India is currently experiencing a devastating second wave of the COVID 19 pandemic. We have continued to report massive numbers of new infections. On 7 May 2021, India recorded over four lakh new cases and 4187 Covid deaths. In the midst of this crisis, it is increasingly important that the population gets inoculated with the COVID 19 vaccine as soon as possible. Moreover, an oxygen crisis in several of the Indian states, especially in Delhi, is also adding a burden to the healthcare system. Inoculating people would be extremely helpful in containing the spread of the virus and reducing the severity of the deadly infections.
For years India has been responsible for exporting more vaccines than any other country. India is the world's largest manufacturer of Covid 19 vaccines, owing to the Serum Institute of India (SII), a biotech and pharmaceutical firm that produces 60% of the world's vaccine supply. Because of its extensive manufacturing capabilities, the nation joined COVAX, a global vaccine-sharing program that offers reduced or free doses to low-income countries. SII was meant to produce up to 200 million COVID 19 vaccine doses for up to 92 countries under the initial agreement announced last year. However, the Covid 19 vaccine campaign, which started in early January, is stumbling and faltering, millions of people are waiting to get vaccinated in India itself. So the question is, how did we go from being the largest supplier of vaccines to a dire shortage of them for our citizens?
The vaccines available in India
India currently uses two vaccines: the Oxford-AstraZeneca vaccine known locally as Covishield and its own Covaxin vaccine, developed jointly by Bharat Biotech and the government-run Indian Council of Medical Research (ICMR). Russia's Sputnik V was also deemed safe to use by the Indian government.
The government agreed to issue vaccines already in use in other countries' emergency approvals. It was decided to "expand the basket of vaccines for domestic use and hasten the speed and coverage of vaccination," according to the statement. The health ministry went on to say that the first 100 people who received the vaccines would be tracked for seven days before the rest of the country could get them. This means that Pfizer and Moderna vaccines will be made available to Indians. However, no details have been given by the government yet.
What causes the shortage?
1. Large population
Most people have attributed the shortage in vaccination to the most obvious reason- the extensive population that needs to be inoculated. India's population is huge and scattered. The process for vaccines to reach 1.39 billion people is time-consuming and complicated. Moreover, from the 1st of May, the government has opened vaccinations for all people above the age of 18. This step has added to the already growing vaccine shortage.
"No amount of advanced planning could have assured that sort of supply, which is needed now with the opening of vaccination for 940 million people in India," said Dr. Chandrakant Lahariya, a doctor based in New Delhi who is also a vaccine, public policy, and health systems expert.
Even before all adults were eligible to receive the COVID-19 vaccine states like Maharashtra had to turn away people from vaccination centers due to a shortage of them. The State government of Maharashtra had to stop the vaccination drive in Mumbai for a period of 3 days due to an extreme shortage. Last week, nearly 700 vaccination centers in Odisha had to close due to shortages, according to health officials who wrote to the central government, warning that the state's available supply would soon run out.
"We also need to understand that the population of India is huge and to produce enough doses for all adults is not an easy task ... We have been working with the government of India since April last year. We have got all kinds of support be it scientific, regulatory, and financial," said Adar Poonawalla, the Chief Executive Officer (CEO) of Serum Institute of India.
2. India’s Vaccine Maitri Program
The second possible reason for the vaccine shortage in India could be its vaccine diplomacy and extensive amounts of vaccine that it has exported to other countries.
The government of India started the vaccine Maitri program at the exact same time as it started its vaccine drive domestically. We were unable to estimate the need or urgency of vaccines in order to inoculate the population and increase immunization. While the case for exporting vaccines to its neighboring countries can be understood – a pandemic in any other country would impact India greatly – but assisting far-off nations when vaccine stock in India itself is limited, is quite questionable.
In total, 66 million vaccine doses were exported, while India's entire vaccine program from mid-January to mid-April provided 130 million doses. this would mean that India exported a month's supply of vaccines that it is now in dire need of.
3. India's Vaccine Policy
Surprisingly, India was extremely cautious about allowing new vaccines into the country. Given the numbers, it was clear that India would need to import vaccines from abroad or allow domestic use of foreign vaccines produced in India beginning in January 2021. Nonetheless, India refused to approve any vaccine other than Covishield or Covaxin until April 2. The government believed that the two available vaccines would be sufficient to meet both domestic and international demand.
India denied approval for Sputnik V in February 2021, citing Dr. Reddy's failure to provide immunogenicity data. Similarly, Pfizer was forced to withdraw its emergency approval application because the government insisted on a local bridging study.
Covishield, on the other hand, was approved in January 2021 despite the fact that its immunogenicity data was not yet available. Trial data from the United Kingdom and Brazil, published in The Lancet, were deemed adequate. Similarly, Covaxin was approved despite the fact that no Phase 3 efficacy data were available. So why weren't Pfizer and Sputnik V approved?
Even though the Indian government has now realized that without the approval of foreign vaccines India will continue to face severe vaccine shortage and has allowed vaccines like Pfizer, Moderna, and Sputnik V. An outcome of delaying the approval of vaccines like Sputnik V is that it will take a few more weeks, if not months, for its supply to begin in India.
4. Mismanagement by the Government
The first wave of the coronavirus in India is expected to end in October 2020, but the government has not yet placed any orders for vaccines. It has also not provided funding to vaccine manufacturers to increase production capacity in anticipation of a successful vaccine.
In January 2021, Covishield, SII's AstraZeneca vaccine, and Covaxin, Bharat Biotech’s vaccine were approved by Indian regulators. Shortly after this India placing order of merely 11 million doses of Covishield and 5.5 million doses of Covaxin. In order to achieve herd immunity by the end of 2021, India would require 200 million doses per month. The pandemic has receded so far in India that it appears that the government does not even expect to have to vaccinate its entire population, as many other countries were preparing to do. "Our numbers were low and there was this constant narrative that India had beaten Covid," says virologist Shahid Jameel.
In March 2021, as the second wave gathered, India finally placed its first big order of vaccines: 100 million doses of Covishield and 20 million doses of Covaxin. It is also attempted to stifle vaccine exports by redirecting the majority of supplies to its own citizens.
What Can India do to solve this problem?
1. Rather than limiting itself to SII and Bharat Biotech, India should grant new licenses to more vaccine manufacturers. SII currently has a monopoly on Covishield production, while Bharat Biotech has a monopoly on Covaxin production. Covaxin, on the other hand, was developed by the National Institute of Virology, Pune, a laboratory of the Indian Council of Medical Research. India should investigate emergency takeovers of industrial production facilities and make immediate investments in vaccine production.
2. A number of candidates, both in India and abroad, are undergoing trials and development at various stages. The government should keep a close eye on all of them and be ready to act on inviting and/or approving them for use in India at any time.
3. Serum Institute has received a total order of 266 million doses of Covishield from the Central government. A previous order for 110 million doses was released on April 28 and is expected to last until July, while another order for 13 million doses is still pending. Taken together, they amount to less than the 200 million doses already anticipated through July. The Indian government needs to resolve this conflicting demand for the stock and then place a confirmed order.
4. The central government must collaborate with Bharat Biotech to increase Covaxin productivity. If it hasn't already been done, the government should issue a purchase order for the entire production of the company so that no stock is exported.