UK asks regulator to assess AZ-Oxford vaccine amid questions

LONDON (AP) — The British government said Friday it has formally asked the country’s medicines regulator to assess whether a coronavirus vaccine developed by AstraZeneca and Oxford University should be authorized for use.

The step comes amid questions about preliminary results from trials of the jab, after the company and the university acknowledged that the most encouraging part of their findings stemmed from a dosing error.

U.K. Health Secretary Matt Hancock said he had asked the Medicines and Healthcare Products Regulatory Agency to determine whether the vaccine “meets rigorous safety standards.”

It’s the second vaccine candidate to reach the formal assessment stage in Britain, following a shot developed by Pfizer and its German partner BioNTech. A third vaccine from U.S. firm Moderna is not far behind.

The British government has ordered 100 million doses of the Oxford-AstraZeneca vaccine, and plans to start distributing it in December if it gains approval.

The regulator said it could not give a time frame for possible approval of the vaccines

MHRA Chief Executive June Raine said “no vaccine would be authorized for supply in the U.K. unless the expected standards of safety, quality and efficacy are met.”

Oxford and AstraZeneca reported Monday that their vaccine appeared to be 62% effective in people who received two doses, and 90% effective when volunteers were given a half dose followed by a full dose. They did not mention at the time, but later acknowledged, that a manufacturing issue had resulted in “a half dose of the vaccine being administered as the first dose” to some participants.

The drugmakers informed the U.K. regulator of the issue when it was discovered, and it was agreed to complete the late-stage trial with two groups.

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