Search the Community

Cuba will start a vaccination drive starting with Havana this Monday and the vaccines used have not been approved for emergency use or have passed Phase 3 of testing ... Of course the US embargo is to blame for the slow development of the Cuban vaccine, that much is sure as always, even as Cuba requests funds to finance the vaccine production from the Global Fund ( main donor is the USA). Cuba has declined to receive free vaccines offered from the COVAX initiative. And 80% of cases in Havana are due to the South African variant. Explosive mix to keep the island closed for some time to come. ---------------------------- The South African variant is responsible for 80% of the deaths from covid in Havana Mass vaccination begins Monday in the capital, disguised as an "intervention study" 14ymedio, Havana | May 08, 2021 https://www.14ymedio.com/cuba/covid-19-coronavirus-vacunas_cubanas_0_3090290942.html The Cuban authorities have recognized that the South African variant of covid-19, one of the most worrying according to the World Health Organization (WHO) along with the British and the Brazilian, is the one that predominates on the island. All three, in any case, said the Minister of Public Health, José Ángel Portal Miranda, "we have them circulating in the country." Portal Miranda specified this Friday in the Round Table that the variant detected in South Africa was found in 68.1% of the deceased studied throughout the country, but that in Havana that rate was 80.4%. As for contagion, an incidence of this variant has been detected in the capital of "almost 50% of the cases studied and in Matanzas, almost 90%, hence the great transmission that this territory has had." In the same program, the minister announced that the Government will begin next week an "intervention study" with the vaccine candidates Abdala and Soberana 02, which will be applied to more than 1.7 million inhabitants of the capital. This massive intervention, says Portal Miranda, is supported by "the results demonstrated in their research stages" of these vaccine candidates, the most advanced of the five developed by the Island (the others are Soberana 01, Soberana Plus and Mambisa) and that They are in phase 3 of clinical trials. The strategy, the minister continued, "constitutes a true pride for all Cubans, amid the brutal blockade imposed by the United States government, which gives greater significance to this feat of Cuban science." Despite the fact that from the beginning of the program the authorities announced that they would give "exclusively" the results of phase 2 of the vaccine candidates, they did not give many details. "The results have a process and will be given in the coming weeks, between the end of May or perhaps later, in June and July," said the president of BioCubaFarma, Eduardo Martínez Díaz, who assured that these results plus the application of more than 400,000 doses in the intervention study in health personnel, "they give us security." "By doing a very deep risk and benefit analysis, where there are practically no risks, and the results of the applied doses demonstrate this, it turns out that at the same time there is a very high potential for benefits," explained Martínez Díaz, while asserting that "There are high levels of neutralizing antibodies and because there is already talk that when these levels are there, there is protection and the probability of efficacy." Olga Lidia Jacobo Casanueva, director of the State Center for Drug Quality (Cecmed), the regulatory entity, also assured that they have followed "each of the stages of the research and development process", "attached to the functions of the center and rigorous necessary ". "We have evaluated the information packages presented by the researchers from the preclinical stage in animal studies to the data originated in each phase of the studies," she explained, without expanding on these data. "For them, we are guided by national regulations and also by foreign ones, and based on the results obtained, we approve the overlapping of phases. All of this contributes to carrying out investigations in less time without neglecting safety. However, Cecmed has not yet issued its authorization for emergency use, so the authorities specified that this intervention study will be "temporary". "We consider that for the month of June we already have the emergency authorization from Cecmed," said the president of BioCubaFarma, who announced that for that month "we estimate that 22.6% of the Cuban population had been immunized, on July 33, 5% and by August 70% of that population ". The population intervention in risk groups and territories will begin in seven municipalities of Havana, where the authorities completed the census on April 24, in which vaccination candidates are expected to be administered to 778,398 people until June, in the first place to the segment of those over 60 years of age. In a second stage, the study scheme will be completed in the remaining eight Havana municipalities between the second half of June and next August in a population group of 928,627 people. With 51% of the deaths in April (116) and almost 50% of the infections, the capital, the most populated region of Cuba with 2.2 million inhabitants, is the one that presents, by far, the most difficult situation since the pandemic began. This has claimed 713 deaths on the island and has a total of 113,876 positives, according to official data. In this regard, Portal Miranda warned that "the forecasts are that confirmed cases will continue to increase at the same rate that we have been able to verify these days, if we do not manage to do things well and do not use all the tools that we have in the country within our reach. ". Right there the minister referred to the situation in India, which "faces a health situation more than heartbreaking due to the pandemic. "That country has already exceeded 20 million cases and 226,000 deaths. However, medical experts believe that the real figures in India could be five to ten times higher than those in official records," said Portal Miranda. The same doubts raise the official Cuban statistics. Several cases, such as that of a 13-year-old girl who died last April or the director of the Pionero magazine, show that although they have been infected by the covid, if at the time of death the PCR offers a negative result, they are not included in the death toll. Cuba's strategy, which rejected the help of the international vaccine fund Covax and is beginning to apply its vaccine candidates en masse without having passed the phases of standardized clinical trials in the world, has been criticized by several specialists. Among them, the Cuban immunologist Eduardo López-Collazo, director of the Research Institute of Hospital La Paz, in Madrid, who despite weighing the technology applied with the Cuban vaccine candidates, assured this newspaper that not completing phase 3 is " very dangerous". Without mentioning these criticisms, which have been disqualified in the official press, the participants in the Round Table insisted on the effectiveness of the tests. "These are types of study that the WHO approves, as long as the safety of the subjects is guaranteed," Minister Portal Miranda added. Nor did they refer to the susceptibilities caused by the country's chronic shortage of medicines in the productive capacity of vaccines. On the contrary, the president of BioCubaFarma said that production is assured. The Molecular Immunology Center, which manufactures the RBD antigen, participates in the production of Soberana 02, detailed Eduardo Martínez Díaz; the Finlay Institute, which conjugates this antigen with tetanus toxoid. "The final vaccine," the formulation of this conjugated antigen, is carried out at the National Center for Biopreparations (Biocen). "For its part, the Engineering Center participates in Abdala Genetics and Biotechnology (CIGB), where the antigen is manufactured, and Laboratorios Aica, where it is formulated. "We are increasingly reaching industrial stability, we have lots of vaccines manufactured to begin the health intervention, which passed a rigorous evaluation process," said the official. Finally, Minister Portal Miranda also referred to the ethical protocol of the study and assured that the "principle of voluntariness" would be guaranteed. The insistence on national sovereignty regarding the issue of covid vaccines contrasts, however, with the request for financing from the Global Fund, whose main donor is the United States. The request for resources was made public by the representative of the United Nations Development Program (UNDP) for Cuba, Maribel Gutiérrez, this Thursday through her social networks.