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LONDON: The British government said on Friday (November 27) that it formally requested the country’s drug regulator to assess whether a coronavirus vaccine developed by AstraZeneca and the University of Oxford should be licensed for use.
The move comes amid questions about the preliminary results of the jab trials, after the company and the university acknowledged that the most encouraging part of their findings was due to a dosing error.
UK Health Secretary Matt Hancock said he had asked the Medicines and Health Products Regulatory Agency to determine whether the vaccine “meets rigorous safety standards.”
It is the second candidate vaccine to reach the formal evaluation stage in Britain, following a vaccine developed by Pfizer and its German partner BioNTech. A third vaccine from the American firm Moderna is not far behind.
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The British government ordered 100 million doses of the Oxford-AstraZeneca vaccine and plans to begin distribution in December if it gets approval.
The regulator said it could not give a deadline for possible approval of the vaccines.
MHRA Executive Director June Raine said that “no vaccine would be authorized to supply the UK unless expected standards of safety, quality and efficacy are met.”
Oxford and AstraZeneca reported Monday that their vaccine appeared to be 62 percent effective in people who received two doses, and 90 percent effective when volunteers received a half dose followed by a full dose. They did not mention at the time, but later recognized, that a manufacturing problem had resulted in “half a dose of the vaccine being given as the first dose” to some participants.
READ: AstraZeneca manufacturing error clouds COVID-19 vaccine study results
Drug manufacturers informed the UK regulator of the problem when it was discovered, and it was agreed to complete the last-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, although the US Food and Drug Administration may take longer. .
Some scientists have expressed concern about the gaps in the data and the way the results were reported. Only 2,741 people received half the dose, making it difficult to know whether the effectiveness observed 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 Diseases at the University of Edinburgh, said Oxford and AstraZeneca needed to answer questions about their results “clearly and completely.”
“Trust is a rare commodity when it comes to vaccines and we must not do anything that could undermine that trust in any way,” he said.
The full results will be published in the medical journal The Lancet, although no date has been given.
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Pfizer and BioNTech said earlier this month that their vaccine is 95 percent effective, and Moderna said its product appears to be 94.5 percent effective, according to preliminary data.
Unlike the Pfizer and Moderna vaccines, the Oxford-AstraZeneca injection does not need to be stored at freezing temperatures, making it potentially easier to distribute, especially in developing countries. It is also cheaper, because AstraZeneca has promised not to benefit from it during the pandemic.
The British government and its scientific advisers have expressed confidence that various vaccines will gain approval, but say all decisions are up to the regulator.
“They will be doing an evaluation with a large amount of data that is currently not in the public domain on efficacy and safety,” said England Medical Director Chris Whitty.
“I think it is always a mistake to make too many judgments before we have the complete information and, in particular, before the regulator, the independent regulator, has had a chance to analyze the data and make an assessment.”
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