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publicado el 25/06/2021

CECMED Evaluates the Abdala Vaccine Candidate for Emergency Use Approval

The dossier of the Abdala vaccine candidate, with an efficiency of 92.28%, has already been submitted by its developer, the Center for Genetic Engineering and Biotechnology (CIGB), to the Cuban regulatory entity, the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), to obtain the authorization for emergency use.

Since the results are positive, this authorization is expected in the next few weeks, informed Eduardo Martínez Díaz, president of BioCubaFarma, at a press conference today. He stressed that CECMED has accompanied the whole process of the development of the Cuban vaccine candidates, with inspections to the production plants and the evaluation of the information that has been generated.

At a press conference, it was informed that the Finlay Vaccine Institute will deliver next week to CECMED the dossier of Soberana 02, which has an efficacy of 62% in two doses.

Representatives of BioCubaFarma, the Finlay Vaccine Institute and the Center for Genetic Engineering and Biotechnology give details on the results of Soberana 02 and Abdala.

Efficacy of Soberana 02 + Soberana Plus scheme evaluated

The director of the Finlay Vaccine Institute, Vicente Verez, said that efficacy is currently being measured in the third dose in which the Soberana Plus candidate is used. "When an analysis of the immune response is made, it is found that the number of subjects that exceed the threshold that correlates neutralizing antibodies should be between 85% and 95%."

This study, which does not yet provide an exact correlation, has been carried out in a province where there is a high presence of the so-called "strains of concern".

When this result is available, the dossier will be submitted to CECMED.

He added that "a high efficacy is expected with the third dose, because there are 96% of the people (of the group studied) that correlate with a high immunity. This does not mean that these people are protected against the disease, but that it is a forecast with an important level of approximation".

An increase in efficacy of between 85 and 95% is expected.

Source: Cubadebate

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