“Highly contagious, respiratory syncytial virus (Rsv) can cause severe respiratory disease, especially in newborns. Globally, RSV is the main cause of outpatient and hospital medical care.” Today there is the possibility of preventing this pathology in all newborns “and drastically reducing hospital admissions, but the Regions proceed in no particular order” and not all are ready to make immunization available before “the seasonal peak, which goes from October-November until March”. Annamaria Staiano, president of the Italian Society of Paediatrics, said this to Adnkronos, recalling the commitment that Sip, together with other scientific societies and associations, is carrying out at an institutional level and “hoping” that all the Regions are ready to make the monoclonal antibody available for newborn coverage by the first peak season, i.e. autumn. “We hope that all Italian newborns can have an equal chance of being protected from RSV regardless of the region in which they are born or live”, she underlines.
“Over 60% of children become infected in the first year of life and 100% within the second – explains Staiano – Bronchiolitis and pneumonia are the most frequent infections under the age of one and are responsible, respectively, for 80% and 40% of hospitalizations”. It is estimated that “every year in Italy the epidemic season of respiratory syncytial virus, which runs from October-November to March, involves, in the cohort in the first year of life alone, approximately 400 thousand newborns, over 230 thousand health interventions requiring medical attention , more than 15 thousand hospitalizations, with approximately 16 deaths”. Furthermore, “during the seasonal peak, up to 80% of beds in neonatal and pediatric intensive care are occupied”, which in Italy are overall “around 1,320 and are not distributed homogeneously throughout the national territory”, with therefore a further difference in access to care.
Against this infection, “until now – underlines President Sip – we only had an old generation monoclonal antibody, reserved for some specific categories of newborns, especially preterm or with complex comorbidities. Today we have a vaccine available which has indications for use during pregnancy for the protection of the newborn, but also a new generation monoclonal antibody, nirsevimab, which can be administered to immunize all newborns, not only premature babies or those with conditions that make them more vulnerable to RSV, but also those born at term. This antibody, which is very easy to handle, is injected only once and prevents the onset of complications in the event of an Rsv infection for the first time – underlines Staiano – we therefore have the opportunity to protect all newborns in their first epidemic season.”
This is “a paradigm shift in prevention – he specifies – because it is the first time that a monoclonal antibody is used as a prevention tool, like a vaccine, so to speak, and not as a therapy. In clinical studies nirsevimab has proven to be safe and effective in drastically reducing, over 80%, hospitalization and therefore the impact on the National Health Service”. In Italy it is estimated that the expenditure associated with RSV infection and its complications is equal to approximately 64 million euros/year in direct costs, to which must be added the indirect costs of the current prophylaxis carried out on high-risk subjects.
Many European countries (France, Spain, Germany, Belgium, Holland, Sweden, Luxembourg, Finland, Ireland) are already ready and have in fact issued recommendations for the use of the monoclonal antibody in immunization campaigns for all children in the next season . Ministries in other countries have made public statements in support of such campaigns.
“In Italy the Regions are moving in no particular order, because this immunization is not part of the vaccination calendar – observes the president Sip – The Regions have their own autonomy. Valle D’Aosta is the first to be activated in 2023 and no child among those treated with the antibody was hospitalized. Other Regions are preparing and have requested to purchase the antibody for administration in October, but a public health strategy is needed that favors immunization, which is why we ask that they take action. campaigns for the prevention of RSV infections”.
The Italian Society of Paediatrics, together with other scientific societies “has expressed its opinion recommending the use of the monoclonal antibody to protect all newborns from the respiratory syncytial virus in the first year of life – Staiano points out – In particular, Sip is part of the Alliance for a childhood free from respiratory syncytial virus, made up of various scientific societies, patient associations, federations and institutions, we all presented together, on the occasion of an institutional event in Rome, the Manifesto entitled ‘. Breathing to grow – Allies for a childhood free from RSV’, which contains actions to protect all newborns from this virus. Sip will certainly continue to work to guarantee a common and uniform direction throughout the national territory, so that they can be regional disparities have been reduced and all children can have an equal chance of being protected from this virus and other diseases, regardless of where they are born or live – reassures the president – We hope that in the month of July all the Regions will have already taken action to start as soon as possible with immunization which – he concludes – is offered free of charge to all newborns and infants or in any case in the first peak season”.
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