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Coronavirus vaccine trials in Oxford will resume despite the scare of side effects

LONDON – The University of Oxford announced on Saturday that 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 side effect reported in a patient from the United Kingdom.

In a statement, the university confirmed the restart at all of its UK clinical trial sites after regulators gave the green light after Sunday’s hiatus.

“The independent review process has concluded and, following the recommendations of the independent safety review committee and the UK regulator, the MHRA, evidence will resume in the UK,”

; he said.

The vaccine 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 is “good news for all” that the process is “up and running again”.

The university said in large studies like this one “some participants are expected to become ill and each case must be carefully evaluated to ensure a careful safety assessment.”

He said around 18,000 people globally have received his vaccine so far. Volunteers from some of the worst affected countries – Great Britain, Brazil, South Africa and the United States – are taking part in the process.

Brazilian health regulator Anvisa on Saturday said it approved the resumption of testing 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 the confidentiality of the participants, an AstraZeneca spokesperson said earlier this week that a woman had developed severe neurological symptoms that resulted in the break. 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 was “committed to the safety of our participants and the highest standards of conduct in our studies and will continue to closely monitor safety.”

Pauses in drug trials are the order of the day and the temporary suspension led to a sharp drop in AstraZeneca’s share price following Tuesday’s announcement.

The Oxford-AstraZeneca study had previously been halted in July for several days after a participant developed neurological symptoms which turned out to be an undiagnosed case of multiple sclerosis that the researchers said was unrelated to the vaccine.

During the third and final phase of the test, researchers look for any signs of possible side effects that may not have been detected in previous patient research. Due to their large size, studies are considered the most important study phase for detecting less common side effects and establishing safety. The studies also evaluate effectiveness by monitoring who gets sick and who doesn’t between patients receiving the vaccine and those receiving a sham injection.

Dr Charlotte Summers, a lecturer in intensive care medicine at Cambridge University, said the pause was a sign that the Oxford team was putting safety issues first, but that it led to “very pointless speculation. “.

“To tackle the global COVID-19 pandemic, we need to develop vaccines and therapies that people feel comfortable using, so maintaining public confidence that we stick to the evidence and don’t draw conclusions before the information is available is critical.” he said. .

Scientists and others around the world, including experts from the World Health Organization, have tried to keep expectations of an imminent breakthrough in coronavirus vaccines in check, pointing out that vaccine trials are rarely straightforward.

Italy’s health minister, Roberto Speranza, welcomed the resumption of vaccine trials, but warned that caution is still needed.

“Science is working to provide the world with efficient and safe vaccines and treatments,” he said. “In the meantime, the key continues to be our behavior.”

Italy, zero point for the European epidemic, is one of the main countries investing in the AstraZeneca vaccine.

Two more vaccines are in massive final-phase testing in the United States, one by Moderna Inc. and the other by Pfizer and Germany’s BioNTech.

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