LONDON — Oxford University announced Saturday it was resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended following a reported side-effect in a U.K. patient.
In a statement, the university confirmed the restart across all of its U.K. clinical trial sites after regulators gave the go-ahead following the pause on Sunday.
"The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator, the MHRA, the trials will recommence in the U.K.," it said.
The vaccine being developed by Oxford and AstraZeneca is widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world.
British Health Secretary Matt Hancock welcomed the restart, saying in a tweet that it was "good news for everyone" that the trial is "back up and running."
The university said in large trials such as this "it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety."
It said globally some 18,000 people have received its vaccine so far. Volunteers from some of the worst affected countries — Britain, Brazil, South Africa and the U.S. — are taking part in the trial.
Brazil's health regulator Anvisa on Saturday said it had approved the resumption of tests of the "Oxford vaccine" in the South American country after receiving official information from AstraZeneca.
Although Oxford would not disclose information about the patient's illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed severe neurological symptoms that prompted the pause. Specifically, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.
The university insisted that it is "committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely."
Pauses in drug trials are commonplace and the temporary hold led to a sharp fall in AstraZeneca's share price following the announcement Tuesday.
The Oxford-AstraZeneca study had been previously stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine.
During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety. The trials also assess effectiveness by tracking who gets sick and who doesn't between patients getting the vaccine and those receiving a dummy shot.
Dr. Charlotte Summers, a lecturer in intensive care medicine at the University of Cambridge, said the pause was a sign that the Oxford team was putting safety issues first, but that it led to "much unhelpful speculation."
Meanwhile, coronavirus infections in the Dakotas are growing faster than anywhere else in the nation, fueling impassioned debates over masks and personal freedom after months in which the two states avoided the worst of the pandemic.
The argument over masks raged this week in Brookings, South Dakota, as the city council considered requiring face coverings in businesses. The city was forced to move its meeting to a local arena to accommodate intense interest, with many citizens speaking against it, before the mask requirement ultimately passed.
Amid the brute force of the pandemic, health experts warn that the infections must be contained before care systems are overwhelmed. North Dakota and South Dakota lead the country in new cases per capita over the last two weeks, ranking first and second respectively, according to Johns Hopkins University researchers.
South Dakota has also posted some of the country's highest positivity rates for COVID-19 tests in the last week — over 17 percent — an indication that there are more infections than tests are catching.
Infections have been spurred by schools and universities reopening and mass gatherings like the Sturgis Motorcycle Rally, which drew hundreds of thousands of people from across the country.
The Republican governors of both states have eschewed mask requirements, tapping into a spirit of independence hewn from enduring the winters and storms of the Great Plains.
In other developments:
• The Vatican said Saturday it was “necessary and urgent” to return to in-person Masses as soon as anti-coronavirus measures permit. The head of the Vatican’s liturgy office, Cardinal Robert Sarah, said in a letter to bishops conferences that virtual liturgies, while useful, were no replacement for the real thing. He said physical presence by the faithful in churches was “vital, indispensable, irreplaceable.”
• India’s confirmed coronavirus tally has crossed 4.6 million after a record surge of 97,570 new cases in 24 hours. India on Saturday also reported another 1,201 deaths, taking total fatalities to 77,472.
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