La Agencia Europea de Medicamentos (EMA) y otros reguladores internacionales reiteraron este viernes que la administración de varias dosis de vacunas contra la COVID-19 “a intervalos cortos no es un enfoque sostenible” a largo plazo.
Estos organismos creen, no obstante, que “cada vez es más clara la necesidad” de administrar inyecciones de refuerzo para extender la protección de las vacunas de la COVID-19.
Estas ideas forman parte de un informe publicado este viernes sobre las conclusiones de un encuentro celebrado la semana pasada de reguladores de fármacos de diferentes regiones, copresidido por la EMA y la Administración de Alimentos y Medicamentos de Estados Unidos (FDA).
En el documento, las agencias instaron a “desarrollar una estrategia a largo plazo” sobre los tipos de vacunas necesarias para gestionar la COVID-19 en el futuro.
“Al analizar posibles enfoques de vacunación contra ómicron y otras variantes del virus, los participantes en la reunión acordaron que la administración de múltiples dosis de refuerzo a intervalos cortos no es un enfoque sostenible a largo plazo”, agregan.
Los participantes incluyeron expertos de la Organización Mundial de la Salud (OMS), la Comisión Europea, Sudáfrica e Israel, entre otros países, que reconocieron que las vacunas ofrecen menos protección contra el contagio y la COVID-19 leve, pero son eficaces contra la hospitalización y la enfermedad grave con ómicron, especialmente después de la dosis de refuerzo.
“Cada vez está más claro que se necesita una dosis de refuerzo para extender la protección de la vacuna”, consideran.
El debate sobre la estrategia a largo es “un debate global en curso”, reconoce la EMA, que subraya que esta discusión “se encuentra en la encrucijada de la ciencia, la política pública y la salud pública” y necesitará de coordinación entre las autoridades de salud pública en todos los niveles.
Sobre la composición de las vacunas actualizadas, los reguladores de medicamentos instan a la comunidad científica internacional y a las farmacéuticas a “buscar enfoques alternativos a las vacunas monovalentes”, explorando la viabilidad de desarrollar vacunas bivalentes o multivalentes que puedan neutralizar otras variantes de interés en el futuro.
De todos modos, enfatizan que cualquier vacuna con una composición adaptada debe ser sometida a estudios clínicos para respaldar su seguridad, calidad y eficacia antes de ser aprobada para su uso en campañas de vacunación masiva.
“Estos estudios deben estar diseñados para demostrar que la respuesta inmune, medida como anticuerpos neutralizantes, generada por la vacuna actualizada es superior a la lograda con las vacunas actuales. La capacidad de las vacunas actualizadas para neutralizar de forma cruzada otras variantes de interés sería una característica adicional”, añaden.
Marco Cavaleri, jefe de Estrategia de Vacunación, advirtió el martes que si en el futuro es necesario volver a vacunar, al menos a grupos de riesgo, el refuerzo podría ofrecerse con la llegada del frío, como ya se hace con la de la gripe, porque “esto aumentaría la respuesta de anticuerpos cuando más lo necesitamos”, a diferencia de las dosis consecutivas.
“La administración repetida de refuerzos con varios intervalos de tiempo cortos podría reducir el nivel de anticuerpos que se pueden producir en cada administración, ya que nuestro sistema inmunológico necesita una cierta cantidad de tiempo para mostrar la respuesta al antígeno que se le presenta. Esto, potencialmente, hará que la vacunación sea un poco menos eficiente con el tiempo”, detalló.
Por: Agencia
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