Vaccines are required to have a higher level of safety compared to other drugs, as these are administered to healthy individuals. In several countries it is becoming mandatory for children to be vaccinated according to their national immunization schedules in mass vaccination campaigns.
In a recent report from China’s regulator (CFDA), about 250,000 defective rabies vaccine doses were administered to children in China. There were serious questions raised on the manufacturing standards for these vaccines. Although there are currently no reports of adverse events linked to these vaccines, the vaccines produced through sub-standard manufacturing processes have a potential to cause major adverse events. Additionally, these vaccines may fail to protect the vaccinated person from targeted infection. This may result in a major public health disaster.
Most often than not, significant quality issues are identified after several doses of defective medicinal products, such as vaccines, have been administered. Advances in technology can play a significant role in preventing major public health hazards due to faulty vaccines and other medicinal products. Digital biosurveillance methods can be used for adverse event surveillance post vaccination. These methods combined with advanced cognitive computing technologies like natural language processing, can quickly assess internet for any content that is related to specific health events.
Advanced Technology to the Rescue
Advanced computing methods can be used for safety monitoring and early detection of potential signals of vaccine-related adverse events. These methods work by mining open-access active-moiety databases and vast scientific literature with clinical case studies. The algorithms then construct a relationship between a medicinal product, a biological target protein and an adverse event. Any possible relationships identified through these methods can be used as a working hypothesis for conducting further assessments.
Cognitive computing technologies have already demonstrated their value in healthcare industry and are making inroads into several specialized areas. Several intelligent applications are being developed that proactively check on a patient’s symptoms, provide recommendations on management of symptoms, disease management and treatment. The real-time data generated from these applications can be used by machine learning algorithms for predicting the occurrence of intended or unintended effects of medicinal products and can prompt early action.
ArisGlobal’s LifeSphere® Safety solutions have been built with the state-of-the-art technologies that efficiently and intelligently capture safety data, automate case processing and allow early detection of safety signals. In addition to regulatory compliance, the system has advanced capabilities that help manufacturers carry out end-to-end pharmacovigilance tasks, so that medicinal-product related safety risks are identified early and risk mitigation activities can be initiated.
For more information, view our on-demand webcast, “ICH Regulation & Compliance in China” to learn the potential impact of new regulations in safety & PV systems.