Chikungunya vaccine assignment on drug development, approval and registration

Question

Task: How pharmaceutical companies can use the Chikungunya vaccine assignment to determine the drug approval and registration process?

Answer

Question 1: The vaccine approval process for Chikungunya vaccine:
This Chikungunya vaccine assignment explores the process involved in drug development and approval. Vaccine approval or registration is a complex and long-term process and can take several years. Achieving the registration of a genetically-modified live virus vaccine to protect against Chikungunya virus in Australia clinical trial is the foremost step. In Australia, any vaccine is approved for consumer use by TGA (Therapeutic Goods Administration). TGA is a major part of the Australian Government Department of Health ensuring that these vaccines are safe and work well among the population (CDC, 2022). Before writing an application for vaccine approval, the company must send one detailed report to TGA which includes information regarding the vaccine, its need, and its benefit to the population. Besides they should also list all the steps and ingredients that the company used while vaccine manufacturing. As already stated above, the clinical trial is one of the most important steps, there information regarding the same and how it is run will also be shared with TGA. Once the information will be reviewed and approved by TGA, the company can apply for the Chikungunya vaccine. In the application, detail conferring to Clinical trials and its efficacy among the population will be listed following with any risks associated with it and its manufacturing process on a large scale if approved. After assessing, TGA will make the decision and the vaccine will be initially approved for 2 years (Australian Government, 2022). After approval of the TGA, the vaccine will be registered to the Australian Register of Therapeutic Goods (the Register). It will record information for the name of the company, vaccine, ingredients used, manufacturing process, and people taking the vaccine.

Question 2: CAR NK cell therapy to treat multiple myeloma:
From the this Chikungunya vaccine assignment research it is clear that CAR NK cell therapy is a major advancement used in the treatment of a patient with refractory or relapsed hematologic malignancies. Its introduction has initiated the immune effector cell treatments associated with improved cytotoxicity (Biederstädt & Rezvani, 2021). To develop this engineered product, NK or the T cells are initially isolated from the donor's or the patient’s blood, which are further transduced with a gene named CAR-encoding genes by using viral vectorsmostly (Lu et al., 2021). These CAR-modified immune cells are further expanded till agood amount of cell numbers are attained. After attaining a sufficient amount, it is adoptively transferred to fight malignant cells in the patient.

To bring the product into the market from the early R&D stage, a clinical trial is a must. After the development of the drug with adequate research and the above-mentioned process, it will go under clinical trial phase 1 (First in man trial phase), which will help to establish, safety, tolerability level, and pharmacokinetics in the population, the cell therapy will be used for. Completion of phase 1 will lead to the initiation of phase 2 which will help to assess the proof of concept trials and pivotal trials. Phase 2 is divided into 2a and 2b, which will help to investigate the frequency of drug dose, its response, along with the type of patient treated and demonstrate the efficacy of a drug. Phase 3 will be followed after that where large, randomized, double-blind, and placebo-controlled tests will be performed to detect risks or side effects associated with it if any (Jingjing et al., 2022). The Chikungunya vaccine assignment concludes that after the trial, the application to the regulatory authority will be sent with all the information related to the cell therapy and once it's approved it can be manufactured and will be brought into the market.

References:
Australian Government (2022), 6 steps to approve a vaccine. Chikungunya vaccine assignment Retrieved on 13th September from: https://www.health.gov.au/sites/default/files/documents/2021/06/covid-19-vaccination-th-ng-tin-n-gi-n-v-6-b-c-ph-duy-t-v-c-xin-6-steps-to-approve-a-vaccine-6-steps-to-approve-a-vaccine-english-resource.pdf
Biederstädt, A., & Rezvani, K. (2021). Engineering the next generation of CAR-NK immunotherapies. International journal of hematology, 114(5), 554–571. https://doi.org/10.1007/s12185-021-03209-4
CDC (2022). Vaccine testing and approval process. Retrieved on 13th September from: https://www.cdc.gov/vaccines/basics/test-approve.html
Jingjing, W., Rongjuan, G., Guojing, F., Xiao LIANG, Z. X., Min, J. I. A., Zixiu, Z. E. N. G., ... & Yunling ZHANG, X. L. (2022). Registration of intervention trials of Traditional Chinese Medicine for four neurological diseases on the Chinese Clinical Trial Registry and ClinicalTrials. gov: a narrative review. Journal of Traditional Chinese Medicine, Chikungunya vaccine assignment 42(1), 148. Retrieved on 13th September from: http://journaltcm.com/EN/article/downloadArticleFile.do attachType=PDF&id=6792
Lu, H., Zhao, X., Li, Z., Hu, Y., & Wang, H. (2021). From CAR-T Cells to CAR-NK Cells: A Developing Immunotherapy Method for Hematological Malignancies. Frontiers in oncology, 11, 720501. https://doi.org/10.3389/fonc.2021.720501Chikungunya vaccine assignment