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Covid Vaccination For Children: Plea In Supreme Court Seeks Disclosure Of Clinical Trial Data, Stay On Vaccine Mandates

Srishti Ojha
17 Jan 2022 8:58 AM GMT
Covid Vaccination For Children: Plea In Supreme Court Seeks Disclosure Of Clinical Trial Data, Stay On Vaccine Mandates
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A plea has been moved before the Supreme Court of India seeking 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.The application has been filed by Dr Jacob Puliyel, a former member of...

A plea has been moved before the Supreme Court of India seeking 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.

The application has been filed by Dr Jacob Puliyel, a former member of the National Technical Advisory Group of Immunization, seeking ad-interim directions in the writ petition earlier filed by him for directions to publicize the data relating to clinical trials and efficacy of the vaccines administered to Indians for COVID-19 pandemic

The application filed through Advocate Prashant Bhushan has stated that these mandates have started surfacing after the Ministry to Health and Family welfare on the 27th of December issued guidelines for COVID-19 Vaccination of Children between 15 to 18 years from 3rd January 2022 onwards.

The application has stated that the Government guidelines were issued only a few days after an announcement was made through a presser on the 24th of December 2021, by the vaccination drive Chief Vinod K Paul, Indian Council of Medical Research Chief, Balram Bhargava and Union health secretary Rajesh Bhushan that their decisions are guided by science and that there isn't any scientific basis yet to necessitate paediatric vaccination.

"In a complete u-turn therefore the scientific basis seems to have altered and within three days guidelines were issued by the Ministry of Health and Family Welfare for vaccinating 15-18 year olds," the application has stated.

Vaccine Mandates for Children: The applicant has pointed out the following vaccination mandates issued for Children in various states: 

  • Government of Haryana notified that vaccinations of eligible persons (more than 15 years) is mandatory.
  • The District Educational Officer, YSR District, Kadapa, Andhra Pradesh, issued instructions to mandatorily vaccinate all children.
  • A news article reported that schools in Karnataka were making vaccinations compulsory fueling fears that vaccinations may be compulsory to sit for board examinations.
  • The notice letter addressed to the 'The Principal Secretaries/Secretaries WCD/SJE (All States/UTs)' from the Ministry of Women and Child Development stating that vaccinations are compulsory for children.
  • The letter by Council for the Indian School Certificate Examinations addressed to all heads of affiliated schools, the Chief Executive and Secretary made it mandatory for children to be vaccinated to sit in examinations. 

The data and scientific studies clearly show that children are hardly at any risk of serious illness due to COVID: 

According to the applicant, the current available evidence clearly shows that the risk versus benefit calculation does not support administering rushed and experimental COVID-19 vaccines to children, who have virtually no risk from COVID-19, yet face known and unknown risks from the vaccines.

Non disclosure of phase 3 trial results in adults and children for vaccines being administered in India: The application has stated that the clinical trial process and data for vaccines including the COVAXIN vaccine being administered through the government immunization programme and the Zydus Cadila vaccine which has received emergency use approval in August 2021, are unknown and remain opaque to public scrutiny.

Therefore, according to the applicant, this raises serious concerns regarding the suitability of these vaccines for use especially in children since phase 3 trial data of these vaccines in adults have not been published in peer reviewed scientific journals nor has the raw data related to these trials been put out for independent scientific scrutiny.

COVID Vaccines do not prevent infection and transmission: 

The application has stated that it has now been well established through peer reviewed scientific studies that vaccines do not prevent infection or transmission for Covid-19 and are not effective in preventing against infection from the new variants.

"For any vaccine to be recommended universally in public interest, the public health rationale underlying such a policy must be based essentially on efficacy and safety of vaccination and transmission of the disease. The efficacy of vaccines in preventing infection or transmission has not been established. This is not being communicated effectively to the public," the application states.

Serious adverse events in children in the age group 15-18 who have been vaccinated in other countries: 

The application has pointed out that serious adverse events and vaccine related deaths have been reported in the UK, the US and Europe especially in children who have been administered COVID vaccines.

The data and scientific studies in countries where children have been given COVID Vaccines show that the vaccines have serious and significant adverse effects on them, which outweighs the adverse effects due to the COVID infection itself.

The applicant has argued that while the potential benefit to an individual child of receiving a Covid-19 vaccine is statistically zero, they play an insignificant role in transmission of Covid-19. There is therefore no demonstrable benefit to the wider society in vaccinating children.

Children are not capable of giving legal consent to the vaccines:

The applicant has argued that Children are not capable of legal consent to the vaccines and the parents who give consent on their behalf are incapable of giving informed consent in the absence of studies and data about the benefits and adverse effects of the vaccines on children.

The application has therefore sought the following two reliefs:

  • Directions the respondents to release the entire segregated trial data for each of the phases of trials that have been undertaken with respect to the vaccines being administered in India for children along with the trial data for those vaccines in adults; and
  • Declare that vaccine mandates for children, in any manner whatsoever, even by way of making it a precondition for accessing educational institutions or sports facilities, is unconstitutional.

Background: The present PIL has been filed seeking public disclosure of clinical trial data and post vaccination efficacy data of COVID vaccines, as is required by International medical norms, and to stop the coercive mandate issued by various governments for vaccination.

The Supreme Court had in August last year issued notice to the Union of India, the Indian Council of Medical Research (ICMR), Drug Controller of India and vaccine manufacturers Bharat Biotech Ltd and Serum Institute of India.

The petitioner had in September 2021 filed an affidavit before the Court arguing that administering vaccines through coercion cannot be a matter of public health since the vaccines are not an effective guarantee against infection and transmission. The petitioner had argued that as vaccination does not prevent transmission of the disease, therefore discriminating against unvaccinated persons by denying them access to services or the means to earn their livelihood is arbitrary, discriminatory and unconstitutional.

Responding to the PIL, the Central Government had submitted before the Supreme Court that it has not mandated for Covid 19 vaccines to be administered mandatorily at this stage. While hearing the case in November, a bench led by Justice Nageswara Rao had observed that the Court will examine if the vaccine mandates of the States are disproportionate.

The Centre had stated that according to "Covid-19 Vaccine Operational Guidelines", a detailed policy document providing broad vision of government regarding Covid-19 vaccination programme formulated by it, covid vaccination is voluntary.

Last week, the Centre stated in an affidavit filed in another case that vaccination cannot be compulsory and that it has not made carrying of COVID vaccination certificate mandatory for any purpose.

Case Title: Jacob Puliyel vs Union of India


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