The Government has told the Supreme Court that COVID-19 vaccination is voluntary and serious or severe effects of inoculation, including death, account for less than 0.01%.
“The percentage of such effect having serious/severe [including deaths] in case of both Covaxin and Covishield is less than 0.01%. This again is in the caveat that any such severe/serious effect including death cannot be attributed to vaccination.”
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The Health Ministry said 2,116 serious and severe AEFI cases have been reported from 1,19,38,44,741 doses administered till November 24.
Vaccination is encouraged for one’s own good and in public health, it said.
“An individual’s ill health has a direct effect on society,” it submitted in a 58-page affidavit before a Bench led by Justice L. Nageswara Rao on Monday.
The very proof that the vaccination is not mandatory is evident from the fact that no benefits or services are attached to it.
The Government said it is transparent about vaccination data.
“Post-vaccination adverse data is already in the public domain,” the Ministry said.
“A report of rapid review and analysis completed for 495 [463 Covishield and 32 Covaxin] cases has been submitted. Another report of 1,356 cases [1,236 Covishield, 118 Covaxin and two Sputnik] serious and severe AEFI cases [including 495 cases already analysed] has been presented to the National Expert Group on Vaccine Administration for COVID-19 [EGVAC].The rapid review and analysis of balance cases is under way and will be completed soon,” the Centre told the court.
The Centre said any death or hospitalisation following vaccination cannot be automatically assumed to be due to vaccination.
“Here, causality assessments help to understand whether the ‘Adverse Event Following Immunisation’ was caused directly due to vaccine, and are conducted at State and national level for the investigated cases.”
It said data relating to clinical trial, approval by the DCGI and vaccination data “required to be and can be released as per law is already available in the public domain”. The minutes of meetings and committee deliberations to the extent permissible are already out, it said.
Dr. Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, wants the court to direct the Government, its bodies and the two domestic vaccine manufacturers — Serum Institute of India and Bharat Biotech — to transparently reveal clinical trial and vaccination data, including the recording and reporting of adverse events.
The court had in August expressed apprehensions whether a judicial order in the case to publish data on clinical trials of COVID vaccines and post-vaccination side-effects would feed vaccine hesitancy amid the pandemic. It had however asked the Government to file its response to the petition.
