Category Archives: CUBA’S VACCINE

CUBA'S VACCINE

The administration of Soberana 02 to more than 150,000 persons

Cuba will vaccinate its entire population against COVID-19 in 2021
Dr. Eduardo Martínez, president of the BioCubaFarma state pharmaceutical enterprise group, reports that work is advancing to expand production capacity of Cuba’s candidate vaccine Soberana 02

Author: Nuria Barbosa León | internet@granma.cu
Author: Juan Diego Nusa Peñalver | internet@granma.cu
january 26, 2021 10:01:39

The BioCubaFarma enterprise group is adjusting capacity to make possible the administration of Soberana 02 to more than 150,000 persons, while a new clinical trial with children has been launched, as more steps are taken along the path to vaccinating the entire population.

Photo: BioCubaFarma
Cuba’s national public health system is waging a hard battle against the new coronavirus, sparing no effort and overcoming physical and intellectual fatigue.

The Party and government’s strong political will has made this possible, along with the impressive work of our scientists who have again reiterated that Cuba will be among the first countries in the world to vaccinate its entire population in 2021, despite the tightening of the U.S. blockade of the island over the past 12 months, stated Dr. Eduardo Martínez Díaz, president of the BioCubaFarma state pharmaceutical enterprise group, on his Twitter account.

The general director of the Finlay Vaccine Institute, Dr. Vicente Vérez Bencomo, has reported that the country is preparing capacity to produce 100 million doses of the injectable Soberana 02 vaccine against COVID-19.

Regarding this announcement, Dr. María Eugenia Toledo Romaní, epidemiologist at the Pedro Kourí Institute of Tropical Medicine (IPK), condemned the escalating sanctions imposed by the United States which have a negative impact on the effort to expand capacity toward this end, stating, “If we are obliged to purchase new machinery and erect more plants, this is extremely difficult given the limitations we face in acquiring the technologies.”

This is why BioCubaFarma is taking advantage of its international experience to sign agreements with other countries that can help with the needed resources and allow the project to advance.

Dr. Toledo additionally explained, “To conduct a Phase 3 clinical study of efficacy, in which we show that vaccinated subjects are less likely to become ill than those who were not vaccinated, we must measure this aspect and then make comparisons to find the necessary statistical evidence to finally determine that the candidate vaccine is no less effective than others on the world market.

SPARING NO EFFORT

Currently underway on the island is a Phase 2b expanded clinical trial

of the candidate vaccine Soberana 02 in persons between 19 and 80 years of age, in the Havana municipalities of La Lisa and Plaza de la Revolución.

Dr. Mayra García Carmenate, research coordinator at the 19 de Abril neighborhood polyclinic, explained that the site was selected for the trials because the facility has met the standard prerequisite of systematically adhering to “best practices,” and has participated in several months of training to prepare staff members involved and subjects who will receive either the vaccine or a placebo.

After administration of the vaccine, participants will remain under observation for one hour to evaluate any adverse side effects and will be actively monitored via out-patient follow up visits for a period of 28 days. If any reaction should occur, the subject is to immediately return to the clinic where a 24-hour medical post will be maintained to evaluate the situation and, if necessary, transfer the subject to the appropriate public health facility.

Dr. García noted that the community’s population is very enthusiastic and many have made their way to the clinic to volunteer. They have confidence in Cuba’s public health system and those selected are proud of their participation and the fact that their neighborhood was chosen for this type of clinical trial, she said, adding “None of those chosen during the recruitment have declined to sign the informed consent agreement.”

Volunteers and technical personnel alike are confident that Cuban science will defeat COVID-19 with intelligence and dedication.

CUBA'S VACCINE

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 →