Since Monday Second Stage Phase III of Soberana 02 in Cuba

The phase III trial of Soberana 02 is demonstrating its efficiency
The phase III trial of Soberana 02 is demonstrating its efficiency. Photo: Prensa Latina

Havana, Cuba: The volunteers of the phase III study of the Cuban anti-Covid-19 Soberana 02 candidate will begin to receive the second dose of the vaccine next Monday, social networks highlight today.

The group of 44 thousand 10 subjects participating in the research in eight municipalities of this capital will be administered the product developed by the Finlay Vaccine Institute (IFV), after passing positively through the first phase, during which they will be injected the first dose of the drug or a placebo.

The initial stage, which began on March 8 last, was valued as a scientific milestone, by bringing together the joint work of various institutions.

Its execution involved several factors, from the certification of vaccinations, the training of personnel, the inclusion of subjects, to the handling of samples, adverse events, monitoring, to the communication strategy, explained the deputy director of the IFV, Yuri Valdes.

In the first week 4,779 volunteers were vaccinated, in the second 12,788, while in the following week the participants reached 17,945 to close with 8,112, he exemplified.

Computerizing and creating a database with all the necessary information was another challenge, and this is one of the most complex and innovative elements of the trial, he stressed.

Today Cuba has a database of vaccinated with which we would have the inventory, but not how to evaluate the efficacy, the impact on the disease, he pointed out.

The database does not contain how the disease transits -he explained-, and hence the need to articulate that information with the medical records of the Ministry of Public Health, to obtain the evolution data of all the PCR tests, which identify the disease virus.

The phase III trial of Soberana 02 is on track to demonstrate its efficacy, that is, its ability to protect people against disease. If everything goes positively, 70 percent of the Cuban population may be vaccinated between July and August, the expert said.

The second candidate that reached phase III trials, Abdala, in which 48 thousand volunteers participate, while several hundred health workers and institutions of the biopharmaceutical industry, do so in a study intervention.

The country is going through a complex epidemiological scenario these days, with figures that for the third consecutive day exceeded a thousand infected daily with the virus, although in recent weeks the cases oscillated between 700 and 800.

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