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FILE – This Saturday, July 18, 2020, file photo shows an overview of AstraZeneca’s offices and corporate logo in Cambridge, England. Late-stage trials of a coronavirus vaccine developed by the University of Oxford and drugmaker AstraZeneca were halted after a woman who received the experimental injection developed severe neurological symptoms, a spokesperson for the drugmaker said Thursday, Sept. 10, 2020 (AP Photo / Alastair Grant, file)
LONDON (AP) – Oxford University announced Saturday it would resume a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended after a side effect reported in a patient from the UK.
In a statement, the university confirmed the restart at all of its UK clinical trial sites after regulators gave the go-ahead following Sunday’s hiatus.
“The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, trials will resume in the UK,” he said.
The vaccine being developed by Oxford and AstraZeneca is widely perceived as 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 reboot, saying in a tweet that it was “good news for everyone” that the trial is “working again.”
The university said that in large trials like this one “some participants are expected to feel unwell and each case must be carefully evaluated to ensure a careful assessment of safety.”
He said that around 18,000 people worldwide have received their vaccine so far. Volunteers from some of the worst affected countries – Great Britain, Brazil, South Africa and the United States – are participating in the trial.
Brazil’s health regulator Anvisa said on Saturday it had approved the resumption of tests of the “Oxford vaccine” in the South American country after receiving official information from AstraZeneca.
Although Oxford did not disclose information about the patient’s illness due to participant confidentiality, an AstraZeneca spokesperson said earlier this week that a woman had developed severe neurological symptoms that led to the hiatus. 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 to the highest standards of conduct in our studies and will continue to closely monitor safety.”
Pauses in drug trials are commonplace, and the temporary suspension caused AstraZeneca’s share price to drop sharply after Tuesday’s announcement.
The Oxford-AstraZeneca study had 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 the researchers said was unrelated to the vaccine.
During the third and final stage of the trial, researchers look for any signs of possible side effects that have not been detected in previous research with patients.
Due to their large size, studies are considered the most important study phase to detect less common side effects and establish safety.
Trials also assess effectiveness by tracking who gets sick and who doesn’t among patients receiving the vaccine and those receiving a sham injection.
Dr Charlotte Summers, professor of intensive care medicine at the University of Cambridge, said the pause was a sign that the Oxford team was prioritizing safety issues, but that it led to “a lot of useless speculation” .
“To deal with the global COVID-19 pandemic, we need to develop vaccines and therapies that people are comfortable using, therefore it is vital to maintain public confidence that we stick to the evidence and do not draw conclusions sooner. that the information is available, “he said. .
Scientists and others around the world, including experts from the World Health Organization, have tried to hold off expectations of an imminent breakthrough for coronavirus vaccines, emphasizing that vaccine trials are rarely straightforward. .
Italy’s Health Minister Roberto Speranza welcomed the resumption of the vaccine trial, but cautioned that prudence remains necessary.
“Science is working to provide the world with efficient and safe treatments and vaccines,” he said. “Meanwhile, the key remains our behavior.”
Italy, which was ground zero for the outbreak in Europe, is one of the main countries to invest in the AstraZeneca vaccine.
Two other vaccines are in huge end-stage trials in the United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech.
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