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The UK government said on Friday it had officially asked the country’s drug regulator to assess whether a coronavirus vaccine developed by AstraZeneca and the University of Oxford should be authorized.
The step comes amid questions about the preliminary results of the vaccine trials, after the company and the university acknowledged that the most encouraging part of their findings came from a dosing error.
British 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 vaccine candidate to reach formal evaluation in Britain, following a shot developed by Pfizer and its German partner BioNTech. A third vaccine from the American firm Moderna is not far behind.
The UK government has ordered 100 million doses of the Oxford-AstraZeneca vaccine and plans to start distributing it in December if it gets approval.
The regulator said he could not give a deadline for possible vaccine approval
MHRA chief executive June Raine said “no vaccine would be authorized for supply in the UK if expected standards of safety, quality and efficacy are not met.
Oxford and AstraZeneca reported on Monday that their vaccine appeared to be 62% effective in people given two doses and 90% when volunteers received a half dose followed by a full dose. They did not mention at the time, but later acknowledged that a manufacturing problem had resulted in “giving half a dose of the vaccine as the first dose” to some participants.
The drugmakers informed the UK regulator of the problem when it was discovered and it was agreed to complete the advanced stage trial with two groups.
AstraZeneca has announced plans to conduct a new global clinical trial to assess the vaccine’s efficacy, but does not expect this to delay regulatory approval in Britain or the European Union – although the Food and US Drug Administration may take longer.
Some scientists have expressed concerns about the data gaps and the way the results were reported. Only 2,741 people received the half-dose, making it unclear whether the efficacy seen in the group is real or a statistical oddity. 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 had to answer questions about their results “clearly and completely.”
“Trust is paramount when it comes to vaccines and we must not do anything that can in any way undermine that trust,” she said.
The full results are expected to be published in the medical journal The Lancet, although no date has been given.
Pfizer and BioNTech said earlier this month that their vaccine was 95% effective, and Moderna said its product appears to be 94.5% effective, according to preliminary data.
Unlike the Pfizer and Moderna vaccines, the Oxford-AstraZeneca vaccine does not need to be stored at freezing temperatures, which makes it potentially easier to distribute, especially in developing countries. It’s also cheaper, as AstraZeneca has agreed not to take advantage of it during the pandemic.
The UK government and its science advisers have expressed confidence that several vaccines will win approval, but say all decisions are up to the regulator.
“They will be doing an assessment with a lot of data that is not currently in the public domain on efficacy and safety,” England Chief Medical Officer Chris Whitty said.
“I think it’s always a mistake to make too many judgments early on before we have the full information and especially before the regulator, the independent regulator, has had a chance to look at the data and make a Evaluation.”
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11/26/2020 19:34:17 (GMT -5: 00)
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