Formal review of new vaccine sought in U.K.
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 vaccine, 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 OxfordAstraZeneca vaccine, and plans to start distributing it in December if it gains approval.
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 later acknowledged that a manufacturing issue had resulted in “a half dose of the vaccine being administered as the first dose” to some participants.
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 U.S. Food and Drug Administration may take longer.