the world’s first injectable vaccine in all babies under the age of one authorized

An unprecedented medical advance: the French Sanofi announces Friday, September 16 that the European Medicines Agency has just given a first green light to its vaccine against bronchiolitis in infants. A previous vaccine already existed but it was reserved for premature babies and babies at high risk.

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The French laboratory Sanofi has developed in partnership with the Swedish-British AstraZeneca a vaccine against injectable bronchiolitis in all babies under one year old. A world first which received the green light on Friday, September 16 from the European Medicines Agency (EMA).

The laboratories were launched in a race of speed, about thirty similar projects being in progress all over the world. The injectable vaccine from Sanofi and AstraZeneca therefore comes first. A huge challenge because each year, 500,000 babies in France are infected with the respiratory syncytial virus (RSV) responsible for bronchiolitis. Last year’s outbreak was unprecedented, and hospitals were overwhelmed. Globally, there are 60,000 infant deaths per year.

Rather than a vaccine, Sanofi-AstraZeneca’s injectable solution is a preventive treatment, a monoclonal antibody that will protect babies under one year of age throughout the epidemic period, that is to say autumn and winter. ‘winter. It reduces infections by 75%. The idea is that babies do not yet have a highly developed natural defense system, so we replace it with this antibody. A vaccine against bronchiolitis already existed but its effectiveness was less and it was reserved only for premature babies and very high-risk babies. There, it will be for all babies under one year old.

Unfortunately, the treatment will not be available this winter because the deadlines are too tight, the epidemic generally starting in the fall, within a few weeks. And it now takes several months of regulatory procedures, so there will be no possible marketing in Europe before the epidemic next year.

Last clarification: when we talk about bronchiolitis, we generally think of children, infants. But be aware that the epidemic also seriously affects the elderly every year. This new preventive treatment is not intended for them. But many pharmaceutical companies are in the process of developing specific vaccines against bronchiolitis for the elderly.


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