After supply constraints last year, Sanofi and partner AstraZeneca have secured regulatory clearance for a new manufacturing line for their drug Beyfortus.
Sanofi said it's ready to meet demand for its RSV shot Beyfortus this year, announcing Monday the clearance by the Food and Drug Administration of a new manufacturing line.
The French pharmaceutical company and partner AstraZeneca are shipping 50 milligram and 100 milligram doses of the antibody drug to private healthcare providers and the U.S. government, ahead of the start of this year's season for respiratory syncytial virus infections in the Northern Hemisphere.
The companies also expect another production line to provide doses of Beyfortus this year, and are continuing to build inventory.
Beyfortus gained U.S. approval last July to prevent RSV in newborns during or entering their first RSV season, as well as in children up to 24 months who are at risk of severe disease.
When the RSV season began, though, the companies struggled to maintain supply. Demand for the shot was higher than expected, leading to a shortage, particularly of the 100 milligram dose recommended for infants weighing 11 pounds or more. Due to the shortage, the Centers for Disease Control and Prevention recommended doses be prioritized for infants who were at higher risk for disease.
RSV affects almost every infant at some point and, while most of the time it causes only mild illness, infections are the leading cause of hospitalizations in newborns. Up until last year, the only preventive drug was another antibody called Synagis, but its use was limited to certain high-risk newborns.
Pfizer's RSV vaccine Abrysvo is approved for maternal use, which passes on passive immunity to the child after birth. The CDC encouraged pregnant women to receive Abrysvo to protect their newborns while Beyfortus was in short supply.
Sanofi said it is shipping doses to the CDC for the agency's Vaccines for Children program. The French pharma also launched a reservation system to help it gauge demand from private healthcare providers.
"The US market is anticipated to have enough supply so that every eligible baby born outside of the season will have access to immunization at a regular checkup and those born during the season will have access at birth," Sanofi said in its statement.