Sex differences in response to COVID-19 mRNA vaccines in Italian population.

Since the beginning of mass vaccination campaign for COVID-19 in Italy (December 2020) and following the rapidly increasing vaccine administration, sex differences have been emphasized. Nevertheless, incomplete and frequently incoherent sex-disaggregated data for COVID-19 vaccinations are currently available, and vaccines clinical studies generally do not include sex-specific analyses for safety and efficacy. We looked at sex variations in the COVID-19 vaccine's effectiveness against infection and severe disease outcomes. We conducted a nationwide retrospective cohort study on Italian population, linking information on COVID-19 vaccine administrations obtained through the Italian National Vaccination Registry, with the COVID-19 integrated surveillance system, held by the Istituto Superiore di Sanità. The results showed that, in all age groups, vaccine effectiveness (VE) was higher in the time-interval ≤120 days post-vaccination. In terms of the sex difference in vaccination effectiveness, men and women were protected against serious illness by vaccination in a comparable way, while men were protected against infection to a somewhat greater extent than women. To fully understand the mechanisms underlying the sex difference in vaccine response and its consequences for vaccine effectiveness and development, further research is required. The sex-related analysis of vaccine response may contribute to adjust vaccination strategies, improving overall public health programmes.