Days after a participant sued vaccine maker Serum Institute of India (SII) alleging 'adverse reaction' caused to him due to its experimental vaccine 'Covishield', Adar Poonawalla-led SII has assured the vaccine won't be released for masses use unless it is proven "immunogenic and safe".
In a statement, SII said the incident with the Chennai volunteer, though highly unfortunate, was in no way induced by the vaccine and that SII is sympathetic with the volunteer's medical condition. All the requisite regulatory and ethical processes and guidelines were followed "diligently and strictly" during the trial process, it clarified.
"The concerned authorities were informed and the principal investigator, DSMB and the ethics committee independently cleared and reckoned it as a non-related issue to the vaccine trial. Post which we submitted all the reports and data related to the incident to the DCGI. It is only after we cleared all the required processes that we continued with the trials," said the company.
The 40-year-old participant, who sued SII for 'severe adverse reaction' due to Covishield, allegedly fell sick 10 days after he was given a shot on October 1. The person reported a severe headache and vomited. After CT scans, COVID-19 tests, and MRI scans, he was shifted to the ICU of a hospital. He was released after 11 days, and the discharge summary says he suffered "acute encephalopathy". Now, the trial participant has demanded a Rs 5 crore compensation.
Additionally, he served an 18-page notice to COVID-19 trial co-sponsor Indian Council of Medical Research (ICMR), Drugs Controller General of India (DCGI), trial site Ramachandra Higher Education and Research, AstraZeneca, and Professor Andrew Pollard, Chief Investigator of the Oxford vaccine trial.
Meanwhile, some participants, who were involved in the Serum Institute of India's vaccine trial, have now sought clarification from ICMR and Indian drug regulator on why they were not informed about the adverse events that took place during testing.
They said they felt cheated and, therefore, will take legal action against the company, DCGI, and the ICMR. A patient rights group, called the All India Drug Action Network (AIDAN) questioned the drug regulator for not halting the trial.
Serum Institute had recruited 1,600 people to begin its Covidshield trial in the country. It has collaborated with Oxford University and AstraZeneca to manufacture coronavirus vaccine in India. The vaccine manufacturer has completed phase-3 human trials and is now seeking emergency approval from DCGI to supply vaccines in the market.