Every year in Italy the epidemic season of the 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 every year. Globally, RSV is the leading cause of medical, outpatient and hospital care for respiratory infection in children under one year of age. Today, thanks to research, we can also count in Italy on the form of passive immunoprophylaxis offered by new generation monoclonal antibodies whose safety and effectiveness and whose use as a new RSV prevention tool available to public health have been widely recognized by the scientific community. Yet, for this to be possible from the next 2024-2025 season also in Italy, concrete and urgent actions are necessary.
Actions that a new Alliance, made up of scientific societies, patient associations, federations, economists and institutions, wanted to outline and illustrate in the Manifesto '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 belonged to the Alliance presented the 5 points of the Manifesto to the press. In the RSV season still underway – it emerged from the meeting – there is no shortage of examples in Europe of successful implementation of this new passive immunoprophylaxis strategy for all newborns and children in their first RSV season. In many European countries, guidance documents in this sense have already been issued by the central health authorities. In recent months, there has been no lack of positions and appeals from the scientific world so that it can also be implemented in Italy, with the tools available today and with a common and uniform direction across the territory, in the face of a healthcare need. public still dissatisfied like the RSV, reducing the impacts for our NHS and the disparities at regional level.
“The integration of monoclonal antibodies intended for the entire cohort of children, an innovative and indispensable tool for preventing RSV bronchiolitis – said Zullo, member of the , the number of medium-serious infections, but also the costs associated with hospital admissions and the therapies adopted. For all these reasons, I made myself available to raise the issue to a parliamentary level and to use the legislative tools made available to political decision-makers as well as citizenship, to ensure that, very soon, passive immunization is made available to all newborns in our country”.
The Alliance, through the combined experiences of institutional figures, clinicians, patients and economists, has created a process 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 – it was underlined during the meeting – the expenditure associated with the management of medically assisted forms of RSV, as well as the management of its complications, is equal to approximately 64 million euros/year in costs direct. Furthermore, the indirect costs determined by the loss of productivity due to premature death (16 deaths related to RSV) must be considered, which are equal 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 court of birth), equal to approximately 43 million euros (in the 2022/2023 season).
Hence the Manifesto 'Breathe to grow – Allies for a childhood free from RSV', with 5 actions that need to be implemented as soon as possible to address what is still an unsatisfied public health need with the weapons available today: 1. Inform immediately the Regions and all health workers, at a national level, on the availability of new preventive tools that allow the protection of all children in the first year of life; 2. 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; 3. Organize information and awareness campaigns, aimed at parents and healthcare workers, on the importance of reducing the risks of RSV infection; 4. Guarantee the protection of the right to health for all children thanks to passive immunoprophylaxis against RSV in a uniform way, throughout the national territory; 5. Ensure joint commitment between national and regional institutions, health workers 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 must face the impact of RSV together with their children.
“We are proud to have promoted such an important dialogue between institutions, patient associations, federations and representatives of civil society – declares 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 children's lives. 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 the Regions. Like Sanofi, our constant commitment is aimed at researching and developing solutions that can also change the approach to prevention and respond to unmet health needs”.
The Alliance and the drafting of the Manifesto saw the participation of senators Ylenia Zaiuto and Ignazio Zullo (X Senate Commission); Luciano Ciocchetti, vice-president of the XII Chamber Commission; Luigi Orfeo, president of the Italian Society of Neonatology (Sin); Giovanni Gabutti, coordinator of the 'Vaccines and Vaccination Policies' working group of the Italian Society of Hygiene, Preventive Medicine and Public Health (Siti); Rino Agostiniani, vice-president of the Italian Society of Paediatrics (Sip); Fabio Midulla, past president of the Italian Society of Childhood Respiratory Diseases (Simri); Paolo Sciattella, member of the CTS Italian Society of HTA; Antonio D'Avino, president of the Italian Federation of pediatricians (Fimp); Pietro Scanzano, health director of the Inmi Lazzaro Spallanzani Institute of Rome and Federsanità delegate; Valeria Fava, Cittadinanzattiva health policy manager; Mario Picozza, president of FederAsma; Adriano Bordignon, president of the Family Associations Forum; Martina Bruscagnin, president of Vivere onlus.
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