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'Out Of 180 Crore Doses, Only 0.004% Adverse Effects' : Centre Tells Supreme Court In Plea For Vaccine Trial Data

Sohini Chowdhury
15 March 2022 4:26 PM GMT
Out Of 180 Crore Doses, Only 0.004% Adverse Effects : Centre Tells Supreme Court In Plea For Vaccine Trial Data
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On Tuesday, the Supreme Court continued hearing the submissions in the plea seeking the Court's directions to the Central Government to publicize the data relating to clinical trials and post vaccine efficacy of the COVID vaccines, in consonance with the requirement of the International medical norms. The Petitioner, Dr. Jacob Puliyel, a former member of the National Technical Advisory...

On Tuesday, the Supreme Court continued hearing the submissions in the plea seeking the Court's directions to the Central Government to publicize the data relating to clinical trials and post vaccine efficacy of the COVID vaccines, in consonance with the requirement of the International medical norms. The Petitioner, Dr. Jacob Puliyel, a former member of the National Technical Advisory Group of Immunization, also assailed the functioning of the Adverse Events Following Immunization (AEFI) reporting system, which, he claimed, lacked transparency.

The petitioner had further challenged the 'coercive' mandates issued by States, particularly, Delhi, Madhya Pradesh, Maharashtra and Tamil Nadu and the 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.

On the last occasion, Advocate, Mr. Prashant Bhushan had argued that without disclosing any data on clinical trials and post vaccination efficacy of the vaccines, some States had imposed vaccine mandates which are not proportionate to personal liberty. He had also argued that in absence of trial data informed consent of the people cannot be obtained, which is a violation of the principle of self determination elucidated in Article 21 of the Constitution.

Appearing before a Bench comprising Justices L. Nageswara Rao and B.R. Gavai, the Solicitor General of India, Mr. Tushar Mehta questioned the bona fides of the petitioner. He expressed his concern that any interference by the Apex Court at this stage would create vaccine hesitancy amongst the people of the country. Mr. Mehta controverted the petitioner's argument qua lack of transparency in the approval process of the vaccines as well as in the functioning of the reporting of adverse effects.

At the outset he put forth some broad principles to assist the Bench as to why it would not be appropriate to entertain the petition. He submitted that the scope of judicial review ought to be modulated considering the magnitude of the crisis. It was asserted that the present case was not such wherein the petitioner is asserting their rights. Moreover, he argued that wisdom of the domain expert ought not to be substituted by that of the Court. Mr. Mehta submitted that a procedure for granting approval was already in place and was followed while seeking approval for the two vaccines being administered in India.

"There are some broad propositions which might guide your lordships' discretion in entertaining a 32 petition or not.

  1. The first consideration would be the magnitude of the problem which not only the nation but the entire human kind faced…It is not just India but the world community is responding to this unprecedented situation.
  2. Second, your lordships will examine that this is not a petition filed by an individual saying my personal right is being affected…It is in the nature of PIL where petitioner says the petitioner says I have no personal rights. There is a PIL which states that others be not vaccinated because I have not satisfied myself about the data.
  3. Third, some articles were shown. They have not assisted with the law by which the process of vaccination is covered. There are layers in the process where domain experts apply their mind periodically repeatedly and thereafter take a particular call. That might be a ground to not substitute the views of the experts.
  4. Next point can be the procedure which the Central Govt. has followed.
  5. As on date, the stand taken by the Central Government is that vaccines are voluntary. There are some States joined as parties who have mandated it. I would also assist your lordships that even a mandate would be a legal mandate and would pass the muster of constitutional validity. Ultimately, it has to balance competing fundamental rights."

He apprised the Bench that till 13.03.2022, 1,80,13,23,547 doses of vaccines have been administered.

"What is the factual situation on ground?…We have data to show it is safe, effective and immunogenic. As per the last available figure, as on 13.03.2022, total 180,13,23,547 doses have been administered."

He further stated that till 13.03.2022, there were 77314 people who have been adversely affected. The degree of adversity was categorised as minor; severe and serious. Minor cases are those where no medical intervention was required, severe are those cases where medical intervention is required and the serious cases involve the possibility of death. He also pointed out that the data pertaining to the adverse effects were contemporaneously placed in the public domain.

"Adverse events - 77314 i.e. 0.004% adverse impact observed. This adverse event includes minor, serious and severe events…Minor means it is self limiting; no medical intervention is required…Severe needs medication intervention. Serious cases are where there is possibility of death being caused. These are minuscule in number; where vaccines may or may not be the cause of death. Hospitalisation is counted as a serious case. Out of 180 crore doses administered only 0.004% adverse effects are found. These figures are periodically uploaded on the website. There is a system of reporting in place."

Mr. Mehta stated that at the stage at which the matter has come up for hearing, both the vaccines administered in India have received approval from the World Health Organisation.

"Your lordships are examining the safety, efficacy and immunogenicity at a stage where both vaccines administered in India…has got approval from the World body i.e. WHO. It is not only Indian experts but globally these vaccines are accepted."

It was submitted that, when the domain experts have already looked into the safety, efficacy, immunogenicity, pharmacodynamics and taken a view, it does not merit judicial interference.

"The scope of the petition is - questions regarding vaccination policy and particular vaccine safety; efficacy and immunogenicity, pharmacodynamics etc. are examined by domain experts. This Hon'ble Court, may not therefore, accept the prayer of the petitioner to exercise judicial review in medical aspects already considered by domain experts."

Mr. Mehta contended that given the magnitude of the crisis the scope of the judicial security in the issue raised in the petition ought to be limited.

"India has officially lost 5 lakh lives…This demands the scope of judicial review be modulated because we were undisputedly dealing with an unprecedented crisis known to humankind. One of the prime concerns of the world and India is to increase the vaccination reach to every individual in the country. Any indulgence by this Hon'ble Court may inevitably result in vaccine hesitancy."

Questioning the intent behind filing a petition that, he believed, had the potential to harm the public at large, Mr. Mehta submitted -

"A result of purported public interest litigation cannot be harm to public interest. The petitioner wants to impose his personal view on the rest of the country. Such a petition cannot have any public interest."

Vaccine Approval Process protocols were followed

He traced the source of power of the Central Government to take administrative decisions pertaining to the vaccines.

"The power of the Central Government flows from provisions of the Epidemic Disease Act, Disaster Management Act, Drugs and Cosmetics Act and the Rules framed thereunder. The provisions of the Drugs and Cosmetics Act and the New Drugs and Clinical Trials Rules 2019 gives broad framework for grant of approval of any new vaccine, which is the term included within the meaning of New Drug as defined under Rule 2(w)(v) of the said rules."

He took the Bench's attention to the different phases for the grant of approval of vaccines. He highlighted that the first stage of trial would be chemical trial, followed by animal trial and then human trial.

"The following are broad stages of vaccine development under the law culminating in the grant of approval of a vaccine. These phrases are very broad and in cases of unprecedented situations…these stages can be suitably modified. The first stage is the chemical testing - whether the vaccine contains the same pharmacological composition that it claims to contain in laboratory chemical tests. Somebody develops a vaccine, he comes before the drug controlling authority with an application that grant me approval for production for clinical trials. First stage would be chemical trial; then animal testing, then human clinical trial. Phase I is safety and tolerability. Trial of different doses. They test on voluntary subjects. Then a decision is taken not by manufacturers but experts that this is a dose that is tolerable to humans. The second is immune response. Whether it is capable of generating antibodies in the blood. Once this ends, Phase II is to decide the dose per individual. Then immune response, then safety…Phase III to confirm findings of Phase I and II and to generate safety and efficacy data on a substantially large number of subjects."

He stressed on the safeguards that are statutorily provided to ensure that the trial is conducted without any impediment and in a transparent manner. A neutral investigator and an Ethics Committee has been mandated to be present at all the trial sites to ensure that best practices are followed.

"Your lordships were told that this happens in an opaque manner and the manufacturer does it. Wherever these trials are going on are called sites…There is statutory provision providing for two safeguards where trials are going.

  1. Appointing neutral investigator.
  2. Then there is a provision for an ethics committee.

It is mandatory to have such a committee at all sites. They examine that the system under good clinical practice guidelines is followed during testing. Statutory authorities can conduct surprise investigations; records can be called for. What was projected before your lordships was that this is conducted in an opaque manner and the manufacturer does it."

He added -

"Statutory mechanisms are in place and have been adequately applied. The decisions of the committee have been contemporaneously uploaded on the website of the Ministry for Health."

Mr. Mehta referred to the relevant provisions of the New Drugs and Clinical Trial Rules, 2019. Rule 2(d) "adverse event"; Rule 2(k) - "clinical trial protocol"; Rule 2(l) - "clinical trial site"; Rule 2(o) - "Ethics Committee"; Rule 2(p) - "Good Clinical Practices Guidelines"; Rule 2(w) - "new drug" which includes vaccine ; Rule 2(bb) "placebo" ; Rule 2(ff) "serious adverse event"; Rule 3 Central Licensing Authority; Rule 6 Requirement of the Ethics Committee; Rule 7 Constitution of Ethics Committee for clinical trial; Rule 11 Functions of Ethics Committee; Rules 12 Proceedings of Ethics Committee for clinical trial; Rule 13 Maintenance of records by Ethics Committee for clinical trial; Rule 19 Clinical trial of new drug or investigational new drug; Rule 20 Oversight of clinical trial site; Rules 25 Conditions of permission for conduct of clinical trial; Rule 29 Inspection of premises relating to clinical trial; Rule 30 Suspension or cancellation of permission to conduct clinical trial, First Schedule - General Principles And Practices for Clinical Trial; Second Schedule - Requirements And Guidelines For Permission To Import Or Manufacture oF New Drug For Sale or to Undertake Clinical Trial; Third Schedule - Conduct of Clinical Trial.

The most relevant provision in the present context which was highlighted by Mr. Mehta is as under -

"(2) Special situations for a new drug where relaxation, abbreviations, omissions or deferment of date may be considered. – (i) Depending on categories and nature of new drugs to be imported or manufactured for sale or clinical trial to be undertaken (viz. New Chemical Entity, biological products, similar biologics, approved new drug or new dosage form or new indication or new route of administration or new strength of already approved drugs, etc.,) requirements of chemical and pharmaceutical information, animal pharmacology and toxicology data, clinical data may differ. The requirements may also differ depending on the specific phase of clinical trial proposed to be conducted as well as clinical parameters related to the specific study drug.

(ii) For drugs intended to be used in life threatening or serious disease conditions or rare diseases and for drugs intended to be used in the diseases of special relevance to Indian scenario or unmet medical need in India, disaster or special defence use e.g. haemostatic and quick wound healing, enhancing oxygen carrying capacity, radiation safety, drugs for combating chemical, nuclear, biological infliction etc., following mechanism may be followed to expedite the development of new drug and approval process.

(A) Accelerated Approval Process: Accelerated approval process may be allowed to a new drug for a disease or condition, taking into account its severity, rarity, or prevalence and the availability or lack of alternative treatments, provided that there is a prima facie case of the product being of meaningful therapeutic benefit over the existing treatment.

a) In such case, the approval of the new drug may be based on data generated in clinical trial where surrogate endpoint shall be considered rather than using standard outcome measures such as survival or disease progression, which are reasonably likely to predict clinical benefit, or a clinical endpoint. These should be measurable earlier than irreversible morbidity or mortality (IMM) and reasonably likely to predict clinical benefit.

(b) After granting accelerated approval for such drug, the post marketing trials shall be required to validate the anticipated clinical benefit.

(c) Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious or life-threatening condition or disease of special relevance to the country, and addresses unmet medical needs. This provision is intended to facilitate and expedite review of drugs so that an approved product can reach the therapeutic armamentarium expeditiously."

Mr. Mehta submitted that the domain experts have applied their mind to each and every stage which culminated into the grant of approval of the vaccines. And he urged that the same should be kept in mind while determining the scope of judicial scrutiny.

"At every stage of the statutory scheme there is statutory intervention by subject experts. That would be a factor that would assist your lordships in deciding the extent of judicial review which your lordships would exercise."

He apprised the Bench about the approval process of Covaxin. It was pointed out that Bharat Biotech International Ltd., who have valuable experience in vaccine manufacturing had sought permission for manufacturing of Covaxin on 23.04.2020 and received the approval for restricted use in emergency situations in critical trial mode with several conditions only on 03.01.2021.

"See the Covaxin approval process. So long as Covaxin in concerned, the manufacturing company M/s. Bharat Biotech International Ltd. applied for manufacture of whole virion inactivated Coronavirus vaccine for test, examination and analysis on 23.04.2020. Developing vaccines is a specialised field. Bharat Biotech had been in vaccine manufacturing since 1996. Therefore had necessary RnD infrastructure in existence. Coronavirus had entered India prior to April, 2020 and the first case in India was detected on 27.01.2020. The first case surfaced throughout the world at the same time, resultantly all scientists and vaccine manufacturers of developed and developing countries of the world started their attempt to develop vaccines as it was reasonably clear that the said virus would cause an unprecedented and unmet medical need in India and globally where its prevalence and severity will also be never seen before. In the world, respective governments have assisted the effort of vaccine manufacturers looking at the unprecedented human crisis. On 23rd April subsequently several meetings of subject experts of the Govt. of India took place to monitor the various stages and issues regarding the vaccine and stages of trial. After 9 months of detailed deliberations, by the said SEC on 03.01.2021. There is a provision for a special approval called accelerated approval process under the Rules.

He refuted the petitioner's argument that the approval was granted hastily within a span of two days.

"Your lordships would recall that their submission was that the approval was given in two days…The facts are the application was on 23rd April. I will substantiate that with documents.

He also contended that the submission of the petitioner pertaining to lack of transparency in the process of grant of approval. On the contrary, he submitted that the SEC met and held discussions with the manufacturer. Amendments were suggested from time to time and after several rounds of deliberation and discussion the approval was granted.

"I have placed the resolutions on record, which was available on the website of Family Welfare contemporaneously. So, the argument that the process was opaque was wrong. The committee has met, the manufacturer remains present, discussions take place; directions are issues; amendments are made; and ultimately resolutions are passed which are placed in the public domain. The SSE, a statutory body constituted in terms of Rule 100, which oversaw the approval process, consists of experts…After approval by the SEC to commence trials various phases of trials were conducted under the supervision of various ethics committees at sites and were evaluated, analysed and considered by SSE in its various meetings, where developer, manufacturers are required to be present with details. The process was fully transparent. All the resolutions were put up on the official website of the Ministry at each and every stage."

He provided a brief timeline for convenience -

"23rd April, 2020 - Bharat Biotech submitted an application to manufacture for test, examination and analysis. CBSCO granted permission to manufacture whole virion inactivated coronavirus vaccine. Bharat Biotech filed an application for clinical trial purpose.

03.01.2021 - CBSCO (Central Drugs Standard Control Organization) granted permission to manufacture for restricted use in emergency situations in critical trial mode with several conditions.

27.01.2022- After one year of emergency use permission. Final approval is given."

He referred to several meetings of the SEC inducing the ones conducted on 25.06.2020, 09.07.2022, 01.09.2020, 03.09.2020, 05.10.2020 to demonstrate that there was ample oversight, discussion, deliberation, and analysis by domain experts. Mr. Mehta also pointed out that the Committee expedited hearings because it was the need of the hour. Moreover, the consideration that the petitioner had alleged to have taken place in two days, he argued, actually took place over a span of more than six months, from April, 2020 to January, 2021.

He also submitted that -

"In view of the emergent need globally faced and in view of the domain experts being satisfied about the safety, efficacy and immunogenicity of Covaxin, it was rolled out by the prioritization globally fixed by WHO. This started from 01.03.2021 at a stage when the data was available."

He submitted that the approval for Covishield was also granted in a similar manner. However, Covishield trials started from Phase II as they had conducted trials abroad and had the requisite certificates for the same.

"Covishield started with Phase II as Phase I was already conducted. It is a foreign vaccine. They wanted manufacturing permission. Chemical test etc. they already had the certificate.They applied for manufacture for trial on 03.05.2020. After a similar procedure restricted emergency use permission was granted on 03.01.2021. Final Approval on 27.01.2022. Regular approval not emergency use approval"

Robust mechanism for addressing adverse effects from immunization

With respect to the issue of reporting adverse effects of immunization, Mr. Mehta asserted that there was a separate committee that was looking into the issue and a robust mechanism was in place to keep a check on the adverse effects of vaccination.

"The National Adverse Event Following Immunization Committee. This is the separate committee of the Central Government and there was no issue with safety concerns of vaccines. I'll point out two other processes...I am trying to point out that there is a robust mechanism. AEFI Committee is there. They are not only on paper…they provide technical guidance on policy."

Mr. Mehta submitted that the National Adverse Event Following Immunization Committee (NAEFIC) provides guidance on policy and implementation to the national AEFI surveillance programme, which demonstrates the country‟s intent of delivering quality immunization services with safe vaccines and ensure vaccine confidence. NAEFIC also updates, reviews AEFI programme guidelines and train officials. They also review reports of causality assessment. The causality assessment finds out whether vaccination is the cause of the event or not.

He highlighted that there is a national causality sub-committee, which has 18 domain experts from various fields and various hospitals. He pointed out that the experts are not Government officers and therefore the causality assessment process is in neutral hands. It was also emphasised that the Central Government had adopted the WHO checklist meant for its Causality Assessment System.

Disclosure of segregated clinical trial data against confidentiality provision

Addressing the issue of disclosure of segregated clinical trial data, Mr. Mehta submitted that by the very nature of the subject matter a confidentiality attached to certain parts of the clinical trial process which cannot be compromised under the law.

"Under the Rules itself an undertaking is given that neither the name nor the medical report and data will be parted with. These are confidentiality provisions. Principles of privacy and confidentiality where identity and records of the human subjects are as far as possible kept confidential. Ought not to be disclosed without any valid, scientific and legal reasons…"

He added that 'legal reasons' would include cases were a suit is filed and the Court is satisfied that the research data is to be looked at; but would not include cases like the present one, which Mr. Mehta argued to satisfy the curiosity of the petitioner.

Mr. Mehta argued that the Helsinki Declaration and the WHO statement relied upon by the petitioner to seek raw clinical trial data only refers to the obligation to disclose final results, findings and outcomes which have already been disclosed.

"The petitioner refers to the Helsinki Declaration and the WHO to support his contention for seeking raw or segregated trial data. This is misleading submissions, as both the Helsinki Declaration as well as WHO statement clearly referred to only obligation relating to disclosure of the results, findings and outcomes of clinical trials which have already been disclosed. They have not submitted any document to show any legal obligation to provide raw data."

He further submitted that the entire drug development process relies on volunteers and if their the is disclosed in the matter the petitioner seeks, it will create hesitancy amongst the future volunteers.

Public Interest Litigation not for gratifying curiosity

Mr. Mehta asserted that the present petition has been filed to satisfy the petitioner's curiosity which is not permissible. To substantiate his submission, he relied on Ashok Kumar Pandey v. State of West Bengal (2004) 3 SCC 349. The relevant portion is extracted hereinunder -

"It is necessary to take note of the meaning of expression 'public interest litigation'. In Strouds Judicial Dictionary, Volume 4 (IV Edition), 'Public Interest' is defined thus:

"Public Interest (1) a matter of public or general interest does not mean that which is interesting as gratifying curiosity or a love of information or amusement but that in which a class of the community have a pecuniary interest, or some interest by which their legal rights or liabilities are affected."

In Black's Law Dictionary (Sixth Edition), "public interest" is defined as follows :

"Public Interest something in which the public, or some interest by which their legal rights or liabilities are affected. It does not mean anything the particular localities, which may be affected by the matters in question. Interest shared by national government...."

[...]

It is depressing to note that on account of such trumpery proceedings initiated before the Courts, innumerable days are wasted, which time otherwise could have been spent for the disposal of cases of the genuine litigants. Though we spare no efforts in fostering and developing the laudable concept of PIL and extending our long arm of sympathy to the poor, the ignorant, the oppressed and the needy whose fundamental rights are infringed and violated and whose grievance go unnoticed, un-represented and unheard; yet we cannot avoid but express our opinion that while genuine litigants with legitimate grievances relating to civil matters involving properties worth hundreds of millions of rupees and criminal cases in which persons sentenced to death facing gallows under untold agony and persons sentenced to life imprisonment and kept in incarceration for long years, persons suffering from undue delay in service matters - government or private, persons awaiting the disposal of cases wherein huge amounts of public revenue or unauthorized collection of tax amounts are locked up, detenu expecting their release from the detention orders etc. etc. are all standing in a long serpentine queue for years with the fond hope of getting into the Courts and having their grievances redressed, the busy bodies, meddlesome interlopers, wayfarers or officious interveners having absolutely no public interest except for personal gain or private profit either of themselves or as a proxy of others or for any other extraneous motivation or for glare of publicity break the queue muffing their faces by wearing the mask of public interest litigation and get into the Courts by filing vexatious and frivolous petitions and thus criminally waste the valuable time of the Courts and as a result of which the queue standing outside the doors of the court never moves, which piquant situation creates frustration in the minds of the genuine litigants and resultantly they lose faith in the administration of our judicial system.

[...]

Courts must do justice by promotion of good faith, and prevent law from crafty invasions. Courts must maintain the social balance by interfering where necessary for the sake of justice and refuse to interfere where it is against the social interest and public good. (See State of Maharashtra vs. Prabhu, (1994 (2) SCC 481), and Andhra Pradesh State Financial Corporation vs. M/s GAR Re-Rolling Mills and Anr., (AIR 1994 SC 2151). No litigant has a right to unlimited drought on the Court time and public money in order to get his affairs settled in the manner as he wishes. Easy access to justice should not be misused as a licence to file misconceived and frivolous petitions. (See Dr. B.K. Subbarao vs. Mr. K. Parasaran, (1996) 7 JT 265). Today people rush to Courts to file cases in profusion under this attractive name of public interest. They must inspire confidence in Courts and among the public.

As noted supra, a time has come to weed out the petitions, which though titled as public interest litigations are in essence something else. It is shocking to note that Courts are flooded with large number of so called public interest litigations where even a minuscule percentage can legitimately be called as public interest litigations. Though the parameters of public interest litigation have been indicated by this Court in large number of cases, yet unmindful of the real intentions and objectives, Courts are entertaining such petitions and wasting valuable judicial time which, as noted above, could be otherwise utilized for disposal of genuine cases.

[...]

Public interest litigation is a weapon which has to be used with great care and circumspection and the judiciary has to be extremely careful to see that behind the beautiful veil of public interest an ugly private malice, vested interest and/or publicity seeking is not lurking. It is to be used as an effective weapon in the armory of law for delivering social justice to the citizens. The attractive brand name of public interest litigation should not be used for suspicious products of mischief. It should be aimed at redressal of genuine public wrong or public injury and not publicity oriented or founded on personal vendetta. As indicated above, Court must be careful to see that a body of persons or member of public, who approaches the court is acting bona fide and not for personal gain or private motive or political motivation or other oblique consideration. The Court must not allow its process to be abused for oblique considerations. Some persons with vested interest indulge in the pastime of meddling with judicial process either by force of habit or from improper motives. Often they are actuated by a desire to win notoriety or cheap popularity. The petitions of such busy bodies deserve to be thrown out by rejection at the threshold, and in appropriate cases with exemplary costs.

[...]

The Court has to be satisfied about (a) the credentials of the applicant; (b) the prima facie correctness or nature of information given by him; (c) the information being not vague and indefinite. The information should show gravity and seriousness involved. Court has to strike balance between two conflicting interests; (i) nobody should be allowed to indulge in wild and reckless allegations besmirching the character of others; and (ii) avoidance of public mischief and to avoid mischievous petitions seeking to assail, for oblique motives, justifiable executive actions. In such case, however, the Court cannot afford to be liberal. It has to be extremely careful to see that under the guise of redressing a public grievance, it does not encroach upon the sphere reserved by the Constitution to the Executive and the Legislature. The Court has to act ruthlessly while dealing with imposters and busy bodies or meddlesome interlopers impersonating as public-spirited holy men. They masquerade as crusaders of justice. They pretend to act in the name of Pro Bono Publico, though they have no interest of the public or even of their own to protect."

Mr. Mehta submitted that at present the stand of the Central Government is that vaccination is voluntary, but it is always open for executive to make it mandatory.

"God forbid, we might require to make it mandatory in future."

Justice Rao stated that the doctrine of proportionality would apply to coercive and mandatory vaccination.

In case of pediatric vaccination trial is conducted on adults

He refuted the submissions in this regard. Mr Mehta submitted -

"Kindly note the bona fides of the petitioner who claims to be an expert. He says that you have conducted trials on a few children. Worldover the system is that in case of pediatric vaccination the trial is always conducted on adults, and a minimum number of children are subject to trial."

Moreover, he 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. It was pointed out that for pediatric vaccines there is a statutory regime in place. The decisions, he argued, are in consonance with the global scientific consensus. Other countries of the world started vaccinating children almost 4 months before India. Bharat Biotech had applied for restricted use permission for pediatric vaccination on 01.02.2021, which after deliberation was granted on 24.12.2021. Thereafter actual vaccination started only in February, 2022 in a phased manner.

Scope of power of Central Government to take measures during a pandemic

Mr. Mehta referred to statutory provisions to demonstrate the wide ambit of power entrusted upon the Central Government to take measures during a pandemic.

The Epidemic Diseases Act, 1897

"Section 2. Power to take special measures and prescribe regulations as to dangerous epidemic disease.—(1) When at any time the State Government is satisfied that the State or any part thereof is visited by, or threatened with, an outbreak of any dangerous epidemic disease, the 8[State Government, if it thinks that the ordinary provisions of the law for the time being in force are insufficient for the purpose, may take, or require or empower any person to take, such measures and, by public notice, prescribe such temporary regulations to be observed by the public or by any person or class of persons as it shall deem necessary to prevent the outbreak of such disease or the spread thereof, and may determine in what manner and by whom any expenses incurred (including compensation if any) shall be defrayed.

Disaster Management Act, 2005

"Section 2(d) "disaster" means a catastrophe, mishap, calamity or grave occurrence in any area, arising from natural or man made causes, or by accident or negligence which results in substantial loss of life or human suffering or damage to, and destruction of, property, or damage to, or degradation of, environment, and is of such a nature or magnitude as to be beyond the coping capacity of the community of the affected area;"

Section 2(e) "disaster management" means a continuous and integrated process of planning, organising, coordinating and implementing measures which are necessary or expedient for—

(i) prevention of danger or threat of any disaster;

(ii) mitigation or reduction of risk of any disaster or its severity or consequences;

(iii) capacity-building;

(iv) preparedness to deal with any disaster;

(v) prompt response to any threatening disaster situation or disaster;

(vi) assessing the severity or magnitude of effects of any disaster;

(vii) evacuation, rescue and relief;

(viii) rehabilitation and reconstruction;

Section 2(i) "mitigation" means measures aimed at reducing the risk, impact or effects of a disaster or threatening disaster situation;

Section 35. Central Government to take measures. —

(1) Subject to the provisions of this Act, the Central Government shall take all such measures as it deems necessary or expedient for the purpose of disaster management."

Reliance was placed on Jacobson v. Massachusetts, 197 U.S. 11 (1905), a judgment of the Supreme Court of the United States wherein the issue of compulsory vaccination was explored. The relevant portion is extracted as under -

"There is, of course, a sphere within which the individual may assert the supremacy of his own will and rightfully dispute the authority of any human government, especially of any free government existing under a written constitution, to interfere with the exercise of that will. But it is equally true that, in every well ordered society charged with the duty of conserving the safety of its members the rights of the individual in respect of his liberty may at times, under the pressure of great dangers, be subjected to such restraint, to be enforced by reasonable regulations, as the safety of the general public may demand.

It is not, therefore, true that the power of the public to guard itself against imminent danger depends in every case involving the control of one's body upon his willingness to submit to reasonable regulations established by the constituted authorities, under the sanction of the State, for the purpose of protecting the public collectively against such danger.

[...]

Looking at the propositions embodied in the defendant's rejected offers of proof, it is clear that they are more formidable by their number than by their inherent value. Those offers, in the main, seem to have had no purpose except to state the general theory of those of the medical profession who attach little or no value to vaccination as a means of preventing the spread of smallpox, or who think that vaccination causes other diseases of the body. What everybody knows, the court must know, and therefore the state court judicially knew, as this court knows, that an opposite theory accords with the common belief and is maintained by high medical authority. We must assume that, when the statute in question was passed, the legislature of Massachusetts was not unaware of these opposing theories, and was compelled, of necessity, to choose between them. It was not compelled to commit a matter involving the public health and safety to the final decision of a court or jury. It is no part of the function of a court or a jury to determine which one of two modes was likely to be the most effective for the protection of the public against disease. That was for the legislative department to determine in the light of all the information it had or could obtain. It could not properly abdicate its function to guard the public health and safety. The state legislature proceeded upon the theory which recognized vaccination as at least an effective, if not the best, known way in which to meet and suppress the evils of a smallpox epidemic that imperiled an entire population. Upon what sound principles as to the relations existing between the different departments of government can the court review this action of the legislature? If there is any such power in the judiciary to review legislative action in respect of a matter affecting the general welfare, it can only be when that which the legislature has done comes within the rule that,

"if a statute purporting to have been enacted to protect the public health, the public morals, or the public safety has no real or substantial relation to those objects, or is, beyond all question, a plain, palpable invasion of rights secured by the fundamental law, it is the duty of the courts to so adjudge, and thereby give effect to the Constitution."

[...]

The liberty secured by the Constitution of the United States does not import an absolute right in each person to be at all times, and in all circumstances, wholly freed from restraint, nor is it an element in such liberty that one person, or a minority of persons residing in any community and enjoying the benefits of its local government, should have power to dominate the majority when supported in their action by the authority of the State.

It is within the police power of a State to enact a compulsory vaccination law, and it is for the legislature, and not for the courts, to determine in the first instance whether vaccination is or is not the best mode for the prevention of smallpox and the protection of the public health.

The matter is to be next heard on 21.03.2022 (next Monday).

[Case Title: Jacob Puliyel v. Union of India]

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