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Three years ago, ICAN sent a letter to members of FDA’s vaccine committee warning of the dangers of Pfizer’s RSV pregnancy vaccine, Abrysvo. A recent study supports ICAN’s position that those concerns were warranted.
In May of 2023, ICAN’s legal team sent a letter to the Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA committee that makes recommendations on whether or not a new vaccine should be approved. In the letter, ICAN asked the committee to hold off on recommending the approval of Abrysvo until concerning safety signals from the clinical trials had been further investigated. The committee ignored ICAN’s warnings and, shortly after, FDA approved the vaccine.
ICAN’s letter highlighted the following concerns from the Abrysvo clinical trial: “In mothers, serious adverse events included prolonged labor, premature delivery, postpartum hemorrhage, arrested labor, and gestational hypertension, the most frequent of which were preeclampsia and fetal distress.”
A recent study shows safety signals for pregnancy-associated hypertensive disorders (including gestational hypertension), premature rupture of membranes (PROM), and preterm PROM, after receipt of the Abrysvo vaccine. In fact, even though this study was sponsored by Pfizer, the study authors couldn’t avoid stating that “[f]urther epidemiological studies are needed to refine risk estimates….”
ICAN will continue to raise alarms about vaccines, especially those given during pregnancy and infancy, and to demand that studies assessing safety actually get done. Maybe next time, our federal health authorities will listen to us—an advocacy group that actually cares about patient safety and takes safety signals seriously—and demand robust safety data before unleashing a vaccine upon pregnant women and their unborn children.
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