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
Identifiers
CAS Number

Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.[2]

Medical uses

It can be used as a third (booster) dose for Soberana 02 vaccine at eight weeks.[3][4][5] It's also studied as an independent single-dose vaccine.[2][6][7]

Efficacy

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

Clinical trials

Booster dose

Further information: Soberana 02 § Clinical trials

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. ^ "Patent Landscape Report COVID-19-related vaccines and therapeutics" (PDF).
  2. ^ a b Cuban Registry of Clinical Trials. "SOBERANA PLUS". Retrieved 2021-09-08.
  3. ^ "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.
  4. ^ Cuban Registry of Clinical Trials. "SOBERANA 02-FaseIII". Retrieved 2021-09-08.
  5. ^ "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.
  6. ^ Cuban Registry of Clinical Trials. "SOBERANA 01B". Retrieved 2021-09-08.
  7. ^ 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 vaccine enhances neutralization response in COVID-19 convalescents, with a very good safety profile: An open-label phase 1 clinical trial". The Lancet Regional Health - Americas. 4 100079. doi:10.1016/j.lana.2021.100079. medRxiv 10.1101/2021.02.22.21252091. PMC 8442527. PMID 34541571.
  8. ^ "Cuba says second COVID-19 vaccine Soberana 2 boasts 91.2% efficacy". Reuters. Retrieved 2021-09-23.
  9. ^ a b Toledo-Romani ME, Garcia-Carmenate M, Silva CV, Baldoquin-Rodriguez W, Pérez MM, Gonzalez MC, Moreno BP, Hernández IC, et al. (2023). "Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: A double-blind, randomised, placebo-controlled phase 3 clinical trial". The Lancet Regional Health - Americas. 18 100423. doi:10.1016/j.lana.2022.100423. medRxiv 10.1101/2021.10.31.21265703. PMC 9803910. PMID 36618081.
  10. ^ "SOBERANA 02-FaseIII". Retrieved 2021-09-09.
  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. Archived from the original on 2021-09-07. 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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