How is Mambisa progressing on the road to authorization as an anti-COVID-19 vaccine?

Candidato vacunal Mambisa, de Cuba.
Candidato vacunal Mambisa, de Cuba.
Candidato vacunal Mambisa, de Cuba.

The vaccine candidate Mambisa – developed by the Center for Genetic Engineering and Biotechnology (CIGB) – is currently in the final stages of clinical trials and, based on the results obtained in the analyses, will apply to the Center for State Control of Medicines, Equipment and Medical Devices for authorization for emergency use as a booster dose in the next few weeks.

Adoption or the right to a family

Candidato vacunal Mambisa, de Cuba.
Candidato vacunal Mambisa, de Cuba.

The vaccine candidate Mambisa – developed by the Center for Genetic Engineering and Biotechnology (CIGB) – is currently in the final stages of clinical trials and, based on the results obtained in the analyses, will apply to the Center for State Control of Medicines, Equipment and Medical Devices for authorization for emergency use as a booster dose in the next few weeks.

Mambisa, whose route of administration is intranasal, is part of two studies, combined with the Abdala vaccine (also from CIGB): one in subjects convalescing from COVID-19, who have not received any immunogen previously, and the other in healthy persons with a previous primary vaccination schedule.

About the first study, carried out primarily in the Hermanos Ameijeiras Hospital, in Havana, Iglemis Figueroa García, main investigator of this clinical study, explained to Granma newspapers that it is a phase I/II trial that started in July 2021. Phase I has been successfully completed, demonstrating the safety of the vaccine candidate.

At the moment -she added- phase II is about to be completed. It has a total of 1,040 convalescent subjects distributed in four groups: two vaccinated with a booster dose of Mambisa, and two others with a dose of Abdala.

Vacuna Abdala y con el candidato Mambisa en convalecientes de la COVID-19.Imagen wen: Santiago Romero Chang
Vacuna Abdala y con el candidato Mambisa en convalecientes de la COVID-19.Imagen wen: Santiago Romero Chang

The researcher pointed out that, initially, the Ameijeiras Hospital was the only site for the clinical trial, it was later spread in sites in the provinces of Pinar del Río, Camagüey and Santiago de Cuba, in order to reach the expected number of convalescent subjects not previously vaccinated in Havana, as most of the inhabitants of the capital had received at least one does of the vaccine by the end of since by the end of.

Regarding the objective of this clinical study, Gerardo Guillén Nieto, PhD, director of Biomedical Research at the CIGB, explained that the final purpose «is to obtain the authorization for emergency use of both vaccines (Mambisa and Abdala) as booster doses in convalescents, that is to say, that either of the two immunogens can be used indistinctly. This depends on the two groups in the study meeting the success criteria, which consists of the volunteers increasing their antibody titers by at least four times, or by 20% the capacity of these antibodies to inhibit the SARS-COV-2 virus in an analytical laboratory test, which is done to check the capacity of antibodies in the patients’ sera».

The prominent researcher stated that they hope to have the results of the laboratory analysis in a couple of weeks, which would be announced at the International Congress of Cuban Biotechnology (BioHabana 2022), scheduled to be held in the Cuban capital from April 25 to April 29.

Regarding the clinical trial on previously immunized healthy volunteers, Dr. Guillén Nieto stated that it included 2,220 subjects who received the initial vaccination scheme with three doses of Abdala, and five and a half months later half of them received a boost dose with Mambisa, and the other half with Abdala.

This study -called Baconao and carried out in Matanzas- has already concluded the inclusion, vaccination, sample collection and laboratory analysis, delivering the data to the Institute of Cybernetics, Mathematics and Physics, in charge of the statistical processing of the results, to be included in the final report of the study, he said.

The Director of Biomedical Research of the CIGB expressed the satisfaction with the results obtained so far. «The results obtained in Phase I of the study have been confirmed, so we hope to be able to present the study report to the National Regulatory Authority to request the authorization for the emergency use of Mambisa,» he said.

He clarified that Abdala already received an Emergency Use Authorization as a vaccine for primary immunization, but in this case, the CIGB would request the authorization as a booster dose, since this immunogen has also been studied as a booster in vaccinated patients.

Dr. Guillén Nieto pointed out that Mambisa is one of the 11 vaccine candidates using the nasal route of administration in the world that have reached the clinical study phase, and is the only one obtained by genetic engineering, that is to say, with recombinant protein, a protein with more than 99% purity, which makes it a very safe drug.

In turn, it contains the same vaccine antigen used in Abdala, which is already authorized as a vaccine and which has been used in the immunization of more than eight million Cubans, he said.

Translated by ESTI

Cuba’s Mambisa among the world’s five nasal anti-Covid-19 vaccine candidates
Cuba’s Mambisa among the world’s five nasal anti-Covid-19 vaccine candidates. Image: Santiago Romero Chang

Author: Liz Conde Sánchez | internet@granma.cu

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