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News > Cuba

Third Cuban Vaccine, Soberana Plus, Approved for Emergency Use

  • Soberana 02 together with Soberana Plus achieved an efficacy of 91.2% in the prevention of the symptomatic COVID-19 disease in its Phase III clinical trials.

    Soberana 02 together with Soberana Plus achieved an efficacy of 91.2% in the prevention of the symptomatic COVID-19 disease in its Phase III clinical trials. | Photo: Cubadebate

Published 24 September 2021 (9 hours 23 minutes ago)
Opinion

On Thursday, September 23, the Center for State Control of Medicines, Equipment and Medical Devices (CECMED) approved the Authorization for Emergency Use (AUE) of the Cuban vaccine Soberana Plus, whose holder is the Finlay Vaccine Institute (IFV).

With this authorization, its indication is extended to the COVID-19 convalescent population over 19 years of age, two months or more after their medical discharge from the hospital or at home, in accordance with the regulations and provisions in force, once it has been proven that it meets the requirements in terms of quality, safety and immunogenicity for this population group.

The team of CECMED inspectors is this week carrying out inspections to the clinical sites in Cienfuegos and from there they completed the evaluation process of this vaccine, in order to speed up the vaccination process of all convalescents in the country, informed the Cuban regulatory authority.

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Soberana 02, Soberana Plus Vaccines Approved by Cuban Agency

The open-ended Phase I clinical trial of Soberana Plus included 30 men and women aged 22 to 57 years, convalescents of COVID-19, who had been diagnosed as mild, and asymptomatic or subclinical. Participants joined the study an average of eight months after hospital discharge or serological diagnosis of SARS-CoV-2 infection.

In addition to its safety and tolerability, the most remarkable results reported the strong immune response developed, which was also confirmed in a Phase II trial with a larger number of participants. The vaccine produced a large increase in antibody levels on day 28 post-vaccination with mean values 21 times higher than the pre-vaccination levels of the subjects studied.

Last August 20, and after concluding the rigorous evaluation process of the vaccine candidates Soberana 02 and Soberana Plus, the CECMED decided to grant the Authorization for Use in Emergencies (AUE) to these vaccines in accordance with the regulations and provisions in force, for their combined scheme of two doses of Soberana 02 plus a booster dose of Soberana Plus, in people over 19 years of age.

"One dose of SoberanaPlus is sufficient to re-stimulate the immunity that developed as a result of the natural infection. Evidence shows that the levels of immunity achieved should be able to protect against delta."

This scheme achieved an efficacy of 91.2% in the prevention of symptomatic disease in its Phase III clinical trial.

In recent days, the prestigious international journal The Lancet Regional Health-Americas, of the Lancet series, included in its pages the first publication of a clinical trial specifically designed to study the impact of a vaccine in people who have already suffered from COVID-19 and are at risk of reinfection. The protagonist of the text is precisely the Cuban vaccine Soberana Plus.

The publication in this high-impact peer-reviewed journal endorses the results of the Cuban immunogen, especially its role in the prevention of reinfection by new SARS-CoV-2 variants, such as delta, in convalescent persons, and also, and no less significantly, its potential as a booster dose for other vaccines, regardless of the technological platform on which they have been developed.

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