Serum Institute ‘assures’ it will release Covid-19 vaccine for mass-use only if safe

PT Jyothi Datta Mumbai | Updated on December 01, 2020 Published on December 01, 2020

Clinical trial volunteer had alleged serious adverse event; company says not linked to trial

Serum Institute of India will not release for mass-use, the Covid-19 vaccine candidate that it is presently testing in India, “unless it is proven immunogenic, and safe,” it said in a public-statement on social media.

“We would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly. The concerned authorities were informed and the Principal Investigator, DSMB (Data and Safety Monitoring Board) and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial. Post which we submitted all the reports and data related to the incident to the DCGI (Drug Controller General of India). It is only after we cleared all the required processes that we continued with the trials,” the statement said in a more reconciliatory tone.

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The vaccine-maker is in collaboration with AstraZeneca and Oxford University to produce and distribute their Covid-19 vaccine candidate in India and other low and middle income countries.

And it had come in for much flak from doctors and health activists, on what they called “strong-arm” tactics after a volunteer on the trial of this vaccine had complained of serious adverse events.

The volunteer’s compensation claim for ₹5 crore was met with a counter-suit from Serum for over ₹100 crore as damages for what it said was a “malicious” charge against it.

Adverse event

The 40-year-old volunteer had experienced neurological problems and disorientation, according to a legal notice sent on his behalf to the SRMC hospital (Sri Ramachandra Higher Education and Research), Serum Institute, AZ, the Oxford University, the Indian drug regulator and Indian Council of Medical Research (ICMR).

The ICMR is also co-sponsor on the trial and has indicated that it will wait for the DCGI to take a call. AZ, the Oxford Vaccine Group have not commented on the issue.

The DCGI has not cleared the air on the issue, as well, something that many in the medical fraternity said was necessary, given that volunteers continue to participate in the trial and the vaccine could well be rolled-out for public use if it is cleared by the regulatory authority.

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Serum Institute further clarified, “The COVISHIELD vaccine is safe and immunogenic. 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.”

“We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe. Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned,” the vaccine-maker said.

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Published on December 01, 2020
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