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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.

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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.

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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.

  • Extremely biased article. The western hegemony over the morality has to end. Those who are questioning India should ask why US stopped raw material supplies to India till it became preeminent that India won’t be able to fulfill commitments to GAAVI. US is responsible for this mess because it wants to promote its own pharma companies. And to the author I have only one line – desh se gaddari mehengi padhegi, corona agar hume nahi chhod raha, to tumhe bhi nahi chhodega.

  • “You get what you pay for” : seeking low cost vaccine manufacturing in a far less regulated country is proven not be a wise choice – worsened by a less-than-reliable leader’s “approval” and “hold-back” ideas. India cannot be compared to western civilization. Pursuit of production “not made in India” is similar to “not made in China”. And if even Brazil rings the bell (yet gets ignored) : the US / western nations must build their own facilities to manufacture their own vaccine (or drugs) supply – which also ensures that safety and quality standards are met (not another Emergent Bio-Solutions please). Home-produced vaxxes and drugs have additional benefit: disable Biden’s dis-enfranchising no-patent notion.

    • Indeed Stuart, and as additional point: good for Pfizer-BioNTech and Moderna to not go in bed with more or less unscrupulous manufacturing nations. Of course India is scrambling with severe damage control – after disastrous un-restricted massive mixing of throngs of unbridled Indians bathing together etc despite strong warnings by Indian health experts, with now deathly ill Covid patients panting “it’s not Covid”. But the resulting hostage taking (of Covax and several nations who ordered AND PAID FOR vaccines) should never be allowed to re-occur. Hard lesson learned (finally) ?

    • Of course there is an exodus of people from India fleeing the hell-hole and seeking much safer/ better controlled / better led countries – with Covid-spread restrictions. This exodus is like the one from Wuhan – the WHO and ALL nations must realize that there is no difference, and influx of Indians MUST be stopped.

  • I think this is an overly biased article. Suggest readers to handle the author’s own opinions with caution.

    When the commitments were made in Jan, India had a good hold on the spread of Covid. Any sane planner ensures planning is done to future expectations, not on basis of fears. If I were to believe the conspiracy theory that India has stopped its exports though it has made a statement that it hasn’t, I would also have to fairly believe that the sudden surge in cases seems to have been injected by a lobby of high priced vaccine sellers looking to make huge profits in the midst of a global health challenge.

    And the fact is that many local centers that administer vaccine have run out of stock. Just in case (sure that it wont be so), India took a hardline on its commitments and exported vials, the same folks would have rants of government making profits from exports at the cost of it’s own citizens.

    Common sense can hint enough about folks that play politics and blame games in the midst of a pandemic.If a developed nation stopped comitted grants in the midst of an economy crisis, would you look at understanding or blaming ?

  • Excellent article, Mr. Thakur. The Government’s complete lax towards vaccination planning combined with its usual dose of jingoism, non scientific and unprofessional approach of regulatory measures have opened the doors of deadly second wave in India. This could and should have been avoided. The thing is even now, at the crux of approaching covid peak, the Modi govt. is planning on building a new palatial home for him and his cronies. Priorities !

    • Pathetic Lies and Fraudulent narrative.

      The Prime Minister’s residence is NOT a “palatial home for him and his cronies”. It is a Govt building – just like the Parliament or the Courts. Further, it serves as the residencial office of the PM and only the PM and his family live in its premises. Finally, even if the new PM residence is built it would not be completed before the end of term of the current PM, making it unlikely for either the PM or anyone else, least of all cronies to enjoy anything without a new mandate.

  • India not only has a right but a duty to vaccinate its citizens. Western Pharmaceutical Companies were supported by their governments to enforce patents in the middle of an unprecedented pandemic. It is only now they are realizing that unless the world as a whole is COVID-19 free the danger will continue. India has to vaccinate its population for the world not just itself. By no means is this stealing nor is this unethical. Unethical practices are what western colonialism did in India, and what neocolonialism does to people of color. Marginalizing people, taking their wealth and taking away their confidence are actions which Western powers did very well, and this lesson is not forgotten by all Indians and people of Indian Origin. There has been not even one apology for the 66 Million Indians who perished in colonial famines, nor the genocide at Jalian Wala Bagh. Lets be real, who will trust the humane intent of those who cannot even atone for transforming the world’s largest economy which was India in 1757 to the world’s largest poor nation in 1947.

    • Excellent reply. You have probably heard the phrase charity begins at home. No one faults Wedtern Governments for refusing vaccine materials to India to safeguard their own resources. But question the very government that is tirelessly working to keep us on the World Stage. Where were we 10 years back? And where are we now, running with the big players!

  • In my opinion, there are 3 ways to Judge MODI , One Old Habits die Hard , A Man Is Know by the company he keeps , if you analyze his past and present behavior, his future be no different , To expect anything Positive From this Crook MODI is like LIVING IN A FOOLS PARADISE.

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