The laboratory race has been launched for several months. The European Medicines Agency (EMA) authorized on Friday July 21 a first vaccine intended to protect infants against the respiratory syncytial virus (RSV), known above all for the scourge of bronchiolitis it causes each winter. Developed by the Pfizer laboratory, it is called Abrysvo.
“Abrysvo is the first RSV vaccine indicated for passive immunization of infants from birth to six months after maternal vaccine administration during pregnancy”the MEA said in a statement.
This vaccine “is also indicated for the active immunization of adults aged 60 years and over”, she wrote. A first vaccine, Arexvy, from the British laboratory GSK, has been authorized in the European Union (EU) since June for people over 60.
One of the leading causes of pediatric hospitalization
Abrysvo has been tested under the EMA fast-track mechanism, as prevention of RSV infection is considered “as being of major interest to public health”.
Very contagious, the virus can cause, in its most severe forms, pneumonia and bronchiolitis, 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”explained the WEA. “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. In France, the number of hospitalizations related to bronchiolitis is estimated at 50,000 each year.
After the flu and Covid-19, the major laboratories are in working order to launch RSV vaccines in the fall, before the epidemic period. Pfizer had already received last month the agreement of the American Medicines Agency to market its Abrysvo vaccine, only for the elderly.
The expected marketing authorization
The opinion of the EMA will now be sent to the European Commission, which must decide on its marketing authorization within the EU.
“If approved, our RSV vaccine candidate for pregnant women could help protect infants immediately from birth up to 6 months of age”said Dr. Annaliesa Anderson, scientific director, research and development of vaccines at Pfizer. “This, together with approval for the elderly, would mark a significant public health advance for the prevention of RSV disease across Europe”she added in a press release.
The European Union has also approved at the end of 2022 a preventive treatment for bronchiolitis jointly developed by AstraZeneca and Sanofi. Intended for infants, nirsevimab is not strictly speaking a vaccine, but works with the same preventive intention.