Covid vaccine makers refuse to disclose data before SC

Covid vaccine makers Bharat Biotech and Serum Institute of India on Tuesday refused before the Supreme Court to disclose their vaccination data, including adverse events following immunisation.

They also claimed motivated pleas were made as an “attempt to cause vaccine hesitancy and public hysteria in the midst of an unprecedented global pandemic.”

Maintaining that strict protocols were adhered to and the allegations of non-disclosure of information had no basis, Bharat Biotech, which manufactured Covaxin, submitted before a bench of Justices L N Rao and B R Gavai that it had extensively published the findings of clinical trials for its Covid-19 vaccine in publicly available reputed peer-reviewed journals, including its website and Lancent medical journal.

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“Covaxin has undergone all necessary clinical trials and the Phase 3 Efficacy Trials revealed a 77.8% vaccine against symptomatic Covid-19 disease, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group,” it said

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

The company followed international best practices for conducting research and Covaxin had undergone all the clinical trials, the vaccine maker said.

“The phase three efficacy trials revealed a 77.8% vaccine against symptomatic Covid-19 disease through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. The efficacy against severe symptomatic Covid-19 disease is shown to be 93.4%. The efficacy data demonstrates 63.6% protection against asymptomatic Covid-19,” it added.

The company had so far delivered more than four billion doses of various vaccines across 123 countries since its establishment in 1996 in Hyderabad and had a portfolio of more than 16 vaccines, including polio, rotavirus, Zika, etc, it said.

“In the backdrop of the fact that the international community is grappling with an unprecedented global pandemic, which has overwhelmed health infrastructure globally and caused massive amounts of casualties. It is a matter of pride for this nation that a domestically manufactured vaccine has come as a solace for not only India but for the world in these trying times,” Bharat Biotech counsel Vipin Nair said in its written statement.

SII also contested any plea for disclosure, saying as a matter of principle the petitioner cannot ask for data. "Our 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,” it said.

The manufacturers were responding to a petition by Dr Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, challenging vaccine mandates, and disclosure of trial data.

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