Latest News – 17 April 2025

Quick Links – Answers to most Frequently Asked Questions

Reporting Suspected Adverse Events for Signal Detection

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

Where can I find information and data on vaccine and medicinal product side effects?

Recognition of Vaccine Damage Handled Exclusively by the Federal States' Social Service Departments

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 Service Department (Landesversorgungsamt) 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.

Vaccination Advice and Recommendations

The Paul-Ehrlich-Institut cannot provide vaccination advice to individuals because it is not a clinical institution. Many factors can influence medical advice and these can only be adequately taken into account through personal contact between the patient and their attending physician. If you have any questions about your individual case, please contact your doctor.

Vaccination recommendations are issued exclusively by the Standing Committee on Vaccination (STIKO) at the Robert Koch-Institut (RKI). The current STIKO recommendations incl. vaccination calendar and additional information organised by infectious disease can be found on the RKI website.

Information from the Robert Koch-Institut on immunisation

Vaccination Advisory Services for Doctors

The Paul-Ehrlich-Institut cannot provide individual vaccination advice because it is not a clinical institution.

 Doctors who have questions about the use of vaccines in individual vaccination cases – such as pre-existing conditions or risk groups – can contact the Immunization Unit at the Robert Koch-Institut (RKI) directly. Telephone consultations (for doctors only) are offered on Thursdays from 12:00 – 14:00; Tel. (030) 18 754 - 35 39.

The Permanent Working Group of Competence and Treatment Centres for high consequence infectious diseases (STAKOB), based at the RKI, offers individual infectiological advice for doctors in cooperation with the German Society for Infectious Diseases (DGI).

Infectiology Advice Network for Physicians – An offer from STAKOB and DGI (German only)

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:

1. 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.
2. 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

3. 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

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:

• FAQ - Frequently asked questions
• Coronavirus dossier
• Vaccine delivery bottlenecks
• Vaccines and biomedicines

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.

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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

Public

Topic	Email
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
Complaints centre in accordance with the section 13 of the General Act on Equal Treatment (Allgemeines Gleichbehandlungsgesetz, AGG)	AGG-Beschwerdestelle@pei.de

Veterinary Medicine

Topic	Email
Requests from the Public and Veterinary Professionals For individual vaccination advice, please contact your treating veterinarian.	veterinaermedizin@pei.de

Regulatory Questions

Topic	Email
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

Topic	Email
Pharmacovigilance Fax: +49 6103 77 1263	pharmakovigilanz@pei.de
Haemovigilance / Tissue Vigilance Phone: +49 6103 77 0 Fax: +49 6103 77 1268	biovigilance@pei.de
IVD-Vigilance Phone: +49 6103 77 0 Fax: +49 6103 77 1268	biovigilance@pei.de
ATMP-Vigilance Phone: +49 6103 77 0 Fax: +49 6103 77 1268	biovigilance@pei.de
Pharmacovigilance (Veterinary) Phone: +49 6103 77 0 Fax: +49 6103 77 1279	vetmittelsicherheit@pei.de

Research

Topic	Email
Research Officer	forschungsbeauftragter@pei.de

Whistleblower Protection Act

Topic	Website
Reporting centre for employees of the Paul-Ehrlich-Institut for information in accordance with the Whistleblower Protection Act (HinSchG)	pei.hinweis-portal.eu

Online Access Act – Information on the Objection Portal

In accordance with Section 1a of the Online Access Act (Onlinezugangsgesetz, OZG), the federal and state governments are obliged to offer their administrative services electronically via administrative portals. This also includes the possibility of lodging an objection to an administrative act via a portal. The two pharmaceutical authorities, the Paul-Ehrlich-Institut (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM), offer a joint portal for this purpose. An objection submitted electronically via the portal must bear a qualified electronic signature due to the legal requirements for the form in accordance with Section 70 Subsection 1 of the Code of Administrative Court Procedure (Verwaltungsgerichtsordnung, VwGO). A corresponding document must be uploaded via the objection portal. The objection portal can be used free of charge and without registration.

Topic	Website
Online Portal for Filing Objections	Link
Special Electronic Legal Mailbox (beA-Portal) for Objections from Authorised Attorneys	Link