EU drug watchdog approves first RSV infant vaccine


RSV normally causes mild, cold-like symptoms, but can be serious for infants the elderly, those with weak immune systems and underlying conditions, and is a leading cause of paediatric hospitalisation in Europe, the EMA said.

In severe cases it can cause pneumonia and bronchiolitis, an inflammation of the small airways deep inside the lungs.

The medicine, called Abrysvo made by Pfizer, was approved in the United States in May.

It followed the EU-wide approval of GlaxoSmithKline's anti-RSV drug called Arexvy last month, which like Pfizer's shot could also be used for people over 60.

"Abrysvo is the first RSV vaccine indicated for passive immunisation of infants from birth through six months of age following administration of the vaccine to the mother during pregnancy," the EMA said.

"This vaccine is also indicated for active immunisation of adults aged 60 years and older," it added.

The approval of the new RSV vaccines is the culmination of a decades-long hunt to protect vulnerable people from the common illness.

Abrysvo is a bivalent vaccine, meaning it protects against more than one virus strain -- and when given to a person, their immune system generates specific antibodies and T-cells (immune system cells) that help prevent RSV infection.

"In case of pregnant individuals, the neutralising antibodies cross the placenta, providing infants with protection up to six months after birth," the EMA said.

Analysts predict the market could be worth more than $10 billion in the next decade, with similar shots from other makers including Moderna and Sanofi expected to follow soon.

The EMA's finding will now be sent to the European Commission for a final decision for EU-wide marketing authorisation.