{"id":239880,"date":"2021-06-03T14:04:16","date_gmt":"2021-06-03T18:04:16","guid":{"rendered":"https:\/\/oncubanews.com\/en\/?p=239880"},"modified":"2021-06-03T14:04:16","modified_gmt":"2021-06-03T18:04:16","slug":"cuba-expects-to-start-covid-19-clinical-trials-in-minors-in-the-coming-days","status":"publish","type":"post","link":"https:\/\/oncubanews.com\/en\/coronavirus\/cuba-expects-to-start-covid-19-clinical-trials-in-minors-in-the-coming-days\/","title":{"rendered":"Cuba expects to start COVID-19 clinical trials in minors in the coming days"},"content":{"rendered":"

Cuba expects to start clinical trials of <\/span>COVID-19 vaccine candidates<\/span><\/a> in minors in the coming days, as part of its strategy to immunize its entire population against the infectious disease.<\/span><\/p>\n

Dr. Vicente V\u00e9rez, director of the Finlay Vaccine Institute (IFV), confirmed this Wednesday that his center is only waiting for the approval of the studies by the Center for the State Control of Medicines, Equipment and Medical Devices (CECMED), to which the evidence file had already been presented seven weeks ago.<\/span><\/p>\n

\u201cIf we are authorized in the next few days, we aspire to start the phase I\/II trials next week in municipalities of Havana,\u201d the specialist said at a press conference, explaining that this test in pediatric ages would be carried out with the Soberana 02 and Soberana Plus candidates, the latter for a third booster shot, following a scheme already applied in research with the adult population.<\/span><\/p>\n

He said that the use of these vaccine candidates \u2014 both produced by IFV \u2014 is based on the safety demonstrated by both in studies and interventions already carried out, in which no serious adverse and unexpected effects have been reported so far.<\/span><\/p>\n

V\u00e9rez pointed out that the clinical trials are expected to involve around 300 children, and that the doses will be applied first to a group aged between 12 and 18 years, and then to a second group between 3 and 11 years.<\/span><\/p>\n

In addition, he pointed out that, unlike other tests of this type carried out in the world, \u201cethically we do not consider that we have the right to use placebos in a pediatric trial in these phases.\u201d However, he assured that they plan to collect \u201cenough immunogenicity data to avoid having to go to an efficacy trial,\u201d and to be able to connect the results of this study with those of others already carried out on the island at other ages.<\/span><\/p>\n

More than a million persons inoculated in Cuba with COVID-19 vaccine candidates<\/a><\/p><\/blockquote>\n