Sanofi/Astrazeneca vaccine gets green light from European Medicines Agency

A new medical advance for newborns? This Friday, Sanofi announces that it has obtained the green light from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for nirsevimab, a medicine to prevent bronchiolitis in infants.

Nirsevimab, jointly developed by the British Astra Zeneca and the French Sanofi, which will market it under the name Beyfortus, is an antibody designed to protect infants throughout the circulation season of respiratory syncytial virus (RSV), the virus responsible for the bronchiolitis.

The first passive immunizing agent

The CHMP issued a favorable opinion and recommended the approval of Beyfortus for the prevention of lower respiratory tract infections caused by RSV in newborns and infants, during the first season of circulation of the virus that they face.

If it is then approved by the European CommissionBeyfortus will become the first and only single-dose passive immunizing agent indicated for all infants, including those who are healthy, born at term or prematurely, or those with certain medical conditions, Sanofi said in its statement.

Bronchiolitis is a common and highly contagious respiratory disease, especially in infants 2 to 8 months old, where it causes coughing and labored breathing. Every year in France, 30% of infants under the age of two are affected.

An antibody developed in the laboratory

“It is the first cause of hospitalization in children under one year old”, underlines Jean-Fran├žois Toussaint, head of R&D in vaccines for Sanofi.

Beyfortus differs from vaccines using traditional technologies because it is a monoclonal antibody, that is to say an antibody developed in the laboratory, which makes it possible to confer so-called passive immunity on the infant, with a single dose.

The infant has not yet been able to build his immune response, “we give him antibodies that will protect him,” explains Jean-Fran├žois Toussaint.

To date, there is only one vaccine (again a preventive medicine) against bronchiolitis, marketed by Astra Zeneca as Synagis.

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