Lab technician operating a computer reviewing data

Government asks MHRA to begin vaccine approval process

As a next step to permitting it for use in the UK, the Government has formally asked the Medicines and Healthcare products Regulatory Agency (MHRA) to evaluate whether the Oxford vaccine can be authorised for wider use.

The University of Oxford has published its interim efficacy results recently, which showed the vaccine to be at least 70% effective in protecting individuals from Covid-19.

While lower than a number of the other vaccines to have also published their preliminary results in recent weeks, the Oxford vaccine’s strength comes in its ability to be stored at significant less cold temperatures – allowing for easier transportation and use in settings with limited or no cold chain capabilities, such as in the community.

The effectiveness of the vaccine also rose to as high as 90% effective when administered as half a dose, followed by a full dose – rather than two full doses.

As a next step to getting the vaccine approved for deployment, it will now be assessed by the MHRA on the grounds of suitability for temporary supply, as soon as the manufacturers submit the necessary safety, quality and efficacy data.

If authorised, the UK would be one of the first countries in the world to receive the vaccine, with the manufacturer of the vaccine reportedly expecting to have as many of four million doses ready for the UK by the end of the year.

By March 2021, they’re targeting as many as 40 million doses to be available for the UK.

The UK Government became the first country in the world to sign an agreement with the University of Oxford and the vaccine manufacturer, securing access to 100 million doses of the vaccine candidate.

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 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.”

The MHRA has already started a rolling review to determine whether the Oxford vaccine meets its strict standards of safety, efficacy and quality.

Once the MHRA receives the full data from the company, its renowned team of scientists and clinicians stand ready to progress its assessment of the vaccine.

Until the end of December, and as part of the transition period, vaccines must be authorised via the European Medicines Agency and that authorisation will automatically be valid in the UK.

However, if a suitable Covid-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation which we have implemented – Regulation 174 – allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need.

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