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Coronavirus | The “excellent results” of Soberana Plus, the Cuban vaccine

The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) approved on Friday the phase II clinical trial of the vaccine candidate Soberana Plus in COVID-19 patients, the institution indicated in a release. Its about “First clinical trial in convalescent patients with a COVID vaccine worldwide”, highlights Vicente Vérez Bencomo, general director of the Instituto Finlay de Vacunas (IFV), in statements collected by BioCubaFarma. “The vaccine has been applied, and in the people that it has been applied it has been agreed that some are convalescing. It has been studied what has happened when the vaccine is applied to this population, but we we decided to design a clinical trial with this group, because the main threat they have is the risk of new strains”.

For her part, Dr. Dagmar García Rivera, IFV’s director of research, highlighted on social networks the “Excellent safety and immunogenicity results with a single dose in phase I” and rated this moment as “Another step for the vaccination of the convalescent, today more necessary in the scenario of mutants”.

The truth is that Cuba has registered a gradual increase in SARS-CoV-2 variants in recent months, according to Dr. María Guadalupe Guzmán, director of the Center for Research, Diagnosis and Reference of the Pedro Kourí Institute (IPK). At the moment, Five variants and six mutational patterns of the disease circulate in the country, with a change in pattern compared to what was observed in 2020, when only the D614G variant was detected.

Strengthens the immune response

Soberana plus is the fifth vaccine candidate developed by Cuba. “With this candidate we select and stimulate only the response against COVID-19 and not against other elements that have been in the pandemic. We believe that this candidate has an important advantage because of his very high security in the convalescentAn aspect that has not occurred with other vaccines, where adverse effects in this group are high, ”explains Vérez.

Likewise, the expert pointed out the ability of the drug to reinforce the immune response that Soberana 02 may produce: “It is not a dose of the same vaccine, we are talking about that combination of two doses of Soberana 02 with one of Soberana Plus raises the immune response even more”. “We also know that the application of a dose of Soberana Plus on subjects with two doses of Soberana 02 is much better than the application of a third of Soberana 02, he added before revealing that “in Phase III the efficacy of the two doses of Soberana 02 will be verified, and of the two of Soberana 02 plus the dose of Soberana Plus, because depending on the new strains that may arise we will have alternatives to be prepared for the future ”.

Finally, Vérez commented that its efficacy against the new variants will also be measured in clinical trials and revealed that Cuban scientists are immersed in obtaining the recombinant protein of this new combination of mutations, to be assembled in the concept of Soberana Plus: “It could be that there was a Sovereign Plus that had the recombinant protein of the new strains and that served as reinforcement. That is the global strategy we have with regard to the new strains, and we believe that combining the three aspects can be very effective ”.

Who will participate in the trial?

Phase two of the clinical trials will take place in the Institute of Hematology and Immunology and the National Center for Sex Education. It will be a randomized, double-blind, placebo-controlled study in which “they will participate convalescent Cuban adults, of both sexes, in ages between 19-80 years, with a history of mild or moderate COVID-19, or asymptomatic infection “, as specified by the CECMED. These volunteers may have a body mass index between 18.5 and 34.9 kg / m2. In addition, individuals with grade I obesity, as detailed in the Public Registry of Clinical Trials.

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