UK regulator approves Oxford/AstraZeneca vaccine

[Born2kill]

The United Kingdom on Wednesday became the first country in the world to approve the coronavirus vaccine developed by the University of Oxford and drugmaker AstraZeneca.

The government said in its announcement that the green light "follows rigorous clinical trials and a thorough analysis of the data by experts" at the regulator, the Medicines and Healthcare products Regulatory Agency, "which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness."

U.K. Health Secretary Matt Hancock told the BBC "hundreds of thousands" of doses of the new vaccine would be available “from Monday."

The U.K. also said in the announcement that it would change the way it would prioritize the administration of the vaccine, upon the recommendation of the Joint Committee on Vaccination and Immunisation (JCVI).

The JCVI "has advised the priority should be to give as many people in at-risk groups their first dose, rather than providing the required two doses in as short a time as possible," the announcement said. "Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer term protection."

Vaccination requires two doses. Rather than given 28 days apart, as done during the clinical trials, the committee advised “the priority should be to give as many people in at-risk groups their first dose, rather than providing the required two doses in as short a time as possible," the announcement said.

The second dose will be administered within 12 weeks.

"Everyone will still receive their second dose,” the government said, adding that the second dose “completes the course and is important for longer term protection."

Hancock told Times Radio that the approval of a second vaccine, after the BioNTech/Pfizer jab, means "I now have a very high degree of confidence that by the spring, enough of those who are vulnerable will be protected, to allow us to get out of this, this pandemic situation."

The U.K. used an EU loophole to allow the temporary supply of coronavirus vaccines during an emergency. The country will have free rein to fully authorize further coronavirus vaccines as of January 1, after the Brexit transition period ends.

The European Medicine Agency is also reviewing the data on the Oxford/AstraZeneca vaccine in a rolling review format. It recommended a full conditional marketing authorization for BioNTech/Pfizer’s vaccine on December 21.

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EMA Deputy Executive Director Noël Wathion told Het Nieuwsblad newspaper in an interview published Tuesday that, for Oxford/AstraZeneca, the the agency had not yet received sufficient information “to warrant a conditional marketing license.”