Vaccines and Therapeutics: Quality System Approach to Clinical Applications

  • Kaiser Jay Aziz-Andersen Director, Grand Medical Consulting LLC, USA

Abstract

Molecular bio-science developments involve applications of mRNA vaccines focused on diagnostic, prophylactic, and therapeutic aspects of COVID-19 related infectious diseases. These applications offer potential solutions for many of the current challenges in treating virus related infectious diseases.  The goal of vaccine design and development is to manufacture and consistently produce a vaccine that is safe and effective. The vaccine discovery starts with design input in terms of identification of etiologic agent, immunogenicity, adjuvant, basic scientific concepts, non-clinical and clinical studies, and finally vaccine licensure (FDA approvals). The Lipid Nanoparticle Technology (LNT) for messenger RNA is being used for COVID-19 vaccines. This technology comprises of identifying and mapping signature features of the virus which encompasses the readability of the virus’s blueprint, its neutralization and activation processes in order to deliver antibody proteins to protect the vaccine recipients’ bodies from encounters with the virus. The administering regimens are studied in clinical research laboratory and study materials are tested in suitable bench testing and biological models projecting vaccine candidate’s prophylactic immune response that is safe and effective. The vaccine manufacturing process requires critical quality control points (CQCPs) monitoring in order to maintain the steriochemical and immunological characteristics of the vaccine molecules and enable production of the vaccine in increasingly dosage quantities for ultimate human use. These aspects of vaccine development are well integrated into the total vaccinology life cycle (TVLC) regulatory requirements. The ultimate regulatory safety and efficacy requirements of the vaccine are proven through phases of clinical trials (class I, II, and III studies). The final process for human use to produce safe vaccine is part of pivotal clinical trials and data under the US FDA’s premarket approval process for full-scale production and availability of safe vaccines for clinical use.


Keywords: mRNA Vaccines, Diagnosis, Prophylaxis, Therapy, COVID-19

Keywords: mRNA Vaccines, Diagnosis, Prophylaxis, Therapy, COVID-19

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Author Biography

Kaiser Jay Aziz-Andersen, Director, Grand Medical Consulting LLC, USA

Director, Grand Medical Consulting LLC, USA

References

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Aziz-Andersen KJ. Vaccines and Therapeutics: Quality System Approach to Clinical Applications. JDDT [Internet]. 15Jun.2022 [cited 1Jul.2022];12(3-S):217-20. Available from: https://jddtonline.info/index.php/jddt/article/view/5361