2023-12-21 16:11:41
A vaccine administered during pregnancy and a new monoclonal antibody for injection in children once morest the respiratory syncytial virus (RSV) will appear on the Belgian market in 2024, the Superior Health Council (CSS) indicated in a press release on Thursday. Several decades of research were necessary to create these two preventive agents that the CSS describes as “safe”.
The CSS recommends the use, as soon as they become available, of the new monoclonal antibody (nirsevimab) to be administered to the child, and of the vaccine intended for pregnant women to protect their child from birth. Nirsevimab, known by the brand name Beyfortus®, received approval from the European Medicines Agency (EMA) in 2022. “A single injection is enough for around five months of protection, reducing the risk of infection by RSV of 75% and the risk of hospitalization of 79%”, assures the CSS.
The maternal vaccine, known by the brand name Abrysvo®, received the green light from the EMA in August. “An injection during pregnancy (preferably between 28 and 36 weeks) might protect the baby from birth until six months of age, reducing the risk of severe RSV infection by 69% and the risk of hospitalization by 57%,” specifies the Council.
In Belgium, the number of RSV infections in children under five is around 14,500 per year, of which 3,200 to 3,600 result in hospitalization, according to one estimate.
The second leading cause of death among babies worldwide
RSV is the leading cause of lower respiratory tract infections or bronchiolitis in babies under one year of age and the second leading cause of death worldwide. Forms can be severe with significant breathing difficulties or pneumonia. “Every winter, it is responsible for significant pressure on the health care system in Belgium,” recalls the CSS. Every year, children are transferred to another center due to a lack of available beds.
Due to the magnitude of morbidity linked to this virus, the Council wishes to encourage RSV prevention for all infants under one year of age during their first RSV epidemic season, and for children aged one at two years of age at higher risk of serious infections due to other comorbidities, during their second RSV epidemic season.
Until now, only palivizumab, also known by the brand name Synagis®, might prevent the virus in Belgium. Its administration procedure required the child to receive a monthly intramuscular injection over five months. It is for this reason as well as its high cost that it is only indicated for patients at very high risk of serious complications due to RSV.
In order to determine the best vaccination strategy, questions remain regarding the relevance of a seasonal prevention schedule or not, the best time to administer the vaccine during pregnancy, prices, possible reimbursements, co-administration of two preventive agents, the exact duration of protection and the cost-effectiveness ratio.
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