The Scientific Committee for Post-Marketing Monitoring of COVID-19 Vaccines (CSV-Covid19), set up on 14 December 2020 by the Italian Medicines Agency (AIFA) in agreement with the Ministry of Health and the Extraordinary Commissioner for the Covid-19 Emergency, held its kick-off meeting on 15 December 2020.

CSV-Covid19, which belongs to AIFA’s Directorate General, will remain in office for two years and its mandate may be renewed based on the evolution of the pandemic and the progress of the COVID-19 vaccination campaign.

According to Nicola Magrini, AIFA’s Director General, CSV-Covid19 is crucial for the National Health Service to ensure the active monitoring of the safety of all COVID-19 vaccines that will arrive in Italy.

Comprising high-profile experts of proven scientific independence, the Scientific Committee will ensure a transparent opinion on the safety of all new vaccines and full compliance with the protocols followed in the vaccination campaign. CSV-Covid19 will help strengthen Italy’s role as an authoritative member of the global research community.

Goals

CSV-Covid19 aims at coordinating pharmacovigilance activities and contributing to the COVID-19-related vaccination campaign, by providing strategic scientific support to AIFA, the Ministry of Health and the National Health Service.

Tasks

• analyse objectives and methods used in (ordinary and extraordinary) pharmacovigilance projects supported by AIFA in order to ensure consistency and quality of results, also providing guidance and monitoring to identify possible criticalities and suggest appropriate solutions;
• make recommendations to AIFA, based on available evidence, on strategic guidelines to ensure safety and effectiveness of vaccination in Italy;
• drawing on analysis and monitoring activities, indicate the need for conducting specific in-depth analyses and make proposals for carrying out supplementary studies or redirecting those that are ongoing;
• suggest objectives and possible formulas of training and information initiatives on COVID-19 vaccination, and contribute to defining a specific national communication plan to support the COVID-19 vaccination campaign;
• promote participation in and synergy with the activities of other support groups that carry out similar tasks at European and international level;
• cooperate with the Technical-Scientific Committee in assessing the overall comparability of the different vaccines.

CSV-Covid19 consists of independent experts in the fields of epidemiology, vaccination monitoring, territorial organisation of vaccinations, regulatory aspects of vaccines, immune responses to vaccinations, vaccine pharmacovigilance, vaccine clinical trials, training of health professionals and communication to the public about vaccination.

The appointed independent experts are:

- Vittorio Demicheli, epidemiologist, Milan – President

- Nicola Magrini, pharmacologist, AIFA Director General, Rome – Vice-president

- Maurizio Bonati, epidemiologist/paediatrician, 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, AIFA President, Rome

- Carlo Pini, biologist, Rome

- Francesco Salvo, pharmacoepidemiologist, Bordeaux (France)

- Miriam Sturkenboom, pharmacoepidemiologist, Utrecht (The Netherlands)

- Eva Benelli, science journalist, Rome

Observers, appointed by national and regional institutions involved in the planning and management of the vaccination campaign, will participate in the activities of CSV-Covid19. Such observers are tasked with ensuring that the information is timely and complete.

The appointed observers are:

Giuseppe Ippolito – “Lazzaro Spallanzani” National Institute of Infectious Diseases, Rome

Franco Locatelli – National Health Council (Consiglio Superiore di Sanità), Rome

Patrizia Popoli – National Health Institute (Istituto Superiore di Sanità) and AIFA Technical-Scientific Committee, Rome

Giovanni Rezza – Ministry of Health, Rome

Silvia Mancini - Médecins Sans Frontières/Doctors Without Borders

Antonio Gaudioso – Cittadinanzattiva

The Health Committee of the State-Regions Conference will appoint an observer with a subsequent own decision.

Published on: 15 December 2020