Following its highly anticipated FDA approval on Monday, the respiratory syncytial virus (RSV) antibody developed by Sanofi and AstraZeneca is now scheduled for evaluation by a committee to determine its inclusion in US immunization guidelines.
The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) will convene on August 3rd to assess and vote on the potential addition of Beyfortus to the children’s vaccine schedule in the United States. The committee will also vote on the antibody’s eligibility for inclusion in the CDC’s Vaccines for Children program, which provides free vaccines to eligible children whose families may face financial constraints.
While Sanofi cannot predict the outcome of the vote, the company finds encouragement in the unanimous recommendation from an FDA advisory committee last month, according to a Sanofi spokesperson.
The recently obtained FDA approval for the antibody covers infants who are born during or enter their first RSV season, as well as children up to 24 months old who remain at risk of severe RSV infection during their second virus season. Sanofi and AstraZeneca intend to make the vaccine available in the United States before the upcoming 2023-24 RSV season, as stated in a joint release.
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“As every infant is at risk from RSV, we believe all babies deserve equal access to RSV protection,” the spokesperson said. “Key to being able to offer protection for all infants is our work with the ACIP to evaluate Beyfortus for placement on the childhood immunization schedule, as the Affordable Care Act (ACA) generally requires insurance coverage for all immunizations administered in accordance with final CDC recommendations.”
RSV is the primary cause of hospitalization among infants under the age of 1 in the US, with an estimated 590,000 infants in this age group requiring medical care for RSV each year, according to the companies. Nearly all children contract the disease before their second birthday.
In related news, GlaxoSmithKline (GSK) recently achieved a world-first approval for its adult RSV vaccine, Arexvy, outpacing its competitors. Pfizer and GSK’s respective vaccines for older adults also received recommendations from ACIP last month through a shared clinical decision-making process, allowing individuals to receive one of the RSV vaccines after consulting with their healthcare provider.
