Maternal RSV vaccine: Further analysis is urged on preterm births

Experts have called for further analysis of trial data and post-approval monitoring of Pfizer’s maternal RSV vaccine candidate after GSK’s trials of a similar product were halted over a rise in preterm births and neonatal deaths.An advisory committee from the US Food and Drug Administration (FDA) is set to discuss the vaccine on 18 May1 as part of a fast tracked priority review, with a decision expected by August.Pfizer published the results of an interim analysis of its phase 3 trial2 in April 2023, saying that the vaccine was effective against medically attended severe RSV in children and that no safety concerns were identified.But the results have raised concerns34 about a possible increase in preterm births, and experts are calling for further analyses of the data and for post-approval monitoring of the vaccine, should the FDA approve it.GSK halts its trialsIn February 2022, GSK halted enrolment and vaccination across three…
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