Court can't sit in verdict of safety analysis on paediatric vaccination: SC

Observing that the Court cannot sit in judgement of leading scientific analysis relating to the safety of paediatric vaccination, the Supreme Court has said that the decision taken by the Centre to vaccinate children in the country is in tune with global scientific consensus and expert bodies.

A bench of Justices L Nageswara Rao and B R Gavai also said that data shows vaccine does not pose any threat to children.

Experts in science may themselves differ in their opinions while taking decisions on matters related to safety and allied aspects, but that does not entitle the Court to second-guess expert opinion, on the basis of which the Government has drawn up its policies.

The decision taken by the Union of India to vaccinate paediatric population in this country is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF, and the CDC has also advised paediatric vaccination, the bench said.

The Union of India contended that paediatric vaccination is advised by global agencies such as the WHO, UNICEF, and the CDC.

Expert opinion in India is in tune with global consensus in favour of vaccination of children. We are informed that 8,91,39,455 doses of COVAXIN has been administered to individuals in the age group of 15 to 18 years as of March 12, 2022. The AEFIs reported are 1,739 minor complaints, 81 serious complaints, and six severe, it had said.

The apex court noted that according to the Union of India, the said data would show that the vaccine does not pose threat to the safety of children.

As regards the clinical trials children are not required to be involved in research that could be carried out equally well with adults and further that, for the clinical evaluation of a new drug, a study in children should be carried out after the Phase III clinical trials in adults, the bench noted.

The apex court was told that to avoid any risks, clinical trials were also conducted on a limited number of children as per the protocol approved by domain experts.

It would not only be beyond our jurisdiction but also hazardous if this Court were to examine the accuracy of such expert opinion, based on competing medical opinions. As already stated, the scope of judicial review does not entail the Court embarking upon such misadventures, the bench said.

The top court rejected the contention of the Petitioner that this Court has to intervene in paediatric vaccination on the ground that it is unscientific.

The judgement came on a plea filed by Dr. Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, who has sought directions to also disclose post-vaccination data regarding adverse events.