Written By: Longjam Dineshwori | Updated : November 29, 2020 10:31 AM IST
Serum Institute has also submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing.
The Serum Institute of India (SII) is in the process of submitting the data for the clinical trials of the Oxford-AstraZeneca COVID-19 vaccine, called Covidshield in India, to the DCGI and seek emergency use authorisation in about two weeks. Adar Poonawalla, Founder and CEO, SII said on Saturday that the trials are more than enough for establishing efficacy and that there will be no delays in the vaccine rollout. He also the Government of India is also looking at getting 300-400 million doses of Covidshield by July.
Meanwhile, a 40-year-old Chennai-based business consultant, who was a volunteer for the Covishield vaccine trails, has sought Rs 5 crore compensation for the severe neurological complications he developed after being administered the test dose.
The volunteer's advocate told IANS that they had sent a legal notice to the Serum Institute; Indian Council for Medical Research (ICMR); AstraZeneca, UK; Drugs Controller General of India; Andrew Pollard, Chief Investigator, Oxford Vaccine Trial; The Jenner Institute Laboratories, University of Oxford; and the Vice Chancellor of Sri Ramachandra Higher Education and Research.
According to the notice, the man was a volunteer for the third phase of human trial of Covishield being conducted at Sri Ramachandra Institute of Higher Education and Research, Chennai to determine the safety and immunogenicity of the vaccine in the health of Indian adults.
The notice was issued on November 21, but till now they have not received any reply from any of the parties to whom the notice was sent, N.G.R. Prasad, Advocate, Row & Reddy told the news agency.
The volunteer had signed the consent form on September 29 and the vaccine was given to him on October 1.
On October 11, the Covishield volunteer woke up with severe headache and vomited. His wife described in the notice that she saw a total behavioural change in him - he was not aware of his surroundings, he showed irritation towards light and sound, and was resisting any effort to make him get up from bed.
He vomited in the ambulance enroute the emergency ward of the Sri Ramachandra Medical College Hospital. The man was discharged from the hospital on October 26, with the discharge summary stating that he had suffered "acute encephalopathy". The discharge summary also mentioned that he was brought into the hospital "in an altered mental state" and was "disoriented." The volunteer was even fastened to the bed as he was aggressive, according to the notice.
The notice further stated that the volunteer is still not stable, has severe mood swings, has problems with comprehending and focusing on things, and is struggling to even do simple routine things like making online payments, leave alone focusing on work-related matters.
So far, neither the regulator (Drugs Controller General of India/Data and Safety Monitoring Committee), the sponsors (ICMR and SII) or the collaborators of the sponsors (AstraZeneca and Oxford University) has contacted the volunteer to find out about the severe adverse effect after vaccination and investigate the severe reaction the test vaccine has had on him.
The notice maintained that this clearly goes against the protocols and guidelines set by the World Health Organization (WHO) in dealing with an Adverse Event Following Immunization (AEFI)/Vaccination.
Now, the volunteer is claiming a financial compensation of Rs 5 crore for all the trauma he is undergoing as well as the testing, manufacturing and the distribution of the vaccine to be stopped immediately, the news agency reported.
