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Soberana 01, Cuba’s vaccine against COVID-19 in clinical trials

Second group of volunteers join Soberana clinical trials
Twenty more Cubans joined the short history of Soberana 01, the country’s first candidate vaccine against COVID-19, on September 2, according to reports from Naturaleza Secreta.

Granmaseptember 10, 2020 10:09:54

Twenty more Cubans joined the short history of Soberana 01, the country’s first candidate vaccine against COVID-19, on September 2, according to reports from Naturaleza Secreta.

This group, composed of volunteers between 60 and 80 years of age, is the second to receive the first dose of the much awaited vaccine, that could make a significant contribution in the battle to contain the virus that is taking lives every day.

This step in the clinical trials took place after several other processes were completed, all carefully organized as part of the clinical trials that Cubans are following closely, hoping for the success that will allow for the entire population to be vaccinated against the new coronavirus.

Prior to the launching of the trials, in accordance with established protocols, all possible volunteers interested in participating where provided a full explanation of the process and signed an informed consent agreement.

A clinical trial is a study, an investigation conducted with volunteers, that on this occasion includes two phases. In the first, two groups were incorporated, one composed of volunteers between the ages of 19 and 59, and another including those aged 60 to 80. Each of these groups were randomly divided into three sub-groups given different doses of the vaccine under investigation or the vaccine VA-MENGOC-BC, as the control group, explained by Dr. Sonia Pérez Rodríguez.

She added that the candidate vaccine Soberana 01 is administered in two doses: the first on what is designated “day zero,” and a second dose 28 days later. The study ends 28 days after the administration of the second dose, thus giving the investigation a duration of 59 days.

The purpose of this phase is to determine if the vaccine is safe, to then be able to extend the study to a larger group of volunteers, and subsequently the population.

“It is a preventative vaccine, and this first phase has but one protocol, to allow us to evaluate the security of the product. This means that we record everything that occurs with the volunteers. If the vaccine is shown to be safe, we will continue the investigation. By evaluating two doses of the product, as the study advances, the most effective and safest dose will be identified, and that will be the one we use in subsequent stages of the clinical trials,” Dr. Pérez added.

Soberana 01 is the world’s 30th candidate vaccine against COVID-19, and the first in Latin America and the Caribbean to receive authorization for clinical trials. The first phase of the study began on August 24, when the proposed vaccine was administered to 20 volunteers between the ages of 19 and 59.

Finlay Institute informs PAHO/WHO of progress on Cuban candidate vaccine

A productive online exchange on progress being made in developing a Cuban vaccine against COVID-19 took place recently between lead researchers at the Finlay Institute, representatives from the Pan American and World Health Organizations (PAHO/WHO), and the Coalition for Epidemic Preparedness Innovation (CEPI).

Carlos Fidel Martín Rodríguez, director of the Cuban Ministry of Foreign Trade and Investment’s International Economic Organizations department, reported the discussion on his Twitter account.

During the exchange, Vicente Vérez Bencomo, general director of the Finlay Institute, reported that trials of the candidate vaccine Soberana are revealing limited risks, raising few questions, and providing promising results in the pre-clinical phase currently underway, which began August 24 with administration of the vaccine to 20 persons between 19 and 59 years of age, and a week later, another 20 volunteers between the ages of 60 and 80.

All participants in the study, as a basic requirement, signed an informed consent agreement, and are in good health. Individuals with well-controlled chronic diseases were also included.

The second phase of the study is scheduled to begin October 30, with the incorporation of more volunteers to reach a total of 676 participants. Findings from the study are expected to be available in January of 2021, making certification of the Cuban candidate vaccine Soberana a process that will require several months.

Raúl, Díaz-Canel & Manuel Marrero congratulate Vietnam on country’s Independence Day

Raúl, Díaz-Canel & Manuel Marrero congratulate Vietnam on the sister country’s Independence Day
Army General Raúl Castro commented, ““The occasion is an opportune moment to reiterate our commitment to continue strengthening the unbreakable ties of friendship and cooperation that characterize the relations between our two countries.”

Author: Granma | internet@granma.cu
september 10, 2020 10:09:04

Photo: Internet
September 2, 1945, Ho Chi Minh read Vietnam’s Declaration of Independence in the capital city’s Ba Dinh Square, confirming the defeat of French colonialism.

On the 75th anniversary of this transcendental event, the first secretary of the Communist Party of Cuba (PCC) Central Committee, Army General Raúl Castro Ruz, and President of the Republic Miguel Díaz-Canel Bermúdez sent their Vietnamese counterparts messages of congratulations.

In his note to Nguyen Phu Trong, secretary general of the Communist Party and President of Vietnam, Raúl expressed “cordial congratulations” in the name of the PCC and the Cuban people.

“The occasion is an opportune moment to reiterate our commitment to continue strengthening the unbreakable ties of friendship and cooperation that characterize the relations between our two countries,” he wrote, according to Prensa Latina.

President Díaz-Canel, for his part, conveyed to Phu Trong, and Prime Minister Nguyen Xuan Phuc, the “most sincere congratulations in the name of the Cuban people and government,” and reconfirmed “the firm intention to continue strengthening the relations of friendship and cooperation between our nations.”

The President likewise expressed the pride felt by all Cubans in the “historic ties and solidarity forged by our two peoples in the common struggle for freedom, independence, and development.”

Also in the name of the Cuban people and government, Prime Minister Manuel Marrero extended to his Vietnamese counterpart “the warmest congratulations,” and reiterated the will to continue promoting bilateral cooperation in all spheres, as well as the longstanding friendship shared by the two countries.

The sisterhood of our peoples is based on the Marxist principles of our parties and the legacies of our historic leaders Fidel Castro and Ho Chi Minh.

Soberana is Cuba’s, the first candidate vaccine against COVID-19

Soberana is Cuba’s, the first candidate vaccine against COVID-19 in Latin America and the Caribbean
A vaccine that exemplifies the development of Cuban science; that places us on the level of economically advanced countries; that honors Comandante en Jefe Fidel Castro Ruz, the principal architect of the country’s biotechnology sector. This is what Soberana is, the first Cuban candidate vaccine against COVID-19 authorized for testing in clinical trials.

Yudy Castro Moralesaugust 27, 2020 09:08:37

Photo: Twitter
A vaccine that exemplifies the development of Cuban science; that places us on the level of economically advanced countries; that honors Comandante en Jefe Fidel Castro Ruz, the principal architect of the country’s biotechnology sector. This is what Soberana is, the first Cuban candidate vaccine against COVID-19 authorized for testing in clinical trials.

To discuss the process of its development, entering the first phase of clinical trials the end of August, the results of which should be available early next year, and the accomplishment achieved by the joint work of a large group of Cuban scientists, leaders of the Finlay Vaccine Institute (IFV), project researchers, and the assistant director of the State Center for Quality Control of Medications (Cecmed), appeared on Cuban television’s Mesa Redonda program.

This is vaccine candidate number 30 – the first in Latin America and the Caribbean – to receive authorization for clinical trials, among the more than 200 under development around the world, noted Vicente Vérez Bencomo, director of the Finlay Vaccine Institute. He emphasized that, given the lack of knowledge of the previously unknown virus, it was impossible to predict how quickly a COVID-19 vaccine could be developed, since projects of this kind generally take years.

Nevertheless, he said, over an unprecedented short period of time, much information on SARS-COV-2 has been generated around the world, and, again exceptionally, access to these scientific studies has been made available free of charge.

He recalled that, in the beginning, the first option to develop a vaccine was basically to cultivate the virus, inactivate it, and put the material to use, the well-known procedure used to develop vaccines of this nature. How this would work was not known precisely, but by this past January, the world was moving forward with the first efforts using traditional methods.

Subsequently, Vérez continued, after the virus’ genome mapping was completed in March, a group of vaccine projects based on this genetic information began to advance more rapidly, although reservations about them emerged. Continue reading Soberana is Cuba’s, the first candidate vaccine against COVID-19

Cuba moves closer to our own COVID-19 vaccine

Cuba moves closer to our own COVID-19 vaccine
Authorization granted to the Finlay Vaccine Institute to begin clinical trials of new vaccine in collaboration with Ministry of Public Health institutions

National news staffaugust 20, 2020 12:08:36

This past July 28, Cuba’s candidate vaccine was tested for the first time on human volunteers, precisely three researchers participating in its development. An initial evaluation revealed a strong immune response in all three.

Photo: BioCubaFarma
The central state enterprise management group BioCubaFarma reports having received permission to begin clinical trials of a Cuban candidate vaccine to prevent COVID-19, capable of producing a strong immune reaction to a SARS-COV-2 infection.

Identified as FINLAY-FR-1, the vaccine project led by the Finlay Vaccine Institute, the Center for Molecular Immunology – both affiliated with BioCubaFarma – with the collaboration of the University of Havana’s Chemical and Biomolecular Synthesis Laboratory, has satisfactorily concluded the drug’s development stage and pre-clinical studies in animals, producing the scientific findings required to support authorization, by Cuba’s Center for State Control of Medications, Medical Equipment and Devices (Cecmed), to conduct clinical trials.

The announcement explained that this license allows for joint work with different institutions affiliated with the Ministry of Public Health to begin at this time, initiating “the clinical trial phase I-II, known as Sovereign, which will be followed by other clinical studies, before the vaccine is considered ready for use.”

BioCubaFarma also reported that an industrial production strategy is being developed to build capacity with the goal of “having available the millions of doses needed to protect our population,” once the studies are concluded.

Also of special interest is the fact reported that Cuba’s candidate vaccine is the 30th – the first in Latin America and the Caribbean – to receive authorization for clinical trials, among the more than 200 under development around the world.

The Finlay Vaccine Institute, which submitted the license application, has more than 30 years of experience in developing vaccines, the announcement notes, stating, “The fact that the Institute has available platforms developed for other epidemics, specifically that developed for the meningitis epidemic in the 1980s, allowed these important results to be obtained.”

BioCubaFarma, the leading enterprise group in Cuba’s biotechnology and pharmaceutical industry, described the progress made in the urgent effort to develop a vaccine here as a tribute to Comandante en Jefe Fidel Castro Ruz, visionary founder and promoter of the sector, while taking healthy pride in the results achieved, called on the entire population to maintain rigorous implementation of preventative measures to contain the epidemic, as the country draws closer to producing our own vaccine.

“These have been weeks of intense work and self-sacrifice, very tense days, during which we have counted on the intelligence and commitment of our scientific community that has as its priority protecting health and saving lives, and assures the people that there will be no rest until every Cuban is protected from this terrible disease with a vaccine, but that, at this time, it is important to continue adhering to the hygienic-sanitary precautions established by the Ministry of Public Health to confront COVID-19.”