Vaccines & immunizations

Vaccine vigilance in Italy

Vaccine vigilance includes all the activities relating to the “detection, assessment, understanding and communication of adverse events following immunization (AEFIs)”. More broadly, pharmacovigilance and vaccine vigilance are a series of activities aimed at continuously assessing all safety information on medicinal products and ensuring that the benefit/risk (B/R) balance of such products remains favourable over time. Therefore, vaccine vigilance is a key tool for monitoring the safety of vaccines also after they have been approved and put on the market.

The EU pharmacovigilance legislation currently consists of laws, regulations and a series of measures known as Good Pharmacovigilance Practices (GVPs). Taking into account the unique specificities of vaccines, specific GVP guidance was developed to ensure the performance of effective vaccine vigilance activities.

Following marketing authorization, each batch of vaccine is subject to the same pharmacovigilance rules as those that apply to other medicines, and safety monitoring is mostly carried out through:

• Active and passive vaccine vigilance
• Periodic safety reports that, as per GVP guidance, vaccine producers are required to prepare during the lifecycle of their product, including:
  • Periodic Benefit-Risk Evaluation Reports (PBRERs), prepared every 1-5 years depending on the type of vaccine, which present and discuss safety data (adverse reactions, signals and risks) and include an evaluation of benefits based on efficacy and effectiveness data
  • Risk Management Plans (RMPs), which present and assess the pharmacovigilance activities and interventions (risk management system) implemented by vaccine companies to identify, characterize, prevent and minimize risks relating to the product
  • Post-authorization safety studies (PASSs), i.e. interventional or non-interventional studies conducted by vaccine companies to identify, characterize or quantify any safety risk, confirm the safety profile of the product or evaluate the effectiveness of risk minimization measures (risk management measures).

Vaccine vigilance is performed by collecting and analyzing spontaneous reports of AEFIs (from doctors, healthcare professionals and patients). Safety signals may be detected, and pharmacoepidemiology studies are conducted to confirm or refute such signals, as well as to quantify potential risks.

AEFI reports are entered into the National Pharmacovigilance Network (Rete nazionale di farmacovigilanza - RNF) database. They can be submitted online, through the IT platform (Vigifarmaco) of the Italian Medicines Agency (AIFA). Alternatively, a paper reporting form can be completed and posted, faxed or emailed to the person responsible for pharmacovigilance in the facility of the reporting party. The above are considered passive surveillance activities.

AIFA assesses each case and submits all serious case reports to the EudraVigilance database (which collects information on suspected adverse reactions to medicines that have been authorized in the European Economic Area). Pharmacovigilance activities also benefit from integration with Vigibase, the WHO international drug monitoring database, which currently receives reports from 125 countries across the world.

RNF ensures the collection, management and analysis of spontaneous reports, but also the rapid dissemination of vaccine safety information provided by AIFA, through a network that includes AIFA, the Regions, the Autonomous Provinces of Trento and Bolzano, Local Health Units, hospitals, research hospitals (IRCCS) and pharmaceutical companies.

The collected data make it possible to quickly identify specific problems that may require further investigation. They also allow assessment of very rare AEFIs, which could not be adequately studied using data from a limited geographical area or a selected sample.

Active vaccine vigilance includes projects that allow collection of suspected AEFIs by encouraging and facilitating reporting by healthcare professionals in specific situations (e.g. for new vaccines or for limited periods of time).