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Second Cuban COVID vaccine ready for Phase III clinical trials

HAVANA, Cuba, Feb 26 (ACN) Cuba has technological platforms, professional experience, genetic engineering and the capacity to conjugate vaccine candidates to obtain better immunogens, which is why the country is moving forward with four anti-Covid-19 vaccine projects.

This is what Marta Ayala Ávila, general director of the Center for Genetic Engineering and Biotechnology, said today in Havana during a press tour of the institution, which develops Abdala and Mambisa, two of the Cuban vaccine candidates.

She said that Abdala, the most advanced one, is in preparation to start its Phase III clinical trials in March, when it will be approved by the Cuban government, when it will be approved by the Center for the State Control of Medicines, Equipment and Medical Devices (CECMED).

She pointed out that each phase increases the number of individuals immunized against the disease, and added that the first phase began at the Saturnino Lora hospital in Santiago de Cuba, with 132 volunteers, and that on the 42nd day of intramuscular application the results were very good.

Hence, on February 1, Phase II of the study began in the same eastern institution, where immunizations have already been administered and 660 people have already been immunized, and were able to neutralize the effect of the virus on the cells, she said.

For Abdala, she said, two immunization schedules have been designed: a short one, in which the individual is immunized on the days of the week, and a short one, in which the individual is immunized on the days of the week.

The other is called long because immunization occurs on days 0, 28 and 56, and the response is evaluated at day 70.

The product is based on the formulation of the RBD (Receptor Binding Domain) protein adjuvanted in aluminum hydroxide, while Mambisa, the other vaccine candidate developed by the CIGB, is based on the formulation developed by CIGB, is a combination of the nucleocapsid antigen of the Hepatitis B virus (AgnHB) and the Hepatitis B virus nucleocapsid antigen (AgnHB) combined with specific proteins.

Mambisa initiated the Phase I/II study on December 7, 2020 at the National Toxicology Center, in Havana, where 88 volunteers received the doses and have reported only mild and low intensity adverse reactions.

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