Covid-19 Pandemic: Shortages, Hesitancy and Pricing Plague India’s Covid-19 Vaccination Programme

The COVID-19 pandemic has affected human lives across the world, in unprecedented ways. One of the health responses to the pandemic has been the development of vaccines, intended to provide acquired immunity against the SARS‑CoV‑2 virus.

What purpose do vaccines serve? Mathew George explained:

As per the biomedical logic, the primary purpose of a vaccine is to induce immunity among individuals to prevent from those diseases against which they get vaccinated. On the other hand, there is a public health dimension, namely immunisation, characterised by its capacity to develop herd immunity, acquired by populations by achieving “threshold coverage.” It is this ability to develop herd immunity that qualifies vaccination as a public health intervention (Fine 1993; Patil 2011).

… From a public health perspective, herd immunity is expected to reduce susceptibility to diseases during epidemic times, as susceptibility will be higher in an unvaccinated population.

In the context of COVID-19 vaccination, an EPW editorial (17 April 2021) observed:

The current vaccines are useful in reducing the severity of COVID-19 and mortality, although the deaths of 180 people (as on 29 March 2021) following vaccine administration in India may ­belie the claim. Reduction of severity of disease and mortality apart, there is now evidence that some of these vaccines also minimise transmission. If so, that is good news as we can expect the epidemic to end a little earlier, unless the virus gives us more nasty surprises.

According to the World Health Organisation, as of 18 February 2021, at least seven different vaccines had been rolled out in countries. India currently offers two vaccines—Covaxin and Covishield—with other options likely to be available soon.

India’s COVID-19 vaccination programme is fraught with problems of insufficient capacity, shortages, mismanagement in implementation, vaccine hesitancy and vaccine wastage. With persons aged above 18 years eligible from 1 May and the new policy of allowing private procurement of vaccines, the challenges for COVID-19 vaccination in India are only likely to increase.

In this reading list, we highlight some of the question marks in India’s COVID-19 vaccination programme and policy options that could be taken up instead.

Why Is There a Vaccine Shortage and What Can Be Done?

While India reels from the impact of a severe second COVID-19 wave in April 2021, social media has been flooded with urgent pleas for help, indicating an acute shortage of hospital beds and oxygen and of treatment options such as remdesivir and plasma. 

Likewise, India’s vaccine shortage also threatens to prolong the COVID-19 crisis. An EPW editorial (17 April 2021) explained:

To date, more than 10 crore doses have been administered with either of these vaccines. However, it is clear that India needs more vaccines and more doses to meet the ­target of universal vaccination, or more modestly, the target of 60% to 70% vaccination coverage to attain some approximation of herd immunity against COVID-19.

What is the root of the problem? Anant Phadke (January 2021) highlighted the inefficiencies at the time of the conception of the vaccination programme itself:

Though vaccination has an important supplementary role to save lives and overcome the remaining pandemic, the government vaccination programme’s speed is grossly inadequate to accomplish this. Launched on 16 January, it is to first cover all health workers and front-line workers totalling 30 million, followed by all those above 50 years of age, totalling 270 million. This total of 300 million to be vaccinated “in the first stage” does not include those below 50 years of age, with comorbidities like diabetes, hypertension or suppressed immunity, etc, who need vaccination on priority as they have much higher Covid-19 mortality.

The government has planned to vaccinate 3 lakh individuals per day; 100 in each of its 3,000 vaccination centres. At this rate, it will take 100 to 1,000 days to cover all 300 million in the priority group. 

Similarly, R Ramakumar (1 May 2021) analysed:

To begin with, the Government of India (GoI) knew of the impending shortage of vaccines. India needed to vaccinate about 966 million adult persons, which would imply about 1,932 million doses of vaccines. If India must vaccinate everyone above the age of 18 in 12 months, the number of doses required would be at least 5.4 million per day. Even after considering the proposed capacity expansions of the Serum Institute of India and Bharat Biotech, India’s total production capacity was not to be more than 3.8 million doses a day. If we set aside about 15% of our capacity for external commitments, production capacity would shrink to 3.3 million doses a day in May 2021. Yet, while many countries approved a diverse basket of vaccines, India limited its official approvals to just two vaccines: Covishield and Covaxin. Why did India not put in place a liberal regime for approving, and importing, more vaccines?

Second, the vaccine business is risky, and early public investments serve to incentivise vaccine companies and reduce risk exposure. Many countries made large at-risk investments in vaccine companies for research and capacity expansion. India failed to do so. Given prior knowledge of the vaccine deficit, why did India not invest in capacity expansion, including in the public sector vaccine companies? Third, India also failed to place advance purchase orders for adequate quantities of vaccines. The first purchase order was placed only in January 2021.

A concurrent issue is the inadequately funded public health system in India. Phadke explained:

Government health workers annually vaccinate 25 and 30 million newborns and pregnant women respectively with around 150 million shots of different vaccines in a year and about 37.5 million in three months. An additional 30 million Covid-19 vaccine shots in the coming three months would mean handling more than double the usual workload. The grossly understaffed public health system (thanks to the policy of privatisation since the 1980s) is already fatigued because of the tremendous extra work during the last 10 months. This additional work of 30 million Covid-19 vaccinations in three months would severely affect the routine immunisation. Just one indication of this—the annual round on 15 January, of the oral polio vaccine to all under-five children, was postponed.

With these inefficiencies inherent in the government’s planned vaccination programme, the shortage of vaccines for the larger population comes as no surprise. So, what can be done to address the shortage? The EPW editorial (17 April 2021) analysed:

Cries of “ramping up” production capacity are meaningful only for the companies making Covishield and, to some extent, ­Covaxin. With only these two companies currently manufacturing vaccines in millions, indicating their capability of scaling up faster, it is unfortunate that the government is dithering on SII’s plea for additional emergency financing to further increase ­production.

Ramakumar noted:

Once hit hard by the shortage of vaccines and rising public anger, the GoI reversed the irrational preference for just two vaccines. On 13 April 2021, it granted emergency-use approval to all “foreign” Covid-19 vaccines approved by the United States Food and Drug Administration, European Medicines Agency, United Kingdom Medicines and Healthcare products Regulatory Agency and Pharmaceuticals and Medical Devices Agency Japan. For a government more eager to trumpet the achievements of atmanirbharta, this was a rather ignominious retreat. Nevertheless, vaccine supply is not expected to ease any time soon. New vaccines are not expected to arrive before June–July 2021.

While beneficial in the longer run, the policy options before the Indian state are not likely to materialise in greater vaccine supply or coverage, any time soon. According to the EPW editorial (17 April 2021),

[T]hough now authorised in India for emergency use, the Russian-origin Sputnik V vaccine will take at least three months to hit the market and maybe six months to make a substantive contribution.

Well-intentioned appeals by civil society to the government to issue compulsory licences (CLs) will certainly be useful in the near long term if the government responds with alacrity, but most Indian companies in pharma production will still have a gestation period of six months to one year to launch a vaccine.

Who Should Procure Vaccines and How Should They Be Priced?

As per the new policy of vaccination, in place from 1 May 2021, 50% of the vaccine doses would be procured directly by the centre and distributed to states, and would be available for healthcare workers, front-line workers, and those above 45 years of age. On the other hand, the remaining 50% would be supplied on the open market to states, private hospitals and industries that can administer vaccines. This 50% would be available for the population aged 18–44 years, at prices self-set by the vaccine providers. 

Ramakumar explained:

On 19 April 2021, India’s vaccine policy took another turn. Under the guise of opening up vaccination for everyone aged 18 years and above, vaccine sales were liberalised and vaccine prices were deregulated. Half of all vaccines produced were set aside for the centre, but the rest were to be contracted and bought directly from vaccine producers by states and private hospitals. 

… Politically, the aim of the ruling dispensation was to evade responsibility for the vaccine shortage. If the states were asked to procure vaccines directly from the vaccine companies, the blame for vaccine shortages could be shifted on to their shoulders. The political image of the Prime Minister could be salvaged.

Highlighting some of the problems with this new policy, the EPW editorial (24 April 2021) analysed:

[T]he new vaccination policy, in the garb of relaxing controls, seeks to pass the burden on to the states as it makes the states responsible to procure vaccines directly from the producers and allows for differential price-setting. This would not only add to the financial burdens of the states that are already squeezed but also could give rise to conflicts between different states. In fact, such conflicts are already visible in the case of oxygen supply, in the absence of decisive mediation from the centre.

The editorial advocated going beyond the framework of cooperative federalism, with a stronger responsibility on the centre. 

The intuitive understanding of the menace requires the central government to act on priority without waiting for others to take initiative. It is supposed to invest enough time in pursuing, supervising and monitoring closely the resources it has distributed among the states. But this does not seem to be happening in the present case.

The new policy also raises the related concern of commercial interests behind vaccine manufacturing companies that could stand to benefit from the open market vaccine procurement arrangement. Such gains for vaccine providers would be at the expense of the general public that would have to bear the cost of the vaccine, or that of the state governments if they announce that the vaccine would be made available free of cost (as many states have done).

Ramakumar explained:

Vaccine producers, it was noted, would “transparently declare their self-set vaccination price.” Indeed, by self-admission, India’s monopolistic vaccine producers were making “normal profits” at the regulated prices. However, they desired “superprofits,” for which they lobbied hard to free prices from all regulations. Deregulation became a tool to quench the thirst of vaccine companies for superprofits.

In January 2021, after Covaxin and Covishield had received emergency-use authorisation, Phadke had noted:

This permission unwittingly helped the commercial interests of these two companies. SII and Bharat Biotech had produced 50 million and 10 million vaccine doses respectively before obtaining this permission! SII is to sell Covishield as a priority to the Indian government at a negotiated price of ₹200 per dose. Thus, SII’s ₹10 billion were at stake. According to reports, SII wants to sell it at ₹1,000 in the open market, which is going to shrink as the epidemic recedes; similar is the case of Bharat Biotech. Full transparency is needed to ensure complete insulation of the regulatory decision-making from such commercial considerations. But information on the members of the Subject Expert Committee, their relations with the concerned pharma companies, if any, the detailed scientific rationale given by the committee for giving this permission is not available in the public domain.

Presently, the prices of a single dose of Covaxin and Covishield in private hospitals after 1 May 2021 are expected to be ₹1,200 and ₹600, respectively, while the prices for state governments would be ₹600 and ₹300, respectively.

Ramakumar explained the dangers of such differential pricing:

Ironically, many neo-liberal commentators have conveniently overlooked the consequent fragmentation of India’s vaccine market. Different prices for different vaccines across the centre, states and private hospitals would only encourage predatory practices in vaccine procurement. The outcome can only be a promotion of inefficiency and inequality and the absence of transparency. Efficiency and ­equity can be maximised only if vaccine procurement is public and centralised, if the vaccine market is regulated and if vaccines are shared across states based on socially desirable criteria.

With the deregulation of procurement and pricing of vaccines, the question arises: Should the onus of supplying COVID-19 vaccines at equitable prices not be on the centre? Should vaccines not be free and universal?

According to Ramakumar,

First, vaccines should be global public goods. They impart not just private benefits, but also social benefits. As such, even mainstream economic theory concedes that vaccine markets are prone to market failures and suboptimalities. Most capitalist states, therefore, are providing vaccines free of cost to all citizens. Second, legal experts have tried to read the right to free vaccines as being implicit within the right to life and personal liberty enshrined in Article 21 of the Constitution. Third, most vaccines, including Covaxin in India, are products of public-funded research. Public investments should not be allowed to be stealthily diverted into private profits, and taxpaying citizens deserve access to free vaccines. Fourth, charging for vaccines would make them unaffordable for a large section of the population, and exacerbate vaccine hesitancy. In sum, there is a clear case for public policy to supply vaccines free of cost to all citizens.

Unfortunately, the central government seems to have withdrawn from its social responsibilities as a welfare state.

Why Is There Vaccine Hesitancy and What Can Be Done?

While the shortages could delay vaccination for the population looking to be vaccinated, continued vaccine hesitancy is also likely to contribute to a slow COVID-19 vaccine roll-out in India.

Vaccine hesitancy had begun to be noted at the start of the vaccination campaign in India itself. In January 2021, Phadke had noted:

In reality, due to widespread vaccine hesitancy, currently only about two lakh instead of three lakh people are being vaccinated daily. This is because of communication failure about the rationale of the permission and the reported nine post-vaccination deaths among the 23 lakh people who vaccinated in the first 12 days. That these deaths are claimed to be unrelated to the vaccine when the system to record, analyse and deal with the Serious Adverse Events Following Immunisation (SAEFI) being mainly on paper, is a concern.

The hesitancy towards taking the COVID-19 vaccine is rooted in concerns regarding the efficacy of the vaccine as well as dangerous side effects.

These were contentious even before the grant of emergency use authorisation to Covaxin and Covishield. An EPW editorial (26 December 2020) had observed:

Covishield and Covaxin Phase 3 trials are in progress in India, but the DCGI now has to consider the interim analysis of trial data and take a call. Phase 3 trials vomma where about half of the study volunteers would have received placebo and the rest the vaccine, are crucial. The comparative frequency of COVID-19 in the two groups determines vaccine efficacy, and that can be known only after the trial is over and all data analysed. The situation we are in calls for both urgency and adherence to protocol. Hence, the public’s trust in the process is essential for trust in the product, and full transparency becomes of utmost importance.

Despite such warnings, when emergency-use authorisation was granted for the two vaccines, their Phase 3 trials had not been completed and trial data was not available publicly. The lack of transparency has continued even after the implementation of the vaccination programme.

Further, who bears the responsibility if any fault in the vaccine causes injury to Indians? Nithyananda K V (April 2021) explained: 

COVID-19 vaccination is mired with legal uncertainty and hurdles, especially from an adversarial legal system in India, and immunity of WHO, which might persuade citizens either to avoid vaccination altogether or postpone getting vaccinated. India cannot delay vaccination, as it would extend the pandemic.

… Hence, building trust and community buy-in becomes more critical. The NFCS (no-fault compensation system for vaccine injury) would motivate reluctant Indians to fearlessly get vaccinated and protect themselves and others against the SARS-COV-19 virus.

He added:

Having a robust and equitable NFCS (no-fault compensation system) for COVID-19 vaccine injury would preempt product liability complaints against the government, and could build confidence and trust among citizens about government-initiated immunisation programmes. This could lead to a higher percentage of population getting vaccinated at the earliest.

The need for government responsibility and transparency becomes even more significant with the possible availability of foreign-made vaccines, going forward. The EPW editorial (17 April 2021) explained:

[B]y the time one is ready with a vaccine, facts change. Viruses mutate and vaccines we have developed through CL (or otherwise) may therefore not be as effective with the new virus variants (though, there is no proof either, as of writing, that existing vaccines will not work with newer ­variants). Or worse, serious side effects like blood clots in the brain leading to strokes (as is possibly the case with the AstraZeneca vaccine, and now that of Johnson and Johnson) may pose new challenges to their acceptability. 

Accordingly, it advocated:

The consequent narrative that the government puts out needs to reflect sincerity, truth and transparency of governance than reek of having swept bad news under the carpet, or routine claims that the bad news is not vaccine-related and all is well. It is no secret that in India, monitoring and follow-up of serious side effects, and associated deaths, is less than desirable. Also, with new foreign-made vaccines being given an easier entry, criticism and searching questions from non-government experts and scientists must be encouraged than dismissed with minatory talk of sedition. The government must realise that ­science and public health are best served by taking decisions based on scientific considerations.

Read More

• Process of a Vaccine Trial | Mukul Kumar and Surabhi Tandon, 2000
• Vaccines to the Rescue | Peehu Pardeshi, 2020
• Underestimation of the COVID-19 Burden: Interpreting the Puzzling Numbers | M S Seshadri and T Jacob John, 2020
• 2020: The Year of the Pandemic | EPW Engage, 2020