The European Medicines Agency (EMA) authorized for the first time, on Friday July 21, a vaccine intended to protect both people aged 60 and over, and infants against the RSV respiratory virus, known above all for the scourge of bronchiolitis it causes each winter. During the winter of 2022-2023, the particularly intense and prolonged epidemic extended from October (nearly two months earlier than usual) to January. She has caused the hospitalization of 26,000 peoplemostly children under the age of two.
First vaccine for infants
Highly contagious, the respiratory syncytial virus (RSV) can cause pneumonia and bronchiolitis in its most severe forms, which lead to thousands of deaths and hundreds of thousands of hospitalizations worldwide. “RSV is a common respiratory virus that usually causes mild cold-like symptoms,” the EMA explained. “But it can have serious consequences for children and the elderly”, and is even “one of the main causes of pediatric hospitalization in Europe”, added the regulator. A vaccine was therefore particularly awaited.
Called Abrysvo and developed by Pfizer, it is “the first RSV vaccine indicated for passive immunization of infants from birth to 6 months after the vaccine has been given to the mother during pregnancy,” the European Medicines Agency (EMA) said. It may also be administered for the active immunization of adults 60 years of age and older. This elderly population also has access to the Arexvy vaccine, from the British laboratory GSK, authorized in the European Union since the end of June 2023. In the United States, the two vaccines are also already available for the elderly.
Ready for winter 2023-2024
After the flu and Covid-19, the major laboratories are in working order to launch the production of vaccines against RSV in the fall, before the epidemic period. Pfizer’s vaccine has also been assessed under the EMA’s accelerated assessment mechanism, because the prevention of RSV infections is considered “of major public health interest”. A Moderna vaccine is also under consideration.
The EMA’s opinion will now be sent to the European Commission, which must decide on its marketing authorization in Europe. “If approved, our RSV vaccine candidate for pregnant women could help protect infants immediately from birth up to six months of age,” said Dr. Annaliesa Anderson, Scientific Director, Research and Vaccine Development at Pfizer, to AFP.
At the end of 2022, the European Union also approved a preventive treatment for bronchiolitis developed jointly by AstraZeneca and Sanofi. Intended for infants, Nirsevimab is not strictly speaking a vaccine but works with the same preventive intention.