by Daniele De Luca *
The monoclonal antibody has already been approved by the European Medicines Agency, but in our country the campaign is destined to be postponed by a year
It seems that the experience accumulated over the many years of the pandemic has not been implemented and put to good use with regards to the epidemic of respiratory syncytial virus (RSV), which represents the main cause of bronchiolitis and other respiratory infections in childhood and causes usually major winter epidemics. Particularly in recent years we have witnessed peaks with the need for hospitalization in neonatal/pediatric intensive care disproportionate to the availability of beds. In many European countries and regions, newborns and infants have had to be moved hundreds of kilometers away from home to care for them. From this year we have the possibility of carrying out a universal, safe (passive) immunization of all newborns and infants with an effective monoclonal antibody with a single administration for the entire winter season.
The antibody has been approved by the FDA (Food and Drug Administration) and EMA (European Medicines Agency), and is being administered universally in North America. Available in Europe, but in fact used patchily in the EU with serious and ethically questionable inequalities. France and Spain began their universal immunization campaign in September, Germany and Luxembourg follow shortly, but no other European country, including Italy, does so. Yet the drug approved for everyone and all newborns deserve to be protected. Certainly, unfortunately, they will not be for this 2023-2024 season. The reasons are multiple and all worrying, as reported in an article recently published in Lancet Regional Health – Europe by a group of experts. These include: further steps at national or regional level, despite centralized European approval; the lack of a preferential implementation path; the lack of public information about RSV and the possible shortage of beds in pediatric/neonatal intensive care.
Excessive regionalization, in some aspects, of the healthcare system also plays a role where a more centralized system would respond more quickly to epidemic emergencies. But there are also other factors such as the relative lack of industrial production capacity and perhaps the lack of attention given to the problem even by us doctors. Rsv infections have a very low mortality, but children with concomitant diseases can die and in any case often require respiratory support in intensive care with consequences in terms of time, resources, costs, as well as anxiety and lost working days for parents. Despite the pandemic, therefore, European and Italian children do not have equal access to beneficial intervention, suffering from discrimination that would be easily avoidable.
* Professor of Neonatology, Universit Paris Saclay; Pediatric Committee Ema (the opinions expressed are personal and in no case attributable to Ema or its internal structures)
October 30, 2023 (modified October 30, 2023 | 09:39)
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