Periodic Reporting for period 1 - GLOBEVAC (Thermostable vaccines to enable global immunization)
Reporting period: 2022-09-01 to 2024-02-29
The challenge:
The majority of vaccines must be stored at low temperatures, necessitating a "cold chain" system, which is expensive and limits global vaccination efforts. Those limitations vary from costs of transportation to storage to feasibility of delivery in absence of infrastructure to efficacy of vaccination when degraded.
Vaccines stand out as one of the top public health strategies to decrease both the occurrence and severity of infectious diseases.
For most vaccines to maintain their safety and efficacy, they need to be stored and transported within a "cold chain," a system where they are consistently kept below certain temperatures, sometimes reaching as low as -80°C. This requirement for cold storage makes it difficult and costly to distribute vaccines quickly and efficiently, particularly in Low- and Middle-Income Countries (LMICs). These regions often lack the infrastructure to maintain and transport vaccines at the necessary low temperatures to distant or isolated communities. This has led to inadequate immunization levels in LMICs and the persistence of vaccine-preventable diseases. Moreover, the cold chain requirements have significantly slowed down the widespread and quick deployment of vaccines in situations like the COVID-19 pandemic, where the need for cold storage has notably increased the costs and logistical challenges of vaccine distribution. In fact, cold chain logistics are responsible for up to 80% of the expenses associated with vaccine programs.
Furthermore many diseases could have been potentially already been eradicated if only the efficacy in transport, storage and distribution with its relative costs would implemented. The key to eradication of many pathogen related diseases is in this gap.
Thus, pushes the society and the scientific community to strive towards new solutions about such important matter, especially in light of potential new pandemic rising and unknown pathological weapons too.
To tackle such problem we have developed a new formulation matrix deriving from the waste wood industry capable or being neutral and already FDA approved to micro encapsulated vaccines from viral based vaccines to mRNA Lipid Nanoparticle Vaccines to ensure long lasting efficacy in different stress conditions like time away from cold chain storage for weeks at different possible high temperatures.
If our project would be successful we would be able to :
- use a green sustainable compound to tackle the issue of vaccines storage and transport,
- eradicate infective diseases in areas where normally vaccines are not effective,
- created a potential storage advantages for vaccinations lowering prices about 80% of their original cost,
- create new market for developing natural biopolymer serving as cryo-preservant not only for vaccines but for other active compounds and biologicals
- create a new technology for the health and national defence in case of biohazard pathogenic threads
The majority of vaccines must be stored at low temperatures, necessitating a "cold chain" system, which is expensive and limits global vaccination efforts. Those limitations vary from costs of transportation to storage to feasibility of delivery in absence of infrastructure to efficacy of vaccination when degraded.
Vaccines stand out as one of the top public health strategies to decrease both the occurrence and severity of infectious diseases.
For most vaccines to maintain their safety and efficacy, they need to be stored and transported within a "cold chain," a system where they are consistently kept below certain temperatures, sometimes reaching as low as -80°C. This requirement for cold storage makes it difficult and costly to distribute vaccines quickly and efficiently, particularly in Low- and Middle-Income Countries (LMICs). These regions often lack the infrastructure to maintain and transport vaccines at the necessary low temperatures to distant or isolated communities. This has led to inadequate immunization levels in LMICs and the persistence of vaccine-preventable diseases. Moreover, the cold chain requirements have significantly slowed down the widespread and quick deployment of vaccines in situations like the COVID-19 pandemic, where the need for cold storage has notably increased the costs and logistical challenges of vaccine distribution. In fact, cold chain logistics are responsible for up to 80% of the expenses associated with vaccine programs.
Furthermore many diseases could have been potentially already been eradicated if only the efficacy in transport, storage and distribution with its relative costs would implemented. The key to eradication of many pathogen related diseases is in this gap.
Thus, pushes the society and the scientific community to strive towards new solutions about such important matter, especially in light of potential new pandemic rising and unknown pathological weapons too.
To tackle such problem we have developed a new formulation matrix deriving from the waste wood industry capable or being neutral and already FDA approved to micro encapsulated vaccines from viral based vaccines to mRNA Lipid Nanoparticle Vaccines to ensure long lasting efficacy in different stress conditions like time away from cold chain storage for weeks at different possible high temperatures.
If our project would be successful we would be able to :
- use a green sustainable compound to tackle the issue of vaccines storage and transport,
- eradicate infective diseases in areas where normally vaccines are not effective,
- created a potential storage advantages for vaccinations lowering prices about 80% of their original cost,
- create new market for developing natural biopolymer serving as cryo-preservant not only for vaccines but for other active compounds and biologicals
- create a new technology for the health and national defence in case of biohazard pathogenic threads
We have assessed the efficacy and safety of our newly developed vaccine formulations both in vitro and in vivo.
Initially, we conducted in vitro experiments to evaluate various nanocellulose-based formulations as cryoprotectants for vaccines (Step 1).
We subjected the vaccine-nanocellulose combinations to stress tests that included changes in temperature, relative humidity, compression, light exposure, and modified atmospheric conditions to assess their stability.
Thanks to prior knowledge in adenovirus work and experience we have validated the efficacy of such technology not only in viral based vaccines like Johnson and Johnson and AstraZeneca ones, we expanded this technology to Enveloped Viruses like Mumps, Rubella, Measles, Influenza, Smallpox with most of them are validation for the veterinary field where pandemics and zoonosis are frequent and dangerous. On top of this we have tested the storage of the enveloped vaccines up to many weeks and at different temperatures (Step 2)
We observed that our formulation worked as good as for the adenoviral vaccines in enveloped viral conditions too.
We then moved towards the hot topic especially after the COVID19 pandemic: mRNA Lipid Nanoparticle Vaccines (LNPs) (Step3)
mRNA vaccines are extremely sensitive to degradation due to lack of refrigeration and on top of that, their application is moving from pure vaccination or infective diseases to cancer vaccines too.
Especially after the Sars-Cov-2 pandemic this technology has shown efficient application as vaccination platform, unfortunately suffering from easy degradation.
The last step consisted in testing our formulation with those mRNA LNPs.
We have validated our technology in a LNP model expressing Green Fluorescent Protein and upon success we moved towards a real RNA vaccine, similar to the one used by Moderna and Pfizer.
We have formulated a SPIKE mRNA LNPs and stressed for 4 weeks at different tempeatures in absence of cold chain.
Our approach outperformed the fresh samples and scored as a powerful weapon in preserving those vaccines perfectly.
We have now validated our technology in all the vaccinations fashion possible for many weeks at high temperatures and tested them in animals too observing generation of antibodies and specific lymphocytes. (Step 4)
At this stage our technology works with all the vaccination platforms opening up a future scenarios in which could be applied to active principle drugs which need refrigeration and functional enzymes too or monoclonal antibodies.
Initially, we conducted in vitro experiments to evaluate various nanocellulose-based formulations as cryoprotectants for vaccines (Step 1).
We subjected the vaccine-nanocellulose combinations to stress tests that included changes in temperature, relative humidity, compression, light exposure, and modified atmospheric conditions to assess their stability.
Thanks to prior knowledge in adenovirus work and experience we have validated the efficacy of such technology not only in viral based vaccines like Johnson and Johnson and AstraZeneca ones, we expanded this technology to Enveloped Viruses like Mumps, Rubella, Measles, Influenza, Smallpox with most of them are validation for the veterinary field where pandemics and zoonosis are frequent and dangerous. On top of this we have tested the storage of the enveloped vaccines up to many weeks and at different temperatures (Step 2)
We observed that our formulation worked as good as for the adenoviral vaccines in enveloped viral conditions too.
We then moved towards the hot topic especially after the COVID19 pandemic: mRNA Lipid Nanoparticle Vaccines (LNPs) (Step3)
mRNA vaccines are extremely sensitive to degradation due to lack of refrigeration and on top of that, their application is moving from pure vaccination or infective diseases to cancer vaccines too.
Especially after the Sars-Cov-2 pandemic this technology has shown efficient application as vaccination platform, unfortunately suffering from easy degradation.
The last step consisted in testing our formulation with those mRNA LNPs.
We have validated our technology in a LNP model expressing Green Fluorescent Protein and upon success we moved towards a real RNA vaccine, similar to the one used by Moderna and Pfizer.
We have formulated a SPIKE mRNA LNPs and stressed for 4 weeks at different tempeatures in absence of cold chain.
Our approach outperformed the fresh samples and scored as a powerful weapon in preserving those vaccines perfectly.
We have now validated our technology in all the vaccinations fashion possible for many weeks at high temperatures and tested them in animals too observing generation of antibodies and specific lymphocytes. (Step 4)
At this stage our technology works with all the vaccination platforms opening up a future scenarios in which could be applied to active principle drugs which need refrigeration and functional enzymes too or monoclonal antibodies.
After validating the different vaccinations uses and which vaccines to preserve we have fast paced moved to interact with the patent attorney for securing the technology and to strengthen the patent.
To ensure the success rate we are now conducting further experiment in larger cohorts of animals and considering other commercial vaccines to be formulated and tested.
We have now reached a stage in which the interest raised by our findings is reaching stakeholders, potential investors and public interest.
We have been interviewed by the main news in Finland and in Italy as well as invited to present our finding in international conferences across Europe and US as well as invited as key note speakers in prestigious campuses in California.
We have worded to be present even in the potential commercialization scenario since our data and readiness suggest the path to forge a start-up company given the huge potential of this project.
For these next steps the support of European Union is essential as they have made the progress of the project possible this far. A potential help with an ERC transition pathfinder is definitely needed to proper the project to the next step and create a concrete reality from a project.
In addition the Spin-off reality would be serving capital attraction and investment from different direction as public health, defence industry and veterinary and large scale food industry as livestocks.
The contribution of the European Research Council is crucial for the success of this project.
To ensure the success rate we are now conducting further experiment in larger cohorts of animals and considering other commercial vaccines to be formulated and tested.
We have now reached a stage in which the interest raised by our findings is reaching stakeholders, potential investors and public interest.
We have been interviewed by the main news in Finland and in Italy as well as invited to present our finding in international conferences across Europe and US as well as invited as key note speakers in prestigious campuses in California.
We have worded to be present even in the potential commercialization scenario since our data and readiness suggest the path to forge a start-up company given the huge potential of this project.
For these next steps the support of European Union is essential as they have made the progress of the project possible this far. A potential help with an ERC transition pathfinder is definitely needed to proper the project to the next step and create a concrete reality from a project.
In addition the Spin-off reality would be serving capital attraction and investment from different direction as public health, defence industry and veterinary and large scale food industry as livestocks.
The contribution of the European Research Council is crucial for the success of this project.