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UK to evaluate AstraZeneca vaccine for approval

2020-11-28T19:02:33.458Z


The UK has formally submitted AstraZeneca's experimental vaccine to the UK Medicines Regulator for evaluation.


4 keys to the AstraZeneca vaccine 2:00

(CNN) -

The UK government has formally referred the experimental coronavirus vaccine developed by British-Swedish pharmaceutical company AstraZeneca, together with the University of Oxford, to the British drug regulator for evaluation.

According to the UK Department of Health and Welfare (DHSC), the referral of the vaccine to the Medicines and Health Products Regulatory Agency (MHRA) 'marks an important first step in getting the vaccine approved for implementation 'across the UK, provided you get regulatory approval.

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“The UK will be one of the first countries in the world to receive the vaccine, if licensed, and AstraZeneca expects 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. ”Added the DHSC.

In a statement Friday, MHRA Executive Director Dr. June Raine said the agency will "rigorously evaluate the latest data and evidence to be presented on the safety, quality and efficacy of the vaccine."

“The safety of the public will always come first.

Our role is to work with the highest standards and safety is our keyword, "he added.

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UK Health Secretary Matt Hancock welcomed the news and tweeted on Friday that the British government is "working tirelessly to be in the best possible position to implement a vaccine" as soon as regulatory approval is obtained.

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The government announcement comes just days after AstraZeneca announced that its experimental vaccine had shown an average efficacy of 70% in large-scale trials.

The vaccine, developed with the University of Oxford, showed 90% efficacy on a dosing regimen, when the vaccine was administered to 2,741 people as a half dose, followed by a full dose at least one month later, and 62% efficacy in a second regimen, when two full doses were administered to 8,895 people at least one month apart.

That averages 70% efficiency, AstraZeneca said.

AstraZeneca

Source: cnnespanol

All news articles on 2020-11-28

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