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Reuters
Trials of a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford will resume after it was stopped due to a reported side effect in a patient in the UK.
On Tuesday, AstraZeneca said studies were being paused while it investigated whether the reported side effect was related to the vaccine.
But on Saturday, Oxford University said it was deemed safe to continue.
The vaccine is considered a strong competitor among the dozens in development.
The University of Oxford said in a statement that “some participants were” expected to feel unwell “in large trials like this one.
The government’s top scientific adviser, Sir Patrick Vallance, echoed this view, telling a Downing Street news conference on Wednesday that what had happened at the Oxford trial was not unusual.
The university added that studies could now be resumed following the recommendations of an independent safety review committee and the UK regulator, the Medicines and Healthcare Products Regulatory Agency.
Oxford University said it would not release information about the patient’s condition for confidentiality reasons, but the New York Times reported that a trial volunteer from the UK had been diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and it can be caused by viral infections.
There was high hope that the vaccine could be one of the first to hit the market, following the successful phase 1 and 2 trials.
Its move to Phase 3 testing in recent weeks has involved some 30,000 participants in the US, as well as the UK, Brazil and South Africa. Phase 3 vaccine trials often involve thousands of participants and can last several years.
The World Health Organization (WHO) says nearly 180 vaccine candidates are being tested worldwide, but none have completed clinical trials.
US President Donald Trump has said he wants a vaccine available in the United States before the Nov.3 election, but his comments have raised fears that politics will be prioritized over safety in the rush for a vaccine.
But the WHO chief scientist has said countries should not start “cutting corners” in the race to develop a vaccine.
“Just because we talk about speed and scale does not mean that we start to compromise or take shortcuts in what would normally be evaluated,” Dr. Soumya Swaminathan said Wednesday.
“The process still has to play by the rules of the game. In the case of drugs and vaccines that are administered to people, first and foremost their safety must be proven,” he said.
Risk of ‘losing control’
Official figures indicate that the coronavirus epidemic in the UK is growing again, after the R number, the virus’s reproduction rate, rose to between 1 and 1.2 for the first time since March.
Meanwhile, daily cases of coronavirus in Scotland have reached a four-month high, according to the latest Scottish government data.
A total of 221 people tested positive for the virus in the past 24 hours, the highest daily number since May 8, when there were 225 positive tests.
Professor Sir Mark Walport, a member of the government’s Sage scientific advisory group, warned that the UK is “on the brink of losing control of the virus”.
He told BBC Radio 4’s Today program: “You just have to look across the Channel to see what is happening in France and what is happening in Spain.”
It comes as a new “rule of six” goes into effect on Monday, limiting indoor and outdoor gatherings to six people in England.
In Scotland, socializing will be limited to a maximum of six people inside and outside, but unlike England, they must be from two households and children under 12 are exempt.
In Wales, also as of Monday, it will be illegal for more than six people from an extended household to meet indoors, but up to 30 can still meet outdoors.
Another 3,497 people tested positive for the virus in the UK, according to the latest government data on Saturday.
Meanwhile, Cabinet Office Minister Michael Gove suggested that fines might be necessary to ensure that people self-isolate when necessary.
He told BBC Radio 4’s Today program: “I don’t want fines imposed, but even more so, I don’t want people to behave in a way that puts the most vulnerable at risk.”
