Vaccines: what do authorisation and safety monitoring check?

Vaccine authorisation and safety monitoring answer different questions. Assessment before marketing, controls on manufactured batches and follow-up after use complement each other. None of these safeguards means that a medicine carries no risk.

Marketing authorisation is based on an assessment of benefits against risks. Authorities examine effectiveness, adverse effects observed in studies, the quality of the product and the quality of its manufacture before deciding whether to authorise it.

Vaccine batches also undergo controls before marketing in the European Union. Checks by the manufacturer are supplemented by those of ANSM or another European health authority, under a system that recognises these controls across participating authorities.

After marketing, pharmacovigilance monitors and evaluates adverse effects. Studies carried out before authorisation cannot fully establish safety in use. Information collected afterwards therefore adds to what is known about the vaccine and supports its continuing assessment.

An event reported after vaccination does not automatically prove that the vaccine caused it. Pharmacovigilance centres examine the timing and medical information, among other details. ANSM may update information or take safety measures in response to assessed risks.

To prepare for vaccination, ask the professional how current information relates to your situation and which effects should prompt you to contact them. A question about monitoring can then become a useful explanation before the procedure and instructions for afterwards.