The Vaccine War – Close Read

The BHU Covaxin study and ICMR bait

Earlier this month, a study by a team at Banaras Hindu University (BHU) in Varanasi concluded that fully 1% of Covaxin recipients may suffer severe adverse events. One percent is a large number because the multiplier (x in 1/100 * x) is very large — several million people. The study first hit the headlines for claiming it had the support of the Indian Council of Medical Research (ICMR) and reporting that both Bharat Biotech and the ICMR are yet to publish long-term safety data for Covaxin. The latter is probably moot now, with the COVID-19 pandemic well behind us, but it’s the principle that matters. Let it go this time and who knows what else we’ll be prepared to let go.

But more importantly, as The Hindu reported on May 25, the BHU study is too flawed to claim Covaxin is harmful, or claim anything for that matter. Here’s why (excerpt):

Though the researchers acknowledge all the limitations of the study, which is published in the journal Drug Safety, many of the limitations are so critical that they defeat the very purpose of the study. “Ideally, this paper should have been rejected at the peer-review stage. Simply mentioning the limitations, some of them critical to arrive at any useful conclusion, defeats the whole purpose of undertaking the study,” Dr. Vipin M. Vashishtha, director and pediatrician, Mangla Hospital and Research Center, Bijnor, says in an email to The Hindu. Dr. Gautam Menon, Dean (Research) & Professor, Departments of Physics and Biology, Ashoka University shares the same view. Given the limitations of the study one can “certainly say that the study can’t be used to draw the conclusions it does,” Dr. Menon says in an email.

Just because you’ve admitted your study has limitations doesn’t absolve you of the responsibility to interpret your research data with integrity. In fact, the journal needs to speak up here: why did Drug Safety publish the study manuscript? Too often when news of a controversial or bad study is published, the journal that published it stays out of the limelight. While the proximal cause is likely that journalists don’t think to ask journal editors and/or publishers tough questions about their publishing process, there is also a cultural problem here: when shit hits the fan, only the study’s authors are pulled up, but when things are rosy, the journals are out to take credit for the quality of the papers they publish. In either case, we must ask what they actually bring to the table other than capitalising on other scientists’ tendency to judge papers based on the journals they’re published in instead of their contents.

Of course, it’s also possible to argue that unlike, say, journalistic material, research papers aren’t required to be in the public interest at the time of publication. Yet the BHU paper threatens to undermine public confidence in observational studies, and that can’t be in anyone’s interest. Even at the outset, experts and many health journalists knew observational studies don’t carry the same weight as randomised controlled trials as well as that such studies still serve a legitimate purpose, just not the one to which its conclusions were pressed in the BHU study.

After the paper’s contents hit the headlines, the ICMR shot off a latter to the BHU research team saying it hasn’t “provided any financial or technical support” to the study and that the study is “poorly designed”. Curiously, the BHU team’s repartee to the ICMR’s makes repeated reference to Vivek Agnihotri’s film The Vaccine War. In the same point in which two of these references appear (no. 2), the team writes: “While a study with a control group would certainly be of higher quality, this immediately points to the fact that it is researchers from ICMR who have access to the data with the control group, i.e. the original phase-3 trials of Covaxin – as well publicized in ‘The Vaccine War’ movie. ICMR thus owes it to the people of India, that it publishes the long-term follow-up of phase-3 trials.”

I’m not clear why the team saw fit to appeal to statements made in this of all films. As I’ve written earlier, The Vaccine War — which I haven’t watched but which directly references journalistic work by The Wire during and of the pandemic — is most likely a mix of truths and fictionalisation (and not in the clever, good-faith ways in which screenwriters adopt textual biographies for the big screen), with the fiction designed to serve the BJP’s nationalist political narratives. So when the letter says in its point no. 5 that the ICMR should apologise to a female member of the BHU team for allegedly “spreading a falsehood” about her and offers The Vaccine War as a counterexample (“While ‘The Vaccine War’ movie is celebrating women scientists…”), I can’t but retch.

Together with another odd line in the latter — that the “ICMR owes it to the people of India” — the appeals read less like a debate between scientists on the merits and the demerits of the study and more like they’re trying to bait the ICMR into doing better. I’m not denying the ICMR started it, as a child might say, but saying that this shouldn’t have prevented the BHU team from keeping it dignified. For example, the BHU letter reads: “It is to be noted that interim results of the phase-3 trial, also cited by Dr. Priya Abraham in ‘The Vaccine War’ movie, had a mere 56 days of safety follow-up, much shorter than the one-year follow-up in the IMS-BHU study.” Surely the 56-day period finds mention in a more respectable and reliable medium than a film that confuses you about what’s real and what’s not?

In all, the BHU study seems to have been designed to draw attention to gaps in the safety data for Covaxin — but by adopting such a provocative route, all that took centerstage was its spat with the ICMR plus its own flaws.

India can do it!

Against the background of the H5N1 pandemic in birds and an epidemic among cattle in the US, the Government of Victoria, in Australia, published a statement on May 21 that the province had recorded the country’s first human H5N1 case. This doesn’t seem to be much cause (but also not negligible cause) for concern because, according to the statement as well as other experts, this strain of avian influenza hasn’t evolved to spread easily between people. The individual in question who had the infection — “a child”, according to Victoria’s statement — had a severe form of it but has since recovered fully as well.

But this story isn’t testament to Australia’s pathogen surveillance, at least not primarily; it’s testament to India’s ability to do it. In Vivek Agnihotri’s film The Vaccine War — purportedly about the efforts of Bharat Biotech, the ICMR, and the NIV to develop Covaxin during the COVID-19 pandemic — Raima Sen, who plays the science editor of a fictitious publication called The Daily Wire, says about developing the vaccine in a moment of amusing cringe on a TV news show that “India can’t do it”. Agnihotri didn’t make it difficult to see myself in Sen’s character: I was science editor of the very real publication The Wire when Covaxin was being developed. And I’m here to tell you that India, in point of fact, can: according to Victoria’s statement, the child became infected by a strain of the H5N1 virus in India and fell ill in March 2024.

And what is it that India can do? According to Victoria’s statement, spotting the infection required “Victoria’s enhanced surveillance system”. Further, “most strains don’t infect humans”; India was able to serve the child with one of the rare strains that could. “Transmission to humans” is also “very rare”, happening largely among people who “have contact with infected birds or animals, or their secretions, while in affected areas of the world”. Specifically: “Avian influenza is spread by close contact with an infected bird (dead or alive), e.g. handling infected birds, touching droppings or bedding, or killing/preparing infected poultry for cooking. You can’t catch avian influenza through eating fully cooked poultry or eggs, even in areas with an outbreak of avian influenza.”

So let’s learn our lesson: If we give India’s widespread dysregulation of poultry and cattle health, underinvestment in pathogen surveillance, and its national government’s unique blend of optimism and wilful ignorance a chance, the country will give someone somewhere a rare strain of an avian influenza virus that can infect humans. Repeat after me: India can do it!

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).

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).

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.