COVID-19 vaccine trial volunteer alleges side effects; seeks Rs five crore compensation
DCGI and ethics committee probing matter; SII rejects charge
Chennai/New Delhi, Nov 29: An Oxford COVID-19 vaccine trial participant in Chennai has sought a compensation of Rs five crore for allegedly suffering serious side effects from the shot, a claim which is being investigated by the Drugs Controller General of India and the institutional ethics committee at the trial site.
A senior ICMR official said that a preliminary assessment has not indicated any causal link between the alleged adverse events shown by the volunteer and the 'Covishield' vaccine.
The 40-year-old business consultant, who was a volunteer for the third phase of the vaccine trial conducted by Serum Institute of India (SII), has alleged he suffered a virtual neurological breakdown and impairment of cognitive functions, and has sent a legal notice to SII and others.
However, the SII on Sunday rejected the charges as "malicious and misconceived" and said it will seek damages in excess of Rs 100 crore.
The man was administered the shot at Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1.
A law firm on his behalf has now sent a legal notice to Director General of ICMR, CEO, Serum Institute of India Private Limited, Pune, Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO, Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator of Oxford Vaccine Trial and Vice Chancellor of Sri Ramachandra Higher Education and Research.
The man has sought a compensation of Rs 5 crore and that the testing, manufacturing and distribution of the vaccine be stopped immediately.
The SII has partnered with British-Swedish biopharmaceutical giant AstraZeneca AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19.
Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division of the ICMR, said the causal link, if any, of the serious adverse events with the investigational product is objectively assessed in any clinical trial following a pre-defined scientific pathway and within a stipulated period.
"Any hurried inquiry or inference is prone to be wrong. Both the institutional ethics committee and the DCGI are investigating the causal links, if any, between the adverse events and investigational product, which is an anti-coronavirus vaccine. A preliminary assessment has not indicated any causal link as yet," Dr Panda said.
According to the legal notice, the information provided in the 'Participant Information Sheet (PIS)' was absolutely certain that Covishield, the vaccine developed by Oxford University, is safe and the man was hence led to believe it.
Hence, he decided to become a volunteer and signed the informed consent on September 29 and the test result for antibodies against coronavirus turned negative the same day.
On October 1, he was administered the vaccine.
Though there was no side effects for the first 10 days, he subsequently had episodes like severe headache and vomiting.
Detailing the sequence of events since October 11 when he was admitted to the Ramachandra Hospital and as narrated by the man's wife, the notice said he showed behavioural changes.
He could neither recognise anyone nor speak and was totally disoriented and was shifted to the ICU and was on October 26 "discharged at our (family's) request", it said.
At home, he seemed quite disoriented at times and was unable to relate to things or work. He would not have volunteered for the test vaccine if all the potential risk factors of the test vaccine had been known to him, the notice given on November 21 said.
"Our client states that he must be compensated, in the least, for all the sufferings that he and his family have undergone and are likely to undergo in the future."
"He further states that he is still far from being all right and has to be under medical care for a long time to come. Therefore, 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 two weeks from the receipt of this notice," it said.
Serum Institute of India said in a statement that the allegations in the notice are "malicious and misconceived" and the volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial.
"While the Serum Institute of India is sympathetic with the volunteer's medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer," it said.
"The 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. In-spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company," Serum Institute said.
It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive, it added.
"The Serum Institute of India will seek damages in excess of (Rs) 100 crore for the same and will defend such malicious claims," the statement said.
The DCGI had on September 11 directed Serum Institute of India (SII) to suspend any new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ''an unexplained illness'' in a participant in the study.
However, on September 15 it permitted the Serum Institute to recommence the trial.
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Modi govt by changing name of MGNREGA exposed its 'hatred' towards Gandhi: Siddaramaiah
Bengaluru (PTI): Karnataka Chief Minister Siddaramaiah on Tuesday said that the union government led by Prime Minister Narendra Modi, attempting to change the name and structure of the MGNREGA, has itself exposed its "hatred" towards the poor and towards Mahatma Gandhi.
He also accused the Centre of "altering" the very structure of the scheme, by shifting nearly 40 per cent of the cost onto the state governments, and called Modi "anti federal".
Suggesting that the NDA government at the Centre start a "Ministry of Name Change", with the Prime Minister himself holding that portfolio, the CM warned of a statewide agitation against this name change move.
The Viksit Bharat Guarantee for Rozgar and Ajeevika Mission (Gramin) (VB-G RAM G) Bill, 2025, that seeks to replace the existing rural employment law MGNREGA, was introduced in the Lok Sabha on Tuesday amid strong objections by the opposition to the "removal" of Mahatma Gandhi's name from it.
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"The Union government led by Prime Minister Narendra Modi, which is attempting to change the name and structure of the Mahatma Gandhi National Rural Employment Guarantee Scheme (MGNREGA), has itself exposed its hatred towards the poor and towards Mahatma Gandhi," Siddaramaiah said in a statement.
Implemented by the UPA government 20 years ago, the MGNREGA scheme has played a crucial role in eradicating unemployment and poverty in rural areas, he said, adding that "this scheme, which guarantees the right to employment to every individual, has received praise from economists both in India and abroad."
Noting that MGNREGA was a genuine form of employment guarantee, the CM said the proposed new structure under the Modi government strips away that guarantee and places the assurance of work at the whims of political leaders.
"This will further deepen caste discrimination and social inequality," he claimed.
Highlighting that the NDA government has altered the very structure of MGNREGA, a scheme whose entire expenditure was earlier borne by the Central government, by shifting nearly 40 per cent of the cost onto the state governments, Siddaramaiah said this stands as clear evidence of the "anti-federal attitude" that Prime Minister Modi has followed ever since coming to power.
"This move will also increase the migration of poor people in search of work as the proposed form does not guarantee employment in their own location -- forcing families to travel long distances to survive," he said.
Naming this scheme after Mahatma Gandhi, who sowed the dream of Gram Swaraj, was a meaningful decision, the CM said, "While Prime Minister Narendra Modi indulges in praising Gandhi during his foreign tours, within the country he has consistently engaged in attempts to erase Gandhi's legacy from key national programmes. From a parivar that seeks to glorify Gandhi's assassin Godse, what different conduct can one really expect?"
"Narendra Modi is widely known for simply changing the names of landmark schemes launched by the UPA government rather than preserving or strengthening them. It would be more appropriate for this government to start a 'Ministry of Name Change,' with the Prime Minister himself holding that portfolio," he said.
More than 25 flagship programmes launched during earlier governments were merely renamed or repackaged by the present regime, the CM further said, listing out that the Nirmal Bharat Abhiyan was rechristened as the Swachh Bharat Mission, while the Basic Savings Bank Deposit Account scheme was rebranded as the Pradhan Mantri Jan Dhan Yojana, among others.
"These changes reflect a consistent pattern of altering names rather than fundamentally strengthening or expanding the original intent of these welfare initiatives," he added.
Stating that the Congress party and state government strongly condemn this "anti-people" decision of the Narendra Modi government, which has snatched food from the plates of the poor, insulted Bapu, and attempted to strangle state governments financially, Siddaramaiah warned about launching a statewide agitation against this move.
"The responsibility of preserving the MGNREGA scheme in its original form must also be taken up by the lakhs of beneficiaries of the scheme. They must hold the BJP leaders of the state accountable and exert pressure on them to raise their voices against this injustice, rising above party lines," he said.
