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.
Meanwhile, says Bloomberg, Pfizer and BioNTech claim that their joint Covid-19 vaccine is “on track” to be submitted for regulatory review “as early as October”. The companies, which recently clinched a $2bn deal to supply 100 million doses to the US government, released more detailed data from early-stage trials suggesting that the drug was “well tolerated” with “mild to moderate fever in fewer than 20% of participants”.
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