The Center for Genetic Engineering and Biotechnology (CIGB) already has the vaccine candidate that contains the antigen of the omicron variant of SARS-CoV-2, and which will continue, from now on, with the corresponding preclinical and clinical evaluations.
This was announced by the member of the Political Bureau of the Central Committee of the Party and general director of the CIGB, Dr. Martha Ayala Ávila, during a technical meeting with the highest authorities of the BioCubaFarma Business Group, where she reported that, immediately, they will continue with the preclinical and toxicological evaluations in animal models, to then move on to the clinical studies phase, in conjunction with the Center for the State Control of Medicines, Equipment and Medical Devices (Cecmed) and the Ministry of Public Health (Minsap).
From the CIGB headquarters, she explained the directive the new vaccine candidate is based on the RBD sequence, that is, the receptor binding domain of human cells, through which this type of coronavirus penetrates. So far, she explained, its immunogenicity has been evaluated in animal models, and it has been shown in these that it has the ability to induce high immunogenicity.
Therefore, she said, “we are in a position to tackle the development of this vaccine candidate now, in order to continue accumulating preclinical studies, carry out clinical studies and, as quickly as possible, analyze when we would be in a position to use the vaccine candidate in the population.
Ayala Ávila also stressed that, based on its technological domain, the CIGB has the capacity to produce this vaccine candidate in its plants, link up with AICA Laboratories, carry out clinical studies in coordination with the MINSAP, always with the approval of the Cuban regulatory authority.
The Member of the Political Bureau of the Party highlighted that, since the CIGB began working on the development of anti-COVID-19 vaccine candidates, it has kept a watch on the evolution of the virus and, based on its mastery of the technological platform that used to develop the Abdala vaccine, it was also obtaining vaccine antigens of other variants.
“We had vaccine antigens based on the Alpha, Beta, Gamma and Delta variants in the laboratory and, when the Omicron variant appeared and became a variant of concern, we then worked on obtaining the antigen to protect ourselves from it,” the directive stressed.
Ayala Ávila pointed out that most of the existing vaccines are based on the D614G variant (detected in Wuhan), but over these two and a half years the virus has evolved, introducing new mutations in important areas of its structure that have to to do with their capacity for infection and transmission, and that they can evade the immune response induced in individuals by previous infections or by vaccines.
She added that the current vaccines, including the Cuban ones, have been able to strengthen immunity, induce a powerful response against the virus and control pandemic outbreaks, but these Omicron variants are far from the original, and it is pertinent to think of a new vaccine candidate to reinforce in the future.
Precisely on this subject, Dr. Eduardo Martínez Díaz, president of BioCubaFarma, specified that the strategy with this vaccine candidate is to use it if, later, a new reactivation is necessary, as scientific forecasts seem to indicate, and for which work is being done. quickly.
This candidate, he added, would be more effective in terms of neutralization against the new variants that are being derived from Omicron, and represents an advantage in that we anticipate other possible variants that may arise. Both scientific authorities highlighted that, for the time being, the reinforcement will be carried out with current vaccines, which have demonstrated the capacity for an immune response against SARS-CoV-2 variants.
Finally, Martha Ayala Ávila stated that “we will try to advance the vaccine candidate as quickly as possible, but we cannot stop doing the things that are required by regulation, complying with good manufacturing practices.”
Source: www.vanguardia.cu
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