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Covid-19: UK government asks regulator to assess Oxford vaccine as questions are raised over interim data

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4670 (Published 27 November 2020) Cite this as: BMJ 2020;371:m4670

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  1. Elisabeth Mahase
  1. The BMJ

The UK government has asked the Medicines and Healthcare Products Regulatory Agency (MHRA) to evaluate whether the University of Oxford and AstraZeneca vaccine can be authorised for temporary supply as soon as the data on safety, quality, and efficacy are submitted.

If approved, the UK could receive four million doses by the end of the year and 40 million by the end of March 2021. But the request comes as questions have been raised over the researchers’ data, and AstraZeneca said that it would run a new global trial to test the lower dosage of the vaccine.1

The Oxford team reported their interim phase III results on 23 November through a press release. They said that the vaccine was found to be 62% effective when given as two standard doses (8895 participants) one month apart, but it was 90% effective when a half dose was followed by a standard dose regimen (2741 participants).2

The analysis included 131 covid-19 cases, …

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