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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.

  • The failure here is our faith placed in government, India’s especially, with its systemic corruption that runs rampant. When you can show me one government project that has come in on time and under budget, you may have a case that they could handle something this important. Until then though, its probably best to let the people manage things themselves.

  • Why can’t they allow poorer countries to make their own vaccines and provide the resources to do so. There also pharamcists, scientists, medical experts etc in these places….And, India may have thought they were okay but instead of bringing them down, everyone can quarantine for a short temporary period until they help their own citizens and on their feet again to help others.

  • How to be an Indian Journalist?

    “Modi does lockdown”: “OMG. So bad. How will poor people eat?”
    “Modi does not do lockdown”: “OMG. So bad. How will Covid be contained?”

    “India exports vaccine”: “OMG. So bad. How will Indians survive?”
    “India does not export vaccine”: “OMG. So bad. How will other countries survive?”

  • This situation should serve as a rallying cry for bringing production of all vaccines and important medicines back to the US, Canada, Western Europe, and Japan. I used to include Israel, but TEVA closed down their Jerusalem manufacturing plant in early 2020, presumably to send production to India. There are a number of important drugs that are presently in severe shortage or unavailable because the world was reliant on India and China for essential drug chemicals production. Quality control has also been a serious problem in China and India, even worse now in India with Modi. No one but the Chinese knows what goes on there. The west has had its own drug manufacturing deficiencies and scandals (see recent J&J shutdown), but these problems were discovered, made public, and dealt with. India and China are free to sell their products to their own citizens and anyone who will buy them, but neither should be the sole source for anything so important.

  • Mt. Thakur is also the hero who exposed the bottomless corruption and dishonesty at Ranbaxy in the early 2000s, when it was peddling adulterated HIV drugs around the world at the beginning of PEPFAR. Ranbaxy ended up pleading guilty to numerous crimes, and paying a half billion dollar fine. Yet the FDA, in its infinite wisdom, kept allowing Ranbaxy to sell new generics and block other generics even while none of its plants were cGMP compliant.

    India does not have the market cornered on incompetent government health agencies.

  • How about the USA share it’s vaccines with the world? This article is such a shameless argument to mock India in this disastrous pandemic.

    • Because India government deserve condemnation for not preparing for second wave and allowing its people to have mass gatherings without mask.

      It also did not prepare enough vaccine and medical necessities. India is four times the population of US. US was having 300K early this year during high cases, that would be equivalent to India 1.2 M cases a day. So what India is going thru is nothing compared to what US had gone thru, expect the local government in US have learned their lesson on the mistakes made on the first wave and had prepared enough resources.

      So India deserve condemnation for living their lives as if the pandemic was over.

  • Journalists need to give all facts; the opinion can be biased. This article does not talk about UK government’s discussion with SII, neither talks about raw material blockage or the wave 2 predictions that influenced government’s thinking. There is no proof that Indian blocked the exports still majorly his arguments are built on that assumption: All of this dilute the sanctity of the article.

    • India did ban the export of N95 and medicines early on the pandemic, in case you are not paying attention to that.

  • For 2 months india was blocked from vaccine raw materials from usa.
    has dinesh thakur wrote, it wold have been unbiased.
    India always helped and stuck to sharing is caring.
    but 50 lakh people died in usa aswell. All across world is taking beating and life sacrifices to lessn the peak curve and bring it down.
    India just cant escape from virus, just like any other nation.
    hopefully all states going again in to lockdown will flatten the curve by month end

  • Its selfish world. US hording vaccine more than need. pharma co don’t want to release patent and share tech no matter people die in poor countries. Now India is in mess and need to secure vaccine for own. That’s it. moral posturing is useless.

    • There is no “hoarded” vaccine in the U.S. There is, right now, 70 million does of vaccine in the U.S. However, 10 million are the AZ vaccine, 6 million of which was just sent to India, the other 4 million to Mexico and Canada. 30 million is in transit from the factories to clinics for injection. 20 million are the Novarex vaccine that has not been approved for use by the FDA and therefore can’t be used. Another 10 million is the J&J vaccine, which was paused from being used due to a blood clot issue.

      The U.S. is making about 30 million doses a week, using all the precursor materials we have. We are injecting around 20 million of those doses. Just two weeks ago we were using all 30 million doses. 70 million doses is about a two week supply – it represents the time it takes for the vaccine to go from the factory to being injected into an arm. It is not hoarded vaccine, it is vaccine in transit.

      It is interesting that you paint the U.S. and India as equivalent. We created the vaccines, paid to expand factories to make them, paid India to make them, and expanded production of precursor chemicals. The U.S. never had the capacity to produce vaccine for the rest of the world – we paid India to do that for us. Why not ask India what happened to your vaccine?

  • This is one of the rare very well written article here in statnews.

    India is starting to display prima donna attitude towards the US. First it was demanding medicine and other thing from US when it has all the money to build space and nuclear technology. Why does US has to donate 100M aid to India when India is not a poor country. So many poorer countries needs those 100M aid and medicine. This shows the US is starting to be under the control of India because of the clot of the Indian American in this countries. That is what happened when the majority of the H1b holders are from India.

    Now India is asking the US to cancel the patent rights of those covid vaccine manufacturers. Add to that some senile Democratic senators who is joining the call to make the patent free. If we give away the vaccine patent, that will discourage any companies to develop vaccine the next time we have a pandemic. Nothing is free in this world. India needs to pay for patents. It has already licensed to AstraZeneca and J&J yet it did not produced the needed vaccine. Making the other vaccine patent free is not going to help them.

    India reminds me of the story of the Ant and the Grasshopper. During the time the the other parts of the world was engulfed in high cases of covid19, India was having parties, weddings, not wearing mask, and rallies. Now that it find itself in a dire situation, it wants the world to give them free aids and free vaccine patents. When the world was having high cases of covid19, India decided to ban export of much needed N95 and medicines especially antibiotics.

    So people who are pressuring Biden to make the vaccine free, shut up. India deserve to be where it find itself now for being over confident that they have natural immunity. The world is not obliged to save them since its government and people squandered the time given to them to prepare for second wave.

    • Heartless people commenting here while millions of people are dying all over the world due to China virus. US should waive all vaccine patents to save not just Indians but rest of the world. Countries need to rise above selfish interests. Also this author has some ulterior motives to blame India for vaccine shortage. India has responsibility towards its own citizens first and other countries have to wait till India fights fires at home.

      I wonder who has paid the author to blame India and give a free pass to America and other rich countries who hoarded vaccines. Also China is not helping with controlling Covid spread. If China didn’t kill the doctor who tried to warn the world, we wouldn’t be in this position.

    • And to add – the two vaccines we have the most of, the Pfizer and Moderna vaccines, are difficult to administer. They must be kept ultra cold, and require two doses. we have had difficulty distributing these vaccines in the U.S. – when they came out the ramp up was quite slow while we worked out the issues. Sending them to poor countries will result in a lot of wastage.

      The J&J vaccine, AZ, and Novarex were supposed to be for the rest of the world – they are not quite as good as pfizer and Moderna, but can be transported at more normal temperatures, and J&J is a single shot immunity. But they were approved much later, and hence production has ramped up a lot slower. We also had problems at a Baltimore plant producing AZ and J&J vaccine – many batches had to be destroyed.

    • I have no problem giving the covid vaccine cheaper to poorer countries, but India is not poor. It has space and nuclear technology. But because of it disregard for human life, it does not invest on medical car for it people.

      One author is Washington post was saying she use her class privilege, India has still those inhuman social class, to get a hospital. This vaccine will probably ends first for those on the higher class to. How does that help the poor ?

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