Sanofi expects RSV vaccinations in younger youngsters to happen forward of the autumn virus season

A doctor injects a vaccine into a young boy

Karl Tapales | moment | Getty Images

Sanofi expects the RSV vaccine for infants to be rolled out in the US ahead of the respiratory virus season this fall, a company spokesman said Friday.

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

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The Sanofi spokesman said the company does not anticipate any production or capacity challenges this RSV season to meet demand. The French drug manufacturer developed jointly with Beyfortus AstraZenecabased in England.

A panel of independent advisors from the Centers for Disease Control and Prevention will meet on August 3 to make recommendations on how to administer the vaccine.

Sanofi is working with the panel to include Beyfortus in the US childhood vaccination schedule, the company spokesman said. The Affordable Care Act requires most private insurance companies to cover the vaccinations on this list at no out-of-pocket cost to families.

Beyfortus works similarly to a vaccine, but vaccination as a drug is regulated because it is a monoclonal antibody. This has led to some uncertainty over whether Beyfortus will be included in the federal Vaccines for Children program, which provides free vaccinations to families with financial difficulties.

Sanofi hopes to add Beyfortus to the program, the spokesman said. CDC advisors will vote on whether to add the vaccine to 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 US that protects all infants from RSV, whether they are healthy or have an illness. Another vaccine called palivizumab is available, but it’s primarily for premature babies or babies with heart or lung problems.

In a clinical study, 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 injection.

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

RSV swamped children’s hospitals last fall, prompting calls for the Biden administration to declare a public health emergency in response to the outbreak.

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