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Alleging serious side-effects, vaccine trial participant seeks Rs 5 cr from Serum Institute


Representational image of Covid vaccine | pixnio


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New Delhi: A Chennai resident, who was a participant in trials for the Covid-19 vaccine being manufactured by the Pune-based Serum Institute of India, has allegedly suffered serious neurological and psychological symptoms after taking the experimental shots.

A law firm has on his behalf sent a legal notice to SII seeking compensation of Rs 5 crore.

The vaccine, Covishield, is being developed by the University of Oxford and drugmaker AstraZeneca. SII has a tie-up with Swedish-British pharma giant for the manufacturing of a billion doses. Covishield is among the frontrunners in the race to develop an effective vaccine against Covid-19.

The legal notice, copy of which has been accessed by ThePrint, states that the participant, who is around 40 years old, “must be compensated, in the least, for all the sufferings that he and his family have undergone and are likely to undergo in future”.

The participant, according to the notice, has been diagnosed with “acute neuro encephalopathy”, which has allegedly been linked as a side-effect of the Covishield shots that he took on 1 October.

In the notice, the law firm, Row and Reddy, has described the trial participant’s condition as “far from being all right” and claimed that he “has to be under medical care for a long time to come”.

Apart from SII, the notice has been sent to the Indian Council of Medical Research (ICMR), Drug Controller General of India (DCGI), Chief Executive Officer (CEO) of AstraZeneca, Professor Andrew Pollard at the Oxford Vaccine Trial, The Jenner Institute Laboratories University and the vice-chancellor of Sri Ramachandra Higher Education and Research where the participant was given the vaccine shot.

The legal notice claims the participant began experiencing headaches and then endured a seven-day stay in the intensive care unit (ICU).

“For all the trauma he is undergoing and with an uncertain future in his health, he should be given a financial compensation of Rs 5 Crores within a period of two weeks from the receipt of this notice,” reads the notice.

It further states that “the testing, manufacturing and the distribution of the vaccine should also be stopped immediately”. The notice warns that if the defendants failed in doing so, the complainant has no other option except to take appropriate legal action against all the parties concerned.

“We haven’t received any response from any of the parties whom we have sent the notice to. We will be left with no other option but to go ahead and file a writ petition and get ready for a legal battle,” advocate R. Rajaram, on behalf of the participant, told ThePrint.

The patient consent form provided by SII, and seen by ThePrint, does offer treatment. “If you get sick during the course of study, we will help you get a proper treatment,” the form states. “In the event of trial related death or injury, you shall be provided medical management as long as required as per the opinion of the study doctor or until the time it is not established that injury or death is not due to the clinical trial, whichever is earlier.”

The participant’s notice, however, has claimed that no one from the trial centre has followed up with them on his health after his discharge from hospital.  

ThePrint contacted SII, AstraZeneca, DCGI and ICMR through texts and email for a response but did not receive any until the time of publishing. ThePrint had also emailed the Press Information Bureau (PIB) as the ICMR and DCGI are government entities but received no response. The copy will be updated when we get a response.


Also read: AstraZeneca plans another Covid vaccine trial to clear uncertainty and confusion


Participant feeling guilty over his decision to volunteer : Notice

The participant, whose identity of whom has been withheld on the request of his lawyer, is an independent business consultant.

According to the participant’s wife’s version in the legal notice, “he is still not stable, has severe mood swings, has problems with comprehending and focusing on things, is finding it difficult to even do simple routine things like making online payments, leave alone focusing on work-related matters”.

His wife has stated that “he is also feeling very bad and guilty” over his decision to volunteer for the Covid-19 test vaccine as now “his two small children, get very scared when he has extreme mood swings and his family have to go through the ordeal because of his decision”.

‘We were told vaccine is safe’

The family has questioned the information provided to him while taking his consent for participation. “Our client further states that there was a categorical assertion about the safety of the vaccine in more than one place in the Participant Information Sheet,” said the notice.

In page 8 of the Participant Information Sheet, the notice mentions “it is explained what might happen after vaccination, which is not even remotely close to what our client experienced”.

“Even an allergic reaction after vaccination is termed as an extremely rare possibility,” the notice mentioned.

The notice mentions that “our client states that there is nothing in the Participant Information Sheet to educate or warn the participants about any serious side-effects of the said vaccine, like the one suffered by him”.


Also read: With Covid vaccine coming, Modi govt tells states & UTs to boost ways to report side effects


 

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