FILE - This Saturday, July 18, 2020 file photo shows a general view of AstraZeneca offices and the corporate logo in Cambridge, England. Late stage trials into a coronavirus vaccine developed by Oxford University and drugmaker AstraZeneca were paused after a woman who received the experimental shot developed severe neurological symptoms, a spokesman for the pharmaceutical said Thursday, Sept. 10, 2020. (AP Photo/Alastair Grant, file)
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Oxford and AstraZeneca resume coronavirus vaccine trial

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By PAN PYLAS

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 UK patient.

In a statement, the university confirmed the restart across all of its UK 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 UK regulator, the MHRA, the trials will recommence in the UK,” 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.

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.”

“To tackle the global COVID-19 pandemic, we need to develop vaccines and therapies that people feel comfortable using, therefore it is vital to maintaining public trust that we stick to the evidence and do not draw conclusions before information is available,” she said.

Scientists and others around the world, including experts at the World Health Organization, have sought to keep a lid on expectations of an imminent breakthrough for coronavirus vaccines, stressing that vaccine trials are rarely straightforward.

Italy’s health minister, Roberto Speranza, welcomed the resumption of the vaccine trial, but warned that prudence was still necessary.

“Science is at work to give the world efficient and secure treatments and vaccines,” he said. “In the meantime, the key continues to be our behavior.”

Italy, which was ground zero for Europe's outbreak, is one of the main countries investing in the AstraZeneca vaccine.

Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech.

Nicole Winfield in Rome contributed.

© Copyright 2020 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.

©2020 GPlusMedia Inc.

5 Comments
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If people get cancer 5 years down the road Doctors will be unable to explain what caused it.

Yet somehow, Big Pharma is certain the chemicals in their injections aren’t the cause of it.

-1 ( +2 / -3 )

Great !!, sorry antivax losers..

0 ( +2 / -2 )

Great !!, sorry antivax losers..

Really? My suggestion is to start gloating when the war is over not during these minor battles.

Did you notice that not one word was said about effectiveness in the article? Even on the safety said there was no word on tests on the age and health related groups who will need this the most.

Both omissions make me think its maybe 20 to 40 percent effective and they are testing it on relatively young healthy people.

Naturally I will be labeled as "anti-vaxx" for not displaying unbridled cheerleader-ish confidence in these pointedly unnamed test vaccines, even though I go totally case by case regarding vaccines and as such totally approve of some. But that's everything now isn't? You are either with us or the enemy right?

1 ( +1 / -0 )

If people get cancer 5 years down the road Doctors will be unable to explain what caused it.

Yet somehow, Big Pharma is certain the chemicals in their injections aren’t the cause of it.

You know what is hugely more likely to produce unexpected side effects and diseases? the natural infection, even if asymptomatic. It produces a dozen extra viral proteins, some made specifically to mess up with the immune system and in a million time larger scales than a vaccine.

Epidemiologically speaking it is terribly simple to find out the reason of something that elevates even slightly the incidence of a disease, as long as the reason is registered. Until now "chemicals" in the vaccines has not been related to cancer, in difference to some viral infections that actually do.

Did you notice that not one word was said about effectiveness in the article? Even on the safety said there was no word on tests on the age and health related groups who will need this the most.

The news is about the resuming of the tests because of observed problems with one volunteer (between literally thousands), effectiveness has already been proved in the preclinical trials and previous phases of the clinical trials, else there would be no reason to continue to phase III, if you go to clinicaltrials.gov and search for NCT04516746 you can see a lot more of details, including that population in special risk for COVID-19 are part of the target group. Since the trial has just began and is blinded it is not logical to expect results from this phase to be available, specially since it is a two dose schedule.

Both omissions make me think its maybe 20 to 40 percent effective and they are testing it on relatively young healthy people.

What does that even mean? 20-40% less viral loads? reduction of risk for complications? reduction of fatalities? presentation of symptoms? again, what makes you expect results from a study that has just begun?

Naturally I will be labeled as "anti-vaxx" for not displaying unbridled cheerleader-ish confidence in these pointedly unnamed test vaccines, even though I go totally case by case regarding vaccines and as such totally approve of some. But that's everything now isn't? You are either with us or the enemy right?

Not really, disregarding scientific information that you ignore, even if it is actually available, or putting an unrealistic standard of proof for the vaccine that does not apply to anything else (like having results before running the tests) may get you called that, but a real antivaxxer is just the person that in unable to accept that a vaccine may be actually safe and effective after the tests are finished.

It is not the same to say we don't have yet the evidence of the phase III (so we cannot know yet how effective and safe the vaccine actually is) and saying that results do not matter, the vaccine has to be poison no matter what.

1 ( +2 / -1 )

These vaccine are not guaranteed to stop a person, from contracting the virus, just lessened the severity of the virus effect

1 ( +1 / -0 )

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