Will FDA mRNA Vaccine Approval Ignore the “Elephant (not) in the Room”: Ultra-Low Absolute Risk Reductions?

Will FDA mRNA Vaccine Approval Ignore the “Elephant (not) in the Room”: Ultra-Low Absolute Risk Reductions?

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

Dr. Ron Brown – Opinion Editorial

August 10, 2021

When the FDA authorized the COVID-19 mRNA vaccines for emergency use, the FDA did not notify the public of both the vaccines’ relative risk reduction measures (vaccine efficacy of approximately 95%) and absolute risk reduction measures (approximately 1%). Medicina | Free Full-Text | Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials (mdpi.com). The FDA’s failure to report the vaccines’ absolute risk reductions violates the FDA’s own guidelines for communicating evidence-based risks and benefits to the public. Communicating Risks and Benefits: An Evidence-Based User's Guide | FDA. The FDA advises authorities to “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.”

Acknowledged by the Lancet Microbe, failure to address this issue of unreported absolute risk reduction measures is the “elephant (not) in the room”...

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