Britain asks regulator to assess Oxford/AstraZeneca COVID-19 vaccine

BRITAIN ASKS REGULATOR TO ASSESS OXFORD/ASTRAZENECA COVID-19 VACCINE

The British government said it has asked its independent medicines regulator to assess 's coronavirus vaccine as part of the formal approval process for the drug to be rolled out by the end of the year. AstraZeneca has completed Phase III clinical trials of its vaccine. But under British rules, the government must also ask the MHRA to green light the drug.

Britain on Friday asked its medicine regulator to assess Oxford University and AstraZeneca's COVID-19 vaccine candidate for temporary supply, a step towards beginning a roll-out before the end of the year.

AstraZeneca expects 4 million doses to be available in Britain by the end of next month, and health minister Hancock is targeting the roll-out to begin before Christmas.

"We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards," Hancock said in a statement.

"This letter is an important step towards deploying a vaccine as quickly as safely possible."

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) is already assessing the vaccine in a "rolling review" as data comes in on safety and efficacy.

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, which showed that the vaccine could be 90% effective when given as a half dose followed by a full dose.

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

Britain's top science adviser said on Thursday that the interim results showed the Oxford/AstraZeneca vaccine worked.

"The headline result is the vaccine works and that's very exciting," Patrick Vallance said during a news conference with Prime Minister Boris Johnson. Chief Medical Officer Chris Whitty said it was up to the regulator to make an assessment.





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