‘SII response is traumatic’: Chennai man who alleged side-effects after vaccine trial

The Serum Institute of India, AstraZeneca and the competent government organisations are yet to respond to the 40-year-old businessman’s legal notice issued on November 21.
Silhouette of a man
Silhouette of a man
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Jaseem (name changed to protect identity) had a hard time getting back on his feet after he was diagnosed with ‘Acute Neuro Encephalopathy’, a sudden neurological dysfunction affecting the brain. According to his family, he could not recognise them, experienced mood swings and could not carry out daily work on his own. He claims it was the result of an extreme side-effect of the COVID-19 vaccine that he was administered on October 1 as part of the trial by the Pune-based pharmaceutical giant, Serum Institute of India Private Limited. The Indian company partnered with Oxford University and AstraZeneca, the British-Swedish pharmaceutical, to manufacture the vaccine in India, under the name Covishield.

He is the 40-year-old Chennai businessman who recently served a legal notice to SII, AstraZeneca and other competent government organisations, demanding a Rs 5 crore compensation, alleging he suffered a severe adverse reaction to the vaccine. He also wanted testing, manufacturing and distribution of the vaccine stopped immediately.

Jaseem and his family stressed that their intention is not the compensation per se but to bring the matter to the notice of the public. In fact, Jaseem is happy that he is slowly able to get back to work and that his wife, parents and children are no longer worried about his health. “I am back to normal and I am able to do my routine work independently without anybody's help. I am also slowly trying to return to my work," he told TNM. However, emotionally, he is still traumatised by the response of the Serum Institute and government authorities.

Responding to the this volunteer’s allegations, the Serum Institute, in turn, threatened him with a Rs 100 crore suit to “safeguard the reputation of the company, which is being unfairly maligned." Terming the serious adverse event (SAE) “unfortunate”, the company outright denied that the symptoms were in no way induced by the vaccine, which is called Covishield in India. Barring a “public statement”, Jaseem has not received any response to his legal notice (issued on November 21) from the company. The government authorities, too, have been maintaining silence throughout.

“I am disappointed and shocked to note that no one from the Sree Ramachandra Medical college and research institute (SRMC), where I received the shot, did a follow-up on my health after I was discharged,” said the business consultant, who hails from Kannur district of Kerala.

Jaseem received the undertrial vaccine on October 1. Ten days later, on October 11, he started experiencing severe headache, vomiting, showing irritation towards light and sound, and unaware of his surroundings. The discharge summary stated that he was "in an altered mental state" and "disoriented" when he was brought to the hospital. He was unable to talk and recognise people, including his own children. According to the legal notice, his wife alleged that even after being discharged after treatment, he was experiencing mood swings and finding it difficult to do simple routine things like making online payments, let alone focussing on work-related matters. “In October, I lost a big, promising project from the US after my condition dented my confidence,” he told TNM.

Jaseem’s wife alleged that the Serum Institute picked up only on the compensation point in her husband's legal notice, which runs up to 18 pages. "Our primary aim is not the compensation but to bring this case to the notice of the people," she reiterates.

Meanwhile, two doctors in Chennai chose to assist the vaccine participant. One of them is Dr Zaheer Ahmed Sayeed, a neurologist, and a doctor from Apollo Hospital. After evaluating Jaseem’s medical condition, the Apollo Hospital doctor gave the businessman a letter asserting that his condition was due to the vaccine.

This correspondent sent an email to the AstraZeneca, the British-Swedish pharmaceutical company that developed the COVID-19 vaccine along with Oxford University, for a response. However, there has been no response yet. Meanwhile, the office of the CEO of the Serum Institute of India Private Ltd said the institute has already put out a statement in this regard, stating the Covshield "is safe and immunogenic”. After the phase-3 trials, Oxford-AstraZeneca claimed their vaccine showed an efficacy of 62% (two full doses) and 90% (a half dose followed by a full dose). The interim results of the clinical trial, which was published on Tuesday in the peer-reviewed Lancet journal, showed that the vaccine showed an overall efficacy of 70%, stating that it is “safe and effective”.

Even as Jaseem is yet to hear from the pharma company, the Serum Institute of India has applied to the Drugs Controller General of India seeking emergency use authorisation for Oxford-AstraZeneca COVID-19 vaccine.

Although his wife, two sons (studying in Class 5 and 2) and parents are relieved that Jaseem has started showing signs of improvement, the family is still awaiting a reply from the pharmaceutical company to his notice. He also hopes the Indian government will intervene in his matter to ensure transparency in the case. “I am aware that this will be a long wait for justice given the way authorities have responded to my notice,” he said.

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