The French laboratory Sanofi obtained, this Friday, September 16, a favorable opinion from the European Medicines Agency (EMA) for its vaccine against bronchiolitis intended for all infants under one year of age.
The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) on September 16 recommended the approval of the vaccine Beyfortus® (nirsevimab) for the prevention of lower respiratory tract infections caused by respiratory syncytial virus (RSV) in newborns and infants, during the first virus circulation season with which they are confronted. It is an investigational, long-acting antibody designed to protect all infants against RSV infection from birth through their first RSV viral season with a single dose. RSV is the most common cause of lower respiratory tract infections in infants, such as bronchiolitis and pneumonia, and one of the leading causes of their hospitalization.
An experimental long-acting antibody
Jointly developed by Sanofi and AstraZeneca, if approved, Beyfortus® will become the first single-dose passive immunizing agent indicated for all infants, whether healthy, full-term or premature, or those with certain health problems such as congenital heart disease, chronic lung disease related to their prematurity, or both.
According to Jean-François Toussaint, Global Head of Vaccine Research and Development at Sanofi: “ The favorable opinion that the CHMP gave […] constitutes one of the most important advances in terms of public health and the fight against RSV in several decades ».
A vaccine that is 79.5% effective
Clinical trials have observed an efficacy (relative risk reduction compared to placebo) of 79.5% of the vaccine against lower respiratory tract infections caused by RSV requiring medical management, such as bronchiolitis or pneumonia , in term and preterm infants, at the start of the first RSV season of life, and 77.3% efficacy against hospitalizations for lower respiratory tract infections caused by RSV.
For the vaccine to be administered in France, it will have to wait for it to obtain marketing authorization from the National Medicines Agency (ANSM).