The European Medicines Agency (EMA) on Friday authorized a first vaccine for infants against the respiratory virus RSV, known above all for the scourge of bronchiolitis it causes each winter.
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Abrysvo, developed by the American Pfizer, is also recommended for people aged 60 and over, like the Arexvy serum from the British laboratory GSK, the first to be authorized in the European Union.
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 after the vaccine is given to the mother during pregnancy,” the EMA said.
Pfizer’s vaccine “is also indicated for the active immunization of adults aged 60 and over,” the European regulator added in a statement.
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 was assessed under the EMA’s fast-track review mechanism because the prevention of RSV infections is considered ‘of major public health interest’.
“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.
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.