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¿Ha aprobado la FDA alguna vacuna Covid-19?

La Administración de Alimentos y Medicamentos (FDA) ha otorgado la Autorización de Uso de Emergencia (Emergency Use Authorization o EUA por sus siglas en inglés) a las vacunas producidas por Pfizer-BioNTech y por Moderna. Hay vacunas adicionales actualmente bajo la Fase 3 de los ensayos clínicos y es posible que pronto presenten datos para su revisión con la FDA.

La Autorización de Uso de Emergencia existe para permitir que la FDA tenga mayor flexibilidad para revisar y autorizar productos para su uso durante emergencias de salud pública, tales como una pandemia.

Para otorgar una EUA, la FDA debe determinar que una vacuna puede prevenir eficazmente una infección o enfermedad, y que sus beneficios superan potenciales riesgos (incluyendo efectos secundarios graves). Si bien la EUA permite que las personas comiencen a recibir la vacuna, los desarrolladores de vacunas continuarán enviando datos a la FDA para lograr una aprobación total de la FDA a través de una Solicitud de Licencia Biológica (BLA por sus siglas en inglés) estándar. La aprobación de una BLA representa el estándar más alto de la FDA, pero requiere de un período de evaluación más largo.

The Food and Drug Administration (FDA) approved the first Covid vaccine -- from Pfizer-BioNTech -- in the summer of 2021. It later approved the Moderna vaccine in January of 2022. This means the vaccine received the standard Biologic License Application (BLA) approval, which represents the FDA’s highest standard and requires a longer period of evaluation.

The FDA had previously granted Emergency Use Authorization (EUA) to the Pfizer-BioNTech vaccine, the Moderna vaccine, and the Johnson & Johnson vaccine. Additional vaccines are in Phase 3 of clinical trials and maybe submitting data for review with the FDA soon. 

Emergency Use Authorization exists to allow the FDA more flexibility to review and authorize products for use during public health emergencies, like a pandemic. In order to grant an EUA, the FDA must determine that a vaccine can effectively prevent infection or disease and that its benefits outweigh potential risks (like serious side effects). While the EUA allows people to start receiving the vaccine, vaccine developers will continue to submit data to the FDA to achieve full FDA approval through a BLA.

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