BREAKING Manuscript: Banoun, Analysis of Beyfortus® (Nirsevimab) Immunization Campaign: Effectiveness, Biases, and ADE Risks in RSV Prevention

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Beyfortus® (Nirsevimab) is now routinely administered to newborns to prevent RSV, marking a first in human antibody treatment at birth. Analysis by Dr. Helene Banoun reveals concerning post-marketing results, indicating worse outcomes and potential antibody-dependent enhancement (ADE), which could worsen RSV infections. Given RSV's prevalence and treatability, Banoun suggests parents might defer this intervention, allowing natural immunity to develop instead.

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https://petermcculloughmd.substack.com/p/breaking-manuscript-banoun-analysis

BREAKING Manuscript: Banoun, Analysis of Beyfortus® (Nirsevimab) Immunization Campaign: Effectiveness, Biases, and ADE Risks in RSV Prevention Acute RSV Infection and Death after Monoclonal Antibody Infusion Suggest Product Backfires in Some Babies Due to Antibody-Dependent Enhancement Fri, 20 Sep 2024 09:31:01 GMT https://petermcculloughmd.substack.com/p/breaking-manuscript-banoun-analysis By Peter A. McCullough, MD, MPH

Beginning in October, 2023, Beyfortus® (Nirsevimab) has been given routinely to all healthy newborns for the prevention of respiratory syncytial virus infection. High-tech synthetic antibodies have never been injected in a human on the first day of life before, so as one could expect, it is a brave new world for babies and the fate of this novel public health intervention.

Dr. Helene Banoun has summarized the clinical trials and the early post-marketing results with Beyfortus (nirsevimab) and the results are not good. Despite theoretical reductions in RSV calculated from the studies, the observed cases of invasive RSV infection and death nearly immediately after the shot are alarmingly imbalanced with worsened outcomes for babies given Beyfortus.

Banoun H. Analysis of Beyfortus® (Nirsevimab) Immunization Campaign: Effectiveness, Biases, and ADE Risks in RSV Prevention. Current Issues in Molecular Biology . 2024; 46(9):10369-10395. https://doi.org/10.3390/cimb46090617

Banoun believes the antibody may make RSV infection worse because of antibody dependent enhancement. That means the antibody grabs the virus and human cells in turn can then attach to the end of the antibody and pull the virus into the cell making the infection worse.

Because half of babies get RSV in the first year of life and it is easily treated with nebulized medicine at home, nirsevimab for all appears to be a dangerous proposition. Not only does the antibody worsen the infection in some victims, but it may globally lead to resistant strains of RSV making it a much bigger public health problem in a few years. If a child is hospitalized with RSV, they can not only be managed oxygen, nebulizers, ribavirin, but also safer monoclonal antibodies (palivizumab) designed for acute use.

Banoun’s analysis suggest parents with healthy newborns should consider deferring on this new biotechnology and allowing the natural immune system to develop on its own.

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Peter A. McCullough, MD, MPH

President, McCullough Foundation

www.mcculloughfnd.org

Banoun H. Analysis of Beyfortus® (Nirsevimab) Immunization Campaign: Effectiveness, Biases, and ADE Risks in RSV Prevention. Current Issues in Molecular Biology. 2024; 46(9):10369-10395. https://doi.org/10.3390/cimb46090617