The Scientific Committee for post-marketing surveillance of Covid19 vaccines (CSV-Covid19), established on 14 December 2020 by the Italian Medicines Agency in agreement with the Ministry of Health and the Extraordinary Commissioner for the Covid-19 emergency, will meet today, 15 December 2020, for the start of the works.
The CSV-Covid19, which belongs to the AIFA General Management, will remain in office for two years and may be renewed based on the evolution of the pandemic and the progress of the Covid-19 vaccination campaign.
“This Scientific Committee represents a point of reference for the National Health System to guarantee active surveillance on the safety of all Covid-19 vaccines that will arrive in Italy. Composed of high-profile experts and proven scientific independence, it will ensure transparent judgments on the full safety of all new vaccines and full compliance with the protocols followed in the vaccination campaign. CSV-Covid19 will help strengthen Italy as an authoritative member of the global research community ”, said AIFA Director General, Nicola Magrini.
Aims
The CSV-Covid19 aims to coordinate pharmacovigilance activities and collaborate on the vaccination plan relating to the Covid-19 epidemic, carrying out a strategic scientific support function to AIFA, the Ministry of Health and the SSN.
Tasks
- examine the objectives and methods used in the pharmacovigilance projects (ordinary and extraordinary) supported by AIFA in order to ensure the consistency and quality of the results, also carrying out a guiding and monitoring function to identify any critical issues and suggest appropriate solutions;
- formulate recommendations to AIFA, based on the available evidence, on strategic guidelines useful for guaranteeing safety and pursuing the effectiveness of vaccination activities in the country;
- starting from the study and monitoring activities, indicate the need for specific in-depth studies and formulate proposals for the realization of supplementary studies or for the reorientation of ongoing studies;
- suggest objectives and possible articulations of training and information initiatives on Covid-19 vaccination and contribute to the construction of a specific national communication plan to support the Covid-19 vaccination campaign;
- promote participation and collaboration with the activities of other support groups with similar tasks present at European and international level;
- collaborate with the technical-scientific Commission in the overall assessment of the overlap between the different vaccines.
The CSV-Covid19 is composed of independent experts, identified in the field of epidemiology and surveillance of vaccinations, the territorial organization of vaccinations, the regulatory aspects of vaccines, immune responses to vaccinations, pharmacovigilance on vaccines, clinical trials on vaccines , training activities for health professionals and public communication on vaccinations.
The independent experts appointed are:
- Vittorio Demicheli, epidemiologist, Milan - President
- Nicola Magrini, pharmacologist, AIFA General Manager, Rome - Vice President
- Maurizio Bonati, epidemiologist / pediatrician, Milan
- Donato Greco, epidemiologist, Rome
- Stefania Salmaso, epidemiologist, Rome
- Rodolfo Saracci, epidemiologist, Lyon (France)
- Guido Forni, Immunologist, Turin
- Angela Santoni, immunologist, Rome
- Giovanna Zanoni, clinical immunologist, Verona
- Giorgio Palù, virologist, President of AIFA, Rome
- Carlo Pini, biologist, Rome
- Francesco Salvo, drug-epidemiologist, Bordeaux (France)
- Miriam Sturkenboom, drug-epidemiologist, Utrecht (The Netherlands)
- Eva Benelli, science journalist, Rome
Some observers designated by the various national and regional institutions involved in the planning and management of the vaccination campaign will also contribute to the activities of the CSV-Covid19, with the task of ensuring that information is timely and complete.
The designated observers are:
Giuseppe Ippolito - National Institute of Infectious Diseases "Lazzaro Spallanzani", Rome Franco Locatelli - Superior Council of Health, Rome Patrizia Popoli - Higher Institute of Health and AIFA Technical-Scientific Commission, Rome Giovanni Rezza - Ministry of Health, Rome Silvia Mancini - Doctors Without Borders
Antonio Gaudioso - Cittadinanzattiva
The Health Commission of the State-Regions Conference appoints an observer with its own subsequent provision.