<?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>S1025-028X2022000200090</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Vacunas anti COVID-19: una mirada desde la perspectiva reguladora]]></article-title>
<article-title xml:lang="en"><![CDATA[Anti-COVID-19 vaccines: a look from the regulatory perspective]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vázquez-Romero]]></surname>
<given-names><![CDATA[Javier Eduardo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Romeu-Álvarez]]></surname>
<given-names><![CDATA[Belkis]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad de Ciencias Médicas de La Habana  ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>08</month>
<year>2022</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>08</month>
<year>2022</year>
</pub-date>
<volume>31</volume>
<numero>2</numero>
<fpage>90</fpage>
<lpage>99</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1025-028X2022000200090&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1025-028X2022000200090&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1025-028X2022000200090&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN El desarrollo de vacunas contra la COVID-19 ha constituido una de las principales prioridades de la comunidad científica global. Hasta la fecha, múltiples vacunas han sido aprobadas para uso por numerosos países y la Organización Mundial de la Salud ha incluido algunas de estas en su programa de listado de uso de emergencia. El presente trabajo ofrece información sobre estos aspectos y analiza el reto colosal que ha representado para el sector regulatorio enfrentarse al creciente desarrollo de vacunas contra la COVID-19, asegurando su calidad, seguridad y eficacia. De igual forma, se abordan los nuevos enfoques en el desarrollo de los ensayos clínicos, o modificaciones en los procedimientos regulatorios existentes, que han sido cuidadosamente adaptados por las agencias reguladoras, sin perder su capacidad de escrutinio y la integridad de la evaluación científico-regulatoria.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT The development of anti-COVID-19 vaccines has been one of the main priorities of the global scientific community. To date, multiple vaccines have been approved for use by numerous countries, and the World Health Organization has already included some of these in its emergency use listing program. This paper offers information on these aspects and analyzes the colossal challenge that facing the growing development of vaccines against COVID-19 has represented for the regulatory sector, ensuring their quality, safety and efficacy. Similarly, new approaches in the development of clinical trials are addressed, or modifications in existing regulatory procedures that have been carefully adapted by regulatory agencies, without losing their scrutiny capacity and the integrity of the scientific-regulatory evaluation.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[COVID-19]]></kwd>
<kwd lng="es"><![CDATA[vacunas]]></kwd>
<kwd lng="es"><![CDATA[regulación de productos sanitarios]]></kwd>
<kwd lng="es"><![CDATA[ensayo clínico]]></kwd>
<kwd lng="en"><![CDATA[COVID-19]]></kwd>
<kwd lng="en"><![CDATA[vaccines]]></kwd>
<kwd lng="en"><![CDATA[medical device legislation]]></kwd>
<kwd lng="en"><![CDATA[clinical trial]]></kwd>
</kwd-group>
</article-meta>
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