The 40-year-old man claims “adverse reaction”; the hospital panel says it is not due to ‘Covishield’.
A 40-year-old volunteer from ‘Covishield’, the vaccine candidate being tested by the Pune-based Serum Institute of India (SII), has sued the company for ₹ 5 crore, claiming the vaccine triggered an adverse reaction, including neurological deterioration and inability to return to life before being inoculated.
It has also demanded, through a legal notice sent to the SII, AstraZeneca and the Oxford Vaccine Group, that the trial of the vaccine, which is now being tested in 1,600 volunteers in India, be stopped immediately.
The person’s discharge summary says he was “discharged upon request” and was recovering from “acute encephalopathy.” He was also deficient in vitamin B12 and vitamin D, and had a probable “connective tissue disorder.”
Dr SR Ramakrishnan, who was the principal investigator for the Chennai arm of the trial and had treated the patient, said The Hindu that the “topic was fine now” but directed more questions to the Serum Institute spokesperson. “He recovered very well and we treated him according to protocol and even came back for a follow-up. All expenses were borne by the hospital, ”he said.
Also read: COVISHIELD completes enrollment of phase 3 clinical trials in partnership with ICMR and Serum Institute of India
The hospital’s institutional ethics committee had delivered a letter, Dr. Ramakrishnan said, saying that the adverse reaction was not due to the study vaccine, and this was also communicated to the Comptroller General of Medicines of India (DGCI), the main regulator.
He said that the recruitment of volunteers for the trial had already concluded, but that his hospital had not received any communication from DCGI since then.
When contacted, an SII spokesperson did not offer additional comment.
The Hindu approached the person’s wife, who said her husband had signed up for the trial in the “spirit of public service.” The person was enrolled for the third phase of the human trial at the Sri Ramachandra Institute for Higher Education and Research, Chennai. He said that the multiple “categorical claims” made on the participant’s information sheet that the vaccine was safe and did not cause serious reactions had “convinced” him that it was “safe.”
Also read: Vaccine injection is ‘painless’, say Covishield trial volunteers
To be sure, clinical trials are carried out, generally through a three-stage process, to verify whether they are really safe, result in the desired immune response, and are effective.
The volunteer, who signed the ‘Informed Consent Form’ on September 29, 2020, was administered a COVID-19 antibody test to rule out a previous infection and received a vaccination on October 1. The Covishield vaccine is a double dose vaccine. trial, with some volunteers receiving a real vaccine and some a placebo, 28 days apart.
A test 11 days later revealed the presence of antibodies, “proof” that the person had indeed received the vaccine and not a placebo. Ten days after the injection, he complained of a severe headache, followed by vomiting that confined him to bed for the rest of the day. His wife, according to the legal notice, said that there was a total “behavior change” in her husband and that he seemed unaware of his surroundings. “He showed irritation towards light and sound, and resisted any effort to get him out of bed,” the ad says.
He was taken by ambulance to the emergency room of Sri Ramachandra Hospital and Medical College. The hospital discharge summary, which The Hindu he has seen, says he was “in an altered state of mind” and was “disoriented.” During his hospitalization from October 11 to October 26, when he was discharged, he had a CT scan as well as an MRI, a COVID-19 test and even had his cerebrospinal fluid examined. He was also transferred to the Intensive Care Unit.
The patient’s wife said The Hindu that her husband has not fully recovered. “We are seeing another neurologist at Apollo Hospital and his tests confirm a dysfunction in his brain. He is slowly recovering and is better than he was [in October] but he can no longer work as before and is passionate about his work, “he said.
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