Therapy Areas: Vaccines
Britain asks its medicine regulator to assess Oxford/AstraZeneca COVID-19 vaccine before expected year end roll out
27 November 2020 -

Reuters news agency reported on Friday that Britain, on 27 November 2020, has asked Britain's Medicines and Healthcare products Regulatory Agency (MHRA), 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.

British pharmaceutical company AstraZeneca Plc (LON: AZN) expects four million doses of its COVID-19 vaccine to be available in Britain by the end of next month.

UK health minister Matt Hancock is reportedly targeting the roll-out to begin before Christmas.

In a statement, Hancock was quoted as saying: "We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards. This letter is an important step towards deploying a vaccine as quickly and safely possible."

Reportedly, 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 23 November 2020, 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 26 November 2020 that the interim results showed the Oxford/AstraZeneca vaccine worked, Reuters added.