October 22, 2020

ECRI warns of fast-tracking COVID-19 vaccines

By: Judy Mathias

Editor's Note

ECRI announced October 21 that its President and CEO, Marcus Schabacker, MD, PhD, will tell the Food & Drug Administration Vaccines and Related Biological Products Advisory Committee on October 22 that a thorough review of 6 months of completed clinical trial data for COVID-19 vaccines is needed to ensure their safety and effectiveness before approval.

Dr Schabacker will present the following ECRI positions:

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  • Review of completed clinical trials is necessary for vaccine safety and effectiveness
  • Vaccine candidates entail old and new risks
  • Lack of vaccine effectiveness poses substantial risk of harm
  • Uncertainty is inherent in vaccine testing
  • Preliminary data are unreliable
  • Regulatory action based on preliminary trial data is a poor non-evidence-based practice.

Complete clinical trial data and careful consideration of the limitations of available data are essential to ensure the safety and effectiveness of a COVID-19 vaccine, Dr Schabacker says.


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