If I had been Bharat Biotech’s teacher and “Where is your data?” had been an examination question, Bharat Biotech would have received 1 out of 10 marks.
The correct answer to where is your data can take one of two forms: either an update in the form of where the data is in the data-processing pipeline or to actually produce the data. The latter in fact would have deserved a bonus point, if only because the question wasn’t precise enough. The question should really have been a demand – “Submit your data” – instead of allowing the answerer, in its current form, to get away with simply stating where the data currently rests. Bharat Biotech gets 1/10 because it does neither; the 1 is for correct spelling.
In fact, the company’s chest-thumping based on publishing nine papers in 12 months is symptomatic of a larger problem with the student. He fails to understand that only data is data, and that the demand for data is a demand for data per se. It ought not to be confused with a demand for authority. Data accords authority in an object-oriented and democratic sense. With data, everyone else can see for themselves – whether by themselves or through the mouths and minds of independent experts they trust – if the student’s claims hold up. And if they do, they confer the object of the data, the COVID-19 vaccine named Covaxin, with attributes like reliability.
(Why ‘he’? The patriarchal conditions in and with which science has operated around the world, but especially in Europe and the US, in the last century or so have diffused into scientific practice itself, in terms of how the people at large have constituted – as well as have been expected to constitute, by the scientific community – scientific authority, expertise’s immunity to criticism and ownership of knowledge production and dissemination apparatuses, typically through “discrimination, socialisation and the gender division of labour”. Irrespective of the means – although both from the company’s and the government’s sides, very few women have fielded and responded to questions about drug/vaccine approvals – we already see these features in the manner in which ‘conventional’ scientific journals have sought to retain their place in the international knowledge production economy, and their tendency to resort to arguments that they serve an important role in it even as they push for anti-transparent practices, from the scientific papers’ contents to details about why they charge so much money.)
However, the student has confused authority of this kind with authority of a kind we more commonly associate with the conventional scientific publishing paradigm: in which journals are gatekeepers of scientific knowledge – both in terms of what topics they ‘accept’ manuscripts on and what they consider to be ‘good’ results; and in which a paper, once published, is placed behind a steeply priced paywall that keeps both knowledge of the paper’s contents and the terms of its ‘acceptance’ by the journal beyond public scrutiny – even when public money funded the research described therein. As such, his insistence that we be okay with his having published nine papers in 12 months is really his insistence that we vest our faith in scientific journals, and by extension their vaunted decision to ‘approve of’ his work. This confusion on his part is also reflected in what he offers as his explanation for the absence of data in the public domain, but which are really his excuses.
Our scientific commitment as a company stands firm with data generation, data transparency and peer-reviewed publications.
Sharing your data in a secluded channel with government bodies is not data transparency. That’s what the student needs for regulatory approval. Transparency applies when the data is available for everyone else to independently access, understand and check.
Phase 3 final analysis data will be available soon. Final analysis requires efficacy and 2 months safety follow-up data on all subjects. This is mandated by CDSCO and USFDA. Final analysis will first be submitted to CDSCO, followed by submissions to peer reviewed journals and media dissemination.
What is required by CDSCO does not matter to those allowing Bharat Biotech’s vaccines into the bloodstreams, and in fact every Indian on whom the student has inflicted this pseudo-choice. And at this point to invoke what the USFDA requires can only lead to a joke: studies of the vaccines involved in the formal vaccination drive have already been published in the US; even studies of new vaccines as well as follow-ups of existing formulations are being placed in the public domain through preprint papers that describe the data from soup to nuts. All we got from the student vis-à-vis Covaxin this year was interim phase 3 trial data in early March, announced through a press release, and devoid even of error bars for its most salient claims.
So even for an imprecisely worded question, it has done well to elicit a telling answer from the student: that the data does not exist, and the student believes he is too good for us all.
Thanks to Jahnavi Sen for reading the article before it was published.