Legal Challenges of the Covid-19 Vaccination Program: A Comparative Discourse between Malaysia and Australia
Keywords:
vaccine, COVID-19, Malaysia, drug control authority, law
Abstract
During the spread of the COVID-19 pandemic, many health-related industries were alarmed and pressured to innovate solutional vaccines to reduce the effect of the COVID-19 pandemic. Extra effort and lab activities had taken place in several jurisdictions to respond to the increased demand for the COVID-19 vaccine. With these attempts, various vaccines were created and entered the market. All countries designed their own COVID-19 programme in the route to combat the viruses. These countries showed their willingness to invest to secure access to vaccines. In parallel to this development, the vaccination program is bombarded with several issues such as safety assurance, equal access to the vaccine, and protests by the anti-vaccine group. The inability to address these issues will jeopardise the success of building herd immunity which is the core in eradicating COVID-19 cases. Thus, this study explored and analysed the issues and challenges to have an effective vaccination program in a battle against the spread of the COVID-19 virus. It is a comparative study between Malaysia and Australia that includes safety measures, anti-vaccine groups and access to vaccines. This study adopts a qualitative method utilising the doctrinal study on the legal framework that describes the scope and limitation of power accorded to the Drug Control Authority of the selected jurisdictions. The research activities also include semi-structured interviews with relevant authorities using online interviews. The data are analysed using content and thematic analysis. Findings to this study may assist in identifying the loopholes within the administrative control on the vaccination program adopted by Malaysia.
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References
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Seale, H., Heywood, A. E., Leask, J., Sheel, M., Durrheim, D. N., Bolsewicz, K., & Kaur, R. (2021). Examining Australian Public Perceptions and Behaviors towards a Future COVID-19 Vaccine. BMC Infectious Diseases, 21(1), 1–9. https://doi.org/10.1186/s12879-021-05833-1
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Wilson, C. (2021a). Anti-vaxxers are flooding Parliament with petitions about vaccines. MSN News. https://www.msn.com/en-au/news/australia/anti-vaxxers-are-flooding-parliament-with-petitions-about-vaccines/ar-AANdz9o
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Australian Government. (n.d.). Australia COVID-19 Vaccination Policy.
Australian Government. (2020). Australia’s Covid-19 Vaccine and Treatment. https://www.health.gov.au/resources/publications/australias-covid-19-vaccine-and-treatment-strategy
Berita Harian. (, June). Kerajaan kaji tindakan undang-undang kepada golongan antivaksin. BH Online. https://www.bharian.com.my/berita/nasional/2021/06/824179/kerajaan-kaji-tindakan-undang-undang-kepada-golongan-antivaksin
Bernama. (2021a). AstraZeneca COVID-19 Vaccine Safe for Use in Malaysia - Dr. Adham. https://www.bernama.com/en/news.php?id=1945100
Bernama. (2021b). Isu pembekalan vaksin COVID-19 syarikat Pfizer tak jejas bekalan untuk Malaysia - Khairy. Astroawani. https://www.astroawani.com/berita-malaysia/isu-pembekalan-vaksin-covid19-syarikat-pfizer-tak-jejas-bekalan-untuk-malaysia-khairy-272033
Blyth, C. C., Flanagan, K. L., Gibbs, R. A., Crawford, N. W., & Cheng, A. C. (2021). Key steps in Our Journey to a COVID-19 Vaccine Program. Medical Journal of Australia, 214(6), 249-251.e1. https://doi.org/10.5694/mja2.50978
Borriello, A., Master, D., Pellegrini, A., & Rose, J. M. (2021). Preferences for a COVID-19 Vaccine in Australia. Vaccine, 39(3), 473–479. https://doi.org/10.1016/j.vaccine.2020.12.032
Clinical Trials Arena. (2020). Australia's Queensland University begins the Covid-19 vaccine trial. Clinical Trials Arena.
Davis, J., Ferreira, D., Denholm, J. T., & Tong, S. Y. (2020). Clinical trials for the prevention and treatment of coronavirus disease 2019 (COVID-19): The current state of play | The Medical Journal of Australia. The Medical Journal of Australia.
Department of Health. (2021a). COVID-19 vaccines | Australian Government Department of Health.
Department of Health. (2021b). How COVID-19 vaccines are tested and approved | Australian Government Department of Health.
Australian Covid-19 Vaccination Policy, (2020). https://www.health.gov.au/resources/publications/covid-19-vaccination-australian-covid-19-vaccination-policy
Department of Health Australian Government. (2021). Australia's s Vaccine Agreements. https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/covid-19-vaccine-government-response/australias-vaccine-agreements
Department of Health Therapeutic Good Administration. (2021). Vaccines overview 14. https://www.tga.gov.au/vaccines-overview
Deplanque, D., & Launay, O. (2021). Efficacy of COVID-19 vaccines: From clinical trials to real life. Therapies, 76(4), 277–283. https://doi.org/10.1016/j.therap.2021.05.004
Emily, H. (2021). Vaccine Doses to Enhance Rollout of Life -. https://www.news-medical.net/news/20210903/UK-and-Australia-will-share-COVID-19-vaccine-doses-to-enhance-rollout-of-life-saving-jabs.aspx
Gelling, P. (2021). Australia imposes penalties on anti-vaxxers. The World. https://www.pri.org/stories/australia-imposes-penalties-anti-vaxxers.
Joslyn Panting, A., Mohd Zin, Z., Jaafar, N., Perialathan, K., Shafizal Sheikh Ilman, S., Ridwan Zakaria, M., & Author, C. (2018). Potential Factors Contributing to Vaccine Hesitancy among Parents in Malaysia: An Overview. International Journal of Health Sciences & Research (Www.Ijhsr.Org), 8(7), 360. www.ijhsr.org
Kashte, S., Gulbake, A., El-Amin, S. F., & Gupta, A. (2021). COVID-19 Vaccines: Rapid Development, Implications, Challenges, and Future Prospects. Human Cell, 34(3), 711–733. https://doi.org/10.1007/s13577-021-00512-4
Kaur, R. J., Dutta, S., Bhardwaj, P., Charan, J., Dhingra, S., Mitra, P., Singh, K., Yadav, D., Sharma, P., & Misra, S. (2021). Adverse Events Reported From COVID-19 Vaccine Trials: A Systematic Review. Indian Journal of Clinical Biochemistry. https://doi.org/10.1007/s12291-021-00968-z
Khoo, Y. S. K., Ghani, A. A., Navamukundan, A. A., Jahis, R., & Gamil, A. (2020). Unique product quality considerations in vaccine development, registration, and new program implementation in Malaysia. Human Vaccines and Immunotherapeutics, 16(3), 530–538. https://doi.org/10.1080/21645515.2019.1667206
Kumari, B. S., G.Sai, H., M.V., Nagabhushanam D.Nagarjuna, R., & Brahmaiah, B. (2016). Current Regulatory Requirements for Registration of Medicines, Compilation, and Submission of Dossier in Australian Therapeutic Goods Administration. International Journal of Advanced Scientific and Technical Research, 6(6), 144–157.
Kuok, Y. C., & Wong, T. (2021). Guide on Covid-19 Vaccination: Regulatory Issues. Rajah & Tann Asia. https://www.christopherleeong.com/media/4389/2021_05_covid-19_vaccines.pdf
Lisa, L. M., & David Kelen, G. (2021). Is the COVID-19 Vaccine Safe? https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/is-the-covid19-vaccine-safe
Loomes, P. (2021). Coronavirus vaccine : What we misunderstand about anti-vaxxers. News.Com.Au. https://www.news.com.au/lifestyle/health/health-problems/coronavirus-vaccine-what-we-misunderstand-about-antivaxxers/news-story/0ef947d1e56e560ee835a0f043f23a33.
MacIntyre, C. R., Costantino, V., & Trent, M. (2021). Modeling of COVID-19 vaccination strategies and herd immunity, in scenarios of limited and full vaccine supply in NSW, Australia. Vaccine, XXXX, 0–7. https://doi.org/10.1016/j.vaccine.2021.04.042
Mukherjee, R. (2020). Global efforts on vaccines for COVID-19 : Since, sooner or later, we all will catch the coronavirus. Journal of Biosciences, 45, 1–10. https://doi.org/10.1007/s12038-020-00040-7
National Centre for Immunisation Research and Surveillance. (2020). Phases of clinical trials | NCIRS.
Panting, A., Mohd Zin, Z., Jaafar, N., Perialathan, K., Sheikh Ilman, S. S., & Zakaria, M. R. (2020). Potential Factors Contributing to Vaccine Hesitancy among Parents in Malaysia : An Overview. International Journal of Health Science and Research, 8(July 2018), 360–365.
Pharmaceuticals Export Promotion Council of India. (2018). Regulatory & Market Profile of Australia. In Pharmexcil.
Pharmout. (2016). White Paper: How to List or Register a Medicine in Australia (pp. 1–17). www.pharmout.net
Ramli, M. A., Suet Yan, D. S., & Lim, M. H. (2020). Combating Covid-19: Legal Requirement and Procedures for the Importation of Vaccine into Malaysia. Azmi & Associates. https://amcham.com.my/wp-content/uploads/Article-20200402-Combating-COVID-19-Legal-Requirements-and-Procedures-for-the-Importation-of-Vaccine-into-Malaysia.pdf
Reset Australia Research Memo. (2021). Anti-vaccination & Vaccine Hesitant Narratives Intensify in Australian Facebook Groups. https://au.reset.tech/uploads/resetaustralia_social-listening_report_100521-1.pdf
Rumetta, J., Abdul-Hadi, H., & Lee, Y. K. (2020). A Qualitative Study on Parents’ Reasons and Recommendations for Childhood Vaccination Refusal in Malaysia. Journal of Infection and Public Health, 13(2), 199–203. https://doi.org/10.1016/j.jiph.2019.07.027
Seale, H., Heywood, A. E., Leask, J., Sheel, M., Durrheim, D. N., Bolsewicz, K., & Kaur, R. (2021). Examining Australian Public Perceptions and Behaviors towards a Future COVID-19 Vaccine. BMC Infectious Diseases, 21(1), 1–9. https://doi.org/10.1186/s12879-021-05833-1
Sharun, K., & Dhama, K. (2021). COVID-19 Vaccine Diplomacy and Equitable Access to Vaccines Amid Ongoing Pandemic. Archives of Medical Research, XXXX, 19–21. https://doi.org/10.1016/j.arcmed.2021.04.006
Silva, J., Bratberg, J., & Lemay, V. (2021). COVID-19 and Influenza Vaccine Hesitancy among College Students. Journal of the American Pharmacists Association. https://doi.org/10.1016/j.japh.2021.05.009
The Secretariat of the Special Committee for Ensuring Access to Covid-19 Supply (JKJAV). (2021). National Covid-19 Immunisation Programme (Issue February). https://www.vaksincovid.gov.my/pdf/National_COVID-19_Immunisation_Programme.pdf
The Special Committee for Ensuring Access to COVID-19 Vaccine. (2020). AstraZeneca COVID-19 Vaccine (AZD1222).
Therapeutic Goods Administration. (2020). What are “therapeutic goods”? Department of Health Therapeutic Goods Administration. http://www.tga.gov.au/what-are-therapeutic-goods
Therapeutic Goods Administration. (2021). COVID-19 vaccine advertising and import compliance. Department of Health. https://www.tga.gov.au/covid-19-vaccine-advertising-and-import-compliance
Therapeutic Goods Administration (TGA). (2021). Advisory Committee on Vaccines (ACV). Australian Government Department of Health Therapeutic Goods Administration. https://www.tga.gov.au/committee/advisory-committee-vaccines-acv
Vaughan, G. (1995). The Australian Drug Regulatory System. Australian Prescriber, NPS Medicinewise, 3 July. https://doi.org/10.18773/austprescr.1995.068
Wan Abhar, W. N. A. (2021). Safety Updates on COVID-19 Vaccine (Comirnaty®). National Pharmaceutical Regulatory Agency (NPRA). https://www.hsa.gov.sg/COVID19-vaccines-safety-updates
Wan Taib, W. R., Mohd Yusoff, N. A., Raja Hussin, T. M. A., & Ahmad, A. (2017). Issues in Vaccine Hesitancy in Malaysia. J. of Biomed. & Clin. Sci, 2(June), 42–46.
Wilson, C. (2021a). Anti-vaxxers are flooding Parliament with petitions about vaccines. MSN News. https://www.msn.com/en-au/news/australia/anti-vaxxers-are-flooding-parliament-with-petitions-about-vaccines/ar-AANdz9o
Wilson, C. (2021b). Australians are embracing anti-vaccine Facebook groups filled with conspiracy theories and lies. MSN News. https://www.msn.com/en-au/news/australia/australians-are-embracing-anti-vaccine-facebook-groups-filled-with-conspiracy-theories-and-lies/ar-BB1gQwJH.
Wong, Y. J., & Lee, S. W. H. (2021). COVID-19 : A call for awareness or mandatory vaccination even in pandemics ? Journal of Global Health, 11, 2019–2021. https://doi.org/10.7189/jogh.11.03005
World Health Organisation. (2021). Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness: Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organisation. 1–11. https://www.who.int/news/item/11-06-2021-statement-for-healthcare-professionals-how-covid-19-vaccines-are-regulated-for-safety-and-effectiveness
Yeoh, L., & Jua Wen, P. (2021). Mandatory Covid-19 Vaccination To Reach Herd Immunity in Malaysia. Lexology. https://www.lexology.com/library/detail.aspx?g=e0e7ae2d-3cff-4d8b-9f7b-3f43e19037f9
Published
2021-10-10
How to Cite
Nasrun, M., Abdul Aziz, N., Yahaya, N. and Abdullah, S. M. (2021) “Legal Challenges of the Covid-19 Vaccination Program: A Comparative Discourse between Malaysia and Australia”, Malaysian Journal of Social Sciences and Humanities (MJSSH), 6(10), pp. 319 - 333. doi: 10.47405/mjssh.v6i10.1078.
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