Bharat Biotech, SII Oppose Plea In Supreme Court For Public Disclosure Of Vaccine Trial Data

Vaccine manufactures Bharat Biotech Ltd and Serum Institute of India opposed a petition in the Supreme Court seeking disclosure of the data on clinical trial and adverse events following immunization in relation to Covaxin and Covishield vaccines developed by them respectively against COVID-19 pandemic.

A bench comprising Justices L Nageswara Rao and BR Gavai was hearing a writ petition filed by Dr.Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, seeking the data of clinical trial and adverse effects of COVID vaccines and challenging the vaccine mandates imposed by some States.

Senior Advocate Guru Krishnakumar, appearing for Bharat Biotech, submitted that Covaxin was indigenously developed in association with the Indian Council for Medical Research.

"The efficacy has been established and it is effective against further variants also. It follows the inactivated virus model which is identified as the safest in the world", he submitted. He refuted the argument of Advocate Prashant Bhushan, who is appearing for the petitioner, that Phase III Trial of the vaccine has not been published. In fact, it was published in Lancent medical journal in November 2021. The counsel showed to the bench the publications in the Lancet journal.

"Therefore, the premise of the petition simply does not stand. Our trials are going on and informed consent is taken", Mr.Krishnakumar submitted. It was his next argument that the WHO guidelines referred to by the petitioner do not mandate the disclosure of the primary data and only the analysis of the data. The petitioner, who claims to be a domain expert, should be aware of this.

It was also emphasised that the issue has to be seen in the light of the fact that over 180 crore doses administered, only 0.004% adverse events were reported. Reference was also made to Section 8(1)(d) of the Right to Information Act which exempts the disclosure of information including commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party.

"The petitioner says give redacted data. Tomorrow you will ask for further details saying I want to study why they had such complications. There won't be an end to this", Krishna Kumar submitted.

The counsel for the SII also opposed the petitioner's plea for disclosure.

"As a matter of principle they cannot ask for data. My data is with the regulator. That is where it should be. There is no locus for them (petitioner). Even under the RTI they have to show there is public interest. But, here, as Mr. Krishna Kumar said, it is in the contrary. My submission is that it is an infructuous petition", the SII's counsel submitted.

Before the arguments of the vaccine companies, the States of Tamil Nadu, Maharashtra and Madhya Pradesh defended the vaccine mandates issued by them. 

Vaccines Can't Be Mandated Without Evidence That Unvaccinated Persons Pose Health Risk : Prashant Bhushan Argues In Supreme Court

'Out Of 180 Crore Doses, Only 0.004% Adverse Effects' : Centre Tells Supreme Court In Plea For Vaccine Trial Data              

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