Sanofi expects an RSV shot of infants before the virus season this fall.

Sanofi A company spokeswoman said Friday that its infant RSV shot is expected to be rolled out in the U.S. this fall ahead of the respiratory virus season.

The Food and Drug Administration on Monday approved Beauforts, a monoclonal antibody that is given as a dose to infants before or during their first respiratory syncytial virus season.

A Sanofi spokesperson said the company does not anticipate any challenges with manufacturing or capacity to meet demand this RSV season. Developed by French pharmaceutical company Beauforts. Astra Zenecawho lives in England.

A panel of independent advisers from the Centers for Disease Control and Prevention will meet Aug. 3 to make recommendations about how the shot should be administered.

Sanofi is working with the panel to add Beauforts to the U.S. childhood immunization schedule, a company spokeswoman said. The Affordable Care Act requires most private insurance to cover the shots on this list at no out-of-pocket cost to families.

Beyfortus works like a vaccine, but the shot is administered as a drug because it is a monoclonal antibody. That has created some uncertainty about whether Beyfortus will be included in the federal Vaccines for Children program, which provides free shots to financially strapped families.

Sanofi hopes to see Beauforts join the program, the spokesperson said. CDC advisers will vote at their August meeting on whether to add the shot to the program.

Vaccines stimulate the body’s immune system to produce antibodies that protect against viral infections, while Beauforts injects these protective antibodies directly into the bloodstream.

Beyfortus is the first shot approved in the US to protect all infants against RSV, regardless of whether they are healthy or have a medical condition. Another shot called palivizumab is available but is mainly for babies who are premature or have heart or lung conditions.

Beauforts was up to 75 percent more effective in preventing lower respiratory tract infections requiring medical attention in infants who received the injection than in 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. About 100 infants die from the virus each year in the United States. According to a study last year.

RSV overwhelmed children’s hospitals last fall, prompting the Biden administration to declare a public health emergency in response to the wave of infections.