Employees operate a filling machine inside a lab at Serum Institute of India, Pune, November 30, 2020. Photo: Reuters/Francis Mascarenhas/Files
- Notwithstanding some discrepancies, India seems to have contributed only 15-16% percent to the world’s output of COVID-19 vaccines.
- The international COVID-19 vaccination programme was India’s golden chance to prove its capabilities in vaccine manufacturing, and to become a saviour-figure for billions.
- But India bungled the chance, with the government making a series of mistakes that repeatedly compromised opportunities to increase vaccine manufacturing output.
The global vaccination drive against the COVID-19 pandemic achieved a significant milestone in the last week of January 2022. Within 13 months of the first COVID vaccine dose being given in the UK, countries across the world have together administered over 10 billion doses, a feat that appeared impossible even six months ago.
However, this achievement hides a stark disparity between countries. High-income countries are giving booster shots even as many people in low-income countries wait for their first doses.
Of the 10.24 billion doses administered until February 7, 2022, high-income countries accounted for 2.24 billion doses, upper-middle-income countries for 4.57 billion doses, lower-middle-income countries for 3.54 billion doses and low-income countries for only 97 million doses, according to Our World in Data.
The gravity of the situation becomes clearer if we look at this in terms of the population. The dose per person is calculated considering the entire population (only some countries have begun to vaccinate children of some age groups).
High income countries with a total population of 1.2 billion have given 1.87 doses per person, and upper-middle-income countries, with 2.5 billion people, have given 1.83 doses per person. Among the latter, China has administered 2.15 doses per person and the rest average 1.43 doses per person.
Lower-middle-income countries with 3.3 billion people in all have been able to provide just 1.07 dose per person. India has administered 1.21 dose per person, with the others in this group managing just under 1 dose per person. Low-income countries with a population of 0.7 billion fared the worst, at a meagre 0.14 dose per person.
Experts have highlighted, commented on and debated this vaccine apartheid extensively, but no solution seems to be on the horizon.
Manufacture of vaccines
A report prepared by the Global Commission of Post-pandemic Policy showed that 10.9 billion doses of COVID vaccines were manufactured globally until December 31, 2021. Of this, China accounted for a whopping 4.9 billion doses. The other large manufacturers were the EU/the UK with 2.6 billion doses, India with 1.6 billion doses followed by the US with 1 billion doses.
Together, these four regions/countries accounted for over 92% of the total manufacturing, with China alone contributing 45% and India 15%.
Two Chinese vaccines, Sinovac with 2.45 billion doses and Sinopharm with 2.25 billion doses, feature at numbers 1 and 4 in the list of the top 5 vaccines that together account for 10 billion doses – 92% of the total quantity manufactured.
The second-most-manufactured vaccine, with a total of 2.36 billion doses, is the Oxford-AstraZeneca vaccine. This vaccine was manufactured in the EU region plus eight countries (China, the UK, India, South Korea, Japan, Thailand, Australia and Argentina).
In India, this vaccine is known as ‘Covishield’, and Pune-based Serum Institute of India (SII) manufactured 60% of the total quantity of this vaccine.
The Pfizer/BioNTech vaccine, with 2.35 billion doses (1.75 billion in the EU and 600 million in the US) is currently the third-most-manufactured vaccine.
The fifth vaccine in the top 5 is the Moderna vaccine, with 626 million doses – 297 million in the US and 329 million in the EU.
The Johnson & Johnson vaccine, with a total of 289 million doses (94 million in the US and 195 million in the EU), Sputnik V (265 million doses, all made in Russia) and Covaxin (202 million doses, all made in India) make up the next three most-used vaccines.
India had administered 1.42 billion doses until December 31, 2021, and exported 116 million doses, yielding a total of 1.54 billion doses. This number suggests that there may be some lag in the reporting of production figures, at least for India.
But notwithstanding this discrepancy, it is clear that India has contributed only 15-16% percent to the world’s output of COVID-19 vaccines.
Should India have done more? Could it have? Considering that everyone, including Indians, expected India to supply vaccines to the world, surely we should have done more.
Could India have done more?
The government set up an inter-ministerial panel in March 2021 to boost the manufacture of COVID-19 vaccines in India. Let’s conduct a thought-experiment centered on this panel to consider what could have been done differently.
Imagine that it is March 2020 and that the Centre has set a target that India will manufacture enough vaccine doses for all Indians and for all people living in low-income countries. At two shots per person this adds up to 4.2 billion doses.
The government then constitutes the inter-ministerial panel. Now imagine that it asks the panel to create a roadmap to maximise the manufacturing of COVID-19 vaccines in India. The panel includes experts from the fields of virology, immunology, vaccine research, manufacturing and logistics, along with officials from the government departments that need to collaborate in this endeavour.
The government tells the panel that it should consider vaccines developed in any country using any technology in its roadmap. The panel is to keep a close watch on all developments across the world on COVID-19 vaccines and make recommendations to the government on an ongoing basis.
The government also assures researchers and manufacturers, including those of chemicals, vials, syringes, etc., of full support. It also works on sourcing funds for this colossal enterprise.
Acknowledging that patent waivers on vaccines may not result in the ability to immediately manufacture vaccines in India, the government opts for technology transfers through collaboration. So it initiates dialogues with international developers and manufacturers of vaccines.
As the results of phase 1 and phase 2 clinical trial results become known, it invites Pfizer, Moderna and AstraZeneca to include India in their phase 3 clinical trials. Simultaneously, it helps the companies identify Indian manufacturers with whom they can associate to manufacture their vaccines in India.
The government also nudges AstraZeneca to tie up with other manufacturers instead of just SII.
Next, it negotiates prices and volumes for India and enters into formal agreements with the companies that also specify the quantities the government will purchase on successful completion of phase 3 trials and after approval by the regulatory authorities.
It handles the indemnity issue pragmatically – with one possibility being to agree to share liability with the company.
Suppose also that the government doesn’t give Bharat Biotech the exclusive rights to manufacture Covaxin. Instead, say it asks multiple manufacturers to make the vaccine under their own brand names, and pay a royalty to both the government and to Bharat Biotech.
The government also invests in research in India for vaccines based on different technology platforms.
This list of activities is only indicative.
Through its panel, the government keeps a close watch on all developments and maintains a flexible, pragmatic and swift approach. It ensures a consistent focus on the manufacturing of more and more vaccine doses in India, irrespective of their origin – domestic or foreign.
Let us continue the thought experiment into the present time and look at some of the likely outcomes of this approach.
Some quantities of the Pfizer and Moderna vaccines have been imported; the Pfizer vaccine is also being manufactured in India, giving Indians the option of mRNA vaccines. Both vaccines are primarily used in cities and tier 1 towns, as the government doesn’t always subsidise the cold-chain facilities and the doses.
Many manufacturers are producing Covaxin in India under different brand names. Bharat Biotech and the Indian Council of Medical Research are also in talks to manufacture the vaccine in other countries.
Ultimately, the quantity of doses manufactured in India is much higher – closer to the output of the EU/UK region.
Suppose India has also continued exporting COVID-19 vaccines throughout 2021 to many lower-middle-income and low-income countries, and has been lauded worldwide for its efforts.
Could the government have pulled this off?
Does this sound far-fetched? No. And if India’s contribution to the global COVID-19 vaccine supply petered off at 15-16%, it suggests that the Indian government deviated from our thought-experiment at some points. Where?
First and foremost, the government overestimated the capacity of Indian manufacturers, and constituted the inter-ministerial panel to augment vaccine manufacturing capacity only in March 2021.
Until then, the government was confident that India could manage with just two vaccines – Covishield and Covaxin. Then Union health minister Harsh Vardhan was also dismissive of Pfizer’s ability to manufacture vaccines for India.
In fact, the Pfizer saga is emblematic of what went wrong with the government’s approach to foreign vaccines.
In January 2021, the regulatory authority insisted on a bridging trial and Pfizer withdrew its application for ‘emergency use’ approval.
Then, in the last week of May 2021, the government completely waived the condition for bridging trials for foreign vaccines. But it refused to indemnify manufacturers against liability claims. While this is understandable in normal times, a pandemic calls for a pragmatic approach, which wasn’t taken.
Reports in June 2021 said that the government was in talks with Pfizer and other companies to find a middle ground, but nothing came of it.
The regulators approved the Moderna vaccine for ‘restricted use’ in late June 2021 and the Indian company Cipla, Ltd. had plans to market the vaccine. However, this didn’t happen.
Covaxin was licensed to just one company, Bharat Biotech, with a low manufacturing capacity, and the company has been slow to increase capacities. As a result, Covaxin had contributed only about 11% to the country’s vaccination campaign up to December 2021.
It’s no surprise that the government had no choice but to take the harsh decision to stop exports of Covishield in May 2021.
There are many more examples, but this should suffice for the moment.
And even if you think the thought-experiment sounds far-fetched – so did the idea that the world could administer 10 billion COVID-19 vaccine doses in less than two years since scientists first identified the novel coronavirus’s genome, and more so since the world’s vaccination capacity was 5 billion doses a year for all vaccines put together until then.
Closer home, we also didn’t think in June 2021 – with only 330 million doses having been administered since January 16, 2021 – that all adults in India would be fully vaccinated by the end of the year, requiring almost 1.5 billion doses. The government didn’t achieve this feat, but it did administer more than a billion shots, which is no mean feat.
So a clearly articulated grand vision and shared objectives, supported by focused execution, is a potent force that can make almost anything possible – especially during a pandemic.
Of course there would have been challenges galore. Some obvious ones include increasing the manufacturing capacity for different types of vaccines, arranging for materials, training and deploying personnel for various operations and enhancing cold-chain facilities.
Collaboration and agreements between companies and between the companies and the government would also have been crucial given the differences in their objectives and approach. The government would also have had to ensure good quality while maintaining affordable prices and tackling vaccine hesitancy.
There would have been many other challenges.
In addition, some will have argued as to why we should expect India to succeed when COVAX didn’t. COVAX is the global initiative led by the WHO, the GAVI vaccine alliance and the Coalition for Epidemic Preparedness Innovations that promotes equitable access to vaccines, especially to low-income countries. It delivered its billionth COVID-19 vaccine dose in mid-January 2022 – which was half the quantity it had promised to deliver by December 2021.
One of the reasons for COVAX’s failure is that it put all its eggs in one basket – namely, SII. When India’s second COVID-19 wave took off in April 2021, SII faced export restrictions that pinched its supply to COVAX.
There are other reasons experts have called COVAX “naïvely ambitious”. The coalition didn’t have a say in how manufacturers allocated their stock to their customers, including COVAX and it didn’t support investment in expanding manufacturing capacity, for two examples.
Yet India could definitely have done what COVAX couldn’t – with rewards that would have more than justified its efforts.
The present Indian government has often declared that the country is on its way to becoming a ‘Vishwaguru’ – a teacher to the world – in the 21st century, as Swami Vivekanand predicted.
But in the absence of clear policy prescriptions required to make the world recognise India as one, such claims have been limited to rhetoric. As Aparna Pande wrote in her 2020 book, Making India Great, “Aspirations must always be matched with capabilities.”
The international COVID-19 vaccination programme was the Indian government’s golden chance to prove the country’s capabilities in the field of vaccine manufacturing, and to actually become a saviour-figure for billions of people worldwide. But India bungled the chance – as well as the chance to move one step closer to being a Vishwaguru.
Neeta Sanghi has over three decades’ experience in managing pharmaceutical supply chains.