A review on risk assessment of formulation development and technology transfer of COVID-19 vaccines
DOI:
https://doi.org/10.17533/udea.vitae.v29n2a348750Keywords:
Vaccine development, Technology transfer, Risk assessment, COVID–19 vaccinesAbstract
BACKGROUND: COVID-19 pandemic situation made the pharmaceutical companies develop the vaccine with different formulations in a short period. OBJECTIVES: The main objective of the review is to focus on different types of vaccine formulations available globally and the importance of technology transfer in vaccine development associated with potential risks. RESULTS: Research on vaccine development led to various types of vaccines, such as Inactivated vaccines, live attenuated vaccines, Ribonucleic acid (RNA) and Deoxyribonucleic acid (DNA) vaccines, viral vector vaccines, and Protein Subunit Vaccines for COVID-19. But the process of vaccine development and technology transfer is lined with various risks and challenges. Through risk assessment, we found some major potential risks involved in product development; this leads to a smoother and more efficient method to develop safe vaccines available for public health. CONCLUSIONS: This review will explain the significance of technology collaboration for the faster development of various formulations of vaccines globally.
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References
Malik YA. Properties of Coronavirus and SARS-CoV-2. Malays J Pathol. 2020 Apr;42(1):3-11. PMID: 32342926. Available from https://pubmed.ncbi.nlm.nih.gov/32342926/
World Health Organization. Statistics reports on corona deaths worldwide. https://covid19.who.int/ 2022 (accessed 26 Feb 2022)
Akin L, Gözel MG. Understanding dynamics of pandemics. Turkish Journal of medical sciences. 2020 Apr 21;50(SI-1):515-9. DOI: 10.3906/sag-2004-133
Wang J, Peng Y, Xu H, Cui Z, Williams RO. The COVID-19 vaccine race: challenges and opportunities in vaccine formulation. AAPS PharmSciTech. 2020 Aug;21(6):1-2. DOI: https://doi.org/10.1208/s12249-020-01744-7
Samaranayake LP, Seneviratne CJ, Fakhruddin KS. Coronavirus disease 2019 (COVID‐19) vaccines: A concise review. Oral diseases. 2021 May 15. DOI: https://doi.org/10.1111/odi.13916
Lv H, Wu NC, Mok CK. COVID‐19 vaccines: knowing the unknown. European journal of immunology. 2020 Jul;50(7):939-43. DOI: https://doi.org/10.1002/eji.202048663
He Q, Mao Q, Zhang J, Bian L, Gao F, Wang J, Xu M, Liang Z. COVID-19 vaccines: current understanding on immunogenicity, safety, and further considerations. Frontiers in immunology. 2021;12. DOI: https://doi.org/10.3389/fimmu.2021.669339
Palacios R, Patiño EG, de Oliveira Piorelli R, et al. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020;21(1):853. Published 2020 Oct 15. DOI: https://doi.org/10.1186/s13063-020-04775-4
Kandeil A, Mostafa A, Hegazy RR, El-Shesheny R, El Taweel A, Gomaa MR, Shehata M, Elbaset MA, Kayed AE, Mahmoud SH, Moatasim Y. Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine: preclinical studies. Vaccines. 2021 Mar;9(3):214. DOI: https://doi.org/10.3390/vaccines9030214
Saleh A, Qamar S, Tekin A, Singh R, Kashyap R. Vaccine Development Throughout History. Cureus. 2021 Jul 26;13(7). DOI: https://doi.org/10.7759/cureus.16635
Minor PD. Live attenuated vaccines: Historical successes and current challenges. Virology. 2015 May 1;479:379-92. DOI: https://doi.org/10.1016/j.virol.2015.03.032
Bodmer BS, Fiedler AH, Hanauer JR, Prüfer S, Mühlebach MD. Live-attenuated bivalent measles virus-derived vaccines targeting Middle East respiratory syndrome coronavirus induce robust and multifunctional T cell responses against both viruses in an appropriate mouse model. Virology. 2018 Aug 1;521:99-107. DOI: https://doi.org/10.1016/j.virol.2018.05.028
Wu SC. Progress and concept for COVID‐19 vaccine development. Biotechnology journal. 2020 Jun 1. DOI: https://doi.org/10.1002/biot.202000147
Dolgin E. The tangled history of mRNA vaccines. Nature. 2021 Sep 1;597(7876):318-24. DOI: https://doi.org/10.1038/d41586-021-02483-w
Carazo S, Talbot D, Boulianne N, Brisson M, Gilca R, Deceuninck G, Brousseau N, Drolet M, Ouakki M, Sauvageau C, Barkati S. Single-Dose Messenger RNA Vaccine Effectiveness Against Severe Acute Respiratory Syndrome Coronavirus 2 in Healthcare Workers Extending 16 Weeks Postvaccination: A Test-Negative Design From Québec, Canada. Clinical Infectious Diseases. 2021. DOI: https://doi.org/10.1093/cid/ciab739
Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, Li P. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020 Oct;586(7830):589-93. DOI: https://doi.org/10.1038/s41586-020-2639-4
Swift MD, Breeher LE, Tande AJ, Tommaso CP, Hainy CM, Chu H, Murad MH, Berbari EF, Virk A. Effectiveness of messenger RNA coronavirus disease 2019 (COVID-19) vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in a cohort of healthcare personnel. Clinical Infectious Diseases. 2021 Sep 15;73(6):e1376-9. DOI: https://doi.org/10.1093/cid/ciab361
Zhou P, Li Z, Xie L, An D, Fan Y, Wang X, Li Y, Liu X, Wu J, Li G, Li Q. Research progress and challenges to coronavirus vaccine development. Journal of medical virology. 2021 Feb;93(2):741-54. DOI: https://doi.org/10.1002/jmv.26517
Tenforde MW, Patel MM, Ginde AA, Douin DJ, Talbot HK, Casey JD, Mohr NM, Zepeski A, Gaglani M, McNeal T, Ghamande S. Effectiveness of severe acute respiratory syndrome coronavirus 2 messenger RNA vaccines for preventing coronavirus disease 2019 hospitalizations in the United States. Clinical Infectious Diseases. 2021. DOI: https://doi.org/10.1093/cid/ciab687
Lin CJ, Mecham RP, Mann DL. RNA Vaccines for COVID-19: 5 Things Every Cardiologist Should Know. Basic to Translational Science. 2020 Dec 1;5(12):1240-3. DOI: https://doi.org/10.1016/j.jacbts.2020.11.006
Gary EN, Weiner DB. DNA vaccines: prime time is now. Curr Opin Immunol. 2020 Aug;65:21-27. DOI: https://doi.org/10.1016/j.coi.2020.01.006.
Tatlow D, Tatlow C, Tatlow S, Tatlow S. A novel concept for treatment and vaccination against Covid‐19 with an inhaled chitosan‐coated DNA vaccine encoding a secreted spike protein portion. Clinical and Experimental Pharmacology and Physiology. 2020 Nov;47(11):1874-8. DOI: https://doi.org/10.1111/1440-1681.13393
Hobernik D, Bros M. DNA vaccines—how far from clinical use?. International journal of molecular sciences. 2018 Nov;19(11):3605. DOI: https://doi.org/10.3390/ijms19113605
Li Y, Bi Y, Xiao H, Yao Y, Liu X, Hu Z, Duan J, Yang Y, Li Z, Li Y, Zhang H. A novel DNA and protein combination COVID-19 vaccine formulation provides full protection against SARS-CoV-2 in rhesus macaques. Emerging microbes & infections. 2021 Jan 1;10(1):342-55. DOI: https://doi.org/10.1080/22221751.2021.1887767
Belete TM. A review on Promising vaccine development progress for COVID-19 disease. Vacunas. 2020 Jul 1;21(2):121-8. DOI: 10.1016/j.vacun.2020.05.002
Arastu K. A brief introduction to Covid-19 vaccines. December 2020. Available from- https://domlipa.ca/sites/default/files/Covid-Vaccines.pdf.
Huang J, Huang H, Wang D, Wang C, Wang Y. Immunological strategies against spike protein: Neutralizing antibodies and vaccine development for COVID‐19. Clinical and Translational Medicine. 2020 Oct;10(6). DOI: https://doi.org/10.1002/ctm2.184
Pandey SC, Pande V, Sati D, Upreti S, Samant M. Vaccination strategies to combat novel corona virus SARS-CoV-2. Life sciences. 2020 Sep 1;256:117956. DOI: https://doi.org/10.1016/j.lfs.2020.117956
Putter JS. Immunotherapy for COVID-19: Evolving treatment of viral infection and associated adverse immunological reactions. Transfusion and Apheresis Science. 2021 Apr 1;60(2):103093. DOI: https://doi.org/10.1016/j.transci.2021.103093
Baldo A, Leunda A, Willemarck N, Pauwels K. Environmental risk assessment of recombinant viral vector vaccines against SARS-Cov-2. Vaccines. 2021 May;9(5):453. DOI: https://doi.org/10.3390/vaccines9050453
Lundstrom K. Application of viral vectors for vaccine development with a special emphasis on COVID-19. Viruses. 2020 Nov;12(11):1324. DOI: https://doi.org/10.3390/v12111324
Lundstrom K. Viral vectors for COVID-19 vaccine development. Viruses. 2021 Feb;13(2):317. DOI: https://doi.org/10.3390/v13020317
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 Central Science. 2021 Mar 29;7(4):512-33. DOI: https://doi.org/10.1021/acscentsci.1c00120.
Tscherne A, Schwarz JH, Rohde C, Kupke A, Kalodimou G, Limpinsel L, Okba NM, Bošnjak B, Sandrock I, Odak I, Halwe S. Immunogenicity and efficacy of the COVID-19 candidate vector vaccine MVA-SARS-2-S in preclinical vaccination. Proceedings of the National Academy of Sciences. 2021 Jul 13;118(28). DOI: https://doi.org/10.1073/pnas.2026207118
Chaudhary S, El-Shorbagi AN, Gupta RK, Kumar A. The Recent Updates on Approaches and Clinical Trials Status of Covid-19 Vaccines Developed Globally. Biomedical and Pharmacology Journal. 2021 Sep 30;14(3):1109-24. DOI: https://doi.org/10.13005/bpj/2214
Kochhar S, Kim D, Excler JL, Condit RC, Robertson JS, Drew S, Whelan M, Wood D, Fast PE, Gurwith M, Klug B. The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines. Vaccine. 2020 Jul 31;38(35):5734-9. DOI: https://doi.org/10.1016/j.vaccine.2020.06.044
Yang S, Li Y, Dai L, Wang J, He P, Li C, Fang X, Wang C, Zhao X, Huang E, Wu C. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials. The Lancet Infectious Diseases. 2021 Aug 1;21(8):1107-19. DOI: https://doi.org/10.1016/S1473-3099(21)00127-4
Wu Y, Huang X, Yuan L, Wang S, Zhang Y, Xiong H, Chen R, Ma J, Qi R, Nie M, Xu J. A recombinant spike protein subunit vaccine confers protective immunity against SARS-CoV-2 infection and transmission in hamsters. Science translational medicine. 2021 Aug 11;13(606):eabg1143. DOI: https://doi.org/10.1126/scitranslmed.abg1143
Kaur SP, Gupta V. COVID-19 Vaccine: A comprehensive status report. Virus research. 2020 Oct 15;288:198114. DOI: https://doi.org/10.1016/j.virusres.2020.198114
Heinz FX, Stiasny K. Profiles of current COVID-19 vaccines. Wiener Klinische Wochenschrift. 2021 Apr;133(7):271-83. DOI: https://doi.org/10.1007/s00508-021-01835-w
Dutta AK. Vaccine against Covid-19 disease–present status of development. The Indian Journal of Pediatrics. 2020 Oct;87(10):810-6. DOI: https://doi.org/10.1007/s12098-020-03475-w
Zhao J, Zhao S, Ou J, Zhang J, Lan W, Guan W, Wu X, Yan Y, Zhao W, Wu J, Chodosh J. COVID-19: coronavirus vaccine development updates. Frontiers in immunology. 2020 Dec 23;11:3435. DOI: https://doi.org/10.3389/fimmu.2020.602256
Kumar A, Dowling WE, Román RG, et al. Status Report on COVID-19 Vaccines Development. Curr Infect Dis Rep. 2021;23(6):9. DOI: https://doi.org/10.1007/s11908-021-00752-3
Yan ZP, Yang M, Lai CL. COVID-19 vaccines: a review of the safety and efficacy of current clinical trials. Pharmaceuticals. 2021 May;14(5):406. DOI: https://doi.org/10.3390/ph14050406
Alam MS, Ahmad J. Pharmaceutical technology transfer: An overview. International Journal of Pharmaceutical Sciences and Research. 2013 Jul 1;4(7):2441. DOI: http://dx.doi.org/10.13040/IJPSR.0975-8232.4(7).2441-49
Singh A, Aggarwal G. Technology transfer in pharmaceutical industry: a discussion. Law and government. 2010;1:2. Available from https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.178.2938&rep=rep1&type=pdf
John RM. Technology transfer in pharmaceutical industry. The Pharma Innovation. 2017 Mar 1;6(3, Part D):235. Available from https://www.thepharmajournal.com/archives/2017/vol6issue3/PartD/6-1-26-206.pdf
World Health Organization. Pharmaceutical production and related technology transfer: landscape report. https://www.who.int/publications/i/item/9789241502351 2022 (accessed 15 March 2022).
Manu C, Vishal NG. Review on Technology Transfer in pharmaceutical industry. International Journal of Pharmaceutical Quality Assurance. 2016;7(1):7-14. Available from http://impactfactor.org/PDF/IJPQA/7/IJPQA,Vol7,Issue1,Article2.pdf.
Guideline IH. Pharmaceutical quality system q10. Current Step. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf 2022 (accessed 15 March 2022).
Das A, Kadwey P, Mishra JK, Moorkoth S. Quality risk management (QRM) in pharmaceutical industry: Tools and methodology. International Journal of Pharmaceutical Quality Assurance. 2014;5(3):13. DOI: https://doi.org/10.25258/IJPQA.5.3.1
World Health Organization. Document on Covid – 19. https://www.who.int/news-room/commentaries/detail/op-ed---covid-19-shows-why-united-action-is-needed-for-more-robust-international-health-architecture. 2022 (accessed 15 March 2022)
Pate MA, Sulzhan B, Kulaksiz S. Safer together—unlocking the power of partnerships against COVID-19. World Bank Blog; 2021. Available from https://blogs.worldbank.org/health/safer-together-unlocking-power-partnerships-against-covid-19
Le-Guillou I. Covid-19: How unprecedented data sharing has led to faster-than-ever outbreak research. Horizon. 2020 Mar. Available from https://ec.europa.eu/research-and-innovation/en/horizon-magazine/covid-19-how-unprecedented-data-sharing-has-led-faster-ever-outbreak-research.
Chesbrough H. To recover faster from Covid-19, open up: Managerial implications from an open innovation perspective. Industrial Marketing Management. 2020 Jul 1;88:410-3. DOI: https://doi.org/10.1016/j.indmarman.2020.04.010
Editor’s note. Scientists and industry are dashing to make more ventilators. The Economist; 2020. Available from https://www.economist.com/international/2020/03/26/scientists-and-industry-are-dashing-to-make-more-ventilators
Reich MR. Public-private partnerships for public health. Nat Med. 2000;6(6):617-620. DOI: https://doi.org/10.1038/76176
World Health Organization. The access to COVID-19 tools (ACT) Accelerator. 2021. https://www.who.int/initiatives/act-accelerator 2022 (accessed 15th March 2022).
Odevall L, Hong D, Digilio L, Sahastrabuddhe S, Mogasale V, Baik Y, Choi S, Kim JH, Lynch J. The Euvichol story–Development and licensure of a safe, effective and affordable oral cholera vaccine through global public private partnerships. Vaccine. 2018 Oct 29;36(45):6606-14. DOI: https://doi.org/10.1016/j.vaccine.2018.09.026
IFPMA & Welcome Trust. How partnerships across sectors can reinvigorate the vaccine pipeline; 2019. Available at: https://www.ifpma.org/wp-content/ uploads/2019/03/290719-IFPMA-TLS_Wellcome-Trust_Collaboration-andPartnerships.pdf 2022 (accessed 15th March 2022).
Rappuoli R, Hanon E. Sustainable vaccine development: a vaccine manufacturer's perspective. Current opinion in immunology. 2018 Aug 1;53:111-8. DOII: https://doi.org/10.1016/j.coi.2018.04.019
Kahn J. How scientists could stop the next pandemic before it starts. New York Times. 2020 Apr 24. Available from https://www.nytimes.com/2020/04/21/magazine/pandemic-vaccine.html.
Kilpatrick C. Oxford tech transfer chief: ‘It’s been the most intense year’. ManagingIP; 2021. Available at: https://www.managingip.com/article/ b1qpym8kzbgcd4/oxford-tech-transfer-chief-its-been-the-most-intense-year 2022 (accessed: 15th March 2022)
Oxford Biomedica. Oxford biomedica signs supply agreement with astrazeneca to expand manufacturing support of COVID-19 vaccine candidate, AZD1222; 2020. Available at: https://www.oxb.com/news-media/press-release/oxfordbiomedica-signs-supply-agreement-astrazeneca-expand-manufacturing 2022 (accessed 15th March 2022).
AstraZeneca. AstraZeneca and Oxford University Announce Landmark Agreement for COVID-19 Vaccine. https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-and-oxford-university-announce-landmark-agreement-for-covid-19-vaccine.html 2022 (accessed 15th march 20220
Pfizer and BioNTech to co-develop potential COVID-19 vaccine. Business Wire; 2020. Available at: https://www.businesswire.com/news/home/ 20200316005943/en/ 2022 (accessed 15th March 2022).
Pfizer Inc. Pfizer and BioNTech announce further details on collaboration to accelerate global COVID-19 vaccine development; 2020. Available at: https:// www.pfizer.com/news/press-release/press-release-detail/pfizer-andbiontech-announce-further-details-collaboration 2022 (accessed 15th March 2022).
BioNTech. Pfizer and BioNTech announce further details on collaboration to accelerate global COVID-19 vaccine development; 2020. Available at: https:// investors.biontech.de/news-releases/news-release-details/pfizer-andbiontech-announce-further-details-collaboration 2022 (accessed 15th March 2022).
Ada GL. The ideal vaccine. World Journal of Microbiology and Biotechnology. 1991 Mar;7(2):105-9. DOI: https://doi.org/10.1007/BF00328978
N Deb B, Shah H, Goel S. Current global vaccine and drug efforts against COVID-19: Pros and cons of bypassing animal trials. Journal of biosciences. 2020 Dec;45(1):1-0. DOI: https://doi.org/10.1007/s12038-020-00053-2
Cohen J. How long do vaccines last? The surprising answers may help protect people longer. Science. 2019 Apr 18;10. https://www.science.org/content/article/how-long-do-vaccines-last-surprising-answers-may-help-protect-people-longer 2022 (accessed 15th March 2022).
To KK, Hung IF, Ip JD, Chu AW, Chan WM, Tam AR, Fong CH, Yuan S, Tsoi HW, Ng AC, Lee LL. COVID-19 re-infection by a phylogenetically distinct SARS-coronavirus-2 strain confirmed by whole genome sequencing. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America. 2020 Aug 25. DOI: https://doi.org/10.1093/cid/ciaa1275
Duffy S. Why are RNA virus mutation rates so damn high?. PLoS biology. 2018 Aug 13;16(8):e3000003. DOI: https://doi.org/10.1371/journal.pbio.3000003
Tirado SM, Yoon KJ. Antibody-dependent enhancement of virus infection and disease. Viral immunology. 2003 Apr 1;16(1):69-86. DOI: https://doi.org/10.1089/088282403763635465
Arvin AM, Fink K, Schmid MA, Cathcart A, Spreafico R, Havenar-Daughton C, Lanzavecchia A, Corti D, Virgin HW. A perspective on the potential antibody-dependent enhancement of SARS-CoV-2. Nature. 2020 Aug;584(7821):353-63. https://www.nature.com/articles/s41586-020-2538-8 2022 (accessed 15th March 2022).
Negro F. Is antibody-dependent enhancement playing a role in COVID-19 pathogenesis?. Swiss Medical Weekly. 2020 Apr 16;150(1516). DOI: https://doi.org/10.4414/smw.2020.20249
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