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publicado el 01/04/2022

Anti-Covid-19 vaccine candidate Mambisa will soon end up clinical trial.

The anti-Covid -19 vaccine candidate , the only one designed in Cuba to be used by nasal airway, is on the last stage of its clinical trial.

Gerardo Guillén, director of Biomedic Researches of the CIGB, entity located in the capital and developer of the inmunogenic, stated that to the date the results obtained from Phase I of the studies are confirmed, reported Prensa Latina.

Read: Candidato vacunal Mambisa incluido en la lista global de inmunógenos por vía nasal .

https://lahabana.gob.cu/post_detalles/es/11432/candidato -vacunal-mambisa-incluido-en-la-lista-global-de-inmunogenos-por-via-nasal

According to PL, the report of the investigation is expected to be presented to the National Regulatory Authority.

The aim is to get the aproval for Emergency Use of this drug and the Abdala vaccine as booster dose in the treatment of Covid-19 convalescents ,which means getting the aproval for the use of both drugs for this purpose.

If both groups selected comply with the success criteria, meaning that the subjects chosen increase four times the amount of anti-bpdies  or at least a 20% of the anti-bodies´capacity of inhibitting the SARS-COV-2 in a lab analitic test.

Guillén confirmed that outcomes from the investigation are expected to come out in a couple of weeks, wich will be announced at the International Congress of Cuban Biotechnology(BioHabana 2022), scheduled to be celebrated in the capital from April 25 to 29.

The Clinical Trial Mambisa, that is been carried  out at Clinico Quirúrgico Hermanos Amejeiras Hospital, in the capital, is about to conclude its Phase II, explained Iglemis Figueroa, main developer of the research.

According to Figueroa, 1040 Covid-19  convalescent subjects were included in the trial, divided into four groups: two of them vaccinated with a booster dose of Mambisa and the other two vaccinated with a booster dose of Abdala.

Despite the capital hospital was the only one selected for the development of the clinical trial , it was necessary to use some spaces in the provinces of Pinar del Río, Camagüey and Santiago de Cuba, detailed.

Related information:

Vacunas cubanas antiCOVID-19 son reconocidas por Organización Mundial de la Propiedad Intelectual.

Informan que Vacuna Abdala alcanza 100% de eficacia ante la enfermedad severa y la muerte en su ensayo fase III.

 

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