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By Deena Beasley
(Reuters) – AstraZeneca Plc said it has stopped global trials, including large, late-stage trials, of its experimental coronavirus vaccine due to unexplained illness in a study participant.
The vaccine, developed with the University of Oxford, has been described by the World Health Organization as probably the world’s leading candidate and the most advanced in terms of development. The suspension clouds prospects for early implementation amid reports the United States was aiming for fast-track approval before the November presidential election.
The British drugmaker said it voluntarily halted the trials to allow an independent committee to review the safety data and was working to speed up the review and minimize any potential impact on the trial schedule.
“This is a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials,” the company said in an emailed statement.
The nature of the illness was not disclosed, although the participant is expected to recover, according to Stat News, which first reported the suspension due to a “suspected serious adverse reaction.”
The United States Food and Drug Administration defines an adverse event as one in which evidence suggests a possible relationship to the drug being tested.
According to a New York Times report citing a person familiar with the situation, a UK-based participant was found to have transverse myelitis, an inflammatory syndrome affecting the spinal cord and often triggered by viral infections.
It is not clear if the disease was directly related to the AstraZeneca vaccine, according to the report. AstraZeneca declined to comment on the report.
ACTION SLIDE
Shares of AstraZeneca fell more than 8% in after-hours trading in the US, while shares of rival vaccine developer Moderna Inc were up more than 4%. Shares in AstraZeneca’s Indian unit AstraZeneca Pharma India Ltd fell more than 12%.
The vaccine, called AZD1222, is in late-stage clinical trials in the United States, Britain, Brazil and South Africa, with additional trials planned in Japan and Russia. The trials aim to enroll up to 50,000 participants worldwide.
South Korea said Wednesday it would study the suspension and review its plan to participate in making the vaccine.
“It is not uncommon for clinical trials to be suspended due to the interaction of various factors,” Health Ministry official Yoon Tae-ho said in a briefing.
The decision to suspend the trial has affected clinical trials being conducted by other vaccine manufacturers, which are looking for signs of similar reactions, Stat said.
The U.S. National Institutes of Health, which is providing funding for the AstraZeneca trial, declined to comment.
Moderna said in an emailed statement that it was “not aware of any impact” on its ongoing COVID-19 vaccine study at this time.
Nine major vaccine developers from the US and Europe pledged Tuesday to uphold scientific standards of safety and efficacy for their experimental vaccines despite the urgency to contain the coronavirus pandemic.
The companies, including AstraZeneca, Moderna and Pfizer, issued what they called a “historic compromise” after heightened concern that safety standards could fail in the face of political pressure to launch a vaccine.
The companies said they will “uphold the integrity of the scientific process as they work toward potential global regulatory filings and approvals of the first COVID-19 vaccines.”
The other signatories were Johnson & Johnson, Merck & Co, GlaxoSmithKline, Novavax Inc, Sanofi and BioNTech.
(Reporting by Deena Beasley; Additional reporting by Peter Henderson in San Francisco, Rocky Swift in Tokyo, Sangmi Cha in Seoul, and Miyoung Kim in Singapore; Editing by Bill Berkrot, Aurora Ellis, and Edwina Gibbs)
