2023-08-01 15:53:57
ALAIN JOCARD / AFP via Getty Images The effectiveness of Beyfortus is estimated at 83% against the risk of hospitalization, according to the results of clinical trials conducted in Europe in recent years.
ALAIN JOCARD / AFP via Getty Images
The effectiveness of Beyfortus is estimated at 83% against the risk of hospitalization, according to the results of clinical trials conducted in Europe in recent years.
HEALTH – The High Authority for Health (HAS) gave the green light on Tuesday August 1 to the reimbursement of Beyfortusa preventative drug against bronchiolitis in infants, according to information from the Parisian what Le HuffPost was able to confirm.
It is now up to the Ministry of Health to decide when the drug will be implemented. In July, the General Directorate of Health considered in any case that, “subject to a favorable opinion from the HAS, this antibody will be available in September”.
This treatment, developed by the French group Sanofi and its British partner AstraZeneca, can be given to children under one year old. This monoclonal antibody (nirsevimab) aims to protect babies against the respiratory syncytial virus (RSV), responsible for bronchiolitis, which returns every winter and infects a large proportion of children under 2 years old.
It is not a vaccine per se because, as explained The Parisianit does not teach the body to make antibodies, but brings them directly to it. “It is a monoclonal antibody with a long duration of protection: it protects almost immediately and this lasts for at least five or six months”, advances to the daily Charles Wolf, head of the Vaccines France branch at Sanofi. Its effectiveness is estimated at 83% against the risk of hospitalization, according to the results of clinical trials conducted in Europe in recent years.
A single shot
The treatment is given as a single injection into the thigh muscle, before the start of the epidemic season or at birth for infants born during this critical period. The recommended dose is 50 mg for children weighing less than 5 kg and 100 mg for children weighing 5 kg or more.
In mid-July, this drug had already been approved in the United States by the American Medicines Agency (DFA) and the European Medicines Agency had already issued a marketing authorization almost a year ago.
During the 2022-2023 winter season, Santé Publique France reported 73,262 visits to the emergency room for bronchiolitis, 26,104 hospitalizations after going to the emergency room and 10,801 SOS Médecins acts. A balance sheet twice as heavy as that recorded, on average, between 2015 and 2020.
More broadly, bronchiolitis affects nearly 30% of infants under 2 years of age each winter, i.e. approximately 480,000 cases per year, and RSV is responsible for the majority of bronchiolitis, according to CORRUSS figuresOperational center for regulation and response to health and social emergencies.
Pfizer is also developing a vaccine for pregnant women, which aims to protect their future baby by antibodies passing through the plasma, on which the European Medicines Agency issued a favorable opinion on July 21. The HAS should soon decide for France.
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