Covid-19 Vaccine Efficacy Overstated, Absolute vs Relative rate reduction
Vaccine clinical trial case definitions for SARS-CoV-2 infection included COVID-19 clinical symptoms; thus the trials were not designed to provide evidence of vaccine efficacy for protection against asymptomatic infections. Vaccine trial outcomes were also tainted by information bias; misclassification of SARS-CoV-2 infections as mild adverse effects of the vaccines vs vaccines adverse effects such as fever, pain, and fatigue = missed diagnosis of infections.
There’s also the fact they never reported Absolute Risk Reduction. Relative Risk Reduction (what was reported) may be sufficient to summarize evidence of a study for comparisons with other studies, but absolute measures are also necessary for applying study findings to specific clinical or public health circumstances. Omitting absolute risk reduction findings in public health and clinical reports of vaccine efficacy is by definition outcome reporting bias: ignoring unfavorable outcomes misleads the public of a treatment’s efficacy and benefits. There’s also ethical and legal obligations of informed consent to consider (people must be educated about the risks and benefits without bias).
The U.S FDA Advisory Committee (VRBPAC) did not follow FDA published guidelines for communicating risks and benefits to the public, when it failed to report absolute risk reduction measures in authorizing the BNT162b2 and mRNA-1273 vaccines for emergency use.
Critical appraisals of reported vaccine efficacy in studies reveals clinically significant insights. A 2018 review of 52 randomized trials for influenza vaccines that studied over 80,000 healthy adults reported an overall influenza vaccine EER of 0.9% and a 2.3% CER, which calculates to a RRR of 60.8%. This vaccine efficacy is consistent with a 40% to 60% reduction in influenza reported by the Centers for Disease Control and Prevention (CDC). However, critically appraising data from the 2018 review shows an overall ARR of only 1.4%, which reveals vital clinical information that is missing in the CDC report. A 1.4% ARR works out to a NNV of approximately 72 people, meaning that 72 individuals need to be vaccinated to reduce one case of influenza. By comparison, the NNV for the Pfzier-BioNTech and Moderna vaccines are 142 and 88.
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