CoronaVac: Perbedaan antara revisi
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'''CoronaVac''' adalah kandidat [[Vaksin COVID-19|vaksin COVID-19 yang]] dikembangkan oleh perusahaan biofarmasi China, [[Sinovac Biotech|Sinovac]] .<ref name="jakartaglobe">{{Cite web|date=August 11, 2020|title=Indonesia Starts CoronaVac Phase 3 Clinical Trials|url=https://jakartaglobe.id/news/indonesia-starts-coronavac-phase-3-clinical-trials|website=Jakarta Globe|archive-url=https://web.archive.org/web/20201013211900/https://jakartaglobe.id/news/indonesia-starts-coronavac-phase-3-clinical-trials|archive-date=October 13, 2020|access-date=2020-08-26|url-status=live}}</ref> Sejak pertengahan tahun 2020, calon vaksin ini menjalani [[Tahap-tahap penelitian klinis|penelitian klinis tahap III]];<ref name="NCname= nct04456595=">{{ClinicalTrialsGov|NCT04456595|Clinical Trial of Efficacy and Safety of Sinovac's Adsorbed COVID-19 (Inactivated) Vaccine in Healthcare Professionals (PROFISCOV)}}</ref><ref>{{Cite web|date=August 10, 2020|title=A Phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-COV-2 inactivated vaccine in healthy adults aged 18-59 years in Indonesia|url=https://www.ina-registry.org/index.php?act=registry_trial_detail&code_trial=16202009080721WXFM0YX|website=PT Bio Farma|publisher=Registri Penyakit Indonesia|archive-url=https://web.archive.org/web/20201011084814/https://www.ina-registry.org/index.php?act=registry_trial_detail&code_trial=16202009080721WXFM0YX%2F|archive-date=October 11, 2020|access-date=August 15, 2020|url-status=live}}</ref> dan saat ini berada dalam uji coba tahap III di Brasil, Chili, Indonesia, dan Turki. CoronaVac menggunakan teknologi serupa yang lebih tradisional seperti pada [[BBIBP-CorV]] dan [[BBV152]], vaksin virus inaktif COVID-19 lainnya yang sedang dalam uji coba tahap III.<ref>{{Cite news|date=2020-06-10|title=Coronavirus Vaccine Tracker|url=https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html|work=The New York Times|language=en-US|issn=0362-4331|access-date=2020-12-27}}</ref>
Pada 7 Januari 2021, [[Instituto Butantan]] dari [[Brasil]] mengumumkan bahwa vaksin ini 78% efektif pada kasus ringan dan 100% efektif melawan infeksi berat dan sedang berdasarkan 220 kasus COVID-19 dari 13.000 sukarelawan tanpa merinci bagaimana tingkat efikasinya dihitung.<ref name=":2">{{Cite news|date=2021-01-07|title=Sinovac’s Covid Shot Proves 78% Effective in Brazil Trial|url=https://www.bloomberg.com/news/articles/2021-01-07/sinovac-covid-shot-78-effective-in-brazil-trial-folha-reports|work=Bloomberg.com|language=en|access-date=2021-01-07}}</ref> [[Turki]] sebelumnya telah mengumumkan tingkat efikasi sebesar 91,25% dari analisis sementara terhadap 29 kasus yang didasarkan pada data dari 1.322 peserta dalam uji coba dengan 7.371 sukarelawan<ref name="reut_Piec">{{Cite web|last=Staff|first=Reuters|date=December 28, 2020|title=Piecemeal data releases threaten to undermine Sinovac's COVID-19 vaccine|url=https://www.reuters.com/article/health-coronavirus-sinovac/piecemeal-data-releases-threaten-to-undermine-sinovacs-covid-19-vaccine-idINKBN2920RT|access-date=January 11, 2021|agency=[[Reuters]]}}</ref><ref name="nyti_Turk">{{Cite web|last=Zimmer|first=Carl|last2=Londoño|first2=Ernesto|date=December 25, 2020|title=Turkey and Brazil Say Chinese Vaccine Effective, With Sparse Supporting Data|url=https://www.nytimes.com/2020/12/25/health/turkey-brazil-sinovac-coronavirus-vaccine.html|access-date=January 11, 2021|newspaper=[[The New York Times]]}}</ref><ref name=":0">{{Cite web|title=Turkish official says CoronaVac vaccine 91.25% effective|url=https://abcnews.go.com/Health/wireStory/turkish-official-coronavac-vaccine-9125-effective-74899577|website=ABC News|language=en|access-date=2020-12-26}}</ref><ref name=":8">{{Cite web|date=December 25, 2020|title=Turkey set to receive 'effective' COVID-19 vaccine amid calls for inoculation|url=https://www.dailysabah.com/turkey/turkey-set-to-receive-effective-covid-19-vaccine-amid-calls-for-inoculation/news|website=Daily Sabah|language=en|access-date=December 26, 2020}}</ref> dan Indonesia mengumumkan tingkat efikasi 65,3 % berdasarkan data dari 1.600 peserta dalam uji coba mereka.<ref name=":5">{{Cite web|last=hermesauto|date=2021-01-11|title=Indonesia grants emergency use approval to Sinovac's vaccine, local trials show 65% efficacy|url=https://www.straitstimes.com/asia/se-asia/indonesia-grants-emergency-use-approval-to-sinovac-vaccine-local-trials-show-65|website=The Straits Times|language=en|access-date=2021-01-11}}</ref>
== Teknologi dan efikasi klinis ==
Pada 7 Januari 2021, hasil dari uji coba tahap III di Brasil pada 13.000 relawan mengungkapkan bahwa vaksin 78% efektif dalam mencegah kasus gejala COVID-19 yang membutuhkan bantuan medis (tingkat 3 pada Skala Perkembangan Klinis WHO<ref name="MarshallMurthy2020">{{Cite journal|last=WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection|year=2020|title=A minimal common outcome measure set for COVID-19 clinical research|journal=The Lancet Infectious Diseases|volume=20|issue=8|pages=e192–e197|doi=10.1016/S1473-3099(20)30483-7}}</ref>) dan 100% efektif melawan infeksi sedang dan berat; efikasi secara keseluruhan, termasuk kasus asimtomatik dan kasus simtomatik yang tidak memerlukan bantuan medis (WHO skala 2) tidak dilaporkan.<ref name="JornaldaUSP">{{Cite news|last=Mariz|first=Fabiana|last2=Caires|first2=Luiza|date=2021-01-07|title=Eficaz em prevenir doença grave e morte por covid, Coronavac deve ter impacto em frear pandemia|url=https://jornal.usp.br/ciencias/eficaz-em-prevenir-doenca-grave-e-morte-por-covid-coronavac-deve-ter-impacto-em-frear-pandemia/|work=Jornal da USP|language=Portuguese|access-date=2021-01-07}}</ref> Dari 220 partisipan yang terinfeksi, 160 kasus berada pada kelompok [[plasebo]] dan 60 kasus pada kelompok yang menerima CoronaVac.<ref name=":22">{{Cite news|date=2021-01-07|title=Sinovac’s Covid Shot Proves 78% Effective in Brazil Trial|url=https://www.bloomberg.com/news/articles/2021-01-07/sinovac-covid-shot-78-effective-in-brazil-trial-folha-reports|work=Bloomberg.com|language=en|access-date=2021-01-07}}</ref>
Pada 24 Desember 2020, Turki merilis hasil uji klinis tahap III dari analisis sementara terhadap 29 kasus yang menunjukkan tingkat efikasi 91,25% yang hanya berdasarkan data dari 1.322 peserta dalam uji coba yang melibatkan 7.371 sukarelawan.<ref name=":02">{{Cite web|title=Turkish official says CoronaVac vaccine 91.25% effective|url=https://abcnews.go.com/Health/wireStory/turkish-official-coronavac-vaccine-9125-effective-74899577|website=ABC News|language=en|access-date=2020-12-26}}</ref><ref name=":82">{{Cite web|date=December 25, 2020|title=Turkey set to receive 'effective' COVID-19 vaccine amid calls for inoculation|url=https://www.dailysabah.com/turkey/turkey-set-to-receive-effective-covid-19-vaccine-amid-calls-for-inoculation/news|website=Daily Sabah|language=en|access-date=December 26, 2020}}</ref><ref name="reut_Piec2">{{Cite web|last=Staff|first=Reuters|date=December 28, 2020|title=Piecemeal data releases threaten to undermine Sinovac's COVID-19 vaccine|url=https://www.reuters.com/article/health-coronavirus-sinovac/piecemeal-data-releases-threaten-to-undermine-sinovacs-covid-19-vaccine-idINKBN2920RT|access-date=January 11, 2021|agency=[[Reuters]]}}</ref><ref name="nyti_Turk2">{{Cite web|last=Zimmer|first=Carl|last2=Londoño|first2=Ernesto|date=December 25, 2020|title=Turkey and Brazil Say Chinese Vaccine Effective, With Sparse Supporting Data|url=https://www.nytimes.com/2020/12/25/health/turkey-brazil-sinovac-coronavirus-vaccine.html|access-date=January 11, 2021|newspaper=[[The New York Times]]}}</ref>
Pada 11 Januari 2021, Indonesia merilis hasil uji klinis tahap III dari analisis sementara terhadap 25 kasus yang menunjukkan tingkat efikasi 65,3% berdasarkan data 1.600 peserta dalam uji coba.<ref name=":52">{{Cite web|last=hermesauto|date=2021-01-11|title=Indonesia grants emergency use approval to Sinovac's vaccine, local trials show 65% efficacy|url=https://www.straitstimes.com/asia/se-asia/indonesia-grants-emergency-use-approval-to-sinovac-vaccine-local-trials-show-65|website=The Straits Times|language=en|access-date=2021-01-11}}</ref>
CoronaVac tidak perlu dibekukan, dan baik vaksin maupun bahan mentah untuk merumuskan dosis baru dapat diangkut dan didinginkan pada {{Convert|2|-|8|C}}, seperti suhu penyimpanan vaksin flu.<ref>{{Cite web|date=2020-11-01|title=CoronaVac: Doses will come from China on nine flights and can...<!--sic-->|url=https://alkhaleejtoday.co/international/5246732/CoronaVac-Doses-will-come-from-China-on-nine-flights-and-can.html|website=AlKhaleej Today|language=ar|archive-url=https://web.archive.org/web/20201216072629/https://alkhaleejtoday.co/international/5246732/CoronaVac-Doses-will-come-from-China-on-nine-flights-and-can.html|archive-date=16 December 2020|access-date=2020-11-01|url-status=live}}</ref> CoronaVac dapat tetap stabil hingga tiga tahun dalam penyimpanan, yang mungkin memberikan beberapa keuntungan saat vaksin didistribusikan ke wilayah yang tidak memungkinkan rantai dingin dijaga dengan baik.<ref>{{Cite news|last=Staff|date=2020-09-07|title=China's Sinovac coronavirus vaccine candidate appears safe, slightly weaker in elderly|url=https://www.reuters.com/article/us-health-coronavirus-vaccine-sinovac-idUSKBN25Y1QM|work=Reuters|language=en|archive-url=https://web.archive.org/web/20201007191846/https://www.reuters.com/article/us-health-coronavirus-vaccine-sinovac-idUSKBN25Y1QM|archive-date=7 October 2020|access-date=2020-10-06|url-status=live}}</ref>
=== Penundaan berulang dalam merilis hasil dari Brasil ===
Informasi yang bertentangan dan tidak lengkap pada uji coba Brasil pada bulan Desember telah menciptakan kebingungan atas efikasi CoronaVac. Brasil menunda merilis data lengkap tentang CoronaVac pada akhir Desember dan hanya mengatakan bahwa efektivitas vaksin ini lebih dari 50%. Sekretaris Kesehatan São Paulo Jean Gorinchteyn kemudian mengatakan vaksin itu tidak mencapai efikasi 90%. Turki menambah kebingunan dengan mengatakan bahwa uji cobanya menunjukkan perkiraan tingkat efikasi 91,25%, meskipun hanya didasarkan pada 29 kasus.<ref name=":23">{{Cite news|date=2021-01-07|title=Sinovac’s Covid Shot Proves 78% Effective in Brazil Trial|url=https://www.bloomberg.com/news/articles/2021-01-07/sinovac-covid-shot-78-effective-in-brazil-trial-folha-reports|work=Bloomberg.com|language=en|access-date=2021-01-07}}</ref>
Rilis data yang lebih pasti tentang efikasi CoronaVac ditunda karena Sinovac perlu merekonsiliasi hasil uji coba yang berbeda menggunakan protokol yang berbeda.<ref name=":24">{{Cite news|date=2021-01-07|title=Sinovac’s Covid Shot Proves 78% Effective in Brazil Trial|url=https://www.bloomberg.com/news/articles/2021-01-07/sinovac-covid-shot-78-effective-in-brazil-trial-folha-reports|work=Bloomberg.com|language=en|access-date=2021-01-07}}</ref> Menurut Covas, kelompok di Brasil dianggap lebih rentan terhadap infeksi dan terpapar muatan virus yang lebih tinggi. Dalam uji coba fase III di Turki dan Indonesia, komposisi relawannya serupa dengan populasi umum.<ref>{{Cite web|date=2021-01-07|title=Coronavac tem eficácia de 78% contra a Covid-19 em estudo no Brasil|url=https://www1.folha.uol.com.br/equilibrioesaude/2021/01/coronavac-tem-eficacia-de-78-contra-a-covid-19-em-estudo-no-brasil.shtml|website=Folha de S.Paulo|language=pt-BR|access-date=2021-01-07}}</ref>
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