The Oxford/AstraZeneca coronavirus vaccine is still being reviewed, the UK’s medicine agency has said, amid reports that doses could be ready by 28 December.
It is thought that the Medicines and Healthcare products Regulatory Agency (MHRA) will give the vaccine the green light at some point during the week of 28 December, triggering its immediate rollout by the NHS.
But Whitehall sources said that while they hoped the vaccine would be available that week, it was by no means certain, and the authorisation could be delayed until the beginning of January.
The delay has caused frustration in Whitehall and the NHS, with the vaccine taking much longer to meet approval than the Pfizer vaccine, which was rolled out in the UK last week.
Complications around the results of the initial trial, unveiled by the University of Oxford last month, appear to be to blame for the delay, with data from the university giving a range of different results for efficacy of the vaccine.
Data from the university suggested that the vaccine has 62% efficacy when one full dose is given followed by another full dose. However, when people were given a half dose followed by a full dose at least a month later, its efficacy rose to 90%. This results in an average efficacy of 70.4%.
A report in the Daily Telegraph said the MHRA would authorise the vaccine on 28 or 29 December, after final data on the vaccine’s performance is submitted to the MHRA on Monday.
Large-scale testing sites, including football stadiums, would be opened in the first week of January to allow the biggest mass-testing programme in the UK so far, the newspaper said.
But an MHRA spokeswoman said: “Our rolling review of the Oxford/AstraZeneca Covid-19 vaccine is ongoing.
“Our process for approving vaccines is designed to make sure that any Covid-19 vaccine authorised meets the expected high standards of safety, quality and effectiveness.
“Any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the Medicines and Healthcare products Regulatory Agency, and no vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met.”
Prof Sarah Gilbert, who has led the design of the vaccine at the University of Oxford, said on Friday that she hoped the vaccine was not “too far off”.
She said the results of the vaccine tests had been positive, but also “intrigued” researchers and “immediately led to thoughts of wanting to do more work”.
“It wasn’t quite the climax that it might have been,” she said. “But we’re very happy with the way the vaccine is performing, really looking forward to the point where people can start to be vaccinated outside of clinical trials.
“Obviously I can’t prejudge that moment, the regulators have to be given their time to make their decisions but I really hope that moment isn’t too far off.”
Martin Marshall, the Royal College of GPs chair, said that approval of the Oxford vaccine could speed up he distribution of the coronavirus vaccine in care homes.
“At the moment we are dealing with this Pfizer vaccine, which is difficult,” he told the BBC Radio 4 Today programme.
“On the assumption that we are going to get approval for the AstraZeneca vaccine, which is much more familiar because it is much more like the flu vaccination, then I think we will be able to roll out at a much faster pace, but certainly over the next few weeks and next couple of months we expect all care homes to be covered.”