New Delhi: A Chennai resident, who was a participant in trials for the Covid-19 vaccine being manufactured by the Pune-based Serum Institute of India, has allegedly suffered serious neurological and psychological symptoms after taking the experimental shots.
A law firm has on his behalf sent a legal notice to SII seeking compensation of Rs 5 crore.
The vaccine, Covishield, is being developed by the University of Oxford and drugmaker AstraZeneca. SII has a tie-up with Swedish-British pharma giant for the manufacturing of a billion doses. Covishield is among the frontrunners in the race to develop an effective vaccine against Covid-19.
The legal notice, copy of which has been accessed by ThePrint, states that the participant, who is around 40 years old, “must be compensated, in the least, for all the sufferings that he and his family have undergone and are likely to undergo in future”.
The participant, according to the notice, has been diagnosed with “acute neuro encephalopathy”, which has allegedly been linked as a side-effect of the Covishield shots that he took on 1 October.
In the notice, the law firm, Row and Reddy, has described the trial participant’s condition as “far from being all right” and claimed that he “has to be under medical care for a long time to come”.
Apart from SII, the notice has been sent to the Indian Council of Medical Research (ICMR), Drug Controller General of India (DCGI), Chief Executive Officer (CEO) of AstraZeneca, Professor Andrew Pollard at the Oxford Vaccine Trial, The Jenner Institute Laboratories University and the vice-chancellor of Sri Ramachandra Higher Education and Research where the participant was given the vaccine shot.
The legal notice claims the participant began experiencing headaches and then endured a seven-day stay in the intensive care unit (ICU).
“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 Crores within a period of two weeks from the receipt of this notice,” reads the notice.
It further states that “the testing, manufacturing and the distribution of the vaccine should also be stopped immediately”. The notice warns that if the defendants failed in doing so, the complainant has no other option except to take appropriate legal action against all the parties concerned.
“We haven’t received any response from any of the parties whom we have sent the notice to. We will be left with no other option but to go ahead and file a writ petition and get ready for a legal battle,” advocate R. Rajaram, on behalf of the participant, told ThePrint.
The patient consent form provided by SII, and seen by ThePrint, does offer treatment. “If you get sick during the course of study, we will help you get a proper treatment,” the form states. “In the event of trial related death or injury, you shall be provided medical management as long as required as per the opinion of the study doctor or until the time it is not established that injury or death is not due to the clinical trial, whichever is earlier.”
The participant’s notice, however, has claimed that no one from the trial centre has followed up with them on his health after his discharge from hospital.
ThePrint contacted SII, AstraZeneca, DCGI and ICMR through texts and email for a response but did not receive any until the time of publishing. ThePrint had also emailed the Press Information Bureau (PIB) as the ICMR and DCGI are government entities but received no response. The copy will be updated when we get a response.
Also read: AstraZeneca plans another Covid vaccine trial to clear uncertainty and confusion
Participant feeling guilty over his decision to volunteer : Notice
The participant, whose identity of whom has been withheld on the request of his lawyer, is an independent business consultant.
According to the participant’s wife’s version in the legal notice, “he is still not stable, has severe mood swings, has problems with comprehending and focusing on things, is finding it difficult to even do simple routine things like making online payments, leave alone focusing on work-related matters”.
His wife has stated that “he is also feeling very bad and guilty” over his decision to volunteer for the Covid-19 test vaccine as now “his two small children, get very scared when he has extreme mood swings and his family have to go through the ordeal because of his decision”.
‘We were told vaccine is safe’
The family has questioned the information provided to him while taking his consent for participation. “Our client further states that there was a categorical assertion about the safety of the vaccine in more than one place in the Participant Information Sheet,” said the notice.
In page 8 of the Participant Information Sheet, the notice mentions “it is explained what might happen after vaccination, which is not even remotely close to what our client experienced”.
“Even an allergic reaction after vaccination is termed as an extremely rare possibility,” the notice mentioned.
The notice mentions that “our client states that there is nothing in the Participant Information Sheet to educate or warn the participants about any serious side-effects of the said vaccine, like the one suffered by him”.
Also read: With Covid vaccine coming, Modi govt tells states & UTs to boost ways to report side effects
This person is a money seeking chancer. I did the trial in the U.K. and there are no guarantees to its safety, it’s a vaccine trial. If they knew it was 100% safe, they wouldn’t do a trial. This person is one of life’s bad people.
To have high safety confidence in their vaccine , I suggest SII /astra zeneca ceo and top executives should vaccinate themselves first before public can believe it is safe enough!
I have been a volunteer for the Oxford AstraZeneca vaccine in the UK since July. As such I can assure you that healthy recipients have nothing to be concerned about. In fact, there has only been one reaction out of 10,000 UK volunteers, and that reaction was to the alternative ‘control’ vaccine MenACWY. Perhaps AstraZeneca should recall all batches of their vaccine, and leave India to purchase those vaccines that require storage temperatures of -70C. That could be interesting!
Is this vaccine approved for clinical trials in the USA?
How many people in the India trial of the SII vaccine were over the age of 50?
How many were below 35?
How many were women?
How many people in India underwent the trials? Only 1 person reported such adverse side effects ?
“…he is still not stable, has severe mood swings, has problems with comprehending and focusing on things, is finding it difficult to even do simple routine things…”
Clear case of brain fog due to an inflamed brain!
ANY vaccine that has ANY side effects should be STOPPED!
Depends on side effects – they are temporary or permanent. The permanent effects are to be studied more. That is why regular vaccine research and trials are supposed to take a long time many years if not more than a decade.
Why they need to produce a vaccine for a simple virus that can be treated even by paracetamol?isn’t it strange?this vaccine is more deadlier than this simple covid..corrupt people thinks about for money only.
The symptoms described are normally faked by a child in grade II and III onwards. If one says one has headache one has it it cannot be disproved. Similarly if one does not want to make an online payment one cannot be forced to. If one is willing to pay the ICU charges and goes on insisting on the symptoms the hospital will keep him in ICU.
Come on le us be real.
Assuming his illness has been certified by a doctor then the truth should come out.
His symptoms could be real. There is a complex interplay between the brain and the immune system. He could have developed an allergic response to the simian adenovirus, who knows? Responses to vaccines or viruses is not same for everybody due to differences in genetics.
He could be suffering from chronic fatigue syndrome for which medical science in the West has poor or little understanding. In the West his symptoms would have been recognised but in India there is not enough expertise or awareness among Indian doctors to diagnose brain fog conditions.
“The participant’s notice, however, has claimed that no one from the trial centre has followed up with them on his health after his discharge from hospital”
If this is true I think it brings up more questions on the way clinical trials are conducted in our country. We need more transparency.
Straight up greedy behavior and such actions should not be entertained at all by any pharma company. If he genuinely asked for compensation for his troubles and lost wages for whatever the company decided that would be fair, but asking for 5 crores straight up is monstrosity.
Forget it, his case will never even be heard by the courts for a long time. Lakhs of cases are pending in our courts anyway.
He will have to depend on SII to pay for his health bills that too in case SII agrees. Sad, in case his allegations are true. Because paying someone’s health bills does not mean you can run the family expenses with it.
If the medical fraternity does not pay attention to this issue they ignore at their own peril as the vaccine will be first given to health workers first. Let’s see what happens in due course.
This is all the print and the wire can do. Scare off people and delay vaccine. Don’t anyone support this yellow journalism.
The Print and the Wire have science teams and do decent science reporting. The Print platform is very broad in it’s coverage unlike the right wing crap-only that emanates from OpIndia, Swarajya etc.
In trials like these, there are generally two groups- one which gets the vaccine, the other control group which doesn’t get the vaccine; rather they get either distilled water or ns for injection. In this case, only very few know whether he is in the vaccine group or control group but the volunteer or his attendants don’t know this. If he is in the control group then his symptoms cannot be attributed to the vaccine at all.
exactly!
Can SII confirm which group he was in ? Hope Print asks this from SII.
If he was in the non-placebo group, this person’s side effects needs researcher attention. It can be checked if he has antibodies to the monkey virus he was injected with. That would confirm anyway that he was injected with the vaccine.
How many were given vaccine and how many fallen I’ll with side effects. It may before planned drama.
We need to await the response from ICMR, DCGI, AstraZeneca and SII through the Print.
I hope the Print brings the truth to light in a scientific and objective manner. Print is a platform with a good science reporting team.
Then what is the remedy fir this disease and why so many pharma companies wasting time,money and people lives?
They’re not wasting money, they are investing in to make multi billions. You sleep tight till you get this vaccine and whatever happens after that you will have to born it anyway. There wont be any rescue for you in that large sicken crowd. Good luck!
I think some of us have to make a choice to not vaccinate ourselves and our families until vaccine safety is known over time. Till then continue wearing a mask and carry on with life and livelihood.
Why only 5 crores ?
5 crores is quite less, true.
Common man’s life is quite cheap and disposable in India. With the delays in our justice system he will suffer chronically until he receives any justice from the courts.
Hi
Volunteering for a trial has some risk associated with. I understand the trials are insured. One cannot sue the pharma unless you can prove negligence. It is like an operation. You sign an undertaking knowing the risk.
If there is a reaction on a the pharma must stop and not one one in a few thousands. They still need to investigate that SII did
If it is a surgery done before then one can always be rest assured that it is a proven surgical method.
But a new vaccine that is a risk , one is introducing something into one’s body which your immune system may or may not be able to adjust to. Wonder how people can take the risk to enroll for vaccine trials if there is no significant monetary benefit for them or their families if there is a serious permanent side effect. How do vaccine companies get participants?
Idiots. Why stop making more vaccines ? Not much people had side effects. The phase-3.0 trial was successful. If 1 person is having side effects, ask him to wait till the other vaccine, the covaxin comes out in may 2021. Covishield should continue
How will the other vaccine help his current side effects? These effects may have become permanent i.e chronic now.
Medical science is still trying to unravel the complex interactions between the brain (Central nervous system) , autonomic nervous system and the immune system.
Safety is the number one goal for any vaccine.
Another vaccine cannot cure permanent side effects created by an earlier vaccine.
Who told the participant to volunteer and doesn’t he know the implications involved in any drug trail … doesn’t the law firm knows about this fact …. didn’t the volunteer signed indemnity certificate before volunteering for trials …absurd and rubbish….not expected this from so called law firm..basics first understand than issue such useless notices…
Somebody has to volunteer for a trial anyway. The society and corporates should bear the cost of health problems due to side effects on those who volunteered. This volunteering is a noble act like an army man sacrificing his life for the country so that you and your family can live peacefully and have a long healthy life.
Nice way to make easy money.
The org should conduct experiment only on willing samples and not by force .The liabilities should be spelt out.Also insurance should be provided so that claims can be settled fast and correctly.
Human beings are not lab rats.
Sometimes side effects of drug trials are permanent. Now this is a vaccine the medical world is in a hurry to release. So also politicians are in a hurry to release good news to the public. If the side effect allegations are proven, what is the poor man to do? Vaccine businesses should conduct their business with ethics. Good science takes time and responsible scientists should put science above profit.
Doesn’t seem to be side effect of the vaccine!
How do you know?
The immune system reactions have definite effects on the brain which are not yet well understood by the medical profession.
What’s your evidence?
Extortion. That’s the name of the game. Opportunists.
Should be examined by specialists to confirm facts.
Will induce fear within the people.
It may be genuine. Media needs to get to the bottom of it and expose if there is substance in the allegations.
SII should exhibit professionalism and ethics and not try to bury the issue.
Which hospital SRM Medical College hospital or TN government hospital. Lack of reviews after trials disturbing news and insensitive on the part of hospital management.
Shows the dismal state of public health in our country.
Weight and height please assuming he is thin as all covid vaccines would be hot in nature. Put ghee drops in nose five times a day. Cold water spray onball joints from bottom to top cold water bath with coconut oil etc taking ghee before sleep and early morning may solve the problem.
Stop this nonsense please. Go ahead and fool the illiterate and illogical masses with your ghee treatment but to appear on the Print platform and peddle this…!
What are you trying to say? That homemade recipes can cure corona?
Or am I misunderstanding?
Now here come the Ayush guys trying to heal encephalopathy with a super duper Ghee vaccine!
People as volunteers sign informed consent form and are ready to take risk, which is commendable. But what 8s also important is patient follow up by study coordinator. This is necessary to ensure long term. Safety Nd also address post trial complications, id any. Legally, this patient may not win, except that he will be getting adequate medical treatment at the cost of sponsor
What on earth could be the reason somebody comes forward innocently for a drug trial or vaccine trial? Are there any laws in this country for clinical trials? Especially if he or she is healthy already, it’s crazy for someone to volunteer when they know there is a chance something can go wrong.