Soberana Plus

Soberana Plus
	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	Full list of Soberana Plus authorizations;
Identifiers
CAS Number	2695520-51-3;

Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.^[2]

Medical uses

It 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

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

Booster dose

Soberana Plus has also been studied as a booster dose for Soberana 02.^[11]^[12]

Single dose

Clinical trials of single-dose Soberana Plus
Phase	Registration		Number of participants			Age of participants
Phase	ID	Date	Total	Vaccine	Control	Age of participants
I	RPCEC00000349	2021-01-05	30	30	0	18-55 years
IIa	RPCEC00000366	2021-04-09	20	20	0	19-80 years
IIb	RPCEC00000366	2021-04-09	430		Placebo-controlled	19-80 years

Authorizations

On 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]

References

^ "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.

[1] "Patent Landscape Report COVID-19-related vaccines and therapeutics" (PDF).

[:0-2] Cuban Registry of Clinical Trials. "SOBERANA PLUS". Retrieved 2021-09-08.

[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. Retrieved 2021-09-08.

[4] Cuban Registry of Clinical Trials. "SOBERANA 02-FaseIII". Retrieved 2021-09-08.

[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. Retrieved 2021-09-08.

[:1-6] Cuban Registry of Clinical Trials. "SOBERANA 01B". Retrieved 2021-09-08.

[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.

[:4-8] "Cuba says second COVID-19 vaccine Soberana 2 boasts 91.2% efficacy". Reuters. Retrieved 2021-09-23.

[:8-9] 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)

[:9-10] 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)

[:6-11] "SOBERANA 02-FaseIII". Retrieved 2021-09-09.

[:7-12] "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 from the original on 2021-09-07. Retrieved 2021-09-07.

[13] Dönmez BB (21 August 2021). "Cuba grants emergency use to 2 virus vaccines". Anadolu Agency. Retrieved 23 September 2021.

[14] "Commercial file SOBERANA Plus Eng" (PDF). finlay.edu.cu.

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