GACVS held its 37th meeting in Geneva, Switzerland, on 6-7 December 2017. The Committee examined three vaccine specific safety issues: progress with pharmacovigilance readiness for the RTS,S malaria vaccine pilot countries, and updates on the safety profiles of both rotavirus and dengue vaccines. It also reviewed three generic issues: the inter-rater reliability of the revised causality assessment algorithm for serious adverse events following immunization (AEFI), guidance on prevention and management of immunization-triggered stress reactions, and harmonized approaches for the vigilance of vaccine and other interventions during pregnancy.
Maternal immunization has the potential of improving health outcomes for women and their babies. The stakeholder meeting gathered technical experts from academia, technical and regulatory agencies. It highlighted considerable efforts ongoing to generate the data necessary to measure progress and minimize risks. It also confirmed that many existing programs are complementary and can potentially build a stronger joint system. Improved pregnancy vigilance will benefit from enhanced collaboration. A task force to address harmonization between data systems is proposed within WHO. Once established, the task force will reach out to multiple stakeholders and propose collaborative mechanisms to synergize expertise and optimize data access.
The sixth Global Vaccine Safety Initiative (GVSI) meeting took place in Kuala Lumpur, Malaysia, from 10 to 11 October 2017. The meeting was hosted by the Ministry of Health of Malaysia in cooperation with the Association of Southeast Asian Nations (ASEAN) Pharmaceutical Product Working Group. Over two days, approximately 92 participants from 24 countries shared lessons learned as well as emerging challenges in vaccine safety surveillance. Tools and approaches to enhance safety surveillance were identified, in particular in order to manage communication to protect the gains of immunisation programmes. A detailed report will be published early 2018.
A “Stakeholders’ meeting on vaccine safety communication” was jointly convened with UNICEF on the 12 - 13 September 2017 in New York, USA. This consultation addressed communication strategies related to vaccine safety confidence. Five areas of common interest were identified and will be developed further: 1/a communication framework; 2/ common messaging; 3/ a platform to share communication resource materials; 4/ quality standards for planning; and 5/ enhanced partners’ collaboration and coordination. During the upcoming Global Vaccine Safety Initiative meeting, inputs will be gathered from our Members States to plan how best and more systematically address vaccine confidence issues globally.
The Global Advisory Committee for Vaccine Safety (GACVS) has developed a template framework for presenters to provide information from multiple sources to assess vaccine safety. This template has been developed particularly for the presentation of pre-licensure clinical trials and post-licensure pharmacovigilance vaccine safety data. The template does not replace existing guidance which detail how clinical trials should be performed and what safety data should be collected. Even though the template will provide comprehensive and consistent presentation format for future safety information at GACVS, it is acknowledged that safety data and issues are unique to a particular product and thus, presentations may need to be adapted accordingly.
GVSI reference documents
- Global Vaccine Safety Blueprint - landscape analysis
- Global Vaccine Safety Blueprint
- The Decade of Vaccine - Global Vaccine Action Plan
Immunization and vaccines safety in WHO regions
Last update: 5 February 2018