FDA approves Merck RSV shot for infants to rival Sanofi AstraZeneca
The Food and Drug Administration has given the green light to Merck’s new shot aimed at shielding infants from respiratory syncytial virus (RSV) in their first season of exposure. This approval paves the way for Merck to launch the drug, named Enflonsia, before the upcoming RSV season.
RSV is responsible for numerous deaths among older individuals and infants annually, making it a significant health concern. The availability of Enflonsia is expected to ease the burden of this seasonal infection on families and healthcare systems.
Merck’s Enflonsia will join the market alongside Sanofi and AstraZeneca’s Beyfortus, offering doctors a new tool to combat RSV. Both Enflonsia and Beyfortus are monoclonal antibodies that provide immediate protection by targeting different aspects of the virus.
Unlike Beyfortus, which is dosed based on infant weight, Enflonsia can be administered regardless of weight, potentially offering a more convenient solution. Sanofi has announced plans to ramp up Beyfortus supply to meet the growing demand.
In addition to these antibody treatments, vaccines for RSV are available for adults and pregnant women from companies like Pfizer, GSK, and Moderna. However, ongoing testing of RSV shots in young children has been paused to address safety concerns.
The efficacy of Enflonsia was demonstrated in clinical trials, showing a significant reduction in RSV-related hospitalizations and lower respiratory infections compared to a placebo. This underscores the potential impact of Enflonsia in combating RSV and its related complications.
As the market awaits recommendations from vaccine advisors, the focus remains on addressing RSV and enhancing immunization strategies to protect vulnerable populations.
Overall, the approval of Merck’s Enflonsia represents a milestone in the fight against RSV, offering a promising new option to safeguard infants during their critical first season of virus exposure.
