Biology:SOBERANA 02

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Short description: Vaccine candidate against COVID-19
SOBERANA 02
Vaccine description
Target diseaseSARS-CoV-2
TypeConjugate vaccine
Clinical data
Other namesFINLAY-FR-2, SOBERANA PLUS[1]
Routes of
administration		Intramuscular

SOBERANA 02, technical name FINLAY-FR-2, is a COVID-19 vaccine candidate produced by the Finlay Institute, a Cuban epidemiological research institute. It is a conjugate vaccine. This candidate followed a previous one called SOBERANA-01 (FINLAY-FR-1).[2] 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.[3] According to the WHO candidate landscape vaccine document, this vaccine requires two doses, the second one being administered 28 days after the first shot.[4]

The name of the vaccine, Soberana, is a Spanish word that means "sovereign".[5]

Technology

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. The spike protein subunit is produced in Chinese hamster ovary cell culture.[2] In a pre-print article scientists from Cuba explain details of the vaccines technology and production.[6][non-primary source needed]

Clinical research

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.[7]

Phase II

Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years.[8][9] Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days.[10] The second phase has been supervised by Iranian officials from the Pasteur Institute.[5]

Phase III

Phase III commenced at the beginning of March as originally scheduled,[11][12] and "ready to publish" results are expected by June.[13][14][15] 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[16][17][18]), and the third a placebo.[11]

Although the trials involve thousands of adult volunteers recruited in Havana,[19] 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.[5][20]

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.” [21]

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[22][23][24] It was previously reported that the Institute will host Phase 3 but the pre-requisites were "technology transfer and joint production".[25][5]

Mexico plans to host a phase 3 trial.[26]

Interventional Study

The "Interventional Study" is set both in Havana,[27] Cuba's capital and Santiago de Cuba, Cuba's second most populous city [28][29] and in other provinces.[30]On May 6, 2021, the Finlay Institute of Vaccines announced on social media that the following adverse events have ben observed : injection site pain (20%), inflammation at the injection site (5%), and general discomfort (5%).[31][32]

Deployment

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  Production
  Deliveries
  Planned Production
  Potential Production

<section end="rbd-dimerauthmap"/>

Deliveries (<section begin="RBD-Dimer_FN"/>0<section end="RBD-Dimer_FN"/>)
Effective production (implies deliveries) (<section begin="SOBERANA_02_EN"/>1<section end="SOBERANA_02_EN"/>)
  1. Cuba[33][34]
Planned production
  1. Iran
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.[35][36] Cuba has also suggested that, once it's approved, it will offer the vaccine to tourists visiting the country.[20][12][37]

The production of the first batch of about 100,000 doses will start in April.[38] 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.[39]

The roll-out began with an "Interventional Trial"[40] that consisted of inoculating 150,000 at-risk participants which seems to be defined as health-care workers.[41][42] 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 CIGB-66, also known as ABDALA).[43][44]

Outside Cuba

Vietnam, Iran, Venezuela, Argentina[45][46][47], Pakistan, India, the African Union, Jamaica and Suriname[48] have expressed interest in purchasing the vaccine, although they are waiting on Phase 3 results.[49][50]

Iran has signed an agreement to manufacture the vaccine[51] and Argentina is negotiating one[45][46][47]. Additionally, the Cuban government offered a "transfer of technology" to Ghana and will also supply "active materials" needed to make the vaccine.[52][53][54]

While price is unknown, pricing will be a middle-ground between the "impact on health and the need for our system to (financially) support the production of vaccines and drugs for the country".[55]

References

  1. ↑ "Cuba's Soberana Plus against Covid-19 is showing good results". Prensa Latina. https://www.plenglish.com/index.php?o=rn&id=67134&SEO=cubas-soberana-plus-against-covid-19-is-showing-good-results. 
  2. ↑ 2.0 2.1 "Targets and strategies for vaccine development against SARS-CoV-2". Biomedicine & Pharmacotherapy 137: 111254. January 2021. doi:10.1016/j.biopha.2021.111254. PMID 33550049. 
  3. ↑ "Rapid response to: Covid 19: Hope is being eclipsed by deep frustration". BMJ 372: n171. January 2021. doi:10.1136/bmj.n171. 
  4. ↑ "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. 
  5. ↑ 5.0 5.1 5.2 5.3 "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. 
  6. ↑ Valdes-Balbin, Yury; Santana-Mederos, Darielys; Quintero, Lauren; Fernández, Sonsire; Rodriguez, Laura; Ramirez, Belinda Sanchez; Perez, Rocmira; Acosta, Claudia et al. (2021-02-09) (in en). SARS-CoV-2 RBD-Tetanus toxoid conjugate vaccine induces a strong neutralizing immunity in preclinical studies. doi:10.1101/2021.02.08.430146. http://biorxiv.org/lookup/doi/10.1101/2021.02.08.430146. 
  7. ↑ "SOBERANA 02 | Registro Público Cubano de Ensayos Clínicos" (in es). Cuban Registry of Clinical Trials. https://rpcec.sld.cu/en/trials/RPCEC00000340-En. 
  8. ↑  , Wikidata Q105047566
  9. ↑ "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. 
  10. ↑ "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/. 
  11. ↑ 11.0 11.1 "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. 
  12. ↑ 12.0 12.1 "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. 
  13. ↑ Mega, Emiliano Rodríguez (2021-04-29). "Can Cuba beat COVID with its homegrown vaccines?" (in en). Nature. doi:10.1038/d41586-021-01126-4. https://www.nature.com/articles/d41586-021-01126-4. 
  14. ↑ "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/. 
  15. ↑ Augustin, Ed (2021-05-12). "Cuba deploys unproven homegrown vaccines, hoping to slow an exploding virus outbreak." (in en-US). The New York Times. ISSN 0362-4331. https://www.nytimes.com/2021/05/12/world/cuba-vaccine.html. 
  16. ↑ "L'esempio cubano sui vaccini" (in it). https://www.ilfoglio.it/salute/2021/05/07/news/l-esempio-cubano-sui-vaccini-2333854/. 
  17. ↑ (in en) Avances de las vacunas cubanas contra la COVID-19, https://www.youtube.com/watch?v=mT4Gg_7PczQ, retrieved 2021-05-07 
  18. ↑ Mega, Emiliano Rodríguez (2021-04-29). "Can Cuba beat COVID with its homegrown vaccines?" (in en). Nature. doi:10.1038/d41586-021-01126-4. https://www.nature.com/articles/d41586-021-01126-4. 
  19. ↑ Yaffe, Helen. "Cuba’s five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa" (in en-UK). 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. 
  20. ↑ 20.0 20.1 "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/. 
  21. ↑ "Cuba sends 100,000 doses of the Soberana 02 vaccine candidate to Iran" oncubanews.com. Retrieved 19 March 2021.
  22. ↑ "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. 
  23. ↑ "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. 
  24. ↑ "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. 
  25. ↑ "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. 
  26. ↑ "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. 
  27. ↑ Marsh, Sarah (2021-03-24). "Nearly all Havana to receive experimental Cuban COVID-19 vaccines" (in en). Reuters. https://www.reuters.com/article/us-health-coronavirus-cuba-idUSKBN2BG0EA. 
  28. ↑ 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. 
  29. ↑ "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. 
  30. ↑ "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. 
  31. ↑ "[Trnslated 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. 
  32. ↑ "[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. 
  33. ↑ Melimopoulos, Elizabeth. "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. 
  34. ↑ "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. 
  35. ↑ "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/. 
  36. ↑ "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/. 
  37. ↑ "'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. 
  38. ↑ "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." 
  39. ↑ "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." 
  40. ↑ "SOBERANA – INTERVENTION | Registro Público Cubano de Ensayos Clínicos". https://rpcec.sld.cu/en/trials/RPCEC00000360-En. 
  41. ↑ "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. 
  42. ↑ "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. 
  43. ↑ 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. 
  44. ↑ "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. 
  45. ↑ 45.0 45.1 "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/. 
  46. ↑ 46.0 46.1 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. 
  47. ↑ 47.0 47.1 de 2021, 6 de Mayo. "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/. 
  48. ↑ 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/. 
  49. ↑ Guenot, Marianne (2021-02-15). "Cuba is working on a homegrown COVID-19 vaccine program. It has a history of fighting disease without help from the West" (in fr). https://www.businessinsider.fr/us/cuba-homegrown-vaccine-program-pressing-on-without-the-west-2021-2?IR=T. 
  50. ↑ 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. 
  51. ↑ "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. 
  52. ↑ Banini | 0542440286, Awofisoye Richard. "CEO OF FDA DISCUSSES PRODUCTION OF COVID-19 VACCINE WITH CUBAN AMBASSADOR" (in en). http://www.fdaghana.gov.gh/news-media.php?page=72. 
  53. ↑ "Cuba To Transfer COVID-19 Vaccine Technology To Ghana". https://www.gnbcc.net/News/Item/5198. 
  54. ↑ "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/. 
  55. ↑ "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/. 

External links




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