Patient safety group warns FDA that fast-tracking COVID-19 vaccines could put Americans at risk

Oct. 22, 2020

U.S. health authorities must approve COVID-19 vaccines only after reviewing six months of trial data, the ECRI patient safety organization stated they will tell U.S. Food and Drug Administration (FDA) advisors on Thursday.

Anything short of that poses significant safety risk to the American public, says ECRI, a nonprofit organization that conducts independent evaluations to inform the healthcare sector.

“Vaccines are some of the safest and most effective ways to protect the American public from disease, but rushed deadlines and incomplete data pose significant safety risks,” says ECRI President and Chief Executive Officer Marcus Schabacker, MD, PhD. “A complete review of trial data is critical for understanding the risks and benefits of COVID-19 vaccines.”

In May 2020, the U.S. government launched Operation Warp Speed (OWS), a public-private partnership intended to develop nine vaccine candidates, with the stated goal of starting distribution by January 2021. Its strategy includes streamlining the vaccine approval process while maintaining appropriate safety and effectiveness controls. ECRI warns that pressure to authorize an early release of a novel coronavirus vaccine without the robust data outlined by OWS could result in significant harm to Americans.

Regulatory action based on preliminary trial data is a poor, non-evidence-based practice that exposes the public to danger, Schabacker says. The topic will be discussed at the October 22 FDA Vaccines and Related Biological Products Advisory Committee, (Docket No. FDA-2020-N-1898). Schabacker will present ECRI’s position during the public comment period:

·        Review of completed clinical trials is necessary to ensure COVID-19 safety and effectiveness.

·         COVID-19 vaccine candidates entail old and new risks.

·         Lack of vaccine effectiveness poses a substantial risk of harm.

·         Uncertainty is inherent to vaccine testing, more so during a pandemic.

·         Preliminary data are unreliable even in clinical trials.

·         Regulatory action based on preliminary trial data makes for poor evidence-based practice.

“Complete clinical trial information and careful consideration of the limitations of available data are essential to ensuring the safety and effectiveness of a COVID-19 vaccine,” Schabacker says. “The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough.”

ECRI has the position statement.

ECRI has the release.

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