Authorities mum on Adverse Event at Covid Vaccine Trial


Safety data of Covid Vaccine- need disclosure

   There are two important aspect of a successful vaccine,

1. Efficacy  for the prevention

2. Safety

       Given that the Covid vaccine is needed urgently and will be developed within a years’ time, some doubts about the safety aspect are natural. But safety can be assured, if the data about side effects is made public.

   All  the  companies  in a bid to rush their  vaccine into the market, are eager to  create an hype. But a caution need to be exercised against such hyping, especially when long term safety data is not available.

  Even the sparse details of the severe side effect,  that leak into the public domain, may be just tip of the iceberg, as far as long term safety data of a vaccine is concerned.

   All the side effects, mild or severe, need to be made known  and  in public domain, rather than exposed later after the use.

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.

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.

“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.

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