{"id":240262,"date":"2021-06-12T07:29:06","date_gmt":"2021-06-12T11:29:06","guid":{"rendered":"https:\/\/oncubanews.com\/en\/?p=240262"},"modified":"2021-06-12T07:29:06","modified_gmt":"2021-06-12T11:29:06","slug":"cuba-to-begin-pediatric-clinical-trial-with-soberana-02-and-soberana-plus","status":"publish","type":"post","link":"https:\/\/oncubanews.com\/en\/coronavirus\/cuba-to-begin-pediatric-clinical-trial-with-soberana-02-and-soberana-plus\/","title":{"rendered":"Cuba to begin pediatric clinical trial with Soberana 02 and Soberana Plus"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">The Finlay Vaccine Institute (IFV) of Havana will initiate a clinical trial of the Soberana 02 and Soberana Plus <\/span><a href=\"https:\/\/oncubanews.com\/tag\/vacunas-cubanas-contra-la-covid-19\/?amp\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">vaccine candidates<\/span><\/a><span style=\"font-weight: 400;\"> in the pediatric population. The trial will begin with a group of minors from 12 to 18 years old, and will later be extended to the group from 3 to 11 years old, according to the note from the Center for State Control of Medicines, Equipment and Medical Devices (CECMED).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The tests will consist of a two-phase \u201csequential, open, adaptive and multicenter\u201d trial, according to the <\/span><a href=\"https:\/\/www.cecmed.cu\/noticias\/aprueba-cecmed-ensayo-clinico-fase-i-ii-candidato-vacunal-soberana-poblacion-pediatrica\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">information released by CECMED in a statement<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The objective will be to \u201cevaluate the safety, reactogenicity and immunogenicity\u201d of both formulas with an administration scheme of two doses of Soberana 02 and a third of Soberana Plus, applied at intervals of 28 days.<\/span><\/p>\n<blockquote class=\"twitter-tweet\" data-width=\"500\" data-dnt=\"true\">\n<p lang=\"es\" dir=\"ltr\">El Estudio Fase I\/II tiene como objetivo evaluar la seguridad, la reactogenicidad y la inmunogenicidad, de un esquema heter\u00f3logo de 2 dosis del candidato vacunal profil\u00e1ctico <a href=\"https:\/\/twitter.com\/hashtag\/Soberana02?src=hash&amp;ref_src=twsrc%5Etfw\">#Soberana02<\/a> y 1 dosis de <a href=\"https:\/\/twitter.com\/hashtag\/SoberanaPlus?src=hash&amp;ref_src=twsrc%5Etfw\">#SoberanaPlus<\/a> en ni\u00f1os y adolescentes cubanos.<a href=\"https:\/\/twitter.com\/hashtag\/SoberanaPediatr%C3%ADa?src=hash&amp;ref_src=twsrc%5Etfw\">#SoberanaPediatr\u00eda<\/a><a href=\"https:\/\/twitter.com\/BioCubaFarma?ref_src=twsrc%5Etfw\">@BioCubaFarma<\/a> <a href=\"https:\/\/t.co\/xdjNS0hOpw\">pic.twitter.com\/xdjNS0hOpw<\/a><\/p>\n<p>&mdash; Instituto Finlay de Vacunas (@FinlayInstituto) <a href=\"https:\/\/twitter.com\/FinlayInstituto\/status\/1403133123769126914?ref_src=twsrc%5Etfw\">June 10, 2021<\/a><\/p><\/blockquote>\n<p><script async src=\"https:\/\/platform.twitter.com\/widgets.js\" charset=\"utf-8\"><\/script><\/p>\n<p><span style=\"font-weight: 400;\">It is the same scheme used in the adult clinical trials of these vaccine candidates, which are already in the final stretch of testing, awaiting data on effectiveness.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe approval issued by CECMED is based on the current epidemiological context, with the considerable increase in positive cases in the pediatric population and based on the safety and immunogenicity results shown by the vaccine candidates, as part of the phase I and phase II clinical trials,\u201d says the note.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">It adds that the two formulas have been shown to be safe and well tolerated in adults \u201cboth in clinical trials and in the intervention study.\u201d The adult trials involved 44,010 volunteers aged 19 to 80 years.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Soberana 02 is a subunit conjugate vaccine \u2014 traditionally very safe \u2014 that combines virus antigen and tetanus toxoid to stimulate the immune system response.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The director of CECMED, Olga Lidia Jacobo, quoted in the statement, affirmed that \u201cthe evaluation and approval process of this clinical trial has been very rigorous, meeting the requirements demanded in pediatric populations.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Cuba, which has been going through the third and worst wave of infections since January and has not managed to drop below a thousand a day for weeks, has to date 153,578 cases and 1,057 deaths from the new coronavirus. Of the total of positive cases up to May 27, more than 18,000 corresponded to minors, 983 of them under one year of age, the note underlines.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Along with Soberana 02 and Plus, the other more advanced formula that Cuba has is Abdala, developed by the Center for Genetic Engineering and Biotechnology (CIGB) and which is also about to conclude its clinical trials. The CIGB also hopes to start pediatric clinical trials shortly.<\/span><\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"aVZHy0dP8x\"><p><a href=\"https:\/\/oncubanews.com\/cuba\/cuba-en-camino-a-los-dos-millones-de-personas-inoculadas-con-candidatos-vacunales-anticovid\/\">Cuba supera el mill\u00f3n de personas inoculadas con candidatos vacunales anticovid<\/a><\/p><\/blockquote>\n<p><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"\u00abCuba supera el mill\u00f3n de personas inoculadas con candidatos vacunales anticovid\u00bb \u2014 OnCubaNews\" src=\"https:\/\/oncubanews.com\/cuba\/cuba-en-camino-a-los-dos-millones-de-personas-inoculadas-con-candidatos-vacunales-anticovid\/embed\/#?secret=TlS87mf8Mh#?secret=aVZHy0dP8x\" data-secret=\"aVZHy0dP8x\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/p>\n<p><span style=\"font-weight: 400;\">These three formulas are already being applied to hundreds of thousands of people as part of a health intervention study, although they still do not have authorization for emergency use, something that the health authorities hope to obtain in the coming weeks in order to start the mass immunization campaign.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Cuban scientific institutions, which have a long experience in the biotechnology sector, are also working on two other formulas: Soberana 01 (intramuscular) and Mambisa (intranasal), which are in previous stages of evaluation.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Cuba is not a member of the Covax Mechanism created by the World Health Organization for low and middle-income countries to access vaccines, nor has it purchased them on the international market.<\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">EFE\/OnCuba<\/span><\/i><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The tests were approved by the island\u2019s regulatory authority, the Center for the State Control of Medicines, Equipment and Medical Devices (CECMED) and will consist of a two-phase \u201csequential, open, adaptive and multicenter\u201d trial, according to the information released in a statement.<\/p>\n","protected":false},"author":3134,"featured_media":240264,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33393,13902],"tags":[29532],"ppma_author":[33546],"class_list":["post-240262","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-coronavirus","category-cuba","tag-coronavirus-in-cuba"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cuba to begin 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