STUDY OF CORONAVIRUS DISEASE 2019 (COVID-19) VACCINATION IN INDONESIA: A LITERATURE REVIEW

Theresia Lidia; Aris Widayati

doi:10.24071/jpsc.003459

STUDY OF CORONAVIRUS DISEASE 2019 (COVID-19) VACCINATION IN INDONESIA: A LITERATURE REVIEW

Theresia Lidia^(1*), Aris Widayati⁽²⁾,

(1) Sanata Dharma University
(2) Sanata Dharma University
(*) Corresponding Author

Abstract

Research and development of the COVID-19 vaccine give hope to all people to stop the COVID-19 pandemic in the world. This literature review explores the safety and efficacy of the COVID-19 vaccine used in Indonesia and discusses Indonesia's current vaccination process. The primary databases for the reviewed articles were PubMed and Mendeley. Others are official websites, such as World Health Organization (WHO); COVID-19 and National Economic Recovery Committee in Indonesia (KPCPEN); the National Agency of Drug and Food Control (NA-DFC–in Bahasa Indonesia: BPOM) of the Republic of Indonesia; the US Food and Drug Administration (FDA), Clinical Trials.gov, COVID-19 vaccine Tracker, the Indonesian regulations, and guidelines regarding COVID-19. The inclusion criteria of the searched articles were those published from December 2019 to April 30, 2021, and those which discussed vaccines' types, efficacy, and safety. Acceptance of the COVID-19 vaccination is quite high (65%). Refusal was related to vaccine safety (30%); effectiveness (22%); distrust of vaccines (13%); fear of side effects (12%); and religious reasons (8%). The COVID-19 vaccines planned by the Indonesia Government have gone through clinical trials phases I to III. The Coronavac vaccine efficacy showed seroconversion that occurred was 92.4% to 97.4%, and no severe side effects have been reported. The ChAdOx1 nCoV-19 efficacy was 66.7% to 76.0%, and none of the tested participants was hospitalized, serious side effects were very small (0.9% to 1.1%). The mRNA-1273 efficacy was 94.1%, and its reactogenicity was mild to moderate. The BNT162b2 efficacy was ≥ 92%, and no severe or specific safety concerns have occurred. The efficacy of the BBIBPCorV vaccine has not been established. Ongoing phase I, II, and III clinical trials will provide more information on safety and immunogenicity for the BBIBP-CorV. Three of the six vaccines have obtained EUA from BPOM and approval from the Indonesian Ulema Council (MUI). A health promotion program about the safety, efficacy, and the 'halal' of the COVID-19 vaccine; acceleration and ensuring access to the COVID-19 vaccination program are urgent to end this pandemic immediately.

Keywords

COVID-19; Indonesia; vaccines; vaccinations

Full Text:

PDF

References

Badan Pengawas Obat dan Makanan, 2021. Badan POM Terbitkan EUA Vaksin COVID-19 Produksi Bio Farma.

Badan Pengawas Obat dan Makanan Republik Indonesia, 2021. BPOM EUA COVID-19 Vaccine ASTRAZENECA [WWW Document]. URL https://cekbpom.pom.go.id/index.php/home/produk/ko58lhtthjm8imdknk6nq1i923/all/row/10/page/1/order/4/DESC/search/1/astrazeneca (accessed 4.10.21).

Badan Pengawasan Obat dan Makanan, 2021. BPOM EUA COVID-19 Vaccine CoronaVac [WWW Document]. URL https://cekbpom.pom.go.id/index.php/home/produk/ko58lhtthjm8imdknk6nq1i923/all/row/10/page/1/order/4/DESC/search/1/coronavac (accessed 4.10.21).

Baden, L.R., El Sahly, H.M., Essink, B., Kotloff, K., Frey, S., Novak, R., Diemert, D., Spector, S.A., Rouphael, N., Creech, C.B., McGettigan, J., Khetan, S., Segall, N., Solis, J., Brosz, A., Fierro, C., Schwartz, H., Neuzil, K., Corey, L., Gilbert, P., Janes, H., Follmann, D., Marovich, M., Mascola, J., Polakowski, L., Ledgerwood, J., Graham, B.S., Bennett, H., Pajon, R., Knightly, C., Leav, B., Deng, W., Zhou, H., Han, S., Ivarsson, M., Miller, J., Zaks, T., 2020. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. New England Journal of Medicine, 384(5), 403–416.

Barrett, J.R., Belij-Rammerstorfer, S., Dold, C. et al., 2021. Phase 1/2 trial of SARS-CoV-2 Vaccine ChAdOx1 nCoV-19 with a Booster Dose Induces Multifunctional Antibody Responses. Nature Medicine, 27(2), 279–288.

Bartsch, S.M., O’Shea, K.J., Ferguson, M.C., Bottazzi, M.E., Wedlock, P.T., Strych, U., McKinnell, J.A., Siegmund, S.S., Cox, S.N., Hotez, P.J., Lee, B.Y., 2020. Vaccine Efficacy Needed for a COVID-19 Coronavirus Vaccine to Prevent or Stop an Epidemic as the Sole Intervention. American Journal of Preventive Medicine, 59(4), 493–503.

COVID19 Vaccine Tracker, 2021. [WWW Document]. URL https://covid19.trackvaccines.org/ (accessed 4.18.21).

Direktur Jenderal Pencegahan dan Penanggulangan Penyakit Kemenkes RI, 2020. Keputusan Direktur Jenderal Pencegahan dan Pengendalian Penyakit No. HK.02.02/4/1/2021 tentang Petunjuk Teknis Pelaksanaan Vaksinasi dalam Rangka Penanggulangan Pandemi Corona Virus Disease 2019 (COVID-19). Indonesia.

Doroftei, B., Ciobica, A., Ilie, O.-D., Maftei, R., Ilea, C., 2021. Mini-Review Discussing the Reliability and Efficiency of COVID-19 Vaccines. Diagnostics.

Ewer, K.J., Barrett, J.R., Belij-Rammerstorfer, S. et al., 2021. T cell and Antibody Responses Induced by a Single Dose of ChAdOx1 nCoV-19 (AZD1222) Vaccine in a Phase 1/2 Clinical Trial. Nature Medicine, 27(2), 270–278.

Food and Drug Administration, 2021.

Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry.

Hodgson, S.H., Mansatta, K., Mallett, G., Harris, V., Emary, K.R.W., Pollard, A.J., 2021. What Defines an Efficacious COVID-19 Vaccine? A Review of the Challenges Assessing the Clinical Efficacy of Vaccines against SARS-CoV-2. The Lancet. Infectious diseases, 21(2), e26–e35.

Indonesian Ministry of Health, Indonesian Technical Advisory Group on Immunization, WHO, UNICEF, 2020. COVID-19 Vaccine Acceptance Survey in Indonesia, World Health Organization.

Kashte, S., Gulbake, A., El-Amin Iii, S.F., Gupta, A., 2021. COVID-19 Vaccines: Rapid Development, Implications, Challenges and Future Prospects. Human cell, 34(3), 711–733.

Kementerian Kesehatan Republik Indonesia, 2021. Peraturan Menteri Kesehatan Republik Indonesia Nomor 10 Tahun 2021 tentang Pelaksanaan Vaksinasi Dalam Rangka Penanggulangan Pandemi COVID-19.

Kementerian Kesehatan Republik Indonesia, 2020. Peraturan Menteri Kesehatan Republik Indonesia No.HK.01.07/MENKES/9860/2020 tentang Penetapan Jenis Vaksin COVID-19.

Kementerian Kesehatan RI, 2010. Peraturan Menteri Kesehatan Republik Indonesia Nomor 904/MENKES/SK/VII/2010 tentang Komite Penasihat Ahli Imunisasi Indonesia (Indonesian Technical Advisory Group on Immunization). Indonesia.

Machindra Kudale, A., Setiati, S., Harapan, H., Wagner, A.L., Yufika, A., Winardi, W., Anwar, S., Gan, A.K., Setiawan, A.M., Rajamoorthy, Y., Sofyan, H., Mudatsir, M., 2020. Acceptance of a COVID-19 Vaccine in Southeast Asia: A Cross-Sectional Study in Indonesia. Frontiers in Public Health, 8, 381.

Majelis Ulama Indonesia, 2021a. Fatwa Majelis Ulama Indonesia Nomor : 02 Tahun 2021 Tentang Produk Vaksin COVID-19 dari SINOVAC LIFE SCIENCES CO. LTD. CHINA DAN PT. BIO FARMA (Persero).

Majelis Ulama Indonesia, 2021b. Fatwa Majelis Ulama Indonesia No 14 Tahun 2021 tentang Hukum Penggunaan Vaksin COVID-19 Produk AstraZeneca.

Mehrotra, D. V, Janes, H.E., Fleming, T.R., Annunziato, P.W., Neuzil, K.M., Carpp, L.N., Benkeser, D., Brown, E.R., Carone, M., Cho, I., Donnell, D., Fay, M.P., Fong, Y., Han, S., Hirsch, I., Huang, Ying, Huang, Yunda, Hyrien, O., Juraska, M., Luedtke, A., Nason, M., Vandebosch, A., Zhou, H., Cohen, M.S., Corey, L., Hartzel, J., Follmann, D., Gilbert, P.B., 2021. Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials. Annals of internal medicine, 174(2), 221–228.

Mellet, J., Pepper, M.S., 2021. A Covid-19 Vaccine: Big Strides Come with Big Challenges. Vaccines, 9(1), 1–14.

Nadia, S., 2020. COVID-19 Vaccination Implementation Policy, Directorate General of Disease Prevention and Control, Ministry of Health.

Oliver, S.E., Gargano, J.W., Scobie, H., et al., 2021. The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Janssen COVID-19 Vaccine — United States, February 2021. MMWR Surveillance Summaries, 70(9), 329–332.

Poland, G.A., Ovsyannikova, I.G., Kennedy, R.B., 2020. SARS-CoV-2 Immunity: Review and Applications to Phase 3 Vaccine Candidates. The Lancet.

Presiden Republik Indonesia, 2021. Peraturan Presiden Republik Indonesia Nomor 14 Tahun 2021 tentang Pengadaan Vaksin dan Pelaksanaan Vaksinasi dalam Rangka Penanggulangan Pandemi COVID-19.

The Oxford COVID Vaccine Trial Group, 2021a. Single-dose Administration and the Influence of the Timing of the

Booster Dose on Immunogenicity and Efficacy of ChAdOx1 nCoV-19 (AZD1222) Vaccine: a Pooled Analysis of Four Randomised Trials. The Lancet, 397(10277), 881–891.

The Oxford COVID Vaccine Trial Group, 2021b. Safety and Immunogenicity of ChAdOx1 nCoV-19 Vaccine Administered in a Prime-boost Regimen in Young and Old Adults (COV002): A Single-Blind, Randomised, Controlled, Phase 2/3 trial. The Lancet (London, England), 396(10267), 1979–1993.

The Oxford COVID Vaccine Trial Group, 2020. Safety and Immunogenicity of the ChAdOx1 nCoV-19 Vaccine against SARS-CoV-2: A Preliminary Report of a Phase 1/2, Single-blind, Randomised Controlled Trial. The Lancet, 396(10249), 467–478.

U.S. National Library of Medicine, 2020. Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine-NCT04508075 [WWW Document]. URL https://clinicaltrials.gov/ct2/show/NCT04508075 (accessed 4.28.21).

Wang, H., Zhang, Y., Huang, B., Deng, W., Quan, Y., Wang, W., Xu, W., Zhao, Y., Li, N., Zhang, J., Liang, H., Bao, L., Xu, Y., Ding, L., Zhou, W., Gao, H., Liu, J., Niu, P., Zhao, L., Zhen, W., Fu, H., Yu, S., Zhang, Z., Xu, G., Li, C., Lou, Z., Xu, M., Qin, C., Wu, G., Gao, G.F., Tan, W., Yang, X., 2020. Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2. Cell, 182(3), 713-721.e9.

World Health Organization, 2020. Pneumonia of unknown cause – China [WWW Document]. January 5. URL https://www.who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en/ (accessed 3.3.21).

Wu, Z., Hu, Y., Xu, M., Chen, Z., Yang, W., Jiang, Z., Li, M., Jin, H., Cui, G., Chen, P., Wang, L., Zhao, G., Ding, Y., Zhao, Y., Yin, W., 2021. Safety, Tolerability, and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Healthy Adults Aged 60 Years and Older: A Randomised, Double-blind, Placebo-controlled, Phase 1/2 Clinical Trial. The Lancet Infectious Diseases, 21(6), 803–812.

Xia, S., Zhang, Y., Wang, Y., Wang, Hui, Yang, Y., Gao, G., Tan, W., Wu, G., Xu, M., Lou, Z., Huang, W., Xu, W., Huang, B., Wang, Huijuan, Wang, W., Zhang, W., Li, N., Xie, Z., Ding, L., Yang, X., 2020. Safety and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine, BBIBP-CorV: A Randomised, Double-blind, Placebo-controlled, Phase 1/2 Trial. The Lancet Infectious Diseases, 21.

DOI: https://doi.org/10.24071/jpsc.003459