AstraZeneca pauses coronavirus vaccine trial, shares slip on rollout doubts

A man receives the AstraZeneca COVID-19 vaccine as part of a clinical trial for a study by UW Health and the University of Wisconsin School of Medicine and Public Health. (File/AFP)
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Updated 09 September 2020

AstraZeneca pauses coronavirus vaccine trial, shares slip on rollout doubts

  • AstraZeneca said on Tuesday it voluntarily paused trials, including late-stage ones, after an illness in a participant
  • It was working to expedite the review to minimize any potential impact on the trial timeline

LONDON: AstraZeneca has suspended global trials of its experimental coronavirus vaccine after an unexplained illness in a participant, knocking the British drugmaker's shares on Wednesday as prospects for an early rollout dimmed.
The vaccine to combat COVID-19, which AstraZeneca is developing with the University of Oxford, has been described by the World Health Organization as probably the world's leading candidate and the furthest developed.
However, AstraZeneca said on Tuesday it had paused trials, including late-stage ones, to allow an independent committee to review safety data, and it was working to minimise any potential impact on the timeline.
The suspension triggered a 3% fall in AstraZeneca's shares, which have the second biggest weighting in the FTSE 100 index and were trading 1.4% lower at 1006 GMT.
"It is obviously a challenge to this particular vaccine trial," Britain's Health Secretary Matt Hancock told Sky News.
The pause follows reports that the United States was aiming for fast-track approval before November's presidential election.
The stakes are high because AstraZeneca, Britain's largest drugmaker by market value, has already agreed to supply close to three billion doses to governments across the globe.
This is more than any other vaccine project, but asked whether the pause would set back the development process, Britain's Hancock said: "Not necessarily, it depends on what they find when they do the investigation".
Most states will contribute financially to developing the vaccine, even if the trial fails.
Britain's medical regulator said it is urgently reviewing information available to determine whether trials can restart as quickly as possible.
A New York Times report citing a person familiar with the situation said a participant based in Britain was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.
Whether this was directly linked to AstraZeneca's vaccine remains unclear, it said. AstraZeneca declined to comment.
A person familiar with the situation told Reuters the illness occurred in the British trial which began in May with more than 12,000 participants, from 5 years old to beyond 70.
The US trial, with a targeted 30,000 participants, was launched last week for the vaccine AZD1222, which is also in late-stage clinical trials in Brazil and South Africa.
Additional trials are planned in Japan and Russia, with a targeted 50,000 participants globally.
South Korea said it would look into the suspension and review its plan to participate in manufacturing the vaccine and health ministry official Yoon Tae-ho added such suspensions of clinical trials were not rare "as various factors interact".
This was echoed by Germany's Leukocare, which is working on a vaccine similar to AstraZeneca's but is at an earlier stage.
"When you are inoculating 20,000 people, it is a foregone conclusion that at some point you will have severe adverse events. As soon as a link to the vaccine can clearly be ruled out, the trial continues," CEO Michael Scholl said.
Immune related conditions such as inflammations, however, would be subject to particular scrutiny, he added.
The Oxford vaccine is designed to instruct human cells to make distinguishing parts of the coronavirus. That allows the immune system to build an arsenal against future infections.
A harmless virus known as adenovirus is used to bring the genetic instruction into the body, an approach which is also being pursued by China's CanSino, Russia's Gamaleya institute or Johnson & Johnson.
Backers of the Gamaleya candidate, the first Russian COVID-19 vaccine, underscored the difference between their jab, based on a adenovirus in humans, and the British contender with an adenovirus found in monkeys.
"We have consistently drawn attention to human adenoviral platform being much safer and much more studied than any other new platform," the head of Russia's sovereign wealth fund Kirill Dmitriev told Reuters.
In choosing a monkey virus, AstraZeneca, as well as Leukocare, are trying to avoid the risk of the immune system attacking the vector, due to a previous bout with an adenovirus.
The decision to put the trial on hold has impacted clinical trials being conducted by other vaccine makers, which are looking for signs of similar reactions, Stat said.
Serum Institute of India said its trials of AstraZeneca's vaccine were ongoing and had not faced any issues.
The US National Institutes of Health, which is providing funding for AstraZeneca's trial, declined to comment.
Moderna said in an emailed statement it was "not aware of any impact" to its ongoing COVID-19 vaccine study.
Leading US and European vaccine developers pledged on Tuesday to uphold scientific safety and efficacy standards for their experimental vaccines.
Nine companies, including AstraZeneca, Moderna and Pfizer, issued an "historic pledge" after concerns that safety standards might slip under political pressure to rush out a vaccine.
The other signatories were Johnson & Johnson, Merck & Co , GlaxoSmithKline, Novavax Inc, Sanofi and BioNTech.


At least two killed as car ploughs into pedestrian zone in German town

Updated 01 December 2020

At least two killed as car ploughs into pedestrian zone in German town

  • The driver was arrested and the vehicle was impounded, Trier police tweeted
  • Two people have died, and 15 others had suffered serious injuries

BERLIN: At least two people including a child were killed and up to 15 injured on Tuesday when a speeding car ploughed into a pedestrian area in the western German city of Trier, authorities said.
Witnesses said people screamed in panic and some were thrown into the air by the car as it crashed through the shopping zone.
Police said several people had been killed, having earlier put the death toll at two, with more than 10 injured. The local newspaper, the Trierischer Volksfreund, put the death toll at four, including a child, but police did not confirm that figure.
"We have arrested one person, one vehicle has been secured," police said, adding that a 51-year-old German suspect from the Trier area was being questioned, police said.
Mayor Wolfram Leibe had rushed to the scene.
"We have a driver who ran amok in the city. We have two dead that we are certain of and up to 15 injured, some of them with the most severe injuries," he told public broadcaster SWR.
"I just walked through the city centre and it was just horrible. There is a trainer lying on the ground, and the girl it belongs to is dead," he told a news conference, with tears stopping him from speaking further.
He told broadcaster N-TV that people who saw the incident were "totally traumatised" and the street "looks a bit like after a war".
Leibe said he did not know the motive for the incident, which shocked residents of Germany's oldest town, founded by the Romans more than 2,000 years ago.
The Trierischer Volksfreund quoted an eyewitness as saying a Range Rover was driving at high speed and people had been thrown through the air. It said the car had Trier plates.
It reported that people screamed in panic when the car drove through the street.
Officers were scouring the area in search of evidence, backed by police dressed in flak jackets and carrying rifles. On the streets, Christmas lights twinkled incongruously.
Germany has tightened security on pedestrian zones across the country since a truck attack on a Berlin Christmas market in 2016 that killed 12 people and injured dozens.
In October 2019, a man opened fire on a synagogue in the city of Halle. After failing to get into the building he went on a rampage outside, killing two people.
In February this year a racist gunman killed nine migrants in Hanau near Frankfurt before killing his mother and himself. Only about a week later, a local man ploughed his car into a carnival parade in the town of Volkmarsen, injuring 61.
Germany has tightened measures to fight the coronavirus, with bars and restaurants closed, but shops and schools are still open.
"What happened in Trier is shocking. Our thoughts are with the relatives of the victims, with the numerous injured and with everyone who is currently on duty to care for the victims," Steffen Seibert, a spokesman for Chancellor Angela Merkel, said on Twitter.