FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee (VRB­PAC) on Fri­day vot­ed 19-0 in fa­vor of au­tho­riz­ing a sec­ond shot of J&J’s Covid-19 vac­cine to fol­low at least two months af­ter the ini­tial dose.

Reg­u­la­tors don’t have to fol­low VRB­PAC’s rec­om­men­da­tion, but they al­most al­ways do. Con­sid­er­ing that the CDC’s ad­vi­so­ry com­mit­tee has al­ready been set to re­view the ex­pand­ed EUA, VRB­PAC’s rec­om­men­da­tion is like­ly to be adopt­ed.

Jo­han Van Hoof

The vote came af­ter Janssen pre­sent­ed da­ta from mul­ti­ple stud­ies sug­gest­ing a sec­ond shot pro­vides a sig­nif­i­cant boost in ef­fi­ca­cy com­pared to the sin­gle-dose reg­i­men, in­clud­ing one tri­al that demon­strat­ed a rough­ly 94% ef­fi­ca­cy rate against mod­er­ate and se­vere Covid-19 in the US. That com­pares to a 74% US ef­fi­ca­cy rate for the sin­gle shot, ac­cord­ing to Janssen’s fi­nal analy­sis from a sep­a­rate study.

To­day’s meet­ing could have gone a few dif­fer­ent ways, ac­cord­ing to the ini­tial vot­ing ques­tion, which asked ad­comm mem­bers to con­sid­er da­ta sup­port­ing both 2-month and 6-month boost­ers. While a boost at 2 months in­creased an­ti­body titers by 3.5- to 6.2-fold, ac­cord­ing to Janssen’s glob­al ther­a­peu­tic head of vac­cines Jo­han Van Hoof, a 6-month boost sug­gest­ed 9- to 12-fold in­creas­es.

How­ev­er, sev­er­al VRB­PAC mem­bers were con­cerned about the small sam­ple size from the 6-month co­hort, which on­ly had da­ta avail­able from 17 pa­tients.

Paul Of­fit

“Al­though it’s like­ly to be fine, it’s re­al­ly hard to make a de­ci­sion for thou­sands and tens of thou­sands and mil­lions of peo­ple based on 17 peo­ple,” said Paul Of­fit, a VRB­PAC pan­elist and pro­fes­sor of pe­di­atrics at Chil­dren’s Hos­pi­tal of Philadel­phia. “It just seems to me the most log­i­cal thing to do at this point would be to say that a sec­ond dose is rec­om­mend­ed for at least two months lat­er.”

Oth­er ad­comm mem­bers unan­i­mous­ly agreed, de­cid­ing to vote on just the 2-month da­ta for now. Many of them em­pha­sized the ur­gency of a boost­er, not­ing that mil­lions of peo­ple who’ve been vac­ci­nat­ed with a sin­gle dose are at a high­er risk for dis­ease com­pared to those who’ve re­ceived one of the mR­NA vac­cines.

There are da­ta that sug­gest the vac­cine’s ef­fi­ca­cy is even less ro­bust than Janssen sug­gest­ed in their pre­sen­ta­tion, the FDA’s top vac­cine leader Pe­ter Marks added, due to a lack of avail­able da­ta.

“The idea of the Janssen vac­cine as one dose was used as an out­reach vac­cine. Many of the peo­ple who got that may not have been part of a health main­te­nance or­ga­ni­za­tion, or an or­ga­nized health­care sys­tem, so track­ing that may have been chal­leng­ing,” he said.

Aman­da Cohn

Aman­da Cohn, ex­ec­u­tive sec­re­tary of the CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices, said study re­sults dis­cussed at a Sept. 22 ACIP meet­ing sug­gest­ed the Janssen vac­cine was on­ly 68% ef­fec­tive against hos­pi­tal­iza­tions in a group of adults who were not im­muno­com­pro­mised, which is sig­nif­i­cant­ly low­er than the rough­ly 80% ef­fi­ca­cy rate against hos­pi­tal­iza­tions than Janssen re­port­ed from their re­al-world study with Ae­tion.

VRB­PAC mem­ber Archana Chat­ter­jee, who’s dean of the Chica­go Med­ical School and VP of med­ical af­fairs at the Ros­alind Franklin Uni­ver­si­ty of Med­i­cine and Sci­ence, said her ini­tial re­sponse to the vot­ing ques­tion was no.

Archana Chat­ter­jee

“How­ev­er, hav­ing lis­tened to the con­ver­sa­tion, and see­ing the da­ta in its to­tal­i­ty, as well as plac­ing it in the con­text of these 15 mil­lion peo­ple who have been vac­ci­nat­ed with a sin­gle dose and whose im­mu­ni­ty may be wan­ing … This is still a pub­lic health im­per­a­tive,” she said.

Pen­ny Heaton, Janssen’s glob­al ther­a­peu­tic area head of vac­cines, chimed in to spec­i­fy that the sin­gle shot’s re­sponse ap­pears to be durable, though less ef­fec­tive than a two-dose reg­i­men.

Some of the VRB­PAC mem­bers al­so spec­i­fied that they would con­sid­er an­oth­er shot the sec­ond dose in a two-shot reg­i­men, as op­posed to a boost­er.

Pen­ny Heaton

“I think this, frankly, was al­ways a two-dose vac­cine. I think it’s bet­ter as a two-dose vac­cine, it’d be hard to rec­om­mend this as a sin­gle-dose vac­cine at this point, giv­en those two month-da­ta,” Of­fit said.

VRB­PAC al­so vot­ed unan­i­mous­ly yes­ter­day to ex­pand Mod­er­na’s Covid-19 vac­cine EUA for boost­er dos­es for cer­tain high-risk in­di­vid­u­als, just a few weeks af­ter vot­ing to au­tho­rize Pfiz­er’s boost­er for the same pop­u­la­tion. Pan­elist Er­ic Ru­bin, ed­i­tor in chief of the New Eng­land Jour­nal of Med­i­cine and an ex­pert on in­fec­tious dis­eases at Har­vard’s pub­lic health school, not­ed yes­ter­day that while Mod­er­na’s da­ta “are not per­fect,” these are “ex­tra­or­di­nary times” — and ad­comm mem­bers seemed to take the same stance with J&J’s vac­cine.

In a mix-and-match study, par­tic­i­pants who re­ceived J&J’s sin­gle shot fol­lowed by a Mod­er­na shot saw a geo­met­ric mean fold rise (the ra­tio of post-vac­ci­na­tion titer val­ue to pre-vac­ci­na­tion titer val­ue) of 76-fold, ac­cord­ing to Kirsten Lyke of the Cen­ter for Vac­cine De­vel­op­ment and Glob­al Health at the Uni­ver­si­ty of Mary­land School of Med­i­cine. That com­pared to a 4.2 GM­FR in those who re­ceived two dos­es of J&J’s vac­cine, and a 35 GM­FR in those who got J&J’s vac­cine fol­lowed by the Pfiz­er/BioN­Tech vac­cine.

“What I would note is that the neu­tral­iz­ing an­ti­bod­ies did in­crease in re­sponse to any boost re­gard­less of the pri­ma­ry vac­ci­na­tion se­ries,” she said, al­so not­ing that the mR­NA vac­cines re­sult­ed in high­er an­ti­body titers in the first 28 days af­ter the boost.

Ofer Levy, a pro­fes­sor of pe­di­atrics at Har­vard Med­ical School and di­rec­tor of Boston Chil­dren’s Hos­pi­tal’s pre­ci­sion vac­cines pro­gram, ex­pressed con­cern over re­cent re­ports that some Amer­i­cans are tak­ing mat­ters in­to their own hands, re­ceiv­ing unau­tho­rized boost­ers and mix­ing prod­ucts.

“In the re­al world, all these kinds of com­bi­na­tions or ex­tra boost­ers al­ready hap­pen­ing,” he said. “So I think it’s a mat­ter of some ur­gency for FDA to help sort out what is ad­mit­ted­ly a com­pli­cat­ed and chal­leng­ing sce­nario. But we can’t hide from it, and I do think we need to give guid­ance to the pub­lic.”

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