In Depth

Race for coronavirus vaccine: who will take part in the human trials?

Oxford University scientists plan to give jab to 5,000 volunteers

Oxford University scientists will tomorrow begin coronavirus vaccine trials on humans, with researchers saying it has an 80% chance of success.

Health Secretary Matt Hancock said the government will give the Oxford researchers £20m to help with trials, and a further £22.5m to scientists at Imperial College, London.

“I can announce that the vaccine from the Oxford project will be trialled in people from this Thursday,” said Hancock.

Who will take part?

The researchers began enrolling volunteers last month, looking for 510 people in good health, aged between 18 and 55.

The trial needs the majority of people taking part not to have been exposed to the virus already, so has excluded volunteers who have previously tested positive for Covid-19, or who have had fever or a cough in the past month.

“Some will inevitably have been exposed, and that is useful too, as we want to know what the vaccine means for people who have been exposed to the coronavirus”, says Sarah Gilbert, professor of vaccinology at the University of Oxford.

The trial will take place in Oxford and Southampton, with three other sites to be added later.

There are plans to extend the maximum age of volunteers from 55 to 70 in phase two of the trials, and then to over 70 in phase three.

Phase three is expected to involve 5,000 volunteers, reports medical journal The Lancet.

The volunteers will be monitored and asked to contact the Oxford scientists if they have any symptoms of coronavirus.

As with most medical trials, there are risks. An accompanying document acknowledges “with any vaccination there is a risk of rare serious adverse events”.

What happens next?

The Oxford team plans to start trials tomorrow, finishing the vaccination trial of the initial volunteers by mid-May.

Phases two and three will follow, with a full set of results expected this autumn.

“The best-case scenario is that by the autumn of 2020, we have an efficacy result from phase three and the ability to manufacture large amounts of the vaccine, but these best-case timeframes are highly ambitious and subject to change,” Gilbert says.

The scientists' ability to determine how well the vaccine works will be affected by how much the virus spreads organically in the population this summer.

“We are also beginning to think about initiating trials with partners in other countries to increase our ability to determine vaccine efficacy,” says Gilbert, who adds that sharing vaccine knowledge with other countries is crucial.

Deals to mass produce the vaccine already been done with three UK manufacturers, and several more abroad.

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Why is developing a vaccine such a big challenge?

Developing a vaccine for a virus usually takes far longer than the few months that scientists have had to work on the coronavirus jab.

“In normal times, reaching this stage would take years and I'm very proud of the work taken so far,” said Hancock. But, he added, “nothing about this process is certain”.

Many in the scientific community are focused on developing a vaccine, but even the more optimistic among them believe the process could take up to 18 months. Even “that is unprecedented in human history”, Rachel Grant, of the Coalition for Epidemic Preparedness Innovations, told Esquire. “No vaccine has ever been developed at that speed.”

There is, however, some good news. While making a vaccine isn’t simple, there is a standard method.

“The actual platform – the backbone of the vaccine – is always the same, whatever the disease,” says Professor Katie Ewer, a senior immunologist at Oxford University, involved in the human trials.

The Oxford vaccine, called ChAdOx1 nCoV-19, has been created from a harmless chimpanzee virus that has been genetically engineered to carry part of the coronavirus, says Sky News.

“Faced with a pandemic, there's always a temptation to cut corners. Every extra day jumping through red tape means thousands of people dead, tens of thousands more infected,” says Esquire.

The magazine notes that “all vaccine development lives in the shadow of a terrible series of events in 1976, when the threat of a swine flu epidemic” caused scientists to cut corners. “Of the inoculated, one in 100,000 contracted a neurological disease called Guillain–Barre syndrome, in which the body’s immune system attacks its own nerves, causing permanent paralysis. Since then, speed has always come second to safety.”

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