Code White

Observations from a nurse

CODE WHITE is a postpartum hemorrhage following birth.

After hearing about this traumatic delivery, I looked up her vaccination status. She had these three “vaccines” in her third trimester before the onset of preeclampsia.

Study details why phase 3 trial of GSK's RSV vaccine for pregnant women was halted early

A study today in the New England Journal of Medicine discusses a phase 3 randomized, controlled trial of GSK's respiratory syncytial virus (RSV) vaccine in pregnant women that was stopped early owing to an increased risk of preterm birth.

Researchers from GSK and the Duke University School of Medicine assessed the efficacy and safety of the RSVPreF3-Mat vaccine in 5,328 pregnant women aged 18 to 49 years and 5,233 infants from November 2020 to February 2022, when enrollment and vaccination were stopped after a link to preterm birth was noted.

"Despite many post hoc analyses, the authors were unable to identify a mechanism by which the receipt of RSVPreF3-Mat might have increased the risk of preterm birth," they wrote. "However, given the findings of the present trial and the modest imbalance in the incidence of preterm birth in the phase 3 trial of the bivalent vaccine [Abryvso], postmarketing surveillance of the bivalent vaccine is warranted."

https://www.cidrap.umn.edu/respiratory-syncytial-virus-rsv/study-details-why-phase-3-trial-gsks-rsv-vaccine-pregnant-women-was

Maybe all RSV vaccines during pregnancy should be halted since the authors were unable to identify the mechanism that increased the risk of preterm birth…

This above patient received the RSV Vaccine Bivalent (ABRYSVO) last November, 2024. Sure sounds like the same shot mentioned above warranting “postmarketing surveillance”.