Soberana Plus

Soberana Plus
A vial of Soberana Plus
Vaccine description
TargetSARS-CoV-2
Vaccine typeConjugate
Clinical data
Trade namesPasteur
Other namesFINLAY-FR-1A
Routes of
administration		Intramuscular
Legal status
Legal status

Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.[1]

Medical uses

It can be used as a third (booster) dose for Soberana 02 vaccine at eight weeks.[2][3][4] It's also studied as an independent single-dose vaccine.[1][5][6]

Efficacy

It combined the Soberana 02, the vaccine booster shot shows an efficacy of 91.2%.[7] The final result of a third dose of Soberana Plus increased the efficacy up to 92.4%.[8] Efficacy against severe disease and death is 100% for the heterologous three-dose regimen.[9]

Clinical trials

Booster dose

Soberana Plus has also been studied as a booster dose for Soberana 02.[10][11]

Single dose

Clinical trials of single-dose Soberana Plus
Phase Registration Number of participants Age of participants
ID Date Total Vaccine Control
I RPCEC00000349 2021-01-05 30 30 0 18-55 years
IIa RPCEC00000366 2021-04-09 20 20 0 19-80 years
IIb 430 Placebo-controlled

Authorizations

On 20 August 2021, Cuba approved Soberana Plus as a booster after two doses of Soberana 02.[12] On 23 September, Cuba approved Soberana Plus for COVID-19 survivors over 19 years old. On 7 December, the authorization was expanded to include COVID-19 survivors from 2 to 18 years old.[13]

See also

References

  1. 1 2 Cuban Registry of Clinical Trials. "SOBERANA PLUS". Retrieved 2021-09-08.{{cite web}}: CS1 maint: url-status (link)
  2. ↑ "ماجرای تزریق اشتباهی واکسن کرونا" [The story of the wrong injection of the corona vaccine]. Iranian Students' News Agency (ISNA) (in Persian). 2021-08-31. Retrieved 2021-09-08.
  3. ↑ Cuban Registry of Clinical Trials. "SOBERANA 02-FaseIII". Retrieved 2021-09-08.{{cite web}}: CS1 maint: url-status (link)
  4. ↑ "IRCT | Efficacy, safety, and immunogenicity of Soberana recombinant vaccine (product of Finlay Institute) based on RBD protein subunit of Sars-Cov-2 in a 2-dose regimen with and without a booster dose: a double-blind, randomized, placebo-controlled phase III clinical trial in the Iranian population of 18-80 years". www.irct.ir. Retrieved 2021-09-08.
  5. ↑ Cuban Registry of Clinical Trials. "SOBERANA 01B". Retrieved 2021-09-08.{{cite web}}: CS1 maint: url-status (link)
  6. ↑ Chang-Monteagudo A, Ochoa-Azze R, Climent-Ruiz Y, Macias-Abraham C, Rodriguez-Noda L, Valenzuela-Silva C, et al. (2021). "A single dose of SARS-CoV-2 FINLAY-FR-1A dimeric-RBD recombinant vaccine enhances neutralization response in COVID-19 convalescents, with excellent safety profile. A preliminary report of an open-label phase 1 clinical trial". medRxiv. doi:10.1101/2021.02.22.21252091. S2CID 232093115.
  7. ↑ "Cuba says second COVID-19 vaccine Soberana 2 boasts 91.2% efficacy". Reuters. Retrieved 2021-09-23.
  8. ↑ Toledo-Romani ME, Garcia-Carmenate M, Silva CV, Baldoquin-Rodriguez W, Pérez MM, Gonzalez MC, Moreno BP, Hernández IC, et al. (2021-11-01). "Efficacy and Safety of SOBERANA 02, a COVID-19 conjugate vaccine in heterologous three doses combination": 2021.10.31.21265703. doi:10.1101/2021.10.31.21265703v1. {{cite journal}}: Cite journal requires |journal= (help)
  9. ↑ Toledo-Romani ME, Garcia-Carmenate M, Silva CV, Baldoquin-Rodriguez W, Perez MM, Gonzalez MC, et al. (2021-11-06). "Efficacy and safety of SOBERANA 02, a COVID-19 conjugate vaccine in heterologous three-dose combination": 2021.10.31.21265703. doi:10.1101/2021.10.31.21265703. {{cite journal}}: Cite journal requires |journal= (help)
  10. ↑ "SOBERANA 02-FaseIII". Retrieved 2021-09-09.{{cite web}}: CS1 maint: url-status (link)
  11. ↑ "IRCT | Efficacy, safety, and immunogenicity of Soberana recombinant vaccine (product of Finlay Institute) based on RBD protein subunit of Sars-Cov-2 in a 2-dose regimen with and without a booster dose: a double-blind, randomized, placebo-controlled phase III clinical trial in the Iranian population of 18-80 years". en.irct.ir. Retrieved 2021-09-07.
  12. ↑ Dönmez BB (21 August 2021). "Cuba grants emergency use to 2 virus vaccines". Anadolu Agency. Retrieved 23 September 2021.
  13. ↑ "Commercial file SOBERANA Plus Eng" (PDF). finlay.edu.cu.
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