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Cuban Sovereign 02 COVID-19 vaccine receives approval for medical trials

Cuban Sovereign 02 COVID-19 vaccine receives approval for medical trials

The Cuban Soberana 02 COVID-19 vaccine prospect will soon begin its medical trials in humans, after its approval by the island’s regulatory body.

The Finlay Vaccine Institute, the scientific entity in charge of its preparation, announced this Tuesday that the vaccine got approval from the Center for State Control of Medicines, Equipment and Medical Devices (CECMED) for the start of phase I medical trials.

” We are delighted to notify you that @CecmedCuba has authorized the stage I scientific trial of the #Soberana02 vaccine prospect, based upon a conjugate vaccine platform with a history in @FinlayInstituto. A knowledge identifies us in the field of #preventive vaccines,” the institution released on Twitter, although without defining a possible date for the start of the tests.

Days earlier, Dr. Vicente Vérez, general director of the Finlay Institute, had actually advanced the imminent approval of this vaccine candidate, the Agencia Cubana de Noticias news firm recalled, which discusses that this vaccine, like Soberana 01, already in human trials, is a molecular or subunit item.

However, following the specialist’s explanations, the company clarifies that Soberana 02 is “the only conjugate vaccine in the job versus the pandemic,” although it is not the first of its kind produced in Cuba, where there is “comprehensive experience in the application of this type of preventive treatments.”

According to Dr. Vérez, throughout the clinical trials of this vaccine prospect– which has already been checked in animals–” it is expected that its security will be shown and that it will attain a protective, effective and long-lasting immune reaction, like Soberana 01, in addition to validate what immunological properties are confirmed in vaccinated topics,” the source mentioned.

In a recent exchange with Cuban President Miguel Díaz-Canel, Vérez stated that the group of Cuban scientists he heads “desires advance decisively in the studies concerning the immune action” of Cuban vaccine candidates before the end of this year, with the objective of “beginning to immunize the Cuban population throughout the first term of 2021.”

Relating to the safety of the drugs, he firmly insisted that “they are based on vaccine technology platforms that already exist and have been evaluated in countless doses.”

Cuba starts scientific trial of its 2nd COVID-19 vaccine candidate

Recently, the clinical organization had actually announced the start of a brand-new medical trial to assess various formulations and dose schedules of Soberana 01 According to what has actually been explained, the research study would carry out its stage I in between October 19 and November 9, and its completion is set up for February 2021.

Currently, Soberana 01 is in phases I and II of clinical trials with just over 700 volunteers. Its trial duration has actually passed without adverse events, as reported up until now.

Created in 1991, the Finlay Vaccine Institute has recognized proficiency in this field, and its most important achievements consist of the advancement of a vaccine versus meningococcal meningitis.

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