No Haste In Granting Emergency Use Authorization To Covaxin & Covishield: Supreme Court

In its judgment holding that the policy of the Union Government on COVID-19 vaccination policy is reasonable, the Supreme Court rejected the contention that restricted emergency use approvals had been granted to COVISHIELD and COVAXIN in haste, without thorough review of the relevant data.

The court observed that the challenge to the procedures adopted by the expertbodies while granting regulatory approval to the vaccines on the ground of lack of transparency cannot be entertained.

Relevant information relating to the meetings of the Subject Expert Committee (SEC) and the National Technical Advisory Group of Immunization (NTAGI) are available in public domain, the bench comprising Justices L Nageswara Rao and BR Gavai noted.

The court added that all relevant data required to be published under the extant statutory regime with respect to ongoing clinical trials and trials that may be conducted subsequently for COVID-19 vaccines must be made available to the public without undue delay.

The writ petitioner, Dr. Jacob Puliyel, a former member of NTAGI, had sought a direction to disclose the detailed minutes of the meetings of the SEC and the NTGAI with regard to the vaccines and to disclose the reasoned decision of the DCGI granting approval or rejecting an application for emergency use authorization of vaccines and the documents and reports submitted to the DCGI in support of such application. It was contended that the clinical trials in respect of the vaccines had not been completed and at present, the vaccines are only authorised for emergency use. That while clinical trials are scheduled to be completed in the year 2023, even the full dataset from the interim analysis conducted has not been made public. That the disclosure of segregated data of clinical trials is essential to determine the adverse effects, if any, across various age groups and diverse populations and accordingly, enable individuals to make more informed decisions on whether to be vaccinated.

Opposing these prayers, the Centre had submitted before the Court that the relevant data was examined by the expert bodies at all stages before granting emergency use approval to the vaccines.

Referring to the materials placed on record, the bench observed disagreed with with the submission that emergency approvals to the vaccines were given in haste, without properly reviewing the data from clinical trials.

We are also of the opinion that the Parliamentary Standing Committee report relied upon by Mr. Bhushan is not relevant and the lapses pointed out therein pertain to the year 2011, which have no obvious connection to the grant of approval to Respondent Nos. 4 and 5(Bharat Biotech Ltd & Serum Institute of India) for the restricted emergency use of their respective vaccines. As long as the relevant information relating to the minutes of the meetings of the regulatory bodies and the key outcomes and findings of the trials are available in public domain, the Petitioner cannot contend that every minute detail relating to clinical trials be placed in public domain to enable an individual to take an informed, conscious decision to be vaccinated or not. Given the widespread affliction caused by the virus, there was an imminent need of manufacturing vaccines which would keep the infection at bay.

The court noted that both the vaccines have been approved by the WHO and that there is material compliance with the procedure prescribed under the Drugs and Cosmetics Act, 1940 and the 2019 Rules, before grant of approval for the emergency use of the two vaccines.

"However, it is made clear that subject to the protection of privacy of individual subjects and to the extent permissible by the 2019 Rules, the relevant data which is required to be published under the statutory regime and the WHO Statement on Clinical Trials shall be made available to the public without undue delay, with respect to the ongoing post-marketing trials of COVAXIN and COVISHIELD as well as ongoing clinical trials or trials that may be conducted subsequently for approval of other COVID19 vaccines / vaccine candidates.", the court added.

The writ petitioner had also referred to a news article in The Wire, according to which Jayaprakash Muliyil, a member of the NTAGI had stated that the NTAGI had not recommended vaccination of children in the age group of 12-14 years. In this regard, the court observed:

It is settled law that courts cannot take judicial notice of facts stated in a news item published in a newspaper. A statement of fact contained in a newspaper is merely hearsay and therefore, inadmissible in evidence, unless proved by the maker of the statement appearing in court and deposing to have perceived the fact reported. In the absence of anything on record in the present case to substantiate the statement made by Mr. Jayaprakash Muliyil,e member of the NTAGI, we are not inclined to take judicial notice of the news article reported in The Wire, even more so in light of the affidavit filed on behalf of the Union of India stating that the relevant data was examined by the expert bodies at all stages before granting emergency use approval to the vaccines. We are also of the opinion that the evidence relating to the approval process of the Rotavac vaccine has no relevance to the dispute in this case. On the basis of the said two incidents, it cannot be concluded that the emergency use approval to COVISHIELD and COVAXIN recommended by the SEC are not in accordance with the statutory regime

Case details

Jacob Puliyel vs Union Of India | 2022 LiveLaw (SC) 439 | WP(C) 607 of 2021 | 2 May 2022

Coram: Justices L Nageswara Rao and BR Gavai

Headnotes

Constitution of India, 1950 - Article 21 - Bodily integrity is protected under Article 21 of the Constitution of India and no individual can be forced to be vaccinated - Persons who are keen to not be vaccinated on account of personal beliefs or preferences, can avoid vaccination, without anyone physically compelling them to be vaccinated. However, if there is a likelihood of such individuals spreading the infection to other people or contributing to mutation of the virus or burdening of the public health infrastructure, thereby affecting communitarian health at large, protection of which is undoubtedly a legitimate State aim of paramount significance in this collective battle against the pandemic, the Government can regulate such public health concerns by imposing certain limitations on individual rights that are reasonable and proportionate to the object sought to be fulfilled. (Para 49, 89(iii))

Covid-19 - Vaccination policy - Current vaccination policy of the Union of India is informed by relevant considerations and cannot be said to be unreasonable or manifestly arbitrary - Contrasting scientific opinion coming forth from certain quarters to the effect that natural immunity offers better protection against COVID-19 is not pertinent for determination of the issue before us. (Para 56,89(iv) )

Covid-19 - Vaccination - Adverse effects following immunization is crucial for creating awareness around vaccines and their efficacy, apart from being instrumental in further scientific studies around the pandemic- Union of India directed to facilitate the reporting of suspected adverse events by individuals and private doctors on a virtual platform and the reports so made shall be publicly accessible after being given unique identification numbers, without listing any personal or confidential data of the persons reporting. (Para 84, 89(viii))

Covid-19 - Vaccination - Cannot conclude that restricted emergency use approvals had been granted to COVISHIELD and COVAXIN in haste, without thorough review of the relevant data - Subject to the protection of privacy of individual subjects, with respect to ongoing clinical trials and trials that may be conducted subsequently for COVID-19 vaccines, all relevant data required to be published under the extant statutory regime must be made available to the public without undue delay. (Para 76 , 89(vi))

Constitution of India, 1950 - Article 21 - Personal autonomy of an individual involves the right of an individual to determine how they should live their own life, which consequently encompasses the right to refuse to undergo any medical treatment in the sphere of individual health.(Para 49, 89(iii))

COVID-19 - Vaccine mandates - Not proportionate - No data has been placed by the Union of India or the States appearing before us, controverting the material placed by the Petitioner in the form of emerging scientific opinion which appears to indicate that the risk of transmission of the virus from unvaccinated individuals is almost on par with that from vaccinated persons. In light of this, restrictions on unvaccinated individuals imposed through various vaccine mandates by State Governments / Union Territories cannot be said to be proportionate. Till the infection rate remains low and any new development or research finding emerges which provides due justification to impose reasonable and proportionate restrictions on the rights of unvaccinated individuals, we suggest that all authorities in this country, including private organizations and educational institutions, review the relevant orders and instructions imposing restrictions on unvaccinated individuals in terms of access to public places, services and resources, if not already recalled (Para 89(v)).

Constitution of India, 1950 ; Article 32, 226 - Judicial review of executive decisions based on expert opinion - Courts do not ordinarily interfere with the policy decisions of the executive unless the policy can be faulted on grounds of mala fide, unreasonableness, arbitrariness or unfairness etc. (Para 21)

Constitution of India, 1950 ; Article 32, 226 - Policy decisions - Court would be slow in interfering with matters of policy, especially those connected to public health. There is also no doubt that wide latitude is given to executive opinion which is based on expert advice. However, it does not mean that this Court will not look into cases where violation of fundamental rights is involved and the decision of the executive is manifestly arbitrary or unreasonable. (Para 25)

Newspaper reports - Courts cannot take judicial notice of facts stated in a news item published in a newspaper. A statement of fact contained in a newspaper is merely hearsay and therefore, inadmissible in evidence, unless proved by the maker of the statement appearing in court and deposing to have perceived the fact reported. (Para 70)

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