Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.[1]
 | |
 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 | |
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]
.svg){kind=small}