Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.[1]
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 |
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]
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]
Soberana Plus has also been studied as a booster dose for Soberana 02.[10][11]
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 |
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]
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