Vaccines Working Party
The Vaccines Working Party (VWP) was established to provide recommendations to the Committee for Medicinal Products for Human Use (CHMP) on all matters relating directly or indirectly to vaccines.
The VWP's tasks include:
- preparation, reviewing and updating of guidelines, in conjunction with other appropriate working parties, to ensure that vaccine-specific issues are fully addressed;
- supporting dossier evaluation of new marketing-authorisation applications for vaccines and of any post-marketing submission, such as variations and follow-up measures;
- at the request of the CHMP, providing scientific advice on general and product-specific matters relating to the pharmaceutical and biological aspects of vaccines, as well as the development and clinical use of vaccines in children and adults;
- liaising with interested parties, such as trade organisations, the pharmaceutical industry, academia and patient organisations;
- European co-operation on vaccine-specific issues, in conjunction with other appropriate working parties. This includes co-operation with the European Commission, the European Directorate for the Quality of Medicines and Healthcare (EDQM) and the Official Medicines Control Laboratories (OMCLs);
- providing advice, through the CHMP, to the European Commission on vaccine-related issues;
- international co-operation, in conjunction with other appropriate working parties, on vaccine-specific issues. This includes co-operation with the World Health Organization (WHO);
- liaison with other working parties and ad-hoc expert groups on vaccine-related matters and other matters of relevance to the work of the VWP;
- providing advice, through the CHMP, to the Co-ordination Group for Mutual-Recognition and Decentralised Procedures - Human (CMD(h)) on general issues and matters relating to vaccines authorised through national or mutual-recognition procedures, and advice on vaccines being developed;
- acting as a focus and catalyst for training on the quality, preclinical and clinical assessment of vaccines;
- contributing to and organisation of vaccine-related workshops and training;
- on request of the CHMP, constituting a rapid-acting crisis group to take on specific issues relating to vaccines, with the objective of exchanging information at the European level and co-ordinating responses to the public in a timely manner, for example in relation to an influenza pandemic, vaccines for emerging or re-emerging diseases (including against pathogens potentially used for bioterrorism) and other public-health issues;
- supporting the conduct of vaccine-specific epidemiological studies, in collaboration with public-health institutions;
- supporting the implementation of the Vaccine Identification Standards Initiative (VISI) for the recording of vaccine usage at the European level to ensure effective pharmacovigilance activities and to facilitate epidemiological investigations;
- monitoring the development of new vaccine technologies and the development of new adjuvants;
- monitoring and providing input for the development of new centralised vaccines, with a view to fostering harmonisation of immunisation schedules so that flexibility is maintained for local, specific public-health needs.
Mandate, rules of procedure and work programme
More information on the VWP's responsibilities and composition is available in these documents:
- Mandate, objectives and rules of procedure for the temporary working parties and drafting groups
The VWP is composed of European experts selected according to their specific scientific expertise.
Up to 12 members, nominated by the CHMP, constitute the core group. The core members identify an alternate who participates at VWP meetings when the core member is not able to attend. Depending on the topics included on the agenda, the Agency, with the agreement of the Chair, may propose up to 12 additional experts for individual VWP meetings.
One representative each from the European Commission and the European Centre for Disease Prevention and Control (ECDC) may attend the VWP's meetings. An observer from the EDQM may also attend. A representative of the WHO can also be invited to attend meetings as an observer for non-product-related issues.
Below (in alphabetical order of surname) are the current members of the VWP. The members' declarations of interests are available in the European expert list.
- Svein Rune Andersen (Vice-Chair)
- Mikael Andersson
- Isabelle Bekeredjian-Ding
- Charlotta Bergquist
- Nele Berthels
- Brigitte Keller-Stanislawski
- Agustin Portela Moreira
- Mair Powell (Chair)
- Eleonora Wijnans