Delay in the Validation of Cuban Vaccines by the WHO is ‘The Fault of the Banks’

According to official data, more than 87% of Cubans have received the complete three-dose scheme of one of the three vaccines against COVID-19. (EFE)

14ymedio bigger14ymedio, Havana, 19 December 2022 — The process of recognition by the World Health Organization (WHO) for Abdala, the Cuban vaccine against COVID-19, remains halted after the documentation was delivered to the health authorities in April. Eight months later, Eduardo Martínez Díaz, president of the BioCubaFarma business group, assures the State newspaper Granma that the problem lies in the American embargo, which forces the banks not to work with the Island.

The doctor explains to the Communist Party newspaper that “one of the components of the evaluation process is behind schedule.” BioCubaFarma announced months ago that it had decided to transfer the production of one of Abdala’s components to its new plant in the Mariel Special Development Zone (ZEDM). WHO experts planned to visit and evaluate the factory by the end of this year, but it will not be possible to do so.

“Although the production line, where the formulation, filling and packaging operations of that complex take place are already active and producing, the line on which the recombinant products are manufactured has delays in its implementation,” says Martínez Díaz.

“This delay is due to the fact that payments have not been made to the company in charge of the commissioning of the equipment and systems of that production line. We have been trying to make payments for nine months, which have not materialized due to the refusal of several banks to make the transfer,” he concludes. The doctor is hopeful that in 2023 the study can be completed and will receive the endorsement of the health authorities, almost three years after the beginning of the pandemic.

In the interview, the expert insists that the Cuban vaccines approved on the Island — Abdala and Soberana 02 and Plus — are “safe, effective and capable of controlling the epidemic,” and that this is supported by the control of the disease in Cuba as well as in the countries that have recognized these vaccines without waiting for the WHO’s approval.

According to Martínez, eight countries have given the authorization “and others are evaluating them,” although it has only been made public, to date, that Iran, Mexico and Nicaragua have given the green light to Cuban serums. In the case of Tehran and Soberana, their manufacture is through a partnership with the Pasteur Institute. Mexico has also approved Abdala after receiving the approval of its regulator, the Federal Commission for Protection against Health Risks. Nicaragua also recognizes the two vaccines.

In addition to the previous three, Venezuela, Vietnam and Belarus have used some of the Cuban serums after receiving lots exchanged or purchased from the Island. At the moment, the number of units delivered abroad and the money obtained through their sale are unknown. The Cuban authorities announced that their vaccines would be economical, although the Nicaraguan press estimates that they cost 7 euros per unit based on a loan requested by Daniel Ortega’s government from the World Bank. However, there is no breakdown to verify the credit.

In any case, Cubans vaccinated with Abdala or Soberana — almost 100% of those immunized on the Island — have had real difficulties traveling to many countries (including the United States and the European Union) where it was mandatory to present a covid certificate or passport with one of the serums recognized by the WHO.

Martínez Díaz in his interview this Monday claims as a distinctive element of Cuban vaccines the high “thermostability” that requires less cold temperature than other vaccines (such as those of Pfizer or Moderna) and are stored at between 2 and 8 degrees. He also says that they can last up to a week at temperatures above 30 degrees celsius, “which makes them attractive for use in poor countries, where there are difficulties in maintaining the chain of refrigeration,” he adds.

The slight side effects and effectiveness that, they claim, have been demonstrated in the studies carried out on the Island, were also argued by the official despite the fact that this would not be a differentiating feature from any of the other authorized vaccines. Martínez emphasizes that the results of the research have been published in several scientific journals, which require that they be subjected to peer review. “To date, more than 20 scientific articles have been published in high-impact journals, and other reports continue to be prepared,” he says.

The doctor insists that Cuba, unlike other countries, has not suffered the onslaught of omicron, although it is hardly verifiable, since it is necessary to sequence each case to find out, something that has not been done in any country in the world and much less on the Island, where the mere diagnostic capacity was very limited at the time of the explosion of the variant. Martínez said, in any case, that this situation is due to the fact that the vaccines developed on the Island decrease their capacity against this variant by two times, while others do so by 20 times.

“This phenomenon that we are observing has its explanation in the nature of the antigen we use and the very design of our vaccines,” he explains. Martínez says that the Island’s laboratories use the RBD antigen, which produces antibodies against a region of the protein that is common in all variants of the virus.

Meanwhile, other vaccines (the ones based on messenger RNA) have used the full spike protein (S), which induces defenses against areas where there are mutations. The American Chemical Society warned at the end of 2021 of the possibility that vaccines based on protein S (Pfizer or Moderna) could fall short if the strategy was not diversified. Since then, pharmaceutical companies have been studying the situation and possible improvements.

“We defend the hypothesis that vaccines based on the RBD antigen can be a universal booster for the rest of the vaccines against COVID-19 by amplifying a protective immunity against the different variants of the Sars-Cov-2 virus, which have circulated or that could be generated in the future. Recently, several groups of scientists around the world have published articles that support this hypothesis,” says Martínez.

Translated by Regina Anavy


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