CoronaVac: Perbedaan antara revisi

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| DrugBank = DB15806
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'''CoronaVac''' adalah kandidat [[Vaksin COVID-19|vaksin COVID-19 yang]] dikembangkan oleh perusahaan biofarmasi Tiongkok, [[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> yang saat ini berlangsung di Brasil, Chili, Indonesia, dan Turki. CoronaVac menggunakan teknologi tradisionalserupa, yangtetapi serupalebih tradisional, dibandingkan dengan [[BBIBP-CorV]] dan [[BBV152]], vaksin virus inaktif COVID-19 lainnya yang juga 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[[Brasil]] 7mengumumkan Januaritingkat 2021efikasi CoronaVac sebesar 50,38% [[Institutopada Butantan]]12 dariJanuari [[Brasil]]2021 mengumumkanberdasarkan bahwadata vaksinlengkap inidari 78%uji efektifcoba pada kasus12.508 ringanpeserta; dantingkat 100efikasi ini hampir 30% efektiflebih melawanrendah infeksidari berathasil danyang sedangdiumumkan berdasarkansebelumnya 220dan kasushampir COVID-19tidak daricukup 13.000untuk sukarelawanmendapatkan tanpapersetujuan merincidari bagaimanaWHO tingkatdan efikasinya dihitungBrasil.<ref name=":2">{{Cite news|date=2021-01-07web|title=Sinovac’sVacina CovidCoronaVac Shottem Proveseficácia 78global de 50,38% Effectivenos intestes Brazilfeitos Trialno Brasil, diz Instituto Butantan|url=https://wwwg1.bloombergglobo.com/newssp/articlessao-paulo/noticia/2021-/01-07/sinovac12/vacina-covidcoronavac-shottem-78eficacia-effectiveglobal-inde-brazil504percent-trialnos-folhatestes-reportsfeitos-no-brasil-diz-instituto-butantan.ghtml|workwebsite=Bloomberg.comG1|language=enpt-br|access-date=2021-01-0712}}</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_Piecbloo_HowE">{{Cite web|last=StaffHong|first=ReutersJinshan|date=DecemberJanuary 2812, 20202021|title=PiecemealHow dataEffective releasesIs threatenChina's toSinovac undermineVaccine? Sinovac'sData COVID-19Confuse vaccineExperts|url=https://www.reutersbloomberg.com/articlenews/healtharticles/2021-coronavirus01-sinovac12/piecemealchina-datavaccine-releasesgoing-threatenglobal-towith-underminefour-sinovacsdifferent-covid-19efficacy-vaccine-idINKBN2920RTrates|access-date=January 1112, 2021|agency=[[ReutersBloomberg News]]}}</ref><ref name="nyti_Turkwsj._Chin">{{Cite web|last=ZimmerPearson|first=CarlSamantha|last2=LondoñoMagalhaes|first2=ErnestoLuciana|date=December12 25,January 20202021|title=TurkeyChinese andCovid-19 BrazilVaccine SayIs ChineseFar VaccineLess Effective, WithThan SparseInitially SupportingTouted Datain Brazil|url=https://www.nytimeswsj.com/2020articles/12/25/health/turkey-brazilchinas-sinovac-coronaviruscovid-19-vaccine.html-is-50-4-in-late-stage-brazil-trials-11610470581|access-date=12 January 11, 2021|newspaper=[[The NewWall YorkStreet TimesJournal]]}}</ref> [[Instituto Butantan]], penyelenggara uji coba, mengatakan angka yang lebih rendah disebabkan oleh standar penghitungan infeksi yang lebih ketat dibandingkan dengan pembuat vaksin lainnya.<ref name=":06">{{Cite web|title=TurkishWhy officialdid saysthe CoronaVacefficacy of China’s top vaccine 91.25drop from 78% effectiveto 50%?|url=https://abcnews.gofortune.com/Health2021/wireStory01/turkish-official-coronavac13/sinovac-vaccine-9125efficacy-effectiverate-74899577drop/|website=ABC NewsFortune|language=en|access-date=20202021-1201-2614}}</ref><ref name=":8">{{CiteSebelumnya, web|date=Decemberpada 25,7 2020|title=TurkeyJanuari set2021, to[[Instituto receiveButantan]] 'effective'mengumumkan COVID-19bahwa vaccinevaksin amidini calls78% forefektif inoculation|url=https://www.dailysabah.com/turkey/turkey-set-to-receive-effective-covid-19-vaccine-amid-calls-for-inoculation/news|website=Dailypada Sabah|language=en|access-date=Decemberkasus 26,ringan 2020}}</ref>dan sementara100% Indonesiaefektif mengumumkanmelawan tingkatinfeksi efikasiberat sebesardan 65,3%sedang berdasarkan data220 kasus COVID-19 dari 113.600000 pesertasukarelawan dalamtanpa ujimerinci cobabagaimana merekatingkat efikasinya dihitung.<ref name=":52">{{Cite web|last=hermesautonews|date=2021-01-1107|title=IndonesiaSinovac’s grantsCovid emergencyShot useProves approval78% toEffective Sinovac'sin vaccine,Brazil local trials show 65% efficacyTrial|url=https://www.straitstimesbloomberg.com/asianews/se-asiaarticles/indonesia2021-grants01-emergency07/sinovac-usecovid-approvalshot-to78-sinovaceffective-vaccinein-localbrazil-trialstrial-showfolha-65reports|websitework=The Straits TimesBloomberg.com|language=en|access-date=2021-01-1107}}</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> sementara Indonesia mengumumkan tingkat efikasi sebesar 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 ==
 
[[Berkas:CoronaVac.jpg|jmpl|Botol kosong CoronaVac]]
== 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>
CoronaVac adalah [[vaksin inaktif]] yang menggunakan teknologi serupa, tetapi lebih tradisional tradisional, dibandingkan dengan [[BBIBP-CorV]] dan [[BBV152]], vaksin virus inaktif COVID-19 lainnya yang juga sedang dalam uji coba tahap III.<ref name="bbc._Covi">{{Cite web|date=16 December 2020|title=Covid: What do we know about China's coronavirus vaccines?|url=https://www.bbc.com/news/world-asia-china-55212787|access-date=18 December 2020|agency=[[BBC News]]}}</ref><ref name="tech">{{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> 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>
 
== Efikasi ==
[[Berkas:CoronaVac.jpg|jmpl|Botol kosong CoronaVac]]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 ===