Sanofi, Astra drug approved to protect infants from RSV in Europe

Sanofi and AstraZeneca Plc’s Beyfortus won European approval to protect infants from respiratory syncytial virus, a common infection that can turn deadly in young children.

The European Commission became the first regulatory body to approve the antibody injection, clearing it for use in all newborns before their first RSV season, Sanofi said in a statement. In clinical trials, a single shot reduced the likelihood that the babies would need medical care for lower respiratory tract infections caused by the pathogen.

Shares in Sanofi and Astra were little changed in early trading Friday.

The approval marks the second bright spot this week in scientists’ decades-long quest to blunt the damage wrought by RSV, which can lead to pneumonia and hospitalisation in infants, and kills tens of thousands of children annually worldwide. On Tuesday, Pfizer said that its RSV vaccine candidate met a crucial endpoint in a late-stage trial.

US filing

Sanofi and AstraZeneca plan to launch Beyfortus for the 2023-2024 winter, according to a Sanofi spokesperson. A US application has been submitted, with acceptance expected later this year, they said. The medicine is expected to generate sales of more than $800 million in 2026, according to Bloomberg Intelligence.

The companies will share all costs and profits for the product, per a global agreement. AstraZeneca leads the development and manufacturing fronts, while Sanofi is responsible for commercialisation and recording sales, according to the statement.

The approval was expected after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Beyfortus in September.

RSV has long been a thorny challenge in virology, infecting almost everyone by their second birthday and then returning repeatedly throughout life. It typically inflicts just a common cold, but it can be dangerous in the small airways of young children, as well as those with weaker immune systems.

Globally in 2019, there were about 33 million cases of acute lower respiratory infections leading to more than three million hospitalisations, according to a statement from AstraZeneca. It added that it’s estimated that were 26,300 in-hospital deaths of children younger than five years.

Stuck for decades

Scientists were stuck for decades when it came to vaccines for RSV. In the 1960s, when they tried giving infants an inactivated form of the virus, the approach backfired, killing two trial participants. Researchers abandoned an effort to create a live-attenuated vaccine because every time they weakened the virus enough to make it safe, it no longer elicited a sufficiently strong immune response.

In recent years, however, researchers have devised new approaches. Pfizer’s vaccine candidate is injected into pregnant women so they can pass on protection to their children. The Sanofi-AstraZeneca therapy, meanwhile, is a long-acting antibody that targets the virus and helps prevent lower respiratory tract infections caused by RSV.

Other companies including Meissa Vaccines Inc are trying new methods to make live-attenuated vaccines, which could offer a way around the traditional safety-versus-efficacy tradeoff.

© 2022 Bloomberg