A Review on Strategies for COVID-19 Vaccine Development and Regulatory Requirements
Abstract
Scientists first identified Human Coronavirus in the year 1965. Then, a study was performed on different human and animal viruses, which were named based on their crown-like appearance. Human coronaviruses are responsible for many children's upper respiratory tract infections. At least five new human coronaviruses have been identified since 2003, including the severe acute respiratory syndrome (SARS) coronavirus, which caused significant morbidity and mortality.1 Per NL and the New Haven, the virus associated with upper and lower respiratory tract disease and likely common human pathogens are identified as the Group-I coronaviruses (SARS- CoV-I). The novel coronavirus (SARS-CoV-II), which appeared in Wuhan, China, in December 2019, is responsible for Coronavirus disease 2019 (COVID-19) and causes respiratory symptoms that can feel like a cold, flu, or pneumonia. Geographical transmission of the virus and the sudden increase in cases are much faster than SARS and Middle East respiratory syndrome (MERS). COVID-19 is the first global pandemic caused by a coronavirus causing outbreaks in 211 countries. The vaccine against COVID-19 is an effective prophylactic strategy for controlling and preventing the virus. The vaccine is being developed in about 90 institutions worldwide. This research paper focuses on COVID-19 vaccine development strategies implemented by various institutions and pharmaceutical companies worldwide and regulatory requirements for vaccine approval.
Keywords: Human Coronavirus, Severe Acute Respiratory Syndrome (SARS), COVID-19 vaccine development strategies
Keywords:
Human Coronavirus, Severe Acute Respiratory Syndrome (SARS), COVID-19 vaccine development strategies
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References
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2. Xu et al. al, "Weather, air pollution, and SARS-CoV-2 transmission: a global analysis," 2021; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8497024/ https://doi.org/10.1016/S2542-5196(21)00202-3
3. FDA (2022). Emergency Use Authorization. Retrieved from Emergency Use Authorization for Vaccines Explained | FDA
4. Cundell T. "The Role of Current GMPs in COVID-19 Vaccine Production." 2021; The Role of Current GMPs in COVID-19 Vaccine Production (pda.org)
5. Naik R. & Peden K," Regulatory Considerations on the Development of mRNA Vaccines" 2020; https://doi.org/10.1007/82_2020_220
6. Alturki S. et al. "The 2020 Pandemic: Current SARS-CoV-2 Vaccine Development." 2020 https://doi.org/10.3389/fimmu.2020.01880
The 2020 Pandemic: Current SARS-CoV-2 Vaccine Development - PubMed (nih.gov)
7. EMA, "Pharmacovigilance Plan of the E.U. Regulatory Network for COVID-19 Vaccines" 2020; https://www.ema.europa.eu/en/documents/other/pharmacovigilance-plan-eu-regulatory-network-covid-19-vaccines_en.pdf
8. COVID-19 Vaccine tracker, "VACCINE CANDIDATES IN CLINICAL TRIALS" 2022; https://covid19.trackvaccines.org/vaccines/#phase-3.
9. Kahn J, & McIntosh K, "History and Recent Advances in Coronavirus Discovery. Pediatric Infectious Disease Journal" 2005; https://doi.org/10.1097/01.inf.0000188166.17324.60
10. Sencer D, "CDC Museum COVID-19 timeline" 2021; https://stacks.cdc.gov/view/cdc/110786
11. AJMC Staff, "A Timeline of COVID-19 Developments in 2020". 2021; https://www.ajmc.com/view/a-timeline-of-covid19-det al.pments-in-2020
12. Wolf B et al., "Review of Current Vaccine Development Strategies to Prevent Coronavirus Disease 2019 (COVID-19)". Toxicologic Pathology. 2020; 48(7):800- 809. https://doi.org/10.1177/0192623320959090
13. Brüssow H, "COVID-19: vaccination problems" Environ Microbiol, 23: 2878-2890. https://doi.org/10.1111/1462-2920.15549
14. Malik J et al., "Targets and strategies for vaccine development against SARS-CoV-2, Biomedicine & Pharmacotherapy," 2021; 137:0753-3322. https://doi.org/10.1016/j.biopha.2021.111254
15. Li YD, Chi WY, Su JH, Ferrall L, Hung CF, Wu TC, "Coronavirus vaccine development: from SARS and MERS to COVID-19" Journal of Biomedical science, 2020; 104 https://jbiomedsci.biomedcentral.com/articles/10.1186/s12929-020-00695-2 https://doi.org/10.1186/s12929-020-00695-2
16. Bok K, Sitar S, Graham BS, Mascola JR, "Accelerated COVID-19 vaccine development: milestones, lessons, and prospects" 2021; https://doi.org/10.1016/j.immuni.2021.07.017
17. Haque A, Pant AB, "Efforts at COVID-19 Vaccine Development: Challenges and Successes" MDPI, 2020; 8(4)739. https://doi.org/10.3390/vaccines8040739
18. Kuter BJ, Offit PA, Poland GA, "The development of COVID-19 vaccines in the United States: Why and how so fast?"PubMed, 2021; 39(18):2491-2495. https://doi.org/10.1016/j.vaccine.2021.03.077
19. Krammer F, "SARS-CoV-2 vaccines in development," Nature, 2020; 516-527. https://www.nature.com/articles/s41586-020-2798-3
https://doi.org/10.1038/s41586-020-2798-3
20. Graham BS, "Rapid COVID-19 vaccine development" Science, 2020; 368.https://www.science.org/doi/10.1126/science.abb8923 https://doi.org/10.1126/science.abb8923
21. Rawat K, Kumari P, Saha L, "Covid -19 vaccine: A recent update in pipeline vaccines, their design and development strategies," Science Direct, 2021; 892. https://doi.org/10.1016/j.ejphar.2020.173751
https://doi.org/10.1016/j.ejphar.2020.173751
22. Shaukat A, Hussain K, Shehzadi N, "COVID-19 vaccines: Development, strategies, types and vaccine usage hesitancy" 2021; 30(3)145-152. https://www.redalyc.org/journal/2034/203468846006/html/
23. Thorpe A, Fagerlin A, Butler J, Stevens V, Drews FA, Shoemaker H, Riddoch MS, Scherer LD, "Communicating about COVID-19 vaccine development and safety". 2022; https://doi.org/10.1371/journal.pone.0272426
24. Heaton PM, "The Covid-19 Vaccine-Development Multiverse. The New England Journal of Medicine" 2020; 383, 1986-1988. https://www.nejm.org/doi/full/10.1056/NEJMe2025111 https://doi.org/10.1056/NEJMe2025111
25. Strizova Z, Smetanova J, Bartunkova J, Milota T, "Principles and Challenges in anti-COVID-19 Vaccine Development" 2021; 182:339-349. https://doi.org/10.1159/000514225
26. Li Y, Tenchov R, Smoot J, Liu C, Watkins S, Zhou Q, "A Comprehensive Review of the Global Efforts on COVID-19 Vaccine Development" ACS,2021; 7(4):512-533. https://doi.org/10.1021/acscentsci.1c00120
27. Lynch HF, Dickert NW, Zettler PJ, Joffe S, Largent EA, "Regulatory flexibility for COVID-19 research", Journal of Law and the Biosciences, 2020; 7(1). https://doi.org/10.1093/jlb/lsaa057
28. Bolislis, Rei W, De Lucia ML, Dolz F, Mo R, Nagaoka M, Rodriguez H, Woon ML, Yu W, and Kühler TC, "Regulatory Agilities In The Time Of COVID-19: Overview, Trends, And Opportunities"2021; 43(1):124-139. https://doi.org/10.1016/j.clinthera.2020.11.015
29. Reicher, Stephen, and Drury J. 2021. "Pandemic Fatigue? How Adherence To Covid-19 Regulations Has Been Mis-represented And Why It Matters". BMJ, 137. https://doi.org/10.1136/bmj.n137
30. Corey L, Mascola JR, Fauci AS, Collins FS, "A strategic approach to COVID-19 vaccine R&D" 2020; 368(6494), 948-950. https://www.science.org/doi/10.1126/science.abc5312. https://doi.org/10.1126/science.abc5312
31. Carneiro DC, Sousa JD, Monteiro-Cunha Jp, "The COVID-19 vaccine development: A pandemic paradigm" 2021; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8127526/ https://doi.org/10.1016/j.virusres.2021.198454
32. Rodney J.Y. Ho, "Warp-Speed Covid-19 Vaccine Development: Beneficiaries of Maturation in Biopharmaceutical Technologies and Public-Private Partnerships", Journal of Pharmaceutical Sciences, 2021; 10(2):615-618, ISSN 0022-3549, https://doi.org/10.1016/j.xphs.2020.11.010
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1.
Kulkarni R, Kallepalli SP, Dharia S, Kamble G, Parvathaneni M. A Review on Strategies for COVID-19 Vaccine Development and Regulatory Requirements. JDDT [Internet]. 15Jan.2023 [cited 21May2024];13(1):159-64. Available from: https://www.jddtonline.info/index.php/jddt/article/view/5868
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