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...

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

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