Coronavirus: Cuba’s vaccine candidate, Soberana 2, in phase 3

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Havana | The vaccine candidate against the coronavirus Soberana 2, developed by Cuba, entered phase 3 of clinical trials on Thursday, Cuban authorities announced, saying they are proud that it is the first Latin American vaccine to advance this far.

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“It is incredible that a small country like Cuba, an island materially poor, but very rich in human terms, has come this far”, underlined during a press conference Doctor Vicente Vérez, director of the institute of Finlay vaccination.

“Our Soberana, the first Latin American vaccine in phase 3!”, Welcomed on Twitter Cuban President Miguel Diaz-Canel.

The recruitment of 44,000 volunteers, aged 19 to 80, has already started and their vaccination should begin next week in Havana, the institute said.

This phase will “last for three months after the last dose injected”, indicated the deputy director of the institute, Yury Valdés, the group of volunteers being divided into three parts: some will receive two doses of Soberana 2 at 28 days of ‘difference, the other two doses plus one dose to boost immunity, and the third a placebo.

But even before the end of this phase, “the partial results can be used to advance further and for example to request an authorization for emergency use” of this vaccine, as has been done for other vaccines in the world, he added.

If Soberana 2 achieves final clearance, it would be the first COVID vaccine designed and produced in Latin America.

The communist country, which remains relatively unaffected by the disease, with 53,308 cases including 336 deaths for 11.2 million inhabitants, has set itself a goal of vaccinating its entire population this year.

“We are preparing to produce one to two million doses per month” in each of the two production sites, “and this should allow us to vaccinate the country in about six months, because the country needs 30 million doses”, s ‘he decides to apply three doses per vaccine, said Eduardo Ojito, director general of the Center for Molecular Immunology.

Then “we try to create a system to go up to 5-10 million monthly doses,” he added.

Under an American embargo since 1962, Cuba began to develop its own vaccines in the 1980s, notably discovering the first vaccine against meningococcus B, and today nearly 80% of the vaccines in its immunization program are produced locally.

Based on this experience, the country is working on four candidate vaccines against the coronavirus: Soberana 1 (currently in phase 2), Soberana 2, Abdala (who is waiting for the green light to go to phase 3), and Mambisa (in phase 1) .

The first three are given by injection, the fourth by nasal spray, with the main advantage that they do not need to be kept in extreme cold like some other vaccines.

A new clinical trial for a fifth candidate, Soberana +, which is based on a reformulation of Soberana 1, has just started for people recovering from the disease.

These projects use a recombinant protein, a technique also used in particular by the American biotechnology company Novavax.

The coronavirus has viral proteins on its surface that allow it to come into contact with cells to infect them. The recombinant protein aims to make the immune system react to this infection.