Soberana Plus

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

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

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]

Clinical trials

Booster dose

Soberana Plus has also been studied as a booster dose for Soberana 02.[8][9]

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 the Soberana Plus for booster.[10]

See also

References

  1. Cuban Registry of Clinical Trials. "SOBERANA PLUS". Retrieved 2021-09-08.
  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.
  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.
  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. "SOBERANA 02-FaseIII". Retrieved 2021-09-09.
  9. "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.
  10. Dönmez BB (21 August 2021). "Cuba grants emergency use to 2 virus vaccines". Anadolu Agency. Retrieved 23 September 2021.
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