Implementation and Effectiveness of an innovative, portable, freeze free Vaccine Carrier tested in selected developing countries: A Gobi Case Study
For further information contact: info@gobi.world
Overview
In recent years, various technological advances have been made to improve the quality of vaccine carriers with the capability of increasing access to safe and timely administration of vaccines, especially in underserved regions of the world. These advances have resulted in the development of Freeze-Preventative Vaccine Carriers designed to prevent vaccine freezing during transportation of vaccines especially in remote rural settings. Other features of these freeze free vaccine carriers include simplifying cold box preparation as the ice packs do not require conditioning, and they prevent water from accumulating around the vaccine vials due to use of fewer icepacks. Independent testing of some of these carriers have revealed vast disparities in efficiencies, capacities, and transformational features. For example, some of these innovations are larger and heavier than the standard cold boxes and, in some cases, some freezing occurred. These disadvantages suggested that further modifications needed to be made to enhance the capacities and efficiencies of the existing generation of freeze-preventative vaccine carriers.
The Introduction and Pre-Qualification of the Gobi Eclipse Freeze Free Vaccine Carrier in 2022 by the World Health Organization (WHO) provided new opportunities for Expanded Program on Immunization (EPI) Managers in several low-medium income countries to assess the second generation of Freeze-Preventative Vaccine Carriers in order to enhance vaccine safety, improve ergonomic dexterity when traveling in difficult terrain, and extend cold life in extreme ambient temperature conditions. As a result, Gobi offered some countries in Africa and South America the opportunity to conduct performance evaluations of the Eclipse Vaccine Carrier for improvements in technical features, innovative transformations and heightened functional utilities especially during vaccination campaigns or regular immunization of new born and under five clinics in those same countries.
This case study highlights the opportunities, benefits and challenges of introducing and using the Eclipse, an innovative portable vaccine carrier, into the cold chain infrastructure of public health systems for safe, effective delivery of vaccines up to the last mile in specific African and Pan American Health Organization (PAHO) countries. The discussion includes a brief history of the development of the Eclipse, examination of the approach/methodology used to collect and analyze data, examination of the tools used for data-gathering, review of the results obtained, assessment of measurable findings, benefits, and conclusion.
History and Development of Innovative Freeze Free Vaccine Carriers
Immunization programs have been undertaken in a number of countries as a cost-effective way to improve public health around the world thereby saving the lives of millions of people. But unfortunately, there have been a number of key barriers that have limited and prevented the development of high-quality products for temporary storage and portability of the vaccines at temperatures of 2-8 degrees C to maintain their potency up to the time of administration. The impetus to move towards the second generation of freeze free vaccine carriers was stimulated by the need to overcome several challenges and gaps in the existing cold chain supply systems to reduce inefficient and unsafe delivery and administration of vaccines in timely ways. Those challenges included but were not limited to the following:
These and other related challenges propelled a reasonable desire by cold box developers to aspire towards a second generation of freeze free vaccine carriers that would be ergonomically suitable, lighter when fully loaded, capable of maintaining safe temperatures in extreme ambient conditions for much longer periods of time, while making energy savings and contributing to carbon neutrality and improvements in emission control standards for those countries and regions. These issues outlined here would become key determinants of the features needed to achieve new, desirable and transformative directions for the next generation of vaccine carriers.
A comparative Review of the Eclipse and other Freeze Free Vaccine Carriers:
In recent years, many manufacturers have worked to achieve optimal products to help transform the marketplace especially in low-middle income countries. However, those efforts, in a number of cases, have been inadequate to meet and surpass the standards for greater positive impact. Appendix 1 illustrates how the Eclipse meets and exceeds other available products in the same category [See Appendix 1].
In order to test the assumptions inherent in the technical features of the Eclipse, it was decided to provide end users with the opportunity to conduct pilot testing for on the ground feedback and assessment of the performance of the Eclipse in mitigating existing challenges and closing gaps.
Methodology/Approach
With WHO PQS Certification, and UNICEF approval of the Eclipse for inclusion in the UNICEF Supply Catalog, as well as presentation and demonstration of the Gobi Eclipse at global public health trade shows such as the TechNet/ WHO World Vaccine Conference in Panama, the BSMA Vaccine Conference in Carson City, California, and the World Vaccine Congress in Washington DC, greater awareness of the product resulted in increased global interest in the device. In-Person demonstration visits of the Eclipse also occurred in the offices of the Ministries of Health in target countries including Sierra Leone, Nigeria, Uganda, and Ethiopia. Sample Eclipse products were also supplied to Malawi and Guinea in Africa and Nicaragua and Paraguay in the Americas. For example, in Sierra Leone, Nigeria, and Paraguay vaccination campaigns were underway and the environment for testing under all conditions were quite suitable.
Sierra Leone, Nigeria and Paraguay were the first set of countries to receive the devices for field testing. This case study is based on their reports. The period of testing was established as 6 weeks for each country between July and September, 2024. Prior to deployment of the Eclipse Vaccine Carriers, EPI managers were provided with the Use and Care Video Instructions, and several video meetings on Teams were held with the Gobi Eclipse support team to answer any questions. Data was obtained from responses provided by health workers who administered the vaccines to vaccine recipients in remote areas of the 3 countries noted above.
[See Assessment Questionnaire: Appendix 2]
Data from this questionnaire provided the information used to assess the efficiency and transformative impact of the Eclipse Vaccine Carrier. The information sought ranged from assessment of the impact of shipping on the product, clarity of labelling instructions, performance versus expectations, changes in the behavior of users, impact on system efficiency relative to current carriers in use, indication of any complaints when using the Eclipse, likes and dislikes of the product, preference for the Eclipse over other thermal cold boxes in use, and availability of temperature monitoring devices. Results from each country are summarized below:
Sierra Leone: The products arrived in good condition with no observable defects in appearance and use, written and video instructions, and the labelling. There were no unexpected user-interface issues and labelling was found to be clear and easy to understand. The products operated as expected and did not require vaccine operators to make significant changes to their behaviors at the point of vaccine administration. Vaccine transportation and handling was found to be more efficient because it is easy to carry. There were no complaints. Health workers liked the size and weight of the Eclipse and could not find any other comparable product in the Second Generation Freeze Preventative category better than the Eclipse. The absence of a temperature monitoring equipment was not an issue as the thermal temperature in the Eclipse performed as stated. Public Health workers in Sierra Leone unanimously found the Eclipse transformative, innovative, and efficient. Participants found the unit’s large capacity and light weight especially appealing for transport to remote centers using multimodal transportation for the greater part of a day.
Nigeria: Northern Region 1: The same observations reported for Sierra Leone were found for the Health Center in Northern Nigeria, Region 1. The consistency of the observations was particularly striking for Northern Nigeria given the very hot ambient temperatures in this part of Nigeria relative to Sierra Leone. Not surprising therefore, additional observations spoke to the efficiency of using one ice pack that prevents freezing but that maintains temperature ranges approved by WHO for over 30 hours. Public Health Workers at this location found the color of the unit an additional bonus as well as the number of holes in the sponge vial holder for easy and safe transportation of antigens that have been opened. As with Sierra Leone vaccination staff reported high satisfaction with the Eclipse compared to other Freeze Preventative thermal units for freeze free duration, lighter weight and ease of carrying.
Nigeria: Northern Region 2: Data obtained from another Health Center in Northern Nigeria replicated the same information obtained from its Northern Region, and for Sierra Leone. Indeed, he product operated as expected and did not require vaccine operators to make significant changes to their behaviors at the point of vaccine administration. Vaccine transportation and handling was found to be more efficient because it is easy to carry. There were no complaints. The health aids at this health center liked the fact that the ice packs did not have to be conditioned. This saves time. Moreover, use of fewer ice packs contributes to enhanced sustainability and energy conservation for the overall cold chain supply system. They also gave positive reviews about the round shape of the Eclipse which prevents bruising from sharp edges that is typical of the rectangular shaped cold box vaccine carriers.
Nigeria: Northern Region 3: Data from the test health center in this region found support for the core variables assessed as reported for the other two centers in Nigeria, with special note about the importance of the use of one icepack, the unit’s portability, and round shape
Paraguay: The Eclipse units were distributed to remote regions from the PNEI-PAI Supervision Department. They arrived sealed with no signs of wear and tear or damage. Immunization assistants who administered vaccines from the Eclipse reported that the instructions and labeling were easy to read especially that Gobi had the instructions/labels in Spanish “in the usual language of the country.” Immunization staff in Paraguay utilized a Fridge-Tag for continuous temperature monitoring of the Eclipse during use and concluded that regular refrigeration range was successfully maintained within the range of +2 C to +8 C. The Paraguay immunization assistants also reported satisfaction that the ice packs did not have to be conditioned prior to use. A particularly interesting finding was that current ice packs in use have 4 per container and often they have to use “plastic bottles inside the vaccine thermos to contain the vaccine vials and avoid direct contact with the cold packs, but with the Eclipse no bottles were used” due to the superior insulation quality. For Paraguay, this feature strengthens efficiency and “is essential to offer quality products to the population.” Some additional important strengths included ideal temperature preservation of vaccines, durability, and resistance in typically tough terrain.
General Observations for Future Product Development: The data reported from the 5 regions above reflect major contributions of the Eclipse to delivering vaccines safely in remote rural areas in West Africa and in Paraguay. Because respondents were also asked to identify suggestions for future product development, some observations, based on country-specific situations offered the following recommendations: Increase the number of holes in the vial sponge holder to support multiple antigen immunization campaigns (when needed), offer a shorter length device option for areas accustomed to smaller units, and to offer temperature monitoring devices as options for procurement planning. It should be noted that in each case, these suggestions were offered as future options that in no way minimized the innovative qualities of the Eclipse Vaccine Carrier.
Analysis of Results and Findings
The results produced from this case study based on customer use in relatively remote regions of some low income/developing countries reinforces the immense value of the device along its key features:
Impact and Future Outlook
As this study shows, there were no motivational incentives provided to the countries that agreed to pilot test the new vaccine freeze free Grade A device. Yet. the reports and observations obtained highlight the fact that this innovation helps to overcome some of the challenges that have limited the safe delivery of vaccines to vulnerable population groups around the world. Its performance, quality and safety will inspire brand awareness to deliver rapid and positive impact. The direction by WHO and other regulatory bodies towards freeze preventative devices puts the Eclipse in a very strong position relative to other products. The provision of cold boxes and innovative vaccine carriers is crucial to preserving vaccines for ensuring a healthy population. The special features of the Eclipse increase geographic coverage and contributes effectively to improved immunization service delivery and health security. By development of the Eclipse, Gobi has created the foundation to strengthen health care systems in many low-income developing countries around the world [see Appendix 3: About Gobi]
References:
Sandeep Kumar et al., (2024) Using freeze-preventive cold boxes in rural Nepal: A study of equipment performance, acceptability, system fit, and cost. Vaccine X; Vol 18, June 2024. Science Direct.com.
Clinton Health Access Initiative., (2021) Revolutionary Vaccine Carrier technology dramatically reduces unwanted freezing during vaccine transportation. Clintonhealthaccess.org
Abdoulaye Gueye et al., (2020) Cold Chain innovations-learnings from field evaluations of freeze protection and energy harvesting. Paper presented at the 16th TechNet Conference. Technet-21.org.
WHO (2021). Guidance on selecting, commissioning, and using freeze-preventative vaccine carriers. World Health Organization published in technet-21.org
Gobi Technologies Inc. Website: About Gobi. https://www.gobi.world
ABOUT GOBI: ADAPTED FROM THE GOBI WEBSITE
“At Gobi we rethink cold energy – how it is produced, stored, and best utilized to enable temperature-controlled delivery of life-enhancing products worldwide.
Our innovation prowess and creativity are actively shaping the future of the cold chain globally. Gobi solutions are different – not just insulation and phase change material (PCM). Gobi solutions are at the intersection of unmet customer need and cutting-edge innovation expertly engineered with the most advanced thermal technology in the world, developed by leading scientists and protected by a strong patent portfolio.
Gobi’s Eclipse brings advanced thermal technology to the Global Health marketplace. Eclipse sets new standards for freeze-free vaccine carriers. Lightest weight, longest cold life, largest payload, smallest footprint, fewest icepacks, strictest control, and the most refined ergonomics, all with a smaller carbon footprint.
And we are just getting started. Based in the USA and Germany, Gobi is an expanding business setting new standards in thermal performance, design and carbon efficiency.
But it’s not just about our technical innovation. Through fierce dedication and collaboration with our partners, our products have enabled the successful distribution of over 2 billion doses of ultra-low-temperature Covid vaccines worldwide.
Gobi partners benefit from a simplified and versatile cold chain experience that cannot be found anywhere else.”
.svg)
.svg)
