As the COVID-19 pandemic continues to wreak havoc across the globe, India has just embarked on a vaccination drive of an incredible scale. The South Asian country is currently struggling with almost 11 million cases of COVID (at time of writing), second only to the United States. Indians have been looking to Covaxin, a domestically-produced COVID vaccine, for a solution to the crisis. But, from the outset, its development has been embroiled in controversy.
Covaxin, or BBV152, is being developed by Bharat Biotech, an Indian pharmaceutical company, in conjunction with the Indian Council of Medical Research, a government body that promotes biomedical research. Similar to the Oxford-AstraZeneca vaccine, Covaxin is administered in two doses and can be stored at 2-8 °C. However, its formula is based on an inactivated sample of the coronavirus, while the Oxford-AZ vaccine uses a modified chimpanzee adenovirus. Bharat Biotech’s achievement has been hailed as a stellar example of public-private partnership for societal benefit.
On the other hand, its development appears to have been injected with nationalist sentiment. Prime Minister Narendra Modi hailed Covaxin as an example of his administration’s Make in India initiative, and ICMR and Bharat Biotech advertised the product as “fully indigenous”, implying that it has been developed domestically by Indians. However, the vaccine uses Alhydroxiquim-II, an adjuvant component to boost immune response, which has been licensed from Kansas-based biotech company ViroVax.
Other critics contend that the rapid development came at the cost of ethical oversight. During Phase 3 trials, Indian media reported that trial participants in the city Bhopal were misled into believing that they had been administered with the actual vaccine. Many of the participants were impoverished or illiterate; some admitted that they had signed documents that they were not capable of understanding and that were not explained to them. These practices violated the principle of informed consent, a key concern in medical ethics. In response to investigations, Bharat Biotech stated that its trials were fully compliant with India’s clinical trial rules for vulnerable subjects.
The controversy touched a nerve in a city that has previously been victimized by the negligence of industry. In December 1984, a leak at the Union Carbide pesticide plant exposed over 500,000 residents of Bhopal and surrounding towns to toxic methyl isocyanate gas. The event is considered one of the worst industrial disasters in history - one whose repercussions are felt even today. And, in a twist of cruel irony, the site of the Covaxin trials is located in the same neighborhood as the Union Carbide facility. Four local nonprofit organizations wrote a letter to Modi, with one activist alleging that over 700 of the 1,700 Covaxin trial participants were survivors of the Bhopal gas tragedy.
Covaxin received emergency authorization from domestic regulators on January 3rd, a month after Bharat Biotech filed its application. However, at the time, no data from Phase 3 clinical trials had been published on the vaccine’s efficacy. Regulators stated that the vaccine was approved “in clinical trial mode”, causing widespread confusion as to its actual approval status. On January 21st, a study published in the Lancet concluded that Covaxin was safe and capable of inducing effective antibody responses; later, a preprint on bioRxiv noted effectiveness against the UK strain of the virus. Despite this, the concerns around lack of transparency and circumvention of scientifically rigorous review remain valid.
The scandalous optics around the Bhopal trial, combined with lack of clarity around Covaxin’s approval status, eroded public trust in India’s immunization efforts. In the initial stages of the national COVID vaccination drive, healthcare workers received jabs of the two vaccines approved at the time, Covaxin and Oxford-AZ. Several workers reported that they were hesitant to take the former due to the dearth of efficacy results.
Despite these worrying incidences, however, India has long held a reputation as a global powerhouse in vaccination. Having eradicated smallpox in 1977 and, more recently, polio in 2014, the country is no stranger to extensive vaccination drives. This history means that India has an established network of cold chains - temperature-controlled transportation and storage infrastructure - which will be vital logistical elements in the distribution process.
In addition, India produces over half the world’s vaccine supply, thus earning the moniker of the pharmacy of the world. The Serum Institute of India is the world’s largest vaccine manufacturer by volume, and has struck a licensing agreement with Oxford and AZ to manufacture their product. As a result, while the vaccine rollout could be delayed by logistical shortfalls in other countries (as is currently occurring in the UK), India is unlikely to face the same problems.
Even so, a vaccination drive in a country so large and diverse is hardly a walk in the park. There are other challenges to be overcome, such as misinformation promoting vaccine hesitancy. For example, Akhilesh Yadav, the chief minister of the most populous state in India, stated that he did not trust the “BJP’s vaccine” as it was developed under an administration that his party opposes. Another legislator from Yadav’s Samajwadi Party, Ashutosh Sinha, backed up his superior’s claims, insinuating that impotence is a side effect.
While this has not yet arisen as a major problem during the COVID crisis, some religious leaders and communities have historically objected to vaccinations. If this were to happen in the 21st century, the issue would likely be exacerbated by the prevalence of digital channels that compound misinformation. On the flip side, a lack of online connectivity and physical infrastructure pose challenges in reaching remote areas: a potential stumbling point for a country where over 70 percent of the population is located in rural regions.
To ground present sentiments of vaccine hesitancy, it is illustrative to look at the work of the historian Niels Brimnes, who studies health and illness in colonial India. Brimnes has written on political and philosophical objections raised by eminent figures against BCG (the vaccine for tuberculosis disease). The famed politician and independence activist Rajagopalachari was an anti-statist who opposed the centralized nature of vaccination drives in India, while also making scientific complaints against the efficacy of BCG. Even Mahatma Gandhi, known as the father of the nation to Indians, touted his preference for indigenous tradition over Western medicinal practices like vaccination.
More recently, Brimnes notes, public health educator Debabar Banerji offered a post-colonial critique of vaccines in India. While accepting vaccination’s scientific benefits, Banerji framed the Western push for polio vaccination as an apology for colonialism, but an insufficient one. This echoes another historical theme: the idea that developing countries are an experimental playground for Western scientists. Banerji’s proposed alternative was to promote sustainable investment in structural improvements to public health, and elevate the voices of local health planners to create an “endogenous body of knowledge” - one better suited to the cultural characteristics of India.
In the post-pandemic era of global relations, the Indian vaccination machine continues to live up to its name as the pharmacy of the world. Bharat Biotech has announced plans to supply Brazil with doses, and US-based Ocugen will bring Covaxin to American markets. Additionally, the Indian government has agreed to donate millions of doses to its regional allies as part of a “vaccine diplomacy” initiative, with several shipments having already gone out. Bangladesh received two million doses, with Bhutan being gifted 150 thousand, and the Maldives, 100 thousand. Other recipients include Bhutan, Nepal, Myanmar, and Seychelles, with South Africa, Afghanistan, Sri Lanka and Mauritius to also receive doses later in the spring.
While altruistic on face, vaccine diplomacy can also be a mechanism to advance strategic interests. One need only look to China and their “Health Silk Road” project for a parallel. By providing medical supplies and relief packages, China has attempted to rebuild their credibility in the field of global health leadership post-COVID. Vaccine diplomacy could serve similar purposes for India, by strengthening ties with allies. The comparison might reveal India’s ambition to compete with China on the geopolitical stage.
At the fundamental level, India’s vaccine drive may signal the conclusion to a public health crisis. Nationalistic pride intertwines with market dynamics, sometimes in tension and sometimes in harmony. On the global stage, humanitarian concerns and strategic intrigues abound. This chapter in the narrative of the world’s largest democracy is filled with compelling, multidimensional narratives, and the denouement is unfolding before our eyes.