The World Health Organisation has approved the first carrier that doesn't require vaccine freezing during transport.
The Path's Freeze-Safe innovation helps protect vaccine potency, reduces the burden on health workers, and provides cost savings to health systems.
The Indian-made carrier using Path's Freeze-Safe reference design passed WHO Performance, Quality, and Safety (PQS) laboratory tests for user independent freeze prevention, which prequalifies it for use in global immunisation programmes.
This is the first low-cost carrier innovation available to address the widespread and long-standing problem of vaccines freezing in the cold chain during the "last mile" of outreach to infants and children.
The carrier is on introductory field trials in Nepal.
Health workers in low- and middle-income countries carry millions of temperature-sensitive vaccines next to ice packs inside vaccine carriers to reduce heat exposure.
However, this risks freezing the vaccines if the ice packs are not conditioned (carefully warmed to around 0°C). Freezing can irreversibly compromise potency, resulting in inadequate protection from disease for people receiving vaccines.
When health workers suspect temperature damage, the vaccine or medication is often discarded -- at great cost to health care programmes.
The breakthrough solution mitigates the risk of vaccines being damaged by freezing or heat in carriers, and eliminates the step of conditioning ice packs. Frozen ice packs can be inserted immediately into the carrier thanks to a built-in barrier that shields the vaccines from reaching negative temperatures and excessive heat.
Many of the newer vaccines that protect children and infants from life-threatening diseases and infections, such as those for human papillomavirus, pneumonia, and rotavirus, are freeze sensitive and cost far more than other vaccines.
In 2015, the United Nations Children's Fund (Unicef) procured approximately $1.7 billion worth of vaccines for immunisation programmes, of which more than $1.2 billion were freeze sensitive.
"Our priority is maintaining vaccine potency for the millions of people living in remote communities," said Pat Lennon, who leads the cold chain team at Path. "In the future, vaccine carriers that prevent freezing will become the new standard for immunisation programmes."
In order to rapidly accelerate introduction of this innovation, Path put the Freeze-Safe reference design into the public domain for any manufacturer to use.
Path staff in Seattle and New Delhi have provided technical advice to three product manufacturers who have adopted the technology. India-based AOV International's product AFVC46 is the first carrier to receive WHO-PQS approval and will be available for purchase through the Unicef supply division catalogue.
"The Freeze-Safe vaccine carrier is a great example of Indian industry helping solve a global public health challenge," said Neeraj Jain, country director of Path's India country programme.
"This 'Made in India' freeze-preventive vaccine carrier can help health workers in India and globally to administer lifesaving vaccines that do not freeze and could help save millions of lives."
Path estimates that more than two million new and replacement carriers will be needed by 2020 for the 73 Gavi-member countries.
Path is conducting field trials, supporting efforts to integrate the carriers into existing health systems, and working with manufacturers as well as adapting the innovation for use in other cold chain equipment.
"Vaccine carriers that prevent vaccines from freezing while in transit and yet are low cost and easy to use can save millions of children's lives," said Dr Benjamin Schreiber, senior health advisor at Unicef.
"These are the type of cutting-edge solutions we need to immunise every child."