India's failure on the vaccine front, and what needs to be done now

The role of the different instruments of policy in tackling the crisis caused by a powerful second wave of COVID infections has now come under sharp scrutiny. There is no doubt that masks, sanitisers, social distancing, testing and quarantine continue to be the mainstay of the policy responses. At the same time, global experience shows that expanded vaccination may also help reduce the spread of infections and weaken the links between infections and death. Hence, countries are racing to vaccinate as large a share of their populations as they can in the shortest time-span.

India is a laggard in this race to vaccinate the population. As on April 17, 2021, the share of the population vaccinated was 48.2 per cent in the United Kingdom, 38.2 per cent in the United States and 18.9 per cent in Germany, but just 7.7 per cent in India.

One of the important reasons for this poor rate of vaccination has been a severe vaccine shortage. Though India is usually celebrated as the “pharmacy of the world”, vaccine shortages have forced the government to turn people away from vaccination centres. At the present rate, a major chunk of India’s population may remain unvaccinated even by April 2022.

Also read: Explainer: Why India’s COVID vaccine production could be slowing down

Poor planning has played a significant role in exacerbating the problem of vaccine shortage. Attention was recently drawn to the need to improve India’s vaccine policy by former Prime Minister Manmohan Singh. In a letter to the Prime Minister, Singh asked him to put in place a transparent and fair policy of sharing vaccines with States and ensure more financial flows to private vaccine companies to expand their vaccine production capacities.

The demand and supply for vaccines in India as well as the role played by policy in ensuring adequate supply of vaccines over the last four months have to be first understood. The numbers are publicly available, and should have been available to India’s vaccine planners all along as well. Unarguably, the government, despite being fully aware of the projections of demand and supply, did not take the necessary steps to boost supply of vaccines.

Demand for vaccines

India has a population of about 138 crore (or 1,380 million) as of 2020. Out of this, about 30 per cent may be assumed to be less than 18 years old. That is, India must vaccinate 966 million adult persons for a 100 per cent coverage. At the rate of two doses, this implies 1,932 million doses of vaccines. A 60 per cent target for vaccination would mean a coverage of 580 million persons. At the rate of two doses, this implies 1,160 million doses of vaccines.

As on April 19, 2021, 123.8 million persons have received at least one dose (i.e., this is the total number of doses). About 107.2 million persons have received the first dose, and about 16.3 million persons have received two doses.

In other words, India must give close to 1,036 million doses of vaccines from here on to meet the 60 per cent target, and 1,808 million doses from here on to meet the 100 per cent target.

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Let us assume further that this target would have to be reached by January 2022. Thus, India has about nine months in hand to achieve this target. So, the monthly target for 60 per cent coverage would be 115 million doses per month or about 3.8 million doses per day. Similarly, the monthly target for 100 per cent coverage would be 200 million doses per month or about 6.7 million doses per day.

This is the approximate overall target. Of course, there is a simplification here, as the second dose is given 4-6 weeks after the first dose. But let us set that aside for simplicity sake.

In January 2021, India had decided on a sequential rollout of vaccines. First, the healthcare workers (HCW) numbering about 10 million and frontline workers (FLW), about 20 million were to be covered. This was to be followed by the prioritised age group of those over 50 years plus those less than 50 years with co-morbidities numbering about 270 million. Thus, in all, 300 million was the target for the vulnerable groups. However, the government first opened the window for those above 65 years and those above 45 years with co-morbidities, and then gradually opened the window for everyone above 45 years.

If we still consider 300 million as the denominator ( if you ignore the 45-50 age group, as accurate data of their size is not available with me), only about one third of the vulnerable category has been covered with the first dose as on April 17, 2021. Compare this with United Kingdom, which has already met its target of offering the first dose to everyone in the top priority groups – i.e., all those over the age of 50 plus those in high-risk categories – before April 15, 2021.

Supply of vaccines

The first point to note is that all the vaccine production in India is not for use in India. First, Indian companies have commercial commitments abroad and secondly, the Indian government grants vaccines to other countries. Thirdly, the Indian government has supply commitments under COVAX of UN-backed international vaccine alliance GAVI. As on April 14, 2021, a total of about 65 million doses were thus sent out of India.

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Within this export of 65 million doses till April 14, 2021, the number of doses sent under the GAVI initiative was about 19 million. However, India’s Serum Institute of India (SII) has an interim commitment to supply about 110 million doses under the GAVI initiative between February and May of 2021. This interim commitment is most likely to be breached. Till April 14, 2021, according to BBC report, SII had supplied only 28 million doses to GAVI and has further stated that it will be able to export more only by June 2021.

SII’s total commitment under the GAVI initiative is reportedly 1.1 billion doses with 200 million as a legal commitment, and the rest on option (of course, a major part of India’s provisions to GAVI would return to India, as India is the largest beneficiary under GAVI with an allotment of 10 million doses).

In other words, India needs an additional production capacity of about 10 per cent-20 per cent after meeting its domestic requirements (10 per cent for the 60 per cent target, and 20 per cent for the 100 per cent target).

Current capacities of vaccine production in India

According to one newspaper report, the SII (that produces Covishield) has a current capacity of 60-70 million doses a month, which is reported to be rising to 100 million doses a month by May 2021. This is corroborated by a Rajya Sabha Committee report, which puts SII’s capacity at 70 and 100 million per month. According to another commentary, SSI’s capacity was only 50 million doses a month till February 2021, which rose to 70 million doses only in March 2021.

Bharat Biotech, which produces Covaxin, is reported to have a current capacity of 6 million doses a month, which is to rise to 15 million doses a month by May 2021 and 58 million doses a month by 2021 end. The Rajya Sabha Committee report puts this figure at 5-10 million doses a month.

Thus, taking all the estimates of capacities in April 2021 into account, India produced only about 76 million doses a month (or 2.5 million doses a day) of Covishield and Covaxin, which were the only two vaccines approved in India till April 13, 2021. Even if we take the higher projected estimates of May 2021 (100 million doses a month for SSI and 15 million doses a month for Bharat Biotech), the total production capacity would be about 115 million doses a month or 3.8 million doses a day).

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From these numbers, the export commitments would have to be deducted. If we make an average of 15 per cent deduction for exports from the capacities, the capacity for Indian use works out to be 98 million doses a month or 3.3 million doses a day. Given the status of public health infrastructure in India, we would further need to add a 5 per cent to 10 per cent deduction for vaccine wastages. If we take a 5 per cent wastage figure, the capacity for Indian use would further fall to 93 million doses a month or 3.1 million doses a day.

These estimates assume that SSI and Bharat Biotech would indeed meet their targets for ramping up production capacities by May 2021; all reports indicate that both may fail in their efforts to ramp up capacities as promised.

Two constraints are worth noting in this context. First, while all vaccine manufacturers in India together have a capacity of 8,200 million doses a year, these are for all types of vaccines. To produce COVID vaccines, these capacities will have to be repurposed. Such repurposing cannot adversely affect the production of other essential vaccines, and hence a complete repurposing is impossible. Repurposing is also time-consuming.

Secondly, the USA has imposed export bans on many vaccine-related raw/intermediate materials, which has adversely affected the speed of vaccine production in producing countries like India. For example, the USA has restricted exports of special pumps and filtration units needed to make vaccines under the Defence Production Act (DPA) to give priority to American vaccine makers.

As we noted earlier, for a 60 per cent coverage target, India would need 117 million doses or about 4 million doses per day. For 100 per cent coverage target, India would need 203 million doses per month or about 7 million doses per day. Clearly, even considering the expanded capacities of May 2021, India’s production capacities are significantly low. One would be surprised if the Government of India did not anticipate this shortage in January 2021 itself. It should have been clear that India was in deficit by about 10 million doses a month to 40 million doses a month depending on the targets planned.

The question is: did the Government of India plan to tide over the anticipated deficit? Given the nature of vaccine shortages, India should have aimed for an expanded regime of approvals and capacity augmentation in vaccine production. More vaccines should have been given permissions and huge investments should have been directed to public and private vaccine producing firms.

Also read: ‘More testing, increasing vaccine output key to fighting COVID wave’

India’s vaccine policy

Surprisingly, India was thoroughly conservative in allowing new vaccines to be introduced into the country. Given the numbers in hand, it was crystal clear right from January 2021 that India would either need to import vaccines from abroad and/or allow domestic use of foreign vaccines produced in India.

Yet, India was refusing approval for any vaccine other than Covishield or Covaxin till April 2021. The reason appears to be a belief based on zero evidence that the two “Made in India” vaccines would be sufficient to meet India’s domestic needs and international commitments (Covishield is not exactly Indian, as SII’s vaccine is based on the Oxford-AstraZeneca master seed).

For example, Sputnik V and Pfizer should have been granted emergency approval in India long ago. In February 2021, India refused approval for Sputnik V on the ground that Dr Reddy’s had not supplied data on immunogenicity. Similarly, Pfizer was forced to withdraw its application for emergency approval because the Government insisted that a local bridging study was necessary.

Strangely, however, Covishield was given approval in January 2021 even though its immunogenicity data was not yet available. Trial data from the UK and Brazil, published in The Lancet was considered adequate. Similarly, Covaxin was given approval even when its Phase 3 data on efficacy was not available. Why were the same yardsticks not applied to Sputnik V and Pfizer? It’s perplexing.

There is more. People in India who argued for emergency approval to more vaccine manufacturers were castigated as anti-Indian and lobbyists of foreign pharmaceutical firms by ministers and ruling party spokespersons.

With a second wave of infections raging in the country combined with a major shortage of vaccines, the Government of India appears to have finally realised its blunder. On April 13, 2021, it decided to grant emergency use approval for COVID-19 vaccines, which were developed and manufactured in foreign countries and granted emergency approval for restricted use by USFDA, EMA, UK MHRA and PMDA Japan. A welcome step, but most delayed.

Announcing the U-turn, VK Paul, member (health) at NITI Aayog said: “We hope and we invite the vaccine makers such as Pfizer, Moderna, Johnson & Johnson and others…to be ready to come to India as early as possible”. Officially, Paul’s statement and request marked the end of the hubris of a government, which wanted to flaunt a misdirected atmanirbhar campaign in the middle of a pandemic rather than save the lives of citizens. A more universal vaccine rollout based on an expanded vaccine production policy may have saved so much of the pain we are currently undergoing.

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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. The Russia Direct Investment Fund (RDIF) has a contract with six Indian firms to produce 650 million doses, which will enormously help India meet its targets for vaccination. But given the delays in approval, the first dose of Sputnik is likely to arrive in India only by June 2021, which is at least six weeks away. There is still no clarity on the number of doses that would become available per month. Similar is the case with Pfizer’s or Johnson & Johnson’s vaccines. Thus, it is important that India rapidly ramps up its production capacity over the next few weeks. This can be done in many ways.

What India needs

While the approval of import of foreign vaccines is a welcome step, India would need to do a lot more in the coming weeks and months. A few points are important to be emphasised here.

• India should issue new licenses to more enterprises to produce COVID vaccines, rather than limit themselves to SII and Bharat Biotech. Currently, SII has a monopoly over the production of Covishield and Bharat Biotech has a monopoly over the production of Covaxin. However, Covaxin was developed by the National Institute of Virology, Pune, which is a laboratory of the Indian Council of Medical Research (ICMR). Why should a private company have monopoly over the production of a publicly developed vaccine?
• India should explore emergency takeover of production facilities in the industrial sector and make immediate investments in the production of vaccines.
• India should also allow selected State governments, which have accredited vaccine-related PSUs, to begin production of vaccines. For example, the Government of Maharashtra requested and received permission from the Government of India to allow production of vaccines in the Haffkine Bio-Pharmaceutical Corporation Limited under its ownership. This is welcome, and more such approvals are needed. Interestingly, Manmohan Singh’s letter asks Government of India to provide financial support from the public exchequer to private vaccine companies, but is conspicuously silent on directing investments to public vaccine production units. We may remember that it was including under Singh’s tenure that public vaccine manufactures in India were starved of funds to favour private vaccine manufacturers.
• Alongside, India should open mass vaccination centres by gradually, but quickly, increasing the number of vaccination centres. India should ultimately aim for 10 million vaccinations a day. The technocratic insistence on using mobile apps that can be installed only on smartphones, which are not accessible for vast sections of India’s poor population; the tendency to experiment with Aadhaar, biometrics and face recognition software in the applications; are all likely to exclude people from vaccination in the time of an emergency like this. The vaccination programme needs to be mass, simple and easy to access for India’s poor.
• India should resist the temptation to deregulate vaccine prices, as demanded by a section of business press and neoliberal spokespersons. Presently, Covishield is priced at ₹150 plus taxes (was ₹200 plus taxes earlier), and Covaxin is priced at ₹206 plus taxes. These are rather affordable prices for vaccines for India’s population. Other vaccines  from Pfizer, Moderna, Sinopharm, Sinovac and Novavax are more expensive (more than ₹1,000 per dose). When these vaccines are introduced in India, they should be subsidised at parity prices for mass vaccination, and not exclusively be reserved for the rich who can afford them.

(R Ramakumar is Professor, Tata Institute of Social Sciences, Mumbai)