Lat­est News - 15.07.2022

Quick Links - Answers to most Frequently Asked Questions

Rapid Tests- SARS-CoV-2 Test Systems

Information on which rapid antigen tests for the direct detection of the SARS-CoV-2 coronavirus will be reimbursable through the GKV going forward
SARS-CoV-2 test systems
Questions and answers about antibody and antigen testing
11 July 2022: Information for Manufacturers and Distributors: COVID-19 Antigen Tests

Please note that we cannot offer any advice or further information on the rapid tests beyond what is offered on our website.

Recognition of vaccination status

The requirements for proof of vaccination are directly regulated in section 22a of the Infection Protection Act (Infektionsschutzgesetz, IfSG) as of 19 March 2022. The requirements for proof of vaccination published at www.pei.de/covid-19-vaccines expired on 19 March 2022.

Section 22a of the Infection Protection Act (IfSG) (unofficial English translation – for information purposes only)
Federal Government - The most important questions and answers about the coronavirus vaccination

For further information, please contact the Federal Ministry of Health.

Vaccination certificates

The Paul-Ehrlich-Institut does not issue vaccination certificates. You can find out what you need to do to obtain a digital vaccination certificate at:
FAQ on Digital Registration on Entry

Recognition of vaccination status for international travel

This is regulated at the federal level.

Federal Government - Information for travellers
Federal Foreign Office - Information on entry restrictions, testing and quarantine regulations in Germany

Reporting of adverse effects after a COVID-19 vaccination

We kindly ask you to report adverse effects online. The Paul-Ehrlich-Institut provides a form for this purpose at https://nebenwirkungen.bund.de (German only). The form is specifically intended for the submission of reports of suspected cases of adverse effects after a vaccination (first, second or booster) with an authorised COVID-19 vaccine. After submitting a report, you will receive a confirmation of receipt and a specific PEI number. This number will not be used to initiate personal contact with the vaccinated person or their relatives. The Paul-Ehrlich-Institut uses suspicious case reports for signal detection— i.e., for identifying possible, previously unknown vaccine risks.

Due to the high number of reports, we are unable to send an acknowledgement of receipt for reports submitted by post or email. We reserve the right to do so for serious adverse reactions for which further clinical information is required.

Safety Reports

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. The most recent report covers the reports up to and including 31 March 2022.

www.pei.de/safety-report

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 Standing Committee on Vaccination at the Robert Koch Institute. The Paul-Ehrlich-Institut is not a clinical institution and therefore cannot offer individual vaccination advice except for information regarding the evaluation of reported suspected cases of side effects.
The COVID-19 vaccination recommendation by STIKO (German only)

Information on vaccine candidats pending approval

The EMA provides information on the status of these procedures at
EMA: COVID-19 vaccines

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.

The Paul-Ehrlich-Institut does not issue vaccination certificates. You can find out what you need to do to obtain a digital vaccination certificate at:
FAQ on Digital Registration on Entry

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.
The COVID-19 vaccination recommendation by STIKO (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:
www.pei.de/covid-19-vaccines

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:
     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.

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.

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

Regulatory Questions

Medicine Safety

Research

Adress

Paul-Ehrlich-Institut
Paul-Ehrlich-Strasse 51-59
63225 Langen
GERMANY