Medicines regulator formally asked to approve UK-developed Coronavirus vaccine

Any approval would be subject to the company submitting the necessary safety, quality and efficacy data.

Matt Bodell
27 November 2020

The move marks a significant first step in getting the vaccine approved for deployment.

The government has formally requested the UK’s independent medicines regulator assess the suitability of Oxford/AstraZeneca’s Covid-19 vaccine.

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Any approval would be subject to the company submitting the necessary safety, quality and efficacy data.

The move marks a significant first step in getting the vaccine approved for deployment, and the country getting back to relative normality.

The UK will be one of the first countries in the world to receive the vaccine, with AstraZeneca expecting to have up to 4 million doses ready for the UK by the end of the year and 40 million by the end of March 2021.

Earlier this week, the University of Oxford and AstraZeneca team published their interim efficacy results, which indicated the vaccine was at least 70 percent effective in protecting individuals from Covid-19.

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This rose to 90 percent effective when administered as half a dose, followed by a full dose – rather than two full doses.

In a letter sent by the Department of Health and Social Care to the Medicines and Healthcare products Regulatory Agency (MHRA), the government has asked the regulator to assess the vaccine for authorisation under Regulation 174 of the Human Medicines Regulations, which enables the temporary supply of medicines to be authorised in response to a public health need.

Health and Social Care Secretary Matt Hancock said:“We are working tirelessly to be in the best possible position to deploy a vaccine as soon as one is approved by the independent regulator the MHRA.

“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 as safely possible.”

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