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]
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 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 | |
| Part of a series on the |
| COVID-19 pandemic |
|---|
 Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom. |
|
.svg.png.webp){kind=small} COVID-19 portal |
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]
Clinical trials
Booster dose
Soberana Plus has also been studied as a booster dose for Soberana 02.[10][11]
Single dose
| 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
- Cuban Registry of Clinical Trials. "SOBERANA PLUS". Retrieved 2021-09-08.
{{cite web}}: CS1 maint: url-status (link) - "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.
{{cite web}}: CS1 maint: url-status (link) - "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.
{{cite web}}: CS1 maint: url-status (link) - 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.
- "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.
{{cite web}}: CS1 maint: url-status (link) - "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.
- 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.
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