SOBERANA 02

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]

SOBERANA 02
Vaccine description
TargetSARS-CoV-2
Vaccine typeConjugate
Clinical data
Other namesFINLAY-FR-2
Routes of
administration		Intramuscular
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 COVID-19 portal

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

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.[1]

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.[5]

Phase II

Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years.[6][7] Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days.[8] The second phase has been supervised by Iranian officials from the Pasteur Institute.[4]

Phase III

Phase III commenced at the beginning of March, as originally scheduled.[9][10] 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.[9]

The Finlay Institute also plans to conduct Phase III in Iran.[11] 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][12] 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.” [13]

Although the trials involve thousands of adult volunteers recruited in Havana,[14] 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][15]

Deployment

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.[16][17] 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,[18] Pakistan, India, and the African Union have "expressed interest" in acquiring it.[17][19] Additionally, the government offered the vaccine to Ghana.[20] Cuba has also suggested that, once it's approved, it will offer the vaccine to tourists visiting the country.[15][10][19]

The production of the first batch of about 100,000 doses will commence in April.[21] 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.[22]

References
  1. 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 = Biomedecine & Pharmacotherapie. 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. 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. "SOBERANA 02 | Registro Público Cubano de Ensayos Clínicos". Cuban Registry of Clinical Trials (in Spanish). Retrieved 24 January 2021.
  6. Cuba inicia nova fase de testes com vacina que desenvolve contra covid-19 (in Portuguese), Universo Online, 19 January 2021, Wikidata Q105047566
  7. "Cuba apuesta por crear primera vacuna de América Latina contra el covid-19". France 24 (in Spanish). 2021-01-21. Retrieved 24 January 2021.
  8. "Cuba negotiates with other countries to develop phase 3 of Soberana 02 vaccine". OnCubaNews English. 2020-12-30. Retrieved 24 January 2021.
  9. "Cuban-developed vaccine enters Phase III trial". ABS CBN. 5 March 2021.
  10. "Coronavirus: Vacuna cubana Soberana 02 alista fase 3 y ensayos". Deutsche Welle (in Spanish). 5 February 2021.
  11. Marsh S (2021-01-09). "Cuba to collaborate with Iran on coronavirus vaccine". Reuters. Retrieved 2021-01-24.
  12. "Iran bans import of UK and US Covid-19 vaccines, saying they're 'completely untrustworthy'". France 24. 2021-01-09. Retrieved 2021-01-24.
  13. "Cuba sends 100,000 doses of the Soberana 02 vaccine candidate to Iran" oncubanews.com. Retrieved 19 March 2021.
  14. 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.
  15. Ribeiro G (4 February 2021). "Cuba to offer coronavirus vaccines to tourists". Brazilian Report.
  16. "Cuba espera fabricar 100 millones de dosis de su candidato vacunal Soberana 02". Nodal (in Spanish). 21 January 2021.
  17. "Vaccino, Cuba pronta a produrre 100 milioni di dosi di 'Soberana 02'". Dire (in Italian). 21 January 2021.
  18. "Jamaica looks to Cuba, India, China for more COVID vaccines". jamaica-gleaner.com. 2021-01-13. Retrieved 2021-02-01.
  19. Meredith S (23 February 2021). "'Sun, sea, sand and Soberana 02': Cuba open to inoculating tourists with homegrown Covid vaccine". CNBC.
  20. "Cuban government offers to transfer COVID-19 Soberana 02 vaccine technology to Ghana". Rio Times Online. 16 February 2021.
  21. "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.
  22. "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.
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