Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednes­day signed off on au­tho­riz­ing the use of het­erol­o­gous — or what FDA calls a “mix and match” of a pri­ma­ry vac­cine se­ries and dif­fer­ent boost­er dos­es — for all cur­rent­ly avail­able Covid-19 vac­cines, in ad­di­tion to sep­a­rate­ly au­tho­riz­ing Mod­er­na and J&J boost­ers.

On the mix-and-match ap­proach, which FDA of­fi­cials in­sist­ed isn’t too con­fus­ing in a press con­fer­ence, the agency of­fered the ex­am­ple of an 18-year-old who re­ceived the J&J shot at least two months ago and may now re­ceive a sin­gle boost­er of the J&J, a half dose of the Mod­er­na, or the Pfiz­er-BioN­Tech boost­er.

An­oth­er ex­am­ple would be some­one who re­ceived the ini­tial two-dose se­ries of Pfiz­er or Mod­er­na, and who is el­i­gi­ble to get a boost­er (i.e., 65 years of age and old­er, 18 through 64 years of age at high-risk of se­vere Covid-19, and 18 through 64 years of age with fre­quent in­sti­tu­tion­al or oc­cu­pa­tion­al ex­po­sure to SARS-CoV-2) may re­ceive a shot of the Mod­er­na, Pfiz­er or a J&J vac­cine, at least six months af­ter com­plet­ing their pri­ma­ry vac­ci­na­tion.

“Fol­low­ing a pre­sen­ta­tion of clin­i­cal tri­al da­ta from the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases, the Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee’s dis­cus­sion of in­for­ma­tion sub­mit­ted for con­sid­er­a­tion, along with the agency’s eval­u­a­tion of the avail­able da­ta, the FDA has de­ter­mined that the known and po­ten­tial ben­e­fits of the use of a sin­gle het­erol­o­gous boost­er dose out­weigh the known and po­ten­tial risks of their use in el­i­gi­ble pop­u­la­tions,” FDA said in a state­ment.

Kirsten Lyke

At that VRB­PAC meet­ing, ex­perts re­viewed da­ta from a mix-and-match study where 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.

Oth­er ex­perts called for the EUA for mix-and-match boost­ers so that they can be tracked, as the het­erol­o­gous sec­ond and third shots are oc­cur­ring in the re­al world with or with­out an FDA au­tho­riza­tion.

Ofer Levy, 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 are 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.”

Sep­a­rate­ly, the agency al­so of­fered an EUA for a sin­gle boost­er half-dose of the Mod­er­na vac­cine that may be ad­min­is­tered at least 6 months af­ter com­ple­tion of the pri­ma­ry se­ries to se­niors, those at high risk of se­vere Covid, and those who work in places where there’s a high risk of ex­po­sure to the virus.

For J&J, FDA said the boost­er may be ad­min­is­tered for any adult, at least 2 months af­ter com­ple­tion of the sin­gle-dose pri­ma­ry reg­i­men.

Pe­ter Marks

Both of those rec­om­men­da­tions for Mod­er­na and J&J boost­ers fol­lowed unan­i­mous votes from the FDA’s vac­cine ad­comm.

The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices will vote on a rec­om­men­da­tion to­day for which groups should re­ceive boost­ers. It will al­so dis­cuss new safe­ty up­dates. But as the Pfiz­er boost­er au­tho­riza­tion showed, the CDC di­rec­tor does not have to fol­low ACIP’s rec­om­men­da­tions.

“We will work to ac­crue ad­di­tion­al da­ta as quick­ly as pos­si­ble to fur­ther as­sess the ben­e­fits and risks of the use of boost­er dos­es in ad­di­tion­al pop­u­la­tions and plan to up­date the health­care com­mu­ni­ty and pub­lic with our de­ter­mi­na­tion in the com­ing weeks,” CBER di­rec­tor Pe­ter Marks said in a state­ment.

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