Serum Institute’s COVID-19 vaccine triggers ‘behavioural change’ in participant; drug regulator silent

A 40-year-old man who volunteered for ‘Covishield’, the vaccine being tested by Pune-based Serum Institute of India (SII), has sued the company for Rs 5 crore. He stated that the vaccine triggered an adverse reaction, including memory loss and an inability to get back to life before being administered the vaccine. SII has partnered with AstraZeneca and Oxford University for producing the vaccine in India.

Even though the ‘serious adverse event’ occurred more than a month ago, the regulator for vaccine trials, the Central Drug Standard Control Organisation (CDSCO) has not issued a statement on it. Neither has it responded to queries about the matter.

In India, the trials for the ‘Covishield’ vaccine is happening across 17 sites and enrolment for it began in August.

This is in sharp contrast to the procedure followed by AstraZeneca and Oxford University when one of the participants in the vaccine trial in the UK fell ill. They had halted the trials until an independent safety monitoring board gave clearance.

The family of the volunteer had sent a legal notice to SII after they realised that the regulatory authority was neither addressing the issue not halting the trial until cleared. The volunteer’s discharge sheet stated that he was “discharged at request” and was recovering from “acute encephalopathy”. It noted that he was “in an altered mental state” and was “disoriented”. He also had Vitamin B12 and Vitamin D deficiency, and had a probable “connective tissue disorder”.

Several news reports have quoted the volunteer’s wife as saying that he had enrolled for the third phase of the human trial at the Sri Ramachandra Institute of Higher Education and Research, Chennai. The volunteer was a business consultant and had signed the ‘Informed Consent Form’ on September 29, 2020.

The legal notice states that the participant information sheet had categorically stated that the vaccine was shown to be safe and induced immune response. He then received the vaccine shot on October 1, 2020.

Ten days after receiving the shot, he complained of a severe headache, followed by vomiting that confined him to the bed for the rest of the day. His wife stated that there was total behavioural change in her husband with signs of memory loss. He had to be rushed to the Sri Ramachandra Medical College and Hospital. During his hospitalisation from October 11 to October 26, he underwent a CT scan as well as an MRI, a COVID-19 test, and even his cerebrospinal fluid was examined. He had to be shifted to the Intensive Care Unit. The volunteer’s wife stated that he has not fully recovered yet and that they were consulting another neurologist at another hospital in Chennai.

“We did a number of tests to find if there was any linkage between his illness and the vaccine, but we did not find any. We provided free medical care till October 26 when the family said they were dissatisfied with the treatment and got him discharged. They brought him back a couple of times for follow up,” said Dr S R Ramakrishnan, the principal investigator at the trial site. He, however, admitted that they were unable to determine why he had become seriously ill. Dr Ramakrishnan also stated the institutional ethics committee also did not find any connection of his illness with the vaccine.

A source close to the family, according to a report in Times of India, stated that though they had demanded for Rs 5 crore as compensation, their focus was not on receiving the money. They wanted the institute to warn other participants of the adverse event, in addition to knowing why the trials had not been halted like in the United Kingdom. The family questioned if the life of an Indian was less valuable than that of a UK national.

The Indian Council of Medical Research, which is a co-sponsor of the trial along with SII, through Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division, stated that according to protocol, the principal investigator at the trial site has to investigate the issue first. This would be followed by an enquiry by the Institutional Ethics Committee at the trial site. ICMR stated that they had informed the drug controller general of India (DCGI), which heads CDSCO, about the adverse event.

Earlier, ‘Covaxin’, a potential COVID-19 vaccine being developed by Bharat Biotech, currently under Phase 3 trials, reported a serious adverse event during Phase I clinical trials in August. At that time too the trials were not halted. It came to light two months after the issue and then the company had released a statement, which said the adverse event during Phase I clinical trials in August 2020 was reported to the CDSCO-DCGI, within 24 hours of its occurrence and confirmation.

Covaxin is being developed byBharatBiotech, in collaboration with the ICMR - National Institute of Virology (NIV).

In this case, it was a 35-year-old participant with no co-morbidities at a trial site in western India. The participant was hospitalised with viral pneumonitis a couple of days after being administered the vaccine.