Around a thousand vehicles in the city of Holguín set off in a Caravan against the Blockade, a genocidal policy imposed by the US government.
The claim is joined by youth leaders, workers from different sectors. Clubs, art instructors and Holguin civil society in general participate in this Caravan.
Respecting the established hygienic and sanitary measures, for this purpose control points have been established made up of students from the medical sciences and from the Hygiene and Epidemiology career.
For more than 60 years, the economic, commercial and financial blockade imposed by the United States on the largest of the Antilles has intensified to unsuspected levels.
In the 21st century, the US administrations did not stop sharpening their genocidal policy against Cuba and hardening economic policies, even since the beginning of the COVID-19 pandemic.
And to the cruelty of the blockade, the world responds with support for Cuba in caravans that recognize the values of the Caribbean nation and the right to its sovereignty and development.
The need of lifting the siege of Cuba, raise awareness of how the measures punish families, the defense of love for the Cuban idiosyncrasy and the collapse of walls of hatred anchored in the past, among other examples, are part of the demands of these caravans organized in numerous cities of the world.
The most recent blockade demonstration on the island comes to light of the limitations imposed to acquire medicines, health equipment, materials and supplies necessary in the midst of the health complexity caused by the new coronavirus.
Given the presence of Sars_Cov2 and so many restrictions, scientists intensified the search for vaccines and drugs, designed physical-mathematical prediction models and new treatment protocols with a strategic approach, which has allowed Cuba to be in the group of countries with ready vaccine candidates to prove its effectiveness to face COVID-19
Of course, the blockade is focused on harming the scientific sector because it hinders exchanges and international cooperation. They have not bowed. With innovation and talent, they eliminate barriers and grow in times of the first great contest of the 21st century.
That is why understanding the consequences of the blockade in all spheres of society is necessary in the face of a century of economic crisis and epidemics. Each initiative organized today by friends in any latitude serves the purpose of sensitizing public opinion and the North American authorities to the end of this genocidal policy against a small island that writes its own history every day.
So joining caravans against the blockade in Cuba and in other regions of the planet says a lot about the feelings of love for our country and its people.
In 2020, the accelerated advance of the SARS-COV-2 virus by several countries and its subsequent denomination as a pandemic demanded immediate responses from science to treat infected people and prevent the disease.
Many were the treatments that arose from the experience of other viral diseases, the readjustment of products designed for other purposes, in addition to the production of vaccines with known technologies and other new generation ones.
The pharmaceutical companies Pfizer, BioNTech and Moderna used messenger RNA (ribonucleic acid) or mRNA, which works by injecting RNA fragments that reach the interior of cells and produce there the SARS-CoV protein S (spike). -2, the immune system produces specific antibodies and memory cells against the virus.
Other companies such as AstraZeneca, the multinational Johnson & Johnson and the Gamaleya Institute - in charge of Sputnik V - used a fragment of the genetic code of the coronavirus that is mixed with a harmless virus, called an adenoviral vector, which transports the genetic material to the human body , infects cells, produces the S protein of SARS-CoV-2 and also creates immune memory against the virus.
Along with these vaccines, some with older technologies were developed, as is the case with the Chinese Coronavac of the Sinovac company based on inactivated viruses, obtained through the multiplication of a virus in cell culture until obtaining a high concentration, then the particles are inactivated with a toxic substance and their proteins maintain an immune response in the vaccinated.
Instead, Cuba bet on its five vaccine candidates, developed by the Finlay Vaccine Institute (IFV) and the Center for Genetic Engineering and Biotechnology (CIGB), for the protein subunits obtained by recombinant route, a technology widely known in the country and with sufficient safety evidence, which is of great importance, because in the face of COVID-19, the times of clinical investigations have been shortened.
About the three vaccine projects of the Soberana series –01, 02 and Plus– of the IFV, the Cuban News Agency spoke with Doctor of Science Rolando Felipe Ochoa Azze, who for 23 years has been dedicated to the activity of clinical trials in the institution and currently works as a specialist in the Directorate of Business Intelligence and responsible for the clinical trials of Soberana Plus by the promoting center.
Cuban scientists decided to bet on protein subunit vaccines. Can this be considered an old technology? What are its potentialities?
In the face of COVID-19 in the world, state-of-the-art technologies have been used and have been shown to induce a high immune response, but adverse events have also been reported in some unwanted cases, such as the formation of blood clots. These events do not violate the risk-benefit criterion to suspend their use, although they do introduce a danger in their use.
Other vaccines approved by the World Health Organization have proven useful in preventing serious disease and are of an older generation than ours, such as those with inactivated viruses.
The Cuban vaccine candidates are based on obtaining the RBD (receptor binding domain) of the S protein, obtained by recombinant route, which, although not of the latest generation, is still used in vaccines produced by large pharmaceutical companies, for For example, it is used in vaccines against hepatitis B produced by various companies in the world, so it cannot be said that they are obsolete technologies.
Our candidates have shown good immunogenicity results, perhaps slightly lower than the latest generation vaccines, but high, and after a third dose with Soberana Plus (FINLAY-FR-01A) this immune response increases notably. In addition, they have the virtue of being safer and less reactogenic.
Soberana 01 (FINLAY-FR-01) contains vesicles from the outer membrane of meningococcus serogroup B (base of the Cuban vaccine against meningococcal meningitis), while Soberana 02 (FINLAY-FR-02) RBD is bound to tetanus toxoid that It is used as part of the scheme with the aim of increasing the immunogenicity of the vaccine, and in both cases the safety has been previously tested.
Regardless of the technology, what is sought is a certain degree of effectiveness against the disease. In the latest generation vaccines, the genetic material that has the RBD information is inoculated so that the cells can produce it, and in our candidates we inject the RBD. The product is the same, one created by the human cell itself and the other injected directly.
How did the IFV vaccine candidates emerge? How many institutions are involved in its development?
The decision of which would be the antigen or protein structure to use was a table design. The coronavirus enters the human cell, uses its synthesis machinery and reproduces itself, and IFV's strategy was to achieve a protein that more closely resembles what can occur after the virus infects the body.
We opted for a recombinant protein from higher mammalian cells and, more specifically, Chinese hamster ovary cells were chosen. It is not that the animal is sacrificed, as one might think, but rather that it is cell lines that exist in laboratories, have been successful and have been known for many years in the world for the production of recombinant proteins.
The protein structure that allows the binding of the virus with the receptor on the human cell is RBD, which was designed in IFV. The Center for Molecular Immunology (CIM) - in charge of several cancer vaccines with this cell line - assumed the reproduction of the RBD, which, once achieved, was sent to the IFV where modifications are made depending on each vaccine candidate.
In the case of Soberana 01, RBD appears in a dimeric form (two proteins joined together), an outer membrane vesicle of the meningococcus serogroup B and aluminum hydroxide are added.
While in Soberana 02 the RBD is obtained from separate molecules, that is, monomeric, that are conjugated, that is, approximately six of them bind to tetanus toxoid and are absorbed in aluminum hydroxide. Likewise, Soberana Plus, a simpler formulation, is made up of two RBD molecules (dimeric format), adjuvated in aluminum hydroxide.
Once each of the formulations are developed, from components that increase the immunogenicity of the product, these are packed in the National Center for Biopreparations, where the production chain ends.
After production comes clinical research When is a product ready for human testing?
Several actors converge in a clinical investigation. The first is the promoter, that is, the institution that develops the vaccine candidate from the performance of preclinical research, primary pharmacological, chemical, biochemical studies and in animal models.
With all these results, authorization is requested from the Center for the State Control of Medicines, Equipment and Medical Devices (CECMED) to start the studies in humans.
For the vaccines of the Sovereign series, the main promoter is the IFV and it is responsible for preparing the research protocol, the data collection notebook, the adverse event diaries, the investigator's manual and other necessary documents, carry out the coordination, select the clinical sites where the trials will take place and guide the work of the principal investigator.
Before including the first volunteer, all trials are registered in the Cuban Public Registry of Clinical Trials, are approved by an Ethics Committee and by CECMED, the national regulatory authority that performs the audits and authorizes the protocols.
Likewise, the investigations are controlled by specialists from the National Center for Clinical Trials Coordination, who supervise and monitor the study, and the Independent Data Monitoring Committee that is in charge of ensuring, together with the Ethics Committee, the confidentiality of the data. results and the good progress of the investigation.
How do IFV vaccine candidates work? Why are all three doses necessary?
Vaccine candidates for both IFV and CIGB function similarly. They use the specific fragments of the virus, the RBD, for the immune system to recognize them and offer an immune response directed at key parts of the pathogen, in this case the RBD, in charge of attaching itself to the cell that the virus is going to infect.
It should be clarified that the body's defense mechanisms have two aspects: one mediated by antibodies, which bind to the virus and prevent them from entering the cell, and the other by T lymphocytes, which protect against the virus by recognizing a diseased cell and delete it. The antibodies work before the virus enters the cell, and then the lymphocytes kill the diseased cell and the virus in it.
In the case of Sovereign vaccines we have not only focused on the stimulation of antibodies, but also of those protective cells. From the beginning, different options and combinations were tested, we wanted the response to be as high as possible and that is why we added Soberana Plus as a reinforcement, being able to stimulate the immunological memory B cells and the T lymphocytes previously developed by the virus or by another vaccine candidate.
As the third dose in an arm of the clinical trial in phases II and III of Soberana 02, it demonstrated a greater immune response without increasing adverse events, as it is a simpler formulation, which introduces the necessary element to reactivate the immune system.