Over the past few days, India, an important and globally recognized hub for vaccine manufacturing, has seen a confluence of developments that are raising new concerns around the need to not just inoculate more rapidly but also on ways to ensure vaccine-manufacturing capacities are adequate to meet the ever rising demand. Consider this: The viral caseload has been touching new highs with numbers well past the one lakh new COVID cases per day; the two COVID vaccine makers in India – the Pune-based Serum Institute of India and the Hyderabad-headquartered Bharat Biotech are already in the news for appeals for grants to augment their vaccine manufacturing capacities. India, which was showcasing its vaccine diplomacy and supplying vaccines to neighbouring countries, has stopped the exports of vaccines. To top it all, it has been more than a year since everyone knew that deliverance was possible only with vaccines, yet nothing was done to revive the Indian public sector units that at one point used to make vaccines. And now, Financial Express Online learns that the government has set up an inter-ministerial committee to look at ways in which the existing two manufacturers could get some of their existing non-COVID vaccine capacities repurposed for making COVID vaccines. In fact, the Drug Controller, we gather, has been working with the two companies to see how some of this could be made possible. One of the senior DCGI (Drug Controller General of India) officials in the know of the developments, tells Financial Express Online that if just the repurposing of the capacities could be worked out well then it is possible to increase the current vaccine supplies by another 50 per cent at the earliest.
Much will have to be seen on how this is done without impacting the supplies of other life saving and basic immunization vaccines that these companies also manufacture and therefore they will need to look at capacities for vaccines other than those for basic immunization.
But then the companies are seeking grants from the government to augment the vaccine-making capacities. On why they need to look to the government, the apparent argument is that the government is the sole buyer and has also imposed price control on the vaccine and now if the existing capacities are to repurposed for COVID vaccines then additional costs need to be incurred – be it to modify or change the existing fermenters or downstream processing or the filteration units. Also, in addition to these costs, business will have to foregone from supply of other products that were manufactured in the facilities being repurposed now for COVID vaccine.
India has so far administered over 90 million doses but is depended on supplies from only two companies and with in that just one company Serum claims to have supplied around 100 million doses to the Indian government – around 90 directly and 10 million though the WHO and GAVI -led COVAX initiative. Serum has this far, manufactured about 210 million doses and supplied 64 million doses for exports with the balance – around 45 million in stock or under testing at the moment.
Augmenting the existing capacities may be the only hope at a time when there are just the two vaccine makers and at least five different vaccines also in the fray but still in the clinical trial stage which means a wait for another three to five months before these vaccines can reach the people.
Most experts have maintained that getting as many people inoculated as possible is the only defense available under the current circumstances and if 70 per cent of India is to be inoculated there is no denying that the demand for vaccines is very high.
Currently, the only other vaccine knocking on the doors of the Indian drug controller for approval is the Russian Sputnik vaccine. Already two meetings with the experts evaluating the vaccines have apparently been completed with both meetings seeking additional data around immunogenicity and once this is resolved, India should have a third vaccine to deploy as well.
Those who have tracked the Indian healthcare sector and the vaccine industry point out that the current situation has also put into sharp focus the point that India has in many ways missed the bus in building vaccine-making capability within the government set up. After having rendered all the public sector manufacturing of vaccines dysfunctional few years ago – around 2008, today the Indian government is left with no option but to look to the private sector to supply the vaccines. There was a time the Indian government had well established units making vaccines out of Kasauli, Mumbai, Coonoor and Chennai. This is all the important at a time when the government hospitals and the public sector has emerged as stellar example of rising up to meet the demands for a massive inoculation drive across the country.
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