The country's leadership and the health authorities agreed on the convenience of applying the first booster dose with the Cuban anti-COVID-19 vaccines, to adolescents and young people between the ages of 12 and 18 who have completed six months of the complete scheme of the primary vaccination.
The proposal was adopted at this week's meeting between the First Secretary of the Central Committee of the Party and President of the Republic, Miguel Díaz-Canel Bermúdez, and the Prime Minister, Manuel Marrero Cruz, with scientists and experts who participate in science activities and technological innovation to confront the coronavirus.
The campaign will cover about 848,000 individuals of these ages. Until now the booster dose was applicable to people 19 years of age and older. The meeting also evaluated another group of actions as part of the vaccination strategy.
One of them was the proposal for new clinical trials, this time in pediatric ages (infants), which are in the evaluation stage by the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed).
Dr. Ileana Morales Suárez, director of Science and Technological Innovation of the Ministry of Public Health (MINSAP), explained that one trial will be the Pequeñuelo Study, Phase I/II, which is promoted by the Center for Genetic Engineering and Biotechnology (CIGB) with the Abdala vaccine, and it will be developed in Havana.
The other trial proposed to Cecmed is the Soberana Futuro Study, Phase I/II, whose promoter center is the Finlay Vaccine Institute. It will take place in Havana and Cienfuegos.
In the meeting, in which the Deputy Prime Minister Inés María Chapman Waugh and the head of the MINSAP, José Angel Portal Miranda, also participated, it was agreed to carry out an intervention with the age group between one year and one year, 11 months and 29 days.
Morales Suárez pointed out that he will take into account previous safety and immunogenicity studies carried out in pediatric ages. He explained that it will be carried out progressively and in two stages:
First stage: Introduction of vaccination through a pharmacovigilance study in girls and boys between one year and one year, 11 months and 29 days. The trial will be carried out in Camagüey, with the Abdala vaccine, and in Cienfuegos, with the Soberanas.
Second stage: Once the first stage is advanced, a partial safety report will be prepared and sent to the Regulatory Authority, which will evaluate its results and those obtained in previous studies. If favorable, it will extend the Emergency Use Authorization to this age group. Once approved, the vaccines will be applied regionally.
It was also proposed to reinforce high-risk groups with the vaccines approved for this, with a second booster dose (it will be carried out after six months of the first booster). People over 60 years of age and immunocompromised people (cancer patients, chronic kidney diseases, transplant recipients, people with immunodeficiencies, among others) are included.
With the purpose of developing other studies that will allow defining new needs for booster doses, the period of application of these and the conditions in which they must be developed, a study on the duration of the immune response in BioCubaFarma workers was also proposed, and another on the duration of the immune response in health workers, with primary vaccination and booster doses, from the IPK and other institutions.
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