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April Thursday

Cuba to begin second dose of Soberana 02 Phase III next Monday in Havana

HAVANA, Cuba, Apr 2 (ACN) Next Monday begins the second dose for volunteers who received the Soberana 02 vaccine candidate on March 8, and successively the rest of the subjects will be immunized, while maintaining the intervention study in Havana with all the necessary rigor and approvals.

On March 31, the first vaccination of the 44,010 persons in the municipalities of Playa, Plaza de la Revolucion, Centro Habana, Habana Vieja, Cerro, La Lisa, Marianao and 10 de Octubre, involved in Phase III of the clinical trial to evaluate the efficacy, safety and immunogenicity of the Cuban drug against SARS-CoV-2, was completed.

This will be carried out in two-dose schemes and in a two-dose scheme with a booster, for the 19 to 80-year-old population, reiterated Yuri Valdes Balbin, deputy director of the Finlay Vaccine Institute (IFV), at Thursday's Informative Program Mesa Redonda.

During the first week, 4,779 people were immunized, in the second week 12,788 and in the third week 17,945, in the 31 clinical sites and 48 vaccination points that were established, the expert pointed out.

The Immunoassay Center, like other entities of the BioCubaFarma Group, also contributes to the Phase III clinical trial of the Soberana 02 vaccine candidate with a diagnostic test, which evaluates the performance of that product.

In just one year, the center developed five diagnostic tests based on SUMA technology for the follow-up of SARS-CoV-2 infection, which detect antibodies and are useful in epidemiological studies that measure the level of exposure of a certain population to the disease.
Among the main milestones achieved by Soberana 02 are the start of Phase I in October, Phase II in December, the production of the first 150,000 doses in February and the start of Phase III in March.

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