RSV Monoclonal Antibody for Infants Found Protective

The peer review journal The Lancet Infectious Diseases published the results from a recent study examining prospective respiratory syncytial virus (RSV) surveillance data to assess the geotemporal prevalence of RSV A and B and functionally characterize the effect of the nirsevimab binding-site substitutions identified between 2015 and 2021.

Nirsevimab (Beyfortus®), an extended half-life monoclonal antibody (mAbs) to the RSV fusion protein, has been developed to protect infants for an entire RSV season. 

This AstraZeneca and Sanofi-funded observational analysis concluded on March 17, 2023, nirsevimab binding site was highly conserved, and escape variants were rare and have not increased over time.

The U.S. Food and Drug Administration (FDA) initially approved an injectable mAbs therapy for children in 1998.

Beyfortus has been granted various regulatory approvals.

As of March 21, 2023, neither the FDA nor the European Medicines Agency approved an RSV vaccine candidate for children or older adults.

However, various authorizations are expected in 2023.