With a handful of manufacturers nearing the end of late-stage clinical trials of Covid-19 vaccine candidates in India, the next challenge that awaits the government lies in finding the requisite workforce to administer the shots to such a humongous population and cold chain logistics for their last-mile distribution in such a vast, hot country.
While India has a 28,000-unit cold storage network that is used for the government’s universal immunisation programme, experts and logistics firms indianexpress.com spoke to highlight that no company had the capability or capacity to transport vaccines colder than -25 degrees Celsius.
Thus, distributing vaccines like that of Pfizer’s mRNA candidate, which has been found to be more than 90 per cent effective in preventing Covid-19 but needs to be stored at -75 degrees Celsius, will be challenging for India. However, the vaccines undergoing trials in India need to be kept between 2 and 8 degrees Celsius, while in transport and storage until delivery.
“Covid vaccines at -25 degrees can be handled in the country as we have the requisite infrastructure in terms of storage and distribution. None of the third-party logistics operators in the country are equipped with -70 degrees cold storage facilities,” Sanjay Sharma, Vice-President, Coldman Logistics, told indianexpress.com.
Seconding him, Pawanexh Kohli, former CEO and chief advisor, National Centre for Cold Chain Development (NCCD), said the problem could be effectively tackled through extensive use of dry ice. “Dry ice in a designated box can retain temperatures at -70 degrees for 24-48 hours,” he said.
Sharma said Coldman has been approached by top Covid-19 vaccine manufacturers to prepare a plug-in kind of solution for storage at -25 degrees, suggesting that the candidates being developed in India wouldn’t require “ultra-cold” temperatures.
“We have certain smaller cold rooms that can store a million doses at -40 degrees also but not in a huge volume. Since the government will have a continuous vaccination programme, so once in a fortnight those one million doses can be rotated. So probably in a month, two million doses can be handled at -30 to -40 degrees,” he said.
With a subgroup formed by India’s expert group on vaccine administration already mapping cold storage facilities across the country, private cold chain logistics firms have begun preparing capacities for storing vaccines. For instance, Siro Clinpharm has set aside three state-of-the-art deep freezers of -20 degrees Celsius for storage of approved vaccines.
“For cold and frozen storage, the temperatures can be monitored through data monitors and integrated softwares. Vaccines being developed by Bharat Biotech, Johnson and Johnson and AstraZeneca-Oxford that have a storage requirement of 2-8 degrees can be handled by Siro,” Akshay Daftary, director of business development, SIRO Clinpharm, told indianexpress.com.
Besides private players, the food cold-chain is also expected to be roped in since it has the maximum reach, with an extensive last mile connectivity, said Kohli, who is also part of the CARUNA platform, which is assisting the government in its Covid-19 efforts. However, Kohli asserted that the major challenge was not cold storage but multiplying the delivery points of the vaccine, ranging from local pharmaceutical shops to even hamburger and pizzeria outlets having functional cold rooms.
“For example, if we consider that a vaccine giver can administer a dose every five minutes and work 10 hours a day, then one can dose 120 others per day. Thus, two vaccine givers per vaccination centre can serve 5,000 people in 21 days. Now, Delhi, with about 20 million residents, will require 4,000 vaccination sites with 8,000 vaccinators if the exercise needs to be completed in 21 days. Moreover, 85 per cent of our villages have below 5,000 population. My concern is that this identification of centres is not happening fast,” said Kohli, who has served in an advisory role for several cold chain logistics firms.
Batting for a mass cluster-based vaccination approach, he said prioritising the vaccine for frontline workers would run the risk of allowing the novel coronavirus to mutate against the vaccine. “The biggest fear is that the vaccine may prove ineffective against a future strain of the virus. Therefore, the deployment of the vaccine should be extensive and expansive,” Kohli said.
Another crucial aspect of the supply chain is monitoring of the vaccine all through its transit until it is dosed. GS1 India, a standards organisation set up by the Ministry of Commerce, said tracking each of the vaccines as it moves across the supply chain is important as patient safety is the key driver for adopting these standards.
So far, GS1 is working with Serum institute of India, Bharat Biotech, Dr. Reddy’s laboratories and Zydus Cadila for vaccine traceability. “At the manufacturing point itself, there needs to be an IT-enabled mechanism. Besides, unique global product identifier (GTIN), date of expiry, batch number needs to be captured at the secondary packaging level and unique carton code (serial shipping container code) at the tertiary packaging level,” GS1 India COO, S Swaminathan, told indianexpress.com
“There are several temperature data logger/IOT devices that can be used to monitor temperature at storage and at time of transportation. This information can be linked to shipment details (unique carton code) for effective monitoring,” Swaminathan said, adding that GS1 had already apprised the country’s drug regulator on the measures required.
The Centre expects to receive and utilise 400-500 million doses and cover approximately 20-25 crore people by July 2021.x
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