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Final phase of Mambisa clinical trials about to end

Final phase of Mambisa clinical trials about to end

Havana, Mar 31 (Prensa Latina) The final stage of the clinical trial of the Mambisa Covid-19 vaccine candidate, the only homegrown devised to be nasally administered, is about to end, media reported Thursday.
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According to Gerardo Guillen, director of Biomedical Research at the Center of Genetic Engineering and Biotechnology, the institution that created this vaccine, the results obtained in the first phase of the trial have been confirmed so far.

He told Granma daily that they will meet the plan of presenting the report of this research to the National Regulatory Authority.

He said that the final goal is to be granted the authorization for the emergency use of this vaccine candidate and Abdala vaccine as a booster shot for convalescents, that is, that either of them can be used for this purpose.

He added that this will happen if both groups meet the success criteria, meaning that volunteers increase their antibody titers at least four-fold or the ability of those antibodies to inhibit the SARS-COV-2 coronavirus by 20 percent in an analytic laboratory test.

The scientist said that they will have the results of the analyses in a couple of weeks, which will be announced at the International Biotechnology Congress (BioHabana 2022), slated in this capital from April 25 to 29.

The second phase of the clinical trial of Mambisa, carried out in Havana’s Hermanos Almejeiras Hospital, is about to end, its leading researcher, Iglemis Figueroa, said.

According to her, a total of 1,040 convalescing subjects were included in the trial, who were distributed in four gorups: two of them made up of those vaccinated with a Mambisa booster shot and another two with a single dose of Abdala.

Although this hospital was the only clinical place prepared for the trial, other places in the provinces of Pinar del Rio, Camagüey and Santiago de Cuba had to be set up as well, she said.


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