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AstraZeneca COVID-19 vaccine trial put on hold
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ASTRAZENECA has suspended global trials of its experimental coronavirus vaccine after an unexplained illness in a participant.
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 minimize any potential impact on the timeline.
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.
Britain’s medical regulator said it is urgently reviewing information available to determine whether trials can restart as quickly as possible.
The stakes are high because AstraZeneca, Britain’s largest drugmaker by market value, has already agreed to supply close to 3 billion doses to governments across the globe.
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.
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