Vaccine major Serum Institute of India (SII) has been issued a legal notice by a participant in the trials of its COVID-19 vaccine candidate, Covishield.
A law firm representing the participant has claimed that the volunteer suffered a serious adverse event after being administered the under-trial vaccine shot. In its notice to the vaccine maker, it also alleged that despite this, SII made no public disclosure about it.
In the notice, which has also been sent to the drug regulatory authority, the firm has demanded financial compensation of Rs 5 crore from the Pune-based vaccine manufacturer, reported The Economic Times.
The publication claims to have reviewed a copy of the legal notice. Moneycontrol couldn't independently verify it.
SII has partnered with global pharma giant AstraZeneca and the Oxford University for COVID-19 vaccine - Covishield.
According to the report, the participant (40) from Tamil Nadu was a part of phase 3 trials conducted at Sri Ramachandra Institute of Higher Education and Research, Chennai.
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In the notice, it was stated that the participant was “assured” that the vaccine had been found to be “safe”, and the study was to further confirm the safety and immune response of Covishield in Indian adults, said the report.
Also, the notice said the suffering of the participant was not even remotely close to what was cited in the participant information sheet.
The participant received the vaccine on October 1 and on October 11, he started experiencing severe headaches and was not able to respond to questions, said the notice. The participant suffered “acute neuro encephalopathy”, it alleged.
“The client was therefore led to believe that taking the Covishield test vaccine was safe and risks associated… would hardly lead to any serious side effect, leave alone severe adverse effect,” said the notice.
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The legal notice was sent on November 21, said the report, adding that R Rajaram, advocate for the complainant, was waiting for SII's response. “We will file a writ petition in court next week,” the publication quoted Rajaram as saying.
Copies of the legal notice have also been sent to the Chief Executive of AstraZeneca, UK, Chief Investigator of the Oxford trials and Vice-Chancellor of Sri Ramachandra Institute, the report said.
SR Ramakrishnan, Principal Investigator at Sri Ramachandra Institute, said an extensive investigation was carried out and they don’t think the adverse event was related to the vaccine, said the report.
The report was submitted to the Data and Safety Monitoring Board, SII, and the drug regulator within the stipulated time, Ramakrishna was quoted as saying. He further said the trials were not halted as they did not receive any such direction either from the sponsor or the drug regulator.
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