CIOMS/WHO Working Group on Vaccine Pharmacovigilance

The report from the Working Group has recently been published in collaboration with WHO. The report covers the activities and outputs of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance (2005-2010) and was published in its full version as a PDF file on the websites of CIOMS and WHO.

History:

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 is currently 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 is 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, and then print it as a CIOMS publication.

Ten meetings have been held since the establishment of the Working Group:

  • 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

The developed business plan and status as of April 2010 is as follows:

  • Vaccine Pharmacovigilance – Status: final, published on CIOMS website
  • Adverse Event Following Immunisation (AEFI) – Status: preliminary agreement for finalisation through written procedure; identification of stakeholders and processes for external consultation determined.
  • Vaccination failure – Status: final as working document, published on CIOMS website, to be supported by examples.
  • Signal in vaccine pharmacovigilance – Status: final points-to-consider document in relation to CIOMS VIII definition of signal agreed.
  • Assessment of severity – Status: addressed in AEFI definitions.
  • Assessment of causality for regulatory purposes – Status: addressed in AEFI definitions.


Published case definitions reviewed and endorsed by the WG

Six case definitions have already been 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 has been 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.

 

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