Clinical Trial and Error

THERE IS A reason why vaccines take such a long period to develop. It must be shown not to just be effective against the virus but also not have side-effects. And long-term side-effects only become apparent in the long term. The period has been crunched from years to a few months with the under trial Covid vaccines. The burden of being overcautious has to thus rest on the vaccine manufacturers. They need to leave large windows of doubt open to prevent a catastrophe given the billions who will take it. All this is why the Serum Institute of India threatening a volunteer of the Covishield vaccine, which India is largely relying on against Covid-19, with a lawsuit that seeks Rs 100 crore in damages, is terrible in both ethics and optics.

The person in question claims to have developed neurological symptoms after taking the vaccine. He has been treated and his condition is improving. He however sought damages of Rs 5 crore for the trauma and losses by way of business opportunities lost. Without the causation link established, you could term such a demand inappropriate. Thousands of others, after all, have taken the vaccine safely so far. But put yourself in the patient’s shoes. Why wouldn’t he believe that the vaccine was the cause of his condition if one followed another? This is, however, a story of most disputes. What is an exception is the Serum Institute’s response. It claims that the counter-lawsuit is necessary to protect its reputation but, in fact, it might make it worse.

For one, the man is a volunteer and was doing a public service that he didn’t have to. By moving against him, that status is not being accorded, indicating a lack of sensitivity and a way to silence him. The appropriate action for Serum Institute would be to say they are looking into it or just remain silent, find out whether there is any possible connection and when they have clear evidence, present it to both the person and the public. In similar recent instances in other countries, they even halted the trials for a couple of days to signal it was being taken seriously. As Amar Jesani, Editor, Indian Journal of Medical Ethics, told the trade magazine Express Pharma in their report, ‘This is the similar kind of neurology event which was reported in the UK and due to which the global clinical trial was halted in the UK, the US, Brazil and in India for a few days. When a similar major neurological event was reported in India, then why was the trial not halted? This time, the DCGI should take immediate action and should instruct to stop the clinical trial immediately till the time facts and evidence related to the participant’s claim is evaluated.’

Also, what is the message other volunteers in the trial take from the Rs 100 crore lawsuit? It is that if you suffer any adverse event, don’t speak out in public. And what then is going to happen when volunteers are needed for future clinical trials?

About The Author

Madhavankutty Pillai

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