Regional Programme for Pre-Vaccination Consultancy and Vaccine Adverse Event Surveillance "Green Channel"

Aims of the activity


Modern vaccinology has led to the development of new, highly immunogenic and safe instruments against infectious diseases. However, demand for safety has also increased along with misinformation and anti-vaccine movements of increasing popularity, particularly in areas where vaccine preventable diseases are uncommon. Although serious adverse events following immunization (AEFIs) are rare, it is sometimes difficult to ascertain a causal association and establish eligibility for further administration at the individual level. For this reason some countries are improving their surveillance systems by establishing clinical evaluation centres for AEFIs.
In 1993, the Veneto Region Public Health Authority approved a project for vaccination improvement which established a special Service for prevention, evaluation, and monitoring of AEFIs, named the Green Channel, at the Department of Pathology, at the University of Verona. In 2005 the Public Health Authority established the Green Channel as a Regional Reference Centre for Pre-Vaccination Consultancy and AEFI Surveillance at the Immmulogy Unit of the University Hospital of Verona.

Official tasks

The Green Channel has the following tasks, as assigned by the Regional Public Health Authority:

• Specialized pre-vaccination consultancy, for the Local Health Units (LHUs), to evaluate the eligibility to vaccination of subjects with history of previous AEFIs or contraindication (CI);
• Management of the regional AEFI surveillance system;
• Monitoring of serious AEFIs reported in the Veneto Region;
• Surveillance of specific AEFIs or events of special interest;
• Publication of annual reports on activity for feedback information to vaccine personnel.

Pre- and Post-Vaccination Consultancy


The consultancy is for subjects who need a specialized examination for suspected AEFIs or CIs to start or continue vaccine administration, as indicated by a standardized pre-vaccination questionnaire used at LHU level to rule out any CI before vaccination. When requested by the Regional Referring Physician, the Green Channel is alerted on specific cases. Here, prior AEFI and/or underlying pathologies as potential risk factors are evaluated by clinical and/or accurate record examination, an in-depth anamnesis, and, eventually, specialized consultation from other disciplines and in vivo/in vitro tests, in order to identify specific sensitizations. Finally, a conclusive report is released to LHU, containing instructions for vaccination with standard procedure or precautions (i.e pre-medication, temporally separated single injections, hospitalization, different vaccine preparation), or, in selected cases, indicating temporary suspension or exemption.
Electronic services (fax, e-mail) on general issues or specific cases regarding AEFIs and CIs are also available for simple or urgent questions and for risk communication.

Regional AEFI Surveillance System

The Regional Surveillance System for AEFIs has been assigned to the Immunology Unit of the University Hospital of Verona, to collaborate also with the Pharmacovigilance System. The AEFI reports sent to the Pharmacovigilance System and forwarded to the Green Channel are examined, classified and computerized into a specific database. Unusual and serious cases are thoroughly studied and followed up to recovery or stabilization of the lesion.


Annual reports

During the overall period, 14 official reports on the consultation and surveillance activity of the Green Channel have been published for the Health Authorities and vaccine personnel of the LHUs.

Training activity

The Green Channel collaborates with the Regional Public Health Authority on training programmes on vaccine safety for health care personnel.

International projects
During the period 2006-2008 the Green Channel participated in the European Project VENICE (Vaccine European New Integrated Collaborative Effort), as leader of the work-package on "Capacity Building in Monitoring, Prevention and Management of Adverse Events following Immunization" (http://venice.cineca.org).
The Green Channel also collaborated on the project VAESCO I, launched by ECDC (European Centre for Disease Prevention and Control) in 2008. The activity on vaccine safety and AEFI surveillance at European level has been carried out by the project VAESCO II (http://www.vaesco.net), launched by ECDC in 2009.


Selected publications

1. G. Zanoni, TMD Nguyen, M Valsecchi, G Gallo, G Tridente. Prevention and Monitoring of Adverse Events Following Immunization: the "Green Channel" of the Veneto Region in Italy. Vaccine 2003: 22; 194-201.
2. G. Zanoni, A. Ferro, M. Valsecchi, G. Tridente. The "Green Channel" of the Veneto Region as a Model for Vaccine Safety Monitoring in Italy. Vaccine 2005; 23:2354-58
3. J Mereckiene, S Cotter, A Nicoll, D Levy-Bruhl, A Ferro, G Tridente, G Zanoni, P Berra, S Salmaso, D O'Flanagan, VENICE Project Gatekeepers Group. National Seasonal Influenza Vaccination Survey in Europe, 2008. Euro Surveill. 2008 Oct 23;13(43). pii: 19017
4. J Mereckiene, S Cotter, JT Weber, A Nicoll, D Lévy-Bruhl, A Ferro, G Tridente, G Zanoni, P Berra, S Salmaso, D O'Flanagan, VENICE Gatekeepers Group. Low Coverage of Seasonal Influenza Vaccination in the Elderly in many European Countries. Euro Surveill. 2008 Oct 9;13(41). pii: 19001.
5. G. Zanoni, A Puccetti, M Dolcino, R Simone, A Peretti, A Ferro, G Tridente. Dextran-specific IgG Response in Hypersensitivity Reactions to Measles-Mumps-Rubella Vaccine.J Allergy Clin Immunol. 2008 Dec;122(6):1233-5. Epub 2008 Oct 15.
6. G. Zanoni, P Berra, I Lucchi, A Ferro, D O'Flanagan, D Levy-Bruhl, S Salmaso, G Tridente. Vaccine Adverse Event Monitoring Systems across the European Union: Time for Unifying Efforts. Vaccine 2009; 27:3376-84.
7. Novadzki IM, Rosário N, Zanoni G, Chiesa E, Puccetti A, Simone R.Hypersensitivity reactions following measles-mumps-rubella vaccine and dextran-specific IgG response. Allergol Immunopathol (Madr) 2010; 38(6):341-3.
8. Zanoni G, Gottin L, Boner A, Piacentini G, Peroni D, Gold M. Case discussion of an immediate serious reaction to hexavalent vaccine mistaken for anaphylaxis. Br J Clin Pharmacol. 2010 Dec;70(6):916-7.
9. Micheletti F, Moretti U, Tridente G, Zanoni G. Consultancy and Surveillance of Post Immunization Adverse Events in The Veneto Region of Italy for 1992-2008. Human Vaccines 2011; 7: Supplement, 234-9.

Programme Head
Dr. Giovanna Zanoni, MD, Allergist and Immunologist

Secretary
Mr. Daniel Lovato

Address
Immunology Unit, Policlinico G.B. Rossi, Azienda Ospedaliera Universitaria Integrata di Verona
Tel. +39 045 8124256-7, Fax: +39 045 8126455, e-mail: canale.verde@ospedaleuniverona.it