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Friday 27 November 2020 6:46 am  |  Updated:  Friday 27 November 2020 7:06 am

Government urges regulator to approve Astrazeneca-Oxford vaccine for emergency supply

By: Edward Thicknesse

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Germany’s leading infectious disease institute said today a first vaccine against coronavirus could be available as early as autumn but warned that it may take longer to control the pandemic.

The government has formally asked the UK’s medicines regulator to authorise Astrazeneca and Oxford University’s coronavirus vaccine for emergency supply.

If the vaccine is approved, it could speed up the rollout of the treatment across the UK.

Regulators will begin to assess the vaccine when they receive full data from ongoing trials being carried out by Astrazeneca.

The decision to seek emergency approval of the vaccine comes a few days after the company revealed that it had a 70 per cent efficacy rate against the disease.

This rose to 90 per cent in a trial which saw participants receive a half dose and then a full dose, but there have been questions over the results.

In order to validate the figures, Astrazeneca’s chief exec today said that the company was mulling a further trial of the half-dose regime.

Read more

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Health officials have written to the Medicines and Healthcare products Regulatory Agency (MHRA) 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.

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

Health 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.” 

If the vaccine is authorised, the company is expected to provide 4m doses to the UK before the end of the year.

By the end of March, the number of shots delivered is expected to rise to 40m. In total, the UK has bought 100m doses of the vaccine.

Read more

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