Sanofi expects baby RSV to be vaccinated ahead of virus season this fall

Sanofi expecting her baby RSV shot to deploy in the US before respiratory virus season this fall, a company spokesperson said Friday.

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

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The Sanofi spokesperson said the company does not expect any manufacturing or capacity issues to meet demand this RSV season. The French drugmaker jointly developed Beyfortus with Astra Zenecawho is based in England.

A group of independent advisers from the Centers for Disease Control and Prevention will meet on August 3 to make recommendations on how the vaccine should be administered.

Sanofi is working with the panel to place Beyfortus on the U.S. childhood immunization schedule, the company spokesperson said. The Affordable Care Act requires most private insurance to cover injections on this list at no cost to families.

Beyfortus works like a vaccine, but the vaccine is regulated as 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 vaccines to families in financial difficulty.

Sanofi hopes to see Beyfortus included in the program, the spokesperson said. CDC advisers will vote on whether to include the plan in the program at their August meeting.

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 vaccine approved in the United States that protects all infants against RSV, whether they are healthy or have a medical condition. Another vaccine called palivizumab is available, but it’s mainly for premature babies or babies with heart or lung disease.

Beyfortus was up to 75% effective in preventing lower respiratory tract infections that require medical attention in infants who received the injection compared to infants who did not receive the vaccine in a clinical trial.

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