RSV Vaccine Receives European Regulatory Approval: Protecting Infants and Elderly Against Severe Respiratory Virus

2023-07-21 20:57:27

The European regulator on Friday authorized a first vaccine intended to protect both infants and people aged 60 and over against the respiratory virus RSV, known especially for the scourge of bronchiolites that it causes every winter. 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 has been given to the mother during pregnancy,” the European Medicines Agency (EMA) said. The vaccine of Pfizer “is also indicated for the active immunization of adults aged 60 years and over,” the EMA added in a statement.

RSV, “one of the main causes of pediatric hospitalization”

After the flu and the Covid-19, the major laboratories are in working order to launch vaccines against RSV in the fall, before the epidemic period. The Arexvy from the British laboratory GSK is available at UNITED STATES since May and in the European Union since June for the over 60s. 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 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. “If approved, our RSV vaccine candidate for pregnant women could help protect infants immediately from birth up to six months of age,” said Dr. Annaliesa Anderson, Scientific Director, Vaccine Research and Development, 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, quoted in a statement.

At the end of 2022, the European Union also approved a preventive treatment for bronchiolitis developed jointly by AstraZeneca and Sanofi. Intended for infants, nirsevimab is not strictly speaking a vaccine but works with the same preventive intention.

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