È It has been estimated that each year in Italy the epidemic season of respiratory syncytial virus (RSV) involves, in the cohort of children in the first year of life alone (400.000 births), over 230.000 health events requiring medical attention, including more than 15.000 hospitalizations and approximately 16 deaths each year. Globally, RSV is the leading cause of medical care, outpatient and hospital for respiratory infection in children under one year of age.
This is why preventing respiratory syncytial virus and its complications in the first months of a child's life is a public health priority that impacts our National Health Service.
Today, thanks to research, Italy can also rely on the form of passive immunoprophylaxis offered by new-generation monoclonal antibodies, whose safety and efficacy and use as a new tool for the prevention of RSV available to public health have been widely recognized by the scientific community.
In the ongoing RSV season, there is no shortage of examples in Europe of successful implementation of this new strategy of passive immunoprophylaxis for all newborns and children in their first RSV season. In many European countries, central health authorities have already issued some guidance documents in this regard.
In recent months, there has been no shortage of positions and appeals from the scientific world so that also in Italy it is possible to implement, with the tools available today and with a common and uniform direction on the territory, a still unsatisfied public health need such as RSV, reducing the impacts for our National Health Service and the disparities at the regional level.
Yet, for this to be possible from the next 2024/2025 season also in Italy, concrete and urgent actions are needed that the new Alliance, composed of scientific societies, patient associations, federations, economists and institutions, wanted to outline and illustrate in the Manifesto entitled 'Breathe to grow - Allies for a childhood free from RSV', the result of multidisciplinary work carried out in recent months and supported by Sanofi.
Today, in Rome, at the invitation and initiative of Senator Ignazio Zullo, the subjects who have joined the Alliance presented the Manifesto to the press. “The integration of monoclonal antibodies intended for the entire cohort of children, an innovative and indispensable tool for preventing RSV bronchiolitis - explained Ignazio Zullo, member of the 10th Commission of the Senate of the Republic and promoter of the initiative - can reduce not only the number of accesses to the facilities and, therefore, the number of medium-serious infections, but also the costs associated with hospital admissions and the therapies adopted.
For all these reasons, I have made myself available to raise the issue to the parliamentary level and to use the legislative tools made available to political decision-makers and citizens alike, to ensure that, very soon, passive immunization is made available to all newborns in our country".
Through the combined experiences of institutional figures, clinicians, patients and economists, the Alliance has created a path of comparison that has framed the scenario in the prevention of RSV on the basis of clinical-epidemiological and economic-health evidence and also of social impact.
In terms of economic impact on the National Health Service, the expenditure associated with the management of medically assisted forms of RSV, as well as the management of its complications, amounts to approximately 64 million euros/year in direct costs. Indirect costs determined by the loss of productivity due to premature death (16 deaths related to respiratory syncytial virus) must also be considered, which amount to approximately 3 million euros, as well as the additional costs of the current prophylaxis carried out on high-risk subjects (approximately 13.000 children, 4,4% of the birth cohort), equal to approximately 43 million euros (in the 2022/2023 season).
These are the five actions that need to be implemented as soon as possible to address, with the weapons available today, what is still an unsatisfied public health need:
– Immediately inform the regions and all health workers, at a national level, about the availability of new preventive tools that allow the protection of all children in the first year of life
– UPDATE the Vaccination Calendar and evolve it, with the introduction of the monoclonal antibody, to a National Immunization Calendar, in time to effectively implement the RSV immunization strategy in the 2024/2025 season
– ORGANIZE information and awareness campaigns, aimed at parents and health workers, on the importance of reducing the risks of RSV infection
– ENSURE the protection of the right to health for all children thanks to passive immunoprophylaxis from RSV in a uniform manner, throughout the national territory
– ENSURE joint commitment between national and regional institutions, healthcare professionals and associations for the implementation of immunization campaigns for the prevention of RSV in children in the 2024/2025 season.
The availability of this form of immunization would also benefit families who have to deal with the impact of RSV together with their children.
The Alliance and the drafting of the Manifesto saw the participation of Senator Ylenia Zambito, member of the 10th Commission of the Senate of the Republic, Senator Ignazio Zullo, member of the 10th Commission of the Senate of the Republic, the Honorable Luciano Ciocchetti, vice-president of the 12th Commission of the Chamber of Deputies, Luigi Orfeo, president of the Italian Society of Neonatology (Sin), Giovanni Gabutti, coordinator of the working group 'Vaccines and vaccination policies' of the Italian Society of Hygiene, Preventive Medicine and Public Health (Siti), Rino Agostiniani, vice-president of the Italian Society of Pediatrics (Sip) and Fabio Midulla, past president of the Italian Society of Infantile Respiratory Diseases (Simri).
Paolo Sciattella, member of the CTS of the Italian Society of HTA, Antonio D'Avino, president of the Italian Federation of Paediatricians (Fimp), Pietro Scanzano, health director of the 'Lazzaro Spallanzani' INMI Institute in Rome - Federsanità delegate, Valeria Fava, head of health policies at Cittadinanzattiva, Mario Picozza, president of Federasma, Adriano Bordignon, president of the Forum of Family Associations and Martina Bruscagnin, president of Vivere Onlus, also contributed to the drafting of the Manifesto.
“We are proud to have promoted such an important dialogue between institutions, patient associations, federations and representatives of civil society,” stated Mario Merlo,
General Manager Sanofi Vaccini Italia - because it represents a further step forward in the implementation of a universal immunization strategy from RSV in the first year of life of children. Ensuring equal access in a uniform manner across the territory is a fundamental aspect. We hope that the Ministry of Health can give a common direction to all regions”.
“As Sanofi,” concluded Merlo, “our constant commitment is to research and develop solutions that can change the approach to prevention and respond to unmet health needs.”
Article published on March 5, 2024 - 15pm