A recent Cochrane review including 14 randomized controlled trials evaluated the safety and effectiveness of various RSV vaccine platforms across different populations. RSV prefusion vaccines provided substantial protection for older adults, reducing laboratory-confirmed lower respiratory tract illness by 77% and acute respiratory illness by 67%, with no meaningful differences in mortality or vaccine-related serious adverse events. Maternal RSV F protein-based vaccines also showed high-certainty evidence of benefit, reducing medically attended RSV illness, severe lower respiratory tract disease, and RSV-related hospitalizations in infants without increasing safety concerns for either mothers or newborns.
Evidence for other populations was limited or very uncertain. Trials involving women of childbearing age and live-attenuated vaccines for infants and children showed unclear effects due to small sample sizes and wide confidence intervals. Across all vaccine types, serious adverse events appeared similar between vaccine and placebo groups, though certainty varied depending on the population and vaccine platform evaluated. Overall, results support strong protective effects of prefusion and maternal RSV vaccines, while highlighting the need for larger trials in younger populations.
Keywords: RSV vaccine, lower respiratory infection, maternal vaccination, vaccine safety