Is Key Safety Data at Risk in Race for COVID Vaccine

added 27.09.2020 07:37

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The FDA has not spelled out what should happen to the placebo arms of vaccine clinical trials if the vaccine is given an EUA.

Lee and other public health experts are worried that an early EUA would end the placebo section of the trials, and they would lose a critical source of comparison, making it more difficult to understand whether a vaccine may cause serious side effects.

If a vaccine is clearly more effective than the placebo during one of these tests, the drug maker could choose to apply for a swift OK from the FDA under an emergency use authorization (EUA).

Major drug makers have collectively pledged that they will not apply for approval until the safety and effectiveness of their vaccines have been demonstrated in large clinical studies.

In a Sept. 23 hearing before the Senate Committee on Health, Education, Labor and Pensions, FDA Commissioner Stephen Hahn, MD, promised Americans that the “FDA will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness.”

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