The article below appeared in Cubadebate, a Cuban news agency, on August 10, 2021. The original in Spanish can be found here. Translation is by World-Outlook.com.

World-Outlook is publishing it because it helps counter the misinformation and lies the big-business media have unleashed this summer against the Caribean nation. This campaign of slanders, exaggeration, and manipulation of facts is part of Washington’s 60-year-long economic war against the socialist country and the unceasing efforts by the U.S. government and its imperialist allies to undermine and overthrow the Cuban Revolution. The article also provides invaluable scientific information on how to confront the Covid-19 pandemic.

NEWS ANALYSIS

By Lisandra Fariñas Acosta

HAVANA, August 10, 2021 — On July 15, U.S. President Joseph Biden publicly referred to Cuba as a failed state, and dismissed the capacity of the island and its health and science system to respond to the enormous challenges imposed by the pandemic.

Mayda Mauri, first vice-president of BioCubaFarma stated, “these are completely uninformed statements aimed at distorting the reality of what is happening in our country.”

At a press conference, Mauri asserted that there is abundant information and data to prove that the statement by the U.S. president is utterly absurd.

The BioCubaFarma Lead Director stated in response to these statements, that a representative number of Cuban scientists will address a letter to Biden,¹ to be circulated soon with arguments that demonstrate both the capacity and political will of the country to continue to confront the challenges of the current pandemic.

“Among those arguments, we emphasize how Cuba has been able, in an innovative and altruistic manner, to respond to the challenges posed by Covid-19, especially in view of the extremely harsh conditions imposed by the U.S. blockade.”

Measures taken against the pandemic from the scientific point of view, he added, have also been guided by the principles of Cuban health policy, which prioritizes continuous cooperation between the Ministry of Public Health and scientific institutions.

Mauri stressed that Cuba’s results in confronting the pandemic are public, “have always been available to all observers,” and highlighted the relatively low mortality rates due to the novel coronavirus, “especially if we compare the Cuban reality with other countries in the world, even developed ones, and in particular with what is happening in the United States.”

The Director stipulated that the open letter will be available in digital format so that scientists, professionals, technicians, whether from the biopharmaceutical industry or from other institutions, public and private companies in the country, who agree with it may add their names.

It will also be available internationally for those who wish to support these concepts and principles, Mauri added and reiterated that the document rejects Biden’s statements deeming Cuba a failed state, “requiring an intervention for a successful vaccination process, and other assertions that we dispute.”

According to Mauri, the letter states in part: “President Biden, you can do a lot of good if you move in the right direction and take into consideration the will of the majority of Cubans living in Cuba. This does not include disregarding and weakening their public health care system, but it does include respect for the nation’s achievements. Let us hope that the common threats posed by the Covid pandemic lead to more collaboration, not more confrontation. History will be the judge.”

Agustín Lage: U.S. bans the supply to Cuba of products to manufacture vaccines

“President Biden stated on July 15 that his administration was prepared to donate vaccines to Cuba if it was assured that an international organization would administer them to reach the average citizen. We must ask ourselves whether that is true, and also to view it in the context of the [economic] blockade,” commented Dr. Agustín Lage Dávila, advisor to the BioCubaFarma Director, and former director of the Center for Molecular Immunology (CIM).

“Title 22 of the Cuban Democracy Act stipulates that exports of medicines and medical supplies should not be restricted, which we know has not been the case, and we have many examples of restriction on exports to Cuba of medical equipment and medical supplies. This document under [Sec. 6004] paragraph (c) (4) states: “except in a case in which the item to be exported could be used in the production of any biotechnological product,” which of course includes vaccines. In other words, the U.S. government explicitly bans the supply to Cuba of products that can be used to manufacture vaccines.

President Joseph Biden alleges that “an international body is needed to guarantee the Cuban people’s access to vaccines,” Dr. Lage Dávila added.

Let us examine some data, all of it from public and easily verifiable sources, he continued.

Pediatric prophylactic immunization coverage in Cuba is over 99%, as evidenced in the UNICEF database. All Cubans are immunized against 13 diseases, and eight of these vaccines are manufactured in Cuba, he explained.

The renowned scientist cited as an example that there has not been a single case of measles in Cuba since 1993. “The United States on the other hand reported 1,292 cases in 2019. The Meningitis B epidemic of the 1980s was halted using an innovative Cuban vaccine. We have participated in international collaboration efforts to vaccinate people in other countries, specifically in the meningitis belt in Africa. Cuba collaborated there at the request of the World Health Organization (WHO). And there is a report, one of many, which ranks Cuba 30th in the world in terms of health, including the richest countries,” he said.

Lage Dávila pointed out that these eight vaccines are manufactured by Biocubafarma, “a group of 32 companies with 61 production lines. An organization with more than 20,000 employees, including 546 PhD scientists and 219 scientists with masters degrees. These are the entities that produce Cuban biotechnological products, which have been inspected by many regulatory agencies in Cuba and from other countries, including highly developed nations, and which have been certified as to good practices. It should be added that the Cuban regulatory agency is recognized by the Pan American Health Organization (PAHO), and is one of the few regulatory agencies recognized by PAHO,” he said.

According to the scientist, the history of immunizations and their date of introduction in the country is the history of conventional vaccines: for diphtheria, tetanus, among other common pathologies. “But this history also includes innovative vaccines that have been the product of Cuban research, and that have also been decisive in eliminating those diseases in Cuba and in reducing certain diseases to insignificant levels.”

“I tell my students at the Center for Molecular Immunology that one can work 20 hours a day for 20 years, just to be able to view that slide (image above). That is what happened in Cuba with the meningococcal Meningitis B epidemic. It was not only a question of producing a vaccine, but also of inventing a vaccine, because at the time of the epidemic, while there existed vaccines against Hepatitis A and C, there was none against [Meningitis] B. The data illustrating this descending curve are not from a clinical trial, they are national population data. The same happened with Hepatitis B, and the significant reduction in the incidence rate of the disease with the introduction of this vaccine, which is a conjugate vaccine, a high-technology vaccine, with which all children are immunized in our country. Something similar been done with the Haemophilus influenzae vaccine, which reduced the incidence of Haemophilus meningitis,” stated Lage Dávila.

The prestigious scientist also stressed that numerous studies have been published on Cuban biotechnology, but he referred in particular to an editorial in Nature, one of the most prestigious scientific journals in the world. “In 2009, Nature said that the Cuban biotechnology system was the best biotechnology system among developing countries in the world. The question we can ask ourselves at this point is whether a country with those results needs someone’s intervention to introduce a vaccine against COVID-19,” he said.

All countries in the world are concerned about this pandemic. “It is no secret that we are in the midst of a peak in the pandemic, but we have to put it in context. Viewing this fact in the broader context of all the data, we can examine mortality, which is to say the number of deaths per number of infected persons. The world average mortality is 2.1%, 1.7% in the United States, 1.4% in Florida, 2.8% in Brazil, and in Cuba it is 0.76%. These data from international sources show that Cuba has half the mortality rate of the United States and the world. As for vaccination rate, which measures the number of vaccines jabs per million inhabitants in a given period, as of August 3, Cuba was ranked first in the world. Again, we must ask if a country in such conditions requires the intervention of some other country to ensure its vaccination coverage.”

“The fact that we say that we do not require an intervention, in the sense that the U.S. government is asserting, does not mean that we do not seek cooperation. We do seek cooperation; in fact, for decades we have sought and promoted cooperation with American scientists, and a clear example of this is the existing exchange for development of a therapeutic vaccine against lung cancer,” he concluded.

Dr. Mitchel Valdés-Sosa, President of the Cuban Neuroscience Center (CNEURO), cited pulmonary ventilators, a vital resource in the face of a pandemic caused by a respiratory virus, as an example of generosity by U.S. scientists, and their willingness to collaborate, in contrast with the hurdles imposed by the blockade and sanctions imposed by the U.S. government against Cuba.

“The ability to purchase spare parts for ventilators has been hindered by the blockade, and should a U.S. entity acquire stock in a European or any other nation’s companies, they immediately lose the ability to export to Cuba,” the academic stated.

Cuba, he said, has acquired more than 213 ventilators and has also received donations to increase ventilator availability.

“We have purchased and delivered 170 additional ventilators for intubated patients, produced by Cuba, which by next week should increase to more than 200. There is a second type of advanced ventilator, which will be produced more quickly in our centers, and we plan to be able to deliver 250 of them in the next few months,” Valdés Sosa said.

The Cuban ventilator, he said, is based on a design by a North American university, the Massachusetts Institute of Technology, where American scientists very generously made their research available to the world. A group of Cuban research centers took that ventilator and adapted it to our conditions. However, the parts used in that ventilator cannot be purchased in the United States, the General Director of the Cuban Neuroscience Center underscored.

“Why?,” asked the scientist. “It happens to fall explicitly under the ban under U.S. law prohibiting any import from the United States of inputs used for the biotechnology industry in Cuba.  If President Biden wants to help Cuba, he should end the blockade or at least those sanctions that can be ended with a single stroke of the President’s pen; and that would be a help,” he emphasized.

Cuba-US: A deep relationship based on on scientific knowledge is possible

Dr. Agustín Lage highlighted that during this pandemic there have been online exchanges with North American universities. “Exchanges with the North American scientific community have always existed with very good will, and hindered only by issues such as the blockade, the granting of visas… but between the scientific communities of both nations there has always existed a high level of mutual respect. For years at the CIM we held a conference dedicated to cancer immunotherapy, and the United States likewise has sent the most professors, even when many are obliged to travel via third countries,” said the professor.

He affirmed that between Cuba and the United States there is a platform for collaboration that could work “if these political obstacles and this almost medieval hostility were overcome. Two countries so close and with a scientific infrastructure that flows from a similar school of scientific thought could accomplish a great deal,” he said.

“In spite of everything we envision future collaboration that, if achieved would be well received the world over, including the American and of course the Cuban people,” Lage said.

Dr. Tania Crombet Ramos, Director of Clinical Research at the Center for Molecular Immunology (CIM), said that scientific collaboration is possible through joint research on the therapeutic lung cancer vaccine CIMAvax-EGF, which this institution is developing with the Roswell Park Institute, in the United States.²

“Despite the pandemic conditions, the advanced Phase III clinical trial has not stopped and we maintain regular exchange with the research team. A profound scientific knowledge-based relationship with the United States is possible. The research is advancing well, we even have a very encouraging preliminary result with a subset of the patients treated with our vaccine, in combination with the other trial molecule, which has shown unexpected strength/resilience. It is to be patented and the joint team from Roswell Park and the CIM is preparing for publication,” the expert explained.

She added that it will not be the only molecule under the joint venture between the two institutions. “We have four cancer molecules that are ready to commence clinical trials in the United States. In the second half of the year we even anticipate that research may begin on the CIMAvax-EGF vaccine, which up to the present has only been used to treat advanced cancer, for preventive therapy, that is, to try to delay or prevent high risk cancer patients, fundamentally those who have a chronic obstructive disease, from developing a malignant neoplasm,” he explained.

A clinical trial has commenced in Cuba and the goal is to commence a clinical trial of a preventive modality by the end of the year in the United States, she said.

Moreover, Dr. Tania Crombet pointed out that Itolizumab is another of the molecules being used in the Cuban protocol and is also used in the United States, “in this case not for Covid-19. This validates the quality of the science done in Cuba, as it is a Cuban patented molecule and is undergoing clinical trials for other autoimmune diseases such as lupus nephritis, transplant rejection prevention and uncontrolled bronchial asthma, all of which confirms the great interest among the scientific community in Cuban science.”

The scientist reported that they recently requested registration authorization for another CIM molecule: NeuroEpo, for treating neurodegenerative diseases such as Alzheimer’s, which could be of great interest in the United States.

“While in Cuba we have 160,000 dementia patients annually, in the United States the number exceeds 6 million. It has been reported that during the pandemic there has been a worsening of the disease due to the isolation imposed by Covid-19. The data from a placebo-controlled trial in Cuba are very positive. It is an intranasal formulation, a very convenient form for patients and caregivers. In this trial it was shown that we were able to improve neuropsychiatric cognitive impairment indices and also cerebral perfusion. We have evidence of improvement in mild and moderate Alzheimer’s with this molecule. We would be very interested in consolidating this evidence in the United States, where it is a major health problem,” concluded Crombet Ramos.

Convalescents: A tentative field of scientific collaboration

Dr. Luis Herrera Martínez, a genetic engineer, founder of the CIGB and scientific and commercial advisor to the BioCubaFarma group, pointed out that the recognition of Cuba’s efforts by the Nature magazine in 2009 “is not old news, but continues to be very valid, precisely because Cuba continues to obtain novel results, recognized by the award of patents by the United States Patent Office. That is the proper entity to determine whether the result is novel or not, and Cuba is one of the third world countries that has filed more patents there,” he said.

Dr. Martínez stated there is a particularly noteworthy aspect: clinical studies have been carried out in Cuba with convalescents, a field where, in his opinion, there may be opportunities to collaborate with the United States. This is also true for the cancer treatment vaccine and Heberprot-P. “In the United States there are more than 35,812,000 convalescents, according to statistics published in the New York Times. However, epidemiologists’ estimates are that the actual figures may be much higher. This may mean on the order of 80 or 90 million convalescents, and there is no defined policy as to what they are going to do with those convalescents,” he explained.

“Cuba was the first country that proposed the study of convalescents, and proposed a solution so that these people would be protected against reinfection, to avoid serious consequences. This is the case of the use of Soberana Plus, which is the first vaccine to be tested on convalescents. This result is very novel and has been recognized, and it is one of the areas in which we could propose collaboration with the Americans, as we have often done before. It is a new field, very up-to-date, for potential cooperation,” he pointed out.

Cuba’s priority is to vaccinate 100% of its population

Mayda Mauri, first vice-president of BioCubaFarma, stated that Cuba’s vaccination priority is to vaccinate 100% of its population against Covid-19.

“Our production companies have already delivered to the Ministry of Public Health around 13 million vaccines doses. With August and September deliveries, we think that the country will be in a position to immunize the entire Cuban population, including children over 3 years of age,” he said.

Thus, the industry will fulfill its commitment to our people to have the entire population immunized before the end of 2021.

“The surpluses we have of vaccines during 2021 will be available for export and only after we have the entire Cuban population immunized by the end of 2021. All the vaccine doses we are able to produce could be exported to the countries with which we establish agreements,” Mauri said.

According to Dr. Gerardo Guillén, Director of biomedical research at the Center for Genetic Engineering and Biotechnology, Cuba remains the country that vaccinates the highest percentage of its population on a daily basis.

“For several weeks Cuba has led in this indicator. As has been often stated: vaccine produced, vaccine administered (vaccine out, vaccine in). We have the advantage of the strength of the Cuban health system. We do not face the limitations of other countries. Cuba is prepared to undertake the mass immunization of its population. It has created this system for another group of vaccines, which facilitates the introduction of vaccines, and that is why we have achieved these high immunization levels,” he explained.

He added that there is a substantial difference between Cuba and other countries, which is the fact that in Cuba practically the entire population wants to be vaccinated. There are countries that advanced rapidly in immunization, but then have slowed down because a significant proportion of the population does not want to be vaccinated. “The anti-vaccine movements during the pandemic are not new, they previously existed regarding other vaccines, and they are even manifested in the rejection of countries that mandate vaccination for certain sectors of the population. We don’t have these problems in Cuba. Here it is the opposite, the population actually demands the vaccine, and those who do not want to be vaccinated are the exception. Of course, there are individuals for which the vaccine is contraindicated. This is why we are confident that we will reach high COVID-19 vaccination rates, similar to those achieved with other vaccines, by the end of 2021,” the expert affirmed.

In this regard, he mentioned that a batch of vaccines without Thimerosal will be available in September. “This is a priority, since there is a percentage of the population that cannot be vaccinated because they are allergic to Thimerosal. There are others who have not been able to be vaccinated due to their chronic decompensated diseases. [“Decompensated cirrhosis is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage” according to the U.S. National Institute of Health; World-Outlook Editor.] The pediatric population cannot yet be immunized since the vaccines for them have not yet been authorized,” said Dr. Guillén, who emphasized that the projected vaccine production is ensured.

Status of emergency authorization trials of pediatric application of Soberana 02 and the Soberana vaccines

Dr. Vicente Vérez Bencomo, General Director of the Finlay Vaccine Institute, reported that the emergency use authorization for Soberana 02 is nearing completion. “We are currently holding meetings with the regulatory authority, and have submitted all necessary documentation. In fact, we already possess most of the data required for the authorization. We have completed everything necessary on our part, so we are in the final stage with the regulatory authority,” he said.

The scientist added that the scaling up of production of the Soberana vaccines (Soberana 02, Soberana Plus and Soberana 01) is proceeding well. Hence, the emergency use authorization should be met with significant availability of doses.

In addition, he reported that the clinical pediatric trials are progressing satisfactorily. “The first group of volunteers received the third dose yesterday. The preliminary results are very good. We anticipate that the emergency use authorizations for the adult population will coincide with the intermediate results of the pediatric trial, and with the availability of doses that will enable us to consider vaccination of our pediatric population sometime in September,” he reported.

“The convalescent trial ended with very good results, we are now in the final stage of data collection and evaluation. We aim to request an emergency use authorization for Soberana Plus, for the entire convalescent population nation-wide, which we expect to implement in September,” said Vérez Bencomo.

Regarding the immunization of pregnant women with one of the Soberana vaccines, he explained that will be decided by the Ministry of Public Health (Minsap). No specific clinical trial is being carried out with this population group. An initial step would be an emergency use vaccine authorization. Following the emergency use vaccine authorization of the Abdala vaccine, Minsap authorized its use for pregnant women, as will likely happen with the Soberana 02 and Soberana Plus vaccines.

Data indicate a reduction in mortality in Havana

Dr. Gerardo Guillén, Director of Biomedical Research at the Center for Genetic Engineering and Biotechnology (CIGB), pointed out that the clinical study provides vaccine efficacy data but not regarding its effectiveness.

“They are two concepts that are often confused, but which are not the same. Efficacy is determined within the framework of a controlled study, which applies inclusion criteria, and hence excludes those with terminal diseases, persons with decompensated basic chronic diseases, etc. Effectiveness is the data obtained from mass vaccine immunizations, which include the entire population. Therefore, when stating that a vaccine is 100% efficacious in preventing mortality and serious disease in a Phase III clinical study, this refers to a controlled study, which is focused on direct attention and follow-up of the participating volunteers, and which excludes certain categories of persons as is common international practice in studies of this type,” the scientist explained.

The data are currently being crunched, and are being prepared to be able to provide a systematic report on the effectiveness of the Abdala vaccine —Dr. Guillén reported—as is the case with other epidemiological data on the development of the epidemic.

“These data require more analysis because the scrutiny of some 40,000 study volunteers is far less difficult than the data for the population as a whole, and especially because these data are only now being gathered. Only four municipalities in the Havana capital province have completed the vaccination series. There is also the problem that people get confused and consider a person vaccinated, when in fact they have only received the first jab, when the person has yet to complete the full series, plus the additional 14-day period for the third jab to stimulate an immune response. So, if these aspects are misunderstood, the figures may be misleading,” said Dr. Guillén.

According to preliminary data, there is clear evidence of a decrease in the mortality rate in Havana compared to the rest of the country, he stated. “It is substantial. If we examine the vaccinated municipalities, the first four that completed the full series in Havana, the decrease is more appreciable relative to the rest of the country and the rest of the provinces. These data are shifting as the other municipalities are completing the immunizations,” he said.

According to the expert, slightly more than half of Havana’s population is still in the midst of the 14-day period following the third vaccine dose. He stressed that in the capital not all the population is vaccinated. There are around 700,000 people who have not been immunized, of whom about 400,000 are children, and others unable to be vaccinated due to various causes.

“Now when we talk about these overall figures for the municipality or the province everyone is included. When they can be further refined, these figures will be even more significant. We know that the vaccine is efficacious, and hence the greater effectiveness against mortality rates. This is significant, because in many countries there is an increase in the number of infections, especially due to penetration by the Delta variant. Countries that have high percentages of vaccinated population have suffered increased transmission and contagion due to this variant. However, they maintain low mortality and intensive care hospitalization rates. The vaccine is very effective against severe illness and mortality. It reduces the cases of transmission, but not at the same level as the severity of the illness and death,” he said.

He added that the data is still being gathered, but the preliminary data, indicate very positive results that vaccination is having in Havana. “To this will be added other municipalities that are in the transition stage, that is to say that they will fully complete the three jabs plus the [14] days, such as Santiago de Cuba province. The Island of Youth completed the protocol along with the first four Havana municipalities, and there have been no deaths for several days,” he added.

Nasalferon and Interferon production stepped up in response to demand

According to Dr. Gerardo Guillén, both Nasalferon and Interferon are being produced, and despite a one-week interruption in Interferon production, it is recovering to meet demand. Travelers and their relatives will receive one drop, nasally, in the morning and another one at night, for a period of between 5 and 10 days.

“Interferon production has increased to maximum to meet demand. Due to the worsening of the epidemic, clinical treatment protocols have also been adjusted in the face of shifting circumstances. For example, an increase in rates among the fully vaccinated population of Havana and the rest of the country has been detected. The vaccinated population are protected against the illness evolution in terms of severity and gravity. Therefore, the current protocol for fully vaccinated, and risk-free individuals, that is, younger than 65 years, without comorbidities, indicates that they do not require Interferon, since they are already protected by the vaccine,” he explained.

“There are no statistical data yet, but as the evolution of the epidemic is shifting. It is now very common to hear of people, even adults, with comorbidities and at high risk, who only suffer mild symptoms and the illness does progress in severity to where they require intensive care, as was the case before vaccination. Interferon is being administered solely to at-risk individuals. This means that an important part of the population does not require this product, and the increase in demand due to the epidemic can be met for the unvaccinated,” said Guillén.

The scientist stressed that this is unique to Cuba. “In no country in the world are people treated early, with a product such as interferon which, as has been previously explained, prevents the evolution of the illness in terms of severity, and helps with post-COVID symptoms. The data speaks to the effectiveness of the protocol in Cuba. It is really something positive, that most people can be treated with interferons from the moment they manifest mild onset symptoms, especially prioritizing at-risk sectors, and of course everyone who is admitted to hospital,” he maintained.

Delta: Up to 1200 times greater viral load than previous variants

Dr. Gerardo Guillén explained that vaccines basically induce a systemic protective response mediated by antibodies, mainly IGg.

“There are two kinds of antibodies, but a systemic response that protects against the evolution, severity, the seriousness of the illness, which leads to previously-identified tissue damage, and which produces COVID-19. The virus enters through the nasopharynx and colonizes the nasal mucosa. The vaccines administered via intramuscular injection do not show the same capacity to induce a response at the mucosal level as is induced at the systemic level, that is to say, they also induce responses at the mucosal level, but the levels of systemic response are much higher,” he pointed out.

“Then transmission, colonization, and illness occur… It has already been published in the world the fact that vaccinated individuals have been infected with the virus, also with high viral loads, and in the case of the Delta variant up to 1,200 times greater load than previous variants. The susceptibility of a person to infection is directly related to the viral load. In other words, previously, a person needed more than 30 to 45 minutes of direct contact with someone to become infected based on the viral load necessary to become infected. Now the time is decreasing, and asymptomatic individuals with a high viral load can transmit the disease, precisely because what is needed to infect others are those high viral loads at the nasopharynx level,” explained the distinguished scientist with the CIGB.

The expert emphasized there is a world-wide reported increase in transmissibility and infections with the appearance of Delta, and a greater number of breakthrough infections among the vaccinated, although this incidence is lower than among unvaccinated. “However, they are not the same levels of vaccine efficacy against severe illness and mortality. There are lower levels of efficacy against transmissibility, and even less with the Delta variant. That is why there is an increase in transmission, even in countries with high vaccination rates. That is not the case with mortality rates, where the vaccine continues to be highly effective,” he pointed out.

Dr. Vicente Vérez Bencomo, General Director of the Finlay Institute of Vaccines, pointed out that one of the bets of Soberana 02, a conjugate vaccine, was to apply the knowledge we had acquired from other antibacterial conjugate vaccines, which had an impact on colonization, and therefore on infection.

There are vaccines such as the pneumococcal vaccine, he said, that have an important effect not only in preventing the disease but also during the asymptomatic carrier state. In the Phase III clinical trial, controlled and developed in a scenario of 74% circulation of the Beta variant, Soberana 02 showed 75% efficacy in preventing infection. “We are now tackling the Delta variant, which appears to have less vaccine escape capacity, but is associated with higher transmissibility and viral load. Both during the Phase III clinical trial that we are carrying out in Iran, as well as the extension from the industrial scale-up and mass immunization with the vaccine, commencing in September, we will obviously gather data on the impact of the vaccine on the infection and to what extent it is capable of reducing not only the illness but also the contagion,” explained Vérez Bencomo.

Dr. Tania Crombet Ramos, Director of Clinical Research at the Center for Molecular Immunology (CIM), commented that recently a CNN headline using data from the Centers for Disease Control and Prevention (CDC) explained the characterization of infected persons in Massachusetts, precisely in the United States, where it is well known that the Delta strain modified transmissibility and vaccine efficacy data.

In the group of Massachusetts’ patients who were infected in a July outbreak in Barnstable County, which includes the summer vacation destination of Provincetown, 75% were vaccinated patients, i.e. three-quarters of the infected patients had the vaccine administered. In addition, viral load characterization was performed between vaccinated and unvaccinated patients, and the viral load of both groups was equivalent. “However, the study showed that regardless of the viral load, there was a much lower rate of deterioration, i.e. the severe forms of the disease were much lower in those vaccinated subjects with the vaccines administered in the United States, which is where the Pfizer, Moderna, and Johnson and Johnson vaccines prevail,” the expert explained.

“We are facing a new illness, there is already talk of boosters; for example, Pfizer was asking for authorization for a third dose, especially for the most vulnerable population. Therefore, we have to carefully study the effect on transmission, especially with the Delta characteristics, which is a different variant from the biological point of view. This does not detract in any way from the utility of the vaccines in preventing severe forms of the illness and mortality,” affirmed Dr. Crombet Ramos.

“Taking all these elements into account,” said Dr. Gerardo Guillén, “treatment protocols have changed. In Cuba, priority has been given to medications aimed at avoiding the severity of the infection, anti-inflammatory drugs for those who really need them, and for other people, other procedures have been implemented. We are already discussing the fact that these viruses are here to stay, and therefore we have to move towards protocols for the new normal,” he said.

Cuban biotechnology seeks to add new products to the COVID-19 therapeutic arsenal

Dr. Guillén highlighted that clinical studies with new antiviral drugs and with products to stimulate innate immunity are ongoing. CIGB 325, an antiviral that has completed Phase I, will now proceed to Phase II-III. Then there is the CIGB 2020 vaccine to boost innate immunity. “These are ongoing projects, and they are being prioritized given this new situation. Cuban science continues to work to develop new products, and to evaluate and expand current products,” he said.

The Director of Biomedical Research of the Center for Genetic Engineering and Biotechnology (CIGB), cited the case of Jusvinza, anti-inflammatory drugs that initially were for adults and later were extended to pregnant women, adolescents, and younger children, “as a result of adjustments in the protocol based on experience with current drugs and also clinical trials and ongoing research with the new products. We continue working on new vaccine candidates, both in previously cited projects as well as other vaccine candidates that include sequences for the mutations,” he said.

“These are not something particular to Cuba, but to the entire world, which is already talking about booster doses, something that will also have to be done in Cuba in the future, but not just yet because our vaccinations have only just been performed. However, in the future there are tools at our disposal that have demonstrated our capacity to continue contributing to the control of the epidemic,” she emphasized.

Dr. Tania Crombet Ramos, Director of Clinical Research at the Center for Molecular Immunology (CIM), maintained that the Cuban protocol continues to have a high recovery rate.

“Even now that we are in the worst moment of the pandemic, we have an 89% recovery rate, which is still a very high percentage of the number of active cases. On average we have 45,000 patients daily and between 450 and 500 patients in intensive care, which tells us that the proportion of people who are reaching severe or critical states is still very low, between 1 and 1.5%. Above all else this ratifies the importance of the early use of antiviral medications (interferon and nasalferon) that have been administered in accordance with the Cuban protocol, which is being adapted more intensively because there are patients who are already at less risk,” said the scientist.

Crombet Ramos referred to Itolizumab, another monoclonal antibody that is already authorized for emergency use, with a very high recovery rate (97%) in moderate and high-risk patients, and more than 85% in severe patients.

“We are now recommencing production of Itolizumab, which will allow us to provide greater coverage with this drug, and not only to be able to use it for severely-ill patients, but also with moderate and high-risk cases. Research continues on a third molecule for the third stage of the illness. Itolizumab is a monoclonal antibody, and the Jusvinza molecule is an immunoregulator peptide [for the treatment of Covid-19 cytokine storms among other therapeutic uses], and we are currently undertaking clinical trials of a monoclonal known in oncology: Nimotozumab. This is a molecule that has been widely validated for safety and efficacy in Cuba and in 25 other countries where it is registered, which should result in improved patient discharge from the hospital with fewer consequences,” the doctor explained.

Regarding Nimotuzumab, the scientist explained that this molecule is expected to be very significant in preventing or reversing [post-COVID-19] pulmonary fibrosis, one of the most worrisome patient complications. “The Cuban protocol is constantly being revised. We continue to carry out research, and every day we study new molecules that may be useful for dealing with viral replication, which is the most important issue, as is the case with second-stage issues of coagulation and inflammation,” said Crombet Ramos.

ENDNOTES

[1] See: Open Letter to President Biden About Covid Vaccines for Cuba.

[2] For more information on this joint U.S.-Cuban venture see: https://www.roswellpark.org/cimavax#:~:text=CIMAvax%2DEGF%20is%20a%20lung,a%20clinical%20trial%20involving%20CIMAvax.%C2%A0%C2%A0%20/%20https://www.roswellpark.org/newsroom/201809-governor-cuomo-announces-first-ever-biotech-venture-between-us-cuba-research