RSV Vaccine Safety Signals Raise Alarming Questions
A new peer-reviewed pharmacovigilance study published in Human Vaccines & Immunotherapeutics analyzed nearly 18,000 adverse event reports tied to the three FDA-approved RSV vaccines — Pfizer’s Abrysvo, GSK’s Arexvy, and Moderna’s mRESVIA. The results raise urgent concerns about vaccine safety, especially for seniors and pregnant women.
A Pharmacovigilance Study with Stark Findings
Researchers used standard pharmacovigilance methods — Reporting Odds Ratios (RORs) and Bayesian Information Components (ICs) — to determine how often specific adverse events occurred after RSV vaccination compared to all other vaccines.
-
Pfizer’s Abrysvo generated 103 positive safety signals, including pregnancy complications, fetal death, and serious neurological injury.
-
GSK’s Arexvy generated 91 signals, including paralysis, Guillain-Barré syndrome, and mini-strokes.
-
Moderna’s mRESVIA had too few reports (just 35 cases) for meaningful analysis — not because it is proven safe, but because insufficient post-market data exists.
Key Safety Signals Identified
GSK Arexvy (RSVPreF3)
-
Ascending flaccid paralysis: ~120× more likely
-
Areflexia (loss of reflexes): ~20× more likely
-
Guillain-Barré syndrome: ~6.9× more likely
-
Mini-strokes (TIA): ~2.9× more likely
-
Immune thrombocytopenia: ~4.1× more likely
-
Congestive cardiac failure: ~2.8× more likely
Pfizer Abrysvo (RSVpreF)
-
Preterm birth: ~267× more likely
-
Premature rupture of membranes: ~152–203× more likely
-
Hemorrhage in pregnancy: ~118× more likely
-
Fetal death: ~33.8× more likely
-
Cesarean section: ~121× more likely
-
Induced labor: ~101× more likely
-
Guillain-Barré syndrome: ~8.5× more likely
-
Facial paralysis: ~3.4× more likely
-
Immune thrombocytopenia: ~3.6× more likely
These aren’t nuisance side effects. They include paralysis, strokes, cardiac failure, immune destruction, and severe pregnancy complications.
Pregnancy Risks in Focus
Pfizer’s Abrysvo is marketed directly to pregnant women — yet the safety signals include hemorrhage in pregnancy, preterm delivery, fetal hypokinesia, and fetal death.
These findings echo what randomized trial data had already shown. A major meta-analysis by Marchand et al found that RSVpreF vaccination during pregnancy was linked to a 24% increased risk of preterm delivery, along with higher rates of systemic maternal adverse events.
Convergence of Evidence
Taken together, both clinical trial data and real-world pharmacovigilance reports converge on the same point: RSV vaccines, particularly Pfizer’s and GSK’s products, are associated with disproportionate risks to mothers, infants, and seniors.
The consistency of these findings suggests the risks are not isolated or coincidental, but systemic safety concerns that demand urgent investigation.
Call for Regulatory Action
Given the magnitude of these safety signals, public health regulators should:
-
Pause RSV vaccination programs in pregnant women and seniors until independent investigations are complete.
-
Conduct long-term studies to assess risks for neurological and immunological damage.
-
Reassess benefit-risk balance for populations targeted by RSV vaccine campaigns.
Conclusion
The RSV vaccine safety signals identified in this peer-reviewed analysis cannot be dismissed as noise. They include life-threatening events that strike at the very populations these vaccines were meant to protect.
Until regulators take these warnings seriously, the health risks to mothers, infants, and seniors remain unacceptably high.
DailyClout.IO will continue to follow this story. For exclusive content sign of to Dr. Naomi Wolf’s Substack now!
Sources and further reading:
-
Human Vaccines & Immunotherapeutics – Taylor & Francis Online
https://www.tandfonline.com/journals/khvi20 -
CDC – RSV Vaccination Information
https://www.cdc.gov/rsv/vaccines -
FDA – Approved RSV Vaccines (Pfizer, GSK, Moderna)
https://www.fda.gov/vaccines-blood-biologics/vaccines/rsv-vaccines -
NIH – Marchand et al. Meta-Analysis on RSV Vaccines
https://pubmed.ncbi.nlm.nih.gov/38890029/