Soberana 02

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Soberana 02
Vaccine description
TargetSARS-CoV-2
Vaccine typeConjugate
Clinical data
Trade namesPasteur
Other namesFINLAY-FR-2, SOBERANA PLUS[1]
Routes of
administration
Intramuscular
Legal status
Legal status

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. 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]

Efficacy[edit]

It has shown an efficacy of 62% after only two doses,[6][7][8] when combined with a booster dose of Soberana Plus, the vaccine showed an efficacy of 91.2%,[9] according to BioCubaFarma.

No pre-print or details of a study have been released as of 9 July 2021.[9]

Pharmacology[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.[2]

Manufacturing[edit]

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.[10][non-primary source needed]

  Production
  Deliveries
  Planned Production
  Potential Production
Deliveries (0)
Effective production (implies deliveries) (1)
  1. Cuba[11][12]
Planned production
  1. Iran
Potential Production
  1. Ghana
  2. Argentina

In Cuba[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.[13][14] Cuba has also suggested that, once it's approved, it will offer the vaccine to tourists visiting the country.[15][16][17]

The production of the first batch of about 100,000 doses will start in April.[18] 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.[19]

The roll-out began with an "Interventional Trial"[20] that consisted of inoculating 150,000 at-risk participants which seems to be defined as health-care workers.[21][22] 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).[23][24]

Outside Cuba[edit]

Vietnam, Iran, Venezuela, Argentina,[25][26][27] Pakistan, India, the African Union, Jamaica and Suriname[28] have expressed interest in purchasing the vaccine, although they are waiting on Phase 3 results.[29][30]

Iran has signed an agreement to manufacture the vaccine[31] and Argentina is negotiating one.[25][26][27] Additionally, the Cuban government offered a "transfer of technology" to Ghana and will also supply "active materials" needed to make the vaccine.[32][33][34]

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.[35]

Clinical trials[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.[36]

Phase II[edit]

Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years.[37][38] Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days.[39] The second phase has been supervised by Iranian officials from the Pasteur Institute.[5]

Phase III[edit]

Phase III commenced at the beginning of March as originally scheduled,[40][16] and "ready to publish" results are expected by June.[41][42][43] 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[44][45][46]), and the third a placebo.[40]

Although the trials involve thousands of adult volunteers recruited in Havana,[47] 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][15]

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.” [48]

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[49][50][51] It was previously reported that the Institute will host Phase 3 but the pre-requisites were "technology transfer and joint production".[52][5]

Mexico plans to host a phase 3 trial.[53]

Interventional Study[edit]

The "Interventional Study" is set both in Havana,[54] Cuba's capital and Santiago de Cuba, Cuba's second most populous city [55][56] and in other provinces.[57] 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%).[58][59]

Authorizations[edit]

  Full authorization
  Emergency authorization

On June 29, 2021, Soberana 02 was authorized for emergency use in Iran.[60]

References[edit]

  1. ^ "Cuba's Soberana Plus against Covid-19 is showing good results". Prensa Latina. Retrieved 10 May 2021.
  2. ^ a b c 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.
  3. ^ Santos IC (January 2021). "Rapid response to: Covid 19: Hope is being eclipsed by deep frustration". BMJ. 372: n171. doi:10.1136/bmj.n171.
  4. ^ "Draft landscape and tracker of COVID-19 candidate vaccines". www.who.int. World Health Organization. Retrieved 2021-02-04.
  5. ^ 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.
  6. ^ "Cuba's homegrown Covid vaccine shows promise". www.ft.com. Retrieved 2021-06-20.
  7. ^ "Cuba encouraged by early efficacy results of homegrown COVID-19 vaccine". www.zawya.com. Retrieved 2021-06-20.
  8. ^ Acosta, Nelson (2021-06-20). "Cuba encouraged by early results of homegrown COVID-19 vaccine amid worst outbreak". The Age. Retrieved 2021-06-20.
  9. ^ a b "Cuba says second COVID-19 vaccine Soberana 2 boasts 91.2% efficacy". Reuters. Retrieved 2021-07-09.
  10. ^ 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". bioRxiv. 16 (7): 1223–1233. doi:10.1101/2021.02.08.430146. PMID 34219448. S2CID 231938961.
  11. ^ Melimopoulos, Elizabeth. "Is Cuba closing in on COVID vaccine sovereignty?". www.aljazeera.com. Retrieved 2021-05-07.
  12. ^ "Optimism as Cuba set to test its own Covid vaccine". BBC News. 2021-02-16. Retrieved 2021-05-07.
  13. ^ "Cuba espera fabricar 100 millones de dosis de su candidato vacunal Soberana 02". Nodal (in Spanish). 21 January 2021.
  14. ^ "Vaccino, Cuba pronta a produrre 100 milioni di dosi di 'Soberana 02'". Dire (in Italian). 21 January 2021.
  15. ^ a b Ribeiro G (4 February 2021). "Cuba to offer coronavirus vaccines to tourists". Brazilian Report.
  16. ^ a b "Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos". Deutsche Welle (in Spanish). 5 February 2021.
  17. ^ Meredith S (23 February 2021). "'Sun, sea, sand and Soberana 02': Cuba open to inoculating tourists with homegrown Covid vaccine". CNBC.
  18. ^ "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.
  19. ^ "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.
  20. ^ "SOBERANA – INTERVENTION | Registro Público Cubano de Ensayos Clínicos". rpcec.sld.cu. Retrieved 2021-04-11.
  21. ^ "Cuba says it's 'betting it safe' with its own Covid vaccine". NBC News. Retrieved 2021-04-11.
  22. ^ "Cuba begins testing 2nd COVID-19 vaccine on health care workers". medicalxpress.com. Retrieved 2021-04-11.
  23. ^ 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.
  24. ^ "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.
  25. ^ a b "ILARREGUI (EMBAJADOR EN CUBA): "DURANTE ESTE AÑO PODREMOS TENER VACUNAS CUBANAS EN ARGENTINA"". RadioCut. Retrieved 2021-05-07.
  26. ^ a b Argentina, Cadena 3. "Argentina comenzó a negociar con Cuba la vacuna Soberana". Cadena 3 Argentina (in Spanish). Retrieved 2021-05-07.
  27. ^ a b de 2021, 6 de Mayo. "Sin definiciones sobre cuándo podrían llegar, el Gobierno avanza para conseguir las vacunas Soberana y Abdala de Cuba". infobae (in Spanish). Retrieved 2021-05-07.
  28. ^ admin (2021-04-09). "Cuba's COVID-19 Vaccines Being Sought After by CARICOM Countries". Caribbean News. Retrieved 2021-05-07.
  29. ^ 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". Business Insider France (in French). Retrieved 2021-05-07.
  30. ^ 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". PAGINA12. Retrieved 2021-05-07.
  31. ^ "Cuban coronavirus vaccine to start third clinical trial phase in Iran". Tehran Times. 2021-04-18. Retrieved 2021-05-07.
  32. ^ Banini | 0542440286, Awofisoye Richard. "CEO OF FDA DISCUSSES PRODUCTION OF COVID-19 VACCINE WITH CUBAN AMBASSADOR". www.fdaghana.gov.gh. Retrieved 2021-05-05.
  33. ^ "Cuba To Transfer COVID-19 Vaccine Technology To Ghana". www.gnbcc.net. Retrieved 2021-05-05.
  34. ^ "Cuban government offers to transfer COVID-19 Soberana 02 vaccine technology to Ghana". Rio Times Online. 16 February 2021.
  35. ^ "Coronavirus: Cuba will produce 100 million doses of its Soberana 02 vaccine". OnCubaNews English. 2021-01-21. Retrieved 2021-05-07.
  36. ^ "SOBERANA 02 | Registro Público Cubano de Ensayos Clínicos". Cuban Registry of Clinical Trials (in Spanish). Retrieved 24 January 2021.
  37. ^ Cuba inicia nova fase de testes com vacina que desenvolve contra covid-19 (in Portuguese), Universo Online, 19 January 2021, Wikidata Q105047566
  38. ^ "Cuba apuesta por crear primera vacuna de América Latina contra el covid-19". France 24 (in Spanish). 2021-01-21. Retrieved 24 January 2021.
  39. ^ "Cuba negotiates with other countries to develop phase 3 of Soberana 02 vaccine". OnCubaNews English. 2020-12-30. Retrieved 24 January 2021.
  40. ^ a b "Cuban-developed vaccine enters Phase III trial". ABS CBN. 5 March 2021.
  41. ^ Mega, Emiliano Rodríguez (2021-04-29). "Can Cuba beat COVID with its homegrown vaccines?". Nature. doi:10.1038/d41586-021-01126-4. PMID 33927405. S2CID 233458503.
  42. ^ "Cuban Vaccine Ready in July. Interview with the Cuban Ambassador to the Czech Republic". Pressenza. 2021-03-23. Retrieved 2021-04-29.
  43. ^ Augustin, Ed (2021-05-12). "Cuba deploys unproven homegrown vaccines, hoping to slow an exploding virus outbreak". The New York Times. ISSN 0362-4331. Retrieved 2021-05-14.
  44. ^ "L'esempio cubano sui vaccini". www.ilfoglio.it (in Italian). Retrieved 2021-05-07.
  45. ^ Avances de las vacunas cubanas contra la COVID-19, retrieved 2021-05-07
  46. ^ Mega, Emiliano Rodríguez (2021-04-29). "Can Cuba beat COVID with its homegrown vaccines?". Nature. doi:10.1038/d41586-021-01126-4. PMID 33927405. S2CID 233458503.
  47. ^ Yaffe, Helen (31 March 2021). "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.
  48. ^ "Cuba sends 100,000 doses of the Soberana 02 vaccine candidate to Iran" oncubanews.com. Retrieved 19 March 2021.
  49. ^ "Iran-Cuba vaccine enters phase three clinical trials". Tehran Times. 2021-04-26. Retrieved 2021-04-28.
  50. ^ "Cuban coronavirus vaccine to start third clinical trial phase in Iran". Tehran Times. 2021-04-18. Retrieved 2021-04-28.
  51. ^ "América Latina apura una vacuna propia. Cuba, adelante; México avanza. Pero no son los únicos". www.poresto.net (in Spanish). Retrieved 2021-04-28.
  52. ^ Marsh S (2021-01-09). "Cuba to collaborate with Iran on coronavirus vaccine". Reuters. Retrieved 2021-01-24.
  53. ^ "Mexico Hopes to Work With Cuba on Covid Vaccine Phase 3 Trial". Bloomberg.com. 2021-02-14. Retrieved 2021-05-07.
  54. ^ Marsh, Sarah (2021-03-24). "Nearly all Havana to receive experimental Cuban COVID-19 vaccines". Reuters. Retrieved 2021-04-28.
  55. ^ 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.
  56. ^ "Intervention study with Covid-19 vaccine candidate Abdala begins". Radio Cadena Agramonte. Retrieved 2021-04-28.
  57. ^ "Cuba administers over 62,000 doses in intervention trials". www.plenglish.com/index.php?o=rn&id=66012&SEO=cuba-administers-over-62000-doses-in-intervention-trials (in Spanish). Retrieved 2021-04-28.
  58. ^ "[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%)". Twitter. Retrieved 2021-05-07.
  59. ^ "[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%)". Facebook. Retrieved 2021-05-07.
  60. ^ "Autorizo de emergencia SOBERANA 02 en Irán". finlay.edu.cu. Instituto Finlay de Vacunas. 1 July 2021. Retrieved 6 July 2021.

External links[edit]