Eficacia teórica, eficacia real de las vacunas
Todas las vacunas contra la COVID-19 aprobadas por la OMS para su inclusión en la lista de uso en emergencias-en inglés, han sido objeto de ensayos clínicos aleatorizados para confirmar su calidad, su seguridad y su eficacia teórica. Ninguna vacuna se aprueba si su índice de eficacia teórica no es superior al 50%. Posteriormente, se mantiene la vigilancia se mantiene para comprobar que siguen siendo seguras y eficaces en la práctica. Sin embargo, ¿cuál es la diferencia entre eficacia teórica y real?
La eficacia teórica de una vacuna, que se mide en un ensayo clínico controlado, se refiere al número de personas vacunadas que presentaron el resultado objeto de estudio (generalmente, la enfermedad) con respecto al número de personas que recibieron un placebo (una vacuna ficticia) y presentaron el mismo resultado. Una vez finalizado el ensayo, se compara el número de enfermos de cada grupo y se calcula el riesgo relativo de enfermar tanto si se administra la vacuna como si se inyecta un placebo. Así, la eficacia teórica mide el grado en que la vacuna reduce el riesgo de enfermarse. Si esta eficacia teórica es elevada, en el grupo que recibió la vacuna se enferman muchas menos personas que en aquel al que se administró un placebo.
Imaginemos, por ejemplo, una vacuna con una eficacia probada del 80%. Eso significa que, de las personas que participaron en el ensayo clínico, aquellas que recibieron la vacuna tenían un riesgo un 80% más bajo de enfermar que las del grupo placebo. Este valor se calcula comparando el número de casos de enfermedad en el grupo vacunado y en el grupo que recibió el placebo. Una eficacia del 80% no significa que enfermará el 20% del grupo vacunado.
La eficacia real de las vacunas es una medida del grado en que estas funcionan en la práctica. Los ensayos clínicos incluyen a un gran número de participantes de todas las edades, sexos y etnias, e incluso con problemas de salud conocidos, pero no pueden representan a la perfección a toda la población. La eficacia observada en los ensayos clínicos se restringe a los resultados específicos en un ensayo, mientras que la eficacia real se mide calculando la protección conferida a las comunidades en su conjunto. Esta eficacia real puede diferir de la eficacia teórica medida en un ensayo, porque no se puede predecir exactamente cuál será la eficacia de la vacunación en la práctica en una población mucho más grande y variable vacunada en condiciones reales.
Fuente: OMS
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