Scientific Committee on Post-Market Surveillance of COVID-19 Vaccines (CSV-Covid19)

On 14 December 2020, AIFA established a scientific committee for the post-marketing surveillance of COVID-19 vaccines (CSV-Covid19).
The CSV-Covid19 will remain in office for two years and may be renewed.

The Scientific Committee is assigned the objective of coordinating pharmacovigilance activities and collaborating on the Covid-19 epidemic vaccination plan, performing a strategic scientific support function for AIFA, the Ministry of Health and the NHS.

The tasks assigned are:

examine the objectives and methods used in AIFA-supported pharmacovigilance projects;
make recommendations to AIFA on strategic orientations to ensure the safety and pursue the effectiveness of vaccination activities in the country;
indicate the need for specific in-depth studies and make proposals for supplementary studies or the reorientation of current studies;
promote participation in and cooperation with the activities of other support groups with similar tasks in the European and international arena;
collaborate with the CTS in the overall assessment of the overlap between the different vaccines.

Single National Ethics Committee of the Lazzaro Spallanzan National Institute for Infectious Diseases

Single National Ethics Committee of the Lazzaro Spallanzani National Institute for Infectious Diseases

Article 17 of the Cura Italia decree-law states that the national opinion on protocols for the testing of medicines for epidemiological emergencies by COVID is provided, limited to

List 648/96 - AIFA How to apply for inclusion of a drug/therapeutic indication not yet authorised by the SSN

In these times of the COVID-19 emergency we often hear about the '648/96' list and reimbursed drugs for off-label use... but what does this mean? With