Category Archives: Cuban Pharmaceutical

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.

A unique drug developed in Cuba is being tested in New York state.

S. E. Anderson <seanderson@mail.com>

Why an American went to Cuba for cancer care

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20 April 2017- bbc.com
•Cuba has faced more than 50 years of US sanctions. Now, for the first time, a unique drug developed on the communist island is being tested in New York state. But some American cancer patients are already taking it – by defying the embargo and flying to Havana for treatment.
Judy Ingels and her family are in Cuba for just six days. They have time to go sightseeing and try out the local cuisine. Judy, a keen photographer, enjoys capturing the colonial architecture of Old Havana.
And while she is in the country, Ingels, 74, will have her first injections of Cimavax, a drug shown in Cuban trials to extend the lives of lung cancer patients by months, and sometimes years.
By travelling to Havana from her home in California, she is breaking the law.
The US embargo against Cuba has been in place for more than five decades, and though relations thawed under President Obama, seeking medical treatment in Cuba is still not allowed for US citizens.
“I’m not worried,” Ingels says. “For the first time I have real hope.”
She has stage four lung cancer and was diagnosed in December 2015. “My oncologist in the United States says I’m his best patient, but I have this deadly disease.”

Continue reading A unique drug developed in Cuba is being tested in New York state.

Cutting edge pharmaceutical production and scientific research in Cuba

Cutting edge pharmaceutical production and scientific research in Cuba
To supervise clinical evaluations required to register patents, and distribute pharmaceuticals and biotechnology produced in Cuba, the National Clinical Trials Coordinating Center was established in 1991, and has been involved in more than 150 such projects over the years
Author: Nuria Barbosa León | internet@granma.cu
Author: Joaquín Rivery Tur | rivery@granma.cu
february 14, 2017 17:02:21

Director Carlos Manuel García noted that the National Clinical Trials Coordinating Center has expert staff in all provinces.

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The Genetic Engineering and Biotechnology Center.

Photo: Orfilio Pelaez

Browsing the web reveals an extraordinary number of sites citing the strength of Cuba’s pharmaceutical and biotechnology industries, along with the number of countries purchasing Cuban products for their populations. Yet the corporate media makes little mention of this accomplishment.
Among the country’s most important, latest-generation medications is Heberprot P, used by more than 225,000 patients in many countries to treat diabetic foot ulcers and avoid a large percentage of amputations. It is currently administered via nano-capsules, making the drug’s anti-microbial impact very effective.

Continue reading Cutting edge pharmaceutical production and scientific research in Cuba