Vaccine Innovation Meta-Model for Pandemic Contexts.
Beatriz C FialhoLeandro GaussPriscila F SoaresMaurício Z MedeirosDaniel P LacerdaPublished in: Journal of pharmaceutical innovation (2023)
The study demonstrates that, in pandemic contexts, a fast-track R&D process based on close collaboration among regulators, industry, and academia and leveraging enabling technologies can drastically reduce the time required to bring safe, stable, and effective vaccines to market by an average of 11 years compared to the traditional R&D process. Furthermore, pharmacovigilance and rigorous monitoring of real-world evidence became critical to ensuring that quality and safe products were authorized for use during a pandemic.