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By Ludwig Burger
LONDON (Reuters) – AstraZeneca suspended global trials of its experimental coronavirus vaccine after an unexplained disease in a British participant, calling into question early deployment.
The COVID-19 vaccine, which UK’s AstraZeneca is creating with the University of Oxford, has been described through the World Health Organization as the world’s leading and most evolved candidate.
However, AstraZeneca said Tuesday that he had suspended testing, adding expired-level tests, to allow an independent committee to review protection data, and was executing to minimize any possible effect on the schedule.
“It’s obviously a challenge for this vaccine trial,” UK Health Secretary Matt Hancock told Sky News.
The pause follows reports that the United States is aiming for fast-track approval before the November presidential election.
The stakes are paramount because AstraZeneca, the UK’s largest drugmaker by market value, has already agreed to deliver approximately 3 billion doses to governments around the world.
That’s more than any other vaccine project. When asked if the pause would delay the progression process, Hancock said, “Not necessarily, it’s what they locate when they do the research. “
Most states will contribute financially to the progression of the vaccine, even if the trial fails.
‘ROUTINE ACTION’
The UK medical regulator said he was urgently reviewing for data on whether trials could be restarted as temporarily as possible.
A New York Times report mentioning a user familiar with the stage said a player based in Britain had transverse myelitis, an inflammatory syndrome that affects the spinal cord and is triggered by viral infections.
It is not known if this is directly similar to the AstraZeneca vaccine, he said. AstraZeneca declined to comment.
“People are in poor health for a multitude of reasons, and the allocation team will now look in depth at the cause of this person’s disease and whether it’s similar to winning the vaccine or not,” Doug said. Brown, executive director of the British Immunology Society.
The Financial Times cited other people connected to the lawsuit who said it could be resumed early next week, after the study’s independent knowledge oversight committee investigated.
AstraZeneca officials were not readily available to comment on this report.
The suspension caused AstraZeneca’s shares to fall as much as 3%, which has the second highest weighting in the FTSE 100 index, but which was trading 0. 5% higher at 1540 GMT.
The trial in the UK began in May with more than 12,000 participants, from five to more than 70 years.
The US trial, with a target of 30,000 participants, was unveiled last week for the AZD1222 vaccine, which is also in clinical trials in Brazil and South Africa.
Additional trials are planned in Japan and Russia, with 50,000 participants worldwide.
South Korea said it would review the suspension and revise its plan to participate in the vaccine, and fitness ministry official Yoon Tae-ho said such suspensions from clinical trials were not unusual “because the dots interact. “
This was done through Leukocare in Germany, which is running with a vaccine similar to AstraZeneca, but at an earlier stage.
“When 20,000 people are inoculated, it is a fact that at some point you will have serious adverse events. As soon as it becomes clear that a link to the vaccine can be ruled out, the trial continues,” chief executive Michael Scholl said.
However, those related to immunity, such as inflammation, would be the subject of special scrutiny, he added.
MONKEY VIRUS
The Oxford vaccine is designed to instruct human cells to produce unique portions of the coronavirus. This allows the immune formula to accumulate an arsenal opposed to long-term infections.
An innocent virus known as adenovirus is used to introduce genetic instruction into the body, and it is also persecuted through the Chinese CanSino, the Russian Gamaleya Institute or Johnson.
Supporters of candidate Gamaleya, Russia’s first COVID-19 vaccine, have pointed to the difference between their human adenovirus vaccine and the UK candidate with adenovirus discovered in monkeys.
“We have constantly drawn attention to the fact that the human adenoviral platform is much safer and much more studied than any other new platform,” the head of Russia’s sovereign wealth fund, Kirill Dmitriev, told Reuters.
By opting for a monkey virus, AstraZeneca, as well as Leukocare, checks the threat of the immune formula that attacks the vector, due to past combat with an adenovirus.
The resolution to suspend the trial appears to have had little effect in clinical trials conducted through other vaccine manufacturers.
The Serum Institute of India said its trials of the AstraZeneca vaccine were ongoing and had encountered a problem.
The U. S. National Institutes of Health, which is an investment in AstraZeneca’s essay, declined to comment.
Moderna said in an email that it “was unkistakable about the impact” of its ongoing study on the COVID-19 vaccine.
Vaccine developers in the US and Europe pledged Tuesday to meet clinical criteria for protection and efficacy for their experimental vaccines.
Nine companies, in addition to AstraZeneca, Moderna and Pfizer, have issued a “historic commitment” after fearing that the protection criteria might simply slip under political pressure to launch a vaccine.
The signatories were Johnson
(Information through Guy Fauconbridge, Estelle Shirbon, Kate Kelland in London, Deena Beasley; Additional information via Peter Henderson in San Francisco, Rocky Swift in Tokyo, Sangmi Cha in Seoul and Miyoung Kim in Singapore; Editing via Alexander Smith and Emelia Sithole-Matarise )