Very 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.
“Abrysvo is the first RSV vaccine indicated for passive immunization of infants from birth to 6 months following maternal vaccine administration during pregnancy”, said the EMA.
The Pfizer vaccine “is also indicated for the active immunization of adults aged 60 years and over”, added the European regulator in a press release.
“One of the main causes of pediatric hospitalization”
After the flu and Covid-19, the major laboratories are in working order to launch RSV vaccines in the fall, before the epidemic period.
In a world first, the United States approved the Arexvy vaccine from the British laboratory GSK in May. The serum has also been available in the European Union since June for people over 60.
Pfizer had already received the green light from the US Medicines Agency last month for its Abrysvo vaccine, but it is reserved for the elderly.
Abrysvo has been assessed under the EMA’s accelerated review mechanism, as the prevention of RSV infections is considered “as being of major public health interest”.
“RSV is a common respiratory virus that usually causes mild cold-like symptoms,” explained the EMA. “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.
The opinion will now be sent to the European Commission which must decide on its marketing authorization within the EU, which is normally a formality.
