Soberana Plus

Short description: Vaccine

Soberana Plus

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|

* Full list of Soberana Plus authorizations

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

## Contents

* 1 Medical uses
* 1.1 Efficacy
* 2 Clinical trials
* 2.1 Booster dose
* 2.2 Single dose
* 3 Authorizations
* 4 See also
* 5 References

## 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

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 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

* Soberana 02

## References

1. ↑ 1.0 1.1 Cuban Registry of Clinical Trials. "SOBERANA PLUS". https://rpcec.sld.cu/trials/RPCEC00000366-En.
2. ↑ "ماجرای تزریق اشتباهی واکسن کرونا" (in fa). 2021-08-31. https://www.isna.ir/news/1400061007069/ماجرای-تزریق-اشتباهی-واکسن-کرونا.
3. ↑ Cuban Registry of Clinical Trials. "SOBERANA 02-FaseIII". https://rpcec.sld.cu/trials/RPCEC00000354-En.
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". https://www.irct.ir/trial/54833.
5. ↑ Cuban Registry of Clinical Trials.. "SOBERANA 01B". https://rpcec.sld.cu/en/trials/RPCEC00000349-En.
6. ↑ "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.
7. ↑ "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/.
8. ↑ 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.
9. ↑ (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.
10. ↑ "SOBERANA 02-FaseIII". https://rpcec.sld.cu/trials/RPCEC00000354-En.
11. ↑ "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.
12. ↑ "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.
13. ↑ "Commercial file SOBERANA Plus Eng". https://www.finlay.edu.cu/blog/wp-content/uploads/2021/12/Commercial-file-SOBERANA-Plus-Eng.pdf.

* v
* t
* e

Artificial induction of immunity / Immunization: Vaccines, Vaccination, Infection, Biology:Inoculat, Inoculation (J07)

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