When the FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee meets next month to dis­cuss the de­vel­op­ment and au­tho­riza­tion of Covid-19 vac­cines, the chair­woman won’t be there.

Hana El Sahly

Hana El Sahly has re­cused her­self from the ex­pert pan­el’s re­view of the top­ic, cit­ing her role as a lead in­ves­ti­ga­tor in Mod­er­na’s Phase III tri­al, Reuters re­port­ed. An as­so­ciate pro­fes­sor of vi­rol­o­gy and mi­cro­bi­ol­o­gy at Bay­lor Col­lege of Med­i­cine in Hous­ton, El Sahly was ap­point­ed the chair­woman last year.

The FDA has yet to re­lease the ros­ter for the Oct. 22 meet­ing. The vac­cine ad­vi­so­ry com­mit­tee cur­rent­ly con­sists of 15 vot­ing mem­bers; they are set to de­lib­er­ate on Covid-19 vac­cines gen­er­al­ly in­stead of de­bat­ing any spe­cif­ic ap­pli­ca­tion.

While this marks the first in­stance an FDA ad­vi­sor has stepped aside due to po­ten­tial or per­ceived con­flict of in­ter­est, it fol­lows two high-pro­file res­ig­na­tions from Mod­er­na’s board for the same rea­son.

Mon­cef Slaoui, the for­mer head of Glax­o­SmithK­line’s vac­cines de­part­ment, stepped off once the White House tapped him as the chief sci­en­tif­ic ad­vi­sor of Op­er­a­tion Warp Speed. Two months lat­er, Brigham and Women’s pres­i­dent Eliz­a­beth Nabel fol­lowed in his foot­steps as her hos­pi­tal was set to be a site for Mod­er­na’s Phase III tri­al.

Work­ing on the broad­er, na­tion­al lev­el, El Sahly re­cent­ly de­scribed her role to the lo­cal af­fil­i­ate ABC13: “Re­view­ing the re­lat­ed doc­u­ments, the com­mu­ni­ca­tions that sort of laid the ground for the process of get­ting the study start­ed.”

Al­though reg­u­la­tors are not bound to fol­low the ad­comm’s rec­om­men­da­tions, this par­tic­u­lar meet­ing is spe­cial. FDA com­mis­sion­er Stephen Hahn has spot­light­ed the event — which will be open to the pub­lic — as an il­lus­tra­tion of the kind of trans­paren­cy and sci­ence-dri­ven ap­proach that his agency is striv­ing for.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

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Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.