As we pass the two-year anniversary of the start of the coronavirus pandemic, we are reminded of where we started and how far we have come. From day one, we have been able to witness scientific advancements on the world stage as the scientific community quickly came together to address this international health crisis. Through these incredible, coordinated efforts by scientists and companies across the globe, we now have a range of tools with which to combat COVID-19, including multiple vaccines which have been shown to reduce the severity and long-term health effects of infection. These vaccines have provided protection for our most at-risk populations and have offered us a path forward as we prepare for the future.
Vaccine development was accomplished in record time due to partnerships between innovative biotech/pharma companies and government agencies. The vaccines currently available include those using mRNA technology and those which are designed using viral vector platforms. Use of mRNA as a vaccine strategy represents a novel application for mRNA technology which is based on decades of research. mRNA vaccines work by introducing mRNA encoding viral protein into a patient. For SARS-CoV-2 vaccines, the patient’s own cells use the mRNA from the vaccine to create the spike protein normally found on the surface of the COVID-19 virus. Since this spike protein is foreign to the human body, the recipient’s immune system generates antibodies and activates cellular immunity against it. The intent is to educate the patient’s immune system prior to infection with COVID-19 so that when the patient is exposed to the virus after vaccination, the immune system is primed and ready to respond to the foreign protein, targeting the virus for clearance. This limits viral replication, reducing disease severity in the patient when compared to unvaccinated individuals.
A second class of COVID vaccines uses other viruses, such as adenovirus, to deliver DNA copies of the spike protein sequence to the recipient. These viral vector vaccines work in a similar manner to the mRNA vaccines in that they create an immune response against the expressed viral protein. However, due to the higher stability of DNA compared to mRNA, the storage and distribution of viral vector vaccines is logistically simpler than that of mRNA vaccines. On the global scale, this allows for vaccination outreach to communities that do not have the necessary storage for the mRNA-based vaccines.
In addition to these more recent advancements in vaccine technology, the more traditional approach of protein-based vaccines could prove to be game-changing. In this approach, spike proteins are created through transfection of viral genes into cells in a laboratory. The cells then produce the proteins encoded by the genes, the proteins are purified, and then the proteins can be mixed with immune-stimulating adjuvants to create the final vaccine product. The genes can also be modified, resulting in new forms of the protein which cause a more potent protective response when administered to the recipient as part of the vaccine.
There are numerous protein-based vaccines in late stage clinical trials that will be submitted for approval soon. As protein-based vaccines do not need the same level of logistics for storage, distribution, and administration compared to the mRNA based vaccines, they will provide a much needed resource for vaccinating populations in poor and remote locations. A global pandemic requires a global solution and we will need these tools to continue helping those in the more vulnerable areas as part of a strategy for moving COVID-19 out of the pandemic phase worldwide.
As the COVID-19 pandemic evolves, our scientific community must continue to be innovative in the development and implementation of new vaccination tools. Along with this, will be a sustained need for adaptable testing strategies to support these programs. At BioAgilytix, we offer services that are essential in characterizing and testing novel vaccine platforms including cell-based assays, immunogenicity testing, and potency assays. We work side-by-side with companies as they develop these new products, offering testing support from early development through clinical trial phases, and providing our extensive expertise with regulatory expectations. As we look towards the future, we will continue to provide support in bringing new vaccines to market and contribute to a way forward from the COVID-19 pandemic.
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BioAgilytix provides biomarker, immunogenicity, cell-based assay, and other laboratory services for pharma and biotech companies around the world. We are a leader in immunogenicity testing, an important step in drug development, evaluating anti-drug antibodies prior to treatment, and analyzing drug efficacy in a patient over time. Contact BioAgilytix today with any questions or requests.