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Vaccines Can't Be Mandated Without Evidence That Unvaccinated Persons Pose Health Risk : Prashant Bhushan Argues In Supreme Court

Sohini Chowdhury
2 March 2022 4:15 PM GMT
Vaccines Cant Be Mandated Without Evidence That Unvaccinated Persons Pose Health Risk : Prashant Bhushan Argues In Supreme Court
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On Wednesday, the Supreme Court began the final hearing in the plea, inter alia, questioning the constitutionality of the vaccine mandates imposed by States, particularly, Delhi, Madhya Pradesh, Maharashtra and Tamil Nadu. On a previous occasion, Advocate, Mr. Prashant Bhushan appearing for the Petitioner, Dr. Jacob Puliyel, a former member of the National Technical Advisory Group of...

On Wednesday, the Supreme Court began the final hearing in the plea, inter alia, questioning the constitutionality of the vaccine mandates imposed by States, particularly, Delhi, Madhya Pradesh, Maharashtra and Tamil Nadu. On a previous occasion, Advocate, Mr. Prashant Bhushan appearing for the Petitioner, Dr. Jacob Puliyel, a former member of the National Technical Advisory Group of Immunization had submitted that the mandates imposed are such that they impinge upon the fundamental rightof the citizens.

A Bench comprising Justices L. Nageswara Rao and B.R. Gavai had agreed to hear the plea on merit to determine if the vaccine mandates were proportionate to personal liberty. On Wednesday hearing Mr. Bhushan at length, Justice Gavai stated that without going into the correctness of the expert reports the limited issue would be to determine that the policy decision taken by the concerned Governments to impose mandates is based on any relevant data.

"The limited enquiry that would be permissible is as to whether the policy decision taken by the concerned Govt. is based on relevant data or not. All these expert reports, should we go into the correctness of this. There would also be reports per contra."

It is pertinent to note that apart from challenging vaccine mandates, the petitioner had also sought the indulgence of the Apex Court to issue directions to the concerned authorities to publicize the data relating to clinical trials and post vaccine efficacy of the COVID vaccines, as is required by International medical norms, and to stop the coercive mandate issued by various governments for vaccination.

He had also beseeched the Court to revamp the Adverse Events Following Immunization (AEFI) reporting system, which, he claimed, at present lacks transparency. Another issue before the Bench was non-disclosure of clinical trial data for the vaccines that are being administered to children in India and a stay on the coercive COVID-19 vaccine mandates introduced in various states and by private establishments for children in the age group 15-18 years.

At the outset Mr. Bhushan highlighted the gravity of the vaccine mandates, which have restricted movement, denied basic amenities and curbed the right to livelihood.

"Vaccine mandates are saying you will not be able to ration or be allowed to travel etc. if you don't take vaccines, that you won't get access to essential services if you don't take vaccines."

On the issue of disclosure of trial data, he submitted that though the petitioner recognises the COVID-19 situated warranted emergency use authorisation, that cannot mean that the clinical trial data and data on adverse effects of the vaccine cannot be made available.

"The petitioner recognizes COVID was an emergency and recognizes emergency authorization, but it does not mean that clinical trial data must not be disclosed, or data on adverse effects are not published..poor adverse event reporting in India, children's vaccines are given against scientific caution."

Mr. Bhushan expressed concern that without placing data on the public domain, the State Government and even private institutions by imposing vaccine mandates were coercing citizens to get vaccinated.

"Disturbing orders are passed by some states and private institutions to force people to take vaccines, even without putting all information in the public domain, enabling a citizen to make an informed decision. Coercing citizens to get vaccines is unconstitutional."

It was pointed out that though the affidavit of the Union Government clearly states that vaccines is voluntary, the State Governments have now directly/indirectly made it mandatory.

"Though GOI says vaccines are voluntary, various states and private institutions have imposed vaccine mandates…Madhya Pradesh says you will not get ration unless you get vaccines

With respect to the State of Maharashtra, Mr. Bhushan submitted their was restriction in movement -

"Maharashtra - all persons connected with the organization or event, ticketed or non-ticketed, as well as all service providers and participants, like player, actors, guests shall be fully vaccinated, any shops establishments where a member of public has aright to come shall be manned by fully vaccinated person, all public transport only by fully vaccinated…You can't travel in public transport, you can't go to any shop, you can't go to Maharashtra, you can't go to any event unless fully vaccinated."

He contended that a larger share of the population was already infected, therefore they have developed antibodies, which would provide better immunity than the vaccine.

"Vaccine is something created to mimic the system...if you have the infection already, then your body already develops antibodies..that's elementary…Serological surveys are showing that more than 75% people have got antibodies to COVID. This shows that they had the injection sometime or the other. And Omicron, which is a highly infectious strain, though milder, almost everybody in the country has had it, either the Omicron version or Delta version. So they have got immunity which is superior to any immunity that vaccine can give you."

Mr. Bhushan informed the Bench that he has not taken COVID vaccine.

"I believe people who are healthy will have only negligible effects due to COVID. I don't know about the long term effects of vaccine. There is no study."

He apprised the Bench that he had done extensive research for the past two years. Reliance was placed on a book titled, 'The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health (Children's Health Defense) - by Robert F Kennedy Jr to show how the narrative, suitable for Big Pharma, interested individuals and mainstream media has been disseminated and fed to the public at large.

"There is a fantastic book which has recently been published by Robert Kennedy Jr, who is the son of the former Attorney General of the US. It is called the 'Real Anthony Fauci'. It is a 300 page book which has 3000 references of Govt. data as well as peer reviewed scientific journals. It was published in Nov, 2021. The introduction gives you the picture, what has happened and how it has happened?"

It was clarified that though their inadequacies in the unrolling of the vaccines, it is not being assailed in the present petitioner. It is only challenging the vaccine mandates

"We are not questioning the unrolling of these vaccines under emergency use authorization even though they were improperly tested; valuation seems to be highly suspected, we are questioning the mandates, which are forcing people to take the vaccines."

He submitted that the mandates were unconstitutional and against scientific caution and emerging scientific evidence.

a. Natural immunity acquired from COVID infection lasts longer than vaccine immunity.

b. Serological studies show that more than 75% of the Indian population has already been infected and therefore they have better immunity to the infection.

c. It was emphasised that vaccines do not prevent from getting infected or prevent transmission of COVID-19 and are especially ineffective in preventing infection from new variants.

"This is important as there are a large number of studies that show that vaccines may help you to avoid serious illness from COVID, but it does not prevent you from getting infected or transmission because the viral load in people who are vaccinated and those who are not is similar."

d. The vaccines have serious adverse effects as have been reported in India and globally.

e. Long term effects are not known since long term trials have not been conducted.

f. Clinical trials in relation to the vaccines have not been completed and vaccines are only authorized for emergency use.

"The phase 3 trials, which are sort of large trials where you get 50,000 people - half of whom are given vaccines and half who are given placebo. There they do not know who has been given the vaccine and who has been given placebo. Normally, phase 3 takes 3 years. In this case they had barely begun the phase 3 trials and emergency use authorizations were given. Immediately they unblinded the placebo and they were told to get the vaccine. With this unblinding it became impossible to study the difference between vaccinated and the unvaccinated people."

g. In the absence of trial data informed consent cannot be obtained. Therefore, the mandates are unconstitutional as it violates the principle of informed self determination which flows from Article 21 of the Constitution.

Mr. Bhushan submitted that for imposing the mandate it had to be clearly demonstrated that by not taking the vaccine an individual is subjecting the public to greater degree of danger.

"There are two aspects to consider - the individual and subjective aspect concerning a fundamental right of the individual which needs to be balanced with the societal objective aspect concerning health as a public interest matter. For any vaccine to be mandated, the public health rationale underlying such a policy must be based essentially on efficacy and safety of vaccination and prevention of transmission of the disease. However, as detailed below, various scientific studies have now emerged that provide evidence that vaccinated people not just transmit the virus, as much as unvaccinated but also that breakthrough infections and hospitalizations are now rampant across various countries in vaccinated populations."

He stated that vaccines might prevent the severity of the illness, but not transmission and therefore it is not a public health concern but a matter of absolute indefeasible right of an individual to take such a decision.

"Yes, vaccines may prevent people from getting seriously ill, but that is a matter of individual decision. It is only I who is going to get ill. It has been held in a large number of judgments by the Constitution Bench that whether I take any medication or not to protect myself is my absolute indefeasible right. If you are healthy your chances of getting ill due to COVID is negligible."

He submitted that in the United Kingdom a vaccine mandate was introduced for healthcare workers. A doctor had questioned the same. Later the Parliamentary Standing Committee had given a report against vaccine mandates. In view of the same, the mandate was withdrawn almost three days back. It was also highlighted that even the High Court of New Zealand had also struck down vaccine mandates issued against police officials and defence service personnel.

"The adverse effects of the vaccine are not known…the long term effects are not known. A doctor had questioned the UK Minister for Health on this - Why are you mandating vaccines for healthcare workers. They have withdrawn the mandate now, just 2 days ago. He said, the vaccine prevents from becoming seriously ill. People who are healthy hardly have a chance of being seriously ill if they get COVID…The Parliamentary Standing Committee in the UK gave a strong report against vaccine mandates and they have withdrawn it. In New Zealand, three days ago, the High Court struck down the mandates issued for police and defence service personnel."

He argued that vaccine mandates cannot put a fetter on the fundamental rights of citizens, denying them the right to livelihood or access to any essential services. The High Court have held that welfare policy for vaccination cannot curb fundamental rights, especially when there exists no reasonable nexus between vaccination and prohibition of continuance of occupation and/or profession. Therefore, the present mandates are arbitrary, discriminatory and unconstitutional.

Natural immunity is enduring and outweighs vaccine immunity

Mr. Bhushan argued that the immunity that results from natural infection is far superior to the immunity acquired from the vaccines. To make good his submission, he referred to an interview of Dr Sanjay Rai, Professor at Department of Community Medicine at AIIMS, Delhi.

"16. Dr, Sanjay Rai, Professor at Department of Community Medicine at AIIMS, Delhi states in an interview that the best protection and possibly lifetime immunity only comes from Natural immunity/natural infection i.e. those who have recovered from COVID-19. He further stated that death due to Covid-19, among those who acquired Natural Immunity is nearly zero and possibility of re-infection is rare. Further that vaccines could cause harm or result in adverse effects if administered to those who have already acquired natural immunity and are also non- susceptible."

He further relied on an article in scientific journal Nature.com

"Article in scientific journal Nature.com "A long-term perspective on immunity to COVID" published in June 2021, further clarifies that studies have shown that memory plasma cells secreted antibodies specific for the spike protein encoded in SARS-Cov-2 even 11 months after the infection. The study shows that immune memory to many viruses is stable over decades, if not for a lifetime."

He stated that if infected people are vaccinated then they develop Antibody Dependent Enhancement, which can also cause serious problems.

Justice Gavai enquired, "Therefore the question would be can we go into these areas, which is predominantly an area of the experts."

Mr. Bhushan responded -

"The High Court of New Zealand in the judgment that they delivered three days ago striking down the mandates dealt with this issue that - what is the mandate of a court dealing with this issue…A court which is mandated to protect fundamental rights cannot throw up their hands."

Justice Gavai was of the opinion, "The limited enquiry that would be permissible is as to whether the policy decision taken by the concerned Govt. is based on relevant data or not. All these expert reports, should we go into the correctness of this. There would also be reports per contra."

Mr. Bhushan stated, "Neither the UoI, nor the States have given any data in their affidavits."

Justice Rao pointed out that the Union Government had mentioned that they have not mandated vaccination. He pointed out that the Union Government had mentioned that they have not mandated vaccination. He further noted that science being a matter of opinion would have some variance.

"...Science is a matter of opinion. The opinion you have might not be shared by some States…"

Mr. Bhushan clarified that he was relying on data and scientific studies and not opinions.

"The Govt is saying that in their opinion the vaccine will prevent spread of this infection without citing any evidence. On the contrary, we have cited tons of scientific evidence to show that it will hardly prevent."

He asserted that with a larger population having been infected at this point in time, such vaccine mandates are not reasonable. He referred to article to substantiate his argument.

"19. An lndian Express article dated 26th July 202l and titled "2 of 3 Indians have Covid-19 antibodies: ICMR serosurvey findings explained'' reports that two-thirds of the general population above the age of 6 years had COVlD-l9 antibodies and that more than half of the children were sero-positive.

A news report titled "Delhi: 97% people have COVID-19 antibodies, shows sero survey" in the Indian Express Times reported that,'Delhi has a seropositivity of 97 per cent for COVID-l9 antibodies, the sixth serological survey conducted in the city has revealed. Children below the age of 18 the sero-prevalence is 88%."

Vaccines do not prevent infection from Covid 19

Placing reliance on various studies, Mr. Bhushan submitted that neither vaccines prevent infection from COVID-19 nor its transmission. He cited examples of Iceland and Israel, where there were outbreaks even when almost their entire population was vaccinated.

"22. Various studies have now been published that show that the vaccines do not prevent infection or transmission of the covid 19 virus. There are many examples of outbreaks of the virus amongst fully vaccinated populations. Examples include Iceland and Israel where a high percentage of the population have been fully vaccinated, yet an increase of cases was experienced.Therefore administering the vaccine through coercion cannot be a matter of public health since the vaccines are not an effective guarantee against infection and transmission."

Even in India, Pathanamthitta, a district in Kerala, witnesses 7000 vaccinated (either one or two doses of Covaxin/Covishied) people getting severely infected by the COVID-19 virus. A study by Banaras Hindu University that some variants might have escaped the vaccine generated immune protection. Medical scientists including doctors from AIIMS have warned against indiscriminate vaccination. It might encourage mutation.

"Many medical scientists have pointed out, including Gabe… (Germany). He has been warning from the beginning that if you undertake a mass vaccination programme during a pandemic you are forcing the virus to mutate and create variants which can be more infectious and more lethal."

He submitted that a study conducted by AIIMS also claimed that the presence of the COVID-19 Delta variant was predominantly found even after the first dose of both doses of the vaccine have been administered, raising serious concerns regarding the effectiveness of these vaccines against variants.

Studies on breakthrough infections indicate that vaccinated people also transmit the virus

There is now compelling scientific evidence that the vaccines are not effective to prevent transmission especially of the new variants.

"…study compared the amount of infectious virus shed by vaccinated versus unvaccinated individuals and held that the Delta variant caused high viral loads and was highly transmissible even by fully vaccinated persons."

He added that in the Massachusetts outbreak 74% of the people were vaccinated. Another study also concluded that vaccinated people can carry as much virus as others and therefore contribute equally to the transmission of the disease. A similar result emerged in a study conducted by the University of Oxford and Public Health Department, England.

Serious adverse events are being reported in India and globally from COVID-19 vaccinations

Mr. Bhushan pointed out that various countries have either rejected or halted the use of Covaxin and AstraZeneca vaccines in their immunisation programmes. He submitted that Bharat Biotech's Covaxin was rejected by Brazil's drug regulator Anvisa because of violations of norms for good manufacturing practices. He highlighted that 16 European countries had banned the use of AstraZeneca COVID-19 vaccines over concerns of blood clotting. The risks pertaining to Moderna were also put forth.

Mr.Bhushan submitted that the adverse effects are not being tracked in India for the lack of a functional monitoring system -

"...the Indian government has not shown any seriousness in tracking adverse events and taking corrective action. The AEFI committee has admitted that the AEFI monitoring system was not functioning properly."

In the absence of trial data and therefore of informed consent, mandates are unconstitutional and violate the principle of informed self determination which flows from Article 21 of the Constitution

He contended that every individual has a fundamental right to decide which medicine or vaccine he will take or not take, if that is only to protect his health. Informed consent is the cornerstone of ethical medical practice. Mandating vaccination in absence of data, which does not allow an individual to make an informed consent is violative of principles of self-determination protected by Article 21.

"Unless factually accurate information is made available, detailing risks as well as benefits, it is not possible for anyone to make a fully informed decision and give informed consent."

Reliance was placed on the decision of the Delhi High Court in Master Hridaan Kumar Minor v. Union of India W.P.(C) 343 of 2019 ("the Measles-Rubella case,), to argue that one must have information as to contraindications before consent for getting vaccinated is obtained.

He submitted that informed consent is necessary for medical procedures and bodily integrity is an integral part of the right to privacy flowing from Article 21 as has been settled in several judgments by the Hon'ble Supreme Court including K Puttaswamy v. UOI (2017) 10 SCC 1 and Common Cause v. UOI (2018) 5 SCC1.

It was pointed out that the Apex Court had declared that an adult human being having the mental capacity to take an informed decision has the right to refuse medical treatment including withdrawal from life saving devices.

Mr. Bhushan emphasised that where filed to obtain clinical trial data, the same was refused on the ground that the companies had refused to share the same.

"Some RTIs were filed asking the Government to seek the trial data. Response was that These vaccine companies are opposing giving the data."

He referred to the draft "Charter of Patient's Rights" issued by the Ministry of Health and Family Affairs, which holds the right to informed consent as one of the patient's legal, fundamental rights, to submit -

"It is my fundamental right not to take vaccines. That right can only be eclipsed only when it can be clearly shown by evidence that by not taking the vaccine I am posing a very serious health hazard to others."

High court orders on discrimination against unvaccinated people

He particularly referred to the Gujarat High Court order dated 22nd June 2021, which stayed the dismissal of the petitioner officer shri Yogendra Kumar by :he India Air Force, seeking an explanation from the Air Force; an order dated 23rd June 2021 passed by the the Meghalaya High court stating that mandatory or forceful vaccination does not find any force in law leading to such acts being liable to be declared ultra vires ab initio. He also referred to an order dated 02.07.2021 passed by the Guahati High Court, wherein it was held that there is nothing to show that the vaccinated persons cannot be infected with the virus or that they cannot be spreaders. The court further held that if the vaccinated and unvaccinated persons can be infected by the covid virus and they can both be spreaders of the virus, the restriction placed only upon the unvaccinated persons, debarring them from earning their livelihood or leaving their houses to obtain essential items is unjustified, grossly unreasonable and arbitrary.

To substantiate his argument that in the absence of data no mandates can be issued, he submitted that the UK Parliamentary committee report dated 09.09.2021 stated that the COVID passport policy lacks scientific evidence and must be done away with. Based on this report the government decided not to issue any vaccine mandates.

He placed reliance on the recent judgment of the High Court of New Zealand, Yardley v. Minister for Workplace Relations and Safety [2022] NZHC 291 where mandates were struck down for lack of adequate evidence to justify such measures by the Crown.

"[97] I am not satisfied that the Crown has put forward sufficient evidence to justify the measures that have been imposed, even giving it some benefit of the doubt. The apparently low numbers of personnel the Order actually addresses, the lack of any evidence that they are materially lower than would have been the case had the internal policies been allowed to operate, and the evidence suggesting that the Omicron variant in particular breaks through any vaccination barrier means that I am not satisfied that there is a real threat to the continuity of these essential services that the Order materially addresses. If there is a threat to these services it will arise precisely because vaccination and other measures are not able to prevent the risk that Omicron will sweep through workforces."

He submitted that in the case at hand, copious data had been provided to make good the submissions raised by the petitioner.

"...In our case we have submitted enormous amount of evidence for the proposition that I have mentioned - vaccines do not prevent you from getting infection. Government has not provided any data or study to the contrary. We have provided copious data from the Govt. sources."

It was pointed out that in the affidavits filed by the Union Government and the State Governments the issues raised by the petitioner had not been addressed.

Non disclosure of data

Mr. Bhushan submitted that the disclosure of segregated data of vaccine clinical trials (segregated for each vaccine and for each age group) that have been undertaken with respect to the two vaccines being administered in India, cannot be undermined and must be disclosed through peer reviewed scientific journals. The disclosure of such information is essential to ascertain whether a certain section of the population is more susceptible to adverse effects, to determine what are the adverse effects in various age groups and on differing populations, etc.

"Whenever trials are done it is done in at least 4 different geographic regions of the country. For COVID vaccine there is a huge difference of impact depending on age, comorbidity etc. Younger people who are healthy are hardly affected by COVID."

He argued that in the past drug manufacturers have concealed, even lied about trial data and therefore the availability of the same in public domain, to be tested by independent researchers, are all the more important.

"Historically there have been many cases of drug manufacturers being caught hiding or manipulating data and concealing side effects or overstating efficacy after the data was examined by independent researchers/scientists. Many drug manufacturers including many who are now involved in the manufacture of Covid vaccine, have been held guilty for manipulating data in the past and have had to pay billions of dollars as fines."

Relying on the Nuremberg Code for medical ethics in human medical research, Mr. Bhushan submitted that -

"every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. Researchers have a duty to make publicly available the results of their research. Negative and inconclusive as well as positive results must be published or otherwise made publicly available.

He argued that in the context of pharmaceutical safety data, the Central Information Commission had mandated the disclosure of clinical study reports of observational studies relating to HPV vaccines after redacting some information like name of patients etc. In the present case, he highlighted, that the minutes of the National Technical Advisory Group on Immunisations (NTAGI),which is the primary advisory committee advising the Ministry of Health and Family welfare on all immunization-related issues, do not specify which member raised an objection nor the evidence quoted by the member to support his contention. This, he stated, raises serious concerns regarding potential conflicts of interest and that cloak of secrecy cannot then be used to cloak conflicts of interests. Referring to a report in National Herald he submitted -

"The Subject Expert Committee (SEC) meeting minutes do little to inspire confidence in the process. A perusal of the minutes of the SEC meetings show that the SEC changed its mind about Bharat Biotech's Covaxin within a span of two days. The Govt. does not disclose the names and institutional relationships of the experts present during each SEC meeting for COVID-19 vaccines. The SEC reviewed the proposals and sent recommendations to the Govt's Central Drug Standard Control Organisation (CDSCO), which decided their approval. The opacity makes it impossible to evaluate potential conflicts of interest."

Mr. Bhushan emhasised that in the context of drug regulation in our country, the need for greater transparency has been noted by the Parliamentary Standing Committee on Health and FamilyWelfare, in its 59th Report (2012) and 66th Report (2013).

He expressed his concern -

"Where is the question of informed consent here. Yet people are being told to take the vaccine…The information provided for Covishield is based on the studies done by AstraZeneca overseas. It only had 1600 participants.

Suppose a vaccine's side effect is myocarditis. If it happens one in 100,000 cases. If you conduct trials in hundreds, you will not get it. That is why 50,000 people are required so that the smallest side effects are picked out."

Referring to the RTI application and the response received in this regards, he submitted -

"An RTI application with the Ministry of Health and Family welfare sought "raw data that sII and Bharat Biotech had to make available to the committee approving COVID-19 vaccines. RTI asked whether the "committee looked at the raw data and/or discuss it?". It also sought data provided by SII and Bharat Biotech related to teratogenicity, genotoxicity, carcinogenicity, fertility and death.

In their reply dated 03.09.2021, the Central Drugs Control Standard Organization stated that the brief of interim clinical trial results/information containing safety, immunogenicity and efficacy results along with side- effects contraindications precautions and instructions for use of Covishield, Covaxin COVID-l9 vaccines are available in Summary of Product Characteristics & factsheet which along with recommendations of Subject Expert Committee are publicly available on CDSCO website."

Thereafter, when the First Appellate Authority was approached they refused to reveal any data stating that the companies (Serum Institute and Bharat Biotech) have refused to disclose data publicly.

Till date there have been many adverse impacts and severe side effects including deaths post vaccination both in India and abroad

He referred to an article in The Hindu, to show that a group of experts had written to the Health Minister and the Drug Controller General of India, appealing for a time bound and transparent investigation following deaths and serious adverse effects after COVID-19 vaccination. It was highlighted that the Adverse Events Following Immunization (AEFI) reporting system in India is an opaque system with serious flaws. First of the concern being the lack of awareness regarding the existence of the system itself.

Children's Vaccine Mandate

On the issue of vaccine mandates for children he submitted that apart from there being no data, the decision to vaccinate children was also taken in haste.

"On 24th Dec, 2021 they said there is no requirement for vaccinating children. In three days there was a complete u-turn and guidelines were published."

He provided scientific studies to show that the overall risk from COVOID-19 for children was very low -

"An article in http://Nature.com (which is one of the highest rated scientific journals) titled "Deaths from COVID incredibly rare among children" states that studies find that the overall risk of death or severe disease from COVID-19 is very low in kids. This 'low' means less than 1 in 100,000."

He referred to other reports and studies to demonstrate children remain at low risk of COVID-19 mortality.

He submitted -

"On 30.12.2021, the ICMR chief, Dr. Barram Bhargava stated in an interview that COVID vaccines do not prevent infection and are primarily disease modifying."

He argued that there was no rationale for vaccinating a vulnerable group such as children with a vaccine that will not prevent them from getting the disease and transmitting it to others.

He further emphasised on the adverse effects of the vaccine on children -

"The trial sizes for children vaccines in India are too small (525: Covaxin, 1000: ZyCov-D). Such low trial sizes cannot capture anything but the most obvious risks…The data and scientific studies in countries where children were given COVlD vaccines show that the vaccines have serious and significant adverse effects on them, which outweighs the adverse effects due to the COVID infection."

On the issue of legal consent, it was asserted that parents who are to provide consent on behalf of children are themselves not made aware of its adverse effects.

"Children are not capable of legal consent to the vaccines and the parents who give consent on their behalf are incapable of giving informed consent in the absence of studies and data about the benefits and adverse effects of the vaccines on children."

Referring to studies he submitted -

"Studies are piling up which show that -

a) those who have recovered from COVID (more than 2/3 population) have more robust and durable immunity than the vaccinated;

b) that the vaccination does not significantly reduce susceptibility to re-infection especially with the new variants nor does it significantly reduce the ability to transmit the virus;

c) healthy children are almost at no risk of serious disease from COVID and administering experimental vaccines to children, about which no medium or long term side effects are known is unethical and irresponsible."

He submitted that the intent of the petitioner is to not question the decision of the domain experts, but to ensure that the decision of the experts be carried out rigorously and faithfully.

In view of the above submissions, he beseeched the Court to step in and exercise its powers of judicial review of executive policy which is manifestly arbitrary and irrational and to set aside any vaccine mandates that have been brought in by the government/private bodies.

Additional Solicitor General, Ms. Aishwarya Bhati appearing for the Union Government submitted that having achieved 96.8% vaccine coverage, the whole challenge pales in significance.

Justice Rao stated that the petition was not challenging vaccination but mandates. He asked Ms. Bhati to make submissions countering the issues raised in the petition the next day.

"He (Mr. Bhushan) said 10 times that he is not challenging vaccination. He is challenging mandatory vaccination."

Ms. Bhati submitted that some time be given as the contentions raised in the written submission are beyond the issues raised in the Writ Petition.

"If this can be taken next Tuesday. Our affidavit was filed in Nov. The aspect of children's vaccines, where a high claim is being made, it was not in the writ. I will have to take instructions on this."

Moreover, she stated the evidence pertaining to the vaccine mandates for children is based on mRNA vaccine, whereas the vaccine given to Children in India was inactivated virus vaccines.

"They have provided evidence for mRNA vaccine, but we are only giving Covaxin to children. It is an inactivated virus vaccine not mRNA vaccine."

The Matter is to be next listed on 8th March, 2022.

[Case Title: Jacob Puliyel vs Union of India]



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