El Ministerio de Salud incluirá a la vacuna de Moderna contra el coronavirus en el estudio colaborativo y federal de evaluación de esquemas combinados de vacunación, que coordina junto a las jurisdicciones participantes e investigadores del Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET).
La investigación evalúa la inmunogenicidad y seguridad del uso de dos dosis distintas de las vacunas contra el virus SARS-CoV-2 que se aplican en Argentina y compara esquemas de vacunación heterólogos y homólogos.
El objetivo del estudio es contar con evidencia nacional para la toma de decisiones a partir del análisis de inmunogenicidad y seguridad de la utilización de diferentes dosis en un mismo esquema de las vacunas disponibles al momento en el país (AstraZeneca, Moderna, Sinopharm y Sputnik-V).
“Hemos definido incorporar la vacuna Moderna en los estudios que buscan determinar la seguridad e inmunidad en la combinación de vacunas“, indicó la ministra Carla Vizzotti.
Y agregó que “avanzar en la producción de evidencia científica en este sentido es muy importante de cara a contar con un abanico mayor de posibilidades para alcanzar esquemas completos en el menor tiempo posible“.
Estudio colaborativo y federal
El estudio es abierto, colaborativo y federal y participan investigadores de la Unidad Coronavirus del Ministerio de Ciencia, Tecnología e Innovación; del CONICET; y de las provincias de Buenos Aires, Córdoba, La Rioja, Mendoza y San Luis, informó la cartera. Incluye a voluntarios mayores de 18 años vacunados con una dosis de vacuna Sputnik V, AstraZeneca o Sinopharm hasta 60 días previos a su enrolamiento, con y sin factores de riesgo identificados para Covid-19 que permanezcan en la jurisdicción donde se inició su estudio hasta el final del mismo.
Están excluidas las personas con inmunocompromiso por enfermedad de base o por tratamiento inmunosupresor; las personas gestantes y en período de lactancia y aquellas que están registradas en el Sistema Integrado de Información Sanitaria Argentino (SIISA) por haber padecido el virus (sintomático o asintomático); como así también quienes hayan presentado una reacción alérgica grave (anafilaxia) a cualquier vacuna.
Los modelos basados en esquemas heterólogos de inmunización con vacunas de plataformas diversas requieren ser evaluados mediante ensayos clínicos que permitan demostrar si los mismos tienen una respuesta similar que los esquemas homólogos ya establecidos. Esto se logra a través de la evaluación comparativa de su inmunogenicidad y reactogenicidad (eventos adversos) con estudios que consideren posibilidades de implementación, sean adaptativos y respondan a situaciones de la vida real.
Por esta razón, el Ministerio de Salud propuso el desarrollo de una red colaborativa para la integración de estudios sobre estrategias de vacunación contra el Covid con el uso de esquemas heterólogos a partir de la evaluación de no inferioridad de estos frente a los esquemas homólogos de vacunación ya implementados mundialmente.
A partir de este estudio se espera poder generar evidencia científica sólida que apoye la toma de decisiones en políticas de salud, con amplia participación federal y objetivos comunes.
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