The Biden ad­min­is­tra­tion’s goal of kick­ing off its boost­er shot dri­ve for the en­tire US pop­u­la­tion this week is not quite go­ing as planned.

First, Pfiz­er ap­plied for ap­proval of a sup­ple­men­tal ap­pli­ca­tion for the boost­er shots, but since last Fri­day’s ad­comm re­view­ing them, the plan has de­volved in­to an EUA, which the FDA is­sued late Wednes­day evening.

The pop­u­la­tion that is now el­i­gi­ble for the boost­er, six months af­ter re­ceiv­ing the first pair of Pfiz­er-BioN­Tech vac­cines, al­so nar­rowed from what Pfiz­er ap­plied for (every­one who’s el­i­gi­ble for the ini­tial Pfiz­er shots) to just those who are 65 or old­er, or at high-risk of a Covid in­fec­tion, in­clud­ing health care work­ers and oth­ers with oc­cu­pa­tion­al haz­ards.

“Af­ter con­sid­er­ing the to­tal­i­ty of the avail­able sci­en­tif­ic ev­i­dence and the de­lib­er­a­tions of our ad­vi­so­ry com­mit­tee of in­de­pen­dent, ex­ter­nal ex­perts, the FDA amend­ed the EUA for the Pfiz­er-BioN­Tech COVID-19 Vac­cine to al­low for a boost­er dose in cer­tain pop­u­la­tions such as health care work­ers, teach­ers and day care staff, gro­cery work­ers and those in home­less shel­ters or pris­ons, among oth­ers,” act­ing FDA com­mis­sion­er Janet Wood­cock said in a state­ment.

The agency said it’s re­ly­ing on an analy­sis from Pfiz­er show­ing that over the last two months, the in­ci­dence of Covid-19 was high­er among the tri­al par­tic­i­pants who com­plet­ed their pri­ma­ry vac­cine se­ries ear­li­er, com­pared to par­tic­i­pants who com­plet­ed it lat­er.

“The FDA de­ter­mined that the rate of break­through COVID-19 re­port­ed dur­ing this time pe­ri­od trans­lates to a mod­est de­crease in the ef­fi­ca­cy of the vac­cine among those vac­ci­nat­ed ear­li­er,” the agency said.

And for those re­ceiv­ing the boost­ers due to high risk of se­vere Covid-19 and in­sti­tu­tion­al or oc­cu­pa­tion­al ex­po­sure risk, they must be adult, 18 through 64 years of age, which ex­cludes the 12-18 age group for which the vac­cine is ei­ther au­tho­rized or ap­proved.

The EUA fol­lows close de­bate and dis­agree­ment among vac­cine ex­perts ad­vis­ing the FDA, and the FDA’s own in­ter­nal vac­cine ex­perts.

The FDA’s ad­comm on vac­cines round­ly re­ject­ed the Pfiz­er/BioN­Tech boost­er shots for all in­di­vid­u­als old­er than 16 by a 16-2 vote Fri­day af­ter­noon. Soon af­ter, how­ev­er, the agency posed a new ques­tion to com­mit­tee mem­bers on lim­it­ing boost­er use to the 65-and-old­er pop­u­la­tion and in­di­vid­u­als at high risk of dis­ease due to oc­cu­pa­tion­al ex­po­sure or co­mor­bidi­ties (which is what the agency in­evitably went with).

That ques­tion, com­ing rough­ly 45 min­utes af­ter the first, passed through the ad­comm with a unan­i­mous 18-0 vote. This vote cen­tered on an EUA — not the sBLA for which Pfiz­er had ap­plied. While CBER head Pe­ter Marks al­lowed the ad­di­tion­al ques­tion and vote, which were not on the agen­da, top CBER of­fi­cial Mar­i­on Gru­ber ques­tioned the move. Gru­ber and her deputy Phil Krause are re­tir­ing soon, at least in part due to the ad­min­is­tra­tion’s over-step­ping its bounds on the boost­er de­ci­sion, they wrote in the Lancet last week.

Krause al­so ques­tioned Pfiz­er at the ad­comm on cer­tain sta­tis­ti­cal dis­crep­an­cies that showed its vac­cine’s ef­fi­ca­cy plum­met­ed to about 60%, where­as his analy­sis through a dif­fer­ent math­e­mat­i­cal process us­ing cas­es per per­son-years re­sult­ed in 93% ef­fi­ca­cy. These dis­parate fig­ures, Krause said, came from the same num­ber of cas­es in a study by Kaiser Per­ma­nente.

The CDC’s ACIP com­mit­tee will meet Thurs­day to dis­cuss its rec­om­men­da­tion on who specif­i­cal­ly should ac­cess boost­ers.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.