The FDA's in­ves­ti­ga­tion of Covid-19 vac­cine safe­ty in chil­dren has ex­pand­ed in­to adults, ac­cord­ing to peo­ple fa­mil­iar with the agen­cy's work — a sig­nif­i­cant widen­ing of scope amid the Trump ad­min­is­tra­tion's plans to re­think US vac­cine pol­i­cy.

The ex­pand­ed probe is be­ing led by Tra­cy Beth Høeg, a long­time skep­tic of the shots who on Mon­day will of­fi­cial­ly take over as act­ing di­rec­tor of the FDA's Cen­ter for Drug Eval­u­a­tion and Re­search.

Høeg has been lead­ing a re­ex­am­i­na­tion of side ef­fect re­ports for chil­dren that claims to have un­cov­ered 10 or more deaths, an as­sess­ment that has gen­er­at­ed dis­agree­ment and con­tro­ver­sy from in­side and out­side the FDA. That as­sess­ment has still not been re­leased by the agency, de­spite the fact that — if ac­cu­rate — it would seem to rep­re­sent an ur­gent safe­ty is­sue.

De­tails from an in­ves­ti­ga­tion by CBER Di­rec­tor Vinay Prasad in­to 10 al­leged child deaths re­lat­ed to Covid-19 vac­cines won't be com­ing soon, an FDA spokesper­son told End­points News on Wednes­day.

FDA spokesper­son Caleb Michaud said the agency was not re­leas­ing any more de­tails in the "near term," since "there are ad­di­tion­al ad­verse event cas­es be­ing in­ves­ti­gat­ed." Michaud did not say what those ad­verse events were, or if they were deaths. Af­ter this ar­ti­cle pub­lished, Michaud added a fol­low-up com­ment say­ing that "FDA’s in­ten­tion is make a re­port pub­licly avail­able by the end of this month that cov­ers the re­port­ed 10 deaths."

A dozen for­mer FDA com­mis­sion­ers, in­clud­ing sev­er­al for­mer Trump ap­pointees, is­sued a scathing re­buke of bi­o­log­ics and vac­cines chief Vinay Prasad's plans to over­haul the agen­cy's reg­u­la­tion of vac­cines.

They said in the New Eng­land Jour­nal of Med­i­cine on Wednes­day that they were "deeply con­cerned by sweep­ing new FDA as­ser­tions about vac­cine safe­ty and pro­pos­als that would un­der­mine a reg­u­la­to­ry mod­el de­signed to en­sure that vac­cines are safe, ef­fec­tive, and avail­able when the pub­lic needs them most."

Prasad's in­ter­nal email, which was re­port­ed on wide­ly (in­clud­ing by End­points News), sug­gests that the pro­posed changes "will up­end core poli­cies" gov­ern­ing vac­cine de­vel­op­ment. The for­mer per­ma­nent and act­ing com­mis­sion­ers of the agency who took part in the NE­JM piece in­clude Scott Got­tlieb, Janet Wood­cock, Rob Califf and Mar­garet Ham­burg.

New CAR-T treat­ments for can­cer will need to prove that they're bet­ter than ex­ist­ing ther­a­pies to win FDA ap­proval, the agen­cy's bi­o­log­ics chief Vinay Prasad said in a jour­nal ar­ti­cle Mon­day, rais­ing the bar on the da­ta that will be re­quired for the prod­ucts.

Prasad co-au­thored the ar­ti­cle in JA­MA with oth­er top FDA of­fi­cials in the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search. De­vel­op­ers of new CAR-T treat­ments will need to take in­to ac­count ex­ist­ing CAR-T ther­a­pies when de­vel­op­ing a con­trol group for tri­als, and gen­er­ate ev­i­dence show­ing "su­pe­ri­or­i­ty of the in­ves­ti­ga­tion­al CAR T-cell ther­a­py com­pared with con­trol."

There are sev­en CAR-T prod­ucts ap­proved for can­cer on the mar­ket, all of which reached pa­tients based on sin­gle-arm tri­als with­out a con­trol group. Oth­ers are run­ning sin­gle-arm tri­als for CAR-Ts in rare or late-line can­cers to win full ap­provals.

The FDA wants to in­cen­tivize US-based drug de­vel­op­ment by adding new fees for com­pa­nies that run their Phase 1 tri­als out­side the coun­try, ac­cord­ing to meet­ing min­utes shared by the agency on Tues­day.

The pro­pos­al, which is still in de­vel­op­ment, would raise the FDA's drug ap­pli­ca­tion user fees for com­pa­nies that con­duct their Phase 1 work abroad. While the US hosts more tri­als than any­where else in the world, ac­cord­ing to WHO da­ta, its share has fall­en off in fa­vor of coun­tries where costs are cheap­er, pa­tients are eas­i­er to find, and reg­u­la­tions can be more lax. Chi­na has par­tic­u­lar­ly de­vel­oped in­to a hotbed for ear­ly-stage clin­i­cal work.

The FDA is re­ex­am­in­ing the safe­ty of