Global Vaccine Safety

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.

The Vaccine Safety Net portal is live!


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.


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