Oxford University academics gave African babies a new TB vaccine linked to the deaths of monkeys in tests.
Nearly 1,400 infants were given the experimental jab even though five of six primates involved in a trial died.
An information sheet given to the parents of the babies in 2009 said the vaccine had been tested on animals and was ‘shown to be safe and effective’. But it did not mention the failed monkey trial.
The details, published last night after an investigation by the British Medical Journal, prompted calls for a tightening of rules governing the way animal research is reported. Oxford researchers were accused of ‘cherry picking’ their scientific evidence.
The babies, from South Africa, were not harmed by the jab – called MVA85A – but it did nothing to protect them against tuberculosis.
Oxford, which later dropped the vaccine, insists it provided the results of the monkey study to regulators in the UK, the US and South Africa before the infant trial began. It had shown no safety issues in four other animal studies – in mice, guinea pigs and other monkeys.
And it had also been tested in 14 studies on humans, involving 400 adults, teenagers and children in the UK, Gambia and South Africa before it was given to infants. The Oxford researchers say the monkeys died in one particular study because they had used a stronger version of TB.
The animals had become ‘very unwell’ and had to be put down. But experts say that should not have stopped Oxford from making the results known to the South African parents – and accused scientists of using a ‘pick and mix’ approach to their findings.
Professor Malcolm Macleod, of the University of Edinburgh, said: ‘We need to develop better and more systematic ways to establish when a drug is ready for clinical trials in humans – and importantly, when it is not.
‘Until our institutions recognise that their core purpose is to produce research of value to society they risk a slow decline in their reputation, and possibly a faster and more serious erosion of public trust in science.’
Jonathan Kimmelman, of McGill University in Canada, said the Oxford case was not an isolated one. ‘It’s widely recognised that animal studies intended to support drug development are often riddled with flaws in design and reporting,’ he said.
‘Unfortunately, there are other cases where new treatments were put into human testing on animal evidence that was foreseeably flawed, incomplete, or even negative.’
Oxford said it would have actually been unethical not to proceed with the baby trial, given that the vaccine had proved promising in so many previous tests. A series of allegations are said to have been made about the trial by a former employee, Professor Peter Beverley, against the scientist who developed the vaccine, Professor Helen McShane.
Three separate investigations by the university cleared her of any wrong-doing. Professor Ewan McKendrick, registrar of the university, said: ‘The third panel in 2016 not only cleared Professor McShane of any academic misconduct but went so far as to add that on the basis of the vaccine’s proven safety in humans and positive phase 1 and phase 2A trials, it would have been unethical not to have proceeded with the phase 2 trials in infants.
‘The time has come to stop the repeated repackaging of criticisms and allegations which independent expert analysis has demonstrated to be without foundation.’
Professor Mike Turner of the Wellcome Trust, which funded the study, said clinical trials were carried out ‘to the highest standard’. ‘The decision to test this candidate vaccine was correct and based on robust, positive data from smaller trials in humans that showed that the candidate vaccine was safe and that it might be effective,’ he added.
‘Human trials do not always generate the same results as animal testing, which is why results in animal models are typically only one of a set of considerations in determining whether to move research forward.’
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