Sanofi’s Infant RSV Shot Set to Roll Out in the U.S. Ahead of Respiratory Virus Season
Sanofi, a leading pharmaceutical company, announced on Friday that it expects its infant respiratory syncytial virus (RSV) shot, Beyfortus, to be available in the United States before the upcoming respiratory virus season this fall. The news came after the Food and Drug Administration (FDA) granted approval for the monoclonal antibody, Beyfortus, which is administered as a single dose to infants before or during their first RSV season.
A spokesperson for Sanofi reassured the public that the company foresees no challenges in manufacturing or meeting demand for the RSV shot this season. The French drugmaker partnered with AstraZeneca, based in England, in the development of Beyfortus.
To ensure the safe administration of the shot, a panel of independent advisors to the Centers for Disease Control and Prevention (CDC) is scheduled to convene on August 3. The panel will provide recommendations on how Beyfortus should be administered.
Sanofi is actively working with the CDC advisory panel to include Beyfortus in the U.S. childhood immunization schedule. Under the Affordable Care Act, most private insurance plans are required to cover shots on the immunization schedule without imposing any out-of-pocket costs on families.
While Beyfortus operates similarly to a vaccine by stimulating the immune system to produce protective antibodies, it is classified as a drug due to its monoclonal antibody nature. Consequently, there is some uncertainty regarding its potential inclusion in the federal Vaccines for Children program, which provides free shots to financially struggling families.
Sanofi hopes that Beyfortus will be incorporated into the program and the CDC advisory panel will vote on the matter during their meeting in August.
Based on clinical trials, Beyfortus has proven to be up to 75% effective in preventing lower respiratory tract infections that require medical attention in infants who receive the injection. This makes it the first shot approved in the U.S. that offers RSV protection to all infants, regardless of their health condition. It should be noted that another shot, palivizumab, primarily serves babies who are preterm or have specific heart or lung conditions.
Scientists consider RSV to be the leading cause of hospitalization among infants in the United States. Shockingly, a recent study revealed that almost 100 infants die annually in the U.S. due to RSV infections. The severity of RSV infections last fall prompted some to call on the Biden administration to declare a public health emergency.
Sanofi’s introduction of Beyfortus holds promise in combatting the alarming prevalence of RSV infections among infants. As public health experts eagerly anticipate the panel’s recommendations, the availability of Beyfortus could significantly reduce hospitalizations and fatalities caused by this respiratory virus.