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MUMBAI, Sept 10 (Reuters) - Serum Institute of India has put on hold trials of AstraZeneca’s potential COVID-19 vaccine in the country until the British drugmaker restarts them, the company said on Thursday.
“We are reviewing the situation and pausing India trials,” Serum, the world’s biggest vaccine manufacturer by volume, said in a brief statement.
AstraZeneca said on Tuesday it had paused trials of its experimental coronavirus vaccine following an unexplained illness in a study participant, but its partner Serum said on Wednesday that trials in India were still ongoing.
The move to pause the trials in India comes after the Drugs Controller General of India (DCGI) V.G. Somani asked Serum for details on the suspension of trials overseas, in a show-cause notice that was reviewed by Reuters.
Somani asked the company to explain why the trials should not be suspended in India until patient safety is established and he warned Serum could face action if it did not offer an explanation.
Serum said on Thursday that it was following the DCGI’s directions and would not comment further on the matter.
The DCGI did not respond to an email seeking comment.
The drugs regulator had in August given Serum approval to run Phase II/III clinical trials on the leading COVID-19 vaccine candidate to determine its safety and immunogenicity.
As long as it can resume trials soon, AstraZeneca should still know before the end of the year whether its experimental vaccine protects people against COVID-19, Chief Executive Officer Pascal Soriot said on Thursday.
Reporting by Euan Rocha in Mumbai; Additional reporting by Sachin Ravikumar in Bengaluru; Editing by Shounak Dasgupta and Sriraj Kalluvila
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