Bengaluru: The last time WHO’s technical advisory committee met to discuss the UN body’s ongoing review of Covaxin – the COVID-19 vaccine manufactured by Bharat Biotech in Hyderabad – its members concluded that they needed still more information from the company before granting approval, and set November 11 as the date for a ‘final’ meeting on the subject.

The committee’s deliberations have already lasted longer than they did for other vaccines that received the WHO’s nod, and even though there have been questions over some of those approvals, Covaxin’s case has turned into a politically fraught one given the Modi government’s stakes in its ‘atmanirbharta’ agenda. Aware of these sensitivities, the WHO appears to be doing all it can to streamline this process.

On October 28, a PTI report suggested that the WHO may practically be helping Bharat Biotech put together a better application to have its COVID-19 vaccine qualified for international use – instead of simply considering what Bharat Biotech chooses to submit.

The WHO officials quoted in the report also seem to go out of their way to emphasise  that the many months the relevant committee is taking to decide on Covax shouldn’t be taken as a comment on the Indian vaccine-manufacturing industry, which they said they “really trust”.

But this praise for the industry also came bundled with some blunt criticism of Bharat Biotech: the company has apparently been submitting data on the EUL of Covaxin “regularly and very quickly”, says PTI, but this has not been enough.

“In the stressful situation we are all working under in this pandemic, it is so important that we’re accurate in the information that we use and that we share,” Bruce Aylward, senior advisor to WHO director-general Tedros Adhanom Ghebreyesus, told PTI, adding: “And we just want to highlight, be on the record, that there were a number of inaccuracies in the way the issue was presented.”

Given the chatter in India about the delayed Covaxin approval, WHO officials insist the organisation’s mandate of saving as many lives as possible and as fast as possible includes ensuring no product lies unused. But “we need manufacturers, the regulator agencies, others we work with to make sure they have the information they need to make those determinations,” PTI quotes Aylward as saying.

“We need to make sure the products are safe and effective and produced to the right quality. And that takes a little bit of time, but it’s in the interest of global safety.”

The Wire Science reached out to the WHO press office to learn more about the information and data the WHO has sought but was told no further media interviews would be scheduled on the subject, presumably until the approval process ends.

Covaxin has prompted a number of red flags: its clinical trial, its emergency-use approval, its rollout and the agonising wait for access to the trial data (followed subsequently by issues of trial ethics and data quality) threw up so many questions, but the Drug Controller General (DCGI), Bharat Biotech and the Indian Council of Medical Research (ICMR) have not deigned to answer any of them, at least not honestly.

This was followed later by questions about how Bharat Biotech, and the Indian government with it, estimated that the company would be able to produce X number of doses by certain dates, only to fall strikingly short on each occasion. Together with Serum Institute’s failure to project output and demand, India – the “vaccine superpower” that ICMR’s Balram Bhargava recently said it was – had a shameful vaccine shortage for the first half of 2021.

As good as the science underlying BBV152 may have been, Covaxin the product has clearly run into problems when subjected to scrutiny by an organisation that has no political stake in its quick approval. This isn’t a comment on the science so much as a reiteration of the oft-overlooked fact that science progressively gives way to social issues that emerge when science’s requirements collide with societal gradients, particularly once the giant phase 3 tests have begun.

Given all of these issues, the WHO committee repeatedly asking for more data from Bharat Biotech regarding Covaxin served to highlight – loudly and effectively – an immutable fact: that the Indian government and Bharat Biotech didn’t have this data at the time the DCGI approved the vaccine for emergency use (in “clinical trial mode” to boot) in January 2021, and probably that Bharat Biotech didn’t have this data ready when it claimed, on more than one occasion, that it had submitted all the information it had on Covaxin to the WHO.

To be sure, the technical committee’s protracted deliberation isn’t just a simple validation process in the larger scheme of things; it has also become a process that has served to embarrass the Indian government, from the clinical trial regulation apparatus to the prime minister’s office.

The technical advisory committee’s process is resistant to “diplomatic” and “political” inputs, even as every meeting of the committee has concluded thus far with demands for more information from Bharat Biotech. This doesn’t prove that the DCGI or the Central Drug Standards Control Organisation bungled their vetting process to push Covaxin’s emergency-use license through earlier this year – but surely suggests it, and that is just as damaging.

The public in India has already made its reservations known. Even with the Indian government’s belligerent support, only some 11% of recipients in India have taken it.

Ultimately, we have arrived at a point that Bharat Biotech occupied in January 2021, when the DCGI, with the Union government’s backing, appeared to use the pressing need for vaccines to push through an inadequately tested product for political reasons. The decision effectively forced people to scramble for Covishield, and when Covishield wasn’t available, to settle for Covaxin despite the many doubts about its efficacy and safety. It was effectively a ‘right to choose without choices’.

This article was originally published as two posts on the author’s blog.