
{"id":240875,"date":"2021-06-27T12:36:25","date_gmt":"2021-06-27T16:36:25","guid":{"rendered":"https:\/\/oncubanews.com\/en\/?p=240875"},"modified":"2021-06-27T12:36:25","modified_gmt":"2021-06-27T16:36:25","slug":"how-was-the-efficacy-of-the-cuban-covid-19-vaccine-candidates-calculated","status":"publish","type":"post","link":"https:\/\/oncubanews.com\/en\/cuba\/how-was-the-efficacy-of-the-cuban-covid-19-vaccine-candidates-calculated\/","title":{"rendered":"How was the efficacy of the Cuban COVID-19 vaccine candidates calculated?"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Just a few days ago, the announcements about the efficacy of <\/span><a href=\"https:\/\/oncubanews.com\/tag\/vacunas-cubanas-contra-la-covid-19\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Cuba\u2019s two main COVID-19 vaccine candidates<\/span><\/a><span style=\"font-weight: 400;\">, the result of the third phase of their clinical trials, made headlines. First, 62% of Soberana 02 was reported in its two-dose scheme \u2014 one of the two administered in the study \u2014, and then that of the three doses of Abdala, at a remarkable 92.28%.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Since then there have been many reactions and comments inside and outside the island. Satisfaction, pride, joy and even euphoria have prevailed not only among the experts and authorities of the country, but in the general population and also among people from all parts of the world, who see in these drugs an indisputable success of Cuban science and a hope in the face of a disease that has kept the planet in suspense for more than a year and has already taken millions of lives.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">However, the incredulity, suspicions, denial and discredit of some have not been lacking either, more for political than scientific reasons, and also those who, from a more measured, more critical stance \u2014 in the broadest sense of the word \u2014, and even without ignoring the result, have called for not shouting from the rooftops until there is more data to help unravel and support the announced figures \u2014 as has happened with other already registered vaccines \u2014, and for their validation by the international scientific community and global entities such as the World Health Organization (WHO).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">After the emotion because of the news, Cuban specialists provided this Thursday more details on the calculation of the efficacy of both vaccine candidates and addressed the steps to follow after revealing that necessary indicator, both for the massive use of the preparations on the island \u2014 at a time when the country is reporting the highest numbers of daily infections and <\/span><a href=\"https:\/\/oncubanews.com\/cuba\/ciencia\/salud-en-cuba\/coronavirus-salud-en-cuba\/coronavirus-cuba-sobrepasa-los-11-mil-casos-activos\/\"><span style=\"font-weight: 400;\">active cases<\/span><\/a><span style=\"font-weight: 400;\"> of the entire pandemic \u2014 as well as for its recognition and commercialization beyond its borders.<\/span><\/p>\n<figure style=\"width: 1140px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/oncubanews.com\/wp-content\/uploads\/2021\/06\/Soberana_otm_0390.jpg\" alt=\"Press conference on the efficacy of the Cuban COVID-19 vaccine candidates, with scientists and executives of the state group BioCubaFarma, in Havana, on June 24, 2021. Photo: Otmaro Rodr\u00edguez.\" width=\"1140\" height=\"760\" \/><figcaption class=\"wp-caption-text\">Press conference on the efficacy of the Cuban COVID-19 vaccine candidates, with scientists and executives of the state group BioCubaFarma, in Havana, on June 24, 2021. Photo: Otmaro Rodr\u00edguez.<\/figcaption><\/figure>\n<p><b>Blessed efficacy<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The percentage of efficacy is the data that everyone expects from the COVID-19 vaccine, which has taken all the spotlight in the race against the clock to produce immunogens against <\/span><a href=\"https:\/\/oncubanews.com\/tag\/coronavirus\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">SARS-CoV-2<\/span><\/a><span style=\"font-weight: 400;\"> and prevent the development of the symptomatic disease as best as possible. Its calculation, which is derived from conducting phase 3 clinical trials with a significant number of people, is not exactly simple and is like the jewel in the crown of the research carried out, after determining the safety and ability to generate immune response in the previous stages of the study.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Thus, the high efficacy reported by the Pfizer-BioNTech, Moderna and Gamaleya (Sputnik V) vaccines, all above 90%, quickly became headlines and mandatory references in the current context. Meanwhile, other internationally recognized and used formulas, such as those of AztraZeneca with the University of Oxford, the single-dose of Johnson &amp; Johnson, the Chinese Sinopharm and the Indian Covaxin stand at more than 70%. Such numbers do not reflect the ability of these preparations to prevent infection, but rather to avoid symptoms of COVID-19 and in many cases decrease \u2014 even when they continue to provide protection \u2014 against new, more contagious strains of the coronavirus.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">As Dr. Eulogio Pimentel, vice president of the state group BioCubaFarma, <\/span><a href=\"http:\/\/www.cubadebate.cu\/noticias\/2021\/06\/24\/resultados-de-eficacia-de-los-candidatos-vacunales-cubanos-e-intervencion-sanitaria-en-el-pais-video\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">explained this Thursday<\/span><\/a><span style=\"font-weight: 400;\"> on the Mesa Redonda television program, the \u201cvaccine efficacy\u201d is defined by the WHO as the percentage of reduction in the incidence of the disease in the vaccinated subjects with respect to the group given placebo in the studies. This is determined \u201cunder the standards and supervision of good clinical practices required by clinical trials\u201d and is expressed mathematically as \u201cone minus the risk of getting sick when you are vaccinated among the risk of getting sick when you are not vaccinated (VE = 1 \u2014 Relative Risk = 1 \u2014 Risk in the vaccinated person \u00f7 Risk in the unvaccinated person).\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">According to these calculations, that a vaccine is, for example, 66% effective \u201cdoes not mean that, of every 100 people, 44 will get sick and 66 will not get sick, but that, if they are vaccinated, there is a 66% probability of not getting sick,\u201d clarified the specialist, who pointed out that in the case of \u201cvaccine efficacy,\u201d although it is related to efficacy, it is not measured in a controlled environment like this, but in its open and massive application in society , \u201cwhich means there is no supervision by the product promoter or the trial\u2019s principal researchers.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe less people are able to be immunized in a population, the less the efficacy\u201d of a vaccine is seen, said Pimentel, and stressed the importance not only of getting vaccinated but also of completing the immunization scheme for each vaccine, so as not to leave \u201ca gap for the entry and spread of the virus.\u201d<\/span><\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"mWlB2qE1of\"><p><a href=\"https:\/\/oncubanews.com\/cuba\/coronavirus-eficacia-de-formulas-cubanas-abre-esperanza-a-primera-vacuna-latinoamericana\/\">Coronavirus: eficacia de f\u00f3rmulas cubanas abre esperanza a primera vacuna latinoamericana<\/a><\/p><\/blockquote>\n<p><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"\u00abCoronavirus: eficacia de f\u00f3rmulas cubanas abre esperanza a primera vacuna latinoamericana\u00bb \u2014 OnCubaNews\" src=\"https:\/\/oncubanews.com\/cuba\/coronavirus-eficacia-de-formulas-cubanas-abre-esperanza-a-primera-vacuna-latinoamericana\/embed\/#?secret=h3yr6hPwqM#?secret=mWlB2qE1of\" data-secret=\"mWlB2qE1of\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/p>\n<p><b>Soberana 02, first cut<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Developed by the Finlay Vaccine Institute (IFV), Soberana 02 beat its older sister, Soberana 01, to advance first to phase 2 and then to phase 3 of clinical trials. The latter was held in Havana as of March, with 28-day intervals between each dose, and involved more than 44,000 volunteers distributed in three groups: one who was administered two doses of Soberana 02, the other to whom a third dose was also injected, this one from another candidate in the family: Soberana Plus \u2014 also used in studies with convalescent patients \u2014 and a third group that received a placebo.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Neither the participants nor the health workers and researchers in the field knew the nominal composition of the groups and it was not until the end of the study that, in order to determine the efficacy, the codes were opened and which volunteers belonged to each one was revealed. This strict protocol, established according to international scientific standards, was also used in the clinical trials of Abdala, the most advanced COVID-19 vaccine candidate at the Center for Genetic Engineering and Biotechnology (CIGB).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In addition, in both cases and following globally established regulations, the efficacy calculation was carried out by a committee of experts who are not part of the vaccine promoter institutions or the teams in charge of research and development of vaccine candidates, but by other scientific institutions such as the Pedro Kour\u00ed Institute of Tropical Medicine (IPK) and the Center for Molecular Immunology (CIM), and the Ministry of Public Health (MINSAP).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cFrom the moment we considered that we had reached the number of cases that would allow an intermediate analysis of the efficacy evaluation to be carried out, it was decided to close the database and hand it over to this independent committee, which first made an analysis by groups of the statistical difference, without knowing what each of the three groups was. They were blinded in this regard,\u201d explained Dr. Vicente Verez, director of the IFV, at a press conference about the particular case of the cut of two doses of Soberana 02.<\/span><\/p>\n<figure style=\"width: 1140px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/oncubanews.com\/wp-content\/uploads\/2021\/06\/Soberana_otm_0421.jpg\" alt=\"r. Vicente Verez, director of Cuba\u2019s Finlay Vaccine Institute (IFV). Photo: Otmaro Rodr\u00edguez.\" width=\"1140\" height=\"760\" \/><figcaption class=\"wp-caption-text\">r. Vicente Verez, director of Cuba\u2019s Finlay Vaccine Institute (IFV). Photo: Otmaro Rodr\u00edguez.<\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">\u201cOn Thursday of last week this committee met with us and informed us that they found statistically significant differences between the groups and that was the green light to hand over the code for each group, which was sealed, of course, since the trial began, and only then it was possible to know who is part of each group,\u201d commented the leader of the development team of the Soberana family of vaccines.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Verez added that \u201cbased on that analysis it was possible to verify how each group behaved\u201d \u2014in the case of the one that includes the application of a third dose of Soberana Plus for this intermediate cut of efficacy, the results were only evaluated up to the second dose of Soberana 02\u2014 and that \u201cwhile the risk of contracting the symptomatic disease among those who received a placebo continued to grow over time, the other groups tended to stabilize and decrease the risk.\u201d<\/span><\/p>\n<p><b>Certainties and forecasts<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The expert carried out a comparative analysis between the immune response registered in the 810 participants in phases 1, 2 A and 2 B of the Soberana 02 clinical trials, and the efficacy calculated now in phase 3, which shows a certain correlation between both indicators \u2014 although not exact \u2014, which allows for making forecasts in this regard, something that, he said, has already been noted by other researchers and publications around the world.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe study revealed that, with a first dose, in the group of 810 people who participated in the first phases, 19.5% exceeded the antibody titer, that is, they developed neutralizing antibodies to the virus,\u201d he explained. \u201cThis allowed us to do initial analyzes that pointed to an efficacy in a dose of between 20% and 30%, to prevent the symptomatic disease of COVID-19. Then, the expert committee concluded that the efficacy in one dose is 30%, which means that there is a 30% lower risk of contracting the disease from receiving one dose of Soberana 02.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cRegarding the results with two doses in the same group of volunteers, it was found that 76.2% exceeded the threshold that correlates to have neutralizing antibody titers. That made us estimate a possible efficacy of between 60 and 70% of the application of two doses in the phase 3 trial. That was what we were expecting. And when the independent committee closed its analysis, it found that the efficacy was <\/span><a href=\"https:\/\/oncubanews.com\/cuba\/candidato-vacunal-cubano-soberana-02-muestra-eficacia-del-62-en-ensayos-clinicos\/\"><span style=\"font-weight: 400;\">62%<\/span><\/a><span style=\"font-weight: 400;\">, a remarkable result considering that it exceeds the 50% considered by the WHO for a vaccine candidate to be effective, and because it was achieved in a scenario where there is a high presence of the so-called \u2018worrisome strains,\u2019 which constituted a great challenge for our study,\u201d he added.<\/span><\/p>\n<figure style=\"width: 1140px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/oncubanews.com\/wp-content\/uploads\/2021\/06\/Soberana_otm_02.jpg\" alt=\"Graphic on the immune response generated by two doses of Soberana 02, presented at the press conference on the efficacy of the Cuban COVID-19 vaccine candidates, with scientists and executives of the state group BioCubaFarma, in Havana, on June 24, 2021. Photo: Otmaro Rodr\u00edguez.\" width=\"1140\" height=\"760\" \/><figcaption class=\"wp-caption-text\">Graphic on the immune response generated by two doses of Soberana 02, presented at the press conference on the efficacy of the Cuban COVID-19 vaccine candidates, with scientists and executives of the state group BioCubaFarma, in Havana, on June 24, 2021. Photo: Otmaro Rodr\u00edguez.<\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">Verez also highlighted that the second requirement established by the WHO to validate a vaccine is that \u201cthe sample has sufficient statistical value so that a minimum confidence interval is greater than 30%, and that is also achieved with Soberana 02.\u201d He added that \u201cthis was determined based on 111 cases of symptomatic COVID found 14 days after the second dose was administered: 62 cases in the placebo, 23 and 26 in the other two groups. And with these data, when the corresponding calculations were made, they determined the efficacy of the 62% that was already announced. For this reason, Soberana 02, in its two-dose schemle, meets the requirements to be considered an effective COVID-19 vaccine,\u201d which, he said, \u201cis a source of great joy for all of us.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The director of the IFV announced that they are now working on calculating the efficacy of the scheme that includes the third dose of Soberana Plus and said that the researchers under his command expect \u201chigh efficacy\u201d from this combination, because 96% of the group studied \u201ccorrelates with high immunity\u201d and \u201cexceeds the threshold of neutralizing antibodies.\u201d This, he said, is a \u201cvery promising\u201d indicator that allows them to make \u201ca forecast with a significant level of approximation,\u201d although, he stressed, \u201cit does not offer an exact or conclusive correlation.\u201d Based on these data, he predicted a possible efficacy of between 85 and 95% for the three-dose scheme.<\/span><\/p>\n<figure style=\"width: 1140px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/oncubanews.com\/wp-content\/uploads\/2021\/06\/Soberana_otm_04.jpg\" alt=\"Graphic on the immune response generated by two doses of Soberana 02 and a third of Soberana Plus, presented at the press conference on the efficacy of the Cuban COVID-19 vaccine candidates, with scientists and directors of the state group BioCubaFarma, in Havana, June 24, 2021. Photo: Otmaro Rodr\u00edguez.\" width=\"1140\" height=\"760\" \/><figcaption class=\"wp-caption-text\">Graphic on the immune response generated by two doses of Soberana 02 and a third of Soberana Plus, presented at the press conference on the efficacy of the Cuban COVID-19 vaccine candidates, with scientists and directors of the state group BioCubaFarma, in Havana, June 24, 2021. Photo: Otmaro Rodr\u00edguez.<\/figcaption><\/figure>\n<p><b>Abdala, the path<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The immunogen named after the character of the well-known epic poem by Cuban poet and national hero Jos\u00e9 Mart\u00ed, astonished many when earlier this week its <\/span><a href=\"https:\/\/oncubanews.com\/cuba\/candidato-vacunal-abdala-9228-de-eficacia-en-sus-tres-dosis\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">high percentage of efficacy was reported: 92.28<\/span><\/a><span style=\"font-weight: 400;\">. After the intermediate cut of the two doses of Soberana 02, the jump of 30 percentage points with respect to it put the candidate produced by the Center for Genetic Engineering and Biotechnology (CIGB) in the spotlight, to the point of being compared with successful COVID-19 vaccines such as those from Pfizer and Moderna, which are currently used in highly developed countries.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The figure, however, did not come out of the blues and it did not surprise those who developed and always bet on the quality of this candidate, which, biotechnologically speaking, is a subunit vaccine based on the RBD receptor binding site of the S protein of the virus. Meanwhile, the most advanced of the IFV vaccine candidate uses this same technology, but combined with tetanus toxoid, in order to enhance the immune response in the face of a possible infection, which is why it turns out to be a conjugate vaccine.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Unlike Soberana 02, which developed its clinical trials in the Cuban capital, Abdala conducted them in the eastern part of the country. The first two phases took place in the capital city of Santiago de Cuba, while already in the third \u2014 and a determining factor to calculate the efficacy \u2014 the studies were extended to the provincial capitals of Granma and Guant\u00e1namo. There were a total of 48,290 participants in the double-blind, randomized and placebo-controlled trials, in which it was also not immediately disclosed who belonged to which group and a scheme of three doses every 14 days was used.<\/span><\/p>\n<figure style=\"width: 1140px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/oncubanews.com\/wp-content\/uploads\/2021\/06\/Soberana_otm_05.jpg\" alt=\"Graphic on the clinical trials of the Abdala vaccine candidate, presented at the press conference on the efficacy of the Cuban COVID-19 vaccine candidates, with scientists and executives of the state group BioCubaFarma, in Havana, on June 24, 2021. Photo: Otmaro Rodr\u00edguez.\" width=\"1140\" height=\"760\" \/><figcaption class=\"wp-caption-text\">Graphic on the clinical trials of the Abdala vaccine candidate, presented at the press conference on the efficacy of the Cuban COVID-19 vaccine candidates, with scientists and executives of the state group BioCubaFarma, in Havana, on June 24, 2021. Photo: Otmaro Rodr\u00edguez.<\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">Although the first stages of the study took place in a context in which the predominant variant of the virus in Cuba and in the world was called D614G, as the third phase progressed, the epidemiological scenario changed radically with the spread of new, more contagious strains, which multiplied the infections and incidence rates throughout the island.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cAlready when we were conducting the phase 3 clinical trial, and especially at the time when we were collecting the information to determine efficacy, we knew that in the eastern region, as was happening in Havana, other variants of SARS-CoV-2 had already begun to circulate, such as Alpha, identified in the United Kingdom, and Beta, which was identified in South Africa, and which are much more contagious,\u201d Dr. Marta Ayala, general director of the CIGB, explained to the press. She pointed out that, taking this context into account, the Abdala developers think that the efficacy data obtained \u201cin a high probability is also expressing protection against these variants that were mostly circulating.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Dr. Ayala commented that, according to the studies carried out, the immune response induced by this vaccine candidate \u201cwas very good and correlates very positively with viral neutralization,\u201d which is linked to the safety demonstrated from the initial and proven tests in ongoing interventions. \u201cWe were able to confirm through an ELISA test from the Roche company that what we had found in terms of the intensity of the response of the vaccinated individuals was really very good and made us foresee that we could also have good results in the evaluation of efficacy. Evaluated by this system, all individuals were positive for the vaccination,\u201d said the specialist.<\/span><\/p>\n<p><b>Data calculated and to be calculated<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The increase in incidence and transmissibility in the eastern region, where phase 3 clinical trials were being carried out, made it possible to accumulate symptomatic COVID-19 cases among study participants necessary for the final calculation of the efficacy of Abdala, which was carried out by independent groups of experts and statisticians \u201cas was established in the protocol,\u201d confirmed the director of the CIGB.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cWe had planned I and II interim cuts, but based on the analysis of the epidemiological situation and the high incidence that occurred in the eastern provinces, we were able to accumulate the number of events that we expected for the final analysis: 153. Of them, 142 were in placebos and 11 in vaccinated volunteers, which gave us 92.28% efficacy. In addition, the limits of the confidence interval are between 85% and 95%, which is very significant and gives us the certainty that we are really in the face of a very reliable figure,\u201d said Marta Ayala, who said that based on the data obtained \u201cthe risk of getting sick for vaccinated individuals is really very low,\u201d while \u201cin placebos, as time progresses, events accumulate and risk increases.\u201d<\/span><\/p>\n<figure style=\"width: 1140px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/oncubanews.com\/wp-content\/uploads\/2021\/06\/Soberana_otm_07.jpg\" alt=\"Graphic on the calculation of efficacy in the clinical trials of the Abdala vaccine candidate, presented at the press conference on the efficacy of the Cuban COVID-19 vaccine candidates, with scientists and directors of the state group BioCubaFarma, in Havana, on 24 June 2021. Photo: Otmaro Rodr\u00edguez.\" width=\"1140\" height=\"760\" \/><figcaption class=\"wp-caption-text\">Graphic on the calculation of efficacy in the clinical trials of the Abdala vaccine candidate, presented at the press conference on the efficacy of the Cuban COVID-19 vaccine candidates, with scientists and directors of the state group BioCubaFarma, in Havana, on 24 June 2021. Photo: Otmaro Rodr\u00edguez.<\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">\u201cWith this 92.28% efficacy, we are among the best vaccines in the world,\u201d said the scientist, who highlighted satisfaction with the result achieved after months of intense work and reiterated that the announced figures meet the requirements of the WHO and other international organizations and to consider that a vaccine candidate is really effective.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Such success, however, does not mean the end of the road, as research continues with the aim of studying other variables and revealing new data on the quality of Abdala as a COVID-19 vaccine.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cWe already announced the efficacy against symptomatic COVID, but there are other variables of the clinical study, which will also reveal efficacy against severe and asymptomatic forms of the disease, and we also want to evaluate what happened after the first and second doses,\u201d explained the expert, according to which, as part of the trials carried out, \u201call the exudates of the volunteers that were PCR positive\u201d have been isolated and \u201cit is planned to carry out a study with the institutions in the country that have the capacity to do the isolation and the sequencing of the virus, as part of a scientific investigation that is of great interest.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">And with regard to the new strains, Dr. Ayala announced that \u201cin our laboratories we have been obtaining recombinant proteins with the mutations of these variables, which we have been evaluating with the serums of individuals vaccinated with Abdala.\u201d As a result, she said, \u201cwe have found that a recognition of these serums is maintained with these proteins, which is indicative that in the immune response that the vaccinated individual have there is an ability to recognize and, why not, dominate the new variable they are facing.\u201d<\/span><\/p>\n<p><b>What\u2019s to come<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Following the announcement of the efficacy of Soberana 02 and Abdala, the next step for both candidates to finally become vaccines is the approval of their use on a large scale by regulatory authorities. In this direction, Abdala\u2019s file was already presented by the CIGB to the Center for the State Control of Medicines, Medical Equipment and Devices (CECMED), for authorization for its emergency use, while that of Soberana 02 will be delivered by the IFV next week, while work continues to calculate the efficacy of the scheme with a third dose of Soberana Plus.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In this regard, Dr. Eduardo Mart\u00ednez, president of the BioCubaFarma group, commented to the press that, thanks to the positive results obtained in the calculation of the efficacy and the rest of the studied indicators, it is expected that said authorization could be granted \u201cin the upcoming weeks\u201d after the pertinent analysis of the Cuban regulatory entity. For his part, Dr. Yury Vald\u00e9s, deputy director of the IFV, recalled that this authorization is not requested based on a single result and that the file to be submitted includes \u201call the information that has been worked on with the vaccine candidates, the results and accumulated clinical evidence, partial reports and other rigorous elements such as the inspections carried out of the production systems.\u201d<\/span><\/p>\n<figure style=\"width: 1140px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/oncubanews.com\/wp-content\/uploads\/2021\/06\/Soberana_otm_0377.jpg\" alt=\"Dr. Eduardo Mart\u00ednez, president of the state group BioCubaFarma, in charge of the development of the Cuban COVID-19 vaccines. Photo: Otmaro Rodr\u00edguez.\" width=\"1140\" height=\"760\" \/><figcaption class=\"wp-caption-text\">Dr. Eduardo Mart\u00ednez, president of the state group BioCubaFarma, in charge of the development of the Cuban COVID-19 vaccines. Photo: Otmaro Rodr\u00edguez.<\/figcaption><\/figure>\n<p><span style=\"font-weight: 400;\">Dr. Eduardo Mart\u00ednez, president of the state group BioCubaFarma, in charge of the development of the Cuban COVID-19 vaccines. Photo: Otmaro Rodr\u00edguez.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Once the permit is granted, two important roads open. First, the mass vaccination in Cuba, which has already been carried out under the studies and health interventions underway \u2014 which have made it possible <\/span><a href=\"https:\/\/salud.msp.gob.cu\/actualizacion-de-la-vacunacion-en-el-marco-de-los-estudios-de-los-candidatos-vacunales-cubanos-y-la-intervencion-sanitaria\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">to administer until now<\/span><\/a><span style=\"font-weight: 400;\"> more than 5.3 million doses of Cuban vaccine candidates and begin immunization of about 2.5 million people on the island \u2014 and secondly, the presentation of the results to journals and international organizations, which support and validate what would be officially the first COVID-19 vaccines developed in Latin America.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Regarding vaccination, Dr. Rolando P\u00e9rez, director of science and research at BioCubaFarma, confirmed that this process is in charge of the Ministry of Public Health (MINSAP), although with the participation of scientists in charge of vaccines, and assured that \u201cthe fundamental principle that governs the immunization strategy is the epidemiological situation of the country.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cIt is, above all, about intervening in the populations and territories at risk, in the regions where we have the most epidemiological problems. These will be the ones that will be prioritized, so that we can cover the places most affected by the disease, with the aim of reducing the incidence. We cannot say now which territory will be first and which will be later, because they are analyzes that are carried out continuously, according to the availability of vaccines and the epidemiological scenario, and with these elements it is decided how to move forward,\u201d explained the executive.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Regarding the presentation of the results to global entities and their possible validation by them, Dr. P\u00e9rez assured that Cuban specialists and health authorities have held systematic exchanges with both the WHO and the Pan American Health Organization (PAHO), to update them on the progress of the Cuban vaccine candidates, and that \u201conce the emergency authorization is obtained in Cuba, we can really plan to enter a certification process.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cIt has been a permanent dialogue,\u201d said the specialist, who announced that after the announcement of the efficacy percentages of Soberana 02 and Abdala, the Cuban side established communication with PAHO and \u201cwe have coordinated a next meeting, to facilitate the exchange of information with experts in Washington and also from the WHO.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A third path that is opening, or rather is being reinforced, is the export of Cuban COVID-19 vaccines, based on previous agreements and conversations with several countries and the growing interest of others after the release of the efficacy data. Nations such as Venezuela, Argentina, Mexico and Vietnam are among those that have already contacted Cuba, while others from Latin America and also from Africa and the Caribbean could join the list. Meanwhile, Iran has been carrying out its own clinical trial of Soberana 02 \u2014 renamed Pasteur there \u2014 and is <\/span><a href=\"https:\/\/oncubanews.com\/coronavirus\/iran-autoriza-uso-de-su-primera-vacuna-anticovid-y-preve-hacerlo-con-la-cubana-soberana-02\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">preparing<\/span><\/a><span style=\"font-weight: 400;\"> to authorize its emergency use in the coming days.<\/span><\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"TeaF8970NE\"><p><a href=\"https:\/\/oncubanews.com\/cuba\/cuba-envio-a-venezuela-30-mil-dosis-de-su-candidato-vacunal-abdala\/\">Cuba envi\u00f3 a Venezuela 30 mil dosis de su candidato vacunal Abdala<\/a><\/p><\/blockquote>\n<p><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"\u00abCuba envi\u00f3 a Venezuela 30 mil dosis de su candidato vacunal Abdala\u00bb \u2014 OnCubaNews\" src=\"https:\/\/oncubanews.com\/cuba\/cuba-envio-a-venezuela-30-mil-dosis-de-su-candidato-vacunal-abdala\/embed\/#?secret=HJvZ0wSLHu#?secret=TeaF8970NE\" data-secret=\"TeaF8970NE\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/p>\n<p><span style=\"font-weight: 400;\">But beyond this, Cuban scientists do not stop and research is ongoing \u2014 to obtain more data from the studies already carried out and also to advance new trials in groups such as convalescents and in pediatric ages, and with other vaccine candidates \u2014, as well as the productive escalation necessary to immunize the Cuban population at the expected rate and to be able to commercialize the vaccines internationally. In this sense, the greatest challenge comes from the difficulties in obtaining certain supplies and materials necessary for the manufacture of Cuban immunogens, due to their shortage and competition for them generated by the pandemic, and the harmful effects of the U.S. embargo\/blockade.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Even so, the island\u2019s specialists claim to be working on technological solutions to face these difficulties and to have a better knowledge of the production process for the sake of successful escalation, which is why they maintain the objective of manufacturing \u201cmillions of doses\u201d this year. With this they hope to fulfill the purpose of vaccinating 70% of the Cuban population at the end of August and making the island the first country in the world to immunize its entire population with its own vaccines.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>There have been many reactions and comments inside and outside the island since the efficacy of Soberana 02 and Abdala was announced. These figures, however, are not the end of the road.<\/p>\n","protected":false},"author":3134,"featured_media":240877,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33393,13902],"tags":[29532],"ppma_author":[33546],"class_list":["post-240875","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-coronavirus","category-cuba","tag-coronavirus-in-cuba"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>How was the efficacy of the Cuban COVID-19 vaccine candidates calculated? | OnCubaNews English<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/oncubanews.com\/en\/cuba\/how-was-the-efficacy-of-the-cuban-covid-19-vaccine-candidates-calculated\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How was the efficacy of the Cuban COVID-19 vaccine candidates calculated? | OnCubaNews English\" \/>\n<meta property=\"og:description\" content=\"There have been many reactions and comments inside and outside the island since the efficacy of Soberana 02 and Abdala was announced. 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