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|The authorization would be based on forthcoming results from a study involving 10,000 people in the UK (Photo: AP)|
The Oxford vaccine produced an immune response in its first human trials, underlining its position as one of the leading candidates in the race to combat a virus that has led to hundreds of thousands of deaths and crippled the global economy, as reported by Yahoo News.
According to New York Post, the authorization, known as a EUA, would be based on forthcoming results from a study involving 10,000 people in the UK — even though federal agencies have said a study of 30,000 people would be needed to win such approval.
Prof. Andrew Pollard, director of the Oxford Vaccine Group, voiced his hope that 50,000 people would be involved in the clinical trial for the Oxford vaccine candidate. He stressed, however, that the size of the trial “isn’t really the issue.”
“What you need is to have enough cases accruing during the time of observation in the trials,” Pollard said. “The size of the trial is critical, first of all for safety — so you want to have good evidence that, after a large number of people have been vaccinated, you’ve got good evidence or safety around the vaccine".
“And, secondly, you want to be able to show whether the vaccine works, and the size of the trial actually is determined largely by what the attack rate of the disease is in the study population,” he continued.
The UK’s chief medical officer, Prof. Chris Whitty, has said a vaccine may not be ready until next winter, according to Yahoo News.
“I think that Chris Whitty is quite rightly being cautious, that it could take as long as that to first of all demonstrate a vaccine works and is safe,” Pollard said.
“Even with 1,000 people, eventually you’ll have enough information to know whether or not a vaccine works, but that could take years,” Pollard said.
“So, having 20,000 people in our trials already means that that period of time will be shorter, but unfortunately I can’t quite predict the future about how many cases are going to occur,” he said.
|(Photo: Cyprus Mail)|
Pollard’s comments come as the Trump administration is weighing a fast-track process that would allow AstraZeneca’s coronavirus vaccine to be used in the US before November’s presidential election, according to a new report.
One plan under consideration would see the Food and Drug Administration issue an “emergency use authorization” for the British drugmaker’s vaccine candidate in October, the Financial Times reported Sunday, citing three people briefed on the plan.
According to Pollard, there are a number of trials that we’re running from Oxford here in the UK, in Brazil, and also in South Africa, and the combined size of those three trials together is around about 20,000 people, and AstraZeneca are moving forwards in their trials in the US, hoping to start enrolling 30,000 people.
“So within the trials of the vaccine that was developed here at Oxford University, we’d expect to have perhaps 50,000 or more people in the trials in total,” he said.
Responding to reports the US is planning an EUA for the Oxford vaccine, Pollard said: “Emergency use authorizations are well established by regulators both in the United States and in Europe.
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