A doctor injects a vaccine into a little boy
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Sanofi expects its infant RSV shot to roll out in the United States before the respiratory virus season this fall, a company spokesman said Friday.
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.
The Sanofi spokesman said the company does not expect any challenges with production or capacity to meet demand this RSV season. The French drugmaker developed Beyfortus together with AstraZeneca, which is based in England.
A panel of independent advisers for the Centers for Disease Control and Prevention will meet on August 3 to make recommendations on how to administer the shot.
Sanofi is working with the panel to place Beyfortus on the US childhood vaccination schedule, the company spokesman said. The Affordable Care Act requires most private insurance to cover shots on this list at no cost to families.
Beyfortus works in the same way as a vaccine, but the shot is regulated like a medicine 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 free shots to financially struggling families.
Sanofi hopes to see Beyfortus included in the program, the spokesman said. CDC advisers will vote on whether to include the shot in the program at their meeting in August.
Vaccines stimulate the body’s immune system to produce antibodies that protect against viral infections, while Beyfortus injects these protective antibodies directly into the bloodstream.
Beyfortus is the first shot approved in the United States to protect all infants against RSV, regardless of whether they are healthy or have a medical condition. Another shot called palivizumab is available, but it’s primarily for babies who are premature or have heart or lung disease.
Beyfortus was up to 75% effective at preventing lower respiratory tract infections requiring medical attention in infants who received the injection compared to infants who did not receive the shot in a clinical trial.
RSV is the leading cause of hospitalization among infants in the United States, according to scientists. Nearly 100 infants die each year in the United States from the virus, according to a survey last year.
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.