While the winter of 2025 marked a historic turning point in Italy with the large-scale introduction of monoclonal antibodies for newborns, achieving coverage above 80%, the spring of 2026 marks the beginning of a new chapter: vaccination during pregnancy. Respiratory Syncytial Virus (RSV) remains the leading cause of hospitalization for children under one year of age, with over 15,000 hospitalizations estimated annually in the newborn cohort in Italy alone. However, as emerged during the European workshop organized in Brussels last March by Cittadinanzattiva-Active Citizenship Network (ACN), the strategy is shifting toward a systems approach that sees maternal immunization as an emerging pillar.
We talked about it with Laura Reali, a pediatrician with forty years of experience in the Italian National Health Service (NHS) and past-President of the European Confederation of Primary Care Paediatricians (EPCCP).
The transition from niche to system: the “biological bridge”
According to Reali, European pediatrics is undergoing a transformation in its approach to prophylaxis, moving “from a niche to a system.” This shift sees maternal immunization as a key element that acts as a biological bridge. Through the administration of the vaccine to a pregnant woman, ideally in the last trimester of pregnancy, a transplacental transfer of IgG antibodies occurs. “All children would be born protected from birth,” explains the ECPCP past-President, emphasizing that recent studies indicate that “maternal vaccination provides good protection for three months and gradually declines over the following six months.”
Maternal vaccination provides good protection during the first three months, which gradually declines over the following six months
This initial window of protection is crucial, as it ensures that the newborn is covered at the time of maximum vulnerability, even where immediate access to neonatal immunization may present logistical challenges.
Complementary, not competing, tools
A key point of the debate concerns the coexistence of maternal vaccine and new-generation monoclonal antibodies, such as nirsevimab, which offer uniform protection for about five months. For Reali, there is no competition: “These tools are strictly complementary within an integrated strategy. While the monoclonal antibody remains an extremely effective strategy, maternal vaccination provides a crucial safety advantage, especially for at-risk pregnancies.”
For preterm infants, or when immediate neonatal immunization is difficult, maternal protection becomes particularly important
The goal must be to fill the gaps in the system. Reali clarifies that maternal vaccination is essential where access to immediate neonatal immunization is difficult or for preterm infants who “are unable to respond very well to these vaccines.” In many European countries, such as France and Spain, these programs already coexist successfully, with encouraging preliminary results in reducing hospitalizations.
The role of professionals and the coherence of the message
In this scenario, the role of community doctors is crucial, but it often comes up against fragmented communication. “What I see is a lack of coherence in the message,” warns Reali. “Very often, mothers arrive full of uncertainty because the healthcare professionals they turn to don’t always provide them with consistent information. The lack of networking and shared training can be a problem. This lack of coherence generates doubts and wastes precious time.”
We can start providing information and raising awareness during antenatal classes
According Reali, virtuous models like the one in Piedmont should be replicated, where women are provided with a comprehensive list of all services and vaccination schedules from the beginning of pregnancy. Pediatricians, while often seeing children after birth, must take action early: “We can provide information and advocate during childbirth preparation classes, explaining that vaccination during pregnancy is a way to best protect the unborn child.”
The challenge of equity and sustainability
Despite scientific evidence, universal adoption of this dual protection is not yet a reality because, as Reali emphasizes, “the choice depends on significant variables such as economic sustainability and the organization of the various healthcare systems.” In Italy, data from Cittadinanzattiva’s VRS Observatory show a two-speed country: while the monoclonal antibody rollout has been synchronized across regions, the maternal vaccine offering has remained limited to isolated areas such as Sicily, Marche, and Basilicata.
This fragmentation is deemed unacceptable, as the protection of a newborn cannot depend on the postal code of birth. On the financial front, the Ministry of Health has allocated €50 million from the National Health Fund to support access to immunization strategies. However, the Observatory’s experts believe this amount is insufficient, as the allocation has remained unchanged from the previous year despite now also covering vaccination during pregnancy.
Scientific innovation must translate into equitable access to care and help reduce regional disparities
While Cittadinanzattiva points out that every euro invested can generate savings between 18 and 48 times greater, reducing social and hospital costs, Dr. Reali urges pragmatic reflection: “Prevention should not be held back by limited financial resources, and institutions should remain firmly focused on the underlying objective of protecting children as best they can.” While awaiting an update to the National Immunization Calendar, the challenge remains to transform scientific innovation into a truly enforceable right, overcoming current regional inequalities.
