Latest News - 09.11.2021
Quick Links - Answers to most Frequently Asked Questions
Reporting of adverse effects after a COVID-19 vaccination
The Paul-Ehrlich-Institut provides a form (https://nebenwirkungen.bund.de, German only), which can be used in particular to report the suspected cases of adverse effects after a vaccination with an authorised COVID-19 vaccine. On receipt of the report, the Paul-Ehrlich-Institut automatically assigns a specific PEI number. However, this number is not used for personal contact with the vaccinated person or their relatives.
The Paul-Ehrlich-Institut needs suspicious case reports for signal detection - i.e. for identifying possible, previously unknown risks from a vaccine. The Paul-Ehrlich-Institut cannot and must not offer individual counselling, as it is not a clinical institution. Therefore, if you suspect a vaccine side effect or complication, please always contact your medical doctor for clarification and treatment.
Information on the third vaccination or booster vaccination
The group of people for whom a booster vaccination is recommended is derived from the vaccination recommendations of the STIKO, the permanent vaccination commission at the Robert Koch Institute. 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.
STIKO on booster vaccination (German only)
Report of side effecta of a third vaccination
It is possible to report side effects after a third vaccination against COVID 19 on the website https://nebenwirkungen.bund.de
The SafeVac app is currently being adapted. Here, this reporting will be possible retroactively.
In Germany, the Paul-Ehrlich-Institut is the authority responsible for monitoring the safety of vaccines and biomedicines. For this purpose, the institute’s Division Pharmacovigilance collects and reviews reports on adverse drug effects and takes the necessary steps if required. Our current safety report has been available since 26 October 2021.
Reports on suspected cases of adverse effects and vaccination complications following a vaccination for the protection against COVID-19 (reporting period 27 December 2020 to 30 September 2021) (German only)
Recognition of vaccination status
On behalf of the German Federal Ministry of Health (Bundesgesundheitsministerium, BMG), the Paul-Ehrlich-Institut publishes at www.pei.de/impfstoffe/covid-19 – in accordance with the COVID-19 Protective Measures Exemption Directive (SchAusnahmV) and the Directive on Coronavirus Entry Regulations (CoronaEinreiseV) – a tabular overview of the vaccines that are recognised for the proof of COVID-19 vaccination protection upon entry into and within Germany.
Recognition of vaccination status for international travel is regulated at the federal level. For current information on foreign travel in light of the coronavirus pandemic, please visit the website of the German Federal Foreign Office:
Federal Foreign Office - Information on entry restrictions, testing and quarantine regulations in Germany
Questions on the implementation of the vaccination
Questions about vaccination interval, possible vaccination schedules etc. are not the responsibility of the Paul-Ehrlich-Institut. Here the Robert Koch Institute (RKI) offers answers:
RKI - COVID-19 and vaccination: Answers to frequently asked questions (FAQ) - German only
COVID-19 Information at the Robert Koch Institute, RKI
Vaccination recommendations are issued by the Standing Commission on Vaccination (STIKO) at the Robert Koch Institute.
- STIKO decision the 12th update of the COVID-19 vaccination recommendation (as of 18 October 2021) (German only)
Vaccination despite pre-existing condidtions or side effects
Please discuss with your vaccinating doctor whether or not a second or third vaccination would be possible after an adverse event.
Vaccinations for patients with allergies
We provide a flow diagram to support your decision on whether you can receive a vaccination with an mRNA vaccine despite your allergy.
Flowchart - Procedure in case of positive allergy history before COVID-19 mRNA vaccination
Composition of the COVID-19 vaccines
The composition of the COVID-19 vaccines can be found in the appropriate SPCs and package leaflets. For all COVID-19 vaccines authorised in Germany, these can be viewed under this link:
How we process your enquiry?
firstname.lastname@example.org: 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:
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.
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.
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.
- 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:
The COVID-19 vaccination recommendation by STIKO (German only)
- 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.
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.