FDA ap­pears un­con­vinced by Pfiz­er's case for Covid-19 boost­er in lead up to ad­comm

At around 9 a.m. on Wednes­day morn­ing, the FDA re­leased Pfiz­er’s de­tailed case to the agency and its out­side ad­vi­sors for au­tho­riz­ing Covid-19 boost­er dos­es. Three hours lat­er, the FDA re­leased its own analy­sis.

For most of the doc­u­ments, it is as if the agency and the com­pa­ny are hav­ing two dif­fer­ent con­ver­sa­tions.

The doc­u­ments pro­vide a pre­lude for an ad­vi­so­ry com­mit­tee hear­ing that will de­bate whether the agency should ap­prove boost­er shots. The is­sue has proven deeply po­lar­iz­ing. Pres­i­dent Biden has promised to au­tho­rize boost­ers based on da­ta from Is­rael and else­where, an­ger­ing some pub­lic health of­fi­cials in and out­side the FDA, who fear the pres­i­dent is in­ter­fer­ing in the agency’s in­de­pen­dence and ar­gue that ex­ist­ing da­ta don’t sup­port such shots, es­pe­cial­ly when much of the world re­mains un­vac­ci­nat­ed.

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