PATH’s Freeze-Safe to begin introductory field trials

The vaccine carrier approved by World Health Organisation to prevent vaccine freezing during transport

This week, the first commercially available freeze-free vaccine carrier will begin introductory field trials in Nepal. This follows the World Health Organisation (WHO) announcement that 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. Reportedly, 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.

PATH’s solution mitigates the risk of vaccines being damaged by freezing or heat in carriers and eliminates the step of conditioning ice packs, reducing health worker burden. 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 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,” says Pat Lennon, who leads the cold chain team at PATH. “In the future, vaccine carriers that prevent freezing will become the new standard for immunization programs.”

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 in their vaccine carrier products. PATH staff in Seattle and New Delhi, India, 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 catalog.

“The Freeze-Safe vaccine carrier is a great example of Indian industry helping solve a global public health challenge,” says Neeraj Jain, Country Director of PATH’s India country program. “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.”

“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,” says Dr Benjamin Schreiber, Deputy Immunization at UNICEF. “These are exactly the type of cutting-edge solutions we need to immunize every child.”

This project was made possible with support from the Bill & Melinda Gates Foundation.