This article was written by Paolo Palma, Co‑Scientific Coordinator at Vaccinopolis and Chair of Paediatrics at the University of Rome “Tor Vergata”. It is taken from the Penta 2025 Annual Report.
The global landscape of infectious diseases is evolving rapidly. Emerging and re‑emerging pathogens, including respiratory viruses, arboviruses and viral haemorrhagic fevers, continue to challenge health systems worldwide. Global mobility, climate change, environmental disruption and geopolitical instability increase the likelihood of outbreaks and accelerate the spread of pathogens across regions. Preparing for future infectious threats therefore requires not only scientific innovation, but also sustained international collaboration and inclusive research strategies.
Within this context, vaccines and monoclonal antibodies represent two complementary pillars of modern infectious disease preparedness. Vaccines remain among the most effective public health interventions, providing durable protection at population level and significantly reducing disease burden, hospitalisations and mortality. High vaccine coverage also contributes to community protection and helps mitigate the broader social and economic consequences of outbreaks.
In parallel, monoclonal antibodies are emerging as powerful tools for rapid and targeted protection. They can provide immediate immunity and be used for pre‑exposure or post‑exposure prophylaxis, as well as for treatment. Their role is particularly important for individuals at increased risk of severe disease or for those who may not mount an adequate immune response to vaccination, including people with chronic conditions or immunocompromising disorders.
Within Penta, several initiatives illustrate how these approaches are being advanced to address both current and future threats. The PIPELINE project focuses on innovative prevention strategies against respiratory viruses in early life, including long‑acting monoclonal antibodies such as nirsevimab for the prevention of RSV in infants, alongside the evaluation of new RSV vaccines designed to protect infants through maternal immunisation. By studying these complementary strategies, PIPELINE contributes to defining optimal protection strategies during early life.
Other initiatives address pathogens with epidemic potential. The European research project MALASSA highlights the growing interest in monoclonal antibodies as effective tools for pandemic preparedness, aiming to developa candidate therapy for the prevention and treatment of Lassa fever, a viral haemorrhagic disease with epidemic potential and currently no licensed vaccines or treatments.
Additional initiatives focus on populations for whom innovative immunological strategies may be particularly beneficial. The ENABLE project investigates the use of broadly neutralising antibodies to improve treatment strategies for newborns living with HIV, with the goal of achieving rapid viral control early in life.
At the same time, vaccine research within Penta is expanding to address long‑standing evidence gaps in populations historically underrepresented in clinical trials. The PregInPoxVac study evaluates the safety and immunogenicity of the MVA‑BN mpox vaccine in pregnant people and infants in the Democratic Republic of Congo. More broadly, maternal immunisation strategies are gaining increasing attention as a means of protecting infants during the first months of life, with vaccines targeting pathogens such as Group B Streptococcus and cytomegalovirus currently under development.
At the European level, these efforts are reinforced through collaborative initiatives such as the European Vaccines Hub for Pandemic Readiness, an EU‑funded programme designed to accelerate the discovery, development and clinical evaluation of vaccines and monoclonal antibodies for pathogens with epidemic or pandemic potential. Within this framework, Penta contributes its expertise in paediatric and maternal infectious disease research, supporting the early and responsible inclusion of children and pregnant people in the development of new preventive strategies.