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LONDON (Reuters) – AstraZeneca suspended global trials of its investigational coronavirus vaccine after an unexplained illness in one participant, kicking off moves at the UK drugmaker on Wednesday as the move saw a decline in customers for the rollout. early.
On Tuesday, AstraZeneca said it had voluntarily suspended the tests, adding complex ones, to allow an independent committee to review the protection data and that it was running to speed up the review and minimize any impact. prospective in the testing schedule.
The vaccine, which AstraZeneca is developing with the University of Oxford, has been described by the World Health Organization (WHO) as the world’s first candidate and the most complex in terms of development.
“Obviously this is a challenge for this specific vaccine trial,” UK Health Secretary Matt Hancock told Sky News, adding: “This is the first time this has happened to the Oxford vaccine. “
The rest of the demand caused a 2% drop in AstraZeneca’s shares in London and a 12% drop in the percentage value of its Indian unit, AstraZeneca Pharma India Ltd. AstraZeneca’s shares, which have the greatest weight in the At the time in the FTSE hundred index, they were down 0. 3% at 8:20 am GMT.
Follow reports that the United States is aiming for fast-track approval before the November presidential election.
When asked if this pause would delay the vaccine progression process, Britain’s Hancock said: “Not necessarily, it’s what they go to when they do the research. “
The BBC reported that a final resolution on resuming the trial will be made through medical regulator MHRA, which may take just a few days.
“This is a regimen action that occurs whenever there is potentially unexplained illness in any of the trials,” AstraZeneca said in an emailed statement.
The nature of the illness has not been disclosed, the player is expected to recover, according to Stat News, which first reported the suspension due to a “suspected serious-looking effect. “
The US Food and Drug Administration defines an adverse occasion as an occasion in which evidence suggests an imaginable date for the drug being tested.
A New York Times report that mentioned someone familiar with the scenario said that a UK player had transverse myelitis, an inflammatory syndrome that affects the spinal cord and is triggered through viral infections.
It is not clear if this is directly similar to the AstraZeneca vaccine, according to the report. AstraZeneca declined to comment.
‘HISTORICAL COMMITMENT’
Called AZD1222, the vaccine is in clinical trials in the United States, Great Britain, Brazil, and South Africa, with additional trials planned in Japan and Russia. The trials aim to recruit up to 50,000 participants worldwide.
South Korea said Wednesday it would review the suspension and reconsider its plan to participate in making the vaccine.
“It is not unusual for clinical trials to be suspended because the dots interact,” Department of Health official Yoon Tae-ho said in a briefing.
The resolution to suspend the trial had an effect on clinical trials conducted through other vaccine manufacturers, which look for symptoms of similar reactions, Stat said.
The US National Institutes of Health, which budget for the AstraZeneca trial, declined to comment.
Moderna said in an email that it is “not aware of any impact” on its current screening of the COVID-19 vaccine at this time.
Nine major vaccine developers from the US and Europe pledged Tuesday to meet clinical criteria for the protection and efficacy of their experimental vaccines despite an urgent desire to involve the coronavirus pandemic.
The companies, adding AstraZeneca, Moderna and Pfizer, have launched what they called a “historic compromise” after higher considerations that protection criteria may simply slip in the face of political tension to launch a vaccine.
The corporations said they will “maintain the integrity of the clinical procedure as they move toward global regulatory filings and approvals of the first COVID-19 vaccines. “
The signatories were Johnson & Johnson, Merck & Co, GlaxoSmithKline, Novavax Inc, Sanofi and BioNTech.
(Information via 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)