Hepatitis B Control in Italy: The 35-Year Impact of Universal Infant Vaccination and Lessons for Global Elimination

In 1991, Italy launched a landmark public health initiative known as the Piazza Protocol, the first nationwide universal hepatitis B virus (HBV) vaccination strategy in the Western world. The programme introduced two major innovations: universal infant vaccination synchronised with compulsory childhood immunisations, and adaptation of the licensed HBV vaccine schedule from 0, 1, and 6 months to 3, 5, and 11 months. By the mid-1990s, national coverage exceeded 95%. Surveillance data from SEIEVA confirm the sustained epidemiological impact: acute HBV incidence fell from 5.1/100,000 in 1991 to 0.22/100,000 in 2022, with no reported cases among children under 14 years since 2021. The prevalence of chronic HBsAg carriers decreased from ~3% in the 1980s to ~1% by 2010% and 0.33% among children under five in 2020. Regional data confirm dramatic reductions, including Afragola (Naples area), where HBsAg prevalence declined from 13.4% pre-vaccination to 0.91% by 2006. Catalonia's regional preadolescent programme (1991) is acknowledged but achieved lower coverage than Italy's nationwide approach. Despite these successes, challenges remain: sporadic cases in unvaccinated groups, adult coverage gaps, and the continued importation of chronic carriers through migration. Italy's early adoption of universal infant vaccination enabled it to meet WHO control targets and provides a durable model for possible HBV elimination.