FINLAY-FR-2

FINLAY-FR-2 also known as SOBERANA-02, is a COVID-19 vaccine candidate produced by the Finlay Institute, a Cuban epidemiological research institute. This vaccine is a conjugate vaccine.[1] This candidate followed a previous one called SOBERANA-01.[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]

FINLAY-FR-2
Vaccine description
Target diseaseCOVID‑19
TypeConjugate vaccine
Clinical data
Other namesSOBERANA-02
Routes of
administration		Intramuscular
Part of a series on the
COVID-19 pandemic
Timeline
2019

2020

2021
Locations
  • By continent
  • By conveyance
International response
Medical response
Impact
  • Socio-economic
  • By industry
 COVID-19 Portal

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.[5][6] 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,[7] Pakistan, India have "expressed interest" in acquiring it.[6]

The name of the vaccine, Soberana, is Spanish for “sovereign”.[8]

Clinical trials

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.[9]

Phase II

Phase IIa involved 100 Cubans, and phase IIb of the vaccine will have 900 volunteers between 19 and 80 years.[10][11] Vicente Vérez, director general of the Finlay Vaccine Institute, said that the vaccine has shown to give an immune response after 14 days.[12] The second phase has been supervised by Iranian officials from the Pasteur Institute.[8]

Phase III

If Phase IIb is approved by Cuban institutions, the Finlay Institute will begin Phase III in Iran.[13] 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.[8][14]

Cuba’s public-health officials said they need to conduct Phase 3 trials abroad because the island doesn’t have a big enough outbreak to get meaningful statistics on vaccine protection.[8]

References
  1. "Phase-1 of clinical trials with Soberana 02 candidate begins in Cuba". Retrieved 2021-01-24.
  2. Gorry C (October 2020). "SOBERANA, Cuba's COVID-19 Vaccine Candidates: Dagmar García-Rivera PhD". MEDICC Review. 22 (4): 10–15. PMID 33295312.
  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. "Cuba espera fabricar 100 millones de dosis de su candidato vacunal Soberana 02". Nodal (in Spanish). 21 January 2021.
  6. "Vaccino, Cuba pronta a produrre 100 milioni di dosi di 'Soberana 02'". Dire (in Italian). 21 January 2021.
  7. "Jamaica looks to Cuba, India, China for more COVID vaccines". jamaica-gleaner.com. 2021-01-13. Retrieved 2021-02-01.
  8. Rasmussen SE, Eqbali A (12 January 2021). "Iran, Cuba, Under U.S. Sanctions, Team Up for Covid-19 Vaccine Trials". The Wall Street Journal.
  9. "SOBERANA 02 | Registro Público Cubano de Ensayos Clínicos". Cuban Registry of Clinical Trials (in Spanish). Retrieved 24 January 2021.
  10. Cuba inicia nova fase de testes com vacina que desenvolve contra covid-19, Universo Online, 19 January 2021, Wikidata Q105047566
  11. "Cuba apuesta por crear primera vacuna de América Latina contra el covid-19". France 24 (in Spanish). 2021-01-21. Retrieved 24 January 2021.
  12. "Cuba negotiates with other countries to develop phase 3 of Soberana 02 vaccine". OnCubaNews English. 2020-12-30. Retrieved 24 January 2021.
  13. Marsh S (2021-01-09). "Cuba to collaborate with Iran on coronavirus vaccine". Reuters. Retrieved 2021-01-24.
  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.
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