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SII pulled up for not pausing vaccine trial

The Drug Controller of India has demanded that the Serum Institute of India (SII), Pune, which is conducting Phase-3 trials on people in India involving U.K.-based AstraZeneca’s COVID-19 vaccine candidate, explain why tests have not been paused in India too until safety has been established.

AstraZeneca on late Tuesday put global trials on hold after reports emerged of “severe adverse reaction” in a volunteer being injected with the vaccine, probably in the United Kingdom. The nature of the event was not known.

This pause would prevail, pending a review by a data safety monitoring board, AstraZeneca said in a statement in response to medical news website, Stat News.

Pune-based SII, which is testing a COVID-19 vaccine, said on Wednesday that so far there had been “no issues” with its trials.

“It has been widely reported in the national and international media that sponsor of the aforesaid vaccine, M/s AstraZeneca has paused the ongoing trial as a volunteer developed an unexplained illness....Serum has not informed the Central Licensing Authority regarding pausing the clinical trial and also not submitted causality analysis of the reported severe adverse event,” said a letter signed by Dr.V.G. Somani, Drug Controller General (India), “I [Somani] give you an opportunity to showcause why permission granted to you should not be suspended till patient safety established.”

The Hindu has viewed this letter.