Vaccine Safety

The safety of vaccines is of paramount importance to manufacturers and to health authorities. Unlike medicines that are used to cure disease or to alleviate symptoms, vaccines are given to large numbers of healthy people with the aim of preventing life threatening or serious disease.

The quality and safety of vaccines must conform to strict regulations. Prior to release a vaccine must satisfy the safety and quality requirements set out in the licensing process. This may be through the centralized procedure (by the EMEA) or by a Mutual Recognition Procedure.

In addition, when the market authorization has been obtained, a further control is required before a vaccine is released to the public. Each batch of vaccine must be tested for quality by the Official Medicines Control Laboratory (OMCL) according to guidelines established by the European Directorate for Quality of Medicines.

When a vaccine has been released for public use, safety monitoring continues. Any adverse events are notified to regulatory authorities. In 2001 the EMEA put in place an electronic system called EudraVigilance which enables the rapid and efficient transmission of adverse event data with the national authorities. More recently pharmacovigilance surveillance has been further strengthened both by the EMEA and with the establishment of the European Centre for Disease Prevention and Control.

The vaccine industry continues to work with the health authorities to address vaccine safety issues. To be able to identify any vaccine administered to a given subject is of interest to all stakeholders involved in public health. In this respect, EVM is concerned about the lack of harmonisation in EU Member States in the provisions required to trace vaccines that are available to the public.

EVM has proposed the establishment of a working group comprising EU authorities and industry representatives to address harmonisation. These proposals were put forward in the EVM paper: "Traceability of Vaccines: EU Harmonisation".

For additional information on the subject of vaccine safety, see the EVM briefing sheet: "Vaccine Safety".

Information on vaccine safety can also be accessed from a number of other sources. The WHO have established the "Vaccines Safety Net" to facilitate the access of public health authorities, health professionals and the public to reliable information on vaccine safety.

© European Vaccine Manufacturers (EVM) - a specialised group of EFPIA 2007