Cuba will produce 1 million doses of its two first COVID vaccines by April

Cuba will produce 1 million doses of its two first COVID vaccines by April
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Fecha de publicación: 
6 February 2021
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 Doctor of Science Vicente Vérez Bencomo, general director of the Finlay Vaccine Institute (IFV), announced that in April they should produce the first million vaccines against COVID-19 from that center, which will allow expanding their application and demonstrating with more evidence their efficacy.

Doctor Verez pointed out that the studies on the vaccine candidates Soberana 01 and Soberana 02 are progressing to achieve the generation of antibodies that prevent the entry of the virus into the cell.

He specified that it is expected to induce an immune response to obtain as many antibodies as those developed by convalescents.

In the case of Soberana 01, he commented that they designed three formulas and in the trial on 60 subjects divided into three groups, it was shown that the vaccine is very safe, since between 80 and 90 percent of the people who receive it have an induction of antibodies against the virus.
Some received a third dose and raised to 95 percent the capacity to generate antibodies with very high levels of neutralization, he added.

He explained that these results and a parallel viral neutralization assay were taken into account in order to continue to Phase II.

The expert said that these criteria make it possible to proceed to Phase II-III, scheduled for March, which should involve between 40,000 and 50,000 people and will have a placebo group.

Soberana 02 in its Phase I, he added, showed safety and efficacy in terms of antibody generation, since more than 70 percent of the patients presented a strong cellular response to the first dose.

Phase II-A included a population of up to 80 years of age with a very similar response even up to the second dose, and we received authorization for Phase II-B with 810 participants, in which there are placebos and around 700 have already received the first administration of the candidate, he said.

Doctor Vérez informed that they also applied a third dose, but of Soberana 01, which reaffirms that the conjugated action is very positive, and he said that if the results are favorable, a vaccination scheme of two doses of Soberana 02 and a third dose of Soberana 01 could be evaluated.

He added that they are currently designing Phase III of Soberana 02, also for March and with placebo, which will be implemented in the province of Havana in about 42 thousand people.

He announced that they are at the stage of escalation of both vaccine candidates, with approximately 100 thousand doses to carry out Phase III of the two variants.

He commented that the capacity to produce the vaccines must have an impact on the population and it is necessary to have enough evidence of their effectiveness, for which reason it is necessary to wait for the results and comply with the international guidelines of the regulatory bodies.
The researcher emphasized that steps are being taken to carry out studies abroad as well.

He also referred to the study of Soberana 01-B, associated to the mutations of the new coronavirus, which is being developed with the Institute of Hematology and Immunology.

The Phase I clinical trial has been carried out with 30 convalescents and so far, with the first dose, 26 out of 30 patients have increased their neutralizing capacity, which constitutes an alternative to face the new COVID-19 mutations, he said.

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