In statements to Prensa Latina, authorities from the center explained that studies on this population group carry more in-depth, detailed analysis, with greater rigour and investigation time than normal ones, considered already quite fast in the contingency of the Covid-19 pandemic.
‘The health of the pregnant woman is that of a healthy adult woman, but there are special studies of teratogenesis, where it is possible to demonstrate that the application of the product does not affect the fetus,’ explained Dr. Vicente Vérez, director of the IFV.
In the case of immunization with Soberana 02 and Soberana Plus, progress has been made in these investigations. Once concluded, we will be in a position to develop a trial or include pregnant women among the people to be vaccinated, said Dr. Vérez.
In this sense, the National Center for Medical Genetics studies women who have become pregnant after receiving a dose of Cuban vaccine candidates.
So far, the effect of these injectables on reproduction has not yet been demonstrated, explained Finlay’s research director, Dagmar García. It is also necessary to carefully analyze the experience on this subject in different countries with other vaccines and to expand the tests on animals.
‘The logic with pregnant women and lactation is in the focus of the research and development of Cuban vaccine candidates, but we must comply with the rigor of preclinical and clinical research in this very vulnerable population,’ said García.
She added that previous analyses showed the transfer of maternal-fetal antibodies in the animals, which constitutes an added value in the face of a possible vaccination of the pregnant woman.
For his part, Dr. Rolando Pérez, director of Science and Innovation of the Cuban Group of Biotechnology and Pharmaceutical Industries, indicated that the risk-benefit relationship, with all the existing evidence, points to the possibility of starting an immunization study in the pregnant.
Cuba is currently going through a complex epidemiological situation due to Covid-19 with the highest numbers of patients infected daily (a maximum of 6,422 on this day).