Sanofi expects infant RSV shot before virus season this fall

Sanofi A company spokesman said Friday that it expects its infant RSV vaccine to be available in the United States ahead of the respiratory virus season this fall.

The U.S. Food and Drug Administration on Monday approved Beyfortus, a monoclonal antibody that can be given as a single dose to infants before or during their first respiratory syncytial virus season.

A Sanofi spokesman said the company does not anticipate any challenges with manufacturing or capacity to meet demand for this RSV season. The French drugmaker co-developed Beyfortus with the French drugmaker AstraZenecaheadquartered in the UK.

An independent advisory group from the Centers for Disease Control and Prevention will meet on Aug. 3 to make recommendations on how to administer the vaccine.

Sanofi is working with the group to include Beyfortus in the U.S. childhood immunization schedule, a company spokesman said. The Affordable Care Act requires most private insurance to cover the vaccines on this list at no out-of-pocket cost to families.

Beyfortus works like a vaccine, but because it is a monoclonal antibody, the vaccine is regulated as a drug. That has created some uncertainty over whether Beyfortus will be included in the federal childhood vaccine program, which provides free vaccinations to financially disadvantaged families.

Sanofi would like to see Beyfortus included in the plan, the spokeswoman said. CDC advisers will vote at their August meeting on whether to include the vaccine in the plan.

Vaccines stimulate the body’s immune system to produce antibodies to protect against viral infection, and Beyfortus injects these protective antibodies directly into the bloodstream.

Beyfortus is the first vaccine approved in the United States to protect all infants from RSV infection, whether they are healthy or have a medical condition. Another injection called palivizumab is available, but it is mainly for babies born prematurely or with heart or lung disease.

In clinical trials, Beyfortus was up to 75 percent effective in preventing lower respiratory tract infections requiring medical attention in infants who received the injection compared to infants who did not receive the injection.

RSV is the leading cause of hospitalization for infants in the United States, according to scientists. Nearly 100 babies in the U.S. die each year from the virus, According to a study last year.

Respiratory syncytial virus overwhelmed children’s hospitals last fall, leading to calls for the Biden administration to declare a public health emergency to deal with the wave of infections.