Authorities mum adverse event in vaccine trial | Economic Times

More than a month and a half after an adverse event occurred in a clinical trial in India of the AstraZeneca vaccine, the Central Drug Standard Control Organisation (CDSCO), the regulator for vaccine trials, has not issued any statement on the occurrence. It also did not respond to queries about whether it has completed its investigation to determine if the trial participant’s illness was related to the vaccine. Serum Institute, which is partnering the pharma MNC and Oxford University for producing the vaccine in India, has also refused to comment.This is in sharp contrast to AstraZeneca and Oxford University going public when one of the trial participants in the vaccine trial in the UK fell ill and halting the trial till an independent safety monitoring board and UK’s regulatory authority gave safety clearance.Information about the occurrence of the serious adverse event (SAE) during the vaccine trial in India came from the family of the trial participant, which has sent the company and the regulators a legal notice.Serum Institute merely stated that it would issue an official statement next week. AstraZeneca had issued a statement within days of the trial participant in UK falling ill and halted the trials across the world in the UK, Brazil and South Africa. The trial was resumed within a week after the independent safety review committee and national regulators gave clearance.The Indian Council of Medical Research is a co-sponsor of the trial along with Serum Institute. Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division of the ICMR, stated that the protocol was for the principal investigator at the trial site to first investigate why the adverse event had occurred followed by an enquiry by the Institutional Ethics Committee of the trial site, Sri Ramachandra Medical College (SRMC), Chennai.“We cannot intervene as we are one of the sponsors of the trial and it should not seem like we are trying to influence the process, which would be inappropriate. We have informed the drug controller general of India (DCGI) about the development and the DCGI’s report on whether the adverse event was related to the vaccine is awaited,” explained Dr Panda. According to the ICMR, it is for the DCGI to take a call on whether or not to halt the trial. The DCGI heads the CDSCO.The 40-year-old trial participant, a business consultant with an MBA from New Zealand who says he took part in the trial deeming it his duty to help such an important venture, was administered the vaccine at SRMC on October 1. Eleven days later, he woke up with a severe headache, and progressively lost his memory, showed behaviour changes, became disoriented and was unable to talk or recognise his family members, according to the legal notice.As soon as he fell ill he was admitted to the ICU in SRMC. “We did a battery of tests to find if there was any linkage to the vaccine, but we did not find any. We provided all medical care free of cost till October 26 when the family said they were dissatisfied with the treatment and got him discharged and took him home. They brought him back a couple of times for follow up but have not been in touch after that,” said Dr S R Ramakrishnan, the principal investigator at the trial site. He added that the institutional ethics committee also did not find any connection to the vaccine, but admitted that they were unable to determine why he had become so seriously ill. The family has questioned how a healthy person declared fit enough to take part in the trial could become so severely ill if it was not due to the vaccine.“Though the legal notice we have served talks of a compensation of Rs 5 crore, our focus is not on monetary compensation. It was sent just last week, more than a month after the occurrence when we saw that none of the authorities was making the adverse event public. They ought to have warned other participants so that they could watch out for similar symptoms. We want to know why the occurrence of the adverse event has been kept under wraps and why the trial was not halted like it was done in the UK. Is an Indian life of less value than that of an UK citizen?” asked a close family friend who has been helping the family cope with the illness.In India, the trial for the study to check the safety and immune response of the Covishield vaccine is happening across 17 sites. It enrolls only healthy volunteers and enrolment started in the last week of August.