A cure arrives for RSV, the respiratory syncytial virus that also affected the newborn son of fashion designer Philipp Plein

There is a new monoclonal drug that has demonstrated high efficacy in bronchiolitis And pneumonia from respiratory syncytial virus and in general against the hospitalizations of children, even very young ones, linked precisely to this virus of order Mononegavirales which is the most frequent cause of lower respiratory tract infections in childhood. This is the same virus that recently hit the third son of the German fashion designer Philipp Plein, Rouge, born in Switzerland last October. Hospitalization was necessary for the little one: he gave an account of it, in two reels above Instagram accompanied by words full of apprehension, the 45-year-old entrepreneur himself is on Christmas Day.

The admission to neonatal intensive care of little Rouge at the Princess Grace hospital in the Principality of Monaco was in fact necessary due to complications related to the syncytial infection, which is affecting many children also in Italy in recent weeks and which in general, since 2021 post-Covid, has returned in all its violence. Another reel from a few days later signaled a slightly improving situation: «Rouge is a real fighter and he is strong, stronger than I can be, he is my hero» wrote the father on Meta's social network.

The cure in a monoclonal antibody

The new drug, already authorized by the European authority EMA but not by the Italian AIFA, isnirsevimab monoclonal antibody (commercial name Beyfortus). A major phase 3 study published in New England Journal of Medicine explains now that the single administration has made a mark an effectiveness of 83.2% in reducing hospitalizations linked precisely to complications such as those from Rsv. Specifically, among over 8 thousand children involved in the survey, only 0.3% of those who received a dose of nirsevimab were hospitalized for lower respiratory tract infections versus 1.5% of those who received traditional prophylaxis. “Now we have a way to prevent 80% of RSV hospitalizations,” he explained Saul FaustPhD at Southampton University Hospital in MedPage. «These results show that this long-acting antibody is safe and it could protect thousands of children from hospitalization when used in conditions similar to routine clinical practice” added the doctor in a press release. Unlike previous clinical studies, “the study context included maternity wards, community pediatric practices and general practices,” the authors specified.

The very serious infectionsthose that led to a saturation level of less than 90% and therefore required oxygen, occurred only in 0.1% of children of the group that had received the monoclonal versus 0.5% in the control group, a ratio which corresponds – for the most serious infections – to an effectiveness of 75.7% in preventing them. The drug, developed by Astrazeneca and Sanofi, has received marketing approval from US FDA last July but for the winter season stocks are still reduced to a minimum. In Europe, as mentioned, the authorization dates back to 2022.

The reasons for the “blockade” in Italy

The practice regarding availability in Italy is instead blocked for almost a year now at AIFAthe Italian Medicines Agency, and so it was not possible to use it for the current season – which is proving to be particularly heavy – nor for its inclusion, as requested by many pediatric scientific societies, in the national immunization calendar for newborns guaranteeing protection for up to five months.

The reason for the quagmire at Aifa is, as we read in one determines last January, the ongoing negotiation between manufacturing companies and the agency with respect to price and refundability by the National Health System. In short, it's a question of money. A very serious length to which, recently, a group of experts also returned – not only as regards Italy – with a letter in the magazine The Lancet Regional Health Europe which denounces the slowness of national agencies in making available in various European countries not only the new monoclonal but also the vaccine to be administered to pregnant women (Abrysvo of Pfizer) to guarantee the immunization of the unborn child. Only France and Spain have started universal immunization of newborns with nirsevimab, in addition to the United Kingdom and the United States, the rest of the European countries – apart from Germany which is in the starting phase – are at a standstill for similar reasons, linked to reimbursement or less than the drug from their respective healthcare systems.

Very heavy delays, considering that the respiratory syncytial virus is one of the main pathogens that affect the respiratory tract in children. Globally, every year, it causes 3.6 million hospitalizations and the death of over 100 thousand children. At the moment we do not have specific therapies for prevention, except another monoclonal antibody, the palivizumabcapable of preventing the most serious forms of lower respiratory tract disease but which however can only be used in a small proportion of children based on clinical indications. Nirsevimab could therefore lead to universal protection for all newborns compared to a virus that has demonstrated in recent years, especially after the long periods of isolation from Covid-19, a very violent return that has put and continues to put the pediatric departments of many hospitals in difficulty.

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