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From the lab to the jab- A steep challenge

The world has been waiting with bated breath for a relief from the ongoing global pandemic. With the vaccine in the horizon, the focus is now shifting to the complex logistics involved in delivering it to the mass population.

As the world’s most promising coronavirus vaccine candidates push toward the crucial phases of development, from factory to syringe, they would need non-stop sterile refrigeration to keep it potent and safe. The large scale immunisation drive would require a substantial increase in not only cold chain points but also cold chain equipment including walk-in coolers, deep freezers and refrigerated vans.

Despite enormous strides in equipping developing countries to maintain the vaccine cold chain, nearly 3 billion of the world’s 7.8 billion people live where temperature-controlled storage is insufficient for an immunization campaign to bring COVID-19 under control. Poor people around the world, among the hardest hit by the virus pandemic are also likely to be the last to recover from it. The vaccine cold chain hurdle is just the latest disparity of the pandemic weighted against the poor, who more often live and work in crowded conditions that allow the virus to spread, have little access to medical oxygen that is vital to COVID-19 treatment, and whose health systems lack labs, supplies or technicians to carry out large-scale testing.

Maintaining the cold chain for coronavirus vaccines would not be easy even in the richest of countries, especially when it comes to those that require ultracold temperatures of around minus 70 degrees Celsius (minus 94 degrees F). Investment in infrastructure and cooling technology lags behind the high-speed leap that vaccine development has taken this year due to the virus.

Indian scenario
India faces a steep challenge for both, its cold chains and distribution infrastructure. The success of any covid-19 vaccination programme will be critically dependent on the robustness of the cold chain.

Meetings to resolve this issue are being held at senior levels as among the Prime Minister, Chief Ministers, and Lieutenant Governors of various states and Union Territories. The plan is to use the existing cold chain network in place for its Universal Immunization Program. But that infrastructure is geared to only immunize children and pregnant women.

The country has more than 28,000 cold chain points, along with over 700 refrigerator vans and 70,000 plus vaccinators to assist in the process of vaccine administration under the Universal Immunisation Program. A distribution of about two billion doses of vaccine for over 1.3 billion population will require a significant scaling up of the existing capacities. With the current immunization program of the government, only 20-25 percent of the overall volume can be distributed.

The necessity is to keep the vaccine product cold, either refrigerated or frozen. This is a constraint especially with large numbers of doses. Many vaccines lose potency when exposed to higher temperatures, and re-cooling does not help. Protocols will require the COVID-19 vaccines to be kept between 2 and 8 degrees Celsius, while in transport and storage until delivery.

The real insurmountable issue will be for the rural Indian setup, where the availability of power in the hinterland is a major concern. Even with a peak power deficit of 0.8 per cent, uninterrupted power is an issue.

According to CBRE South Asia, in 2019 the overall cold storage capacity in India translates to 37-39 million tonnes. However, only a small number of cold chain providers have capacities of around 5000 tonnes, and of these, very few are pharma compliant as per the guidelines of WHO. Besides, a vast portion of the cold storage available in India is used for agricultural produce.

Combining the agri cold chain and the pharma cold chain could be an option since the agri-cold chain can handle the temperature range of 2-8 degrees Celsius for storing most vaccines. However, vaccine makers’ requirement of a sterile environment could be a challenge if agri and pharma cold chains are combined.

The supply-chain is also looking to involve airlines, and logistics service providers. Airlines are gearing up to meet the challenge of transporting the vaccine. IndiGo is planning to launch dedicated freight services. SpiceJet is in the process of expanding its cold-chain facilities including putting in place temperature-controlled warehouses and containers, thermal blankets and data loggers.

Along with Snowman Logistics, Blue Dart Express, Allcargo Logistics, and Mahindra Logistics are among those competing to transport vaccines. For instance, Snowman Logistics has reserved space for more than 10,000 pallets, which will hold 70 million doses of the vaccine, across all its locations. It is already managing vaccine distribution of influenza/swine flu and typhoid.

BlueDart is constructing additional conditioning rooms, for storing the vaccines at eight locations including Mumbai, Chennai, Hyderabad, Ahmedabad, Pune, Kolkata, Delhi, and Bengaluru.

An expert group overseeing the vaccine distribution plan has started talking to not only private and public sector entities, but also food tech firms like Swiggy and Zomato to identify refrigeration facilities at the district level and for last-mile delivery.

Given the panic, there are fears of pilferage too. Secured loading and safeguarding at every point in vaccine’s transport is highly important too.

Pharma companies update
The storage requirements of a vaccine depend on the temperature they need to be kept at for their potency to remain intact. Each vaccine candidate has a particular temperature range for its storage, even if the same technology is used in its development.

The leading vaccines have indicated an optimal temperature for storage can go well below zero degree Celsius (down to minus 80 degrees Celsius) and between 2 degrees Celsius and 8 degrees Celsius at the point of delivery.
Pfizer’s vaccine needs to be stored at minus 70 degrees Celsius and thawed and injected within five days. The vendor has offered that it will provide a dry ice pack container that will help maintain the temperature of minus 70 degrees Celsius for up to 10 days. And the company is working on a powdered version of its vaccine to overcome cold storage challenges.

Moderna has reported that its vaccine can be stored at refrigerator temperatures (2 to 8 degrees Celsius) for up to 30 days but needs freezer storage of minus 20 degrees Celsius for longer periods.

Russian Sputnik V vaccine requires minus 18 degrees Celsius for its storage in the liquid form while the lyophilized or free-dried form can be stored at refrigerator temperatures.

Serum Institute’s Oxford-AstraZeneca and Bharat Biotech’s vaccine, both in phase three trials will need storage at 2 to 8 degrees Celsius.

The struggle is far from over
The size and temperature requirement for storage of the vaccine will make distribution and administration of vaccine an enormous challenge. Insufficient last mile connectivity, cooling facilities in the final delivery stages and lack of storage at clinics will not be easy on such a high scale. Current inadequate protocols for constructing and operating a cold storage facility in India, funding constraints, and the lack of modern technology will need to be addressed. A Herculean task indeed!

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