HAVANA, March 16 Cuban authorities denied on Tuesday that they had tested Sovereign 02 or other vaccine candidates on children or tourists who visited the island.
“No child has been vaccinated in any of the three phases of clinical trials of Soberana 02, nor in any of the phases through which the other vaccine candidates have already passed,” said the official Cubadebate media outlet.
“This will not be done until vaccines demonstrate their effectiveness in adults.” “Soberana 02 has only been tested in Havana, where teaching activities have been suspended since January, so schools are closed and it is impossible for children to have been vaccinated there,” added the media.
While the MINSAP recently announced progress in phase III of its clinical trial of the vaccine candidate Soberana 02 and is preparing to begin the same process for the candidate Abdala, this week the health authorities reported mild adverse events and discomfort in some of the people who received the dose of Sovereign 02.
In Miami news media this week, testimonies of an alleged Cuban mother circulated, who spoke of adverse reactions to the vaccine in children admitted to a pediatric hospital, or of tourists vaccinated on the island.
At the beginning of March, Dagmar García Rivero, Director of Research at the Finlay Vaccine Institute (IFV), stated that “advancing to a clinical trial in children carries a higher regulatory rigor, and therefore it is usually necessary to advance in adult populations before evaluating vaccine candidates in children ”.
However, the specialist said that the Cuban government does not rule out starting tests on children soon. “We remain determined to move to pediatric clinical trials in the short term. This clinical trial is currently under review. We would be talking about evaluating the best formulation of the Soberana 01 and Soberana 02 vaccine candidates in the pediatric population.
We have decided to move in the age range of 5 to 18 years of age, starting first in the population of 12 to 18. Once security is covered in this group, we would go down to the age range of 5 to 12 years. That is what we can say so far, because it is not yet a clinical trial that we have submitted to the national regulatory entity, ”said García Rivero. “In April we could be starting the pediatric clinical trial,” she concluded.
The government publication also ruled out that Cuba had supplied the Sovereign 02 vaccine to Italian and European tourists and assured that the authorities have not officially promoted the so-called “vaccine tourism.
“The country advances in the first place to immunize its entire population before the end of 2021,” said Cubadebate. The Cuban authorities also denied having received any kind of “donation” of vaccines, much less to apply to tourists.
Although Cuba, the supposed “medical power”, is the only country in Latin America that has not yet started a massive vaccination campaign against the coronavirus, the government has used the official press to proclaim the virtues of the five Cuban vaccine candidates: Sovereign 01, 02 and Plus, Abdala and Mambisa, whom he calls “genuine fruits of Cuban science.”
With 42,000 volunteers to test the vaccine in Cuba and about 100,000 in Iran, Sovereign 02 is expected to soon get the green light from the local pharmaceutical regulator, the Center for State Control of Medicines, Equipment, and Devices (Cecmed).
The executives of BioCubaFarma, the state company responsible for research and development of vaccines, estimate that – provided the tests go well – Cuba could manufacture 100 million doses this year.
Meanwhile, the Cuban Ministry of Public Health (MINSAP) reported this Tuesday three deaths from coronavirus in Cuba and 792 new infections. 23,140 patients are kept in isolation centers and Cuban hospitals for epidemiological clinical surveillance. Of these, 3,746 people are suspected cases and 3,956 are confirmed active.