FDA Head Says A COVID-19 Vaccine Could Get Emergency Approval Without Phase 3 Trial Results: FT

Aditya Raghunath
·2 min read

The United States Food and Drug Administration is willing to expedite the COVID-19 vaccine authorization process, including granting emergency use authorization to a candidate before it completes late-stage clinical trials, according to Chairman Stephen Hahn.

What Happened: Hanh told the Financial Times that the FDA will only take such a step after weighing the risks and benefits of any coronavirus vaccine, instead of using the procedure as a tool for a political agenda before the 2020 Presidential elections.

Hahn reportedly told FT that the federal agency is prepared to approve a vaccine before the completion of phase three clinical trials. The FDA commissioner also hinted at the possibility of issuing emergency authorization for use in restricted groups, rather than a blanket approval.

One of the significant points in consideration for the upcoming 2020 elections is the response to the pandemic outbreak by the current administration. However, the FDA clarified that its decision to sanction trials will not be driven by the re-election prospects of Donald Trump.

AstraZeneca Plc (NYSE: AZN) is working on a vaccine with Oxford University, which could be fast-tracked by the administration in September before the Stage Three trials are successfully completed, according to another FT report.

Pfizer Inc (NYSE: PFE), Johnson and Johnson (NYSE: JNJ), Moderna Inc. (NASDAQ: MRNA), and Inovio Pharmaceuticals Inc (NASDAQ: INO) are also performing clinical trials for their COVID-19 vaccine candidates.

Why It Matters: Vaccine manufacturers face a systematic and inevitable risk during testing and there is a lobby actively seeking protection against litigation in the European Union. Reports suggest that AstraZeneca has already managed to receive liability protection in certain countries.

The FDA earlier this month granted EUA for use of convalescent plasma to treat hospitalized COVID-19 patients.

Photo courtesy: U.S. Department of Defense

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