Cuba: Soberana 02 and Abdala To Start Phase III Trials in March

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In a meeting with the press that began this Thursday at the Center for Genetic Engineering and Biotechnology (CIGB) in Havana, the president of the BioCubaFarma Business Group, Eduardo Martínez, confirmed that medical personnel had applied thousands of doses during phases I and II in which the vaccine demonstrated a potent immunological response.

“Now we are waiting for the regulatory authority of CECMED (Center for State Control of Medicines, Equipment and Medical Devices) to evaluate the information that has been delivered, and we are confident that we will have the approval to move forward to this phase,” he said.

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For his part, engineer Jorge Luis Vega, CIGB’s production director, stressed that the safety of both immunogens had been demonstrated and added that “then the immunogenicity, that is, the response of a controlled number of individuals, is tested, and subsequently the efficacy that is demonstrated in the field with more people.”

The general director of the CIGB, Marta Ayala Ávila, emphasized that more individuals participate in the clinical studies as one advances from one phase to another. Therefore, there is a more significant number of people immunized.

“Phase I began at the Saturnino Lora hospital in Santiago de Cuba with 132 volunteers. Two immunization schemes were carried out: a short one, where the individual is immunized on days 0, 14, and 28, and on days 42 and 56, we then can measure the immune response. In the other scheme, immunization occurs on days 0, 28, and 56, and the response is evaluated at 70”, he explained.

During phase II, which began on February 1 at the Santiago health center itself, a total of 660 people were immunized.

“In the case of Abdala, all the individuals induced specific antibodies to the protein with which they were immunized, which were able to neutralize the effect of the virus on the cells,” he said, adding that Cuban scientists have tried to develop a preventive vaccine in less than eight months when research requires between 10 and 15 years.

While touring one of the CIGB plants where the antigen – through yeast cells – of the Abdala vaccine candidate is currently being produced, Jorge Luis Vega summarized the immunogen production process:

“The first step is cell propagation, where the yeast cell thawing is done, and then it undergoes a small volume propagation process then to enter the inoculation phase in the industrial-scale reactor and then go through a purification process so that the product has the quality characteristics. This is where the active ingredient comes out so that the finishing industry – Aica Laboratories – can formulate and fill the bulbs.”

Vega added that “when phase III of the clinical trials are concluded, an evaluation process is carried out in which the sanitary registration of the product is approved. In the end, a verdict is issued as to whether the product is apt to be marketed in Cuba and, eventually, abroad.”

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