Vaccine Pharmacovigilance

CIOMS/WHO Working Group on Vaccine Pharmacovigilance

The report from the Working Group was published in collaboration with WHO in 2010. The report covers the activities and outputs of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance (2005-2010)

The Working Group was established in November 2005 at the request of WHO to:

1. Develop general definitions strictly focused on Vaccine Pharmacovigilance

2. Contribute to the development review evaluation and approval of definitions on adverse events following immunisation as developed by the Brighton Collaboration (BC) process and to their dissemination:
– In endorsing already existing definitions
– In participating in the review of definitions under development
– In proposing priorities for the development of new definitions
– Facilitating the translation and dissemination of the definitions

3. Collaborate with other CIOMS working groups especially that on Standardised MedDRA Queries (SMQs) and CIOMS VIII on Application of Signal Detection in Pharmacovigilance.

The Working Group was composed of members from the pharmaceutical industry, regulatory agencies, governmental institutions, and academia both from industrialised and developing countries as well as from international organizations. The aim of the group was to complete a final document including all general definitions as well as the Introduction and Definition sections of all endorsed Brighton Collaboration definitions by the end of 2010.

Eleven meetings were held:

• November 22-23, 2005, in Geneva, Switzerland
• May 30-31, 2006, in Langen, Germany
• November 6-7, 2006, in Brussels, Belgium
• May 30-June 1 2007 in Geneva, Switzerland
• October 29-30, 2007 in Bethesda, MD, USA
• May 27-28, 2008 in London, UK.
• October 27-28 2008 in Ottawa, Canada
• May 11-12, 2009 in Zürich, Switzerland
• October 26-27, 2009 in Atlanta, USA
• April 12-13, 2010 in Lyon, France
• October 4-5, 2010 in New York, USA

Outcomes

Published case definitions reviewed and endorsed by the WG:

Six case definitions were published in English, Spanish and French on the Brighton Collaboration website:
– Fever
– Hypotonic-Hyporesponsive Episode (HHE)
– Intussusception
– Nodule at injection site
– Persistent crying
– Seizure

New case definitions reviewed and endorsed by the WG:

– Abcess
– Anaphylaxis
– Aseptic meningitis
– Cellulitis
– Diarrhoea
– Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM)
– Fatigue
– Fever
– Guillain-Barré Syndrome (GBS)
– Hypotonic Hyporesponsive Episode (HHE)
– Induration
– Intussuception
– Nodule
– Overall local reaction
– Rash
– Smallpox adverse events definitions
– Swelling
– Thrombocytopenia
– Unexplained sudden infant death (USID)

Comparability of SMQs and Brighton Collaboration (BC) case definitions:

The MedDRA Maintenance and Support Services Organization (MSSO) performed a mapping between concepts in the published Brighton Collaboration vaccine adverse event definitions and terms in MedDRA Version 11.1 (September 2008). The following BC definitions were mapped:

– Abscess at injection site
– Anaphylaxis
– Aseptic meningitis
– Cellulitis at injection site
– Diarrhoea
– Eczema vaccinatum
– Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM)
– Fatigue
– Fever
– Generalized vaccinia
– Hypotonic-hyporesponsive episode
– Inadvertent inoculation
– Induration at or near injection site
– Intussusception (acute)
– Nodule at injection site
– Persistent crying
– Progressive vaccinia
– Rash (including mucosal involvement)
– Robust take
– Seizure (generalized convulsive)
– Sudden infant death syndrome
– Swelling at or near injection site
– Thrombocytopenia

During the mapping process, concepts in the case definitions that are not already part of MedDRA were identified. These findings made the WG decide to make a recommendation to the Brighton Secretariat that Brighton working groups consider MedDRA terms when developing new definitions.

CIOMS VIII Signal Detection Working Group

Comments regarding various Signal definitions were sent to CIOMS WG VIII. A vaccine-specific point-to-consider document as an annex to Signal definition in collaboration with CIOMS WG VIII was finalized. 

WHO-UMC Working Group on vaccine identifiability

The WG recommended that a drug dictionary for vaccines is needed and supports the Uppsala Monitoring Centre (UMC; WHO Collaborating Center for International Drug Monitoring) in their efforts in this respect.