The All India Drug Action Network has called for clarity from the Indian drug regulator on a Covid-19 vaccine clinical trial done at a Chennai hospital. This follows allegations of a serious adverse event (SAE) reported by a healthy volunteer who participated in the trial of the vaccine-candidate developed by the AstraZeneca-Oxford University combine.

The trial was conducted in India by the Serum Institute, who have labelled the charges “malicious” and denied a link between the vaccine and the volunteer’s medical condition. Responding to the volunteer’s allegations and legal notice seeking compensation of ₹5 crore, Serum Institute said on Sunday that it would seek damages of over ₹100 crore.

Seeks transparency

The development has elicited a response from several quarters, including doctors who have called for greater transparency from the drug regulator, the CDSCO (Central Drugs Standard Control Organisation), on the issue.

Expressing shock at what they called the vaccine-maker’s “attempt at intimidation of a clinical trial participant”, Aidan pointed out that in a Phase 2/3 trial, “safety is one of the primary endpoints in addition to immunogenicity.”

Serum has a production and distribution alliance on the vaccine in India and low and middle-income countries, and the Indian Council of Medical Research (ICMR) is a co-sponsor on the trial. An ICMR representative had told BusinessLine that the trial had followed protocol and that a causal link was not seen in a preliminary review. He did add that they would wait for the drug regulator to take a call.

“Given that the SAE took place in October, it is of serious concern that CDSCO did not pause the trial to investigate the SAE when it was reported. The silence from the CDSCO which granted permission for the trial is deafening,” Aidan said.

Calling Serum’s counter-suit “unacceptable”, Aidan said, “the trial was recruiting healthy volunteers, and a participant who received the first dose in the trial has and continues to suffer neurological problems.”

“CDSCO must inform the public as to why the trial was not and has not been halted while it is contemplating the serious adverse event. We would also like to know what protocols are being followed to investigate the SAE and reach a conclusion,” the note set, calling for details on the role of the other review committees that reviewed the event.

“The Serum Institute and ICMR, co-sponsors of the trial, must inform all trial participants about the handling of SAEs and simultaneously release the detailed protocol of the trial, along with any amendments made to the protocol, in the public domain immediately,” it added.

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