Bivalent vaccine: New opportunities for protection against respiratory syncytial virus adults and newborns

Respiratory syncytial virus (RSV) infection represents a global public health challenge, causing millions of hospitalizations and thousands of deaths annually among children and adults. Until recently, effective specific preventive measures were unavailable. For a long time, RSV infection was regarded primarily as a pediatric issue; however, in recent years, attention has grown regarding its impact on older adults and individuals with chronic conditions. A breakthrough in immunoprevention occurred in 2023–2024 with the approval of the first effective vaccines, including Abrysvo, authorized by the U.S. Food and Drug Administration (FDA) for three target populations: individuals aged 60 years and older, pregnant women for the protection of infants during their first six months of life, and adults aged 18–59 years with underlying risk factors. The vaccine is administered as a single dose, preferably prior to the onset of the RSV season. Clinical trials demonstrated high efficacy: in adults ≥ 60 years, 66.7% against lower respiratory tract RSV disease and 85.7% against severe forms; with maternal immunization, efficacy reached 81.8% within the infant’s first 90 days of life and 69.4% through day 180. Concomitant administration with seasonal influenza vaccine in individuals ≥ 65 years was shown to be feasible without compromising immune response or increasing the frequency of adverse events. The vaccine’s safety profile is favorable: the most common reactions were local (injection site pain) and systemic (headache, myalgia, fatigue), predominantly mild and transient. In pregnant women, an increased risk of preterm birth was observed, leading to a restriction limiting vaccination to gestational weeks 32–36. Thus, Abrysvo represents an important tool within a comprehensive RSV prevention strategy, enabling simultaneous protection of vulnerable adult populations and newborns through maternal immunization. Incorporating the vaccine into national immunization programs has the potential to substantially reduce the burden of RSV infection, alleviate pressure on healthcare systems, and improve the quality of life for millions of people.

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