Early vaccination against bronchiolitis from birth in September

France is currently facing a major concern: a shortage of medicines that could directly affect the health of its population. The shortage particularly affects an essential antibiotic, amoxicillin, especially in the treatment of children.

The French National Authority for Health (HAS) recently issued a favorable opinion on the Beyfortus vaccine, developed by Sanofi in partnership with AstraZeneca, marking a significant step forward in the fight against bronchiolitis. This decision paves the way for reimbursement of the vaccine for all infants under one year of age, with vaccination possible from the day of birth. Tests conducted on 8,000 infants during the 2022‑2023 winter season revealed that Beyfortus dramatically reduced bronchiolitis‑related hospitalizations, with an efficacy of 83%.

Bronchiolitis affects approximately 30% of infants under the age of 2 in France each year, or approximately 480,000 cases. It results in the hospitalization of 2 to 3% of infants under the age of one. France will thus become the first country in the world to launch a bronchiolitis vaccination campaign for the 2023‑2024 season, with reimbursement guarantees and exceptional measures in place for this winter, including zero out‑of‑pocket costs for parents.

The special regime provides for the administration of a single dose of the Beyfortus vaccine, providing immediate protection for approximately six months, thus covering the entire epidemic season, which runs from October to March. All babies, from birth to one year of age, are eligible for vaccination.

It is also important to note that negotiations between Sanofi and the authorities on the price and distribution terms of Beyfortus are still ongoing and are likely to continue for several months. To guarantee access to the vaccine as early as September, the government has implemented a waiver system. Santé Publique France has already acquired a stock of doses from Sanofi, which is responsible for marketing the vaccine. This stock is already partly in France, in Val‑de‑Reuil (Eure), in the Sanofi logistics center, and will be delivered to maternity wards and other healthcare facilities starting in August, with a view to vaccinating newborns as soon as they are born starting in September. This vaccination will be completely free for parents, with no upfront costs.

For babies already born, parents will be able to go to a pharmacy with a prescription from their doctor to obtain the vaccine dose. It should be noted that pharmacies will not have stock; they will have to order the vaccine as needed, and Sanofi is committed to responding quickly to demand. As with the Covid vaccination during the pandemic, this first 2023 vaccination campaign will be free.

Sanofi is reassuring about shortage fears, stating that the laboratory already has several hundred thousand doses produced worldwide. The French laboratory is already in contact with maternity hospitals for rapid delivery, regardless of their orders.

Starting next year, France will implement a standard vaccination regimen, the precise details of which, including financial details, will be defined once the ongoing negotiations are completed. The Ministry of Health will soon provide additional information to healthcare professionals regarding the prescription and vaccination with Beyfortus.