Health Economic Impact of Maternal Bivalent Stabilized Prefusion F Subunit Vaccine for Prevention of Respiratory Syncytial Virus Infections Among Infants in Germany

OBJECTIVES: Bivalent stabilized prefusion F subunit vaccine (RSVpreF) was recently granted market authorization in Germany for prevention of lower respiratory tract disease (LRTD) due to respiratory syncytial virus (RSV; RSV-LRTD) in infants via maternal vaccination, providing protection from birth. We evaluated the potential health benefits and additional costs associated with the implementation of a maternal RSVpreF vaccination program in Germany.

METHODS: A static population-based model was used to evaluate clinical outcomes and economic costs of RSV-LRTD during the first year of life, and expected impact of RSVpreF. Model inputs (i.e., population characteristics, disease/fatality rates, costs) were based on German data, where available. Uptake of RSVpreF was assumed to be 40%; effectiveness was based on trial data (“MATISSE”). The impact of different maternal vaccination programs—year-round (MV-Y) and seasonal (MV-S; expected delivery date between Oct-Mar)—was evaluated versus no intervention (NoInt). A scenario analysis with higher year-round uptake (60%) and sensitivity analyses varying inputs by ±20% were performed.

RESULTS: With NoInt, there were 88,266 RSV-LRTD episodes (hospitalized [RSV-H]: 22,995; ambulatory [RSV-Amb]: 65,270) and total costs of 126.4 million € (direct: 115.3M €; indirect: 11.0M €). MV-Y prevented 13,249 RSV-LRTD episodes (RSV-H: 4,503; RSV-Amb: 8,746) and increased total costs by 45.1 million € (direct: 46.9M €; indirect: -1.9M €). MV-S prevented 8,895 RSV-LRTD episodes (RSV-H: 3,170; RSV-Amb: 5,725) and increased total costs by 16.2 million € (direct: 17.4M €; indirect: -1.2M €). Increasing year-round uptake prevented 50% more episodes (vs. base case uptake). Sensitivity analyses identified RSV-H incidence and vaccine effectiveness as key model drivers.

CONCLUSIONS: RSVpreF could substantially reduce the burden of RSV among infants, preventing 1.5x as many cases with year-round versus seasonal maternal vaccination, with even greater benefits if year-round vaccine uptake could be increased. Our findings highlight the large potential impact of a maternal RSVpreF program on infants.