The director of the National Institute for Food and Drug Surveillance – Invima, Julio Aldana, confirmed, on February 3rd, during the presidential program ‘Prevención y Acción’, that in record time the arrival of the Sinovac vaccine was authorized, which, according to President Iván Duque, went through all the evaluation of experts, in a fast and diligent process.
“Fruit of the effort of the national government, headed by President Iván Duque, focused on access to vaccines and also leveraged on the health standard in force in Colombia, which among other things, has been recognized by the Pan American Health Organization as a facilitating element in this whole process and also fruit of an articulated work between entities, Today, in record time, the Invima authorized the importation of the vaccine CoronaVac, from the pharmaceutical company Sinovac, which joins other vaccines that have already been authorized for this ambitious vaccination plan of the Government,” confirmed Aldana.
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Two important clinical trials will also start in Colombia
At the same time, he emphasized that “this week the protocol that initiates two important clinical trials was also authorized, one from the German company CureVac AG, with the clinical trial called Herald, and the other from an important Australian company called Clover.”
According to the executive, “with this, there are now four clinical trials running in the country and which allow more than 36,000 Colombians to have access to this biological product.”
He also pointed out that these actions “somehow endorse the confidence in the health agency, the Colombian regulatory agency, and in this public policy that has positioned Colombia as a reference country in research and development, not only of vaccines, but also of other substances aimed at the treatment of COVID-19”.
On February 1st, Invima announced that it had approved the start of the Phase II/III clinical trial for the vaccine against elcovid-19, G trimeric SARS-CoV-2 – SCB-2019, sponsored by the Australian biopharmaceutical company Clover.
According to a statement from the institute, “the trial consists of providing 2 doses of SCB-2019 22 days apart, to adults over 18 years of age, with the aim of generating initial data on the safety and efficacy of the substance in patients.”
This trial currently has only one authorized center located in the city of Barranquilla, and it is expected that in the next few days the request for inclusion of four centers will be submitted to Invima, which will be located in the departments of Cundinamarca, Valle del Cauca, Meta and Casanare.
The development of the study will have an estimated duration of approximately 13 months, during which approximately 34,000 volunteers are expected to be recruited worldwide, of which 8,000 will be in Colombia.
Invima assured that the CVnCoV mRNA vaccine will be applied in two doses to adults over 18 years of age. According to the Institute, the biologic “is based on mRNA (messenger RNA) developed on a technological platform, exclusive property of Curevac AG, which uses mRNA molecules without chemical modifications as the basis for the vaccine”.
As reported by Invima, “the biopharmaceutical company has generated phase I and II trials to collect initial safety, reactogenic and immunogenic data on 2 doses of CVnCoV, administered 28 days apart.”
“In October 2020, they enrolled more than 250 subjects in the Phase I clinical trial called CV-NCOV-001, where they evaluated different doses of the vaccine. Additionally, the Phase IIa clinical trial, CV-NCOV-002, is ongoing, where they evaluated the CVnCoV vaccine at selected dose levels in adults over 61 years of age,” the health authority noted.
At this moment, the clinical trial is being carried out in Belgium, Germany and the Netherlands, will last approximately 28 months and it is expected that 36,500 volunteers will participate in the world and approximately 6,000 in Colombia.
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