Shares in AstraZeneca bounced this week after the US government signalled that it is considering fast-track approval for the group’s Covid-19 vaccine. In April AstraZeneca agreed a deal with Oxford University, which originally discovered the vaccine, to develop and distribute it.
The government could ask the US Food and Drug Administration (FDA) to grant an “emergency use authorisation” (EUA) based on data from the final-stage UK trial, rather than wait for the more extended study normally required by US regulators. Such a move, possible as early as September, would allow President Donald Trump to claim he has “turned the tide” on the virus. Not so fast, say Rhys Blakely and Henry Zeffman in The Times. AstraZeneca says it is “too early” to begin talks with US regulators about an EUA. Nonetheless, 17,000 people have been enrolled in trials in Britain, South Africa and Brazil. So if enough data emerged to convince AstraZeneca to apply for an EUA, the FDA would be under pressure to grant it quickly. It has already approved 21 Covid-19 drugs, including an antibody treatment, on an emergency basis.
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