Maternal RSV vaccination for infant protection: A systematic review and meta‐analysis of phase 3 trials with an integrated economic evaluation

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This peer-reviewed review article presents a systematic review and meta-analysis of four phase 3 randomized controlled trials assessing maternal RSV vaccination for infant protection, with an integrated scenario-based economic evaluation for Mexico. The study pooled trial evidence on vaccine efficacy and safety and applied absolute effect estimates to Mexico’s annual birth cohort to estimate potential health and economic impact.

Key findings

  • Maternal RSV vaccination reduced the risk of infant RSV infection by 53% and severe RSV disease by 64% during the first 90–180 days of life.
  • The number needed to vaccinate was estimated at 85 to prevent one RSV infection and 127 to prevent one severe RSV-related illness.
  • No increased risks were observed for preterm birth, pre-eclampsia, gestational hypertension, stillbirth/fetal death, adverse cardiac events, or composite pregnancy, puerperium, and perinatal adverse outcomes.
  • Evidence certainty was rated moderate for prevention of any RSV infection and high for prevention of severe RSV disease.
  • In Mexico, a universal maternal RSV vaccination program at US$295 per dose was projected to prevent approximately 20,769 RSV infections, 14,882 severe cases, and 228 neonatal deaths annually, but at high costs per event averted.
  • At a public-sector price of US$50 per dose, estimated cost-effectiveness improved substantially, with costs falling to US$4,550 per infection averted and US$6,350 per severe case averted.

How can the findings be used?

These findings can support decisions on maternal RSV vaccine introduction, particularly in settings with high infant RSV burden and limited access to neonatal intensive care. The economic scenarios highlight the importance of vaccine price negotiations, local burden data, and implementation through antenatal care platforms.

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