New Delhi: Bharat Biotech International Ltd has told the Supreme Court that Covaxin has undergone all necessary clinical trials and the Phase 3 efficacy trials revealed the vaccine is 77.8 per cent effective against Covid.
The vaccine manufacturer said it has extensively published the findings of clinical trials in publicly available reputed peer reviewed journals and on its website.
The company, in the written submissions filed through advocate Vipin Nair, said: “It may be noted that the answering respondent has extensively published the findings of clinical trials in publicly available reputed peer reviewed journals and are available inter alia, on the website of the answering respondent.”
“Covaxin has undergone all necessary clinical trials and the Phase 3 Efficacy Trials revealed a 77.8 per cent 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 company added that the efficacy against severe symptomatic Covid-19 disease is shown to be 93.4 per cent and the efficacy data demonstrates 63.6 per cent protection against asymptomatic COVID-19.
The company’s response came on a petition filed by Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, seeking the data of clinical trials and adverse effects of Covid vaccines and also challenging the vaccine mandates issued by some state governments.
The company said the petitioner has made baseless allegations against the approval granted to it, when the same was carried after strict adherence to protocols established by the regulatory authorities after conducting due diligence, and urged the top court to dismiss the PIL.
“The petitioner has falsely and without correct reference to the key documents, alleged that the respondent company has not published its clinical trial data. The rules and practice are fairly clear in this aspect from a reading of the WHO Statement on public disclosure of clinical trial results,” it added.
It also said submission of the petitioner that it has not published Phase 3 clinical trial data in peer reviewed journals is unsubstantiated as it has submitted the key outcomes and main findings in one of the most respected and peer reviewed journal in the field of medicine, The Lancet.
“It is also submitted that not only is the endeavour of the petitioner, defamatory to the answering respondent, the unsubstantiated pleas therein are likely to cause hysteria and panic during the present global pandemic and promote vaccine hesitancy. On that ground alone, the present writ petition is liable to be dismissed,” said the document.
The company said 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.
It also accused the petitioner of being not a bona fide litigant as he had earlier filed a plea seeking segregated data of ‘Rotovac vaccine’ made by it in Delhi High Court. In 2015, this plea was by the dismissed by the high court and the top court in 2016 and he did not disclose this in instant PIL.
The top court has reserved its judgment in the matter.
