All of you here are trying to downplay the most significant aspect discussed here so far: the ARR of the mRNA vaccines is 0.7%, respectively 1.1%. It is the ARR factor which counts, NOT the RRR percentage.
Here is the peer reviewed paper which establishes these facts of science:
https://www.mdpi.com/1648-9144/57/3/199/htmAbstract
Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy. The present article uses clinical epidemiologic tools to critically appraise reports of efficacy in Pfzier/BioNTech and Moderna COVID-19 mRNA vaccine clinical trials. Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows: relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016; absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000. For the Moderna vaccine mRNA-1273, the appraisal shows: relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004; absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000. Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures. Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy.
As was also noted in the BMJ Opinion, Pfizer/BioNTech and Moderna reported the relative risk reduction of their vaccines, but the manufacturers did not report a corresponding absolute risk reduction, which “appears to be less than 1%”. Absolute risk reduction (ARR) and relative risk reduction (RRR) are measures of treatment efficacy reported in randomized clinical trials. Because the ARR and RRR can be dramatically different in the same trial, it is necessary to include both measures when reporting efficacy outcomes to avoid outcome reporting bias.
Ironically, the omission of absolute risk reduction measures in data reviewed by the VRBPAC overlooks FDA guidelines for communicating evidence-based risks and benefits to the public. The FDA’s advice for information providers includes:
“Provide absolute risks, not just relative risks. Patients are unduly influenced when risk information is presented using a relative risk approach; this can result in suboptimal decisions. Thus, an absolute risk format should be used.”
The New England Journal of Medicine also published clinical trial data on safety and efficacy for the BNT162b2 vaccine and the mRNA-1273 vaccine, but with no mention of absolute risk reduction measures.
Relative Versus Absolute Risk Reduction
So exactly how much risk reduction are the manufacturers crediting their vaccine with?
The reduced risk of COVID-19 infection reported by the manufacturers is approximately 95%, which is an accurate relative risk reduction measure. However, missing from the vaccine reports are absolute risk reduction measures which are much more clinically relevant to the reduced risk of COVID-19 infection. The absolute risk reduction of the vaccines in the present critical appraisal is approximately 1%, indicating practically no clinical efficacy or usefulness of the vaccines to reduce COVID-19 infection.
Essentially, the vaccine is useless and ineffective?
For applied clinical and public health interventions, yes, they appear to be almost completely ineffective. The members of the FDA advisory committee overlooked FDA guidelines to include absolute reduction measures when reporting clinical trial outcomes to the public, leading to outcome reporting bias in the FDA’s authorization of the mRNA vaccines.
Reporting relative risk outcomes, without absolute risk outcomes, has been a huge problem in research for decades. Notice that the ARR numbers are close to zero. The vaccines have almost no effect at all!