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Title: Government asks drug regulator to 'understand the data' behind Oxford's Covid vaccine amid fears trial data was based on 'shaky science'
Source: [None]
URL Source: http://www.scoopyweb.com/2020/11/go ... nt-asks-drug-regulator-to.html
Published: Nov 27, 2020
Author: Chris Martenson
Post Date: 2020-11-27 13:13:00 by Horse
Keywords: None
Views: 47

'NO ONE who got the dose that had 90% success rate was aged over 55'

MHRA will assess the Oxford/AstraZeneca vaccine as soon as it gets full data

Race is now on between Oxford and Pfizer for first approval in the UK

Same process began on Pfizer's '95% effective' jab last week after trial results

But confusion over efficacy of AstraZeneca jab has led firm to start a new trial

Best results were seen in a group given the wrong dose by accident, study shows

Health Secretary Matt Hancock has asked the UK's drugs regulator to 'understand the data' coming out of Oxford University's coronavirus vaccine trial amid a row over the science behind the jab's promising results.

Officials last night asked the Medicines and Healthcare products Regulatory Agency (MHRA) to consider giving emergency approval for the jab, so that it could be given out from next month if it is deemed safe and effective.

It comes after confusing trial results from Oxford found under-55s accidentally given too little of the vaccine actually had better protection from coronavirus than those who got the full doses, making it unclear how effective the vaccine really is.

The MHRA is doing the same analysis of Pfizer's jab and 'emergency approval' does not bypass any safety checks but means it can be given out as soon as regulators are satisfied, rather than waiting for official paperwork to be finalised. This was made possible by a specific new law brought in during the summer.

Oxford's trial results this week suggested the vaccine is somewhere between 62 and 90 per cent effective, depending on the dosage people are given.

The jab turned out to be most effective among 2,741 volunteers accidentally only given a half-dose the first time they had the injection, followed by a full dose. But none of those were over 55, according to reports, meaning they didn't represent the vulnerable group who will rely on the vaccine in the real world.

Scientists said claiming the vaccine could be 90 per cent effective for everyone based on that chance result was 'shaky science' and its manufacturer, AstraZeneca, yesterday announced it would carry out another clinical trial to confirm the results.

The company's share price has dropped by almost eight per cent since it unveiled the results on Monday amid confusion over whether the dosing error will harm the vaccine's chances of approval. There are doubts about how it will go down in the US, which has pre-ordered 500million doses of the jab.

If the vaccine turns out to be less effective than Pfizer's, Britain could face 'tough choices' about whether to give more people that one, according to one expert.

Professor David Salisbury, a former vaccines director at the Department of Health, said on Radio 4 today: 'If it comes through at 62 per cent and the other vaccines that are coming through so far at 90 per cent then I think you have to think very carefully: what do we with 100million doses of a product that isn't protecting as well as the alternatives?'

Britain is moving closer by the day to getting a vaccine that could bring an end to the coronavirus outbreak, with public health officials expecting people to start getting appointments in less than two weeks' time.

It comes it was claimed today that suspected North Korean hackers tried to break into the systems of AstraZeneca in recent weeks, as the company races to deploy its vaccine for the Covid-19 virus.

The hackers posed as recruiters on networking site LinkedIn and WhatsApp to approach AstraZeneca staff with fake job offers, sources said. They then sent documents purporting to be job descriptions that were laced with malicious code designed to gain access to a victim's computer.

Exactly how well the vaccine being developed by Oxford University and AstraZeneca works is not yet clear, because an error in the dosing made it more effective in some people but scientists say there weren't enough people in that group to be sure of the results

Former Department of Health vaccines chief Professor David Salisbury said the UK will face 'tough choices' if Oxford's vaccine is less effective than others

Former Department of Health vaccines chief Professor David Salisbury said the UK will face 'tough choices' if Oxford's vaccine is less effective than others

Health Secretary Matt Hancock said: 'We are working tirelessly to be in the best possible position to deploy a vaccine as soon as one is approved by the independent regulator the MHRA.

'We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards.

'This is an important step towards deploying a vaccine as quickly as safely possible.'

The MHRA will look in detail at the results of the clinical trial run by the Oxford and AstraZeneca team to decide how good their vaccine is. NO10 DENIES PLANS TO PUT UNION JACK FLAG ON OXFORD'S VACCINE

Downing Street said there were 'no plans' to have the Union flag printed on the Oxford University and AstraZeneca coronavirus vaccine, following reports that Number 10's 'Union Unit' had asked for the British flag to appear on packaging.

The Prime Minister's official spokesman told reporters: 'There are no plans for the Union Jack to be on doses.

'We've said previously the manufacturing for some of the leading potential vaccines is already under way so they can be rolled out quickly if and when approved.

'Manufacturers are well versed in the best ways to package products like this.'

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