Cuba is ready for the most worrisome mutation of SARS-CoV-2

HAVANA, Cuba, Apr 9 (ACN) Cuba is prepared for the most worrying mutation of SARS-CoV-2 so far, the E484K, which decreases to a greater extent the neutralizing capacity of antibodies, both in convalescents and vaccinated people.

We have the genes that code for the Receptor Binding Domain (rbd) variant of this mutation of the new coronavirus first identified in South Africa, said Eduardo Martinez Diaz, president of the Group of the Biotechnological and Pharmaceutical Industries of Cuba (BioCubaFarma).

PhD Martinez pointed out that the E484K is common in the three most dangerous variants of the virus: the one that appeared in the United Kingdom, the one in Brazil and Japan, and the South African one.

In this sense, he expressed that there is a working group, in coordination with the Pedro Kourí Institute of Tropical Medicine, focused on obtaining new antigens for vaccine variants.

Many experiments are being carried out, even to predict possible mutations that could escape the protection capabilities of current drugs, and in that case, we would have the antigens ready to incorporate them into our vaccine candidates or develop others, said the expert.

However, he explained, to date no scientific result has shown that one of the mutants escapes the capacity of the vaccines obtained in the world against COVID-19, and the levels of antibodies of the Cuban proposals are at the same level or higher than the others.

Martinez Diaz added that the neutralizing potential of the virus has been reduced, up to 10 times in the Pfizer and up to 12 times in the Moderna, that is why it is important to have high levels of antibodies and that is why in Cuba it was decided to apply a third dose.

As regards the progress of the Phase III clinical trials, he assured that they are progressing positively; the application of the second dose of Soberana 02 is expected to be completed on April 28 - when the inoculation of one of the groups will be concluded -, while others will finish with the third administration on May 26.

On the other hand, the second dose of Abdala is expected to be completed on April 17 and the third dose on May 1; therefore, he emphasized, between the second half of May and June, the first cut of the study could be made and effectiveness data could be available to opt for an authorization of emergency use.

Martinez Diaz added that, at the same time, the intervention study in healthcare workers and the biopharmaceutical sector is progressing at a rate of 78 percent, and between tomorrow and Saturday the first dose should be completed.

In addition, he said that they plan to carry out other intervention studies to further scale up vaccination in the population, in order to guarantee the safety of the candidates in a larger number of people, in the context of the real world and to move this process forward.

This is possible, he emphasized, because risk analyses have been made where the safety of the drugs is evidenced, and most of the events after vaccination are mild and moderate, with favorable levels of induced immune response.

The executive also explained that they continue working with the other vaccine candidates, for which they soon expect the authorization of the Phase II clinical study in convalescents with Soberana Plus, and they are requesting a clinical study in convalescents with Mambisa.
In addition, they are preparing the protocols of Soberana 02 and Abdala for their evaluation in children from 5 to 18 years of age, and a clinical study with Soberana 01 is planned for another region of the country, he said.

The president of BioCubaFarma said that in order to assume these projections, the country has six plants participating in the production of vaccines, and they already assume the final step in obtaining the antigen for the formulations, over two thousand liters of fermentation.