Este miércoles, la Administración de Alimentos y Medicamentos (FDA) autorizó las dosis de refuerzo desarrolladas para la variante ómicron BA.4/BA.5, para ser aplicadas como complemento a la vacuna dirigida a la cepa original de la mencionada variante, optimizadas por dos de las compañías que han creado productos para tratar el covid-19: Pfizer/BioNTech y Moderna.
Con esta modificación a las autorizaciones de uso de emergencia, ambas vacunas pueden ser administradas desde los 2 meses siguientes a una serie de vacunación primaria o a un primer refuerzo. Sin embargo, hay diferencias en los grupos etarios en los que los biológicos dirigidos a la variante ómicron pueden ser utilizados: la vacuna de Moderna puede administrarse en personas desde los 18 años, mientras que la de Pfizer/BioNTech puede inocularse a partir de los 12 años.
También le puede interesar: Pfizer y Moderna buscan autorización de vacunas de refuerzo ante la FDA
Para esta nueva decisión, la agencia revisó datos clínicos sobre vacunas bivalentes dirigidas a la variante ómicron original, caracterizada por su alto nivel de transmisibilidad y por ser responsable de aumentos inusitados de los casos de covid-19 en Estados Unidos y otros países cuando las medidas de bioseguridad se flexibilizaron. Según la FDA, aunque la información no está dirigida estrictamente a las subvariantes, los datos son relevantes y pueden hacer una gran diferencia.
“Las vacunas bivalentes autorizadas contra covid-19 o refuerzos actualizados, incluyen un componente de ARNm de la cepa original para proporcionar una respuesta inmunitaria ampliamente protectora contra la enfermedad y un componente de ARNm común entre los linajes de la variante omicrón BA.4 y BA.5”, destacó la agencia en el comunicado oficial.
No olvide leer: “En el sistema de salud hay mafias que se aprovechan de los recursos del SOAT”: Fasecolda
Otros ajustes realizados por la FDA para la administración de las vacunas covid-19
Además de la autorización de las vacunas de refuerzo, la FDA indicó que las vacunas monovalentes de ARNm contra covid-19 no están autorizadas como dosis de refuerzo para personas de 12 años o más.
“El público puede estar seguro de que la FDA ha puesto mucho cuidado en garantizar que estas vacunas bivalentes cumplen nuestras rigurosas normas de seguridad, eficacia y calidad de fabricación para la autorización de uso de emergencia”, indicó Peter Marks, integrante del Centro de Evaluación e Investigación Biológica de la FDA.
No olvide leer: Moderna demanda a Pfizer por patente de tecnología ARNm
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