The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave the green light on Friday, September 16, for the future marketing of a vaccine against bronchiolitis for newborns. The drug, called “Beyfortus”, uses a monoclonal antibody, nirsevimab, was developed jointly by the French laboratories Sanofi and Swedish-British AstraZeneca.
Franceinfo takes stock of this step taken in the prevention and fight against this seasonal disease which mainly affects babies under 2 years old, but also the elderly.
The first bronchiolitis drug that can be injected into all newborns
The use of nirsevimab for the prevention of the virus respiratory syncytial (RSV), responsible for bronchiolitis, is recommended by the EMA for ‘newborns and infants during the first virus circulation season they experience’the institution said in a statement. (link in English).
The approval of the European health authority, which paves the way for a marketing authorization (AMM) for this health product, represents a medical advance, but also a world first. It is to date the only vaccine against RSV which should be able to be injected into all babies under 1 year of age. Until now, another antibody, palivizumab, marketed under the name Synagis (AstraZeneca), was already available, but only for premature or at-risk children.
Although requiring a venous injection, Beyfortus is, in practice, not exactly a vaccine. Unlike the traditional vaccine process, which allows the human body to produce the antibodies it needs to defend itself against a virus, the administration of nirsevimab, which is similar to a preventive treatment, directly introduces an antibody “designed to attach to the protein (…) which the virus needs to infect the body. When nirsevimab attaches to this protein, the virus becomes unable to enter the cells of the body”, specifies the EMA. Suitable prevention for newborns, who have not yet built up their entire immune system.
One dose is sufficient to immunize an infant
In a press release (link in English) dating from the month of May, the Sanofi laboratory says it has found following clinical trials an effectiveness of 79.5% of nirsevimab against forms of infections requiring medical monitoring, and 77.3% against hospitalizations. Unlike its predecessor, Synagis, which requires the injection of several doses (in PDF)a single injection is enough to be effective. “Because the drug is slowly eliminated from the body, over several months, a single dose of Beyfortus protects infants against the virus” during the infectious season, explains the EMA.
In France, the seasonal epidemic generally begins at the beginning of autumn and ends at the end of winter, writes Public Health France (SPF). After the EMA’s decision, it is now the European Commission and the national health agencies who will now have to give a possible green light in the coming months for marketing authorization in all EU Member States. If the marketing authorization is well approved, we will therefore have to wait until the fall of 2023 to see this product actually circulate on the European and French market.
This is good news for the hospital…
Bronchiolitis is a respiratory disease, most often benign when properly treated. VSIn infants 2 to 8 months old, it can cause a strong cough and labored breathing. And it is very contagious. Hospitals fear each year the start of the epidemic and the risk of saturation of their pediatric services. In an opinion dated October 2021, the Scientific Council recalled that around 2,000 hospitalizations could take place each week during a bronchiolitis season in France, making the disease one of the main causes of congestion in pediatric wards during the cold season.
Public Health France figures for its part at 30% the average proportion of children under 2 years old affected each year by RSV. The arrival of a vaccine that can be administered on a large scale brings hope to see a drop in the number of emergency and pediatric hospitalizations linked to bronchiolitis.
At the global level, progress could also be made on child health and infant mortality. In 2015, the virus caused “about 33 million lower respiratory tract infections in children under 5 worldwide; 3.2 million of them required hospitalization. About 59,600 children died, the vast majority (43,600) in low- and middle-income countries, details the EMA in its press release.
… And for Sanofi
For the French pharmaceutical laboratory, the favorable opinion of the EMA is obviously good news, especially after its failure to develop a vaccine against Covid-19. It is also a not insignificant prospect at the financial level. “When you are first to market, you have a competitive advantage, especially in terms of price,” explained on franceinfo Frédéric Bizard, professor of economics at ESCP Business School and founding president of the Institut Santé.
Besides infants, bronchiolitis also affects the elderly. If Sanofi obtained the first authorization to market its product for toddlers, pharmaceutical companies GSK and Pfizer could manage to develop a vaccine against bronchiolitis for immunocompromised people and seniors. For its part, the Moderna laboratory is betting on the technique of messenger RNA (mRNA) to set up a preventive treatment. As a result, the potential market, estimated at around ten billion euros according to Frédéric Bizard, is colossal.