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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 02Cuba’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.
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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.
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