The ‘Vaccine Row’ in India explained: between a jab and a hard place 

On December 21, US President Joe Biden rolled up a sleeve and smiled at television cameras as he received a Covid-19 jab. “I urge you to take it. There is nothing to worry about,” tweeted the 78-year-old. In Israel, Prime Minister Benjamin Netanyahu, 71, took a shot on television, to encourage his country. Days later, Britain’s Queen Elizabeth, 94, and Prince Philip, 99, received theirs at Windsor Castle. At Vatican, Pope Francis, 84, took his shot and told reporters: “It is a moral choice. It is about your life but also the lives of others.”

The future suddenly looks a little brighter. If 2020 was a year of fear, 2021 promises to be one of liberation. Central to it is the stunning triumph of science over a new illness that sickened 99 million people and snuffed out 2.1 million lives in less than a year. With scientists working at breakneck speed to introduce new innovative vaccines, novel coronavirus SARS-CoV-2 is predicted to fade into something like a common cold in not too distant a time. “It's bittersweet that we have the beginning of what will ultimately be the end game of this pandemic,” Dr Anthony Fauci, immunologist and the listened-to voice right now, has announced.

When and how that comforting time will take shape is far from clear. The future hinges on key variables: time, safety, efficacy and acceptance. As the world rolls out the first of the new vaccines, worries are mounting: How safe are they? How well will they control the virus? How quickly can vaccination be rolled out to everyone? Who should get it first? How long will vaccines protect? With limited vaccine doses available, and a pandemic claiming lives every day, a complex calculation has begun. The world is making a historic policy decision, but in wholly uncharted territory.

Challenge: who should get it?

Every country faces different challenges in the race to get a vaccine to millions of people. The first challenge is that of prioritising people: Who should get the vaccine first? As Dr Jayaprakash Muliyil, epidemiologist and former principal of Christian Medical College, Vellore, explains, at one end there are the vulnerable seniors and those with underlying medical conditions (comorbidity). Global data show the single largest predictor of death from coronavirus is age. At the other end are younger people in essential services, who come in contact with many in course of a day, can become sick or super-spreaders. Should policy-makers try to prevent deaths by vaccinating the former or slowdown transmission by targeting the latter?

In most countries—US, UK, Canada, the European Union, India—the plan is to save older people first, with varying age cut-offs: The first priority in the US is people over 74, in UK the over 80s, in India the 50-plus. Some countries, say China and Indonesia, are giving it first to the 18-59 age bracket, people who are in essential services, who come in contact with many in course of a day, are socially active. About 172 countries, including India, that are signatory to the COVAX global initiative for equitable vaccine access, are giving earliest doses to front-line healthcare workers.

Challenge: how safe is the vaccine?
Questions remain on the safety, side effects and efficacy of the new vaccines, points out Dr. Able Lawrence, professor of clinical immunology at Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow. Created at record speed (the average time to develop vaccines is about 10 years), nobody knows just how well they work, as none of the vaccines have been fully approved.

The very first vaccines for Covid-19 to complete phase 3 testing—by Pfizer-BioNTech and Moderna Inc—use experimental mRNA technological platforms. As for adenoviral vaccines (by Oxford-Astrazeneca, Sputnik V, CanSino, Johnson & Johnson) they have not proved effective against human diseases so far (except perhaps rabies). And vaccines based on inactivated virus particles (Bharat Biotech’s Covaxin) run the potential risk of enhanced respiratory disease upon infection with the coronavirus.

Challenge: trust in the vaccines
The most crucial challenge is of trust in the vaccines, says Dr Swapneil Parikh, internal medicine specialist and healthcare entrepreneur, who co-authored the first book on the pandemic in India, The Coronavirus: What you Need to Know about the Global Pandemic. “With vaccines, there is often a lot of misinformation, disinformation and anti-science movements and these feed uncertainties and fear in society,” he says. “We need to be proactive in countering these with correct information.” The rate of severe adverse events with the current Covid-19 vaccines is somewhere in the range of 1 in 100,000 to 1 in 1 million, he explains. Whereas, the chances of severe Covid-19 infection is between 1 in 20 to 1 in 1,000. A risk-to-benefit analysis clearly favours vaccination, he adds.

The new vaccines make out immune systems work very hard, what is called ‘reactogenicity’ by scientists. We need to be upfront in telling people that one-third to half of all people vaccinated will have some minor adverse effects, but they are all manageable. The most important thing one needs people to understand is a related adverse event and an unrelated adverse event. If you take a population of 10 million people, statistics show, 300 of them will die as a natural course of life in 24 hours—with or without vaccination. Over the next two months 10,000 people will die: heart attacks, stroke, cancer and so on. These are just the expected frequencies of these conditions in society. What happens is, in case of people who are vaccinated often false co-relations are made between incidental and related adversities. “It is important to let people know that the risks are less and benefits are much more.”

Trust develops only when all the fear and anxiety are managed with better communication and more transparent processes, explains Dr Parigh. Pfizer, Moderna, Astrozeneca, in fact, most vaccine-makers have already published research protocols, all of which are accessible online. Bharat Biotech, however, has not published the research protocols of its Covaxin vaccine. “We don’t know how they are conducting the study. This is where the need for transparency comes in,” he adds.

Leading by example

While elderly world leaders are stepping forward as exemplars of public spiritedness and authority, a few are conspicuously absent from the list of the vaccinated, triggering furious speculation: Prime Minister of India Narendra Modi, 70, the President of China, Xi Jinping, 67, and the Russian President, Vladimir Putin, 68. China is silent on why Xi Jinping and the top leaders of the ruling Communist Party and party cadre are yet to take Covid-19 vaccine jabs. Similarly, Kremlin has announced that protecting the economy and avoiding a return to lockdown are Putin’s priority, but he will—eventually—get the jab. They are, however, doling out millions of doses of state-owned vaccines to neighbours and friends in need. One-upmanship and smear campaigns are in the air.

When will PM Modi take his shot? No one knows for sure. On January 16, he launched the first phase of India’s vaccine drive on 30 million healthcare and frontline workers via video link. Officials in the Prime Minister’s Office told reporters anonymously that the PM is likely to take the vaccine around March or April, when the second phase is rolled out among 30 million Indians—people over age 50, with underlying medical conditions (comorbidity) and compromised immunity. Apparently, at a January 11 meeting with chief ministers, he has shot down the suggestion of including politicians in the first phase: “Politicians should not try to jump the queue.” When asked which vaccine will he go for, the officials refused to respond.

Uncomfortable questions

As the ruling class stays away from public inoculation, a vaccine row has broken out, with the Opposition voicing apprehensions over the safety and efficacy of India’s indigenous vaccine. “While in every country the head of the government has taken the vaccine, why has no responsible functionary of the government taken the vaccine shots first, if it is so safe and reliable?” Congress leader and MP from Anandpur Sahib, Manish Tewari, has asked, pointing a finger at the Modi government for not allowing people to choose their vaccine of choice: “It militates the doctrine of informed consent that lies at the heart of medical ethics.” Congress leader Priyank Kharge has asked for disclosure of vaccine data, Samajwadi Party president Akhilesh Yadav has expressed lack of trust, while RJD leader and MLA, Tej Pratap Yadav, has called Modi to take a shot first.

Not just politicians, doctors and scientists are also asking for disclosure of data on vaccine trials. In a statement, the Progressive Medicos and Scientists Forum has demanded that all data pertaining to the vaccine trials should be made public to enable scientists and healthcare workers to make informed choice regarding administration of vaccines for themselves and for their larger communities: ”All healthcare workers should have the option of opting out without any fear, coercion or any other adverse impact on them, including linking vaccination status to air travel restrictions.”

It’s not just India, since September 2020 researchers across the world have been urging vaccine-makers to share detailed blueprints of their studies, so that outside experts can evaluate them. In a rare move, the two drug companies leading the vaccine race—Moderna and Pfizer—bowed to public pressure and growing suspicion, abandoning their traditional secrecy and released comprehensive data of ongoing clinical trials and evaluation of their vaccines. In November, vaccine developers AstraZeneca and University of Oxford (with Serum Institute of India) faced a major controversy for cherry-picking data and not revealing that its sample size of elderly participants was very small.

The big issue: Covaxin

On January 3, right after the World Health Organization allowed restricted emergency approval to vaccines, the Drugs Controller General of India has extended it to two vaccines: Covishield by Serum Institute of India (with AstraZeneca and Oxford) and Covaxin by Bharat Biotech (with ICMR). Covaxin, however, is still under phase 3 clinical trial. Its efficacy, immune response and potential unacceptable side-effects are yet to be published. No peer-reviewed studies has also evaluated its safety. The approval has shocked the scientific community and raised concerns: How can a vaccine be cleared for emergency use by millions of vulnerable people in a clinical trial mode? The DGCI has assured that the vaccine is "safe and provides a robust immune response.” Bharat Biotech, a reputed vaccine-maker, has called the vaccine “200% safe.”

Yet scientists and health experts are not pleased. “There are a few precedents of emergency approval of vaccines,” explains Dr Muliyil. “The WHO, for instance, gave emergency authorisation to Ebola vaccine made by Merck in Liberia and Guinea, although the human clinical trial was still underway.” But, then, these happen in urgent situations of emergency. Ebola, for instance, was killing 50 per cent of the infected. “Where is the emergency in India now,” he asks. From a peak infection rate of about 96,000 a day in September 2020, the coronavirus is now infecting about 10,000 people a day. The death rate has also come down from 1200 a day in September to 140 a day now.

“Not every vaccine is created equally,” says Dr Parikh. For Bharat Biotech’s Covaxin, there is phase 1 and 2 immunogenetic and safety data, but this data does not equal to phase 3 efficacy or safety. “Right now, there isn’t enough publicly available data to come to a scientific opinion about Covaxin,” he points out. But by the time the large swathe of general public is due for vaccine all these data will be out and questions answered, he believes. “Right now some of these questions cannot be answered.”