Shortage of Sanofi and AstraZeneca’s RSV Prophylactic Beyfortus Amidst Surging Demand

Sanofi and AstraZeneca’s Beyfortus, a prophylactic for respiratory syncytial virus (RSV), has become scarce due to a surge in demand during the RSV season, shortly after receiving FDA approval. The Centers for Disease Control and Prevention (CDC) has issued guidance recommending that available Beyfortus 100-mg doses be prioritized for infants at the highest risk of severe RSV disease, such as those under six months of age and those with underlying health conditions.

Sanofi is collaborating with the CDC to ensure fair distribution and attributes the supply shortage to unexpectedly high demand, despite having an aggressive supply plan designed to outperform previous pediatric vaccine launches. According to a statement from Sanofi, they are working with their manufacturing partner, AstraZeneca, to expedite additional supply and explore various measures to expand the manufacturing network.

Beyfortus gained FDA approval in July as a passive immunization for RSV-related lower respiratory tract disease in newborns, infants born during or entering their first RSV season, and young children up to 24 months old who remain at risk from the virus through their second season.

Even before receiving official approval, Beyfortus was expected to have high demand as the first option of its kind. In June, Kimberly Tutwiler, the head of Sanofi’s global RSV franchise, mentioned that manufacturing of Beyfortus was already underway for the U.S., with expectations to meet the demand for the upcoming season.

With the RSV season beginning, Pfizer’s Abrysvo also offers a prophylactic option, recommended for individuals between 32 and 36 weeks pregnant to protect infants from RSV-associated lower respiratory tract disease during their first six months of life. Pfizer’s Abrysvo received approval shortly after Sanofi and AstraZeneca’s green light.

Prior to the approval of Sanofi’s medication, Synagis, a treatment by Swedish Orphan Biovitrum (SOBIV.ST), was the sole sanctioned preventative therapy available in the United States for infants at high risk. According to statistics from the American Academy of Pediatrics, an estimated 1% to 3% of children under 1 year in the country have to be admitted to a hospital as a result of RSV.

Sanofi stated that it is collaborating with AstraZeneca to identify additional solutions to meet the increasing demand.