Pune-based Serum Institute of India (SII), world's largest vaccine maker by volume, on Thursday (10 September) halted the trials of Oxford-AstraZeneca's Covid-19 vaccine in India until the British-Swedish drugmaker AstraZeneca restarts them.
"We are reviewing the situation and pausing India trials till AstraZeneca restarts them," Serum Institute said in a tweet.
The development comes a day after AstraZeneca had paused a late-stage trial of its Covid-19 vaccine following a suspected adverse reaction in a study participant in UK.
Following the incident, AstraZeneca had put on hold the trials of the vaccine and would only restart them after a review by a data safety monitoring board.
AstraZeneca has partnered with Serum Institute for manufacturing of one billion doses of the experimental Covid-19 vaccine.
Earlier on Wednesday (9 September), the Serum Institute had said that Indian trials of the vaccine will continue as the company had not faced any issues in the trials. It had also said that the AstraZeneca had paused the trials for review and it could restart soon.
The Serum Institute's latest decision comes after the DCGI issued a show-cause notice to the vaccine maker for not informing it about AstraZeneca suspending the clinical trials of the Oxford vaccine candidate in other countries, and also for not submitting casualty analysis of the "reported serious adverse events", reports Business Today.
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