Soberana 02
{{short description|Vaccine against COVID-19}}
{{Use dmy dates|date=August 2021}}
{{Infobox drug
| type = vaccine
| target = SARS-CoV-2
| vaccine_type = conjugate
| tradename = Pasteur
| image = Soberana 02 vaccine logo.png
| caption =
| image2 = Soberana 02 vaccine vial.png
| legal_status = Full and emergency authorizations
Full list of Soberana 02 authorizations
| routes_of_administration = Intramuscular
| synonyms = FINLAY-FR-2
Pasteurcovac, Pasto Covac, پاستوکووک
| caption2 = A vial of Soberana 02
| DrugBank = DB16524
| CAS_number = 2543416-58-4
}}
{{COVID-19 pandemic sidebar}}
Soberana 02 or Soberana 2, technical name FINLAY-FR-2, is a COVID-19 vaccine produced by the Finlay Institute, a Cuban epidemiological research institute. The vaccine is known as PastoCovac ({{langx|fa|پاستوکووک}}) in Iran, where it has been developed in collaboration with the Pasteur Institute of Iran.{{cite journal | vauthors = Mallapaty S | title = Iran hopes to defeat COVID with home-grown crop of vaccines | journal = Nature | volume = 596 | issue = 7873 | page = 475 | date = August 2021 | pmid = 34404947 | doi = 10.1038/d41586-021-02216-z | s2cid = 237198729 | doi-access = free | bibcode = 2021Natur.596..475M }}{{cite web |url=https://www.pasteurcovac.ir/ |title=PasteurCovac |publisher=Pasteur Institute of Iran |access-date=31 January 2022 |archive-date=17 January 2022 |archive-url=https://web.archive.org/web/20220117041401/https://www.pasteurcovac.ir/ }}{{Cite web|date=2021-04-26|title=Iran-Cuba vaccine enters phase three clinical trials|url=https://www.tehrantimes.com/news/460275/Iran-Cuba-vaccine-enters-phase-three-clinical-trials|access-date=2021-09-07|website=Tehran Times|language=en}}
It is a conjugate vaccine that requires two doses, the second one being administered 28 days after the first shot.{{cite journal | vauthors = Gorry C | title = SOBERANA, Cuba's COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD | journal = MEDICC Review | volume = 22 | issue = 4 | pages = 10–15 | date = October 2020 | pmid = 33295312 | doi = 10.37757/mr2020.v22.n4.11 | s2cid = 228079254 | doi-access = free }} A third (booster) dose of Soberana Plus may also be given on day 56. It has received emergency use authorization in Iran in June 2021, and in Cuba in August 2021, where it has also been approved for children above 2 years old.{{cite journal | vauthors = Hotez PJ, Bottazzi ME | title = Whole Inactivated Virus and Protein-Based COVID-19 Vaccines | journal = Annual Review of Medicine | volume = 73 | issue = 1 | pages = 55–64 | date = January 2022 | pmid = 34637324 | doi = 10.1146/annurev-med-042420-113212 | s2cid = 238747462 | doi-access = free }}
The name of the vaccine, Soberana, is a Spanish word that means "sovereign".{{cite web|date=12 January 2021|title=Iran, Cuba, Under U.S. Sanctions, Team Up for Covid-19 Vaccine Trials|url=https://www.wsj.com/articles/iran-cuba-under-u-s-sanctions-team-up-for-covid-19-vaccine-trials-11610481712|website=The Wall Street Journal|vauthors=Rasmussen SE, Eqbali A}} It followed a previous candidate vaccine called SOBERANA-01 (FINLAY-FR-1).
Medical uses
The vaccine requires two doses, the second one being administered four weeks after the first shot.{{Cite web|title=Draft landscape and tracker of COVID-19 candidate vaccines|url=https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines|access-date=2021-02-04|website=www.who.int|publisher=World Health Organization|language=en}}{{Cite web|title=SOBERANA 02-FaseIII|url=https://rpcec.sld.cu/trials/RPCEC00000354-En|access-date=2021-09-09}} A third (boost) dose of Soberana Plus may also be given on eight weeks.
= Efficacy =
The interim results of a Phase III trial in Cuba has shown an efficacy of 71.1% after only two doses, increasing to 92.4% after adding a dose of Soberana Plus.{{Cite medRxiv |vauthors=Toledo-Romani ME |title=Efficacy and safety of SOBERANA 02, a COVID-19 conjugate vaccine in heterologous three-dose combination |date=6 November 2021 |medrxiv=10.1101/2021.10.31.21265703v2}} The trial was undertaken while the delta variant was gradually taking over from beta in Havana.
The interim results of the Phase III trial in Iran show that the efficacy of a two-dose regimen is 51.31% against symptomatic disease, 78.35% against severe disease, and 76.78% against hospitalization. A third dose of Soberana Plus increases the efficacy against symptomatic disease to 70.58%, 83.52% against severe disease, and 91.76% against hospitalization. 89% of the cases in the Iranian trial were identified as having the delta strain.
The final results of the Phase III trials in Cuba show an efficacy against symptomatic disease of 71.0% against the beta and delta strains, while a third dose of Soberana Plus increased the efficacy up to 92.4%. Efficacy against severe disease and death is 100% for the heterologous three-dose regimen.
The final results of the Phase III trial in Iran show an efficacy of 67% against symptomatic disease and 96.5% against severe disease and hospitalization for a heterologous three-dose regimen.{{Cite web|last=طاهره نبی الهی قهفرخی|date=2021-11-21|title=نتایج مطالعات ۶ واکسن ایرانی کرونا ارایه شد|url=https://www.irna.ir/news/84550239/نتایج-مطالعات-۶-واکسن-ایرانی-کرونا-ارایه-شد|access-date=2021-11-23|website=ایرنا|language=fa}}{{Cite web|last=جبارپور|first=عبدالکریم|date=2021-12-02|title=پاستوکووک ۹۶.۵ درصد از بستری و ابتلای شدید به کرونا پیشگیری می‌کند|url=https://www.irna.ir/news/84561525/پاستوکووک-۹۶-۵-درصد-از-بستری-و-ابتلای-شدید-به-کرونا-پیشگیری-می-کند|access-date=2021-12-09|website=IRNA|language=fa}} No deaths were observed in the trial group that received the three-dose regimen.{{Cite web|date=2021-11-21|title=توضیحاتی درباره اثربخشی واکسن پاستوکووک/ عوارض پس از تزریق پاستوکووک|url=https://www.isna.ir/news/1400083023713/توضیحاتی-درباره-اثربخشی-واکسن-پاستوکووک-عوارض-پس-از-تزریق-پاستوکووک|access-date=2021-11-23|website=ایسنا|language=fa}} Unlike the Phase III trials in Cuba, the majority of cases throughout the entire trial were of the delta strain (more than 90% at the time of vaccine evaluation).{{Cite web |date=2021-11-20|title=واکسن پاستوکووک ۹۵ درصد از موارد شدید و بستری کرونا پیشگیری می‌کند|url=https://www.bultannews.com/fa/news/752681|publisher=Bultan News|access-date=2021-11-23|website=fa|language=fa}}
A 2021 multicentre, randomised, double-blind, placebo-controlled, phase III trial of Soberana 02 showed acceptable vaccine efficacy against symptomatic COVID-19 and COVID-19–related severe infections. The trial was conducted in Iran and, for a 2-dose treatment, showed an efficacy of 49.7% against symptomatic disease, 76.8% against severe disease and 77.7% against hospitalisation. When a third dose of Soberana Plus was added to the treatment, the efficacy improved to 64.9% for prevention of symptomatic disease, 96.6% for prevention of severe disease, and 96.6% for prevention of hospitalisation.{{cite journal | vauthors = Mostafavi E, Eybpoosh S, Karamouzian M, Khalili M, Haji-Maghsoudi S, Salehi-Vaziri M, Khamesipour A, Jalali T, Nakhaeizadeh M, Sharifi H, Mansoori Y, Keramat F, Ghodrati S, Javanian M, Doroud D, Omrani MD, Asadi H, Pouriayevali MH, Ghasemian R, Farshidi H, Pourahmad M, Ghasemzadeh I, Mounesan L, Darvishian M, Mirjalili MR, Toledo-Romani ME, Valenzuela-Silva C, Verez-Bencomo V, Gouya MM, Emadi-Koochak H, Haghdoost AA, Biglari A | display-authors = 6 | title = Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial | journal = JAMA Network Open | volume = 6 | issue = 5 | pages = e2310302 | date = May 2023 | pmid = 37133864 | pmc = 10157429 | doi = 10.1001/jamanetworkopen.2023.10302 | publisher = JAMA network | s2cid = 258461748 }}
Pharmacology
FINLAY-FR-2 is a conjugate vaccine. It consists of the receptor binding domain of the SARS-CoV-2 spike protein conjugated chemically to tetanus toxoid.
Professor Ihosvany Castellanos Santos said that the antigen is safe because it contains parts instead of the whole live virus, and therefore it does not require extra refrigeration, like other candidates in the world.{{cite journal|vauthors=Santos IC|date=January 2021|title=Rapid response to: Covid 19: Hope is being eclipsed by deep frustration|journal=BMJ|volume=372|page=n171|doi=10.1136/bmj.n171|doi-access=free}}
Manufacturing
The spike protein subunit is produced in Chinese hamster ovary cell culture.{{cite journal | vauthors = Malik JA, Mulla AH, Farooqi T, Pottoo FH, Anwar S, Rengasamy KR | title = Targets and strategies for vaccine development against SARS-CoV-2 | journal = Biomedicine & Pharmacotherapy | volume = 137 | page = 111254 | date = May 2021 | pmid = 33550049 | pmc = 7843096 | doi = 10.1016/j.biopha.2021.111254 }} In the ACS Chemical Biology article, scientists from Cuba explain details of the vaccines technology and production.{{cite journal | vauthors = Valdes-Balbin Y, Santana-Mederos D, Quintero L, Fernández S, Rodriguez L, Sanchez Ramirez B, Perez-Nicado R, Acosta C, Méndez Y, Ricardo MG, Hernandez T, Bergado G, Pi F, Valdes A, Carmenate T, Ramirez U, Oliva R, Soubal JP, Garrido R, Cardoso F, Landys M, Gonzalez H, Farinas M, Enriquez J, Noa E, Suarez A, Fang C, Espinosa LA, Ramos Y, González LJ, Climent Y, Rojas G, Relova-Hernández E, Cabrera Infante Y, Losada SL, Boggiano T, Ojito E, León K, Chiodo F, Paquet F, Chen GW, Rivera DG, Garcia-Rivera D, Verez Bencomo V | display-authors = 6 | title = SARS-CoV-2 RBD-Tetanus Toxoid Conjugate Vaccine Induces a Strong Neutralizing Immunity in Preclinical Studies | journal = ACS Chemical Biology | volume = 16 | issue = 7 | pages = 1223–1233 | date = July 2021 | pmid = 34219448 | doi = 10.1021/acschembio.1c00272 | s2cid = 235734990 | url = https://hal.archives-ouvertes.fr/hal-03443835/file/2021.02.08.430146v2.full.pdf }}
{{infobox
| image = {{Graph:Map|scale=50|defaultValue=gainsboro
|CU=blueviolet
|IR=blueviolet
|GH=yellow
|AR=yellow
}}
| caption = {{leftlegend|blueviolet|Production}}
{{leftlegend|dodgerblue|Deliveries}}
{{leftlegend|green |Planned Production}}
{{leftlegend|yellow|Potential Production }}
}}
;Production
- Cuba{{Cite web| vauthors = Melimopoulos E |title=Is Cuba closing in on COVID vaccine sovereignty?|url=https://www.aljazeera.com/news/2021/4/29/cuba-is-closing-in-on-covid-19-vaccine-sovereignty|access-date=2021-05-07|website=www.aljazeera.com|language=en}}{{Cite news|date=2021-02-16|title=Optimism as Cuba set to test its own Covid vaccine|language=en-GB|work=BBC News|url=https://www.bbc.com/news/world-latin-america-56069577|access-date=2021-05-07}}
- Iran (under name of PasteurCoVac)
;Potential Production
- Ghana
- Argentina
= In Cuba =
The Cuban government says it is planning to produce 100 million doses of its vaccine to respond to its own demand and that of other countries.{{cite web|url=https://www.nodal.am/2021/01/cuba-producira-100-millones-de-dosis-de-su-vacuna-soberana-02/|language=es|title=Cuba espera fabricar 100 millones de dosis de su candidato vacunal Soberana 02|website=Nodal|date=21 January 2021}}{{cite web|url=https://www.dire.it/21-01-2021/596443-vaccino-cuba-pronta-a-produrre-100-milioni-di-dosi-di-soberana-02/|language=it|website=Dire|date=21 January 2021|title=Vaccino, Cuba pronta a produrre 100 milioni di dosi di 'Soberana 02'}} Cuba has also suggested that, once it's approved, it will offer the vaccine to tourists visiting the country.{{cite web|url=https://brazilian.report/coronavirus-brazil-live-blog/2021/02/04/tourists-will-be-able-to-vaccinate-against-covid-19-in-cuba/|website=Brazilian Report|title=Cuba to offer coronavirus vaccines to tourists|date=4 February 2021|vauthors=Ribeiro G|access-date=8 February 2021|archive-date=4 February 2021|archive-url=https://web.archive.org/web/20210204194858/https://brazilian.report/coronavirus-brazil-live-blog/2021/02/04/tourists-will-be-able-to-vaccinate-against-covid-19-in-cuba/|url-status=dead}}{{cite web|date=23 February 2021|title='Sun, sea, sand and Soberana 02': Cuba open to inoculating tourists with homegrown Covid vaccine|url=https://www.cnbc.com/2021/02/23/soberana-02-cubas-covid-vaccine-could-be-made-eligible-for-tourists.html|website=CNBC|vauthors=Meredith S}}
The production of the first batch of about 100,000 doses will start in April.{{cite web|url=https://www.dw.com/es/coronavirus-vacuna-cubana-soberana-02-alista-fase-3-y-ensayos/a-56477155|website=Deutsche Welle|title=Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos|language=es|date=5 February 2021|quote=Las expectativas sobre Soberana 02 son tales que el titular del organismo estatal que desarrolló la vacuna, Vicente Vérez, confirmó que mientras se aguarden los resultados de la Fase 3 solo en La Habana, en abril se dará inicio a la producción del primer lote, de alrededor de 100 mil dosis.}} José Moya, representative of the World Health Organization and the Pan American Health Organization (PAHO) in Cuba, suggested that after the vaccine passes all clinical stages, it could be included as part of PAHO's Revolving Fund.{{cite web|url=https://www.jornada.com.mx/notas/2021/02/07/politica/cuba-anuncia-fase-3-de-la-vacuna-soberana-02/|title=Cuba anuncia fase 3 de la vacuna Soberana 02|language=es|website=La Jornada|date=7 February 2021|quote=Una vez que superen las etapas clínicas, la OMS podría contar con el fármaco cubano, afirmó Moya, y "pasar a ser parte del grupo de vacunas que se oferten a través del Fondo Rotatorio", un mecanismo que desde hace cuatro décadas permite gestionar antígenos e insumos a los países de las Américas.}}
The roll-out began with an "Interventional Trial"{{Cite web|title=SOBERANA – INTERVENTION {{!}} Registro Público Cubano de Ensayos Clínicos|url=https://rpcec.sld.cu/en/trials/RPCEC00000360-En|access-date=2021-04-11|website=rpcec.sld.cu}} that consisted of inoculating 150,000 at-risk participants which seems to be defined as health-care workers.{{Cite web|title=Cuba says it's 'betting it safe' with its own Covid vaccine|url=https://www.nbcnews.com/news/latino/cuba-says-betting-safe-covid-vaccine-rcna643|access-date=2021-04-11|website=NBC News|date=10 April 2021 |language=en}}{{Cite web|title=Cuba begins testing 2nd COVID-19 vaccine on health care workers|url=https://medicalxpress.com/news/2021-03-cuba-2nd-covid-vaccine-health.html|access-date=2021-04-11|website=medicalxpress.com|language=en}} On April 11, 2021, the Ministry of Public Health of Cuba announced that 75,000 health-care workers were inoculated with their first dose of either of the two Cuba's Phase III vaccines (the other being Abdala).{{Cite web|last=Ministry of Public Health of Cuba|date=11 April 2021|title=[Translated] "The administration of the 1st dose of the Cuban vaccine candidates #Soberana02 and #Abdala to the 75 thousand health workers and Biocubafarma who are part of the intervention study taking place in #LaHabana has concluded."|url=https://twitter.com/minsapcuba/status/1381064729217671175|access-date=2021-04-11|website=Twitter|language=en}}{{Cite web|title=Cuban scientists, health workers received first anti-Covid-19 dose|url=http://www.plenglish.com/index.php?o=rn&id=66247&SEO=cuban-scientists-health-workers-received-first-anti-covid-19-dose|access-date=2021-04-11|website=www.plenglish.com/index.php?o=rn&id=66247&SEO=cuban-scientists-health-workers-received-first-anti-covid-19-dose|language=es-ES}}
By April 2022, Cuba inoculated 9.9 million of its 11.2 million residents, 6.4 million have received booster doses. The vaccine campaign using domestic products was heralded as a huge success by Cuban President Miguel Diaz-Canel when case loads were down significantly since January 2022. The Soberana vaccine preparations were particularly effective in children, preventing 70,000 pediatric cases before the Omicron wave hit.[https://www.plenglish.com/news/2022/04/13/diaz-canel-underscores-success-of-covid-19-vaccination-among-children/ "Diaz-Canel underscores success of Covid-19 vaccination among children"] {{Webarchive|url=https://web.archive.org/web/20220413183859/https://www.plenglish.com/news/2022/04/13/diaz-canel-underscores-success-of-covid-19-vaccination-among-children/ |date=13 April 2022 }}. Prensa Latina. Retrieved 17 April 2022.[https://english.news.cn/20220411/98fa6fa0656b438490aa421c84708e95/c.html "Cuba reports lower numbers of COVID-19 cases, deaths"] Xinhua. Retrieved April 17 2022.
= Outside Cuba =
Vietnam, Iran, Venezuela, Argentina,{{Cite web|title=Ilarregui (Embajador en Cuba): "Durante Este Año Podremos Tener Vacunas Cubanas en Argentina" | trans-title = Ilarregui (Ambassador to Cuba): "During this year we will be able to have Cuban vaccines in Argentina" |url=https://radiocut.fm/audiocut/ilarregui-embajador-en-cuba-durante-este-ano-podremos-tener-vacunas-cubanas-en-argentina/|access-date=2021-05-07|website=RadioCut|language=es}}{{Cite web |title=Argentina comenzó a negociar con Cuba la vacuna Soberana | trans-title = Argentina began negotiating the Soberana vaccine with Cuba |url=https://www.cadena3.com/noticia/internacionales/argentina-comenzo-a-negociar-con-cuba-la-vacuna-soberana_291435|access-date=2021-05-07|website=Cadena 3 Argentina|language=es}}{{Cite web |title=Sin definiciones sobre cuándo podrían llegar, el Gobierno avanza para conseguir las vacunas Soberana y Abdala de Cuba|url=https://www.infobae.com/politica/2021/05/07/sin-definiciones-sobre-cuando-podrian-llegar-el-gobierno-avanza-para-conseguir-las-vacunas-soberana-y-abdala-de-cuba/|access-date=2021-05-07|website=infobae|date=7 May 2021 |language=es-ES}} Pakistan, India, the African Union, Jamaica, and Suriname{{Cite web |date=2021-04-09|title=Cuba's COVID-19 Vaccines Being Sought After by CARICOM Countries|url=https://www.caribbeannationalweekly.com/caribbean-breaking-news-featured/cuba-covid-19-vaccines/|access-date=2021-05-07|website=Caribbean News|language=en}} have expressed interest in purchasing the vaccine, following Phase 3 results.{{Cite web| vauthors = Guenot M |date=2021-02-15 |title=Cuba is working on a homegrown COVID-19 vaccine program. It has a history of fighting disease without help from the West |url=https://www.businessinsider.fr/us/cuba-homegrown-vaccine-program-pressing-on-without-the-west-2021-2?IR=T|access-date=2021-05-07|website=Business Insider France|language=fr}}{{Cite web |date=2021-01-22|title=Soberana 02: Cuba prepara cien millones de dosis de la vacuna contra el coronavirus {{!}} "No somos una multinacional. Nuestro fin es crear salud", dijo el director del Instituto Finlay de Vacunas | trans-title = Soberana 02: Cuba prepares one hundred million doses of the coronavirus vaccine {{!}} "We are not a multinational. Our goal is to create health," said the director of the Finlay Vaccine Institute | language = es |url=https://www.pagina12.com.ar/318881-soberana-02-cuba-prepara-cien-millones-de-dosis-de-la-vacuna|access-date=2021-05-07|website=PAGINA12}}
Iran has signed an agreement to manufacture the vaccine{{Cite web|date=2021-04-18|title=Cuban coronavirus vaccine to start third clinical trial phase in Iran|url=https://www.tehrantimes.com/news/459979/Cuban-coronavirus-vaccine-to-start-third-clinical-trial-phase|access-date=2021-05-07|website=Tehran Times|language=en}} and Argentina is negotiating one. Additionally, the Cuban government offered a "transfer of technology" to Ghana and will also supply "active materials" needed to make the vaccine.{{Cite web|title=CEO of FDA Discusses Production of Covid-19 Vaccine With Cuban Ambassador|url=http://www.fdaghana.gov.gh/news-media.php?page=72|access-date=2021-05-05|website=www.fdaghana.gov.gh|language=en|archive-date=28 June 2021|archive-url=https://web.archive.org/web/20210628003544/http://www.fdaghana.gov.gh/news-media.php?page=72|url-status=dead}}{{Cite web|title=Cuba To Transfer COVID-19 Vaccine Technology To Ghana|url=https://www.gnbcc.net/News/Item/5198|access-date=2021-05-05|website=www.gnbcc.net}}{{cite web|date=16 February 2021|title=Cuban government offers to transfer COVID-19 Soberana 02 vaccine technology to Ghana|url=https://riotimesonline.com/brazil-news/mercosur/mercosur-latin-america-caribbean/cuban-government-offers-to-transfer-covid-19-soberana-02-vaccine-technology-to-ghana/|website=Rio Times Online}}
While the price is currently unknown, the commercialization strategy of the vaccine will be a combination of the "impact on health" and the capability of Cuba's system to financially support "the production of vaccines and drugs for the country", per the director of the Finlay Institute, Vicente Vérez.{{Cite web|date=2021-01-21|title=Coronavirus: Cuba will produce 100 million doses of its Soberana 02 vaccine|url=https://oncubanews.com/en/cuba/coronavirus-cuba-will-produce-100-million-doses-of-its-soberana-02-vaccine/|access-date=2021-05-07|website=OnCubaNews English|language=en-US}}
Up to 27 November 2021, 8 millions doses of Pasteurcovac have been produced in Iran.{{Cite web|date=2021-11-27|title=تولید ۸ میلیون دز واکسن "پاستوکووک"؛ تاکنون / زمان تزریق دز سوم این واکسن|url=https://www.isna.ir/news/1400090302121/تولید-۸-میلیون-دز-واکسن-پاستوکووک-تاکنون-زمان-تزریق-دز-سوم|access-date=2021-11-27|website=ایسنا|language=fa}}
Clinical trials
| class="wikitable sortable mw-collapsible"
|+SOBERANA vaccine family clinical trials ! colspan="3" |Registration ! rowspan="2" |Group ! rowspan="2" |Participants ! rowspan="2" |Phase |
| Date
!ID !Title |
|---|
| 2020-08-13
|[https://rpcec.sld.cu/en/trials/RPCEC00000332-En RPCEC00000332] |SOBERANA 01 |
|676 |I/II |
| 2020-10-17
|[https://rpcec.sld.cu/en/trials/RPCEC00000338-En RPCEC00000338] |SOBERANA 01A |
|60 |I |
| 2020-10-27
|[https://rpcec.sld.cu/en/trials/RPCEC00000340-En RPCEC00000340] |SOBERANA 02 |
|40 |I |
| rowspan="2" |2020-12-17
| rowspan="2" |[https://rpcec.sld.cu/en/trials/RPCEC00000347-En RPCEC00000347] | rowspan="2" |SOBERANA 02A |
|100 |IIa |
* two doses batch 1 FINLAY-FR-2 + booster FINLAY-FR-1A
|810 |IIb |
| 2021-01-05
|[https://rpcec.sld.cu/en/trials/RPCEC00000349-En RPCEC00000349] |SOBERANA 01B |
|30 |I |
| 2021-03-03
|[https://rpcec.sld.cu/trials/RPCEC00000354-En RPCEC00000354] |SOBERANA 02-FaseIII |
|44,010 |III |
| 2021-03-19
|[https://rpcec.sld.cu/en/trials/RPCEC00000360-En RPCEC00000360] |SOBERANA - INTERVENTION |
|150,000 | |
| rowspan="2" |2021-04-09
| rowspan="2" |[https://rpcec.sld.cu/trials/RPCEC00000366-En RPCEC00000366] | rowspan="2" |SOBERANA PLUS |
|20 |IIa |
* 1-dose FINLAY-FR-1A
|430 |IIb |
| 2021-04-24
|[https://www.irct.ir/trial/54833 IRCT20210303050558N1] |Phase III in Iran |
|24,000 |III |
| 2021-06-10
|[https://rpcec.sld.cu/en/trials/RPCEC00000374-En RPCEC00000374] |SOBERANA PEDIATRIA |
|350 |I/II |
= Phase I =
FINLAY-FR-2, which started being developed in October 2020, had 40 volunteers for its Phase I, according to the Cuban Public Registry of Clinical Trials, with an open, sequential and adaptive study to assess safety, reactogenicity and explore immunogenicity of the vaccine.{{Cite web|url=https://rpcec.sld.cu/en/trials/RPCEC00000340-En|title=SOBERANA 02 {{!}} Registro Público Cubano de Ensayos Clínicos|access-date=24 January 2021| work = Cuban Registry of Clinical Trials |language=es}}
= Phase II =
Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years.{{Cite Q|Q105047566}}{{Cite web|url=https://www.france24.com/es/minuto-a-minuto/20210121-cuba-apuesta-por-crear-primera-vacuna-de-américa-latina-contra-el-covid-19|title=Cuba apuesta por crear primera vacuna de América Latina contra el covid-19|date=2021-01-21|access-date=24 January 2021|website=France 24|language=es}} Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days.{{Cite web|url=https://oncubanews.com/en/cuba/cuba-negotiates-with-other-countries-to-develop-phase-3-of-soberana-02-vaccine/|title=Cuba negotiates with other countries to develop phase 3 of Soberana 02 vaccine|date=2020-12-30|access-date=24 January 2021|website=OnCubaNews English|language=en-US}} The second phase has been supervised by Iranian officials from the Pasteur Institute.
= Phase III =
File:Así es la tercera fase de Soberana 02 - snap.png
Phase III commenced at the beginning of March as originally scheduled,{{cite web|url=https://news.abs-cbn.com/overseas/03/05/21/cuban-developed-vaccine-enters-phase-iii-trial|title=Cuban-developed vaccine enters Phase III trial|website=ABS CBN|date=5 March 2021}}{{cite web|url=https://www.dw.com/es/coronavirus-vacuna-cubana-soberana-02-alista-fase-3-y-ensayos/a-56477155|website=Deutsche Welle|title=Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos|language=es|date=5 February 2021}} and "ready to publish" results are expected by June.{{cite journal | vauthors = Mega ER | title = Can Cuba beat COVID with its homegrown vaccines? | journal = Nature | date = April 2021 | pmid = 33927405 | doi = 10.1038/d41586-021-01126-4 | s2cid = 233458503 }}{{Cite web|date=2021-03-23|title=Cuban Vaccine Ready in July. Interview with the Cuban Ambassador to the Czech Republic|url=https://www.pressenza.com/2021/03/cuban-vaccine-ready-in-july-interview-with-the-cuban-ambassador-to-the-czech-republic/|access-date=2021-04-29|website=Pressenza|language=en}}{{Cite news| vauthors = Augustin E |date=2021-05-12|title=Cuba deploys unproven homegrown vaccines, hoping to slow an exploding virus outbreak.|language=en-US|work=The New York Times|url=https://www.nytimes.com/2021/05/12/world/cuba-vaccine.html|access-date=2021-05-14|issn=0362-4331}} The trial volunteers are divided into three groups: some will receive two doses of the vaccine 28 days apart, another group will get two doses plus a third immune booster (Soberana Plus{{Cite web|title=L'esempio cubano sui vaccini|url=https://www.ilfoglio.it/salute/2021/05/07/news/l-esempio-cubano-sui-vaccini-2333854/|access-date=2021-05-07|website=www.ilfoglio.it|language=it}}{{Citation|title=Avances de las vacunas cubanas contra la COVID-19| date=29 April 2021 |url=https://www.youtube.com/watch?v=mT4Gg_7PczQ|language=en|access-date=2021-05-07}}), and the third a placebo.
Although the trials involve thousands of adult volunteers recruited in Havana,{{Cite web| vauthors = Yaffe H |title=Cuba's five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa|url=https://blogs.lse.ac.uk/latamcaribbean/2021/03/31/cubas-five-covid-19-vaccines-the-full-story-on-soberana-01-02-plus-abdala-and-mambisa|access-date=2021-03-31|website=LSE Latin America and Caribbean blog|date=31 March 2021|language=en-UK}} Cuba's public health officials have said that they will also need to conduct phase III trials abroad because the island doesn't have an outbreak of sufficient scale to produce meaningful statistics on vaccine protection.
On March 13, 2021, the Cuban Biotechnology and Pharmaceutical Industries Business Group (BioCubaFarma) announced on social media that it had sent 100,000 doses of its Soberana 02 coronavirus vaccine candidate to the Pasteur Institute of Iran for clinical testing, "as part of the collaboration with other countries in the development of COVID-19 vaccines."[https://oncubanews.com/en/cuba/science-cuba/cuba-sends-100000-doses-of-the-soberana-02-vaccine-candidate-to-iran/ "Cuba sends 100,000 doses of the Soberana 02 vaccine candidate to Iran"] oncubanews.com. Retrieved 19 March 2021.
On April 26, 2021, it was reported that a Phase III conducted by the Pasteur Institute of Iran was approved to be started in Iran{{Cite web|date=2021-04-26|title=Iran-Cuba vaccine enters phase three clinical trials|url=https://www.tehrantimes.com/news/460275/Iran-Cuba-vaccine-enters-phase-three-clinical-trials|access-date=2021-04-28|website=Tehran Times|language=en}}{{Cite web|date=2021-04-18|title=Cuban coronavirus vaccine to start third clinical trial phase in Iran|url=https://www.tehrantimes.com/news/459979/Cuban-coronavirus-vaccine-to-start-third-clinical-trial-phase|access-date=2021-04-28|website=Tehran Times|language=en}}{{Cite web|title=América Latina apura una vacuna propia. Cuba, adelante; México avanza. Pero no son los únicos|url=https://www.poresto.net/opinion/2021/4/27/america-latina-apura-una-vacuna-propia-cuba-adelantemexico-avanza-pero-no-son-los-unicos-250356.html|access-date=2021-04-28|website=www.poresto.net|date=27 April 2021 |language=spanish}} It was previously reported that the Institute will host Phase 3, but the pre-requisites were "technology transfer and joint production".{{Cite news|date=2021-01-09|title=Cuba to collaborate with Iran on coronavirus vaccine|language=en|work=Reuters|url=https://www.reuters.com/article/uk-health-coronavirus-cuba-iran-idUSKBN29E0JO|access-date=2021-01-24|vauthors=Marsh S}}
The Phase III trial in Iran has been conducted on 24,000 adults, aged between 18 and 80 years old in 8 cities.{{Cite web|title=IRCT {{!}} Efficacy, safety, and immunogenicity of Soberana recombinant vaccine (product of Finlay Institute) based on RBD protein subunit of Sars-Cov-2 in a 2-dose regimen with and without a booster dose: a double-blind, randomized, placebo-controlled phase III clinical trial in the Iranian population of 18-80 years|url=https://en.irct.ir/trial/54833|access-date=2021-09-07|website=en.irct.ir|archive-date=7 September 2021|archive-url=https://web.archive.org/web/20210907170221/https://en.irct.ir/trial/54833|url-status=dead}} The interim results of the Phase III trial in Iran show that the efficacy of a two-dose regimen is 51.31% against symptomatic disease, 78.35% against severe disease, and 76.78% against hospitalization.{{Cite web|date=October 9, 2021|title=اثربخشی واکسن پاستور در پیشگیری از بستری کرونایی ۹۲ درصد است + جزئیات| trans-title = Pasteur vaccine is 92% effective in preventing coronary hospitalization + details | url=https://www.tasnimnews.com/fa/news/1400/07/17/2586231/اثربخشی-واکسن-پاستور-در-پیشگیری-از-بستری-کرونایی-92-درصد-است-جزئیات|access-date=2021-11-02|website=خبرگزاری تسنیم {{!}} Tasnim News Agency|language=fa}}{{Cite web|date=2021-10-09|title=کاهش حدود ۶۰ درصدی اثربخشی "فایزر" مقابل "دلتا" / جزییات ایمنی‌زایی واکسن "پاستوکووک" | trans-title = About 60% reduction in Pfizer efficacy against Delta / Immunogenicity details of Pastococcus vaccine |url=https://www.isna.ir/news/1400071711103/کاهش-حدود-۶۰-درصدی-اثربخشی-فایزر-مقابل-دلتا-جزییات-ایمنی-زایی|access-date=2021-11-02|website=ایسنا|language=fa}} A third dose of Soberana Plus increases the efficacy against symptomatic disease to 70.58%, 83.52% against severe disease, and 91.76% against hospitalization. The study was conducted when the delta variant was predominant in the country, with 89% of the cases in the Iranian trial identified as having the delta strain. Given the limited number of reported deaths in the trial, it was virtually impossible to analyze efficacy against death for both the two and three dose regimens.
Mexico plans to host a phase 3 trial.{{Cite news|date=2021-02-14|title=Mexico Hopes to Work With Cuba on Covid Vaccine Phase 3 Trial|language=en|work=Bloomberg.com|url=https://www.bloomberg.com/news/articles/2021-02-14/mexico-hopes-to-work-with-cuba-on-covid-vaccine-phase-3-trial|access-date=2021-05-07}}
The final results of the Phase III trials in Cuba show an efficacy against symptomatic disease of 71.0% against the beta and delta strains, while a third dose of Soberana Plus increased the efficacy up to 92.4%. Efficacy against severe disease and death is 100% for the heterologous three-dose regimen.
The final results of the Phase III trial in Iran show an efficacy of 67% against symptomatic disease and 96.5% against severe disease and hospitalization for a heterologous three-dose regimen. No deaths were observed in the trial group that received the three-dose regimen. Unlike the Phase III trials in Cuba, the majority of cases throughout the entire trial were of the delta strain (more than 90% at the time of vaccine evaluation).
= Children and adolescents trials =
In June 2021, Soberana started clinical trials for children and adolescents aged 3–18 from Phase I/II.{{Cite web|url=https://rpcec.sld.cu/en/trials/RPCEC00000374-En|title=SOBERANA PEDIATRIA|access-date=12 August 2021| work = Cuban Registry of Clinical Trials }}{{Cite web|url=https://rpcec.sld.cu/en/trials/RPCEC00000384-En|title=SOBERANA PEDIATRIA CLINICA 1|access-date=12 August 2021| work = Cuban Registry of Clinical Trials }}
= Interventional Study =
The "Interventional Study" is set both in Havana,{{Cite news| vauthors = Marsh S |date=2021-03-24|title=Nearly all Havana (sic) to receive experimental Cuban COVID-19 vaccines|language=en|work=Reuters|url=https://www.reuters.com/article/us-health-coronavirus-cuba-idUSKBN2BG0EA|access-date=2021-04-28}} Cuba's capital and Santiago de Cuba, Cuba's second most populous city{{Cite web|last=BioCubaFarma|date=April 6, 2021|title=[Translated] Updating the vaccination process with vaccine candidates #Soberana02 and #Abdala during ongoing clinical trials.#VacunasCubanasCovid19|url=https://twitter.com/biocubafarma/status/1379259492861419521/photo/1|access-date=2021-04-11|website=Twitter|language=es}}{{Cite web|title=Intervention study with Covid-19 vaccine candidate Abdala begins|url=https://www.cadenagramonte.cu/english/show/articles/32479:intervention-study-with-covid-19-vaccine-candidate-abdala-begins|access-date=2021-04-28|archive-url=https://web.archive.org/web/20210428092906/https://www.cadenagramonte.cu/english/show/articles/32479:intervention-study-with-covid-19-vaccine-candidate-abdala-begins|archive-date=2021-04-28|website=Radio Cadena Agramonte|language=en}} and in other provinces.{{Cite web|title=Cuba administers over 62,000 doses in intervention trials|url=http://www.plenglish.com/index.php?o=rn&id=66012&SEO=cuba-administers-over-62000-doses-in-intervention-trials|access-date=2021-04-28|website=Prensa Latina|language=es-ES}} On May 6, 2021, the Finlay Institute of Vaccines announced on social media that the following adverse events have been observed: injection site pain (20%), inflammation at the injection site (5%), and general discomfort (5%).{{Cite web|title=[Translated] In more than 62 thousand applied doses of #Soberana02 the safety of the vaccine has been demonstrated. Adverse effects have been: 👉 Pain at the injection site (20%). 👉 Redness at the injection site (5%). 👉 Feeling of general malaise (5%).|url=https://twitter.com/finlayinstituto/status/1390331432904560649|access-date=2021-05-07|website=Twitter|language=en}}{{Cite web|title=[Translated]In more than 62 thousand applied doses of #Soberana02 the safety of the vaccine has been demonstrated. Adverse effects have been: 👉 Pain at the injection site (20%). 👉 Redness at the injection site (5%). 👉 Feeling of general malaise (5%).|url=https://www.facebook.com/login/?next=https%3A%2F%2Fwww.facebook.com%2F105671940004676%2Fposts%2F925218158050046|access-date=2021-05-07|website=Facebook|language=en}}
=Authorizations=
{{#section:List of COVID-19 vaccine authorizations|soberana2authmap}}
{{See also|List of COVID-19 vaccine authorizations#Soberana 02}}
On June 29, 2021, Soberana 02 was authorized for emergency use in Iran.{{cite web |title=Autorizo de emergencia SOBERANA 02 en Irán |url=https://www.finlay.edu.cu/blog/autorizo-de-emergencia-soberana-02-en-iran/ |website=finlay.edu.cu |publisher=Instituto Finlay de Vacunas |access-date=6 July 2021 |date=1 July 2021}}
On August 20, 2021, Soberana 02 was authorized for emergency use in Cuba.{{cite news |title=Cuba grants emergency approval to second homegrown COVID-19 vaccine |url=https://www.gmanetwork.com/news/scitech/science/800262/cuba-grants-emergency-approval-to-second-homegrown-covid-19-vaccine/story/ |publisher=GMA News |date=21 August 2021}} On September 3, 2021, the authorization has been expanded to children in the age 2–18 years old.{{Cite web|title=Aprueba el CECMED la Autorización de Uso en Emergencia a la Vacuna cubana SOBERANA® 02 en población pediátrica {{!}} CECMED|url=https://www.cecmed.cu/noticias/aprueba-cecmed-autorizacion-uso-emergencia-vacuna-cubana-soberanar-02-poblacion-pediatrica|access-date=2021-09-09|website=www.cecmed.cu|language=es}}
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Category:Cuban COVID-19 vaccines