Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.[2]
 | |
 A vial of Soberana Plus | |
| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | Conjugate |
| Clinical data | |
| Trade names | Pasteur |
| Other names | FINLAY-FR-1A |
| Routes of administration | Intramuscular |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
Medical uses
editIt 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
editIt 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
editBooster dose
editSoberana Plus has also been studied as a booster dose for Soberana 02.[11][12]
Single dose
edit| 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
editOn 20 August 2021, Cuba approved Soberana Plus as a booster after two doses of Soberana 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
editReferences
edit- ^ "Patent Landscape Report COVID-19-related vaccines and therapeutics" (PDF).
- ^ a b Cuban Registry of Clinical Trials. "SOBERANA PLUS". Retrieved 2021-09-08.
- ^ "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.
- ^ Cuban Registry of Clinical Trials. "SOBERANA 02-FaseIII". Retrieved 2021-09-08.
- ^ "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.
- ^ Cuban Registry of Clinical Trials. "SOBERANA 01B". Retrieved 2021-09-08.
- ^ 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.
- ^ "Cuba says second COVID-19 vaccine Soberana 2 boasts 91.2% efficacy". Reuters. Retrieved 2021-09-23.
- ^ 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) - ^ 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) - ^ "SOBERANA 02-FaseIII". Retrieved 2021-09-09.
- ^ "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.
- ^ Dönmez BB (21 August 2021). "Cuba grants emergency use to 2 virus vaccines". Anadolu Agency. Retrieved 23 September 2021.
- ^ "Commercial file SOBERANA Plus Eng" (PDF). finlay.edu.cu.
