Does maternal RSVpreF vaccination raise risk of hypertensive disorders of pregnancy?
We pooled 9 studies, <148,000 pregnancies: an 8% relative increase (RR 1.08, 1.02–1.13)
Limited to gestational hypertension, significant only in observational studies.
#RSV#RSVpreF#Pregnancy
Did Pfizer enroll even a single subject in any of the post-marketing studies they committed to with the approval of the 2025-2026 COVID vaccine?
• Placebo-controlled efficacy/safety data in healthy 50-64s (the study that was halted for recruitment problems but is still listed as pending = no subjects enrolled)
• Immunogenicity and safety data in the current indicated population (also listed as pending, justified how?)
• Potential circulating/persistent spike (also pending)
Will we ever get these data or will FDA quietly release these studies and never ask again? Will the media ask what this means for the new COVID vaccine framework? Did it quietly leave with the leadership that established it? Why does it appear there may have never been a serious plan to conduct these studies?
Signals of adverse drug reactions can be based on different study designs. Daniele Sartori sat down in the Research Corner to discuss the findings of his scoping review and highlight the evidence base and features of ADR reports.
Full video 📺 https://t.co/mj5uDWnhj9
There are currently two RSV vaccines that are FDA approved, Arexvy which is GlaxoSmithKline's and Abrysvo, Pfizer's. Both are approved in adults 60 years of age and older and Abrysvo is the only one approved in pregnant women between 32 and 36 weeks of pregnancy.
Sequential near-real-time monitoring would have revealed that Vioxx caused heart attacks 3.5 years before it was withdrawn. All pharmaceuticals should be monitored in near-real-time.
https://t.co/XozOKLPrYQ
🚨New @BMJ_Open :
Early passive pharmacovigilance study of the #RSVpreF (#Abrysvo) vaccine in #pregnant women shows reported adverse events align with pre-licensure trials, but a previously observed safety signal for #preterm#birth persists.
https://t.co/5e9TtsEiWf
🚨New @BMJ_Open :
Early passive pharmacovigilance study of the #RSVpreF (#Abrysvo) vaccine in #pregnant women shows reported adverse events align with pre-licensure trials, but a previously observed safety signal for #preterm#birth persists. Active surveillance is needed.
🔗https://t.co/5j7Xz89osH
#RSV #Pfizer #Abrysvo #pretermbirth #pharmacovigilance