No new guid­ance, but here's some ad­vice: FDA draws a line in the sand for Covid-19 vac­cine de­vel­op­ers

Less than a day af­ter re­ports emerged that the White House cit­ed in­dus­try op­po­si­tion in a move to block stricter Covid-19 vac­cine guide­lines, the FDA is spelling out ex­act­ly what reg­u­la­tors have been com­mu­ni­cat­ing to de­vel­op­ers look­ing for an emer­gency use au­tho­riza­tion.

In do­ing so, the reg­u­la­tors are of­fi­cial­ly draw­ing a line in the sand amid an in­creas­ing­ly chaot­ic cam­paign to bring a vac­cine to mar­ket at record speed.

In the brief­ing doc­u­ments for the Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee ahead of its Oct. 22, 2020 meet­ing, the agency tucked in two ap­pen­dices. The first was a lengthy guid­ance from June, unedit­ed, on de­vel­op­ment and li­cen­sure of a vac­cine to pre­vent Covid-19. But the sec­ond — a doc­u­ment ti­tled “Sum­ma­ry of Ad­vice Pro­vid­ed to In­di­vid­ual Spon­sors in Re­sponse to Ques­tions Re­gard­ing Emer­gency Use Au­tho­riza­tion of Vac­cines to Pre­vent COVID-19” — is new to the pub­lic.

Per the 5-page sum­ma­ry, the FDA has sug­gest­ed to spon­sors that their EUA re­quests should meet a high­er bar than what’s out­lined in the guid­ance. These ad­di­tion­al safe­ty and ef­fi­ca­cy re­quire­ments match the stricter stan­dards that the FDA was about to pub­lish be­fore the White House over­ruled them.

As­sum­ing com­pa­nies fol­low the ad­vice (and CBER chief Pe­ter Marks has em­pha­sized that they “knew what we’re ex­pect­ing”), it would be all but im­pos­si­ble for any vac­cine de­vel­op­er to sub­mit an up-to-par ap­pli­ca­tion be­fore Elec­tion Day, let alone get cleared for EUA as Pres­i­dent Don­ald Trump has promised.

For in­stance, the FDA said it’s told spon­sors to re­port da­ta with a me­di­an fol­low-up of at least two months af­ter “com­ple­tion of the full vac­ci­na­tion reg­i­men” to mon­i­tor ad­verse events; safe­ty num­bers on “well over 3,000 vac­cine re­cip­i­ents”; and “a to­tal of 5 or more” se­vere Covid-19 cas­es in the place­bo group to as­suage con­cerns about vac­cine-in­duced en­hanced res­pi­ra­to­ry dis­ease.

Then there’s the ad­vice for com­pa­nies to pro­vide a de­tailed de­scrip­tion of their man­u­fac­tur­ing process and con­trols no less than one month pri­or to seek­ing an EUA. That means for an EUA to be is­sued by Nov. 3, a com­pa­ny would have sub­mit­ted this in­for­ma­tion days ago.

Each of these sub­mis­sions, the FDA added, will be scru­ti­nized in­di­vid­u­al­ly by the same pan­el of out­side ex­perts it has con­vened in two weeks:

FDA ex­pects to con­vene an open ses­sion of FDA’s VRB­PAC pri­or to the is­suance of any EUA for a COVID-19 vac­cine, to dis­cuss whether the avail­able safe­ty and ef­fec­tive­ness da­ta sup­port au­tho­riza­tion of an EUA for the spe­cif­ic re­quest un­der re­view. This dis­cus­sion will be spe­cif­ic to the par­tic­u­lar vac­cine that is the sub­ject of the EUA re­quest and will be sep­a­rate from, and in ad­di­tion to, any gen­er­al dis­cus­sion by the VRB­PAC re­gard­ing the de­vel­op­ment, au­tho­riza­tion and/or li­cen­sure of vac­cines to pre­vent COVID-19.

Oct. 22, though, will be when the gen­er­al dis­cus­sion hap­pens. Reg­u­la­tors have asked the ad­comm to ex­plore what ad­di­tion­al stud­ies vac­cine de­vel­op­ers should con­duct, ei­ther be­fore or af­ter an OK, to eval­u­ate their can­di­dates. Should they be do­ing tri­als in chil­dren and preg­nant women? Is there a need for post-mar­ket­ing safe­ty stud­ies fol­low­ing a full BLA ap­proval? What about post-EUA safe­ty fol­low-up?

Pfiz­er/BioN­Tech, Mod­er­na, As­traZeneca/Ox­ford, J&J and a slate of oth­ers will sure­ly be tun­ing in.

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