FDA should 'under no circumstances' fast-track a COVID-19 vaccine, says patient safety group

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Heather Lieberman (L), 28, receives a COVID-19 vaccination from Yaquelin De La Cruz at the Research Centers of America in Hollywood, Florida, on August 13, 2020. CHANDAN KHANNA/AFP via Getty Images
  • "[U]nder no circumstances" should US authorities approve a COVID-19 vaccine without six months of follow-up data on participants in clinical trials, a patient safety nonprofit said Wednesday.

  • Earlier this month, the FDA issued safety guidelines that say vaccine makers should follow clinical trial participants for two months before seeking emergency authorization.

  • But in comments to the FDA, the Emergency Care Research Institute says approving a vaccine with such limited data could pose "significant safety risks."

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There could be "very severe" consequences from rushing out a COVID-19 vaccine before clinical trials are completed, according to the Emergency Care Research Institute, a nonprofit that advises public and private health care providers on safeguarding patient safety.

"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," Dr. Marcus Schabacker, president and CEO of ECRI, said in a statement on Wednesday.

The comments come as the US Food and Drug Administration is holding a teleconference on Thursday to discuss the development and authorization of a vaccine for the novel coronavirus.

President Donald Trump has claimed a vaccine could be authorized before the November election. But earlier this  month the FDA issued safety standards, opposed by the White House, that instruct pharmaceutical companies to monitor clinical trail participants for at least two months before seeking emergency approval.

But ECRI, in a policy paper submitted to the FDA, maintains that no vaccine should receive emergency approval with such limited data. Indeed, "under no circumstances" should US authorities authorize a vaccine without a full six months of follow-up information, it says.

"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 said. "The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough."

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