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The European Medicines Agency authorizes the first vaccine for infants against RSV – Pfizer’s Abrysvo

The European Medicines Agency (EMA) on Friday authorized a first vaccine for infants against the respiratory syncytial virus (RSV), known especially for the bronchiolitis epidemic it causes every winter, reports AFP.

The Abrysvo vaccine, developed by the American company Pfizer, is also recommended for people over the age of 60, as is the Arexvy serum, manufactured by the British laboratory GSK, the first authorized in the European Union, according to Agerpres.

Highly contagious, respiratory syncytial virus (RSV) can cause, in its most severe forms, pneumonia and bronchiolitis that lead to thousands of deaths and hundreds of thousands of hospitalizations globally.

“Abrysvo is the first vaccine against RSV indicated for passive immunization of babies from birth six months after the vaccine was administered to the mother during pregnancy,” said the EMA.

The Pfizer vaccine “is also indicated for active immunization of adults over the age of 60,” the European regulatory agency added in a statement.

After the flu and COVID-19, the big laboratories are ready to launch vaccines against RSV from autumn, before the epidemic period.

In May, the United States approved the Arexvy vaccine, produced by the British laboratory GSK, for the first time in the world. The serum is also available in the European Union from June for people over 60.

Pfizer received the green light from the US Food and Drug Administration last month for its Abrysvo vaccine, but it is reserved for the elderly.

Abrysvo was evaluated under the EMA’s accelerated evaluation mechanism, as the prevention of RSV infections is considered “of major public health interest”.

“RSV is a common respiratory virus that generally causes mild cold-like symptoms,” the EMA explained.

“But it can have serious consequences for children and the elderly” and is also “one of the main causes of pediatric hospitalization in Europe”, the agency added.

The approval will now be sent to the European Commission, which must decide on its authorization for marketing in the European Union, a step which, normally, is a formality.

2023-07-21 19:37:55
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