Medicine:Soberana 02

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Short description: Vaccine against COVID-19
Soberana 02
Soberana 02 vaccine logo.png
Soberana 02 vaccine vial.png
A vial of Soberana 02
Vaccine description
Target diseaseSARS-CoV-2
TypeConjugate vaccine
Clinical data
Trade namesPasteur
Other namesFINLAY-FR-2
Pasteurcovac, Pasto Covac, پاستوکووک
Routes of
administration		Intramuscular
Legal status
Legal status
  • Full and emergency authorizations
Full list of Soberana 02 authorizations
Identifiers
DrugBank

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 (Persian: پاستوکووک‎) in Iran, where it has been developed in collaboration with the Pasteur Institute of Iran.[1][2][3]

It is a conjugate vaccine that requires two doses, the second one being administered 28 days after the first shot.[4] A third (booster) dose of Soberana Plus may also be given on day 56. It has received emergency use authorization in Iran on June 2021, and in Cuba on August 2021, where it has also been approved for children above 2 years old.[5]

The name of the vaccine, Soberana, is a Spanish word that means "sovereign".[6] It followed a previous candidate vaccine called SOBERANA-01 (FINLAY-FR-1).[7]

Medical uses

The vaccine requires two doses, the second one being administered four weeks after the first shot.[8][9][10] A third (boost) dose of Soberana Plus may also be given on eight weeks.[8][9]

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.[11] The trial was undertaken while the delta variant was gradually taking over from beta in Havana.[11]

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.[12][13] 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.[12] 89% of the cases in the Iranian trial were identified as having the delta strain.[13]

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%.[11] Efficacy against severe disease and death is 100% for the heterologous three-dose regimen.[11]

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.[14][15] No deaths were observed in the trial group that received the three-dose regimen.[16] Unlike the Phase III trials in Cuba,[11] the majority of cases throughout the entire trial were of the delta strain (more than 90% at the time of vaccine evaluation).[17]

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.[18]

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.[7]

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.[19]

Manufacturing

The spike protein subunit is produced in Chinese hamster ovary cell culture.[7] In the ACS Chemical Biology article, scientists from Cuba explain details of the vaccines technology and production.[20] <section end="soberana02-authmap"/>

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  Production
  Deliveries
  Planned Production
  Potential Production

<section end="rbd-dimerauthmap"/>

Production
  1. Cuba[21][22]
  2. Iran (under name of PasteurCoVac)[2]
Potential Production
  1. Ghana
  2. 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.[23][24] Cuba has also suggested that, once it's approved, it will offer the vaccine to tourists visiting the country.[25][26][27]

The production of the first batch of about 100,000 doses will start in April.[28] 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.[29]

The roll-out began with an "Interventional Trial"[30] that consisted of inoculating 150,000 at-risk participants which seems to be defined as health-care workers.[31][32] 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).[33][34]

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.[35][36]

Outside Cuba

Vietnam, Iran, Venezuela, Argentina,[37][38][39] Pakistan, India, the African Union, Jamaica, and Suriname[40] have expressed interest in purchasing the vaccine, following Phase 3 results.[41][42]

Iran has signed an agreement to manufacture the vaccine[43] and Argentina is negotiating one.[37][38][39] Additionally, the Cuban government offered a "transfer of technology" to Ghana and will also supply "active materials" needed to make the vaccine.[44][45][46]

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.[47]

Up to 27 November 2021, 8 millions doses of Pasteurcovac have been produced in Iran.[48]

Clinical trials

SOBERANA vaccine family clinical trials
Registration Group Participants Phase
Date ID Title
2020-08-13 RPCEC00000332 SOBERANA 01
  • two low doses FINLAY-FR-1
  • two high doses FINLAY-FR-1
  • control (VA-MENGOC-BC®)
 676 I/II
2020-10-17 RPCEC00000338 SOBERANA 01A
  • two high doses FINLAY-FR-1 + booster FINLAY-FR-1
  • two high doses FINLAY-FR-1 + booster FINLAY-FR-1A
  • two high doses FINLAY-FR-1A + booster FINLAY-FR-1A
  • two low doses FINLAY-FR-1A + booster FINLAY-FR-1A
 60 I
2020-10-27 RPCEC00000340 SOBERANA 02
  • two low doses FINLAY-FR-2 + booster FINLAY-FR-2
  • two high doses FINLAY-FR-2 + booster FINLAY-FR-2
  • two low doses FINLAY-FR-2 + booster FINLAY-FR-1A
  • two high doses FINLAY-FR-2 + booster FINLAY-FR-1A
 40 I
2020-12-17 RPCEC00000347 SOBERANA 02A
  • two doses FINLAY-FR-2 (batch 1) + booster FINLAY-FR-2
  • two doses FINLAY-FR-2 (batch 2) + booster FINLAY-FR-2
  • two doses FINLAY-FR-2 (batch 1) + booster FINLAY-FR-1A
  • two doses FINLAY-FR-2 (batch 2) + booster FINLAY-FR-1A
 100 IIa
  • two doses batch 1 FINLAY-FR-2 + booster FINLAY-FR-1A
  • two doses batch 2 FINLAY-FR-2 + booster FINLAY-FR-1A
  • placebo
 810 IIb
2021-01-05 RPCEC00000349 SOBERANA 01B
  • 1-dose FINLAY-FR-1A
 30 I
2021-03-03 RPCEC00000354 SOBERANA 02-FaseIII
  • two doses FINLAY-FR-2
  • two doses FINLAY-FR-2 + booster FINLAY-FR-1A
  • placebo
 44,010 III
2021-03-19 RPCEC00000360 SOBERANA - INTERVENTION
  • two doses FINLAY-FR-2 + booster FINLAY-FR-1A
 150,000
2021-04-09 RPCEC00000366 SOBERANA PLUS
  • 1-dose FINLAY-FR-1A
 20 IIa
  • 1-dose FINLAY-FR-1A
  • placebo
 430 IIb
2021-04-24 IRCT20210303050558N1 Phase III in Iran
  • two doses Soberana 02
  • two doses Soberana 02 + booster Soberana Plus
  • placebo
 24,000 III
2021-06-10 RPCEC00000374 SOBERANA PEDIATRIA
  • two doses FINLAY-FR-2 + booster FINLAY-FR-1A
 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.[49]

Phase II

Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years.[50][51] Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days.[52] The second phase has been supervised by Iranian officials from the Pasteur Institute.[6]

Phase III

A vial of Soberana 02 vaccine in Iran for use in the phase III clinical trials
A woman getting vaccinated as part of phase III trials

Phase III commenced at the beginning of March as originally scheduled,[53][26] and "ready to publish" results are expected by June.[54][55][56] 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[57][58][54]), and the third a placebo.[53]

Although the trials involve thousands of adult volunteers recruited in Havana,[59] 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.[6][25]

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.” [60]

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[61][62][63] It was previously reported that the Institute will host Phase 3, but the pre-requisites were "technology transfer and joint production".[64][6]

The Phase III trial in Iran has been conducted on 24,000 adults, aged between 18 and 80 years old in 8 cities.[10] 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.[12][13] 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.[12] 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.[13] 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.[13]

Mexico plans to host a phase 3 trial.[65]

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%.[11] Efficacy against severe disease and death is 100% for the heterologous three-dose regimen.[11]

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.[14][15] No deaths were observed in the trial group that received the three-dose regimen.[16] Unlike the Phase III trials in Cuba,[11] the majority of cases throughout the entire trial were of the delta strain (more than 90% at the time of vaccine evaluation).[17]

Children and adolescents trials

In June 2021, Soberana started clinical trials for children and adolescents aged 3–18 from Phase I/II.[66][67]

Interventional Study

The "Interventional Study" is set both in Havana,[68] Cuba's capital and Santiago de Cuba, Cuba's second most populous city[69][70] and in other provinces.[71] 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%).[72][73]

Authorizations

On June 29, 2021, Soberana 02 was authorized for emergency use in Iran.[74]

On August 20, 2021, Soberana 02 was authorized for emergency use in Cuba.[75] On September 3, 2021, the authorization has been expanded to children in the age 2–18 years old.[76]

See also

  • COVID-19 vaccine clinical research
  • COVID-19 pandemic in Cuba
  • COVID-19 pandemic in Iran
  • Healthcare in Cuba
  • Pharmaceuticals in Iran

References

  1. ↑ "Iran hopes to defeat COVID with home-grown crop of vaccines". Nature 596 (7873): 475. August 2021. doi:10.1038/d41586-021-02216-z. PMID 34404947. Bibcode: 2021Natur.596..475M. 
  2. ↑ 2.0 2.1 "PasteurCovac". Pasteur Institute of Iran. https://www.pasteurcovac.ir/. 
  3. ↑ "Iran-Cuba vaccine enters phase three clinical trials" (in en). 2021-04-26. https://www.tehrantimes.com/news/460275/Iran-Cuba-vaccine-enters-phase-three-clinical-trials. 
  4. ↑ "SOBERANA, Cuba's COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD". MEDICC Review 22 (4): 10–15. October 2020. doi:10.37757/mr2020.v22.n4.11. PMID 33295312. 
  5. ↑ "Whole Inactivated Virus and Protein-Based COVID-19 Vaccines". Annual Review of Medicine 73 (1): 55–64. January 2022. doi:10.1146/annurev-med-042420-113212. PMID 34637324. 
  6. ↑ 6.0 6.1 6.2 6.3 "Iran, Cuba, Under U.S. Sanctions, Team Up for Covid-19 Vaccine Trials". 12 January 2021. https://www.wsj.com/articles/iran-cuba-under-u-s-sanctions-team-up-for-covid-19-vaccine-trials-11610481712. 
  7. ↑ 7.0 7.1 7.2 "Targets and strategies for vaccine development against SARS-CoV-2". Biomedicine & Pharmacotherapy 137: 111254. May 2021. doi:10.1016/j.biopha.2021.111254. PMID 33550049. 
  8. ↑ 8.0 8.1 "Draft landscape and tracker of COVID-19 candidate vaccines" (in en). World Health Organization. https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines. 
  9. ↑ 9.0 9.1 "SOBERANA 02-FaseIII". https://rpcec.sld.cu/trials/RPCEC00000354-En. 
  10. ↑ 10.0 10.1 "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". https://en.irct.ir/trial/54833. 
  11. ↑ 11.0 11.1 11.2 11.3 11.4 11.5 11.6 11.7 "Efficacy and safety of SOBERANA 02, a COVID-19 conjugate vaccine in heterologous three-dose combination". medRxiv. 6 November 2021. doi:10.1101/2021.10.31.21265703. https://www.medrxiv.org/content/10.1101/2021.10.31.21265703v2. Retrieved 29 May 2022. 
  12. ↑ 12.0 12.1 12.2 12.3 "اثربخشی واکسن پاستور در پیشگیری از بستری کرونایی ۹۲ درصد است + جزئیات" (in fa). October 9, 2021. https://www.tasnimnews.com/fa/news/1400/07/17/2586231/اثربخشی-واکسن-پاستور-در-پیشگیری-از-بستری-کرونایی-92-درصد-است-جزئیات. 
  13. ↑ 13.0 13.1 13.2 13.3 13.4 "کاهش حدود ۶۰ درصدی اثربخشی "فایزر" مقابل "دلتا" / جزییات ایمنی‌زایی واکسن "پاستوکووک"" (in fa). 2021-10-09. https://www.isna.ir/news/1400071711103/کاهش-حدود-۶۰-درصدی-اثربخشی-فایزر-مقابل-دلتا-جزییات-ایمنی-زایی. 
  14. ↑ 14.0 14.1 طاهره نبی الهی قهفرخی (2021-11-21). "نتایج مطالعات ۶ واکسن ایرانی کرونا ارایه شد" (in fa). https://www.irna.ir/news/84550239/نتایج-مطالعات-۶-واکسن-ایرانی-کرونا-ارایه-شد. 
  15. ↑ 15.0 15.1 جبارپور, عبدالکریم (2021-12-02). "پاستوکووک ۹۶.۵ درصد از بستری و ابتلای شدید به کرونا پیشگیری می‌کند" (in fa). https://www.irna.ir/news/84561525/پاستوکووک-۹۶-۵-درصد-از-بستری-و-ابتلای-شدید-به-کرونا-پیشگیری-می-کند. 
  16. ↑ 16.0 16.1 "توضیحاتی درباره اثربخشی واکسن پاستوکووک/ عوارض پس از تزریق پاستوکووک" (in fa). 2021-11-21. https://www.isna.ir/news/1400083023713/توضیحاتی-درباره-اثربخشی-واکسن-پاستوکووک-عوارض-پس-از-تزریق-پاستوکووک. 
  17. ↑ 17.0 17.1 "واکسن پاستوکووک ۹۵ درصد از موارد شدید و بستری کرونا پیشگیری می‌کند" (in fa). Bultan News. 2021-11-20. https://www.bultannews.com/fa/news/752681. 
  18. ↑ "Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial". JAMA network. 3 May 2023. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2804452. 
  19. ↑ "Rapid response to: Covid 19: Hope is being eclipsed by deep frustration". BMJ 372: n171. January 2021. doi:10.1136/bmj.n171. 
  20. ↑ "SARS-CoV-2 RBD-Tetanus Toxoid Conjugate Vaccine Induces a Strong Neutralizing Immunity in Preclinical Studies". ACS Chemical Biology 16 (7): 1223–1233. July 2021. doi:10.1021/acschembio.1c00272. PMID 34219448. 
  21. ↑ "Is Cuba closing in on COVID vaccine sovereignty?" (in en). https://www.aljazeera.com/news/2021/4/29/cuba-is-closing-in-on-covid-19-vaccine-sovereignty. 
  22. ↑ "Optimism as Cuba set to test its own Covid vaccine" (in en-GB). BBC News. 2021-02-16. https://www.bbc.com/news/world-latin-america-56069577. 
  23. ↑ "Cuba espera fabricar 100 millones de dosis de su candidato vacunal Soberana 02" (in es). 21 January 2021. https://www.nodal.am/2021/01/cuba-producira-100-millones-de-dosis-de-su-vacuna-soberana-02/. 
  24. ↑ "Vaccino, Cuba pronta a produrre 100 milioni di dosi di 'Soberana 02'" (in it). 21 January 2021. https://www.dire.it/21-01-2021/596443-vaccino-cuba-pronta-a-produrre-100-milioni-di-dosi-di-soberana-02/. 
  25. ↑ 25.0 25.1 "Cuba to offer coronavirus vaccines to tourists". 4 February 2021. https://brazilian.report/coronavirus-brazil-live-blog/2021/02/04/tourists-will-be-able-to-vaccinate-against-covid-19-in-cuba/. 
  26. ↑ 26.0 26.1 "Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos" (in es). 5 February 2021. https://www.dw.com/es/coronavirus-vacuna-cubana-soberana-02-alista-fase-3-y-ensayos/a-56477155. 
  27. ↑ "'Sun, sea, sand and Soberana 02': Cuba open to inoculating tourists with homegrown Covid vaccine". 23 February 2021. https://www.cnbc.com/2021/02/23/soberana-02-cubas-covid-vaccine-could-be-made-eligible-for-tourists.html. 
  28. ↑ "Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos" (in es). 5 February 2021. https://www.dw.com/es/coronavirus-vacuna-cubana-soberana-02-alista-fase-3-y-ensayos/a-56477155. "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." 
  29. ↑ "Cuba anuncia fase 3 de la vacuna Soberana 02" (in es). 7 February 2021. https://www.jornada.com.mx/notas/2021/02/07/politica/cuba-anuncia-fase-3-de-la-vacuna-soberana-02/. "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." 
  30. ↑ "SOBERANA – INTERVENTION | Registro Público Cubano de Ensayos Clínicos". https://rpcec.sld.cu/en/trials/RPCEC00000360-En. 
  31. ↑ "Cuba says it's 'betting it safe' with its own Covid vaccine" (in en). https://www.nbcnews.com/news/latino/cuba-says-betting-safe-covid-vaccine-rcna643. 
  32. ↑ "Cuba begins testing 2nd COVID-19 vaccine on health care workers" (in en). https://medicalxpress.com/news/2021-03-cuba-2nd-covid-vaccine-health.html. 
  33. ↑ Ministry of Public Health of Cuba (11 April 2021). "[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.""] (in en). https://twitter.com/minsapcuba/status/1381064729217671175. 
  34. ↑ "Cuban scientists, health workers received first anti-Covid-19 dose" (in es-ES). http://www.plenglish.com/index.php?o=rn&id=66247&SEO=cuban-scientists-health-workers-received-first-anti-covid-19-dose. 
  35. ↑ "Diaz-Canel underscores success of Covid-19 vaccination among children". Prensa Latina. Retrieved 17 April 2022.
  36. ↑ "Cuba reports lower numbers of COVID-19 cases, deaths" Xinhua. Retrieved April 17 2022.
  37. ↑ 37.0 37.1 "ILARREGUI (EMBAJADOR EN CUBA): "DURANTE ESTE AÑO PODREMOS TENER VACUNAS CUBANAS EN ARGENTINA"" (in en). https://radiocut.fm/audiocut/ilarregui-embajador-en-cuba-durante-este-ano-podremos-tener-vacunas-cubanas-en-argentina/. 
  38. ↑ 38.0 38.1 Argentina, Cadena 3. "Argentina comenzó a negociar con Cuba la vacuna Soberana" (in es). https://www.cadena3.com/noticia/internacionales/argentina-comenzo-a-negociar-con-cuba-la-vacuna-soberana_291435. 
  39. ↑ 39.0 39.1 "Sin definiciones sobre cuándo podrían llegar, el Gobierno avanza para conseguir las vacunas Soberana y Abdala de Cuba" (in es-ES). 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/. 
  40. ↑ admin (2021-04-09). "Cuba's COVID-19 Vaccines Being Sought After by CARICOM Countries" (in en). https://www.caribbeannationalweekly.com/caribbean-breaking-news-featured/cuba-covid-19-vaccines/. 
  41. ↑ "Cuba is working on a homegrown COVID-19 vaccine program. It has a history of fighting disease without help from the West" (in fr). 2021-02-15. https://www.businessinsider.fr/us/cuba-homegrown-vaccine-program-pressing-on-without-the-west-2021-2?IR=T. 
  42. ↑ Página12 (2021-01-22). "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". https://www.pagina12.com.ar/318881-soberana-02-cuba-prepara-cien-millones-de-dosis-de-la-vacuna. 
  43. ↑ "Cuban coronavirus vaccine to start third clinical trial phase in Iran" (in en). 2021-04-18. https://www.tehrantimes.com/news/459979/Cuban-coronavirus-vaccine-to-start-third-clinical-trial-phase. 
  44. ↑ "CEO of FDA Discusses Production of Covid-19 Vaccine With Cuban Ambassador" (in en). http://www.fdaghana.gov.gh/news-media.php?page=72. 
  45. ↑ "Cuba To Transfer COVID-19 Vaccine Technology To Ghana". https://www.gnbcc.net/News/Item/5198. 
  46. ↑ "Cuban government offers to transfer COVID-19 Soberana 02 vaccine technology to Ghana". 16 February 2021. https://riotimesonline.com/brazil-news/mercosur/mercosur-latin-america-caribbean/cuban-government-offers-to-transfer-covid-19-soberana-02-vaccine-technology-to-ghana/. 
  47. ↑ "Coronavirus: Cuba will produce 100 million doses of its Soberana 02 vaccine" (in en-US). 2021-01-21. https://oncubanews.com/en/cuba/coronavirus-cuba-will-produce-100-million-doses-of-its-soberana-02-vaccine/. 
  48. ↑ "تولید ۸ میلیون دز واکسن "پاستوکووک"؛ تاکنون / زمان تزریق دز سوم این واکسن" (in fa). 2021-11-27. https://www.isna.ir/news/1400090302121/تولید-۸-میلیون-دز-واکسن-پاستوکووک-تاکنون-زمان-تزریق-دز-سوم. 
  49. ↑ "SOBERANA 02 | Registro Público Cubano de Ensayos Clínicos" (in es). Cuban Registry of Clinical Trials. https://rpcec.sld.cu/en/trials/RPCEC00000340-En. 
  50. ↑  , Wikidata Q105047566
  51. ↑ "Cuba apuesta por crear primera vacuna de América Latina contra el covid-19" (in es). 2021-01-21. https://www.france24.com/es/minuto-a-minuto/20210121-cuba-apuesta-por-crear-primera-vacuna-de-américa-latina-contra-el-covid-19. 
  52. ↑ "Cuba negotiates with other countries to develop phase 3 of Soberana 02 vaccine" (in en-US). 2020-12-30. https://oncubanews.com/en/cuba/cuba-negotiates-with-other-countries-to-develop-phase-3-of-soberana-02-vaccine/. 
  53. ↑ 53.0 53.1 "Cuban-developed vaccine enters Phase III trial". 5 March 2021. https://news.abs-cbn.com/overseas/03/05/21/cuban-developed-vaccine-enters-phase-iii-trial. 
  54. ↑ 54.0 54.1 "Can Cuba beat COVID with its homegrown vaccines?". Nature. April 2021. doi:10.1038/d41586-021-01126-4. PMID 33927405. 
  55. ↑ "Cuban Vaccine Ready in July. Interview with the Cuban Ambassador to the Czech Republic" (in en). 2021-03-23. https://www.pressenza.com/2021/03/cuban-vaccine-ready-in-july-interview-with-the-cuban-ambassador-to-the-czech-republic/. 
  56. ↑ "Cuba deploys unproven homegrown vaccines, hoping to slow an exploding virus outbreak." (in en-US). The New York Times. 2021-05-12. ISSN 0362-4331. https://www.nytimes.com/2021/05/12/world/cuba-vaccine.html. 
  57. ↑ "L'esempio cubano sui vaccini" (in it). https://www.ilfoglio.it/salute/2021/05/07/news/l-esempio-cubano-sui-vaccini-2333854/. 
  58. ↑ (in en) Avances de las vacunas cubanas contra la COVID-19, https://www.youtube.com/watch?v=mT4Gg_7PczQ, retrieved 2021-05-07 
  59. ↑ "Cuba's five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa" (in en-UK). 31 March 2021. 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. 
  60. ↑ "Cuba sends 100,000 doses of the Soberana 02 vaccine candidate to Iran" oncubanews.com. Retrieved 19 March 2021.
  61. ↑ "Iran-Cuba vaccine enters phase three clinical trials" (in en). 2021-04-26. https://www.tehrantimes.com/news/460275/Iran-Cuba-vaccine-enters-phase-three-clinical-trials. 
  62. ↑ "Cuban coronavirus vaccine to start third clinical trial phase in Iran" (in en). 2021-04-18. https://www.tehrantimes.com/news/459979/Cuban-coronavirus-vaccine-to-start-third-clinical-trial-phase. 
  63. ↑ "América Latina apura una vacuna propia. Cuba, adelante; México avanza. Pero no son los únicos" (in spanish). https://www.poresto.net/opinion/2021/4/27/america-latina-apura-una-vacuna-propia-cuba-adelantemexico-avanza-pero-no-son-los-unicos-250356.html. 
  64. ↑ "Cuba to collaborate with Iran on coronavirus vaccine" (in en). Reuters. 2021-01-09. https://www.reuters.com/article/uk-health-coronavirus-cuba-iran-idUSKBN29E0JO. 
  65. ↑ "Mexico Hopes to Work With Cuba on Covid Vaccine Phase 3 Trial" (in en). Bloomberg.com. 2021-02-14. https://www.bloomberg.com/news/articles/2021-02-14/mexico-hopes-to-work-with-cuba-on-covid-vaccine-phase-3-trial. 
  66. ↑ "SOBERANA PEDIATRIA". Cuban Registry of Clinical Trials. https://rpcec.sld.cu/en/trials/RPCEC00000374-En. 
  67. ↑ "SOBERANA PEDIATRIA CLINICA 1". Cuban Registry of Clinical Trials. https://rpcec.sld.cu/en/trials/RPCEC00000384-En. 
  68. ↑ "Nearly all Havana (sic) to receive experimental Cuban COVID-19 vaccines" (in en). Reuters. 2021-03-24. https://www.reuters.com/article/us-health-coronavirus-cuba-idUSKBN2BG0EA. 
  69. ↑ BioCubaFarma (April 6, 2021). "[Translated Updating the vaccination process with vaccine candidates #Soberana02 and #Abdala during ongoing clinical trials.#VacunasCubanasCovid19"] (in es). https://twitter.com/biocubafarma/status/1379259492861419521/photo/1. 
  70. ↑ "Intervention study with Covid-19 vaccine candidate Abdala begins" (in en). https://www.cadenagramonte.cu/english/show/articles/32479:intervention-study-with-covid-19-vaccine-candidate-abdala-begins. 
  71. ↑ "Cuba administers over 62,000 doses in intervention trials" (in es-ES). http://www.plenglish.com/index.php?o=rn&id=66012&SEO=cuba-administers-over-62000-doses-in-intervention-trials. 
  72. ↑ "[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%)."] (in en). https://twitter.com/finlayinstituto/status/1390331432904560649. 
  73. ↑ "[TranslatedIn 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%)."] (in en). https://www.facebook.com/login/?next=https%3A%2F%2Fwww.facebook.com%2F105671940004676%2Fposts%2F925218158050046. 
  74. ↑ "Autorizo de emergencia SOBERANA 02 en Irán". Instituto Finlay de Vacunas. 1 July 2021. https://www.finlay.edu.cu/blog/autorizo-de-emergencia-soberana-02-en-iran/. 
  75. ↑ "Cuba grants emergency approval to second homegrown COVID-19 vaccine". GMA News. 21 August 2021. https://www.gmanetwork.com/news/scitech/science/800262/cuba-grants-emergency-approval-to-second-homegrown-covid-19-vaccine/story/. 
  76. ↑ "Aprueba el CECMED la Autorización de Uso en Emergencia a la Vacuna cubana SOBERANA® 02 en población pediátrica | CECMED" (in es). https://www.cecmed.cu/noticias/aprueba-cecmed-autorizacion-uso-emergencia-vacuna-cubana-soberanar-02-poblacion-pediatrica. 

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