In India, pseudo-nationalism trumps science in vaccine clearance

The recent regulatory clearance given to an indigenous developed vaccine candidate in India is an example of vaccine nationalism at its worst and jettisoning of all the principles of an evidence-based, scientific approach

January 09, 2021 by Prabir Purkayastha

It is disturbing the way the Indian government and the regulatory authorities have handled the emergency use of vaccines for COVID-19. It began with emergency use being granted to Oxford-AstraZeneca-Serum Institute’s (Oxford-SII) Covidshield vaccine, and the furor in the BJP’s [India’s ruling Bharatiya Janata Party] social media-troll army for not granting similar approval for the indigenous National Institute of Virology-ICMR-Bharat Biotech’s (NIV-BB) Covaxin, framing it as an angrezi [foreigner] versus Indian vaccine issue. It was a display of vaccine nationalism at its worst and jettisoning of all the principles of an evidence-based, scientific approach in favor of the supposed nationality of the vaccine. Any criticism of such a demand was vilified as pro-foreigner, forgetting the same troll army’s “nationalist” fervor to acquire defense equipment from abroad.

The Central Drug Standards Control Organization (CDSCO) caved in under the ruling party’s social media pressure, granting emergency use for Covaxin as well. Though the CDSCO has hedged clearance with certain extra riders, the fact is that Covaxin has yet to submit any efficacy data from its phase 3 trials and is a clear violation of CDSCO’s earlier position requiring efficacy data from phase 3 trials. This is what the scientific community, including the people’s science movement – the All India Peoples Science Network – were critical of.

The uproar in the Indian science community has been on two counts. One is the lack of transparency— the complete absence of any public information based on CDSCO’s decisions, even on the clearance accorded to the Oxford-SII vaccine. The second is not disclosing the basis of clearing the NIV-BB’s vaccine. Further, the rider of allowing mass vaccination “in a clinical trial mode” has not been clarified by CDSCO, nor was its statement that this decision was based on phase1 and 2 trial data and safety data from phase 3 trials. Safety and immune response is a part of phase 1 and 2 trials; phase 3 trials are primarily for judging efficacy. CDSCO’s statement makes it clear that crucial efficacy data from the phase 3 trials have yet to be submitted.

Though India’s COVID-19 cases are coming down, we are by no means out of the woods. We are still among the top ten countries in the number of new cases. With more infectious COVID-19 strains emerging in the UK and South Africa, there is a possibility of another wave if such strains take hold in the country.

We do need vaccines for a mass vaccination program, starting with the front-line health workers, followed by workers in essential services, and older people. This is a formidable task in itself as the slow and botched examples of vaccine rollouts come in from the US and other countries. We also have anti-vaxxers, whose scientific understanding is on par with those peddling cow science. The last thing we need is a non-science based effort to promote a vaccine or vaccines, that are based not on science and evidence but mass hysteria in social media.

Certain caveats are in order here. Will Bharat Biotech vaccines be safe and produce a reasonably good immune response? Most probably yes. Phase 1 and 2 trials are for determining immune response and safety, though in smaller numbers than in phase 3 trials. However, an immune response is not enough, as we need to know whether such an immune response can reduce the chances of infection. That is why the two-arm phase 3 trial: it is to see significant differences in infections between those receiving the vaccine arm and the other arm, who have received the placebo. This is the meaning of the 50% level of efficacy as a minimum bar imposed by most regulators: the number of infected in the vaccine arm should be at least half of those in the placebo arm. The recent figures of five vaccines that have shown efficacies well above 50% are the ones by BioNtech-Pfizer, Moderna and Gamaleya – which show an above 90% efficacy –   China’s Sinopharm at 79% and Oxford-Astra-Zeneca’s at 70%.

Is it likely that Bharat Biotech’s vaccine will have the desired efficacy level –  better than 50% as set by most regulators? Probably yes. It is an inactivated virus vaccine, one of the oldest vaccine technologies. Adding adjuvants, adding chemical agents to boost the immune response of the body is also not new, though one of the adjuvants in the Bharat Biotech vaccine is a new one from a US company. Yes, the adjuvant is foreign, the virus is international, only its inactivated form is Indian! Is it safe? Again yes, though a larger phase 3 trials can sometimes uncover safety issues not seen during the more limited phase 1 and 2 trials.

Then why the hue and cry among the scientific community? It is the damage to the scientific institutions that we have built in this country, when a regulator, under pressure, clears a vaccine violating its guidelines and follows completely different criteria simply because the vaccine is indigenous. For the record, Gamaleya with Dr. Reddy’s Lab and Pfizer have both made applications to CDSCO and are awaiting clearance with relatively much stronger cases.

The other problem with CDSCO’s clearance of the vaccines is that no details of either the data or the regime of vaccination to be followed have been provided. “Sources” within the ministry have said that India will follow the UK regulator’s approach in spacing the two shots. The UK regulator has stated that in the two-shot vaccines, the second shot will be given within 12 weeks of the first, though the phase 3 efficacy trials were conducted in much narrower gaps between the two. The argument is that the first shot itself provides significant immunity and protection against serious illnesses. The UK authorities are in emergency mode with their numbers shooting up rapidly with the new variant of the virus and an impending collapse of the hospitals. The FDA – the US regulator –  is also under pressure with the US facing ongoing spikes in various states, and still leading the world in the number of new cases. The FDA, however, has said that it will stay with the same regime as phase 3 trials in terms of the gap between the first and second shots.

Again, the opaqueness of India’s handling of the COVID-19 pandemic is visible here as well. There is no transparency on the spacing between the two shots, how the vaccine will be rolled out, who are the groups who will be vaccinated first, how the priorities are being decided, the role of the state governments, and so on. On view is the government’s understanding that the pandemic is only an administrative challenge, not a public health one. Again, a completely top-down approach which led to the fiasco of a draconian lockdown with a four-hour notice appears to be in the offing. The CDSCO’s opaque clearances are very much a part of this top-down, secretive approach of the Modi government. And just for the record, we are still under two emergency laws – the Epidemic Prevention Act and the Disaster Management Act.

For those who believed that COVID-19 was just another flu, or that we would get herd immunity if we let the epidemic rip through our population, have been proven woefully wrong. Sweden, the poster child of the herd immunity policy, is now discovering the cost of such an approach. Neither does the data support those who suggested that the choice was between epidemic and economic. Countries that have controlled the epidemic like China, Korea and Vietnam have suffered the least economic losses. Those who thought that keeping the economy open at the cost of the infected and the dead will help have seen their economy sink with rising numbers as people have imposed their own voluntary lockdowns.

This is why vaccines are our one chance to return to normalcy; or at least near normalcy. That is why the importance of getting the vaccine decisions right, as well as the vaccine roll-out and implementation.

Shining torches, banging thalis [plates] and chanting ‘go corona, corona go’ [some forms of ‘prevention’ seen during the early stages of the virus], did not help us. A botched vaccine campaign is the last thing this country needs. But with a regime focused in its a headlong rush towards the middle ages, targeting food, women’s right to love and marry and promoting “cow science”, actual science is clearly at a discount. CDSCO’s capitulation to BJP’s social media demand for a “nationalist” vaccine does not augur well for us. Neither does the opaque, top-down, authoritarian approach of the Modi government to essentially a public health challenge