Sanofi expects infant RSV shot before virus season this fall

Sanofi It expects to launch its infant RSV shot in the United States ahead of this fall’s respiratory virus season, a company spokesperson said Friday.

The Food and Drug Administration on Monday approved Beyfortus, a monoclonal antibody given as a single dose to infants before or during the first respiratory syncytial virus (RSV) season.

A Sanofi spokesperson said the company does not anticipate any challenges with manufacturing or the ability to meet demand this RSV season. Beyfortus was jointly developed by the French pharmaceutical company AstraZenecawhich is based in England.

A committee of independent advisers to the Centers for Disease Control and Prevention will meet on August 3 to make recommendations on how to give the shot.

A company spokesperson said Sanofi is working with the commission to put Beyfortus on the US childhood immunization schedule. The Affordable Care Act requires that most private insurance cover the shots on this list with no out-of-pocket costs for families.

Beyfortus works similarly to the vaccine, but the vaccine 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 Children’s Vaccine Program, which provides free shots to financially struggling families.

The spokesperson said Sanofi hopes to see Byfortus included in the program. CDC advisors 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 infection, while Bifortus injects these protective antibodies directly into the bloodstream.

Beyfortus is the first dose approved in the United States that protects all children from respiratory syncytial virus, regardless of whether they are otherwise healthy or have a medical condition. Another injection called palivizumab is available but it’s primarily for babies who are premature or have heart or lung disease.

Beyfortus was up to 75% more effective in preventing lower respiratory tract infections requiring medical care in infants who received the injection than in infants who did not receive the vaccine 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 study last year.

RSV swept through 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.