The 40-year-old volunteer, who works as a management consultant, wanted to investigate why he had severe neurological complications after being vaccinated with Covidshield shots at the Serum Institute of India, but the company intimidated him with a threat of over 100 rupees in damages, said its supporters.
“We have not yet received a response to the legal notice sent to various parties including the Serum Institute. We have seen messages from the Serum Institute threatening our customer with a lawsuit for 100 rupees,” said NGR Prasad , Advocate, Row & Reddy told IANS.
“Our client had limited their entitlement to just Rs 5 crore and wanted the investigation into the cause of their serious neurological problems and prevent the vaccine from affecting other people,” added Prasad.
On the flip side, the Serum Institute intimidates its volunteers without addressing the root cause, and threatens over 100 rupee damage.
“The client is willing to legally fight back if necessary,” R. Rajaram, another attorney for the volunteer, told IANS.
The two proponents said this was a medico-legal case and the evidence would be sought from medical professionals in support of their client.
“The volunteer was a healthy man before the vaccination. He was only tested for coronavirus infection before being vaccinated with Covidshield. He was found negative for coronavirus infection,” Prasad said.
“No other medical tests were done to determine his health,” added Prasad.
He said that in case of a side effect, investigation into the problem should have been done right away – whether it was a vaccine or not.
“But it was not done, despite the severe neurological health complications our client developed,” said Prasad.
In response to the volunteer’s legal notice, the Serum Institute said in a media statement on Nov. 29, “The claim is malicious as the volunteer was specifically informed by the medical team that the complications he suffered were unrelated to the vaccine study That he went through to be aware of this, he still decided to go public and defame the company’s reputation. ”
The company is silent about the basis on which the medical team advised the volunteer that his neurological problems are independent of the vaccine study he went through.
Prasad said no further medical tests were performed on his client to determine his pre-vaccination health or any other pre-existing ailments.
“The allegations in the notice are malicious and misunderstood. While the Serum Institute of India agrees with the volunteer’s health, there is absolutely no association with the vaccine trial and the volunteer’s health. The volunteer falsely blames his or her medical problems the Covid vaccine study, “the Serum Institute had said.
“It is evident that the intent to divulge such malicious information is a skewed financial motive. The Serum Institute of India will seek more than 100 crore in damages and defend such malicious claims,” the company issued a counter threat .
“We 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, Oxford University; and the Vice Chancellor of Higher Education and Research in Sri Ramachandra, “said Prasad.
According to the legal notice, the volunteer, a 40-year-old male, is married with two children, approximately 12 and 7 years old.
When we heard of the request for volunteers for the third phase of the human study at the Sri Ramachandra Institute for Higher Education and Research (formerly Sri Ramachandra Medical College & Research Institute or SRMC) to deliver the Covid-19 vaccine developed by Oxford University test, the public spirit in him wanted to volunteer, it said in the notice.
The volunteer was informed by the Ramachandra Institute that it is a randomized controlled trial to determine the safety and immunogenicity of Covishield (Covid-19 vaccine) for the health of Indian adults.
The “Participant Information Sheet” given to him stated that the sponsors were (a) the Serum Institute of India Pvt Ltd (SII) and (b) the Indian Medical Research Council (ICMR); and the investigation site is Sri Ramachandra Higher Education and Research (considered a university), Chennai, and the investigator is SR Ramakrishnan.
According to the announcement, Oxford University has developed a vaccine against Covid-19, according to the ‘participant information sheet’.
This vaccine was previously tested in the UK on around 500 healthy adults aged 18 to 55 years. It has been found to be safe and to induce an immune response. There are currently three major clinical trials in the UK, Brazil and South Africa involving thousands of healthy adults with this vaccine. The SII worked with Oxford University and AstraZeneca (a UK pharmaceutical company) to produce this commercial-scale vaccine called Covishield. ”
According to the notice, the Sri Ramachandra Institute and the investigator also assured the volunteer that the vaccine has already been found safe and that this study will further validate Covishield’s safety and immune response in Indian adults.
“Our client further states that the content on page 8 of the participant information sheet continued to ensure the safety of the vaccine, even though two participants in the UK developed unexplained neurological symptoms that were believed to be unrelated to the vaccine,” said in the message.
According to the notice, there will be nothing in the participant information sheet to educate or warn participants about serious side effects of the vaccine, such as those they may have suffered.
The volunteer signed the consent form on September 29th. Since the test for antibodies against Covid-19 was negative, he was given the vaccine against the Covishield study on October 1.
There were no side effects 10 days after the vaccination, but on October 11th the volunteer woke up at 5:30 am with a severe headache and fell asleep again and did not get up when his wife tried to wake him up at 9:00 am and woke up at 2:00 pm and vomited, fell asleep again, and said he had a bad headache. There was a total change in behavior in him – he was unaware of his surroundings, he showed irritation to light and sound and resisted every effort to get him out of bed, the message said, citing his wife.
The Covishield volunteer vomited in the ambulance on his way to the emergency room at Sri Ramachandra Medical College Hospital. “According to the hospital discharge schedule, he was taken to the hospital” in an altered state of mind “and was” disoriented “.
The Covidshied volunteer was released from hospital on October 26th. The discharge summary states that he suffered from “acute encephalopathy”.
“He says that in the 16 days he was in the hospital almost all kinds of medical tests and examinations were done on him to relate his neurological set to one of his previous health conditions, that is, to another factor than the test vaccine given to him on October 1. However, all tests performed on him were negative, confirming that the health setback was due to the test vaccine he received on October 1. and not on any previous state of health, “the message said.
The volunteer was even tied to the bed as he was aggressive.
Citing his wife, the notice states that the volunteer is still unstable, has severe mood swings, has trouble understanding and focusing on things, and it is difficult, let alone, to do simple routine tasks like paying online work. related issues. So much so that he feels totally frustrated and no longer has any confidence.
Even after a month of the serious side effect of the vaccine, neither the Drugs Controller General of India nor the sponsors (ICMR and SII) or the sponsors’ staff (AstraZeneca and Oxford University) have contacted him to find out about the serious side effects after vaccination and to investigate the serious reaction the test vaccine had on him.
According to the notice, this clearly violates the protocols and guidelines of the World Health Organization (WHO) in dealing with an adverse event after immunization (AEFI) / vaccination.
“The WHO protocol clearly states that ‘the criteria for initiating an investigation (an AEFI) could be established within two working days for major events and five working days for non-serious events’ and’ a report must be prepared as soon as possible This means that an immediate decision can be made about the need for action and investigation, ”the message says.
“Our client’s wife states that EEG tests performed on November 12th (18 days after discharge from hospital) found” dysfunction of both hemispheres “and” dysfunction of the ascending sensory pathways on both sides of both lower extremities ” Psychiatric examination carried out on the same day shows “slight deficit in verbal and visual memory functions”, “slight deficit in dealing with complex information” and “an underfunction in overall cognitive functions” “, says the communication.
The volunteer is seeking financial compensation of Rs.5 billion for all the trauma he is going through and whose health is uncertain, and testing, manufacturing and distribution of the vaccine should also be stopped immediately.
When contacted, a Sri Ramachandra Higher Education IANS spokesman said the matter was still open and unable to comment on the matter, even though the volunteer had not filed a lawsuit.