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The Oxford / AstraZeneca coronavirus vaccine is still under review, the UK medicine agency said, amid reports that doses could be ready by Dec. 28.
The Medicines and Health Products Regulatory Agency (MHRA) is believed to give the vaccine the green light sometime during the week of December 28, prompting its immediate launch by the NHS.
But Whitehall sources said that while they expected the vaccine to be available that week, it was by no means safe, and authorization could be delayed until early January.
The delay has caused frustration in Whitehall and the NHS, as the vaccine has taken much longer to reach approval than the Pfizer vaccine, which was launched in the UK last week.
Complications surrounding the results of the initial trial, revealed by the University of Oxford last month, appear to be to blame for the delay, and data from the university give a variety of different results on the vaccine’s efficacy.
Data from the university suggested that the vaccine is 62% effective when a full dose is administered followed by another full dose. However, when people received a half dose followed by a full dose at least a month later, their efficacy increased to 90%. This results in an average efficiency of 70.4%.
vaccine dose
A report in the Daily Telegraph said the MHRA would authorize the vaccine on December 28 or 29, after final data on the vaccine’s performance is presented to the MHRA on Monday.
Large-scale test sites, including football stadiums, would open in the first week of January to enable the largest mass testing program in the UK so far, the newspaper said.
But an MHRA spokeswoman said: “Our ongoing review of the Oxford / AstraZeneca Covid-19 vaccine is ongoing.
“Our process to approve vaccines is designed to ensure that any licensed Covid-19 vaccine meets the expected high standards of safety, quality and efficacy.
“Any vaccine must undergo robust clinical trials in accordance with international standards, with oversight provided by the Medicines and Healthcare Products Regulatory Agency, and no vaccine would be authorized to supply in the UK unless the standards are met. expected safety, quality and efficacy. “
Professor Sarah Gilbert, who has led the design of the vaccine at the University of Oxford, said Friday that she hoped the vaccine was not “too far off.”
He said the results of the vaccine tests had been positive, but they also “intrigued” the researchers and “immediately led them to think about wanting to do more work.”
“It was not the climax that it could have been,” he said. “But we are very happy with the way the vaccine is performing, and we look forward to the point where people can start getting vaccinated outside of clinical trials.
“Obviously, I cannot prejudge that moment, regulators should have their time to make their decisions, but I really hope that moment is not too far away.”
Martin Marshall, president of the Royal College of GPs, said the approval of the Oxford vaccine could speed up the distribution of the coronavirus vaccine in nursing homes.
“Right now we are dealing with this Pfizer vaccine, which is difficult,” he told BBC Radio 4 Today.
“Assuming we are going to get approval for the AstraZeneca vaccine, which is much more familiar because it looks so much more like the flu vaccine, I think we will be able to roll it out at a much faster rate, but certainly more over the next several weeks and years. next months we hope that all nursing homes are covered. “
