Lawyers representing a Chennai-based volunteer of the Oxford Covishield COVID-19 vaccine trial said that the Pune-based Serum Institute of India (SII) was attempting to intimidate their client. This, after SII filed a Rs.100 crore defamation suit against the 40-year-old businessman for his legal notice alleging that he suffered a severe adverse reaction to the vaccine.
SII had partnered with drug manufacturer AstraZeneca and the University of Oxford to produce Covidshield vaccine in the country and the participant was administered the shot at Chennai's Ramachandra Institute of Higher Education and Research on October 1. Ten days after the shot, he allegedly began experiencing neurological and psychological symptoms and has said that he was unable to even complete simple everyday tasks. In a legal notice, he demanded a compensation of Rs.5 crore, in addition to halting all plans to manufacture and distribute the vaccine.
â€śOur client states that the severe trauma he went through from 11th October 2020, because of the â€śAcute Neuro Encephalopathyâ€ť that he suffered, is an extreme side-effect of the test vaccine that he took on 1st October 2020,â€ť said the legal notice issued by NGR Prasad & R Rajaram Advocates, on behalf of the participant. "Our clientâ€™s wife states that he is still not stable, has severe mood swings, has problems with comprehending and focusing on things, and is finding it difficult to even do simple routine things like making online payments, leave alone focusing on work-related matters,â€ť it explains.
SII in its statement addressing these allegations however, painted the claims as malicious and as an attempt to malign the reputation of the company.
â€śThe claim is malicious because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent,â€ť the statement said. â€śThe volunteer is falsely laying the blame for his medical problems on the Covid vaccine trial. In spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company.â€ť
Responding to this, the participant's advocates questioned SII's motives behind the statement.
"This is a clear attempt to intimidate our client. Why else will they file a Rs.100 crore defamation suit. Our client is merely asking for Rs.5 crore compensation for the health problems he is facing and to take care of his family," says advocate Prasad. "Moreover, if you look at their statement it is clear that they are unwilling to even investigate what exactly happened and if the side-effects are due to the vaccine. Our client wants the manufacturing of the vaccine to be stopped because he fears others could get affected the same way," he adds.
Advocate Rajaram meanwhile tells TNM that neurological and psychological side-effects were never mentioned in possible 'harm' the vaccine could cause.
"There was nothing in the participant information sheet to warn or educate the client about the side-effects that he faced after 10 days. There was in fact an assertion that the vaccine was 'safe' and our client believed this," he explains.
TNM is in possession of the participant information sheet and some of the side effects mentioned include -
â€˘ Due to vaccine administration, you may have injection site reactions such as pain, tenderness, redness, warmth, itch, swelling and hardening.
â€˘ Some other side effects may occur such as fever, chills, fatigue, feeling of discomfort, headache, joint pain, muscle pain and nausea.
â€˘ In addition to this, there is an extremely rare possibility that you may develop an allergic reaction immediately following vaccination. Allergic reaction may include rash, hives, difficulty in breathing and in very rare instances if not treated it may be fatal. Therefore, Doctor will monitor you at least 30 minutes after each vaccination and treat you immediately in case of such a reaction.
â€˘ After receiving the study vaccine, if you get infected with Coronavirus, then there may be a very rare possibility of increase in severity of the disease. This is called disease enhancement due to vaccines. Currently, it is not known whether COVISHIELD or Oxford/A2-ChAdox 1 ncov-19 vaccine can cause disease enhancement.â€™
â€˘ Drawing blood can cause pain, redness, swelling at the site of blood draw.
â€˘ In addition to the risks described above, all clinical trial participants are likely to experience increased inconvenience due to the visits.
â€˘ In addition, there could be other side effects that we have not foreseen.â€ť
"The defamation suit is an attempt to make our client withdraw the case," says Rajaram. "Instead of addressing the problem at hand, SII is using intimidation as a tool to avoid allegations."