Vaccines on the market in Belgium meet strict standards for quality, safety and efficacy. They are subject to extensive evaluations and are strictly controlled both before and after being placed on the market.
Before a vaccine is placed on the market, it is extensively tested in clinical trials. During the clinical trials, the safety of the vaccine is extensively tested in a large number of subjects. The most common side effects can then be identified. It is important to keep monitoring the safety of vaccines after they are on the market. The safety of approved vaccines for use in Europe is monitored by the European Medicines Agency (EMA) and national competent authorities. More information on pharmacovigilance is available on our website.
The final composition of the vaccine, including adjuvants and residuals, is subject to extensive testing to ensure safety. When certain substances are present in a concentration that may cause a reaction in sensitive or allergic individuals, this is explicitly stated in the information about the vaccine provided to healthcare professionals and patients. For example, the package insert states whether special precautions have to be taken when using a vaccine in people with certain allergies, for example a vaccine containing traces of chicken egg protein in people with chicken egg protein allergy.
All vaccines on the market in Belgium have been assessed for quality, efficacy and safety. The FAMHP carefully and critically reviews all studies with and about the vaccine and, together with other European countries, evaluates whether the vaccine can be allowed on the market.
Side effects
As with other medicines, some people may experience side effects from a vaccine. Side effects usually occur shortly after vaccination, are often mild and short-lived. Side effects are also rare, and approved vaccines are considered extremely safe.
The most common side effects after vaccination are pain or redness at the injection site, and mild fever. Serious side effects are rare.
The known side effects of a medicine are stated in the package insert and in the Summary of Product Characteristics (SPC). These documents can be found in the medicines database.
Report any side effects of a vaccine via this form.
Contraindications
Some vaccines cannot be administered to persons with certain allergies or conditions. In the event of a contraindication, the risks of vaccination outweigh the potential benefits.
An allergy to one of the components in the vaccine is a contraindication to vaccination. If a person has had anaphylactic shock in the past after vaccination, this vaccine must not be administered again. Other contraindications include immune disorders and certain medical treatments. In principle, these individuals cannot be administered live attenuated vaccines such as vaccines against measles, mumps, rubella, varicella or typhoid (oral). They may well benefit from group immunity if those around them are vaccinated.
Always discuss with your health care professional which vaccines can be administered if there is a contraindication.
Vaccines and pregnancy
Some vaccines are not recommended during pregnancy. Vaccination with live attenuated vaccines such as vaccines against measles, mumps, rubella and varicella should preferably not be administered during pregnancy. A woman should also preferably not become pregnant in the month following the administration of a live attenuated vaccine.
Other vaccines may well be recommended during pregnancy, such as the vaccine against whooping cough, influenza, COVID-19, and more recently the vaccine against RSV.
Always discuss with your healthcare professional which vaccines can be administered during or after pregnancy.
Evaluation of the registration dossier
Before a vaccine is placed on the market, the manufacturer must submit a registration dossier to the authorities (the FAMHP and the EMA) who evaluate it. The registration dossier contains data of both quality (such as manufacturing process, composition of vaccine), preclinical data (such as metabolism, toxicology) and clinical data (safety and efficacy). The 'quality' component is evaluated by Sciensano, in collaboration with the FAMHP. Only when all data has been accepted can the vaccine be approved.
Testing of each vaccine batch by the manufacturer
Each vaccine batch must be tested by the manufacturer for the following parameters:
- active substance;
- purity;
- integrity;
- residual protein impurity;
- pH;
- sterility;
These tests are performed using validated testing methods. The results must fall within established limits approved by the authorities. Vaccine batches whose values are outside the stated limits cannot be released. Only vaccine batches that fully meet the stated specifications can be released and used.
Testing of each vaccine batch by an independent laboratory
Unlike other medicines, vaccines in Europe must be checked by an accredited and independent laboratory (Official Medicines Control Laboratory, OMCL). For Belgium, this is Sciensano.
Before a vaccine batch is placed on the market, it is tested by the manufacturer and an additional test is carried out by the control laboratory. If the results meet the stated specifications, a certificate is created that the batch can be released (batch release certificate). If the results are not satisfactory, this particular batch must be destroyed. The test results from the reference lab therefore provide an additional guarantee of the quality, safety and efficacy of the vaccine.
Inspections by the authorities
All vaccine production sites are inspected by the authorities. This takes place before a vaccine is approved, and also after approval. Inspectors verify that production and control tests are in accordance with the registration dossier, and are carried out according to good manufacturing practices (GMP).