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December 19, 2022
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Delays at the production plant slow down WHO recognition of Cuban vaccines against COVID-19

OnCubaNews

The approval of the World Health Organization (WHO) for Cuban vaccines against COVID-19 It is still not completed because the experts from the health agency have not been able to inspect the production plant, due to the delay in the start-up of one of its lines.

Dr. Eduardo Martínez Díaz, president of the BioCubaFarma business group, said to the official newspaper Granma that the visit of WHO specialists to the CIGB-Mariel biotechnological complex scheduled for the end of this year could not materialize because the line of recombinant products has not started to function.

«This delay is due to the fact that it has not been possible to make payments to the company in charge of commissioning the equipment and systems of that production line. We have been trying to make the payments for nine months, which have not materialized due to the refusal of several banks to carry out the transfer operation,” the manager explained to the outlet.

Martínez Díaz clarified that in the plant where the production of the abdala vaccine The lines in which the formulation, filling and packaging operations are carried out are already active. He added that information from the dossier of that drug has been sent and is being exchanged with the WHO authorities. “Despite these difficulties, progress is being made and we hope that the evaluation process will be completed in 2023,” he said.

The president of BioCubaFarma also referred to the scientific validation process of the vaccines designed and produced on the Island. In this sense, he specified that all the results have been published in recognized scientific journals, “they have been reviewed by international experts, in a peer review process, which is what it is called.

To date, more than 20 scientific articles have been published in high-impact journals and “Cuban vaccines have also been evaluated by regulatory authorities from various countries, which have finally granted the Emergency Use Authorization. At this time, eight countries have given this authorization and others are evaluating them,” he specified.

More than a year after the start of mass immunization against COVID-19 in Cuba, its own vaccines prove to be safe, effective and capable of controlling the epidemic. According to Martínez Díaz, they have several characteristics that distinguish them from others that have been developed, due to their safety, high thermo-stability and effectiveness.

The expert explained that after tens of millions of doses applied in Cuba and in other countries, adverse events are mild and with a very low frequency, even in the pediatric population between 2 and 18 years of age, an experience that he described as “unique in the world to date.

He also stressed that unlike other vaccines that require special conditions for storage, at freezing temperatures, Cuban vaccines can be stored between two and eight degrees Celsius.

“It has even been shown that they maintain their quality characteristics at temperatures above 30 degrees Celsius, for at least a week, which makes them attractive for use in poor countries, where there are difficulties in maintaining the cold chain,” he stressed. a Granma.

Panel of international experts asks to reduce barriers to the Cuban biotechnology sector

He added that clinical studies have shown efficacy greater than 90%. The evidence of effectiveness, he said, was the decrease in the transmission of the disease in Cuba as of October 2021, when 60% immunization of the population was reached, using the Abdala and Soberana vaccines.

Also, he appreciated that the Cuban vaccines have been shown to be effective against the omicron and delta variants.



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