CDC Observational Study Output Used to Claim High Effectiveness of Long-Acting mAb in Infants—90% in Preventing Hospitalization

Data derived from the Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) purportedly shows that&nbsp;nirsevimab, a long-acting monoclonal antibody product,&nbsp;has been highly effective in protecting infants from hospitalizations associated with respiratory syncytial virus (RSV).&nbsp;Serious limitations should be noted despite this study&rsquo;s seemingly positive output. Observational studies can't prove causation because they are purely descriptive and non-experimental.&nbsp;In observational studies, researchers can't assign subjects to treatment or control groups using a random mechanism, for example.&nbsp;This makes it difficult to draw a causal relationship between the treatment and the observed outcomes. However, real-world evidence research such as this CDC-sponsored study offers valuable information complementing actual randomized controlled trial findings.
Approved  as BeyfortusTM (Sanofi and AstraZeneca) by the U.S. Food and Drug Administration (FDA) last year, TrialSite earlier in 2024, raised the risk-benefit analysis question.  When it comes to prevalence and morbidity and mortality associated with RSV and newborns, was the monoclonal antibody (mAb) worth safety risks, both known as well as unknown given the vulnerability of the targeted patient population?