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The British government, on Friday, said it has formally asked the country’s medicines regulator to assess whether a coronavirus vaccine developed by AstraZeneca and Oxford University should be authorised 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.
UK Health Secretary Matt Hancock said he had asked the Medicines and Healthcare Products Regulatory Agency (MHRA) 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 US firm Moderna is not far behind.
Orders 100 million doses
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 authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met.”
Oxford and AstraZeneca reported on Monday that their vaccine appeared to be 62 per cent effective in people who received two doses, and 90 per cent effective when volunteers were given a half dose followed by a full dose.
They did not mention at the time, but later acknowledgedthat a manufacturing issue had resulted in “a half dose of the vaccine being administered as the first dose” to some participants.
AstraZeneca-Oxford vaccine candidate shows 70-90% efficacy
The drugmakers informed the UK regulator of the issue when it was discovered, and it was agreed to complete the late-stage trial with two groups.
AstraZeneca has said it plans to conduct a new global clinical trial to assess the vaccine’s efficacy, but does not expect that to delay regulatory approval in Britain or the European Union, though the US Food and Drug Administration may take longer.
Some scientists have expressed concerns about gaps in the data and the way the results were reported. Only 2,741 people received the half dose, making it hard to know if the effectiveness seen in the group is real or a statistical quirk. A total of 8,895 people received two full doses.
Eleanor Riley, professor of Immunology and Infectious Disease at the University of Edinburgh, said Oxford and AstraZeneca needed to answer questions about their results “clearly and completely”.
“Trust is at a premium when it comes to vaccines and we must not do anything that might in any way undermine that trust,” she said.
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