AZ Will Sideline ‘Lucky Mistake’ Data To Secure COVID-19 Vaccine Approval
UK Regulator Asked To Get On With Review; US Unlikely To Accept Data
A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.
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The latest round-up from the Pink Sheet of developments relating to COVID-19.
The European Medicines Agency will continue working over the Christmas period so that it can complete its assessment of the newly filed marketing applications for BioNTech/Pfizer’s and Moderna’s COVID-19 vaccines as soon possible.
EU and UK regulators are vying for vaccine filings, and the EMA will consider changing the terms of the marketing authorization for remdesivir after a WHO panel advised against its use in COVID-19. An Austrian biotech firm is investigating the prophylactic potential of a carrageenan-based spray.