<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1025-028X</journal-id>
<journal-title><![CDATA[Vaccimonitor]]></journal-title>
<abbrev-journal-title><![CDATA[Vaccimonitor]]></abbrev-journal-title>
<issn>1025-028X</issn>
<publisher>
<publisher-name><![CDATA[Finlay Ediciones]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1025-028X2023000100009</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Farmacovigilancia intensiva de vacunas SOBERANA®02 y Soberana®Plus en población pediátrica en el Centro de Inmunología Molecular]]></article-title>
<article-title xml:lang="en"><![CDATA[Intensive pharmacovigilance of SOBERANA®02 and Soberana®Plus vaccines in pediatric population at the Center for Molecular Immunology]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Saurez-Martínez]]></surname>
<given-names><![CDATA[Giselle]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Viada-González]]></surname>
<given-names><![CDATA[Carmen Elena]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Álvarez-Cardona]]></surname>
<given-names><![CDATA[Mabel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Piedra-Sierra]]></surname>
<given-names><![CDATA[Patricia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Trujillo-Fornaris]]></surname>
<given-names><![CDATA[Dayamí]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Gorrita-Mora]]></surname>
<given-names><![CDATA[Linet]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodríguez-Lastre]]></surname>
<given-names><![CDATA[Laudelina]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Gómez-Escobar]]></surname>
<given-names><![CDATA[Belkis Felicia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Puga-Gómez]]></surname>
<given-names><![CDATA[Rinaldo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sánchez-Ramírez]]></surname>
<given-names><![CDATA[Belinda]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro de Inmunología Molecular  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Hospital Pediátrico Docente &#8220;Juan Manuel Márquez&#8221;  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Clínica Central &#8220;Cira García&#8221;  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2023</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2023</year>
</pub-date>
<volume>32</volume>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1025-028X2023000100009&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1025-028X2023000100009&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1025-028X2023000100009&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN Las vacunas SOBERANA®02 y SOBERANA® Plus contra el coronavirus tipo 2 causante del síndrome respiratorio agudo severo, recibieron autorización de uso en emergencia por la autoridad reguladora de Cuba, y de inmediato aconteció una campaña de vacunación masiva en población pediátrica, lo que devino en una inminente movilización de centros de vacunación y vigilancia de sus eventos adversos. El Centro de Inmunología Molecular realizó un estudio de farmacovigilancia intensiva que evalúo el cumplimiento del esquema heterólogo con ambas vacunas, su seguridad y la incidencia de casos positivos a COVID-19 en niños y adolescentes después de completar el esquema de inmunización. Desde el 15 de septiembre al 31 de diciembre del 2021, participaron 529 sujetos entre 2 y 18 años de edad, de ambos sexos, sin antecedentes de infección por coronavirus tipo 2 del síndrome respiratorio agudo severo, procedentes de 35 municipios y 12 provincias cubanas, quienes recibieron vacuna SOBERANA®02 (dos dosis) y SOBERANA®Plus (una dosis). Se realizó vigilancia de eventos adversos hasta 30 días después de la última dosis recibida. Se consultó la plataforma informática nacional Higia Andariego para identificar los casos positivos al virus del síndrome respiratorio agudo severo coronavirus 2, hasta 3 meses de haber completado la vacunación. El 98,5% de los participantes completó el esquema de vacunación y en el 6,6% se notificó algún evento adverso con relación consistente a la vacunación. Predominaron las reacciones locales (dolor, eritema, inflamación), sobre las reacciones sistémicas (fatiga y febrícula), de intensidad ligera o moderada. Se logró un elevado cumplimiento del esquema de inmunización, con un perfil de seguridad favorable, los sujetos con esquema completo de inmunización no enfermaron de COVID-19.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT The severe acute respiratory syndrome coronavirus 2 vaccines, SOBERANA®02 and SOBERANA®Plus, received authorization for emergency use by the Cuban regulatory authority; a massive vaccination campaign was immediately launched in the pediatric population, which led to an imminent mobilization of vaccination centers and surveillance of adverse events. The Molecular Immunology Center conducted an intensive pharmacovigilance study to evaluate compliance of the heterologous scheme with both vaccines, their safety, and the incidence of COVID-19 positive cases in children and adolescents after completing the immunization schedule. From September 15 to December 31, 2021, a total of 529 subjects between 2 and 18 years of age, of both sexes, without a history of infection by severe acute respiratory syndrome coronavirus type 2, from 35 municipalities and 12 Cuban provinces, who received SOBERANA®02 (two doses) and SOBERANA®Plus (one dose) vaccines, were included in the study. Surveillance for adverse events was performed up to 30 days after the last dose received. The national computer platform Higia Andariego was consulted to identify positive cases for severe acute respiratory syndrome coronavirus 2 up to 3 months after completing vaccination. According to the report, 98.5% of the participants completed the vaccination schedule and 6.6% of them reported some adverse event consistently related to vaccination. Local reactions (pain, erythema, inflammation) prevailed over systemic reactions (fatigue and fever), of light or moderate intensity. High compliance with the immunization schedule was achieved, with a favorable safety profile; subjects with a complete immunization schedule did not become ill with COVID-19.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[COVID-19]]></kwd>
<kwd lng="es"><![CDATA[SARS-CoV-2]]></kwd>
<kwd lng="es"><![CDATA[programas de inmunización]]></kwd>
<kwd lng="es"><![CDATA[vacunación masiva]]></kwd>
<kwd lng="es"><![CDATA[vacunas]]></kwd>
<kwd lng="es"><![CDATA[estudio observacional]]></kwd>
<kwd lng="en"><![CDATA[COVID-19]]></kwd>
<kwd lng="en"><![CDATA[SARS-CoV-2]]></kwd>
<kwd lng="en"><![CDATA[immunization programs]]></kwd>
<kwd lng="en"><![CDATA[mass vaccination]]></kwd>
<kwd lng="en"><![CDATA[vaccines]]></kwd>
<kwd lng="en"><![CDATA[observational study]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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<surname><![CDATA[Iniguez-Rojas]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Rodríguez-González]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Martinez-Cabrera]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Real-World Effectiveness of the SOBERANA 02 and SOBERANA Plus Vaccine Combination in Children 2 to 11 Years of Age during the SARS-CoV-2 Omicron Wave in Cuba: A Regression Discontinuity Study]]></article-title>
<source><![CDATA[SSRN]]></source>
<year>2023</year>
</nlm-citation>
</ref>
</ref-list>
</back>
</article>
