The Financial Times reported on Sunday that the U.S. Food and Drug Administration (FDA) might grant an emergency use authorization (EUA) in October to a vaccine for COVID-19 being developed by AstraZeneca (AZN +0.00%) and licensed from Oxford University. The vaccine, AZD1222, is currently in a phase 3 clinical trial that is now trying to enroll 30,000 people around the world in order to assess the safety and efficacy of the vaccine candidate.
With the COVID-19 pandemic having so far killed over 800,000 people worldwide -- and with reports that President Trump is trying to fast-track a vaccine before this November's U.S. election -- there is pressure on the FDA to grant approval for a vaccine as soon as possible. According to the Financial Times report, one plan being considered is for AstraZeneca to submit an EUA based on part of the phase 3 study being conducted in the U.K., involving a subset of 10,000 people.
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According to FDA guidance, emergency use authorization might happen after "a determination by the FDA that the known and potential benefits of a product, when used to diagnose, prevent, or treat serious or life-threatening diseases, outweigh the known and potential risks of the product." None of the phase 1 vaccine trials would likely be deemed sufficient for an EUA, as they have only safety and antibody data and are not testing efficacy in people.
While AstraZeneca's 10,000 subset of its phase 3 trial would likely be sufficient for an EUA, the company denies any talks with U.S. officials about submitting one, according to Fortune magazine. "AstraZeneca has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility," the company said in a statement on Monday.
