COVID-19 Vaccine Could Receive FDA Authorization Before Completion of Phase 3 Trials; Experts Demand Independent Data Review

The US Food and Drug Administration (FDA Silver Spring, MD, USA) could bypass the normal approval process to authorize a COVID-19 vaccine before the completion of Phase 3 clinical trials if the benefits outweighed the risks.

In an interview with the Financial Times, Dr. Stephen Hahn, head of the US FDA, said the decision to approve a COVID-19 vaccine would probably be one of the most important and sensitive ones in US public health history. China and Russia have been criticized by public health officials for approving COVID-19 vaccines ahead of their completion of Phase 3 trials. However, according to Dr. Hahn, a safer way to make a COVID-19 vaccine available before the end of Phase 3 trials would be to issue an emergency authorization for use by certain groups instead of a blanket approval.

“It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Dr. Hahn told the Financial Times. “If they do that before the end of Phase 3, we may find that appropriate. We may find that inappropriate, we will make a determination.”

“Our emergency use authorization is not the same as a full approval,” added Dr. Hahn. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”

However, several physicians and experts are demanding an independent commission to review data from COVID-19 vaccine trials before allowing it on the market. Given the negative steps taken by government agencies during the pandemic and growing public distrust of vaccines, physicians and experts feel the need for a layer of review independent from the government in order to instill confidence among the public about the vaccine’s safety and effectiveness. They believe that the findings of an FDA committee would be met with skepticism by the public due to the impression that the research is being hurried and could result in an unsafe COVID-19 vaccine. Experts are advocating an apolitical and independent group that could add an extra layer of review to the entire COVID-19 vaccine approval system to reassure the public and increase trust in the vaccine.

Bioethicist Arthur Caplan, director of medical ethics at NYU Langone Health, told CNN, "We're used to this world where if the FDA or the CDC or the NAS says something is safe and effective, that's enough, but I don't think this time that's sufficient to overturn public skepticism," referring to the US Centers for Disease Control and the National Academy of Sciences. "I think we desperately need an independent national commission."

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US Food and Drug Administration (FDA)