A law firm who is representing a 40-year-old participant in the Covishield trials– the vaccine that is under development by Pune-based Serum Institute of India (SII), has sent a legal notice to the company and to the drug regulatory authority. Internationally, the vaccine technology has been developed by AstraZeneca.

The notice stated that the participant had suffered a serious adverse event after getting administered the under-trial vaccine. The firm has demanded a financial compensation of Rs 5 crore. The legal notice has also alleged that despite this adverse event, there was no public disclosure made.

It had caused a contrast with SII to halt India trials due to an adverse event that was reported in the UK, when the global trials were also stopped. Trials were resumed after receiving regulatory clearance.

R Rajaram, who is the advocate for the complainant, said that they were waiting for the response on the legal notice sent on 21st November. They will file a writ petition in court by next week. The participant is a man from Tamil Nadu and was a part of phase 3 trials that was conducted at Sri Ramachandra Institute of Higher Education and Research in Chennai.

Copies of the legal notice are sent to the chief executive of AstraZeneca, UK, along with the chief investigator of the Oxford trials and also the vice-chancellor of Sri Ramachandra Institute.

Principal investigator at Sri Ramachandra Institute, SR Ramakrishnan, said that an extensive inquiry has been carried out and they don’t think the adverse event was due to the vaccine. The report was already submitted to the Data and Safety Monitoring Board, SII and to the drug regulator in the specified time. He said that the trials were not halted as they didn’t receive any such information either from the drug regulator or the sponsor.

According to the legal notice, the participant was “assured” that the vaccine was found to be “safe,” and the study will further confirm safety and immune response of Covishield vaccine in Indian adults. The client was made to believe that taking the Covishield test vaccine was very safe and risks associated would not lead to any serious side effect.

Rajaram further stated that the participant experience was not at all close to what was cited in the information sheet. It was mentioned that the participant might experience “injection site reaction, such as pain, tenderness, chills, fever, fatigue, joint pain, headache or other common symptoms.” The information sheet mentioned that there was a rare possibility of severe COVID infection if participants contracted the infection post-vaccination.

As per the notice, the participant received the vaccine on 1st October. On 11th October, he started suffering from severe headaches and wasn’t able to respond to questions. The participant suffered acute neuro encephalopathy and was hospitalized. He was discharged from hospital on 26th October but still not stable. He suffers from severe mood swings, comprehension problems and finds difficult to do simple, routine things.

The notice further has mentioned that there was no follow-up from the hospital, the company, the sponsors or the drug regulatory authority.

Source: The Economic Times