After bagging a highly anticipated FDA nod Monday, Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody now has a date on a committee's calendar to determine its place in U.S. immunization guidelines.
The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will convene Aug. 3 to evaluate and vote on Beyfortus’ potential addition to the children’s vaccine schedule in the U.S.
The committee will also vote on the drug’s place in the CDC’s Vaccines for Children program, which provides free vaccines to eligible kids whose families might not otherwise be able to pay for the recommended vaccines.
While Sanofi “cannot speculate” on how the vote will turn out, the company is encouraged by last month’s unanimous recommendation from an FDA advisory committee, a Sanofi spokesperson said.
“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.”
The antibody's recent FDA approval covers infants who are born during or entering their first RSV season, plus children up to 24 months of age who remain at risk of severe RSV through their second virus season. Sanofi and AZ plan to make the vaccine available in the U.S. before the upcoming 2023-24 RSV season, the two companies said in a release.
RSV is the leading cause of hospitalization for babies under the age of 1 in the U.S., with an estimated 590,000 infants in the age group requiring medical care each year, according to the companies. Nearly all children are infected with the disease before their second birthday.
Elsewhere on the RSV front, Pfizer and GSK scored nods for their respective vaccines for older adults earlier this summer. ACIP recommended both shots last month under a shared clinical decision-making process, in which individuals can receive one of the RSV vaccines after consulting with their healthcare provider.