Opin­ion: The FDA's mR­NA vac­cine full ap­proval re­views are mov­ing plen­ty fast. Start the man­dates now

As the US con­tin­ues to en­joy a sur­plus of pro­tec­tive Covid vac­cines, some ex­perts are hop­ing that a tran­si­tion from EUA to full ap­proval sta­tus for the two mR­NA vac­cines will boost the pub­lic’s trust in them and in turn, amp up the coun­try’s vac­ci­na­tion lev­els just in time to block the resur­gence of Covid that we’re see­ing else­where dri­ven by the Delta vari­ant.

While such a quick up-shift may have that im­me­di­ate ef­fect, let’s not lose sight of the fact that the FDA is like­ly to re­view the Pfiz­er/BioN­Tech and Mod­er­na vac­cines in record time. And their mas­sive trove of re­al-world safe­ty and man­u­fac­tur­ing da­ta don’t make that easy. Even still, the FDA is plan­ning its Covid vac­cine ap­proval re­views to last about half the time (3-4 months) that it cur­rent­ly takes the agency to sign off on a pri­or­i­ty drug/vac­cine ap­pli­ca­tion (6 months), and just a frac­tion of the time for a non-ex­pe­dit­ed new drug ap­pli­ca­tion (12 months).

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