Serum says no correlation with trial & volunteer’s condition

Vaccine-maker Serum Institute of India has labelled as “malicious and misconceived” the allegations of an adverse event made against the AstraZeneca-Oxford University Covid-19 vaccine candidate. It will seek damages in excess of ₹100 crore, it added, to defend against such claims.

Serum Institute has a production and distribution alliance for the vaccine in India and low- and middle-income countries and is undertaking clinical trials in India. Over the weekend, the Prime Minister was at Serum Institute’s Pune facility, as part of his review of the country’s vaccine preparedness.

“While the Serum Institute of India is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medical problems on the Covid vaccine trial,” the company said.

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Legal notice

The development follows a legal notice sent to the company on behalf of a 40-year-old volunteer, who participated in the trial that took place at Chennai’s Sri Ramachandra Institute of Higher Education and Research. A notice to the company, the hospital and the drug regulator said that the healthy individual experienced severe adverse events requiring hospitalisation. Linking this to the trial, it sought ₹5-crore compensation, besides calling for a halt to the vaccine trial, manufacture and distribution.

Volunteer ‘informed’

“The claim is malicious because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. In spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company,” Serum Institute said, adding, “It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive.”

Let them sue: Lawyer

To the Serum statement, NGR Prasad, lawyer for the petitioner, said: “Let them sue us. The patient information sheet did talk of 'unknown side-effects', but how can that be such a serious one.”

No causal link?

Earlier, Samiran Panda, ICMR’s Head of Epidemiology and Communicable Diseases Division, told BusinessLine the Indian Council of Medical Research was aware of the adverse event. “Preliminary information is that the examination does not indicate any causal association as yet. But we will wait for the DCGI (Drug Controller General of India) to take the final call.”

The ICMR is a co-sponsor of the India trials being done by Serum.