Updated: September 10, 2020 4:14:07 pm
The trials were halted by AstraZeneca after one participant, who reportedly took part in the phase 2/3 clinical trials underway in the United Kingdom, developed a “potentially unexplained illness”.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI’s instructions and will not be able to comment further on trials,” an official statement issued by SII said. The adverse event seen in the UK case has not been noted in any of the 100 Indian participants dosed so far.
The development comes a day after the Drug Controller General of India (DCGI) issued a show-cause notice to the Pune-based Serum Institute of India for failing to share the information about the pause on AstraZeneca vaccine.
Serum, the world’s largest manufacturer of vaccines by volume, has an agreement with AstraZeneca to manufacture and market the vaccine in India and other low and middle income countries. The Oxford vaccine candidate, named Covishield in India, was administered to a first set of volunteers on August 26.
A volunteer enrolled in the Oxford vaccine trial had been found to have an inflammatory syndrome called transverse myelitis – but it was unclear when this was diagnosed, and whether it was directly linked to the administration of the AZD1222 vaccine, The New York Times reported.
AstraZeneca announced early on Wednesday that it had “voluntarily paused vaccination” in its ongoing global trials to “allow review of safety data by an independent committee” after the event triggered its standard review process.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials. In large trials illnesses will happen by chance, but must be independently reviewed to check this carefully,” an AstraZeneca spokesperson said.
What has raised concern among the scientific community is the fact that this is the first such incident that has been reported from the clinical trials of dozens of coronavirus vaccine candidates that are currently being done.
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