The Centre on Monday told the Supreme Court that it has not mandated for COVID-19 vaccines to be administered mandatorily at this stage and all data relating to clinical trial approved by Drugs Controller General of India (DCGI), and vaccination data that is required to be and can be released as per law is already available in the public domain.
The affidavit filed by Centre in the top court said that at this juncture, the entire concentration of the Central and the State Governments should be and is on vaccination drive and encouraging people to get vaccinated.
“It is, therefore, not desirable at this juncture to invest time finding out motives behind a few elements attempting to act against the interest of the nation at the cost of violating the right of crores of citizens to be protected from pandemic”, the government said.
It said that the decision regarding approval of COVID-19 vaccines has been taken by expert committees consisting of domain experts based on and after verifying data/information supplied by the manufacturers and after considering its efficacy and safety.
“The minutes of meetings and committee deliberations to the extent permissible are already in the public domain. Decisions regarding approval of COVID-19 vaccines have been taken by expert committees consisting of domain experts based on and after verifying data/information supplied by the manufacturers and after considering its efficacy and safety", the government said.
It added that post-vaccination adverse data is already in the public domain and the concerned authorities are continuously monitoring and examining this data and “The Central Government has not mandated for COVID-19 vaccines to be administered mandatorily at this stage”.
The government said that “all data relating to clinical trials, approval by DCGI and vaccination data that is required to be and can be released as per law is already available in the public domain”.
The Centre in its affidavit filed in a plea by Jacob Puliyel said that this petition is filed purportedly as a Public Interest Litigation and if entertained, would harm the public interest.
“Therefore, it is submitted that approval to Covaxin and Covishield vaccines has been granted for restricted emergency use after following the procedure prescribed under Rules of 2019 and the Drugs and Cosmetics Act, 1940 and after detailed deliberations among eminent scientific experts, taking all precautions necessary, considering the COVID-19 pandemic”, the government said.
It said that any misgivings and misconceived doubts and motivated propaganda against vaccination can only result in a potential threat of setting vaccine hesitancy again, which will not be in the public interest.
"Once it is placed before this Court that -there is a statutory regime in place and the regime is followed--this Court, may not undertake the exercise any further as it would enable the petitioner and handful of others like him to create serious misgivings and misconceived doubts against the vaccination in the process of this petition itself”.
The government added that the year 2020 and 2021 witnessed one of the most severe tragedies engulfing not only India but the entire humankind, threatening virtually the existence of the human race.
“It has posed unprecedented challenges before the human race. Every country started their own earnest efforts to deal with this pandemic called COVID-19. All human efforts throughout the world were concentrated towards tackling this pandemic and also attempting to prevent it”, it said.
The government said that the Petitioner is fully aware of the facts but has chosen to give a false picture before this court for the reasons best known to him.
“In the process, however, he has raised a false alarm and warning against efforts of the nation to combat an unprecedented tragedy faced by the human race. Such an attempt is to be viewed very seriously at a time when the Central Government, all State Governments and Union Territories are individually and collectively making all possible efforts to vaccinate every individual”, it said.
The Centre said that the court may, therefore, be pleased to dismiss this petition as not maintainable, hit by principles of suppression of material facts and the subject matter being outside the scope of judicial review with exemplary costs.
It said that applying the provisions of the Second Schedule, the Central Licensing Authority that is Drugs Controller General (CDSCO), in detailed consultation and deliberation with the Subject Expert Committee (SEC) and after examining the efficacy of the vaccine and its effects granted permission for restricted emergency use of COVAXIN and COVISHIELD vaccines of Bharat Biotech International Ltd. and Serum Institute of India Ltd. respectively under the Accelerated Approval Process.
It added there is also an established protocol for reporting and causality assessment for any Adverse Event Following Immunisation (AEFI) following vaccination with Universal Immunization Program (UIP) and Non-UIP vaccines.
The government said that for COVID-19 vaccination, the same system of AEFI surveillance is being used and the surveillance system has been further strengthened for adult vaccination, especially for a novel vaccine which has been given only Emergency Use Authorization (EUA).
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)