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Frequently asked questions (FAQ)

Frequently asked questions (FAQ) (Source: PEI)

Can I receive a vaccination if I am allergic to chicken egg white?

Most vaccines, for example individual vaccines against hepatitis A and hepatitis B as well as combination vaccines for the primary immunisation of infants and young children (against diphtheria, pertussis, tetanus, hepatitis B, polio, haemophilus influenzae type B) do not contain any chicken egg white and do therefore not present any problems for people with egg white allergy.

MMR vaccines (measles, mumps, rubella), MMRV (measles, mumps, rubella, varicella (chickenpox)), yellow fever, tick-borne encephalitis (TBE) and influenza may contain traces of egg white. If you are allergic to chicken egg white, please contact your doctor, who will carry out an individual benefit-risk assessment for you before performing a vaccination, and who can take precautionary measures during a vaccination (for example, follow-up of the vaccinee in the doctor’s office). You will find further information and answers to this question on the web pages of the Robert Koch Institute:

What must be considered when vaccinating persons who are allergic to chicken egg white allergies? (German only)

Where can I find out about the composition of vaccines?

The Paul-Ehrlich-Institut offers a lot of information about vaccination on its website, e.g. a list of all vaccines approved in Germany:

www.pei.de/vaccines.

In the last column of each table, we offer links to the pages on which the so-called technical and usage information is linked. This includes all information e.g. on the use, the contraindications and the composition of vaccines.

What is the difference between an SmPC (Summary of Product Characteristics) and a package leaflet?

The package leaflet is enclosed with the drug packages and contains the most important information and instructions for patients.

The SmPC is specific to physicians and is more detailed. You can find the links to the specialist information on our vaccine list in the last column of the table by following this link:

www.pei.de/vaccines.

Do vaccines contain aluminium?

Vaccines do not contain any pure aluminium, but certain vaccines contain aluminium compounds as an adjuvant.

Attenuated live vaccines do not require an enhancer. These include, for example, vaccines against measles, mumps, rubella and chicken pox (varicella).

Inactivated vaccines, however, such as vaccines against whooping cough, TBE (tick-borne encephalitis), meningococci, tetanus and diphtheria vaccines contain aluminium compounds as enhancers. This is necessary because such vaccines contain only killed pathogens or parts thereof that do not sufficiently stimulate the immune system without an enhancer. Here, the enhancer helps the immune system to build an effective immune protection.

The content of aluminium compounds of all vaccines authorised in Germany and Europe is well below the permitted limit specified in the European Pharmacopoeia.

Every day, every human being absorbs aluminium in the form of a chemical compound from the air, drinking water, and food. In comparison to that, the additional uptake of aluminium compounds via vaccinations in a person's life is minimal.

Do vaccines contain mercury?

Today's vaccines approved in Germany are thiomersal-free, which means they are free from mercury compounds, as they are supplied in pre-filled syringes. The only exceptions are pandemic and prepandemic inactivated influenza vaccines in multi-dose containers. The latter may contain thiomersal, in the form of an organic mercury compound, as a preservative.

For more information about vaccinating and thiomersal, see:

Are mercury compounds of vaccines harmful and dangerous? (German only)

The vaccine was not stored as prescribed. Can I use it anyway, i.e. can I still be vaccinated with it?

The quality, efficacy and safety of a vaccine are only guaranteed if the vaccine has been stored correctly. The respective summary of product characteristics (SmPC) provides information on the required storage conditions, which are documented by extensive studies. You can find the links to the SmPC on our vaccine list in the last column of the table by clicking on this link:

www.pei.de/vaccines.

Why is there a trivalent and a tetravalent vaccine against influenza?

For many years, trivalent (3-fold) influenza vaccines were common. They contained pathogen components (components) of two virus strains of type A and of one virus strain of type B. Since 2016, tetravalent (quadrivalent or quadruple) vaccines are also available. They contain an additional type B virus strain. This provides a broader protection against circulating influenza viruses.

From the 2018/2019 season, the recommendation of the Ständige Impfkommission (STIKO, Standing Vaccination Commission) for tetravalent vaccines applies.

Background: In the last few years it has become apparent that during the flu season both lines of the B-strain circulated to an ever increasing extent. Therefore, the World Health Organization (WHO) recommends two A-type strains and two B-type strains for the composition of strains for influenza vaccines:

Recommended composition of influenza virus vaccines for use in the 2018-2019 northern hemisphere influenza season.

Why can vaccine shortages occur?

The production of vaccines is complex and time consuming. The production of the influenza vaccine takes about six months, the production of combination vaccines with five or six components for primary immunisation of infants and young children up to two years.

Vaccines are complex biomedical drugs. They are based on biological starting material. Before the time the finished vaccine is available, it goes through hundreds of quality checks. If there are problems with the production of a component, for example, if pathogens do not replicate as planned, or if quality requirements are not fulfilled, it is possible that large amounts of vaccine doses will be lost. In that case, delays in delivery may occur.

I need a vaccination, but the vaccine is not available. How do I proceed?

The Paul-Ehrlich-Institut provides an overview of supply shortages of vaccines on its internet pages. Follow this link:

www.pei.de/supply-shortages (German only).

There you can read when certain affected vaccine products are likely to be available again, whether there are alternative vaccines and - if that is not the case - how to get to the advice for action of the Ständige Impfkommission (STIKO, Standing Vaccination Committee) at the Robert Koch Institute (RKI),

I need advice on a vaccination. Who can I contact?

For medical advice please contact your treating doctor.

The Paul-Ehrlich-Institut is not a medical care provider like a hospital or a clinic and is not entitled to provide advice on vaccinations to individuals. Many factors are important for medical advice, which can only be adequately taken into account in personal contact between doctor and patient.

I suspect that I am suffering from vaccination damage. How should I proceed?

If you suspect that you are suffering from vaccination damage, you will have to make an application for recognition of your vaccination damage at the responsible Versorgungsamt (public support institution) in your federal state. This link provides an overview of such support institutions:

Public support institutions in Germany (German only).

The Paul-Ehrlich-Institut has no responsibilities related to vaccine damage recognition.

I did not tolerate the vaccine and had severe side effects. What can I do?

Please discuss with your doctor what you can do against the reaction.

Also ask your doctor to report suspected vaccine complications online to the Paul-Ehrlich-Institut:

Online registration form for doctors (German only).

You can also make this announcement yourself in a special form for the public:

Online reporting form for consumers (German only).

The Paul-Ehrlich-Institut needs such reports to detect possible, very rare side effects, and, if necessary, to be able to react.

I would like to travel. Which vaccinations do I require?

Please contact the institutes offering advice on travel medicine:

How safe are vaccines?

Before a vaccine is marketed, it must undergo an extensive marketing authorisation procedure, either in Germany (national marketing authorisation procedure) or at the European Medicines Agency (EMA) (centralised procedure by the EU Commission).

The quality, effectiveness and safety of the vaccines are thoroughly examined and evaluated. A positive benefit-risk assessment is a prerequisite for the approval of a vaccine.

Even then, the vaccine undergoes regular official batch control tests. Before a newly produced vaccine batch is approved to be sold on the market in Germany, a batch release by the Paul-Ehrlich-Institut (PEI) must have been approved after independent batch testing.

This usually includes an experimental test in the laboratory. The Paul-Ehrlich-Institut is one of the "Official Medicines Control Laboratories" (OMCL) that fulfils this role in Europe.

Important publications:

Is it possible that the Changchun Changsheng Company exported vaccines to Germany?

No. All vaccines marketable in Germany either have a national marketing authorisation granted by the Paul-Ehrlich-Institut (PEI) or a so-called centralised marketing authorisation from the EU Commission granted in a procedure by the European Medicines Agency (EMA). The centralised marketing procedure is valid in all EU member states (plus Norway and Iceland). The vaccines manufactured or marketed by the Chinese company Changchun Changsheng have neither a national nor a centralised EU marketing authorisation.

Is there a possibility that marketing authorisation holders who market vaccines in Germany have manufacturing sites in China?

No. None of the marketing authorisation holder has a manufacturing site in China or purchases antigen components from China for the vaccines authorised in Germany or in the EU.

How can I be sure that the vaccine which I receive will contain an effective component?

Vaccines are subject to official batch testing. After in-house controls at the manufacturer, the PEI – or another recognized official testing laboratory for the examination and independent quality control of medicines from another European country also performs experimental batch control tests on the samples to be tested from the vaccine batches. During these tests, the PEI would identify any vaccines that do not contain an antigen component, i.e. an active ingredient, such as the Chinese rabies vaccines about which the media reported. Patients in Germany can be sure that the vaccines administrated in Germany and the EU are safe and effective.

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