Oxford’s covid vaccine ‘could be before regulator by end of year’
CLINICAL TRIALS for the Oxford coronavirus vaccine may have gathered enough safety and efficacy data by the end of the year, a leading scientist has said.
Professor Andrew Pollard, director of the Oxford Vaccine Group, said it is “just possible” that there may be enough clinical trial data on Oxford University’s Covid-19 vaccine to put before regulators this year.
His comments came after England’s chief medical officer, Professor Chris Whitty, said a vaccine for coronavirus may not be ready until next winter.
Prof Pollard told BBC Radio 4’s Today programme: “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 and then to go through the processes of regulators looking at that very carefully to make sure everything’s been done correctly.
“But it is also just possible that, if the cases accrue rapidly in the clinical trials, that we could have that data to put before regulators this year, and then there would be a process that they go through in order to make a full assessment of the data.”
Asked about the timing of a possible vaccine, he said: “That depends very much on the number of cases that occur in the weeks and months ahead.
“Even with 1,000 people eventually you’ll have enough information to know whether or not a vaccine works, but that could take years. 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.”
Prof Pollard said he hoped that 50,000 people would be involved in the clinical trial for the Oxford University 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 accruing during the time of observation 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’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.”
Preliminary results of phase one/two clinical trials of the University of Oxford’s vaccine candidate suggest it is safe and induces an immune reaction.
Phase two, in the UK only, and phase three trials to confirm whether it effectively protects against the virus are taking place in the UK, Brazil and South Africa.
Clinical trials may have gathered enough safety and efficacy data by the end of the year, and there may be enough data to put the vaccine before regulators this year.
The size of the trial is critical, first of all for safety. Professor Andrew Pollard, director of the Oxford Vaccine Group.