When Covid-19 began sweeping across the globe in 2020, many experts expected India to be the vaccine savior of the developing world. That thought bubble has burst.
In the early days of the pandemic, as multiple vaccines were being rushed into clinical trials, intellectual property laws and patents were being viewed as big barriers that would prevent low-income countries from accessing lifesaving vaccines. That hasn’t come to pass. Instead, the real problems stem from the abject lack of procurement planning by a country that has immense vaccine manufacturing capacity and its shoddy regulatory oversight.
Of the five of vaccines developed so far in the Global West, at least three companies — Johnson & Johnson, AstraZeneca, and Novavax — licensed their technologies to Indian manufacturers as far back as last year. The Russian Direct Investment Fund (RDIF) licensed its technology for the Sputnik V vaccine to Hyderabad-based Dr. Reddy’s. And the Indian government, in partnership with Bharat Biotech, another Hyderabad-based company, has developed a vaccine called Covaxin. There is no shortage of vaccine candidates for the low-income countries.
Multiple manufacturing facilities in India have been licensed to manufacture these vaccines, including the Serum Institute of India (SII), which can turn out 1.5 billion doses a year, Biological E, Dr. Reddy’s, Bharat Biotech and Indian Immunologicals Ltd., Hetero, and possibly the government-run Haffkine Institute. There is no shortage of technology on offer or manufacturing capacity for vaccines and it is time to move beyond the IP debate.
India’s prime minister, Narendra Modi, boasted at the World Economic Forum in January 2021 how India had beaten the pandemic and would save other countries with its vaccine exports. There was some truth to that at the time since COVAX, a global initiative aimed at equitable access to Covid-19 vaccines, had contracted with the Serum Institute of India, the world’s largest vaccine manufacturer, for at least 200 million doses. The company, based in Pune, India, had a license to manufacture the Oxford-AstraZeneca and the Novavax vaccines. The agreement also gave COVAX an option to procure several million more doses if needed.
These were to go primarily to low-income countries unable to compete with the high-income countries who were busy securing vaccine doses for themselves. The Gates Foundation even provided $300 million of “at-risk funding” to SII through Gavi, one of the COVAX coordinators, to help the institute scale up its facilities. Seth Berkley, the CEO of Gavi, described the deal with SII as “vaccine manufacturing for the Global South, by the Global South, helping us to ensure no country is left behind when it comes to the race for a Covid-19 vaccine.”
According to government records, SII had exported 66.2 million doses of Covid-19 vaccines to 95 countries as of April 21. Of these, 19.8 million doses were supplied to COVAX, 10.7 million doses were exported as part of a grant by the Indian government to low-income countries, and 35.7 million doses were sold to countries around the world by SII through commercial contracts.
But when the full force of the second wave of the pandemic hit India, its government reacted in a knee-jerk manner by imposing a de facto ban on all vaccine exports, including to COVAX, and redirected all supplies from SII to India. Although the Indian government has officially denied the imposition of any such ban, and there does not appear to be any legal order to that effect, COVAX has announced to intended recipients in low-income countries that orders will be delayed by a few months due to delays at SII, largely due to an increased demand for vaccines in India.
In an interview with the Associated Press on April 7, Adar Poonawalla, the Serum Institute of India’s CEO, all but confirmed the ban, saying he hoped to resume exports in two months. But given the disaster unfolding in India and the pressure on its government to meet a huge domestic demand for vaccines, it is unlikely that SII will be allowed to export any doses until a majority of Indians are vaccinated.
This sudden ban on exports has surely come as a rude shock to COVAX, which arranged for the “at-risk funding” and which is owed at least another 180 million doses by SII, at the very minimum. It is also a blow to countries that may have had their own contracts with SII.
To be sure, India needs to vaccinate close to 950 million people to achieve 70% coverage of its residents. It boggles my mind that the government couldn’t compute the manufacturing capacity available in the country in order to place advance orders several months ago, instead of waiting for a second wave to decimate its citizenry.
The situation would have been different had the Indian government bought up SII’s manufacturing capacity last year, before the company made commitments to COVAX and other buyers. It would have been hard to fault the country for trying to protect its people.
Instead, the government waited until after aid dollars and advance payments financed the scale-up of SII’s manufacturing facilities to meet the demand from COVAX and other countries before stepping in and stopping exports to low-income countries that had been assured equal access to vaccines by the COVAX organizers. In essence, India is “stealing” vaccines meant for low-income countries for its own use.
This is a scandal without precedent. So it’s strange that no one from COVAX appears to be complaining, possibly because the major stakeholders behind the initiative do not want to rub Modi the wrong way, especially the Gates Foundation (which once gave Modi its Goalkeeper’s Award) after his government barred the Public Health Foundation of India from receiving funds from the Gates Foundation.
Lax regulatory oversight
Failing to make good on its promises to make millions of vaccine doses for low-income countries isn’t the only thing tarnishing India’s vaccine manufacturing industry. Regulatory issues are another factor.
In the normal course of events, most new therapies, including vaccines, go through rigorous and transparent reviews by regulators such as the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, and the European Medical Agency before they enter the market, after which regulators in low- and some middle-income countries often rubber-stamp approvals largely because they do not have the capacity to evaluate new therapies on their own.
In India, the Central Drug Standards Control Organisation (CDSCO) has a dodgy reputation on approving new drugs — a standing committee of Parliament has accused the CDSCO of approving drugs based on highly questionable data. At least two vaccines, Sputnik V and Covaxin, which have not yet received emergency use authorization by trusted Western regulators, have been approved for use in India and some low-income countries. Covaxin was approved even before the conclusion of Phase 3 clinical trials, presumably because the Modi government wanted to showcase a made-in-India vaccine.
Only the Brazilian regulator, ANVISA, red-flagged both vaccines over major regulatory concerns. These included issues over inactivation protocols at Bharat Biotech, whose Covaxin vaccine is based on an inactivated virus, and replication concerns with the adenovirus vector used in Sputnik V. There are also major data integrity concerns regarding the clinical trials conducted to assess the safety and efficacy of Covaxin.
Despite the gravity of these concerns, and ANVISA rejecting both vaccines, CDSCO blithely moved forward with its approval and has offered no comments on the findings by the Brazilian regulator.
It is worth questioning the opportunity cost of proceeding with these two vaccines with known regulatory and safety issues. Apart from the obvious implications for public health over the use of potentially questionable vaccines, there is also the issue of using valuable and scarce manufacturing facilities for making such vaccines, especially since alternatives exist that have undergone rigorous evaluations for safety and efficacy.
Not enough attention is being paid to this issue by institutions like the World Health Organization, whose stamp of approval is sought by low-income countries trying to make decisions on how to vaccinate their populations.
Building regulatory capacity in countries that have the ability to manufacture vaccines is not something that can be accomplished overnight. And it is especially difficult when nationalism drives decision-making over scientific temperament. Exporting vaccines without complete assessment of their safety and efficacy and the highest standards of regulatory evaluation will pose potentially dire consequences for health in low-income countries.
A tarnished future
The lesson from India’s Covid-19 vaccine sagas is stark and simple: Can India be considered a reliable supplier of vaccines during the next pandemic? The country’s reputation as the “pharmacy of the developing world” is taking a beating thanks to its vaccine heist and rickety regulatory capacity.
Who will trust a country that blocked the export of paid-for vaccines in the middle of a pandemic? The owner of SII, who will probably be sued for breach of contract by multiple parties, has already announced it will set up manufacturing facilities outside India — a sign for the rest of the world of the Indian government’s missteps in managing this pandemic. Could there be a worse fall from grace for a country whose prime minister was boasting just a few months ago of saving the rest of the developing world?
Dinesh Thakur is a public health activist whose work focuses on improving the quality of affordable medicines.