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Vaccines Can't Be Mandated Without Evidence That Unvaccinated Persons Pose Health Risk - Prashant Bhushan Argues in Supreme Court
Vaccines Can't 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,
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.
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A Bench comprising Justices L. Nageswara Rao and B.R. Gavai had agreed to hear the
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
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Per Constituency
"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
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.
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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.
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
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
"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
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,
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
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
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,
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
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
"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
g. In the absence of trial data informed consent cannot be obtained. Therefore, the
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
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
"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
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
"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
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
to the immunity acquired from the vaccines. To make good his submission, he referred to
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
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
He stated that if infected people are vaccinated then they develop Antibody Dependent
Justice Gavai enquired, "Therefore the question would be can we go into these areas,
"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
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
"...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
He asserted that with a larger population having been infected at this point in time, such
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.
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
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
virus. A study by Banaras Hindu University that some variants might have escaped the
vaccine generated immune protection. Medical scientists including doctors from AIIMS
"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
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
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
unvaccinated individuals and held that the Delta variant caused high viral loads and was
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
that Bharat Biotech's Covaxin was rejected by Brazil's drug regulator Anvisa because of
countries had banned the use of AstraZeneca COVID-19 vaccines over concerns of blood
Mr.Bhushan submitted that the adverse effects are not being tracked in India for the lack
"...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
In the absence of trial data and therefore of informed consent, mandates are
unconstitutional and violate the principle of informed self determination which flows
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
which does not allow an individual to make an informed consent is violative of principles
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
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
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
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,
"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
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
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
"...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.
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
susceptible to adverse effects, to determine what are the adverse effects in various age
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
"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.
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
He argued that in the context of pharmaceutical safety data, the Central Information
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
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
"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
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
Health and FamilyWelfare, in its 59th Report (2012) and 66th Report (2013).
"Where is the question of informed consent here. Yet people are being told to take the
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
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,
In their reply dated 03.09.2021, the Central Drugs Control Standard Organization stated
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
Till date there have been many adverse impacts and severe side effects including
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
"On 24th Dec, 2021 they said there is no requirement for vaccinating children. In three
He provided scientific studies to show that the overall risk from COVOID-19 for children
"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
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
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.
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
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."
a) those who have recovered from COVID (more than 2/3 population) have more robust
and durable immunity than the vaccinated;
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
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
"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
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