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Soberana Plus

From Wikipedia, the free encyclopedia
Vaccine

Pharmaceutical compound
Soberana Plus
A vial ofSoberana 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
Part ofa series on the
COVID-19 pandemic
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
virus iconCOVID-19 portal

Soberana Plus, technical nameFINLAY-FR-1A, is aCOVID-19 candidate vaccine produced by theFinlay Institute, aCuban epidemiological research institute.[2]

Medical uses

[edit]

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

Efficacy

[edit]

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.[10]

Clinical trials

[edit]

Booster dose

[edit]
Further information:Soberana 02 § Clinical trials

Soberana Plus has also been studied as abooster dose forSoberana 02.[11][12]

Single dose

[edit]
Clinical trials of single-dose Soberana Plus
PhaseRegistrationNumber of participantsAge of participants
IDDateTotalVaccineControl
IRPCEC000003492021-01-053030018-55 years
IIaRPCEC000003662021-04-092020019-80 years
IIb430Placebo-controlled

Authorizations

[edit]

On 20 August 2021, Cuba approved Soberana Plus as a booster after two doses ofSoberana 02.[13] 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.[14]

See also

[edit]

References

[edit]
  1. ^"Patent Landscape Report COVID-19-related vaccines and therapeutics"(PDF).
  2. ^abCuban Registry of Clinical Trials."SOBERANA PLUS". Retrieved2021-09-08.
  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. Retrieved2021-09-08.
  4. ^Cuban Registry of Clinical Trials."SOBERANA 02-FaseIII". Retrieved2021-09-08.
  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. Retrieved2021-09-08.
  6. ^Cuban Registry of Clinical Trials."SOBERANA 01B". Retrieved2021-09-08.
  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 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 10.1101/2021.02.22.21252091.
  8. ^"Cuba says second COVID-19 vaccine Soberana 2 boasts 91.2% efficacy".Reuters. Retrieved2021-09-23.
  9. ^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:10.1101/2021.10.31.21265703.S2CID 240302516.{{cite journal}}:Cite journal requires|journal= (help)
  10. ^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.S2CID 240302516.{{cite journal}}:Cite journal requires|journal= (help)
  11. ^"SOBERANA 02-FaseIII". Retrieved2021-09-09.
  12. ^"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 fromthe original on 2021-09-07. Retrieved2021-09-07.
  13. ^Dönmez BB (21 August 2021)."Cuba grants emergency use to 2 virus vaccines". Anadolu Agency. Retrieved23 September 2021.
  14. ^"Commercial file SOBERANA Plus Eng"(PDF).finlay.edu.cu.
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