(ANSA) – ROME, NOVEMBER 10 – The first new generation monoclonal antibody capable of protecting all newborns from respiratory syncytial virus, through a prophylaxis capable of drastically reducing the risk of hospitalization, should receive the green light in Europe in 2023. Mario Merlo, general manager of Sanofi Pasteur, explained to ANSA the functioning and the results of this preventive therapy, on the sidelines of the award ceremony of # WhySì, the initiative aimed at promoting forgotten vaccinations.
Respiratory syncytial virus is a very widespread pathogen in the cold months and which can be very dangerous for infants and young children, in which it can lead to a high risk of hospitalization due to respiratory failure and dehydration.
Furthermore, hospitalizations for this virus concern, in 93% of cases, children without particular risk factors, such as prematurity. The recent death of two newborns in Italy and the story on Instagram published by Fedez and Chiara Ferragni after their daughter’s hospitalization, brought to attention a problem against which pediatricians have raised the alarm, especially in view of next winter .
“In the phase 2 study, the monoclonal antibody – Merlo emphasizes – showed 78% protection from the risk of hospitalization, according to the results published in the New England Journal of medicine (NEJM). The study has just ended. phase 3, conducted on about 3,000 newborns, which compared the drug with placebo and confirmed the results. The data will be submitted to the European Medicines Agency (EMA) in 2023. Hopefully, by 2024 it could be authorized and available in Italy “. Today in Italy there is a monoclonal that can be administered in 5 doses only to very premature births. “The new antibody – explains Francesca Trippi, Sanofi Pasteur medical director) – in addition to being single-dose, has been studied on the entire pediatric population under 12 months of age, because it has been seen that hospitalizations for syncytial virus also largely concern children healthy, without risk factors “. (HANDLE).
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Source From: Ansa
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