India has suffered terribly from the failure of its populist government to order anything like the number of doses it needs – and must now hope that the international community acts with urgency
On 28 April when the Indian government announced it would lower the age of vaccination from those aged 45 and older to anyone over 18, Annie Jain went on CoWin, the government-run mobile app to seek an appointment. As hours stretched to days, Jain enlisted friends to try registering her, turning her vaccination attempts into an elaborate operation.
As it turned out, within about five seconds of registration opening for the day, slots on CoWin ran out, simply because there was no supply of doses in her city, Guwahati, and across much of the country. For weeks Jain, a 27-year-old corporate lawyer, spent hours every day trying to book appointments for herself, her family and her household help – but in vain.
She was plagued by fear of contracting Covid again – compounded by the shortness of breath and increasing weakness she still felt, more than a month after she had notionally recovered from an initial bout of the virus; all of which made her quest to be vaccinated feel all the more frantic and urgent.
Nearly a month later, when she did finally secure a slot, and was standing outside a vaccination centre, Jain heard confusing news. The government had declared that people who had recovered from Covid could not contract it for six months – and so, according to this dubious scientific analysis, she need not get vaccinated after all (she had the jab anyway).
Jain planned to return to Mumbai, expecting her law firm to end its work from home policy, but stayed on when she heard that the arrangement had been extended. The shortage of vaccines and fear of an impending third wave meant that, to this day, commuter trains are still not running, restaurants and shops open for only a few hours a day and are shut over weekends, and schools and colleges only operate online.
In this once-frenetic city, government-run vaccine centres stay shut for days at a stretch due to a lack of dosage supply and long lines form outside when they are open. Dr Dnyaneshwar Waghmare, who works at a private hospital that offers Covid treatment and vaccination not far from Jain’s Mumbai home, says that for a few weeks they were so short of doses that they were only administering shots of Covaxin, India’s homegrown Covid vaccine, to those who had already had their first shots. They could not give Covishield, AstraZeneca’s India-made vaccine to anyone – for the simple reason that they had no stock.
Barely eight per cent of all Indians have received both vaccine shots. Supply shortages, unpredictable policy shifts, a continuing but so far unsuccessful international campaign for a waiver on drug patents and a measure of vaccine hesitancy: all have plagued the Indian government’s vaccination strategy, such as it is.
More than 400,000 people have died of Covid and 30 million Indians contracted the virus – a figure that probably underestimates the real total – making India the third worst affected country in the world, after the United States and Brazil. India may be home to the world’s largest vaccine maker, Serum Institute of India in Pune, and the world’s third largest pharmaceutical industry. But only about a quarter of its population have received at least one shot.
“The real stumbling block has been that there is just not enough supply,” says Achal Prabhala, coordinator of the AccessIBSA project which campaigns for access to medicines. “Two things the Indian government did not do until March were that it didn’t encourage increased production of vaccines or secure orders for enough vaccines.”
Strict lockdowns helped India get through the first wave without as much devastation as some other countries. In January, the prime minister, Narendra Modi, declared a (seriously premature) victory over Covid – even delivering Indian made vaccines to other countries through Covax, the multilateral vaccine alliance.
The government placed an initial order of little more than 15 million vaccine doses – barely scratching the surface when you bear in mind that the country has a population of 1.3 billion. By then, the UK, US and Canada had already procured sufficient doses to vaccinate their respective populations many times over, cornering most of the global vaccine supply.
In early April, Covid cases in India began rising again, soaring to more than 100,000 a day for much of that month and May. Soon, a shortage of hospital beds, oxygen, medicines, ventilators and even crematoria was crippling the country.
When Jain developed a headache, fever and weakness on 1 April, she found it hard even to get tested. “There was a ‘no’ for me everywhere. My friends told me [to] forget about a hospital bed.” Alone in the city, reading of rising cases in the media and hearing that her friends were sick and dying of a disease she thought affected mostly older people, Jain says she was “very fearful.” “I was checking my breath on the oximeter all the time.”
“No other country had planned to vaccinate as few people as us,” says Murali Neelakantan, a lawyer who has worked with the drug manufacturers, Cipla and Glenmark, and now runs a legal practice, Amicus. “Other countries have ordered three times the doses, assuming three doses – a potential booster dose. If we apply that same test, India would need four billion doses. India has ordered a fraction of that so far. We have no plan for a four billion dose delivery although we do have capacity to make them.”
In the last week of April, the government faced rising public anger. It arrested people for sticking up posters saying that the country’s vaccines had been given away by Modi – a particularly painful charge in a country in which every vaccination certificate carries the prime minister’s photograph, and radio ads thank him personally for it.
With the Supreme Court also applying pressure over the faltering roll-out, the government suspended vaccine exports and placed an order for 160 million additional doses for domestic use. “It was as if the Indian government was slowly realising [the scale of] India’s population,” Prabhala says.
While vaccines developed by Pfizer and Moderna using mRNA technology have slowed the course of the pandemic in many countries, they remain unavailable in India. The government – which had earlier not approved Pfizer for use in the country – stepped up negotiations with both companies after the second wave. It waived the usual requirements for domestic bridging trials and batch-testing.
The two companies are also believed to have asked for government indemnity from potential lawsuits – a request that is apparently being seriously considered. A Pfizer spokesperson told Reuters that the company is only seeking the same indemnities it has sought from other countries where its vaccine has been sold.
“In spite of the public interest at stake, there is no transparency about the negotiations being conducted behind closed doors between the Indian government and vaccine manufacturers,” says Malini Aisola, co-convenor of the All India Drug Action Network (AIDAN), a healthcare watchdog.
“All vaccines at this point have received emergency use approvals through limited testing and accelerated regulatory processes. Adverse events observed during large scale use are still being investigated for possible causal linkages with vaccines, as clinical trials are not expected to pick up all side effects,” Aisola says – emphasising the need for transparency to build public confidence. Confusion over the intervals between jabs and lack of reliable public information about potential side effects (overwhelmingly short-term) have nurtured some vaccine hesitancy.
Covid had left Jain herself with a lingering weakness, while the vaccination had caused a fever and other side effects even as she returned to working long days. As she says: “You are getting long symptoms that even doctors did not know about.”
Aisola says that no high-quality evidence is being collected about the side effects of vaccination and that the investigation of mistakes made while administering the vaccine are in shambles.
“In this negotiation [on approval and indemnity], the company knows how much India needs the vaccine – but the Indian government knows nothing about the company’s development costs or process,” says Mohga Yanni Kamal, a long time health policy campaigner who has worked with Oxfam. As ever, the drug companies have the upper hand in all negotiations: only more so in countries such India, where the need is so acute.
At the World Trade Organisation, India – alongside South Africa – has also pushed for a waiver on vaccine patents. This would potentially enable the development and production of “own-brand” formulations of established vaccine types to be more widely manufactured and distributed, at an appreciably lower cost.
Neelakantan, who has worked for Cipla, points to the most compelling precedent – the company’s famous recreation of AIDS drugs in 2001 which were then offered in Africa at a fraction of the cost charged by large pharmaceutical companies. This did much to stem the march of AIDS across the continent. He believes a patent waiver could be a similarly potent weapon in the battle against Covid.
Others, such as Yogesh Pai, a professor of intellectual property at the New Delhi based National Law University, warn that – even if patent waivers are granted – pharma companies may well file lawsuits to delay the process. There is also the broader question of the impact such waivers may have upon future medical science. “Retrospectively taking away IP – that too without compensation, will disincentivise the research process,” Pai adds.
Furthermore: patent waivers alone are clearly insufficient in themselves. For Indian companies to begin reproducing Pfizer and Moderna’s vaccines quickly would involve wholesale technology transfer at a pace that may not be realistic.
India’s deadly second wave, concentrated in April and May, only proved how urgent is the need for these vaccines in the battle with the increasingly pitiless enemy that Covid is proving to be. In Dr Waghmare’s hospital in Mumbai, while patients tended to be over 60 in the first wave, many were aged between 20 and 50 in the second. They often stayed in hospital for up to two months, battling complications such as encephalitis and black fungus.
Recalling those dark days as they affected Delhi, Tanya Aggarwal, a lawyer who spent more than a week in hospital with Covid (as did her husband) says, “It was hard to find someone who did not have it then.” There was a black market for oxygen cylinders, concentrators and medicines, she says. When it all failed, there were serpentine queues outside the city’s crematoriums.
The background to this dire story is one of cunning viral evolution: new variants, like the Delta mutation first identified in India, are being discovered all over the world and will play their part in India’s third wave (as, of course, may additional home-grown variants, thriving in a largely unjabbed population).
The fastest path to mass vaccination – in theory, at least – might be to ramp up domestic production, through licensing agreements with foreign manufacturers, or of Covaxin and Astra Zeneca’s Covishield, the vaccines already available in India.
“We have the infrastructure to make four billion doses. We just need a plan,” says Neelakantan. But how quickly could this be done? The tragedy, he says, is that if this initiative had been launched in December, we might already have been on track to reach this target by the end of 2021.
Indians sometimes call their country “the world’s pharmacy” and so its struggles to produce sufficient vaccines for its own population are especially poignant. The suspension of vaccine exports has left Covax and many developing countries starved of the doses they require.
Neelakantan suggests manufacturing in a disaggregated, decentralised and imaginative way – deploying bioreactors in some factories, vial fillers in others and assembling the complete vaccines elsewhere. He also suggests repurposing government-run plants for emergency medical manufacture.
One reason drug companies have struggled so far is that the government did not place advance orders for vaccines – and too often failed to pay for the orders it did place. As National Law University’s Pai says. “The best way to increase supply would have been to make advance manufacturing commitments with vaccine makers. But the government would have found it hard to commit such money since there is no coherent policy designed to achieve it.”
The government would have faced criticism if it had committed such money and the second wave had not been as devastating as it actually was, he adds. There is, Pai says, a need for a proper legal framework that allows the government to commission meaningful predictive modelling and to pre-order vaccines in line with the results.
On 15 July, the central government made its largest purchase to date, for 660 million doses of Covishield and Covaxin, to be delivered between August and December. But supplies still lag, and are not achieving anything like the pace required if India’s 944 million adults are to receive both doses in time to prevent a humanitarian crisis.
In a significant change of policy, the central government has also begun buying all vaccines itself – replacing the pre-existing system whereby much procurement was delegated to state governments and to private hospitals. This left a disproportionately large supply in the hands of private institutions charging high prices – while state governments struggled to buy stock for publicly run hospitals, the central government has also now enabled people to walk in to centres for vaccination, ending the CoWin app registration-only system – a system that had, in practice, only extended the country’s chasm-like digital divide to the life-or-death realm of vaccines. People without smartphones had not been able to book vaccine appointments and get vaccinated, effectively excluding more than 100 million Indians.
Globally, too, there is a growing movement to persuade wealthier countries to give away the supplies they have stockpiled. But AIDAN’s Aisola warns: “This trying to shame wealthy countries into sharing vaccine doses has been going on, but has only resulted in weak pledges of vaccine donations of small quantities or diverting unused doses to poor countries as an act of charity. Ultimately, the key lies in expanding local and regional production and enabling more countries to build vaccine manufacturing capabilities.”
Even now, an Indian pharma company is developing a homegrown mRNA vaccine. But the cold truth remains: with millions of doses lying unused in other countries, the fastest way to increase vaccine supply with any urgency would be to import them, in huge quantities with all possible speed.
Yet, as we saw at the G7 summit in June and the G20 meeting of finance ministers in Venice earlier this month, the gap between walk and talk, rhetoric and reality, is still immense. The international community accepts the morality and logic of global vaccination – how could it not? – but does not follow up this recognition with the action required.
And where does this leave India? On the first day of the parliamentary session on 19 July, Modi took the unusual step of stopping to speak to reporters. He looked forward, he said, to a meaningful discussion during this session on the global pandemic in general, and the country’s own vaccination drive in particular.
There were, he boasted, already 400 million Indians who, having received the jab, were Baahubali – or “Strong Arms”. A characteristic framing from a self-styled strong man populist leader. But will such bombast be matched by practical policy to prevent many more avoidable deaths? For the answer to that question, many millions of vulnerable Indians can only wait.
Saumya Roy is a Mumbai-based journalist, social entrepreneur and author of Mountain Tales: Love and Loss in the Municipality of Castaway Belongings (Profile Books)
We need to act urgently
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