what we know about Beyfortus produced by Sanofi, after the green light from the European Medicines Agency

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 sale of a vaccine against bronchiolitis for newborns. The drug, called “Beyfortus”, uses a monoclonal antibody, nirsevimab, developed jointly by French laboratories Sanofi and Swedish-British AstraZeneca.

Franceinfo examines this measure taken to prevent and fight this seasonal disease that mainly affects children under 2 years old, but also the elderly.

The first bronchiolitis drug that can be injected in all newborns

The use of nirsevimab for the prevention of the virus respiratory syncytial (RSV), which is responsible for bronchiolitis, recommended by the EMA for ‘newborns and infants in the first period of viral circulation 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 breakthrough, but also a world first. It is currently the only vaccine against RSV that must be injected into all children under 1 year of age. Until now, another antibody, palivizumab, marketed under the name Synagis (AstraZeneca), is available, but only for premature or high-risk babies.

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 protect itself against a virus, the administration of nirsevimab, similar to a preventive treatment, directly identifies of an antibody. “is designed to attach to a protein (…) that the virus needs to infect the body. When nirsevimab attaches to this protein, the virus can no longer enter the body’s cells”, determines the EMA. Appropriate prevention for newborns, who have not yet established their entire immune system.

One dose is enough to vaccinate the child

In a press release (link in English) from the month of May, the Sanofi laboratory said that it found after clinical trials an effectiveness of 79.5% of nirsevimab against forms of infection that require medical monitoring, and 77.3% against hospitalization. Unlike its predecessor, Synagis, which requires the injection of multiple doses (in PDF)one injection is enough to be effective. “Because the drug is slowly eliminated from the body, for several months, a dose of Beyfortus protects infants against the virus” during the infectious period, explained the EMA.

In France, the seasonal epidemic usually begins at the beginning of autumn and ends at the end of winter, writes Public Health France (SPF). Following the EMA’s decision, it is now up to the European Commission and the national health agency to give a possible green light in the coming months for marketing authorization in all EU States. If the marketing authorization is well approved, therefore we will have to wait until the fall of 2023 to see that this product actually circulates in the European and French market.

This is good news for the hospital…

Bronchiolitis is a respiratory disease, usually benign if properly treated. VSIn infants 2 to 8 months old, it can cause a strong cough and difficulty breathing. And it is very contagious. Hospitals fear every year the beginning of the epidemic and the risk of saturation of their pediatric services. In an opinion dated October 2021, the Scientific Council recalls that almost 2,000 hospitalizations can occur every week during bronchiolitis in France, making the disease one of the main causes of overcrowding in pediatric wards during cold weather.

Public Health France calculates its share of 30% the average proportion of children under 2 years affected each year by RSV. The arrival of a vaccine that can be administered on a large scale brings hope to see a reduction in the number of emergencies and pediatric hospitalizations associated with bronchiolitis..

At the global level, child health and child mortality may also improve. In 2015, the virus caused “About 33 million lower respiratory tract infections in children under 5 years of age worldwide; 3.2 million of them require hospitalization. About 59,600 children die, the majority (43,600) in low and middle- middle income countries, EMA details in its press release.

… And for Sanofi

For the French pharmaceutical laboratory, the favorable opinion of the EMA is clearly good news, especially after its failure to develop a vaccine against Covid-19. It is also not a small prospect on a financial level. “If you are the first in the market, you have a competitive advantage, especially in terms of price,” explained to franceinfo Frédéric Bizard, professor of economics at the ESCP Business School and founding president of the Institut Santé.

Besides infants, bronchiolitis also affects the elderly. When Sanofi obtained the first approval to market its product for children, pharmaceutical companies GSK and Pfizer are able to develop a vaccine against bronchiolitis for immunocompromised people and the elderly. 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 huge.

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