FDA post­pones ad­comm for Pfiz­er's Covid-19 vac­cine for the youngest age group

The FDA on Fri­day af­ter­noon said it’s no longer mov­ing for­ward with its plan to au­tho­rize two dos­es (while wait­ing for da­ta on a third dose) of Pfiz­er’s Covid-19 vac­cine for the youngest group of chil­dren, from 6 months through 4 years of age.

Pe­ter Marks FDA

“Based on the agency’s pre­lim­i­nary as­sess­ment, and to al­low more time to eval­u­ate ad­di­tion­al da­ta, we be­lieve ad­di­tion­al in­for­ma­tion re­gard­ing the on­go­ing eval­u­a­tion of a third dose should be con­sid­ered as part of our de­ci­sion-mak­ing for po­ten­tial au­tho­riza­tion,” FDA’s top vac­cine of­fi­cial Pe­ter Marks and act­ing FDA com­mis­sion­er Janet Wood­cock said in a state­ment while an­nounc­ing that next week’s VRB­PAC meet­ing would be de­layed.

Marks said the da­ta, some of which was “late-break­ing,” are com­ing in very rapid­ly be­cause of the large num­ber of cas­es of Omi­cron and “at this time it makes sense to wait for the third dose be­fore tak­ing ac­tion.”

Janet Wood­cock

“The da­ta we saw made us re­al­ize we need to see a third dose in or­der to pro­ceed with an au­tho­riza­tion,” he added.

The ex­ten­sion al­lows the FDA time to re­ceive up­dat­ed da­ta on the two and three-dose reg­i­men, Pfiz­er said, while con­duct­ing a thor­ough eval­u­a­tion of it.

The com­pa­ny had ini­tial­ly said in De­cem­ber that it would test a third dose of its Covid-19 vac­cine in the tri­al af­ter an­nounc­ing that non-in­fe­ri­or­i­ty was not met for chil­dren be­tween the ages of two and five when com­pared to old­er teenagers in the cur­rent tri­al. But for the youngest group, from 6 months to 2-years-old, non-in­fe­ri­or­i­ty was met.

But Marks said it was a “safe as­sump­tion” that the ef­fi­ca­cy de­ci­sion would be based on clin­i­cal da­ta from Pfiz­er.

Pfiz­er said in a state­ment that in these chil­dren, da­ta on the first two 3 µg dos­es in this age group are be­ing shared with the FDA on an on­go­ing ba­sis. Cas­es con­tin­ue to ac­cu­mu­late ac­cord­ing to the study pro­to­col and more da­ta are be­ing gen­er­at­ed be­cause rates of in­fec­tion and ill­ness re­main high in chil­dren of this age, es­pe­cial­ly due to the re­cent Omi­cron surge.

“The in­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee (DMC) for the study sup­ports the con­tin­u­a­tion of the tri­al ac­cord­ing to the pro­to­col and be­lieve that the da­ta col­lect­ed to date in­di­cate the vac­cine is well tol­er­at­ed and sup­port a po­ten­tial three-dose reg­i­men,” Pfiz­er added.

Some pub­lic health ex­perts said they thought FDA was cor­rect in press­ing the pause but­ton.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

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