UK asks regulator to evaluate Oxford / AstraZeneca COVID-19 vaccine



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LONDON (Reuters) – Britain on Friday asked its drug regulator to evaluate the COVID-19 vaccine candidate from the University of Oxford and AstraZeneca for temporary supply, a step towards starting its rollout before the end of the year.

FILE PHOTO: In this illustration taken on October 31, 2020, vials with a decal that reads “COVID-19 / Coronavirus Vaccine / Injection Only” and a medical syringe are seen in front of the AstraZeneca logo displayed. REUTERS / Dado Ruvic

AstraZeneca expects 4 million doses to be available in Britain by the end of next month, and Health Minister Hancock is aiming for the rollout to start before Christmas.

“We have formally asked the regulator to evaluate the Oxford / AstraZeneca vaccine, understand the data and determine if it meets rigorous safety standards,” Hancock said in a statement.

“This letter is an important step toward implementing a vaccine as quickly and safely as possible.”

Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) is already evaluating the vaccine in a “continuous review” as data on safety and efficacy arrive.

Hancock has also asked the MHRA to approve the Pfizer / BioNTech candidate after it was shown to be 95% effective.

Oxford and AstraZeneca published interim efficacy results on Monday, showing that the vaccine could be 90% effective when administered as a half dose followed by a full dose.

Questions have been raised about the Oxford / AstraZeneca data and the robustness of that result, although the MHRA approved the use of the half-dose / full-dose regimen received by a subgroup in the trial.

Britain’s chief scientific adviser said Thursday that interim results showed the Oxford / AstraZeneca vaccine worked.

“The main result is that the vaccine works and that is very exciting,” Patrick Vallance said during a news conference with Prime Minister Boris Johnson. Medical director Chris Whitty said the regulator should conduct an evaluation.

Report from Alistair Smout; William Schomberg Editing

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