Oxford coronavirus vaccine “could pass regulators by the end of the year”


Blood samples from coronavirus vaccine trials are processed inside the Jenner Institute in Oxford (Photo: AP)

There may be enough data on the Oxford coronavirus vaccine to be submitted to regulators by the end of the year.

Professor Andrew Pollard, director of the Oxford Vaccine Group, said the timing was “just possible”.

His comments came after England’s chief medical officer Professor Chris Whitty said a coronavirus vaccine might not be ready until next winter.

Clinical leads are currently underway for the potential vaccine from the University of Oxford.

Professor Pollard told BBC Radio 4’s Today program: ‘I think Chris Whitty is rightly cautious that it could take that long to demonstrate first that a vaccine works and is. sure, then to go through the processes of the regulators. at this very carefully to make sure everything was done correctly.

“But it’s also just possible that if the cases are increasing rapidly in clinical trials, we may have this data to submit to regulators this year, and then there would be a process that they would go through in order to do a full assessment. Datas. “

Asked about the timing of a possible vaccine, he said: “It depends a lot on the number of cases that arise in the weeks and months to come.

“Even with 1,000 people, you will eventually have enough information to know whether a vaccine works or not, but it could take years. So having 20,000 people in our trials already means that this period of time will be shorter, but unfortunately I can’t quite predict the future of how many cases will occur.

Professor Pollard said he hopes 50,000 people will be involved in the clinical trial of the University of Oxford’s Covid-19 vaccine candidate.

But he stressed that the size of the trial “isn’t really the issue,” adding, “What you need is to have enough cases accumulated during the observation period in the trials.”

“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 have good evidence or safety around it. vaccine.

“And, second, you want to be able to show whether the vaccine is working, and the size of the trial is actually determined in large part by the rate of disease attack in the population being studied.

“And so if you have a very, very rare disease, you need a huge test size, so you can show whether the vaccine is working. But in a situation like the coronavirus right now, depending on what region or country you are in, the size of the trial could be smaller or larger, simply depending on how many cases are occurring in that. community at that time.

Blood samples from coronavirus vaccine trials are processed inside the Jenner Institute in Oxford (Photo: AP)

He added: “We’re running a number of trials from Oxford here in the UK, Brazil and also South Africa, and the combined size of those three trials together is around 20,000 people, and AstraZeneca is moving. forward in their trials in the United States, hoping to start recruiting 30,000 people.

“So in the trials of the vaccine that was developed here at the University of Oxford, we would expect to have maybe 50,000 or more people in the trials in total. ”

Of reports that the United States is planning emergency clearance for the Oxford Covid-19 vaccine, he said: “Emergency use approvals are well established by regulators in the United States and in Europe; in fact, you may know that this week the FDA (the United States Food and Drug Administration) granted emergency use authorization for plasma therapy.

“So the emergency emergency use authorization process is well established, but it still involves having carefully conducted data, just as we collect information about vaccines in clinical trials that are conducted in a rigorous manner and evidence of their effectiveness.

“And so, for our round of trials that we’re doing out of Oxford, we expect to have safety data first and then evidence that the vaccine actually works.

“And before anything progresses from there, it would of course be AstraZeneca that would then pass that on to regulators. ”

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