The vaccine of the pharmaceutical giant Pfizer, marketed under the name Abrysvo, targets the respiratory syncytial virus (RSV), which can cause pneumonia and bronchiolitis in its most severe forms.
The vaccine is authorized for pregnant women between 32 and 36 weeks' gestational age, the U.S. Food and Drug Administration (FDA) said in a statement. The single injection will be performed in a muscle.
Children will be protected during their first six months of life, the FDA explains, thanks to antibodies transmitted by the mother.
This same vaccine was already approved since May in the United States for people 60 years and older.
It was also approved in July by the European Medicines Agency (EMA) -- for both babies and the elderly -- but the European Commission must now decide on its marketing authorization within the European Union.
This virus "is a common cause of illness in children, and infants are among those most at risk of developing severe disease, which can lead to hospitalizations," said Peter Marks, head of the FDA, welcoming this new option against a disease "potentially fatal".
Outbreaks of RSV, a highly contagious virus, are seasonal.
Last winter, hospitals were stormed on both sides of the Atlantic in the face of an epidemic of impressive magnitude.
The Centers for Disease Control and Prevention (CDC), the main federal public health agency in the United States, will in turn have to recommend the vaccine before the injections begin.
The United States records between 58,000 and 80,000 hospitalizations each year related to the virus in children under 5 years of age, and 100 to 300 deaths, according to the CDC. It is the leading cause of hospitalization for toddlers in the country.
After decades of research, pharmaceutical companies are in a race for a multi-billion dollar market.
The British pharmaceutical giant GSK had obtained in early May the first authorization in the world for a vaccine against bronchiolitis, granted by the FDA for adults aged 60 and over. Pfizer then quickly obtained similar approval.
Moderna is also on board.
The European Union and the United States have also recently authorized a preventive treatment for bronchiolitis developed jointly by AstraZeneca and Sanofi. Intended for infants, nirsevimab (marketed under the name Beyfortus) is not strictly speaking a vaccine, but works with the same preventive intention.
The CDC recommended in early August an injection of these monoclonal antibodies for all children under eight months of age, born during or entering their first epidemic season.
© 2023 AFP