Post-marketing safety surveillance monitoring of RSV vaccines including Bancel's MODERNA mRNA RSV vaccine revealed serious adverse outcomes begging the question, why has FDA left these on market?

serios flags e.g. serious reports, important medical events (IMEs), including immune thrombocytopenia, Three pregnancy-related IME signals–hemorrhage in pregnancy, fetal death, and fetal hypokinesia

What is FDA waiting on? What else do they need to pull this? Why were these RSV vaccines like the COVID mRNA vaccines marketed directly to expectant mothers?

Study: ‘described notable reporting patterns related to RSV vaccines using real-world data from VAERS. For protein subunit vaccines (RSVPreF3 and RSVpreF), disproportionately elevated reporting was observed for inflammatory neurological events (e.g., GBS, facial paralysis), immune thrombocytopenia, and atrial fibrillation – AEs that are clinically significant and merit further investigation, especially in older adults. Additionally, for RSVpreF, higher-than-expected reporting frequencies were noted for pregnancy-related events, including hemorrhage in pregnancy, fetal death, and fetal hypokinesia.’

‘study utilized real-world data from large-scale spontaneous reporting systems to detect AEs that were disproportionately reported following RSV vaccination’…

This report dovetails with the prior 2024 meta-analysis report by Marchand et al. (who looked at the RSVpreF vaccination in pregnancy) and found that ‘RSVpreF vaccination results in systemic adverse events and an increase in preterm delivery.’ (RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacy)…

RSVpreF vaccination in pregnancy: a meta-analysis of maternal-fetal safety and infant efficacy - PubMed

Full article: Post-marketing safety monitoring of RSV vaccines: A real-world study based on the Vaccine Adverse Event Reporting System (VAERS)

Post-marketing safety monitoring of RSV vaccines: A real-world study based on the Vaccine Adverse Event Reporting System (VAERS)

Zhuocheng Bao, Weixi Gao et al.

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