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  • Are maternal vaccines effective and safe for mothers and infants? A systematic review and meta-analysis of randomised controlled trials

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Are maternal vaccines effective and safe for mothers and infants? A systematic review and meta-analysis of randomised controlled trials
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  • Published on: 3 November 2023
    Safety of maternal RSV vaccines

    This review article, which concludes that "There was no evidence of a significant effect of any of the maternal vaccines on the reported safety outcomes." makes no reference to GSK's trial of RSVpreF vaccine (NCT04605159) that was terminated in February 2022. The decision to stop vaccinations was announced more than a year before the article was submitted (1).
    The decision to halt the trial was made following a recommendation from the Independent Data Monitoring Committee based on an observation from a routine safety assessment.
    The GSK safety signal is discussed in the article by Mazur et al (authors’ reference 18).

    The fact that a large trial of a maternal vaccine had been stopped for safety reasons should have been included in this article, and perhaps modified the conclusions.

    (1) https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-ph...

    Conflict of Interest:
    None declared.