Global Vaccine Safety

GACVS highlight of December 2015 meeting

The Global Advisory Committee on Vaccine Safety (GACVS) held its 33rd meeting in Geneva, Switzerland, on 2–3 December 2015. The Committee examined the clinical and population characteristics of cluster immunization anxiety-related reactions and the detection of vaccine safety signals from spontaneous reporting databases. It also reviewed vaccine-specific safety issues concerning RTS,S malaria vaccine, safety of human papillomavirus (HPV) vaccines, pandemic influenza vaccine and narcolepsy, and the safety profile of smallpox vaccines. GACVS findings and recommendations were published in the WHO Weekly Epidemiological Record on 22 January 2016.

Report on the Fourth Global Vaccine Safety Initiative Meeting

The Fourth Global Vaccine Safety Initiative meeting took place in Evian, France on 14-15 October 2015. The Global Vaccine Safety Initiative (GVSI) is the implementation mechanism for the Global Vaccine Safety Blueprint, which is the WHO strategy to optimize the safety of vaccines in all countries through effective use of pharmacovigilance principles and methods.

During two days, immunization programme managers and national regulatory authorities pharmacovigilance staff from more than thirty countries gathered with representatives from UN agencies, academic institutions, pharmaceutical companies umbrella organizations, partner and funding agencies.

The overall objective of the meeting was for Member States and partners to interact and exchange information on progress with implementation of national and global vaccine pharmacovigilance activities, share new ideas, innovations, explore new frontiers in vaccine safety, build partnerships and collaborations and define plans for further development.

National workshop on AEFI causality assessment and capacity building - Zimbabwe

At request of the Ministry of Health, WHO organized a Zimbabwe specific, “Advanced course on causality assessment of AEFI” in Harare from 2 – 5 November 2015. 21 participants from Medicines Control Authority of Zimbabwe (MCAZ), National Regulatory Authority for Medicines, Zimbabwe, MOHSW EPI team and WHO Zimbabwe attended.

The key facilitators included a medical officer from EPI division, Ghana, a Medicines expert from Tanzania Food and Drug Authority, Medical Officer from WHO IST ESA, Professor of Paediatrics from University of Adelaide and vaccine safety expert from WHO HQ in Geneva.

The tangible outcomes included finalisation of Zimbabwe national AEFI reporting form, development of a national AEFI reporting framework, development of a joint work-plan for 2016-2017 by MCAZ and EPI and decision to use Zimbabwe DHIS2 software to report AEFI. Multi-country research collaboration in vaccine safety using WHO tools was also conceptualised.

National workshop on AEFI causality assessment and vaccine safety communications - Ukraine

At request of the ministry of health (MoH) Ukraine, WHO organized an Advanced AEFI Causality Assessment and Communications Training in Kiev, 17-21 August 2015. The 16 participants included experts from MoH, National Immunization Program, Department for post marketing surveillance of medicines, immunobiologicals and vaccines, Communication experts, Paediatric immunologists, AEFI committee members, Academicians and WHO country office and UNICEF Ukraine.

Coordinated by staff from WHO HQ, EURO and a vaccine safety expert from Dalhousie University, Canada, the workshop focused on enhancing capacity to strengthen AEFI surveillance, improve AEFI reporting, investigation and causality assessment practices and communicate effectively on vaccine safety issues. The uniqueness of this training was the inclusion of the communication component into the training sessions. Participants learnt to prepare and prioritise action for vaccine safety-related events and also learnt how to address difficult questions posed by the media and the public.

GVSI highlights