Universal vaccination programs have eliminated smallpox and reduced serious diseases including measles, mumps, rotavirus, and polio. But in the coming few months, India will witness another great event in its history — the great Covid vaccination exercise. This is vaccination going to be one of the most anticipated events in the country. This mass universal vaccination drive might prove to be a daunting task.

Making of a vaccine

A vaccine has to pass three tests to be successful – quality, ease of delivery, and public acceptance.
Quality, in turn, has three attributes – safety, efficacy, and duration of protection.
These are initially assessed in animals, then in humans through rigorously three-phased clinical trials involving thousands of persons, followed by post-marketing surveillance of several thousands more.

India’s potential in vaccine-making

The universal immunisation programme in India has well established and time-tested vaccine distribution systems.
India has run massive immunisation programme earlier too, makes 60% of the world’s vaccines and is home to half a dozen major manufacturers, including Serum Institute of India – the largest in the world.
Not surprisingly, there’s no lack of ambition when it comes to vaccinating a billion people against Covid-19.
India plans to receive and utilise some 500 million doses of vaccines against the disease and immunize up to 250 million people by July next year.

Mechanisms available

India’s vaccine distribution network is operated through four government medical store depots (GMSDs) in Karnal, Mumbai, Chennai and Kolkata, which procure vaccines from the manufacturers.
About 53 state vaccine stores get their supplies either from these GMSDs or directly from manufacturers.
The state vaccine stores then distribute the vaccines to regional, district and sub-district level cold chain points via insulated vans.
The vaccine management has improved over the years thanks to a real-time supply chain management system known as the electronic vaccine intelligence network (eVIN).

EVIN: The COVID-19 delivery system will use the UIP platform, with the innovative Electronic Vaccine Intelligence Network enhancing efficiency and diligence.

CO-WIN Platform: This user friendly mobile app for recording vaccine data is working as a beneficiary management platform having various modules. Once people start to register for the app, the platform will upload bulk data on co-morbidity provided by local authorities.

India’s efficacy

India ranked within the 51-75 percentile range among 89 countries on effective vaccine management as per a global analysis by WHO-UNICEF in 2018.
Its performance was relatively poor when it came to following the required vaccine arrival procedures and using the MIS system for estimating demand of vaccine, syringe, etc.

Various challenges looming before the roll-out of Vaccine

[A] Infrastructure and other ground challenges

For India, the magnitude of the task at hand is huge. If we have 1.3 billion Indians, a two-dose vaccine (such as Moderna or Oxford vaccine) implies 2.6 billion doses that need to be given across the nation.

(1) Supply-chain challenges

The supply chain of the vaccines has to be strictly monitored for temperatures as the vaccines tend to be very sensitive to temperature variations.
Storing the vaccines in temperature controlled boxes proves to be challenging in India, because of problems with electricity supply, which in many places in India tends to get interrupted frequently.

(2) Infrastructure challenges

Getting vaccines to people who need them will require over a billion vials to be manufactured, filled and shipped, at top speed and in some cases, under extreme stress.
India needs to scale up its cold chain and distribution infrastructure for the last-mile connectivity.
Cooling facilities in the final delivery stages and a lack of storage at clinics would pose the biggest challenge to delivering vaccines on a high scale.

(3) Inter-state disparity

What adds to the vaccination challenge is the inter-state disparity in the distribution of cold chain points across the country.
Jharkhand, Uttar Pradesh, and Bihar are among the least served states when it comes to cold chain infrastructure.
It won’t be easy to fill such deficits given that most of the private sector cold chain network is concentrated in the bigger cities and towns.

[B] Access challenges

(1) Access and affordability

Vaccine distribution poses another daunting challenge, and is accompanied by questions such as how much it will cost and who will pay for it.
Some of the concerns are about corruption over access to vaccines.

(2) Vaccine safety

It is essential to assess safety as the vaccine will be administered to healthy persons.
This is a concern because some candidate vaccines have previously been known to have serious adverse effects.
The choices of vaccines, distribution, identifying groups for early vaccination, storage and more importantly, trained personnel, all play a role, the experts underline.

(3) Uptake and monitoring

Apart from distribution and delivery, other issues would be vaccine uptake and monitoring.
Vaccine uptake requires confidence in the vaccines and the delivery system.
Documentation of vaccination and the tracking and investigation of vaccine safety events are essential components of monitoring.
India also has to battle with vaccine hesitancy. These have not been done well looking at the past experience.

[C] Ethical challenges

Acute humanitarian crises pose complex ethical dilemmas for policy-makers, particularly in settings with inadequate health-care services, which often become dependent on external agencies for urgently needed care.

When resources, especially staff, are scarce, decision-makers often choose among interventions – implicitly or explicitly – on the basis of cost-effectiveness because they are seeking to maximize benefits.

Many ethical issues surround the development and use of vaccines. These issues include

Requiring vaccination by law;
Development and testing of vaccines;
Informed consent about the benefits and risks of vaccination; and
Equitable distribution of vaccines

Among these, one is very crucial, i.e.

#Prioritization

It is a matter of distributive justice. Distributive justice requires the fair allocation of scarce basic resources, such as shelter, food, potable water and vaccines is not an exception to this.

Different rules govern decision-making and priority-setting during acute crises.
Objective, transparent processes for making priority-setting decisions are extremely important to maintain trust in the vaccination plans.
Incidentally, the intent behind identifying the high-priority groups to receive the vaccine first was to safeguard them from severe disease and not to break the virus transmission chain.

Prioritized group as per our Health Ministry

Prioritized Population Groups include:

Healthcare Workers in both Government and Private Healthcare facilities
Frontline Workers including personnel from state and central police department, armed forces, home guard, civil defence organizations, disaster management volunteers and municipal workers and
Prioritized Age Group, which includes those aged above 50 years & those with co-morbidities

(Note: This is not the sequence, but categorization.)

[D] The biggest global challenge: Vaccine Nationalism

Vaccine nationalism occurs when a country manages to secure doses of vaccine for its own citizens or residents before they are made available in other countries.
This is done through pre-purchase agreements between a government and a vaccine manufacturer.
It is harmful to equitable access to vaccines.

Why it has to go away?

Most vaccine development projects involve several parties from multiple countries.
With modern vaccines, there are very few instances in which a single country can claim to be the sole developer of a vaccine.
And even if that were possible, global public health is borderless. As COVID-19 is illustrating, viruses can travel the globe.

“An outbreak anywhere is an outbreak everywhere”.

Way forward

Considering the large population and limited capacity of production and distribution of vaccine, it will not be easy to provide everyone around the world with the vaccine at the same time.
There is a need to develop a strategy for the same which will guide us in deciding who should receive the vaccine first.
In this context, any effective vaccine that is developed should be treated as a global public good and should be distributed equally around the world, regardless of where it was invented or of a country’s ability to pay.
There has to be a comprehensive global framework that will ensure priority for the most vulnerable populations.
International institutions — including the WHO — should coordinate negotiations ahead of the next pandemic to produce a framework for equitable access to vaccines during public health crises.

Conclusion

The allocation of a limited supply of vaccine calls for a fine balance between utility and equality and fairness. Accountability demands that decision-making be explicit, documented and open to public review.

Efforts to maximize utility can conflict with the egalitarian goal of helping the neediest.
When limited supplies are allocated to the most vulnerable, overall health utility is sometimes suboptimal.
From the perspective of value pluralism, balancing utility and equality should be the goal, rather than prioritizing one or the other.
When it comes to vaccination, the utility is fortunately often greatest when the most socially disadvantaged groups are targeted.