(Reuters) - India’s drug regulator has asked Serum Institute of India to suspend recruitment in its clinical trials of AstraZeneca Plc’s potential COVID-19 vaccine in the country until further orders, Reuters partner ANI reported on Friday.
V.G. Somani, the drugs controller general of India, has also asked for increased safety monitoring of those already vaccinated with the experimental vaccine, ANI reported here, citing an order issued by the regulator.
The move places further restrictions on the trials, which have already been put on hold by Serum on Thursday after the DCGI had asked the vaccine maker for details on the suspension of trials overseas, in a show-cause notice that was reviewed by Reuters.
Friday’s order has been issued after Serum responded to the show-cause notice, according to ANI.
Somani had warned that Serum could face action if it did not offer an explanation for why the trials should not be suspended until patient safety is established, after AstraZeneca decided earlier in the week to pause global trials in the wake of an unexplained illness in a study participant.
The DCGI, Serum and AstraZeneca did not immediately respond to Reuters’ requests for comment.
The drugs regulator had given last month Serum approval to run mid- to late-stage clinical trials on the leading COVID-19 vaccine candidate to determine its safety and ability to trigger immune response.
Reporting by Manojna Maddipatla in Bengaluru; Editing by Maju Samuel
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