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April 23, 2020

Shipping Vaccines without a Cold Chain?

Written by SmartSense | Pharmacy Safety, Supply Chain

A challenge that has faced the immunizations market has been not only the availability of vaccines, but transporting them to middle and lower-income nations. The cold chain to support transportation and storage has not been developed enough.


However, this situation could be changing as scientists and researchers around the world are developing vaccinations that can be transported in the absence of cold chain infrastructure. When a vaccine is able to reach the right people, in the right regions, it can make a huge difference and positively impact the health of that nation and region.


One only has to look at the polio vaccine and what it did to help eradicate the disease some 60 years ago. Through immunization programs, the disease poliomyelitis was largely eliminated and controlled. Before the vaccine, there were some 20,000 cases in existence of this paralytic disease in the United States alone. After the vaccine was introduced in 1961, transmission of polio was curtailed to almost none, given that the last case was reported in 1979.


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In polio vaccines, as with others, a live biological substance is part of the dose. Therefore, it requires very carefully controlled transportation and storage. As of late, new developments and methods to produce vaccines have provided a longer shelf life and made it even cheaper to be stored without a need for a cold storage facility.


New Research, New Capability

Until now, vaccines had to be refrigerated during transport and storage was carefully temperature controlled. The vaccines had a shorter shelf life and sometimes only lasted a few months. Obviously, this is problematic for developing nations and remote areas lacking the infrastructure of refrigeration and electricity. However, recent university research in Mexico is building vaccines that allow them to be transported without the requirement of cold storage.


Specifically, researchers developed a novel technology that does not require refrigeration and has a shelf life of many years. They’ve adapted a strategy that uses insect viruses to enable them to survive outside of their hosts for extended periods of time. Part of the strategy is a very specific protein that forms crystals around the virus and protects it from the environment.


Creating such vaccines will also help reduce their total cost. About 80% of the cost of a vaccination can be attributed to its cold storage and transport. It's an expensive venture to build a supply chain that can move such product under demanding conditions for it to remain effective and viable by the time it reaches its destination and ultimately winds up being used for immunizations of citizens.


A Global Effort

Additional research is taking place at other laboratories around the world. An article in the European Pharmaceutical Manufacturer magazine reported that the Center for Process Innovation (CPI) and vaccine maker ImmunoBiology are working on a project that "could remove the need for cold chain in low- and middle-income countries." They're working together to develop a heat stabilized formula for a multi-antigen candidate, called PnuBioVax. This substance is designated to protect against pneumococcal diseases. They plan to implement a heat stable formulation that will eliminate the need for a cold chain.


If this effort is successful, it will impact millions, possibly billions, of people in countries that simply do not have the infrastructure to receive vaccines and subsequent immunizations because of the economic status of those nations. Instead of trying to change the infrastructure, thankfully, scientists around the world are changing the characteristics and qualities of the vaccinations so they can be transported and stored without a robust cold chain. If successful, these efforts can have major positive health impacts. As a result, logisticians and world health experts are looking forward to the next steps in the process.


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