The Food and Drug Administration on Monday approved Beyfortus, a monoclonal antibody that is administered as a single dose to infants before or during their first respiratory syncytial virus season.
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The Sanofi spokesperson said the company does not expect any challenges with manufacturing or capacity to meet demand this RSV season. The French drugmaker jointly developed Beyfortus with AstraZeneca, which is based in England.
A panel of independent advisors to the Centers for Disease Control and Prevention will meet on Aug. 3 to make recommendations about how the shot should be administered.
Sanofi is working with the panel to place Beyfortus on the U.S. childhood immunization schedule, the company spokesperson said. The Affordable Care Act requires most private insurance to cover shots on this list with no out-of-pocket costs for families.
Beyfortus works similar to a vaccine, but the shot is regulated as a drug because it is a monoclonal antibody. This has created some uncertainty about whether Beyfortus will be included in the federal Vaccines for Children program, which provides shots for free to families who are struggling financially.
Sanofi hopes to see Beyfortus included in the program, the spokesperson said. The CDC advisors will vote on whether to include the shot in the program at their August meeting.
Vaccines stimulate the body’s immune system to produce antibodies that protect against viral infections, while Beyfortus injects these protective antibodies directly into the blood stream.
Beyfortus is the first shot approved in the U.S. that protects all infants against RSV, regardless of whether they are healthy or have a medical condition. Another shot called palivizumab is available but it is primarily for babies who are preterm or have heart or lung conditions.
Beyfortus was up to 75% effective at preventing lower respiratory tract infections that require medical attention in infants who got the injection compared to infants who did not receive the shot in a clinical trial.
RSV overwhelmed children’s hospitals last fall, leading to calls for the Biden administration to declare a public health emergency in response to the wave of infections.