Soberana Plus Explained

Type:vaccine
Vaccine Type:conjugate
Target:SARS-CoV-2
Tradename:Pasteur
Legal Status:Full list of Soberana Plus authorizations
Routes Of Administration:Intramuscular
Synonyms:FINLAY-FR-1A

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.[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! colspan="2"
RegistrationNumber of participantsAge of participants
IDDateTotalVaccineControl
IRPCEC000003492021-01-053030018-55 years
IIaRPCEC000003662021-04-092020019-80 years
IIb430Placebo-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

Notes and References

  1. Web site: Cuban Registry of Clinical Trials. SOBERANA PLUS. 2021-09-08.
  2. Web site: 2021-08-31. ماجرای تزریق اشتباهی واکسن کرونا . The story of the wrong injection of the corona vaccine . 2021-09-08. Iranian Students' News Agency (ISNA) . fa.
  3. Web site: Cuban Registry of Clinical Trials. SOBERANA 02-FaseIII. 2021-09-08.
  4. Web site: 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. 2021-09-08. www.irct.ir.
  5. Web site: Cuban Registry of Clinical Trials.. SOBERANA 01B. 2021-09-08.
  6. Chang-Monteagudo A, Ochoa-Azze R, Climent-Ruiz Y, Macias-Abraham C, Rodriguez-Noda L, Valenzuela-Silva C, Sanchez-Ramirez B, Perez-Nicado R, Gonzalez-Mugica R, Hernandez-Garcia T, Orosa-Vazquez I . 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 . 2021 . 10.1101/2021.02.22.21252091.
  7. News: Cuba says second COVID-19 vaccine Soberana 2 boasts 91.2% efficacy. en-US. Reuters. 2021-09-23.
  8. Toledo-Romani ME, Garcia-Carmenate M, Silva CV, Baldoquin-Rodriguez W, Pérez MM, Gonzalez MC, Moreno BP, Hernández IC, González-Mujica Romero R, Tabio OS, Velazco Villares PM . 8 . 2021-11-01. Efficacy and Safety of SOBERANA 02, a COVID-19 conjugate vaccine in heterologous three doses combination . 2021.10.31.21265703. 10.1101/2021.10.31.21265703. 240302516 .
  9. Toledo-Romani ME, Garcia-Carmenate M, Silva CV, Baldoquin-Rodriguez W, Perez MM, Gonzalez MC, Moreno BP, Hernandez IM, Romero RG, Tabio OS, Villares PV . 6 . 2021-11-06. Efficacy and safety of SOBERANA 02, a COVID-19 conjugate vaccine in heterologous three-dose combination . en . 2021.10.31.21265703 . 10.1101/2021.10.31.21265703 . 240302516 .
  10. Web site: SOBERANA 02-FaseIII. 2021-09-09.
  11. Web site: 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. 2021-09-07. en.irct.ir. 2021-09-07. https://web.archive.org/web/20210907170221/https://en.irct.ir/trial/54833. dead.
  12. News: Dönmez BB . Cuba grants emergency use to 2 virus vaccines . 23 September 2021 . Anadolu Agency . 21 August 2021.
  13. Web site: Commercial file SOBERANA Plus Eng . finlay.edu.cu.

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Soberana Plus".

Except where otherwise indicated, Everything.Explained.Today is © Copyright 2009-2024, A B Cryer, All Rights Reserved. Cookie policy.