India’s ‘robbery’ of vaccine jeopardizes global access to Covid-19 vaccines – fr

India’s ‘robbery’ of vaccine jeopardizes global access to Covid-19 vaccines – fr

WWhen Covid-19 began sweeping the world in 2020, many experts expected India to be the vaccine savior of the developing world. This thought bubble has burst.
At the start of the pandemic, as multiple vaccines were rushed through clinical trials, intellectual property laws and patents were seen as big hurdles that would prevent low-income countries from accessing life-saving vaccines. This does not happen. Instead, the real problems stem from the abject lack of procurement planning by a country with immense vaccine manufacturing capacity and shoddy regulatory oversight.

Of the five vaccines developed so far in the Western world, at least three companies – Johnson & Johnson, AstraZeneca and Novavax – have licensed their technologies to Indian manufacturers as early as last year. The Russian Direct Investment Fund (RDIF) has licensed its technology for the Sputnik V vaccine to Dr Reddy’s based in Hyderabad. And the Indian government, in partnership with Bharat Biotech, another Hyderabad-based company, has developed a vaccine called Covaxin. There is no shortage of candidate vaccines for low-income countries.


Several manufacturing facilities in India have been licensed to manufacture these vaccines, including the Serum Institute of India (SII), which can produce 1.5 billion doses per 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 proposed technologies or vaccine manufacturing capacities and it is time to get out of the debate on intellectual property.

Indian Prime Minister Narendra Modi boasted at the World Economic Forum in January 2021 about how India had beaten the pandemic and would save other countries with its vaccine exports. There was some truth to this 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 Novavax vaccines. The deal also gave COVAX the ability to source several million additional doses if needed.


These were to be aimed primarily at low-income countries unable to compete with high-income countries that were busy procuring doses of the vaccine themselves. The Gates Foundation even provided $ 300 million in “venture funding” to SII through Gavi, one of the COVAX coordinators, to help the institute expand its facilities. Seth Berkley, CEO of Gavi, described the deal with SII as “making vaccines for countries in the South, by countries in the South, helping us to ensure that no country is left behind in the race. to the Covid-19 vaccine ”.

According to government records, SII had exported 66.2 million doses of Covid-19 vaccine to 95 countries as of April 21. Of these, 19.8 million doses were supplied to COVAX, 10.7 million doses were exported under a grant from the Indian government to low-income countries, and 35.7 million doses were sold to countries around the world by SII under commercial contracts.

But when the full force of the second wave of the pandemic hit India, her government reacted instinctively 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 such a ban, and there does not appear to be a legal order to it, COVAX has announced to intended recipients in low-income countries that the orders will be delayed by a few months due to delays at SII, largely due to increased demand for vaccines in India.

In an interview with the Associated Press on April 7, Adar Poonawalla, CEO of the Serum Institute of India, all but upheld 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, SII is unlikely to be allowed to export doses until a majority of Indians are vaccinated.

This sudden export ban was surely a shock to COVAX, which organized the “risk financing” and which owes at least 180 million additional doses per SII, at a minimum. It is also a blow to countries that may have had their own contracts with SII.

Certainly, India needs to vaccinate nearly 950 million people to achieve coverage of 70% of its residents. I am amazed that the government cannot calculate the manufacturing capacity available in the country to place advance orders several months ago, instead of waiting for a second wave to decimate its citizens.

The situation would have been different if the Indian government had purchased SII’s production capacity last year, before the company made commitments to COVAX and other buyers. It would have been difficult to fault the country for trying to protect its people.

Instead, the government waited until aid dollars and advance payments funded the scale-up of IBS manufacturing facilities to meet demand from COVAX and other countries before stepping in and to stop exports to low-income countries which had obtained equal access to vaccines by the COVAX organizers. In essence, India is “stealing” vaccines destined for low-income countries for its own use.

It is an unprecedented scandal. So it’s strange that no one from COVAX seems to be complaining, perhaps because the main players behind the initiative don’t want to rub Modi the wrong way, especially the Gates Foundation (which has already given Modi its prize of the goalkeeper) after his government banned the public. Health Foundation of India to receive funds from the Gates Foundation.

Lax regulatory oversight

Failure to deliver on promises to manufacture millions of doses of vaccine for low-income countries is not 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 regulatory bodies such as the United States Food and Drug Administration, the Regulatory Agency medicines and health products in the UK and European Medical before they enter the market, after which regulators in low- and middle-income countries often approve approvals largely because they lack the capacity to evaluate new therapies on their own.

In India, the Central Drug Standards Control Organization (CDSCO) has a bad reputation for approving new drugs – a parliamentary standing committee accused CDSCO of approving drugs based on highly questionable data. At least two vaccines, Sputnik V and Covaxin, which have yet to receive 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 Phase 3 clinical trials were concluded, possibly because the Modi government wanted to introduce a vaccine made in India.

Only the Brazilian regulator, ANVISA, has reported the two vaccines due to major regulatory concerns. These included problems related to the inactivation protocols of Bharat Biotech, whose Covaxin vaccine is based on an inactivated virus, and replication problems with the adenovirus vector used in Sputnik V. de Covaxin.

Despite the seriousness of these concerns and the rejection of the two vaccines by ANVISA, CDSCO cheerfully moved forward with its approval and made no comment on the Brazilian regulator’s findings.

It is worth considering the opportunity cost of proceeding with these two vaccines with known regulatory and safety issues. Besides the obvious public health implications of using potentially questionable vaccines, there is also the problem of using valuable and scarce manufacturing facilities to manufacture such vaccines, especially as there are alternatives that have been rigorously evaluated for their safety and effectiveness.


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