Medicine:Soberana Plus
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 A vial of Soberana Plus | |
| Vaccine description | |
|---|---|
| Target disease | SARS-CoV-2 |
| Type | Conjugate vaccine |
| Clinical data | |
| Trade names | Pasteur |
| Other names | FINLAY-FR-1A |
| Routes of administration | Intramuscular |
| Legal status | |
| Legal status |
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Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.[1]
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] The final result of a third dose of Soberana Plus increased the efficacy up to 92.4%.[8] Efficacy against severe disease and death is 100% for the heterologous three-dose regimen.[9]
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
- ↑ 1.0 1.1 Cuban Registry of Clinical Trials. "SOBERANA PLUS". https://rpcec.sld.cu/trials/RPCEC00000366-En.
- ↑ "ماجرای تزریق اشتباهی واکسن کرونا" (in fa). 2021-08-31. https://www.isna.ir/news/1400061007069/ماجرای-تزریق-اشتباهی-واکسن-کرونا.
- ↑ Cuban Registry of Clinical Trials. "SOBERANA 02-FaseIII". https://rpcec.sld.cu/trials/RPCEC00000354-En.
- ↑ "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". https://www.irct.ir/trial/54833.
- ↑ Cuban Registry of Clinical Trials.. "SOBERANA 01B". https://rpcec.sld.cu/en/trials/RPCEC00000349-En.
- ↑ "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. 2021. doi:10.1101/2021.02.22.21252091.
- ↑ "Cuba says second COVID-19 vaccine Soberana 2 boasts 91.2% efficacy" (in en-US). Reuters. https://www.reuters.com/business/healthcare-pharmaceuticals/cuba-says-second-covid-vaccine-soberana-2-boasts-912-efficacy-2021-07-09/.
- ↑ Efficacy and Safety of SOBERANA 02, a COVID-19 conjugate vaccine in heterologous three doses combination. 2021-11-01. pp. 2021.10.31.21265703. doi:10.1101/2021.10.31.21265703.
- ↑ (in en) Efficacy and safety of SOBERANA 02, a COVID-19 conjugate vaccine in heterologous three-dose combination. 2021-11-06. pp. 2021.10.31.21265703. doi:10.1101/2021.10.31.21265703.
- ↑ "SOBERANA 02-FaseIII". https://rpcec.sld.cu/trials/RPCEC00000354-En.
- ↑ "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". https://en.irct.ir/trial/54833.
- ↑ "Cuba grants emergency use to 2 virus vaccines". Anadolu Agency. 21 August 2021. https://www.aa.com.tr/en/latest-on-coronavirus-outbreak/cuba-grants-emergency-use-to-2-virus-vaccines/2341850.
- ↑ "Commercial file SOBERANA Plus Eng". https://www.finlay.edu.cu/blog/wp-content/uploads/2021/12/Commercial-file-SOBERANA-Plus-Eng.pdf.
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