Is Covaxin’s WHO approval guaranteed?

I suspect after reading this PTI report that the WHO is practically helping Bharat Biotech put together a better application to have its COVID-19 vaccine, Covaxin, get the body’s approval for international use, instead of simply considering what Bharat Biotech chooses to submit. The overall tone of the report is mollificatory – as if the WHO wishes to appease both the angry and the doubtful that the many months the relevant committee is taking to decide on Covaxin’s candidature shouldn’t be taken as a comment on the Indian vaccine-manufacturing industry. The biggest supplier of vaccines to the WHO’s COVAX initiative is Serum Institute of India, in Pune, so the WHO has a conflict of interest when it says it holds the industry in good esteem. But even vis-à-vis Bharat Biotech (whose production planning and output have both been disappointing), PTI writes:

India’s Bharat Biotech has been submitting data on the EUL of Covaxin “regularly and very quickly” to a technical committee which hopes to have a final recommendation to the WHO next week, a top official of the global health agency said on Thursday, stressing that the UN body “trusts” the Indian industry that manufactures high quality vaccines.

There is something of an analogy with customer service. Say two companies both sell the same product at the same price. Company A’s customer service is excellent and its product has a quality rating of 75%. Company B’s customer service is average and its product has a quality rating of 100%. Which company will you buy from? I’d pick Company B because being spared the trouble of having to contact customer service is more valuable than having to contact customer service and then having a good experience. The same goes for Bharat Biotech’s application with the WHO for Covaxin: the company has been submitting more information “regularly and very quickly”? Great. But why does it have to do this at all instead of keeping all the data ready before any kind of approval?

This characterisation of Bharat Biotech by the “top official” also feeds into what the committee is prepared to do en route to Covaxin’s apparently impending approval. As the PTI report says later:

[Bruce Aylward, senior advisor to the WHO chief,] added that WHO’s job is to save as many lives as possible and as fast as possible. This includes ensuring no product lies unused.

Considering COVAX’s premise, to ensure everyone everywhere has access to vaccines instead of just the rich guys (and ignoring its inability to fulfill this mandate so far), what Aylward says is desirable, that all good vaccines should be used up. But this also raises a question about where the WHO draws the line between rejecting a bad application and accepting a bad application and helping to make it good.

Covaxin is clearly a bad product – 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 none of the Drug Controller General, Bharat Bitoech or the Indian Council of Medical Research (ICMR) have 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, so much so that 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 is untrustworthy. This isn’t a comment on the science so much as a reiteration of the oft-overlooked fact that science progressively gives away to social issues that emerge in non-linear fashion 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 Drug Controller General 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 info it had on Covaxin to the WHO.

Now, with a WHO committee member seemingly suggesting that Covaxin’s approval is a question of when, not if, are we to believe that the vaccine is really good and that we’re all thinking about it wrong? This is an important question, to me at least, because one less-than-ideal alternative is to contemplate how one committee can ‘fix’ a vaccine – by legitimising it with its approval – that is so broken that even with the Indian government’s support, only some 11% of eligible Indians have taken it. Another is to confront the similarly dispiriting possibility that millions of people are so desperate for vaccines around the world that the WHO can no longer afford to stop at being a quality filter – and should step up to help insincere vaccine-makers over the fence. (Recall the ‘right to choose without choices’ from January?)

Any which way, the implied promise of approval seems to me to be too much of an easy way out for Bharat Biotech, and the intractable, unabashed Indian government behind it.