LONDON -- Oxford University announced Saturday that it was resuming a trial for the coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended after 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.
"The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator ... the trials will recommence in the U.K.," it said.
AstraZeneca chief executive Pascal Soriot says the vaccine could still be available by the end of the year.
This vaccine is widely perceived to be one of the strongest contenders among the dozens in various stages of testing around the world. In July, Oxford reported initial results showing the vaccine increased levels of protective neutralizing antibodies and immune T-cells that target and destroy infected cells.
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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-hit 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 because of participant confidentiality, an AstraZeneca spokesman has said a woman developed severe neurological symptoms, prompting 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 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."
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Pauses in drug trials are commonplace, and the temporary hold led to a sharp fall in AstraZeneca's share price.
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 vaccines, stressing that trials are rarely straightforward.
Italian 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.
AstraZeneca is one of several companies taking part in the U.S. government's Operation Warp Speed program to fast-track a coronavirus vaccine. In May, the company signed a $1.2 billion deal with the U.S. to support clinical studies and supply 300 million doses. It has pledged to provide the vaccine on a not-for-profit basis during the pandemic and has lined up deals around the world to supply almost 3 billion doses.
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.
PANDEMIC RESOLUTION
The U.N. General Assembly overwhelmingly approved a wide-ranging resolution on tackling the pandemic over objections from the United States and Israel, which protested a successful last-minute Cuban amendment regarding sanctions.
The 193-member world body adopted the resolution Friday by a vote of 169-2, with Ukraine and Hungary abstaining. It was a strong show of unity by the U.N.'s most representative body, though many countries had hoped for adoption by consensus.
The resolution, which is not legally binding, is the third and most extensive on the crisis. It says the pandemic poses "one of the greatest global challenges in the history of the United Nations," and calls for "intensified international cooperation and solidarity to contain, mitigate and overcome the pandemic and its consequences."
The resolution urges U.N. member states "to enable all countries to have unhindered timely access to quality, safe, efficacious and affordable diagnosis, therapeutics, medicines and vaccines ... as well as equipment for the COVID-19 response."
And it recognizes "the role of extensive immunization against COVID-19 as a global public good for health in preventing, containing and stopping transmission in order to bring the pandemic to an end, once safe, quality, efficacious, effective, accessible and affordable vaccines are available."
Cuba succeeded in amending the resolution to urge all countries "to refrain from promulgating and applying any unilateral economic, financial or trade measures not in accordance with international law and the Charter of the United Nations that impedes the full achievement of economic and social development, particularly in developing countries."
The United States was then overwhelmingly defeated in attempts to remove two paragraphs, one referring to women's rights to "sexual and reproductive health" and the other to "promoting global sustainable transport."
In addition to arguing against the language on sanctions, the United States opposed all references to the World Health Organization, which the Trump administration stopped funding, accusing the U.N. agency of failing to do enough to stop the virus from spreading when it first surfaced in China.
It accused China of hiding the truth about the outbreak from the world in the early days, which "imperiled all of us and caused needless additional suffering and death."
Chinese diplomat Xing Jisheng responded, alluding to the recent revelation that President Donald Trump "recognized the danger of the virus at a very early stage, but deliberately played it down to avoid panic." He asked: "Who is hiding the truth?"
Xing also asked why the U.S., with the most advanced medical system in the world, has the most covid-19 cases. "If the United States is serious about fighting the pandemic, it should focus on protecting lives and health of its people, instead of being busy with blame-shifting," he said.
POSITIVE PARTY
In Oxford, Ohio, college students held a house party over Labor Day weekend that included people who had recently tested positive for the coronavirus, according to police body camera footage.
Oxford police cited six men Saturday who attended a party near Miami University on charges of violating the state's mass-gathering and quarantine ordinance. Body-camera footage shows an officer arriving at a home near the campus and finding men without masks on the porch.
One of the men tells police there are 20 people there, twice the number allowed to congregate in Ohio. The officer asks the group to disperse while he runs the ID of one of the residents.
"I've never seen this before," the officer is heard saying to the student after running his ID. "There's an input on the computer that you tested positive for covid?"
"Yes," the student answers. He goes on to disclose that he tested positive a week before and that every single person at the party has covid-19, including two people from the house across the street.
"Oh, God. This is what we're trying to prevent," the officer responds. "We want to keep this town open."
Information for this article was contributed by Pan Pylas, Nicole Winfield, Edith M. Lederer, Farnoush Amiri and staff members of The Associated Press; and by Stephanie Baker and Cynthia Koons of Bloomberg News.
