A doctor injects a vaccine into a boy
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Sanofi expects the infant RSV vaccine to be rolled out in the U.S. this fall ahead of respiratory virus season, a company spokesperson said Friday.
The Food and Drug Administration on Monday approved Beyfortus, a monoclonal antibody administered as a single dose to babies before or during their first respiratory syncytial virus season.
The Sanofi spokesman said the company does not expect production or capacity issues to meet demand this RSV season. The French drug manufacturer developed together with Beyfortus AstraZenecawhich is based in England.
A panel of independent consultants from the Centers for Disease Control and Prevention will meet on Aug. 3 to make recommendations on how to administer the injection.
Sanofi is working with the panel to put Beyfortus on the U.S. childhood vaccine schedule, the company spokesman said. The Affordable Care Act requires most private insurance policies to cover shots on this list at no out-of-pocket cost to families.
Beyfortus works similar to a vaccine, but the injection is regulated like a drug 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 injections to families struggling financially.
Sanofi hopes that Beyfortus will be included in the program, said the spokesperson. The CDC advisers will vote on whether or not to include the injection in the program at their meeting in August.
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 US-approved injection to protect all babies against RSV, whether they are healthy or have a medical condition. Another injection called palivizumab is available, but it’s primarily for babies who were born prematurely or have heart or lung disease.
Beyfortus was up to 75% 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 in a clinical trial.
RSV is the leading cause of hospitalization in infants in the US, according to scientists. Every year in the US, nearly 100 babies die from the virus, This is according to a study from last year.
RSV overwhelmed children’s hospitals last fall, prompting calls for the Biden administration to declare a public health emergency in response to the wave of infections.