UK asks regulator to assess AZ-Oxford vaccine amid questions

British government said Friday it has formally asked country’s medicines regulator to assess wher a coronavirus vaccine developed by AstraZeneca and Oxford University should be authorized for use.

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

U.K. Health Secretary Matt Hancock said he h asked Medicines and Healthcare Products Regulatory ncy to determine wher vaccine “meets rigorous safety standards.”

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

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

regulator said it could t give a time frame for possible approval of vaccines

MHRA Chief Executive June Raine said “ vaccine would be authorized for supply in U.K. unless expected standards of safety, quality and efficacy are met.”

Oxford and AstraZeneca reported Monday that ir 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. y did t mention at time, but later ackwledged, that a manufacturing issue h resulted in “a half dose of vaccine being ministered as first dose” to some participants.

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

AstraZeneca has said it plans to conduct a new global clinical trial to assess vaccine’s efficacy but does t expect that to delay regulatory approval in Britain or European Union -- though U.S. Food and Drug ministration may take longer.

Some scientists have expressed concerns about gaps in data and way results were reported. Only 2,741 people received half dose, making it hard to kw if effectiveness seen in group is real or a statistical quirk. A total of 8,895 people received two full doses.

Elear Riley, professor of Immulogy and Infectious Disease at University of Edinburgh, said Oxford and AstraZeneca needed to answer questions about ir results “clearly and completely.”

“Trust is at a premium when it comes to vaccines and we must t do anything that might in any way undermine that trust,” she said.

Full results are due to be published in medical journal Lancet, though date has been given.

Pfizer and BioNTech said earlier this month that ir vaccine is 95% effective, and Moderna said its product appears to be 94.5% effective, according to preliminary data.

Unlike Pfizer and Moderna vaccines, Oxford-AstraZeneca jab does t need to be stored at freezer temperatures, making it potentially easier to distribute, especially in developing countries. It is also cheaper, because AstraZeneca has agreed t to profit from it during pandemic.

British government and its scientific visers have expressed confidence that multiple vaccines will win approval, but say all decisions are up to regulator.

“y will make an assessment with lots of data that is t currently public domain on efficacy and on safety,” said England’s Chief Medical Officer, Chris Whitty.

“I think it’s always a mistake to make too many judgements early before we have full information and particularly before regulator, independent regulator, has h ir chance to look at data and make an assessment.”

(Im Credit: AP)