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‘Adverse event’ won’t impact Covishield licensing, says Health Secretary Rajesh Bhushan

NEW DELHI: The incident of a vaccine trial participant suing Serum Institute of India, alleging a “serious adverse event”, will not impact timelines for possible rollout of the vaccine as there was no connection between the two, the government and the vaccine maker said.

“There is no connection between the adverse event and the licensing, these are two standalone processes,” Union health secretary Rajesh Bhushan said on Tuesday.

Mechanisms for monitoring adverse events and prompt reporting are in place, and “due timely action was taken” in the said case, he said.

“Most of the trials of vaccines are multi-centric and multi-site,” Bhushan said. “Each hospital has an institutional ethics committee, which is independent of the government and the vaccine manufacturer. When in course of the clinical trial any adverse event (is reported), this committee takes note of it and within a period of 30 days gives a report to the Drug Controller General of India (DCGI) about the event as well as its comments.”

Serum Institute, too, has denied allegation of side-effect of Covishield, a Covid-19 vaccine candidate it developed along with Oxford University andAstraZeneca, saying the complainant Chennai volunteer’s condition was “in no way induced by the vaccine”.

The Pune-based vaccine manufacturer, which is expected to apply for emergency use of Covishield soon, also assured it wouldn’t release its vaccine for mass use until it’s proven safe and immunogenic.

As reported by ET, a Chennai-based volunteer has allegedly suffered serious adverse event after he was administered with the vaccine. A law firm representing the 40-year-old volunteer sent a legal notice to the company and the drug regulatory authority.

The notice alleged that the participant suffered a serious adverse event after being administered the under-trial vaccine, and is demanding financial compensation of 5 crore. It also alleged that despite the incident the company did not make any public disclosure.

SII on Tuesday said, “The incident with the Chennai volunteer, though highly unfortunate, was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer’s medical condition.”

The vaccine manufacturer claimed all requisite regulatory and ethical processes and guidelines were followed “diligently and strictly” in the concerned case.

“The concerned authorities were informed and the principal investigator, DSMB and the ethics committee independently cleared and reckoned it as a non-related issue to the vaccine trial,” it said in a statement. “Post which we submitted all the reports and data related to the incident to the DCGI. It is only after we cleared all the required processes that we continued with the trials.”


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