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.
The Global Advisory Committee on Vaccine Safety - June 2017 meeting
The Global Advisory Committee on Vaccine Safety (GACVS) held its 36th meeting in Geneva, Switzerland, on 7-8 June 2017. The Committee examined 3 vaccine specific safety issues: pharmacovigilance planning for the anti-malaria vaccine, RTS,S/AS01 (RTS,S), pilot implementation programme in 3 countries; updates on the safety profiles of Bacillus Calmette-Guérin (BCG) vaccine and human papilloma virus (HPV) vaccine; and the generic issue of development of standards and a template for the review of the safety profile of vaccines during GACVS meetings.
Indian and Zimbabwean experts gathered in India from 24 to 30 April 2017 in order to apply the WHO revised methodology for causality assessment of Adverse Events Following Immunization (AEFI). A total of 250 anonymized cases of serious AEFI from both countries were evaluated. The workshop, organized by the International Clinical Epidemiology Network (INCLEN), will allow to assess the inter - and intra-country agreement in classification of cases and provide inputs for reviewing and revising the current methodology. An electronic AEFI causality assessment software developed by WHO was also evaluated. This study is being conducted under the oversight of the Global Advisory Committee on Vaccine Safety (GACVS) and the findings will be deliberated at the December 2017 GACVS meeting.
The Vaccine Safety Net portal was established by WHO to facilitate contacts, exchange of information, tips and news among Network members and also provide a collaborative platform for members to develop common projects on vaccine safety communication using digital means. The portal is also centralizing and helping further disseminate, to the public and health care professionals, reliable information on the safety of vaccines, on both long standing and emerging public health issues.
The portal was launched mid February 2017 and during the first month was already consulted by more than 2700 visitors mainly from India, Italy and the United States, who viewed close to14 800 pages.
WHO Calls the Highest Level of Government in African Countries to Ensure Strong Vaccine Safety System
A high-level working dinner to discuss the Global Vaccine Safety Initiative (GVSI) policy was held on 23 March, 2017 with more than 80 participants from AU Member States and delegates, senior level officials from African Union Commission, partners, and distinguished invited guests at the African Union Commission in Addis Ababa, Ethiopia. This advocacy dinner meeting was organized by World Health Organization (WHO) in collaboration with the African Union Commission. The meeting aimed to ensure that African countries establish strong vaccine safety systems. It also intended to provide the vision for a future where vaccine safety concerns are addressed in a rigorous and transparent fashion and share perspectives on 21st century approaches that are relevant to African Countries.
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: 4 September 2017