Global Vaccine Safety

Sixth Global Vaccine Safety Initiative (GVSI) meeting


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.

Stakeholders’ meeting on vaccine safety communication


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.

WHO guidance for vaccine safety presentations to GACVS


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.

Evaluating Vaccine Safety Causality Assessment


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.


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