
Contact Persons
Public
Topic | Email |
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Hotline for Public and Healthcare Professionals
Monday and Thursday: 2 p.m. to 3 p.m.
Phone: +49 6103 77 2222
The hotline does not offer individual vaccination advice, please contact your treating doctor. | anfragen@pei.de |
Requests for the Freedom of Information Act | ifg@pei.de |
Press Office
For journalists only | presse@pei.de |
Job Opportunities / Career | bewerbungen@pei.de |
Contact Point Clinical Trials
For people involved in a clinical trial, their legal representative or one of their authorised representatives, pursuant to section 40 sub-section 5 AMG
Phone: +49 6103 77 1810
Fax: +49 6103 77 1277 | ct@pei.de |
German Haemophilia Registry
Phone: +49 6103 77 1860 | dhr@pei.de |
Biology Association | biologischer-verein@pei.de |
Representative of severely disabled persons
Christoph Stärk
Phone: +49 6103 77 1841 | schwerbehindertenvertretung@pei.de |
Veterinary Medicine
Topic | Email |
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Requests from the Public and Veterinary Professionals
For individual vaccination advice, please contact your treating veterinarian. | veterinaermedizin@pei.de |
Regulatory Questions
Topic | Email |
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Innovation Office / Advice for Pharmaceutical Companies | innovation@pei.de |
Reference Material
Order of reference material | refmat@pei.de |
Central Office Preimplantation Genetic Diagnosis
Phone: +49 6103 4411 | zpid@pei.de |
eSubmission
Contact for inquiries on technical aspects of submissions | eSubmission@pei.de |
Medicine Safety
Research
Whistleblower Protection Act
Topic | Email |
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Reporting centre for employees of the Paul-Ehrlich-Institut for information in accordance with the Whistleblower Protection Act (HinSchG)
| pei.hinweis-portal.eu |
Adress
Paul-Ehrlich-Institut
Paul-Ehrlich-Strasse 51-59
63225 Langen
GERMANY