As this year’s respiratory syncytial virus (RSV) season approaches, Beyfortus makers Sanofi and AstraZeneca are making preparations to avoid last year's supply issue with a newly approved filling line. In all, the partners plan to provide enough supply to cover every eligible infant in the U.S.
Sanofi has begun shipping the antibody in its 50 mg and 100 mg doses to private healthcare providers and the CDC's Vaccines for Children program to get ahead of the upcoming RSV season, which typically spans from November to March, the company said in Monday press release.
With doses already produced and packaged—and the new filling line expected to add capacity—the Beyfortus partners expect to provide the U.S. market with enough supply for every eligible baby born during the virus season, plus those born outside of the season.
Sanofi and development and manufacturing lead AstraZeneca continue to work together to “build inventory for this and future seasons,” the drugmaker said in the press release.
The long-acting monoclonal antibody was approved last year to prevent RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season and for children up to 2 years old who remain vulnerable to severe disease through their second season.
Two out of every three infants are infected with the virus over their first year of life and “almost all” are infected by their second birthday, according to Sanofi.
“This upcoming season, we look forward to Beyfortus offering its demonstrated real-world protection to as many infants as possible,” Sanofi’s head of vaccines for North America, Thomas Greiner, said in a company statement.
Beyfortus garnered 547 million euros (about $592 million) in sales during its first year on the market. Supply constraints that Sanofi attributed to “higher than anticipated demand” quickly hampered the launch, prompting a Senate probe and a CDC advisory to prioritize available doses.
Now that additional supply is locked down, the company is “confident” that the drug will cross into blockbuster status as a $1 billion earner this year, Triomphe said in a July call.
Meanwhile, in the adult RSV vaccine market, Moderna may have been “overly optimistic” about its ability to compete during its first RSV season, chief financial officer Jamey Mock said during the company’s recent R&D day conference, as quoted by European Pharmaceutical Manufacturer. The company plans to be "more realistic" going forward, according to the publication.
GSK and Pfizer also compete in the adult RSV vaccine arena. Earlier this year, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) tweaked its RSV vaccination recommendations to include all adults aged 75 years and older and those ages 60 to 74 with a higher risk of severe disease due to underlying medical conditions. The ACIP recommends a single lifetime RSV vaccine dose.
The committee separately recommends Beyfortus for infants.