India's one billion COVID vaccine doses: A milestone, and miles to go

India must study the mistakes it made in the process of achieving the 100 crore doses milestone and review the performance of its vaccination drive, derive lessons and prepare for the period ahead rather than indulge in premature political celebration or commemoration.

A woman receiving the shot during the three-day intensive vaccination drive, at her home at Saram in Puducherry on July 30. Vaccinators and female health workers in villages did door-to-door campaigns throughout the country to motivate people to get vaccinated.

crore COVID-19 vaccine shots had been administered globally, which included 223 crore shots by China and around 105 crore shots in India. As the vaccine doses administered are dependent on the population size of a country, only China and India are expected to administer 100 crore or more shots.

On October 21, India became the second country in the world to administer 100 crore vaccine shots. India’s vaccination drive, which started on January 16, has witnessed more challenges than successes. Therefore, the symbolic milestone of 100 crore shots signifies that India crossed the halfway mark of 188 crore doses it had set for itself to be achieved by December. Yet, it is a reminder that the target of full vaccination for all adults is far away as only 31 per cent of the eligible population has received both shots and 45 per cent has received just one shot. At the time of administration of 100 crore shots, approximately 24 per cent of the eligible adult population was yet to receive its first shot.

Milestones are important to celebrate and to acknowledge the efforts and contribution of vaccine scientists, manufacturers, programme managers, health facilities and their staff, vaccinators and female health workers in villages who did door-to-door campaign to motivate people to get vaccinated. However, we should not be waiting for such milestones to appreciate any of them. It is equally important that this milestone is utilised to review the performance of the vaccination drive, derive lessons and prepare for the period ahead.

History of vaccination in India

India has a more than two-century-old history of vaccination. The first shot of smallpox vaccination in India was administered in Bombay on June 14, 1802. In the following years, vaccination efforts increased. In the 1890s, a laboratory in Shillong became the first unit to start producing smallpox vaccine lymph. Some of the early vaccine trials in India started in the 1830s. However, one of the first major trials conducted was on the cholera vaccine in 1893. Clinical trials on other vaccines such as typhoid and rabies were completed successfully by the late 19th and early 20th century. With the plague outbreak in 1896, the world’s first plague vaccine was developed in India in 1897, which was also the country’s first indigenous vaccine. India’s first vaccine research institute was set up at Kasauli (Himachal Pradesh) in 1904/05, followed by the setting up of the Pasteur Institute of India in Coonoor (Tamil Nadu) in 1907, and smaller vaccine institutes in many Indian provinces in the decades between 1910 and 1930. Soon after Independence, the BCG vaccine laboratory was set up at Guindy in Madras. From 1952, many private vaccine-manufacturing units and a few public sector units were set up. These manufacturers started supplying and fulfilling the vaccine requirements of two-thirds of low- and middle-income countries (LMICs). India became not just the pharmacy for high-quality and low-cost medicines but a vaccine production house for many of the LMICs.

There is a long history of mass-scale vaccination for adults and children. In 1951, India started the first mass-scale BCG vaccination, which included the adult age group as well. It conducted smallpox eradication efforts and vaccination drives, which resulted in the country reporting the last case of smallpox in 1977. Fresh from the success of smallpox eradication and newly created vaccination infrastructure and trained vaccinators, India launched the Expanded Programme of Immunisation (EPI) in 1978, which was renamed the Universal Immunisation Programme (UIP) in 1985. In the past two and half decades, India has regularly conducted mass-scale vaccination drives for polio elimination and against measles and rubella.

Under polio elimination efforts, as part of the National Immunisation Day (NID), India regularly administered about 17 crore polio vaccine shots in seven days, achieving around 99 per cent coverage of targeted beneficiaries. The polio vaccination drive was conducted at least twice every year for many years and continues to sustain India’s polio-free status. In fact, for a few years, around 70 to 100 crore polio vaccine doses used to be administered through two NIDs and a few subnational immunisation days in select States until India became polio free.

Soon after India reported the last case of poliomyelitis on January 13, 2011, building upon the success of the initiatives, the country focussed its efforts on further strengthening adverse events following immunisation (AEFI) surveillance and vaccine cold chain capacity and introduced a number of new vaccines in the UIP.

It is on account of this more than two-century-long history of vaccine research and development, and programme implementation and nearly four decades of EPI and UIP that immunisation is considered one of the better performing government health programmes in the country. Under the UIP, vaccines to protect against a dozen diseases, some in multiple shots, are administered to 2.7 crore children and 3 crore pregnant women by more than 200,000 vaccinators through 90 lakh sessions in a year, reaching around 600,000 villages. These efforts are supported by 30,000-odd cold chain points, community mobilisation, front-line worker participation, and a robust AEFI-reporting system, all of which have been strengthened in the past 15 years. It is no surprise that nearly 90 per cent of all vaccines administered in India are delivered through government health care facilities. The contribution of the private sector in vaccines has been 10-15 per cent.

It is against this backdrop that ever since COVID-19 was declared a pandemic and discussion on COVID-19 vaccine development started, India was considered a flag-bearer to deliver vaccines to its population and to the rest of the world.

COVID-19 vaccines

By mid-October, India finally achieved more COVID-19 vaccine supply than demand, and vaccination drives seemed to have been stabilised. India also resumed export of COVID-19 vaccines after a gap of around six months. However, India’s COVID-19 vaccine journey was not smooth for most of the past 18 months

In mid-2020, India set up technical experts groups to prepare for COVID-19 vaccine roll-out and for prioritisation of vaccine beneficiaries, among other things. The government formed partnerships with vaccine manufacturers for research on indigenous vaccines. The COVID-19 vaccine communication strategy was released by the end of December 2020. However, these efforts courted controversies early on.

In July 2020, a letter from the Indian Council of Medical Research (ICMR), which was interpreted as seeming to insist on completion of vaccine clinical trials in six weeks created a media furore. On January 3, 2021, one of the two COVID-19 vaccines was given emergency use authorisation (EUA) in clinical trial mode, without phase III clinical trial data. This was questioned by many people, and some even argued that this resulted in hesitancy among health workers to get vaccinated.

The COVID-19 vaccination was rolled out for health workers on January 16. Their initial hesitancy resulted in low uptake. Vaccination was opened in a phased manner to different age groups, which is a right approach, as recommended by a technical expert group. However, the uptake continued to remain low. The Indian government and the vaccine manufacturer, as part of the global commitment and under the ‘Vaccine Maitri’ initiative, started exporting vaccines. Until March 31, India had exported more vaccine doses than those administered in the country. The vaccines manufactured in India were sent to 80 countries. The first lot of COVID-19 vaccines supplied by COVAX—co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi and the World Health Organisation, along with the key delivery partner UNICEF—was produced in India.

However, by the March end and early April 2021, the demand for vaccines in India increased with the emergence of the second wave of COVID-19. There was not enough supply. Manufacturers were not able to scale up their production capacity as originally indicated. India put vaccine export on hold, yet the queues at vaccination centres were long.

In April, vaccination was opened to health workers, front-line workers and adults older than 45 years. With the number of COVID-19 cases rising every day, the public demand for opening the vaccination to those in the 18-44 age group increased. The technical expert group on immunisation was not supportive of this. But, contrary to the advice of technical experts, the government announced its decision to start vaccination of all adults.

In mid-April, when the target population was around 33 crore and there was a shortage of vaccines for this population, the opening of the vaccination drive to those in the 18-44 age bracket resulted in a threefold increase in the eligible population while the vaccine supply situation remained unchanged. The elegantly named liberalised and accelerated phase III COVID-19 vaccination policy was implemented from May 1. It had a range of provisions, including a differential pricing of COVID-19 vaccines for Central and State governments and for the private sector with eightfold variations. A quarter of the total COVID-19 vaccines produced in India were earmarked for sale to the private sector and they were to be made available on payment. The State governments were also asked to purchase vaccines for the 18-44 years age group directly from the manufacturer, with their own funds.

There was utter chaos. The private sector had access to all vaccines. The State governments had no previous experience of direct purchase of vaccines and had to compete with one another to secure vaccines from the manufacturer. Moreover, the States had not budgeted for such an expenditure. Many State government were reportedly taken by surprise. The outcome was that the limited vaccine supply was distributed sparsely, with many government vaccination centres having to close temporarily. People waiting for their second dose found it difficult to get it. May witnessed a lower daily COVID-19 vaccination rate than April. After a lot of chaos and struggle, the vaccine policy was further revised on June 7, with the Centre taking the responsibility of procuring vaccines on behalf of States. This was implemented from June 21. Although scarcity of vaccine supply and other challenges continued, the situation started improving from August before stabilising in October.

Time to reflect and learn

India celebrated the ‘100 crore doses’ as a high-profile political event. Celebration of any milestone is important, but a premature celebration comes with its own risks. Some of the early proclamations such as ‘the pandemic was over’ and that ‘the country had defeated Corona without vaccines’ gave room for complacency and resulted in the ferocious second wave.

Keeping in mind that nearly one-fifth of the adult population is yet to turn up for its first shot, around 83 crore more shots need to be delivered as first and second shot, and since there are some indications of vaccine hesitancy, we need to prepare well, by looking at the mistakes made in the process of achieving the 100 crore doses milestone and learn lessons.

One of the overarching characteristics of India’s COVID-19 vaccination drive was disconnect between policy formulation and securing supply and delivery on the ground. India’s health policymakers and technical experts spent a lot of time in prioritisation of target beneficiaries for COVID-19 vaccination, but arguably sufficient attention was not given to secure the vaccine supply. Otherwise, why should it have taken 13 days from vaccine authorisation to actual roll-out? This was because the government started working with manufacturers only after the EUA was given. If there was an emergency for regulatory approval, the emergency approach for procurement should also have been followed. Some of the chaos in the vaccination drive was attributable to political interference in what should have been an entirely technical decision. As an example, contrary to the recommendation of technical experts, as a populist move the government opened COVID-19 vaccination to adults in the 18-44 age group, a decision which can be called a misadventure.

Misleading claims

One of the misleading claims in the COVID-19 vaccination in India is that the vaccines were provided for free. The fact is that nearly all countries provide vaccines to their citizens free of cost. India did not. The Indian government allocated a quarter of the limited vaccine supply to the private sector and allowed it to be charged at the four- to eightfold price at which the government procured the vaccine. In doing so, it made three mistakes. One, by allowing manifold price differences for two different purchasers, it tacitly legitimised overcharging. Two, those who could afford it had easier access to vaccines.

Thus, the government policies introduced inequities, which should have been avoided. Third, a quarter of vaccines sold at four- to eightfold higher price could mean that effectively the total cost paid by people would have been far greater than government spending on vaccines. As such, to claim that vaccines were provided free of cost to all is far from the truth. Further, because the earmarked vaccine allocation exceeded their ability to use it, the private sector COVID-19 facilities nearly always had excess supply while government vaccination centres in the same locality remained closed for want of vaccines. This resulted in inefficiency in health service delivery. This should be considered a policy error, never to be repeated.

In the end, despite uninterrupted supply, the private sector contributed 6-7 per cent of the total COVID-19 vaccination. It would be worth pondering for future policy formulation why the share of the private sector in COVID-19 vaccination was low while it contributes to 10-15 per cent of childhood vaccination in India.

The COVID-19 vaccination uses a digital platform for registration and issue of vaccination certificates. However, the availability of vaccination data in the public domain has remained suboptimal. Although, of late, some more data have become available, vaccination data on various stratifiers and by types of AEFI, etc., which could be programmatically useful, are not available. It is time COVID-19 vaccination data were made easily available to researchers. There is an emerging issue of COVID-19 vaccination of children. The decision on that should entirely be based on a calm assessment of scientific evidence and full set of data from clinical trials.

Experience from the last many months shows that India needs to work upon regulatory approval more transparently and regain credibility, which has been partially dented by some missteps in decision-making.

In the week in which India achieved cumulative 100 crore vaccine shots, of nearly 41 crore adults who had received their first shots, 10 crore individuals were due for their second shot and yet had not returned to vaccination centres. This could be an early indication of challenges and vaccine complacency that might be settling in in the programmes, and the government needs to ensure that each one of them return for their second shot on time. Special communication campaigns and personal contact programmes are needed to target those who are yet to start on COVID-19 vaccination.

Two private sector vaccine manufacturers supplied nearly all COVID-19 vaccines in India. In addition to vaccine manufacturing, the private sector could provide the much-needed capacity augmentation in the area of supply chain and vaccine administration. The syringes used for vaccination drives were provided by the private sector. All these are proof of what can be achieved with effective public-private partnership for a public purpose. More such ‘partnership for public purpose’ should be explored and formed and the existing one strengthened. However, any public health programme cannot and should not be fully dependent on the private sector. It is time India revived its public sector vaccine-manufacturing units (some of which were closed a few years ago) and built its capacity for vaccine research and development and manufacturing.

In the times ahead, there would be technical decisions on mix and match of COVID-19 vaccines as well as whether (or not), and, if yes, for which population subgroups, the booster doses will be needed. This requires use of global evidence as well as programmatic data. This is another reason the government must use vaccination data more effectively. Make data accessible for analysis by health experts. In addition, the desegregated and stratified vaccination data are used for targeted strategies and focussed programmatic interventions. There are lessons for the future of adult vaccination in India and the government needs to give that serious consideration.

In the vaccination programme, risk communication and community engagement aspects need to be improved. The science communication by the government needs to be handled in a better manner. Some of the challenges and misinformation, such as a third wave will affect children, show that the government’s science communication needs strengthening. Science communication is needed to tackle hesitancy and also to address emerging issues such as why all children need not be vaccinated.

As four vaccines for use among children are at different stages of EUA, recommended for EUA and in clinical trials, it is likely that some of these vaccines might be recommended for use in high-risk children. To optimise the limited roll-out of COVID-19 vaccines in children for future decision-making, AEFI recording, and reporting has to be strengthened at all levels.

India has resumed vaccine exports as part of its ‘Vaccine Maitri’ programme. The country can do more in the global fight against the pandemic by ensuring vaccines for the rest of the world.

Lessons for broader health systems

If India is thinking of achieving the humongous task of 188 crore vaccinations, it is because of the decades of investment it made in various aspects of the vaccination programme. India’s health systems have been chronically underfunded and promises are unfulfilled. We should learn from the vaccination programme. Government funding for the overall health service system should be increased urgently and sustained for many years to come. That is the only way India can be prepared for future epidemics and pandemics.

It is time to look beyond COVID-19 vaccination and examine whether vaccination efforts have contributed to strengthening the health care system’s capacity to deliver routine immunisation of children. It is also time to bring coverage of routine vaccines for infants and children back on track, which, according to field reports, has suffered a setback. The COVID-19 vaccination drive has benefited from the UIP infrastructure, which has evolved over four decades. Yet, only 70 to 80 per cent of India’s children are fully vaccinated. In Bangladesh, Sri Lanka and Thailand, 95 per cent of the target group of children are vaccinated year after year. More importantly, COVID-19 vaccination efforts should ensure that the coverage of vaccines for children in India reaches 95 per cent and is sustained.

The right time to celebrate

The success of any vaccination programme should be measured against its objective and predefined parameters. The success of polio eradication was celebrated when India attained the polio-free status. Until then, the focus was on those who were unvaccinated. In its COVID-19 vaccination drive, India should have that kind of approach. Premature political celebration or commemoration can be bad news from the citizens’ perspective. With every celebration, the politician extracts mileage out of the initiatives and shifts his gaze to other things. India cannot afford to lose sight of the public cause. It should not settle for anything less than 95 per cent coverage with both shots of COVID-19 vaccines. That will be the day to celebrate.

Dr Chandrakant Lahariya, a medical doctor and epidemiologist, is a vaccines and health system expert based in New Delhi. His forthcoming book, Pause is an opportunity: The Transformative Potential of Schools Re-opening in India, is scheduled for release in 2022. He is the lead author of Till We Win: India’s fight against the COVID-19 Pandemic (Penguin Books) along with Dr Gagandeep Kang and Dr Randeep Guleria .