In India, less than one in every 10,000 jabs have led to serious adverse reactions — not necessarily due to the vaccine

The Centre has told the Supreme Court that 2,116 serious and severe adverse event following immunisation (AEFI) cases have been reported from 1,19,38,44,741 doses of Covid-19 vaccine administered till November 24, and vaccination is not linked to any benefits or services.

In a 447-page affidavit, the Ministry of Health and Family Welfare said: "It is humbly submitted that 2,116 serious and severe AEFI cases have been reported from 1,19,38,44,741 doses of COVID-19 vaccine administered till 24th Nov 2021. A report of rapid review and analysis completed for 495 (463 Covishield & 32 Covaxin) cases has been submitted. Another report of 1,356 cases (1,236 Covishield, 118 Covaxin & 2 Sputnik) serious and severe AEFI cases (including 495 cases already analysed) has been presented to NEGVAC."

The Ministry said the percentage of such effect having serious/severe (including deaths) in case of both Covaxin and Covishield is less than 0.01 per cent. "This again is in the caveat that any such severe/serious effect including death cannot be attributed to vaccination," it added.

On the aspect of vaccine mandates, the Centre said Covid-19 vaccination is voluntary, however, it is emphasised and encouraged that all individuals take vaccination for public health and in his/her interest as well as public interest.

"Covid-19 vaccination is also not linked to any benefits or services. The Central government has not mandated for Covid-19 vaccines to be administered mandatorily at this stage," added the affidavit.

The Centre's response came on a plea filed by Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, seeking transparency in clinical trial data for the vaccines being administered in India under emergency use authorisation and also a stay on the vaccine mandates, which is being issued by various state governments.

The Health Ministry said post vaccination adverse data is already in the public domain and the authorities concerned are continuously monitoring and examining this data. "It is humbly submitted that all data relating to clinical trial, approval by DCGI and vaccination data that is required to be and can be released as per law is already available in the public domain," added the affidavit.

It said the clinical data generated in a clinical trial resides with the sponsor of the clinical trial and the data is submitted to the regulatory authorities for obtaining various permissions/licenses etc. "The regulatory authority may verify the veracity of the data submitted. However, there is no regulatory provisions under which the regulatory authorities can direct the sponsor to place the full clinical trial data in public domain," it added.

The affidavit added: "It is submitted that, any death or hospitalisation following vaccination cannot be automatically assumed to be due to vaccination; herein, 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".

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