Ieri FDA ha approvato definitivamente Comirnaty (il vaccino Pfizer-BioNTech) per la prevenzione del COVID-19. Prima era autorizzato per uso emergenziale ed ora è passato ad un'autorizzazione classica, ma è lo stesso vaccino di prima: funzionava prima e funziona ora. Era sicuro prima ed è sicuro ora.

Questo, comunque, riguarda noi europei fino ad un certo punto, poiché EMA non aveva approvato Comirnaty per uso emergenziale sin dall'inizio, bensì aveva optato per una commercializzazione per uso condizionato (CMA).

"CMA is a pragmatic tool for the fast-track conditional approval of a medicine to address an unmet medical need. Its purpose is to make an innovative drug immediately available to target a seriously debilitating, rare or life-threatening disease devoid of any treatment, to provide patients with a major therapeutic advantage over existing treatments, or to save as many lives as possible in course of public health emergencies—such as a new pandemic 7. Approval is granted on the condition that an applicant company will supply additional information after the drug placing on the market. CMA guarantees that the medicine meets sufficient standards for safety, efficacy and quality; that is, that the benefit/risk balance is favorable. But, comprehensive data are still required post-approval, unlike after a normal marketing authorization where all data are submitted before authorization is granted."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8314028/

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