Soberana approved for emergency use in minors

Soberana approved for emergency use in minors
Fecha de publicación: 
1 September 2021
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Dr. Vicente Vérez Bencomo, general director at Finlay Vaccine Institute detailed in a radio-television program, dedicated to the immunization process in Cuba against Covid-19, that “the technological platform of Soberana 02 vaccine is being designed on the basis of child vaccines. And not only systemic antibodies are generated, but also those expressed at the mucosa level, which help fighting the infection.”

Regarding the clinical trial Soberana Pediatría, the professor pointed out that, in the case of adolescent from 12-18 years old, the 93% of them responded well to the first two doses of Soberana 02, while the other 7% fell short of the expected levels. On the other hand, in children from 3-11 years old, less than 1% did not meet the expected levels. With the third dose, the immune response was higher.

“We delivered the request to the regulatory authority to extend the emergency use authorization in pediatric population from 2-18 years old. To achieve it, the country needs 4.2 million doses, which are being produced right now and the process must be concluded by September 15th,” Dr. Bencomo added.

In relation to Soberana Plus, he also confirmed that “the plan is to use it as reinforcement to other existing vaccines like Sputnik and AstraZeneca. In some international studies and places where Cuba has collaborated, there is a marked interest in the capability of Soberana Plus to strengthening immunity as it is a proven effective vaccine.”

“You may have a natural immunity against the strain that affected you, but it will not be effective against a mutant strain. Therefore, it is crucial that we protect both convalescents and children.” He also highlighted that it is very likely that as children usually develop the disease in a mild way, their natural immunity may be weak.

We are getting close to make the request to extend the emergency use authorization to child convalescents. Soberana Plus in children who already got infected by Covid-19 would be “two months after they tested negative to the disease and proven healthy. 500,000 doses are needed to do so, which are being produced and must be ready by September.”

How long does the response of antibodies last?

The studies I and II of the combination of two doses of Soberana 02 with one dose of Soberana Plus proved that four or five months after the last shot, the number of antibodies drop slightly, but “remains above the level we believe positive,” detailed the director of the Finlay Vaccine Institute.

Although the quality of antibodies drops, but less, “we are having perhaps less number of antibodies, but those with higher affinity remains,” which is what we expect with the design of Soberana 02 and Plus. Likewise, he highlighted that “this study will allow us to know when to execute an immunity reinforcement.”

On the other side, Bencomo talked about the clinical trial Soberana Centro, which has in Soberana 01 its main approach. “We have witnessed that Soberana 01 is particularly effective in non-responders of the system.” Therefore, this vaccine candidate has the ability to increase the immune response in that small group on non-responders to vaccination.

Cienfuegos remains the hotspot for implementing the concept of immunological closure. “We want that the peak of immunity matches with the time in which the peak of the coverage to all population arrives. Having the highest number of individuals in a determined space with the best possible immune response, which may directly affect the virus spreading.”

Translated by Sergio A. Paneque Díaz / CubaSí Translation Staff

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