In a letter dated January 19, 2021, Union home secretary Ajay Bhalla wrote to the chief secretaries of state governments requesting them to prosecute those who the government deems to be spreading rumours about the safety and immunogenicity of the COVID-19 vaccine candidates that are currently party of India’s vaccination drive.
Bhalla writes in the letter, a copy of which The Wire has seen, that the “National Regulatory Authority has found both the vaccines safe and immunogenic” and then proceeds to claim “unfounded and misleading rumours are circulating in the social and other media creating doubt about the safety and efficacy”.
To this end, Bhalla concludes by “urging” the chief secretaries to install measures to “check” the spread of these offending messages and to “promptly disseminate factual messages”. He also suggests penal against those “found to have indulged in such activities” according to the Disaster Management Act 2005 and the IPC.
Bhalla’s instruction effectively attempts to tip the scales of an ongoing debate about vaccine hesitancy in favour of the government.
The Drug Controller General of India approved the two vaccine candidates, Covaxin and Covishield, on January 3 in controversial circumstances. Covaxin didn’t, and still doesn’t, have phase 3 clinical trial data as proof of its efficacy – while Covishield, whose phase 3 trials were conducted abroad by its parent company, AstraZeneca, has still to answer for lingering doubts about the data from which its efficacy and safety were estimated.
The Government of India commenced its nationwide vaccination drive on January 16, starting with healthcare and frontline workers as the first recipients of doses of these vaccine candidates.
“The letter is worded carefully, since it mentions only ‘rumour-mongering’ in the context of ‘safety and immunogenicity of the vaccines’,” said Gautam Menon, a professor of physics and biology at Ashoka University and who has been working on disease transmission models since the pandemic began.
Indeed, Bharat Biotech – which is Covaxin’s maker – had successfully completed phase 1 and 2 trials by December 2020. These two phases are used to determine safety and immunogenicity respectively. The company had uploaded the preprint paper corresponding to the phase 1 trial earlier, while The Lancet published a peer-reviewed version on January 21, 2021. The phase 2 trial’s preprint paper is available here.
“Those concerned about the Covaxin rollout have highlighted the absence of efficacy data,” Menon continued, “which is assessed in phase 3 trials. It’s here that no information is available in the public domain” – and which independent observers have been asking from the government.
So, as Menon said, “Much will depend on how [the phrase] ‘spreading rumours’ will be interpreted.”
The circumstances of Covaxin’s approval in particular have triggered multiple doubts about its use. While independent experts have said that this vaccine candidate is likely to be safe and meaningfully efficacious given the technology it uses is old and well-understood, they have also said the government’s own eagerness and its unnecessary subversion of the regulatory process prompt doubts as to why.
This in turn has given rise to vaccine hesitancy around the country, including among doctors shortlisted to receive the vaccine candidates. The hesitancy is reflected in the sub-par vaccination numbers on the first and subsequent days of the vaccination drive.
However, paralleling this sentiment has been a public debate – or public joust, more like – about whether asking questions about the vaccine candidates’ safety and efficacy ‘even after the DCGI has approved them’ amounts to undermining the regulator’s authority and, thus, promoting vaccine hesitancy.
This argument has been popular within the right-wing especially since Union science and health minister Harsh Vardhan’s comment that the people should simply trust the government and fall in line with the DCGI’s verdict. And caught on the other side of this debate are journalists who have continued to ask questions about the missing efficacy data for Covaxin – as well as the episodic hype and spin accompanying pronouncements about the candidates.
For example, most recently, a not insignificant number of mainstream news publications reported that The Lancet had endorsed Covaxin – as opposed to simply reviewing and publishing the phase 1 trials paper, as written by the researchers who conducted the trial. However, as public health consultant Dr Jammi Nagaraj Rao pointed out in The Wire Science, The Lancet also commissioned an independent commentary on the results that categorically pointed out three pending questions, the first of which is (quoted verbatim from Dr Rao’s article): “Will [Covaxin] be efficacious?”
This is the same question that journalists as well as independent scientists and medical workers have been asking about Covaxin – and thus far have been met with silence or evasive answers. And already, nearly 2 million frontline and healthcare workers have received doses of one or the other candidate (the break-up is not known).
There is also no clarity on whether police personnel or entities at the state or central level will stop to check whether a supposed “rumour-monger” is spreading “unfounded claims” about a candidate’s immunogenicity or efficacy before pressing charges against them.
Menon worried that Bhalla’s letter, thus, carries “the danger of conflating anti-vaxxers spreading misinformation with those who are raising well-founded questions about the large-scale rollout of Covaxin in the absence of any information about its efficacy.”
(This is not a minor issue since even former AIIMS director Dr Mahesh Chandra Misra asserted to Karan Thapar during a recent interview that “immunogenicity is efficacy”.)