Alcove

Science, culture, complexity

Tag: Balram Bhargava

  • On Agnihotri’s Covaxin film, defamation, and false bravery

    Vivek Agnihotri’s next film, The Vaccine War, is set to be released on September 28. It is purportedly about the making of Covaxin, the COVID-19 vaccine made by Bharat Biotech, and claims to be based on real events. Based on watching the film’s trailer and snippets shared on Twitter, I can confidently state that while the basis of the film’s narrative may or may not be true, the narrative itself is not. The film’s principal antagonist appears to be a character named Rohini Singh Dhulia, played by Raima Sen, who is the science editor of a news organisation called The Daily Wire. Agnihotri has said that this character is based on his ‘research’ on the journalism of The Wire during, and about, the pandemic, presumably at the time of and immediately following the DCGI’s approval for Covaxin. Agnihotri and his followers on Twitter have also gone after science journalist Priyanka Pulla, who wrote many articles in this period for The Wire. At the time, I was the science editor of The Wire. Dhulia appears to have lovely lines in the film like “India can’t do this” and “the government will fail”, the latter uttered with visible glee.

    It has been terribly disappointing to see senior ICMR scientists promoting the film as well as the film (according to the trailer, at least) confidently retaining the name of Balram Bhargava for the character as well; for the uninitiated, Bhargava was the ICMR director-general during the pandemic. (One of his aides also has make-up strongly resembling Raman Gangakhedkar.) In Pulla’s words, “the political capture of this institution is complete”. The film has also been endorsed by Sudha Murthy and received a tone-deaf assessment by film critic Baradwaj Rangan, among other similar displays of support. One thing that caught my eye is that the film also retains the ICMR logo, logotype, and tagline as is (see screenshot below from the trailer).

    Source: YouTube

    The logo appears on the right of the screen as well as at the top-left, together with the name of NIV, the government facility that provided the viral material for and helped developed Covaxin. This is notable: AltBalaji, the producer of the TV show M.O.M. – The Women Behind Mission Mangal, was prevented from showing ISRO’s rockets as is because the show’s narrative was a fictionalised version of real events. A statement from AltBalaji to The Wire Science at the time, in 2019, when I asked why the show’s posters showed the Russian Soyuz rocket and the NASA Space Shuttle instead of the PSLV and the GSLV, said it was “legally bound not to use actual names or images of the people, objects or agencies involved”. I don’t know if the 2019 film Mission Mangal was bound by similar terms: its trailer shows a rocket very much resembling the GSLV Mk III (now called LVM-3) sporting the letters “S R O”, instead of “I S R O” ; the corresponding Hindi letters “स” and “रो”; and a different logo below the letters “G S L V” instead of the first “I” (screenshot below). GSLV is still the official designation of the launch vehicle, and a step further from what the TV show was allowed. And while the film also claims to be based on real events, its narrative is also fictionalised (read my review and fact-check).

    Source: YouTube

    Yet ICMR’s representation in The Vaccine War pulls no punches: its director-general at the time is represented by name and all its trademark assets are on display. It would seem the audience is to believe that they’re receiving a documentarian’s view of real events at ICMR. The film has destroyed the differences between being based on a true story and building on that to fictionalise for dramatic purposes. Perhaps more importantly: while AltBalaji was “legally bound” to not use official ISRO imagery, including those of the rockets, because it presented a fiction, The Vaccine War has been freed of the same legal obligation even though it seems to be operating on the same terms. This to me is my chief symptom of ICMR’s political capture.

    Of course, that Agnihotri is making a film based on a ‘story’ that might include a matter that is sub judice is also problematic. As you may know, Bharat Biotech filed a defamation case against the Foundation for Independent Journalism in early 2022; this foundation publishes The Wire and The Wire Science. I’m a defendant in the case, as are fellow journalists and science communicators Priyanka Pulla, Neeta Sanghi, Jammi Nagaraj Rao, and Banjot Kaur, among others. But while The Wire is fighting the case, it will be hard to say before watching The Vaccine War as to whether the film actually treads on forbidden ground. I’m also not familiar with the freedoms that filmmakers do and don’t have in Indian law (and the extent to which the law maps to common sense and intuition). That said, while we’re on the topic of the film, the vaccine, defamation, and the law, I’d like to highlight something important.

    In 2022, Bharat Biotech sought and received an ex parte injunction from a Telangana court against the allegedly offending articles published by The Wire and The Wire Science, and had them forcibly taken down. The court also prevented the co-defendants from publishing articles on Covaxin going forward and filed a civil defamation case, seeking Rs 100 crore in damages. As the legal proceedings got underway, I started to speak to lawyers and other journalists about implications of the orders, whether specific actions are disallowed on my part, and the way courts deal with such matters – and discovered something akin to a labyrinth that’s also a minefield. There’s a lot to learn. While the law may be clear about something, how a contention winds its way through the judicial system is both barely organised and uncodified. Rahul Gandhi’s own defamation case threw informative light on the role of judges’ discretion and the possibility of a jail term upon conviction, albeit for the criminal variety of the case.

    The thing I resented the most, on the part of sympathetic lawyers, legal scholars, and journalists alike, is the view that it’s the mark of a good journalist to face down a defamation case in their career. Whatever its origins, this belief’s time is up in a period when defamation cases are being filed at the drop of a hat. It’s no longer a specific mark of good journalism. Like The Wire, I and my co-defendants stand by the articles we wrote and published, but it remains good journalism irrespective of whether it has also been accused of defamation.

    Second, the process is the punishment, as the adage goes, yet by valorising the presence of a defamation case in a journalist’s record, it seeks to downplay the effects of the process itself. These effects include the inherent uncertainty; the unfamiliar procedures, documentation, and their contents and purposes; the travelling, especially to small towns, and planning ahead (taking time off work, availability of food, access to clean bathrooms, local transport, etc.); the obscure rules of conduct within courtrooms and the varying zeal with which they’re implemented; the variety and thus intractability of options for legal succour; and the stress, expenses, and the anxiety. So please, thanks for your help, but spare me the BS of how I’m officially a good journalist.

  • Something more foolish than completing phase 3 trials in 1.5 months?

    That the Union government and the Indian Space Research Organisation (ISRO) had entered into a more intimate, but not necessarily more beneficial, relationship became evident in 2019 when then ISRO chairman K. Sivan trotted out a series of dubious claims to massage the fate of the Chandrayaan 2 mission, whose lunar surface component had obviously failed. Anyone who follows Indian spaceflight news is familiar with the adage ‘space is hard’ and all of them abide by it (there’s an argument that we shouldn’t extend the same courtesy to more mature space programmes). Yet Sivan was determined to salvage even more, going so far at one point to call the whole mission (orbiter + lander) a “98% success”.

    Shortly after news of the lander’s fate became clear to ground control, Prime Minister Narendra Modi, who was present as the chief guest, consoled Sivan with his customary hug even as ISRO at large withdrew into a shell of silence, offering only the occasional scrap of what it knew had happened to the lander. The vacuum of information allowed a trickle of speculation, but which was soon overwhelmed by a swell of conspiracies and, as is inevitable these days, a virtual barrier erected by right-wing commentators and bots that suppressed all questions asking for more information in the public domain. This ISRO, and the attendant public experience of India’s spaceflight programme, was markedly different from the ISRO of before – a feeling that Sivan deepened with other claims about the amount of time ISRO would need to realise its ‘Gaganyaan’ human spaceflight mission, which has already been delayed by three years. Sivan had unknowingly underestimated the amount, had deliberately communicated a shorter duration, had communicated the actual time but to which government officials couldn’t agree, or something else happened. The first possibility would’ve been unlikely were it not for the COVID-19 pandemic – but then it would seem that even if Sivan’s successor, S. Somanath, were to push back and ask for more time, the government has made up its mind: New Indian Express reported on December 8 that ISRO had received “instructions from the government” to send Indian astronauts to space on its GSLV Mk III rocket before the 2024 Lok Sabha elections! This has to be the second most unintelligent decision the government has made in the limited context of large-scale undertakings involving science and the lives of people, after Balram Bhargava’s subsequently rescinded threat in mid-2020 for researchers to complete the Covaxin phase 3 clinical trial in time for Prime Minister Modi’s Independence Day address less than two months away. It’s not clear if the government will rescind its demand of ISRO; the report itself is brief and doesn’t mention any resistance from the spaceflight mission team. But how this squares with minister Jitendra Singh’s statement in parliament last week, that the first crewed mission will only liftoff in late 2024 and that “crew safety is paramount”, is unclear. Assuming that the government will continue to push ISRO to launch in the first half of 2024, a flight based on a schedule modified to accommodate the demand may surpass the foolishness of Bhargava’s ask.

    Every human spaceflight mission is inordinately complex. ISRO will have to design and test every component of the launch vehicle, crew capsule, mission profile, ground systems and crew management beforehand, in different conditions. It has to anticipate all possible failure scenarios and arrange for both failure-avoidance systems and failsafes. The timeline may have been more flexible in the early days of the undertaking, when the systems being tested were less composite, but not so today. When the government “instructs” ISRO to launch the ‘Gaganyaan’ crewed flight before the 2024 Lok Sabha elections (which are around 18 months away), it’s practically asking ISRO to devise a testing schedule that will be completed – irrespective of the tests’ outcomes – in this period all so it can use the mission’s outcomes (developed with government funds) as part of its election campaign. It’s effectively asking ISRO to sideline science, safety standards and good sense. Imagine one safety test going awry, and which ISRO might in other circumstances have liked to fix and redo. With “instructions” like those of the government, it won’t be able to – jeopardising the mission itself as well as the lives of the astronauts and the reputation of the Indian space programme in the international arena. The government simply shouldn’t make such a frighteningly asinine demand, and instead allow ISRO to take all the time it needs (within reasonable limits) to successfully complete its first human spaceflight mission.

    ISRO has of late also embarked on programmes to increase its commercial revenue, even though it’s a “space research organisation”. If a crewed mission fails because the organisation let itself be cowed by the national government into trimming its testing process, all so a political party could use the launch as part of its poll propaganda, all of the organisation’s other rockets will confront doubts about their safety and whether they won’t threaten satellites worth hundreds of millions of dollars. A lot of ISRO’s work on ‘Gaganyaan’ has also happened to the exclusion of other launch vehicles and scientific missions, including (but not limited to) the reusable launch vehicle, the semi-cryogenic engine and the Aditya L1 space-probe. Its low rate of production of new rockets recently forced it to postpone the Chandrayaan 3 mission to accommodate the OneWeb satellites (in a commercial contract) in its launch manifest. Setting aside questions of ISRO’s relatively low funding and internal priorities, even if ‘Gaganyaan’ succeeds out of luck, the prospects of all of these adversely affected projects will suffer at least further reputational consequences. If ‘Gaganyaan’ fails, the future will be a lot worse.

    Just as the Covaxin incident opened a window into how the Indian government was thinking about the COVID-19 vaccination drive and the role of science in shaping it, a demand of ISRO to launch realise its human spaceflight mission with a hard deadline opens a window into the Indian government’s considerations on ‘Gaganyaan’. The BJP government revived ISRO’s proposal for a human spaceflight mission in 2014, approved it in 2017 and allocated Rs 10,000 crore in 2018. Did it do so only because of how the mission’s success, should it come to pass, would help the party win elections? It’s desirable for a party’s goals and the country’s goals to be aligned – until the former crimps the latter. But more importantly, should we be concerned about the government’s heuristic for selecting and rejecting which spaceflight missions to fund? And should we be concerned about which publicly funded projects it will seek more accountability on?

    There have been standing committee and audit reports calling ISRO out for slow work on this or that matter but the government at large, especially the incumbent one since 2019, has taken pains to maintain a front of amicability. It might be mildly amusing if a political party promises in its pre-poll manifesto to get ISRO in shape, and then in line, by readying a reusable launch vehicle for commercial missions by 2025 or launching five scientific missions in the next four years – but standing in the way of that is more than a knack to translate between public sentiment and technological achievement. It requires breaking a longstanding tradition of cosying up to ISRO as much as granting it autonomy while simultaneously underfunding it. We need the national government, most of all, to pay more attention to all ISRO projects on which there is evidence of dilly-dallying, and grapple honestly with the underlying issues, rather than poke its nose in the necessarily arduous safety-rating process of a crewed mission.

    Featured image: A GSLV Mk III rocket lifts off on its first orbital flight, July 2017. Credit: ISRO.

  • The biopolitics of Covaxin

    In a new investigation, STAT has reported fresh problems with Covaxin’s approval process in India, including the phase 2 trial dropping its placebo arm in favour of one preordained to make Covaxin look good and Bharat Biotech – the maker – commencing phase 3 trials based on results from animal studies. I’m also filing the report under “yet another instance of a pro-government Indian entity responding to the foreign press but not the local press” (following this). Krishna Mohan, one of the company’s directors, responded to STAT by admitting to a wrongdoing, massaging other similar actions, and pointing a finger at the Indian government.

    Is this spine? In response to similar evidence-based allegations of wrongdoing, Bharat Biotech met The Wire Science and The Wire with a defamation suit, a demand of Rs 100 crore and that the two sites not publish articles with “defamatory content” vis-à-vis the company, and obtained an ex parte injunction against 14 articles. This was in addition to the seemingly blanket refusal to respond to our questions for reports we were filing. Other senior Bharat Biotech officials also refused to communicate to anyone else asking probing questions about Covaxin’s clinical trials. No: his quote sounds more like Mohan trying to save Bharat Biotech’s face in front of a western audience (the one our government wants us to believe is inferior) while spinning India’s Bharat’s own take on the vaccine approval process.

    Mohan told STAT that they didn’t take any shortcuts – at least not those that weren’t first “vetted” by the Central Drug Standards Control Organisation (CDSCO), a.k.a. the drug regulator. That is to say, the shortcuts were CDSCO-approved, so they weren’t shortcuts. I’m inclined to agree: the rules are after all not based on principles of natural justice but on what the government deems acceptable. /s

    Of all the allegations, the one that irks me most is the modification to the phase 2 trial. It compromises our ability to learn anything useful about Covaxin, replacing that knowledge with knowledge of how much better one formulation of Covaxin is from another. The drug regulator should have known this is what the trial would have ended up checking, and if it approved this design anyway, it has engaged in wilful neglect – neglect of science, neglect of integrity, neglect of its mandate to look out for the people. But if we’re to believe Mohan, it’s just “product development” for an unprecedented time, not public health:

    “In a classic sense of product development, we would do everything the right way — play by the book and all the rules of the game would be followed. But here was a situation the world didn’t foresee. … Please don’t think there was any issue with the veracity of the data. Yes, it was an unusual approach, but it was dictated by the nature of the pandemic.”

    Ah, a classic tactic: Why did you burn down the forest? “It’s the climate crisis, which is unprecedented, and we needed land to erect smog towers.”

    Later in the article, in the face of a similar allegation – changing the phase 2 trial protocol – Mohan defends the regulator and blames discrepancies in trial numbers on a company struggling to coordinate multiple teams working separately from each other while being guided by the rule of “let’s get the data out”. I’d buy what he was saying if he was talking about his company HQ installing new air-conditioners and conducting tests of indoor air quality. But he’s talking about a clinical trial for a vaccine, placing misleading data in the public domain and – crucially – implicating a national drug regulator that he claims was in the know but didn’t act.

    To STAT, he’s saying they were distracted by the “safety of individuals”, the “ethics of handling subjects” and “manufacturing”, but to Indian journalists, he as well as the regulator have been mum on questions raised by the WHO and ANVISA on manufacturing practices and by almost everyone else about the People’s Hospital death and data.

    A (somehow) bigger problem arises soon after when Mohan says:

    “Whatever we did was with the clear intention of doing it right. There was no question of reducing sample sizes. … There were not off the cuff or random thoughts. … It was extensively debated with keeping the final objective in mind of getting a vaccine in time and not cutting any corners.”

    Getting a vaccine in time and not cutting any corners? It’s baffling that the last sentence is intended as clarification rather than as a potentially tacit admission of wrongdoing. I’m sure you remember when ICMR chief Balram Bhargava called on hospitals around India to complete Covaxin’s phase 3 trials in less than two months, in time for Prime Minister Narendra Modi to avail the vaccine for public use on Independence Day 2020. One independent scientist asked me what I thought Bhargava might have been smoking at the time; it was hard to say.

    But what’s tempting to speculate now is that the government realised, based on the backlash to Bhargava’s announcement, that a) a phase 3 trial in six weeks was a bigger problem than it believed, b) it wouldn’t work to have its vaccine development plan in public, c) it could accelerate Covaxin’s clinical trials by forcing Bharat Biotech to do so, and d) approve Covaxin without phase 3 trials by assimilating the drug regulator – all to achieve a similar outcome. Or at least I speculate in the absence of evidence. And until there is, we remain needles in veins.

  • Disappointing persons of the year 2021

    I’m starting to think that in this day and age, you will but err when you pick individuals for traditionally ‘prestigious’ awards, prizes, recognitions, etc., probably because the sort of people who can stand out by themselves have to have had the sort of clout and power that typically comes not through personal achievement as much as systemic prejudice – or they need to have screwed up on a magnitude so large that the nature of their action must overlap significantly with a combination of centralised power and lack of accountability. And on the spectrum of possibilities between these two extremes lie The Week‘s and Time‘s persons of the year 2021.

    The Week has picked – wait for it – Indian Council of Medical Research (ICMR) director-general Balram Bhargava for his leadership of India’s medical response to the country’s COVID-19 crises. I doubt I’d lose my journalistic equipoise if I said he deserved to be the “clown of the year” not just because Bhargava, and ICMR with him, has made many batty claims throughout the epidemic – principally in press conferences – but also because, to echo the recent words of Barton Gellman, he has pushed an independent medical research body outside the democratic system and into the prime minister’s office.

    Yet The Week‘s article justifying its choice makes no mention of these transgressions and sticks only to Bhargava making life-impacting decisions at 3 am – like tens of thousands of healthcare workers around the country, who did that and kept their collective spine – and a can-do attitude in which The Week fails to see that “getting things done” to the appreciation of your colleagues also means that unless someone takes more initiative than they’re expected to, the organisation is systematically incapable of going “over and beyond”, so to speak. One way or another, it’s not hard to conclude that Bhargava will leave ICMR worse than it was when he joined.

    Time‘s person of the year 2021 is Elon Musk. Its profile reads much less like the profilee is doing the profiler a favour, but it also fails to overcome the suspicion that it expects the sheer magnitude of Musk’s ambitions for the world to absolve him of his failures – failures that appear like minor glitches in a grand, technocratic future-vision to Silicon Valley and Wall Street honchos (and their mimics worldwide) but to anyone else suggest something worse but also familiar: a plutocracy in which each billionaire is only looking out for himself, or at best his company’s interests.

    Time‘s profile is essentially a paean to the extent to which Musk’s Tesla and SpaceX companies have reinvigorated their respective industries (automotives and spaceflight) through innovations in manufacturing and industrial management, but it’s often presented in a context-limited, value-neutral fashion that prompts concerns that the magazine wouldn’t have had access to Musk if it didn’t promise to write nice things about him.

    For example, Time writes that “Musk’s … announcement of a $100 million climate prize rankled some environmentalists because of its inclusion of proposals for direct-air carbon capture,” and that its sole criticism is that this tech doesn’t work. But the greater issue is that focusing on carbon capture and storage technologies is a technofix that allows Tesla and other vehicle-makers to evade responsibility to reduce the demand for carbon, and that Musk’s ‘challenge’ is really a bid through philanthrocapitlism to prolong ‘business as usual’ climate scenarios. For another related example, about Tesla’s success with electric vehicles, the profile says:

    That has made Musk arguably the biggest private contributor to the fight against climate change. Had the 800,000 Teslas sold in the last year been gas-powered cars, they would have emitted more than 40 million metric tons of CO₂ over their lifetimes—equivalent to the annual emissions of Finland. But EVs may ultimately be less important to the climate fight than the central innovation that made them possible: batteries. Tesla has repurposed the lightweight, energy-dense cells that power its cars for huge grid-scale batteries that provide essential backup for renewables. Demand for Tesla’s smaller home-based Powerwall, which can store electricity from rooftop solar systems, has spiked as consumers look for alternatives to the grid, driven by everything from February’s Texas power shortage to the fire risk in California that has led to power shutoffs.

    Yet the profile doesn’t mention that even when electrified, more and more people owning cars only exacerbates the underlying problem – the demand for electricity, from a climate mitigation standpoint, and urban traffic and congestion – and that we need cities to shift to more affordable, usable and efficient modes of public transport. (The profile also and obviously doesn’t include Musk’s comment in 2017 that he dislikes public transport because he grossly mistrusts other people.) And if Tesla’s technologies will ultimately benefit the US’s, and the world’s, public transport systems, it’s hard to imagine the extent to which they would’ve also undermined our fight for climate and social justice by then.

    Instead, this is profiteering, plain and simple, and Time‘s failure to see it as such – throughout the profile, not just in this instance, it repeatedly tries to reflect the world’s aspirations in his own – seems to me to be a symptom of a desire to coexist with Musk more than anything else. Once in a while the profile has a few paragraphs of complaints against Musk and his businesses, only for them to be followed by an excuse for his behaviour or an indication that he was sanctioned appropriately for it, and never anything that goes far enough to contemplate what Musk’s politics might be. “Something about our upbringing makes us constantly want to be on the edge,” Elon’s brother Kimbal says – in the same paragraph that makes the profile’s sole meaningful allusion to the centrality of lucrative NASA contracts to SpaceX’s success. That, to me, said enough.

    I wish both The Week and Time had picked persons of the year who make the world fairer and better in spite of the people they’ve actually picked – but at the same time must conclude that perhaps this is one more tradition whose time has ended.

    Featured image credits: ICMR/Facebook and Steve Jurvetson/Flickr.

  • The vaccine that was built from scratch

    I have no plans to read ICMR chief Balram Bhargava’s new book, Going Viral, about the “inside story” of Covaxin’s making, and am grateful for that reason for Dr Jammi Nagaraj Rao’s quick but seemingly thorough review in The Wire Science. My lack of interest in the book itself also means I’m going to take those bits from the book quoted in Rao’s review literally, in no need of additional context (a reasonable assumption given the rest of the review and Bhargava’s now-tattered reputation). With this preamble: reading Rao’s review brought three things to mind.

    First, is the Indian clinical research establishment aware of the catch-22 inherent to defending its decisions regarding Covaxin over and over in the public domain? Of the two major COVID-19 vaccines in use in India, Covishield hasn’t prompted even a tenth of the amount of defending (say, by number of words or inches in newspaper columns) Covaxin has seemed to need to maintain its reputation – even when there were multiple news reports in February and March to suggest Covishield may be associated with most vaccine-associated severe adverse events at the time.

    Then again, the establishment will say – as it has said so far – that Covaxin has required defending because you were bent on attacking it for no good reason. And with Bhargava continuing to deflect criticism in his book, this circus will only continue. However, while both us critics and the establishment can keep going, as if our energies were conserved, the catch-22 is that Covaxin’s reputation is not: the longer the circus goes on, the more it will decline.

    Second, the Indian government has progressively invaded multiple public institutions and yoked their machineries to the ruling party’s electoral agenda. Perhaps the most ‘notable’ was the fall of the Election Commission, which, in a recent example, drafted the dates for West Bengal’s assembly poll phases to the BJP’s convenience. But Balram Bhargava’s new book seems to be a new frontier: Rao’s review indicates that Going Viral is one large advertisement for the Indian government, and for the BJP by extension. It’s a new frontier because it’s a book, and it’s a book by the head of a public institution that the government has already invaded. Put another way, there may be nothing Bhargava can say or do as the ICMR chief – including write a book – that we can assume will have any distance between himself and the party itself. (Once he’s done as ICMR chief, of course, the party is likely to offer him a cushy posting in some low-intensity government position.)

    Now, it is tempting to consider that by guiding the composition of a whole book and stamping some pandering functionary’s name on the cover, the BJP is also attempting to invade the space of books as an expression of intellectual achievement, of the sort that the current government has liked to associate with its fiercer critics.

    Third, there is a curious line in Rao’s review that may provide the fort of insight into Covaxin’s development that no government official (at least of this government) will ever admit. Rao writes that the book

    … is not a detailed exposition of the science behind vaccine development in general or Covaxin’s development in particular. There is a retelling of the well-known Edward Jenner story, and some interesting details about why Bharat Biotech was uniquely placed to develop Covaxin: mainly that it operated BSL-3 facilities and had a track record of developing vaccines from scratch.

    One reason the BJP, essentially Prime Minister Narendra Modi, blessed Bharat Biotech was that it could develop vaccines from ‘scratch’? Why should this matter during a pandemic with billions of people around the planet desperately looking for an affordable and good-quality vaccine – except the power that the words “homegrown” and “Made in India” carry for the party, and the government? Neither I nor others can offer dispositive proof that this is what Prime Minister Modi was thinking when he toured Bharat Biotech’s and Serum Institute’s facilities in November last year; the closest we can come is the way in which the party-government combine micromanaged every aspect of Covaxin – down to its ridiculous approval on January 3, 2021, in “clinical trial mode”.

    This façade of self-sufficiency is just that, as two counter-examples can show. First, let me quote from Rao’s review:

    … in his zeal to characterise Covaxin as a ‘completely indigenous vaccine, an epitome of Atmanirbhar Bharat’, Bhargava overlooks the fact that the thing that made Covaxin appropriately immunogenic was the inspired use of an adjuvant called Alhydroxyquim-II, under license from an American research company named Virovax. The licensing arrangement between Virovax, funded by the US National Institute of Health, and Bharat Biotech dates to before the pandemic, in 2019, in a collaboration set up at a meeting organised by the Indo-US Vaccine Action Program. The terms were later extended to include Covaxin.

    Second, there’s a twisted irony in insisting on building a vaccine from scratch at home (because that is politically advantageous) instead of equally supporting both vaccine development and license-based vaccine-manufacturing, then dragging your feet on licensing a vaccine when you do have one to public-sector manufacturers within the country (much less anyone else), while demanding in international fora that vaccine-makers abroad and their respective governments be okay with waiving IP rights to broaden manufacturing.

  • 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.

  • Where the atmanirbharta in spine?

    Truth be told, I didn’t expect CSIR chief Shekhar Mande could be so disingenuous. “India didn’t have to depend on western countries,” he says. What is this abject refusal to thank other countries for help – and preferring instead to take their help and rewriting the past to pretend we didn’t need any?

    Of all those who received at least one dose of a COVID-19 vaccine in India, 88% received Covishield, which was first conceived by scientists in the UK and licensed by a British-Swedish pharmaceutical company to an Indian manufacturer. Even Covaxin, which accounts for the remaining 12% (screw Sputnik V), draws on technologies perfected by scientists in the US, among other places, against the SARS and MERS viruses. And while India’s drug controller approved a glut of drugs to treat severe COVID-19, the rights to the most popular among them and which also demonstrated some efficacy in any well-designed trials and observational studies – remdesivir – belong to a Californian pharmaceutical company.

    Some of the special containers and chemical reagents required to conduct RT-PCR tests are mostly imported. Indian industry adapted in a relatively short span of time to boost local production of masks, PPE kits and syringes, but there’s a lot that it depended on the west for and for which the west depended on India.

    In The Statesman article, ICMR chief Balram Bhargava also says, “The experience of developing Covaxin has instilled self-confidence in us that India is now much more than the pharmacy of the world. It is also a vaccine superpower.” Kind sir, India is no longer the ‘pharmacy of the world’. And we’d have to be a shitty kind of “vaccine superpower”, whatever that means, to a) run low on vaccines and syringes and completely fail to see that coming, b) celebrate 100-crore preordained inoculations, c) go so gung-ho with COVID-19 that we fail to deliver doses of a DTP vaccine to 3 million children in a year (the world’s highest) and d) preferentially award vaccine-making contracts to private companies.

    Of course, BB has been a foregone conclusion for a while. But that Mande can thump his chest like this… Are we to believe, then, that the rumours about why the Manipal Centre for Virus Research was shut, just as the pandemic was beginning, are true? That it was poised to undermine, with its foreign funds, foreign collaborations and foreign-trained scientists, the ‘Make in India’ narrative that the government as much as the government-funded scientific enterprise is wedded to.

    Perhaps the most regrettable thing about Mande’s comment is that – if the head of India’s largest government-funded scientific research establishment is prepared to lie in public, and to himself, that Indian researchers, manufacturers, traders, healthcare workers and patients didn’t want for anything that wasn’t already available in the country in early 2020, he is also prepared to believe there aren’t any problems that need to be fixed or resolved today either. I sincerely hope I’m wrong, but I don’t have my hopes up. Whatever we’re atma-nirbhar with today, it isn’t spine among government scientists, it seems.