A health worker administers a dose of COVID-19 vaccine to a beneficiary in Patna, December 31, 2021. Photo: PTI
New Delhi: The Union government on Tuesday told the Supreme Court that as of March 13 this year, a total of over 180 crore doses of COVID-19 vaccines were administered in the country and 77,314 adverse events, which come to 0.004%, have been reported.
The government said that over 8.91 crore doses of vaccine Covaxin have been administered in the age group of 15-18 years as of March 12 and the number of adverse events following immunisation (AEFI) reported are 1,739 minor, 81 serious, and six severe.
The Union government told a bench of Justices L.N. Rao and B.R. Gavai that a substantial number of individuals in the country are vaccinated and the vaccines have proved to be very effective and safe.
It said both vaccines – Covaxin and Covishield – generate antibodies and adverse events are also found to be minimum.
Further, the efficacy, safety, and immunogenicity of these vaccines, which are rolled out after an elaborate procedure by domain experts, are also accepted by the World Health Organisation (WHO) which shows recognition by global experts also, solicitor general Tushar Mehta and additional solicitor general Aishwarya Bhati said in their brief submission on behalf of the Union government.
The court is hearing arguments on a plea seeking directions for disclosure of data on clinical trials of COVID-19 vaccines and post-jab cases. The arguments would continue on March 21.
“As per the last available figure (i.e. as of March 13, 2022), the total number of doses administered is 180,13,23,547 and the total number of adverse events reported (including minor, severe, and serious cases) are 77,314 (0.004 per cent),” the Union government said.
Regarding vaccination of minors, it said the question of paediatric vaccination was taken up at a stage where more than substantial data on the safety and immunogenicity of Covaxin in adults was available.
It is relevant to note that as of March 12, 2022, 8,91,39,455 doses of Covaxin have been administered in the age group of 15-18 years age group. In this age group, the number of AEFIs reported are 1,739 (minor) (0.014%), 81 (serious) (0.0009%) and 6 (severe) (0.00001%), the brief submissions of the two law officers said.
It is evident from this data that the expansion of vaccination drive to include the paediatric population does not pose a safety risk to the vaccine recipients, it said.
The Union government said the questions regarding vaccination policy and a particular vaccine’s efficacy, safety, immunogenicity, pharmacodynamics, etc are examined repeatedly and periodically by domain experts of various medical fields comprising of various committees.
This court, would not, therefore, accede to the prayer of the petitioner to exercise judicial review in issues concerning several, scientific and medical aspects which are already considered by domain experts drawn from all over the country representing various medical faculties, it said.
The government said prayers made in the plea, steps taken by authorities, and judicial review of the court are required to be considered based upon an indisputable fact that not just India but the entire human race was passing through literally an existential crisis in the form of a pandemic on a scale not known to humankind earlier.
Under such extreme and extraordinary circumstances, this court could suitably modulate its power of judicial review while examining the actions of the executive, it said.
It said one of the prime concerns of the world and particularly India is to increase the vaccination reach to every individual in the country and any indulgence by the court may inevitably result in vaccine hesitancy.
It elaborated the broad stages of vaccine development under the law.
The Union government said so far as Covaxin is concerned, the manufacturing company Bharat Biotech International Limited had applied for the manufacture of whole-virion inactivated coronavirus vaccine for the test, examination, and analysis on April 23, 2020.
It said several meetings of the subject expert committee of the government took place to monitor various stages and issues and eventually only the emergency use and approval was granted after nine months of detailed deliberations on January 3, 2021.
It said so far as Covishield is concerned, it is manufactured in India but the vaccine was originally developed in the United Kingdom.
It said there is a technology transfer as per commercial understanding between the manufacturer of Covishield in India and AstraZeneca in the UK and the same process of evaluation was followed in the case of Covishield as was done for Covaxin.
The above-referred facts show that the procedure followed is absolutely transparent under the oversight of independent and neutral domain experts right from the Subject Expert Committee till the final authority which grants the approval. The entire details are placed on the official website of the Ministry to ensure transparency, it said.
It said there is confidentiality attached to certain parts of the clinical trial process which cannot be compromised under the law.
Such data cannot be demanded by anyone under the garb of filing of public interest litigation either to satisfy his curiosity or in furtherance of his attempts to create vaccine hesitancy, it said.
Advocate Prashant Bhushan, appearing for the petitioner, had earlier argued that whether to get vaccinated or not is an individual decision and in the absence of informed consent, mandatory vaccination was unconstitutional.