A doctor is administering a vaccine to a baby boy.
Karl Tapales | Moment | Getty Images
Sanofi anticipates the release of its infant RSV shot in the United States before the respiratory virus season this fall, according to a company spokesperson.
The Food and Drug Administration granted approval on Monday for Beyfortus, a monoclonal antibody that is administered in a single dose to infants before or during their first respiratory syncytial virus (RSV) season.
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The Sanofi spokesperson expressed confidence that the company will not face any manufacturing or capacity challenges to meet the demand this RSV season. Beyfortus was developed in collaboration with AstraZeneca, based in England.
An independent advisory panel to the Centers for Disease Control and Prevention is scheduled to meet on August 3rd to make recommendations regarding the administration of the shot.
Sanofi is collaborating with the panel to include Beyfortus in the U.S. childhood immunization schedule. Under the Affordable Care Act, most private insurance is required to cover shots on this list without any out-of-pocket costs for families.
Beyfortus functions similarly to a vaccine, but it is classified as a drug due to its monoclonal antibody nature. This has raised concerns about its inclusion in the federal Vaccines for Children program, which provides free shots to financially struggling families.
Sanofi hopes that Beyfortus will be included in the program, and the CDC advisors will vote on its inclusion at their August meeting.
Vaccines stimulate the body’s immune system to produce antibodies that protect against viral infections, while Beyfortus directly injects these protective antibodies into the bloodstream.
Beyfortus is the first shot approved in the U.S. that protects all infants against RSV, regardless of their health or medical condition. Another shot called palivizumab is available, but it is primarily for preterm babies or those with heart or lung conditions.
In a clinical trial, Beyfortus demonstrated up to 75% effectiveness in preventing lower respiratory tract infections requiring medical attention in infants who received the injection compared to those who did not.
According to scientists, RSV is the leading cause of infant hospitalization in the U.S., resulting in nearly 100 deaths each year, as reported in a study from last year.
RSV overwhelmed children’s hospitals last fall, prompting calls for the Biden administration to declare a public health emergency to address the wave of infections.
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