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Area of Science:

  • Global Health
  • Vaccinology
  • Pediatric Infectious Diseases

Background:

  • The World Health Organization (WHO) recommended the RTS,S malaria vaccine in October 2021 for children aged 5 months and older in high-transmission areas.
  • Recommendations were based on Phase 3 trials and an ongoing Malaria Vaccine Implementation Programme (MVIP).

Purpose of the Study:

  • To critically evaluate the mortality data from the Malaria Vaccine Implementation Programme (MVIP).
  • To assess the scientific evidence supporting the claimed impact of the RTS,S vaccine on child mortality.

Main Methods:

  • Analysis of potential confounding factors in MVIP mortality data.
  • Review of the statistical significance and duration of the MVIP assessment.
  • Comparison of MVIP findings with Phase 3 trial results, particularly regarding sex-specific mortality.

Main Results:

  • Identified significant issues with MVIP mortality data, including potential confounding and inappropriate use of surrogate markers.
  • The observed effect on mortality was not statistically significant, and the assessment period was shorter than planned.
  • Concerns remain regarding potential increased mortality in vaccinated girls compared to boys, as suggested by Phase 3 data.

Conclusions:

  • The claimed mortality benefits of the RTS,S vaccine in the MVIP are not supported by robust scientific evidence.
  • Further rigorous evaluation, including independent data assessment and adherence to planned analyses, is necessary.
  • Future vaccine roll-outs must prioritize comprehensive safety evaluations, especially concerning sex-specific mortality differences.