A 40-year-old man who took part in the 'Covidshield' vaccine trial here has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to Serum Institute and others, besides seeking a halt to the trial.
Alleging that the candidate vaccine was not safe, he has also sought cancelling approval for its testing, 'manufacture and distribution', failing which legal action would be taken.
The legal notice has been sent to Pune based Serum Institute of India (SII), which has collaborated with Oxford University and Astra Zeneca, a pharmaceutical company, in connection with making of the vaccine, 'Covidshield.'
The Indian Council of Medical Research, one of the sponsors besides SII, and Sri Ramachandra Institute of Higher Education and Research, which administered the vaccine to the man, have been served with the notice.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The man, it alleged, suffered acute encephalopathy, damage or disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was due to the test vaccine.
The trauma he underwent after taking it 'cleary proves' that the vaccine was not safe as made out to be and all the stakeholders were trying to hide the adverse effect that the vaccine has had on him, the notice claimed.
An electroencephalogram (EEG) test showed that the brain was affected partially (dysfunction involving both hemispheres and the ascending sensory pathways on both sides from both the lower extremities).
A pyschiatric evaluation revealed mild deficit in verbal and visual memory functions and an under functioning in overall cognitive functions, it said. "He has gone through extreme sufferings, both neurologically and psychologically. The vaccine had led to a virtual neurological breakdown in him."
The notice said it is impossible to "quantify monetarily, the sufferings, trauma, pain and humiliation (of hands, legs and body being tied and fastened firmly to the bed), which he and his family have undergone and are likely to undergo for a long time to come". When contacted, a spokesperson for Ramachandra said,"we also have got the notice," but declined to elaborate. 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 vomitting.
A doctor suggested investigations like a CT-scan as the man was oblivious of what was happening around him and could not respond to questions. 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." 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.
But on the other hand, there was a clear assertion of the safety nature of the test vaccine in the PIS which made him to become a volunteer, the notice said. The legal notice has also been addressed to the Drugs Controller General of India, Professor Andrew Pollard, chief investigator, Oxford vaccine trial, The Jenner Institute investigator, Laboratories of the University of Oxford and Astra Zeneca UK. "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 crore within a period of two weeks."
Though he suffered severe adverse reaction to the vaccine, the stakeholders failed to follow any of the guidelines mandated by World Health Organisation, it said. The notice also said the testing, manufacturing and the distribution of the vaccine should be stopped immediately failing which the man would have no other option except to take legal action against all the parties concerned. The Drugs Controller General of India and the institutional ethics committee at the implementation site are investigating if the adverse event as claimed to have been suffered by a COVID-19 vaccine trial participant are related to the shot administered to him.