SOBERANA 02

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SOBERANA 02
Vaccine description
TargetSARS-CoV-2
Vaccine typeConjugate
Clinical data
Other namesFINLAY-FR-2
Routes of
administration		Intramuscular
Part of a series on the
COVID-19 pandemic
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Timeline
2019

2020

2021

Locations
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International response
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Impact
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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).[1] 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.[2] According to the WHO candidate landscape vaccine document, this vaccine requires two doses, the second one being administered 28 days after the first shot.[3]

The name of the vaccine, Soberana, is a Spanish word that means "sovereign".[4]

Technology[edit]

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.[1] In a pre-print article scientists from Cuba explain details of the vaccines technology and production.[5][non-primary source needed]

Clinical research[edit]

Phase I[edit]

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.[6]

Phase II[edit]

Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years.[7][8] Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days.[9] The second phase has been supervised by Iranian officials from the Pasteur Institute.[4]

Phase III[edit]

Phase III commenced at the beginning of March as originally scheduled,[10][11] and "ready to publish" results are expected by June.[12][13] 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, and the third a placebo.[10]

The Asian country signed an agreement with Cuba after the country's supreme leader, Ayatollah Ali Khamenei, said the country won't import vaccines from the U.S. or the U.K, calling them untrustworthy.[4][14]

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.” [15]

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 and will also start in Mexico,[16][17][18] although details were unclear. It was previously reported that the Insititute will host Phase 3 but the pre-requisites were "technology transfer and joint production".[19]

Although the trials involve thousands of adult volunteers recruited in Havana,[20] 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.[4][21]

Interventional Study[edit]

The "Interventional Study" is set both in Havana,[22] Cuba's capital and Santiago de Cuba, Cuba's second most populous city [23][24] and in other provinces.[25]

Deployment[edit]

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.[26][27] Vicente Vérez, director general of the Finlay Vaccine Institute, said that they have already agreed to distribute the medicine to Vietnam, Venezuela and Iran, while other countries like Jamaica,[28] Pakistan, India, and the African Union have "expressed interest" in acquiring it.[27][29] Additionally, the government offered the vaccine to Ghana.[30] Cuba has also suggested that, once it's approved, it will offer the vaccine to tourists visiting the country.[21][11][29]

The production of the first batch of about 100,000 doses will start in April.[31] 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.[32]

The roll-out has began by a "Interventional Trial"[33] that consist of inoculating 150,000 at-risk participants which seems to be defined as health-care workers.[34][35] On April 11, 2021, the Ministry of Public Health of Cuba announced that 75,000 health-care workers were inoculated their first dose of either of the two Cuba's Phase III vaccines (the other being CIGB-66, also known as ABDALA).[36][37]

References[edit]

  1. ^ a b Malik JA, Mulla AH, Farooqi T, Pottoo FH, Anwar S, Rengasamy KR (January 2021). "Targets and strategies for vaccine development against SARS-CoV-2". Biomedicine & Pharmacotherapy. 137: 111254. doi:10.1016/j.biopha.2021.111254. PMC 7843096. PMID 33550049.
  2. ^ Santos IC (January 2021). "Rapid response to: Covid 19: Hope is being eclipsed by deep frustration". BMJ. 372: n171. doi:10.1136/bmj.n171.
  3. ^ "Draft landscape and tracker of COVID-19 candidate vaccines". www.who.int. World Health Organization. Retrieved 2021-02-04.
  4. ^ a b c d Rasmussen SE, Eqbali A (12 January 2021). "Iran, Cuba, Under U.S. Sanctions, Team Up for Covid-19 Vaccine Trials". The Wall Street Journal.
  5. ^ Valdes-Balbin, Yury; Santana-Mederos, Darielys; Quintero, Lauren; Fernández, Sonsire; Rodriguez, Laura; Ramirez, Belinda Sanchez; Perez, Rocmira; Acosta, Claudia; Méndez, Yanira; Ricardo, Manuel G.; Hernandez, Tays (2021-02-09). "SARS-CoV-2 RBD-Tetanus toxoid conjugate vaccine induces a strong neutralizing immunity in preclinical studies". doi:10.1101/2021.02.08.430146. Cite journal requires |journal= (help)
  6. ^ "SOBERANA 02 | Registro Público Cubano de Ensayos Clínicos". Cuban Registry of Clinical Trials (in Spanish). Retrieved 24 January 2021.
  7. ^ Cuba inicia nova fase de testes com vacina que desenvolve contra covid-19 (in Portuguese), Universo Online, 19 January 2021, Wikidata Q105047566
  8. ^ "Cuba apuesta por crear primera vacuna de América Latina contra el covid-19". France 24 (in Spanish). 2021-01-21. Retrieved 24 January 2021.
  9. ^ "Cuba negotiates with other countries to develop phase 3 of Soberana 02 vaccine". OnCubaNews English. 2020-12-30. Retrieved 24 January 2021.
  10. ^ a b "Cuban-developed vaccine enters Phase III trial". ABS CBN. 5 March 2021.
  11. ^ a b "Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos". Deutsche Welle (in Spanish). 5 February 2021.
  12. ^ Mega, Emiliano Rodríguez (2021-04-29). "Can Cuba beat COVID with its homegrown vaccines?". Nature. doi:10.1038/d41586-021-01126-4.
  13. ^ "Cuban Vaccine Ready in July. Interview with the Cuban Ambassador to the Czech Republic". Pressenza. 2021-03-23. Retrieved 2021-04-29.
  14. ^ "Iran bans import of UK and US Covid-19 vaccines, saying they're 'completely untrustworthy'". France 24. 2021-01-09. Retrieved 2021-01-24.
  15. ^ "Cuba sends 100,000 doses of the Soberana 02 vaccine candidate to Iran" oncubanews.com. Retrieved 19 March 2021.
  16. ^ "Iran-Cuba vaccine enters phase three clinical trials". Tehran Times. 2021-04-26. Retrieved 2021-04-28.
  17. ^ "Cuban coronavirus vaccine to start third clinical trial phase in Iran". Tehran Times. 2021-04-18. Retrieved 2021-04-28.
  18. ^ "América Latina apura una vacuna propia. Cuba, adelante; México avanza. Pero no son los únicos". www.poresto.net (in Spanish). Retrieved 2021-04-28.
  19. ^ Marsh S (2021-01-09). "Cuba to collaborate with Iran on coronavirus vaccine". Reuters. Retrieved 2021-01-24.
  20. ^ Yaffe, Helen. "Cuba's five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa". LSE Latin America and Caribbean blog. Retrieved 2021-03-31.
  21. ^ a b Ribeiro G (4 February 2021). "Cuba to offer coronavirus vaccines to tourists". Brazilian Report.
  22. ^ Marsh, Sarah (2021-03-24). "Nearly all Havana to receive experimental Cuban COVID-19 vaccines". Reuters. Retrieved 2021-04-28.
  23. ^ BioCubaFarma (April 6, 2021). "[Translated] Updating the vaccination process with vaccine candidates #Soberana02 and #Abdala during ongoing clinical trials.#VacunasCubanasCovid19". Twitter (in Spanish). Retrieved 2021-04-11.
  24. ^ "Intervention study with Covid-19 vaccine candidate Abdala begins". Radio Cadena Agramonte. Retrieved 2021-04-28.
  25. ^ "Cuba administers over 62,000 doses in intervention trials". http://www.plenglish.com/index.php?o=rn&id=66012&SEO=cuba-administers-over-62000-doses-in-intervention-trials (in Spanish). Retrieved 2021-04-28. External link in |website= (help)
  26. ^ "Cuba espera fabricar 100 millones de dosis de su candidato vacunal Soberana 02". Nodal (in Spanish). 21 January 2021.
  27. ^ a b "Vaccino, Cuba pronta a produrre 100 milioni di dosi di 'Soberana 02'". Dire (in Italian). 21 January 2021.
  28. ^ "Jamaica looks to Cuba, India, China for more COVID vaccines". jamaica-gleaner.com. 2021-01-13. Retrieved 2021-02-01.
  29. ^ a b Meredith S (23 February 2021). "'Sun, sea, sand and Soberana 02': Cuba open to inoculating tourists with homegrown Covid vaccine". CNBC.
  30. ^ "Cuban government offers to transfer COVID-19 Soberana 02 vaccine technology to Ghana". Rio Times Online. 16 February 2021.
  31. ^ "Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos". Deutsche Welle (in Spanish). 5 February 2021. 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.
  32. ^ "Cuba anuncia fase 3 de la vacuna Soberana 02". La Jornada (in Spanish). 7 February 2021. 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.
  33. ^ "SOBERANA – INTERVENTION | Registro Público Cubano de Ensayos Clínicos". rpcec.sld.cu. Retrieved 2021-04-11.
  34. ^ "Cuba says it's 'betting it safe' with its own Covid vaccine". NBC News. Retrieved 2021-04-11.
  35. ^ "Cuba begins testing 2nd COVID-19 vaccine on health care workers". medicalxpress.com. Retrieved 2021-04-11.
  36. ^ 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."". Twitter. Retrieved 2021-04-11.
  37. ^ "Cuban scientists, health workers received first anti-Covid-19 dose". www.plenglish.com/index.php?o=rn&id=66247&SEO=cuban-scientists-health-workers-received-first-anti-covid-19-dose (in Spanish). Retrieved 2021-04-11.

External links[edit]

Retrieved from "https://en.wikipedia.org/w/index.php?title=SOBERANA_02&oldid=1021302297"