The Union government’s affidavit stated that Adverse Events Following Immunization (AEFIs) are reported for every vaccine.
“Just as a medicine has side effects, AEFIs are reported for every vaccine in the world. A vaccine beneficiary always has the option to access even more information about the vaccine and its possible adverse effects from health workers at the vaccination site or their doctor before making an informed choice of their own,” the Union Health Ministry contended.
On the compensation being sought, the affidavit said that the petitioners have other legal remedies including approaching a civil court for damages.
It was also emphasised that a strict liability on Union or State governments for administering the vaccine is not legally tenable, since the vaccines are manufactured by third-parties.
“There is no material to suggest how the State can fastened with strict liability for the tragic death of the respective children of the Petitioners which is the requirement in law to sustain a claim for compensation against the State under Article 32 of the Constitution,” the affidavit stated.
Pertinently, it was submitted that the concept of lack of informed consent is not applicable in a voluntary vaccination programme.
Informed consent is a principle in medical ethics/law, which says that patients must have sufficient information and understanding before they are to make decisions about any treatment or medicine they will be receiving.
“All relevant information on COVID-19 vaccination is made freely available in public domain by both the vaccine manufacturer and Ministry of Health and Family Welfare….It is humbly submitted that once a vaccine beneficiary, who has access to all relevant information, chooses to voluntarily enter a vaccination center and receive vaccination, the question of lack of informed consent does not arise,” the affidavit said.
The regulatory mechanism for administering vaccines in India is a well-established one based on experts opinions at various levels, it was further highlighted.