COVID-19 vaccine rollout in India seen as high-handed and reckless by many people
There have been reports of enrollment for trials without due diligence, of multiple adverse reactions and of lack of clarity on how vaccine producers have responded to allegations and complaints
As India rolls out what will be the world’s largest vaccination drive to contain the Sars-Cov-2 pandemic, it is instructive to look back to another time and another disease that was sought to be tamed with an equally large rollout.
It was almost 100 years ago that the vaccine called BCG (short for Bacillus Calmette-Guerin) was introduced to fight tuberculosis; now considered to be the world’s most widely used vaccine. In post-Independence India, the BCG campaign was billed as the largest immunisation campaign the world had seen. And it faced tough resistance from several quarters, the most notable of them being from India’s last Governor General C Rajagopalachari, who published an influential pamphlet titled ‘BCG – Why I Oppose It’ in 1955.
In a letter to The Hindu on 17 May 1955, Rajagopalachari asked two questions to highlight his reservations against the vaccine: (1) Is there no danger in mass inoculation by live BCG? (2) Does the attenuated Bovine tubercle bacillus create an immunity against the normal human infection? (as quoted in the book ‘The Politics of Vaccination – A Global History’; Manchester University Press, UK, 2017).
The opposition from Rajaji and a host of others took on multiple arguments and complex hues, in particular questions on safety and efficacy. But some of the doubts were also on the influence of Western medicine in the then newly independent India, the need for a focus on hygiene and sanitation rather than a vaccine and the government’s role in managing the health needs of citizens.
The history is interesting and relevant in the sense that it speaks of scepticism that was inherent in the Indian mind set towards an intrusive technology and that the scepticism came even from well-informed and highly-educated minds who otherwise bought into the idea of modern, evidence-based medicine.
Added to this is the constituency of those who till date refuse to buy into the idea of health offered by formally trained doctors and health professionals, partly because of costs, ease of reach or ignorance, or belief in the diverse set of Indian systems of medicine.
This history is compounded in unknown and uncertain ways today given India’s poor health services, the loss of credibility of health professionals, particularly given the way some hospitals have treated patients during the pandemic and a renewed government-led interest and push in support of Indian systems of medicine that has seen many doctors and surgeons questioning the approach of the authorities.
It is in this context that India embarks on the massive drive to control the pandemic by what holds the promise of a definitive solution – a vaccine. In this, the launch of the vaccination drive on Saturday (January 16) is truly an important milestone and the Prime Minister was right in pointing out: “Such a vaccination drive at such a massive scale was never conducted in history. There are over 100 countries having less than three crore population and India is administering vaccination to three crore people in the first phase only. In the second phase, we’ve to take this number to 30 crores.”
And as the Chairman and Managing Director of Bharat Biotech Dr. Krishna Ella, leading the team behind Covaxin, said on January 3 on the ‘emergency use’ approval of the vaccine: “…a giant leap for Innovation and novel product development in India. It is a proud moment for the nation and a great milestone in India’s scientific capability, a kick-start to the innovation ecosystem in India.”
Covaxin is an indigenous vaccine being developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune. The other vaccine, Covishield, is developed by AstraZeneca and Oxford University and is manufactured by the Serum Institute of India.
Both vaccines have received emergency approval but the wording is slightly different. In the case of Covishield, the ‘Subject Expert Committee’ recommended granting of permission for “restricted use in emergency situations subject to certain regulatory conditions,” according to a press release issued on January 3 titled “Drugs Controller General of India (DCGI) on Restricted Emergency approval of COVID-19 virus vaccine”.
In the case of Covaxin, the indigenous vaccine, the same release says: the Committee has “recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode…”
Why and what is the difference between the two, and the difference between emergency approval and restricted approval? Strictly speaking, if approval for Covaxin is in clinical trial mode, the vaccine cannot be rolled out for use by the government.
These are ultra-modern vaccines, prepared in a vastly compressed time frame from what was until now thought to be required for a vaccine, and it showcases the power and capacity of technology to respond to an emerging threat. What should the government have done to make this the smoothest take off that it has ever had?
It is, in fact, in the interest of the government, politically and for the sake of health and the revival of the economy, that there should be no issues, concerns, doubts or questions about dealings with the manufacturers, integrity of data and due process so that the people are doubly assured. With this achieved, there may still be naysayers, but the authorities would have covered as many risks aspossible. Without this, the risk is of a mammoth project running into more controversy than it can handle.
It is here that questions can be asked as to the way in which the government has gone about the process, often overzealous in its push and overemphatic about this being one more muscular, gung-ho achievement under a government that likes to talk in the tone of grandiose achievements.
The first one that will not go away and will likely lead to “vaccine hesitancy” is the simple question on transparency. There have been reports of enrollment for trials without due diligence, of multiple adverse reactions and of lack of clarity and openness on how the relevant vaccine producer or the Indian authorities have responded to the allegations and complaints.
This is an extremely sensitive matter, and once the waters have been muddied, it will become very difficult to a) signal to the manufacturers that the government expects the highest standards in terms of data and trial processes and b) bring back confidence of the public in the process and the vaccine.
Already, there are anecdotal accounts of some doctors privately advising patients to avoid the vaccines, and some doctors asking themselves if they would take up offers for the vaccine as it is rolled out first to health workers. In short, the level of scepticism is very high early into the programme and signal trouble ahead. Best practices, which are well laid out, may entail some more delays but they eventually lead to a wide buy-in.
It is not too late to fix some of the issues. As Dr. T Jacob John, a leading virologist noted for his frank views, said in an interview: “If the government can right away give clear explanations of the alleged safety problems – factually – that will help. Also, if the Regulator could clarify why the two vaccines have not been assessed on par, that will help. The terms "restricted use", "emergency use", and the purpose of the vaccine roll out when the epidemic is dying out and such details will help.”
Dr.John had advocated a national joint Task Force approach to enable building of trust with all players being asked to work together for designing, testing, manufacturing vaccines expeditiously, in collaboration, with the government ensuring some fund investment and avoiding industry competition.
In his words: “The crucial attributes to be available for comparison are safety and efficacy. In times of a pandemic, urgency was important. That is why I have favoured a joint Task Force approach instead of letting companies go forward and then the CDSCO sitting in judgment, and giving differential assessments to the two vaccines, leading to questions about the transparency and trustworthiness, and the health ministry not clearing the air by saying if the reported adverse events were or were not related to the vaccines - all these were eminently avoidable.”
In many ways, the launch of the vaccinations can be seen as high-handed and reckless, with the downside of damaging the credibility of India’s capacities and as a global supplier of vaccines. But from another lens, it is being called a bold move achieved in good time. And to make this bold move achieve its given purpose, the authorities must ensure they live by some simple principles – “to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs,” which are the words in the mission statement of the Central Drugs Standard Control Organisation under the Ministry of Health and Family Welfare.
(The writer is a journalist and a faculty member at Bhavan’s SPJIMR. Views are personal)
Syndicate: The Billion Press
Published: 17 Jan 2021, 2:00 PM