Duke Uni­ver­si­ty has come up with one of the most se­vere vac­cine man­dates in the books. Their mes­sage to more than 22,000 fac­ul­ty and staff: Get a jab of ei­ther the J&J, Mod­er­na or Pfiz­er/BioN­Tech vac­cines, or get fired. And don’t come back look­ing for a job lat­er.

Ex­emp­tions for med­ical and re­li­gious rea­sons will be con­sid­ered, but any­one al­lowed to take that route will al­so be sub­ject­ed to dai­ly mon­i­tor­ing for symp­toms and week­ly tests, ac­cord­ing to their state­ment to staff, sent to End­points News.

The bot­tom line from provost Sal­ly Ko­rn­bluth and ad­min­is­tra­tion VP Kyle Ca­vanaugh:

Vac­ci­na­tion is the best way to pro­tect your­self and your loved ones from se­ri­ous ill­ness re­lat­ed to COVID-19, and it is (the) on­ly way we will bring an end to this pan­dem­ic.

Duke is al­ready close to its goal, with 91% of staff and fac­ul­ty vac­ci­nat­ed.

News of the Duke de­mand spread fast on Mon­day morn­ing, com­ing as a whole host of busi­ness­es — in­clud­ing a wide swathe of bio­phar­ma — have been man­dat­ing a Covid-19 vac­cine. Now that Pfiz­er/BioN­Tech has a full ap­proval, the hope among many ex­perts is that more man­dates can push wider adop­tion at a time the Delta vari­ant has been rack­ing up a surg­ing wave of new in­fec­tions.

Hous­ton Methodist was one of the first health cen­ters to man­date a vac­cine, fir­ing or ac­cept­ing res­ig­na­tions from dozens of work­ers. And oth­er com­pa­nies have been ratch­et­ing up the pain for non­com­pli­ance. That in­cludes Delta, where health in­sur­ance will now cost more for the unin­sured. — John Car­roll

Eli Lil­ly gets a green light to re­sume an­ti­body sales

In Eli Lil­ly’s Q2 call, their ex­ecs re­vealed that sales of its mon­o­clon­al an­ti­bod­ies for Covid-19 treat­ment were slashed af­ter dis­tri­b­u­tion was halt­ed na­tion­wide. Now, two months since the ship­ments were paused, the FDA is re­sum­ing its use in a lit­tle less than half of the US.

The FDA has now spec­i­fied that Eli Lil­ly’s mAb com­bo of bam­lanivimab and ete­se­vimab is al­lowed for use in states and ter­ri­to­ries in which the com­bined fre­quen­cy of vari­ants that are re­sis­tant to the drug are less than 5%, the agency an­nounced.

While the an­ti­bod­ies were deemed in­ef­fec­tive against the Be­ta and Gam­ma vari­ants — which were trend­ing up­ward when dis­tri­b­u­tion was first halt­ed — the cock­tail can still neu­tral­ize the Delta and Al­pha vari­ants. Giv­en the dom­i­nance of Delta (and rel­a­tive fall of Be­ta and Gam­ma), it ap­pears Lil­ly’s drugs can once again play a role in the pan­dem­ic.

There are 22 states in which that ap­plies: Col­orado, Con­necti­cut, Illi­nois, In­di­ana, Iowa, Kansas, Maine, Mass­a­chu­setts, New Hamp­shire, Michi­gan, Min­neso­ta, Mis­souri, Mon­tana, Ne­bras­ka, North Dako­ta, Ohio, Rhode Is­land, South Dako­ta, Utah, Ver­mont, Wis­con­sin, and Wyoming. On Fri­day, the FDA and the HHS’ As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse start­ed dis­tri­b­u­tion of both bam­lanivimab and ete­se­vimab to­geth­er and ete­se­vimab alone.

The two mAbs were first au­tho­rized for emer­gency use by the FDA on Feb. 9 for use in pa­tients ages 12 years and old­er, Covid-19 pos­i­tive and at risk of hos­pi­tal­iza­tion. But as the Be­ta and Gam­ma vari­ants be­came more fre­quent, the dis­tri­b­u­tion of the com­bo was halt­ed, first in nine states — in­clud­ing Ore­gon, Mass­a­chu­setts and Flori­da — where the fre­quen­cy of vari­ants was high­er than 10%, then through the en­tire coun­try.

The list of places where the use of the mAb is not al­lowed in­cludes Wash­ing­ton DC, Amer­i­can Samoa, Guam and Puer­to Ri­co, among a num­ber of states.

Sales of the mAb were $148 mil­lion in the sec­ond quar­ter — a far cry from the $809 mil­lion the drugs post­ed in Q1 — af­ter the US halt­ed dis­tri­b­u­tion of the com­bo amid a rise in vari­ants. The pause is es­ti­mat­ed to cost Eli Lil­ly about $375 mil­lion, ac­cord­ing to one biotech an­a­lyst.

The Delta vari­ant has be­come the dom­i­nant vari­ant of the virus in the US, ac­cord­ing to the CDC. Based on as­says, bam­lanivimab and ete­se­vimab are ex­pect­ed to be ef­fec­tive against the Delta and Al­pha vari­ants, but not the Gam­ma, Be­ta or Delta-plus vari­ants.

States and ter­ri­to­ries that al­ready have re­ceived sup­ply but aren’t cur­rent­ly per­mit­ted to ad­min­is­ter the treat­ment are al­lowed to hold on to it for fu­ture use, the FDA said. Bam­lanivimab and ete­se­vimab are just one of three mAb treat­ments au­tho­rized to treat Covid-19. Re­gen­eron’s Re­gen-Cov and Glax­o­SmithK­line/Vir’s sotro­vimab are still able to be used with­out any re­stric­tions.

FDA al­so re­voked the EUA for bam­lanivimab alone in April be­cause it was no longer as ef­fec­tive as the com­bo ther­a­py. — Josh Sul­li­van

White House stick­ing with 8-month boost­er shot rec­om­men­da­tion

NI­AID’s An­tho­ny Fau­ci said Sun­day that the Biden ad­min­is­tra­tion is “stick­ing with” its rec­om­men­da­tion for a third dose of the coro­n­avirus vac­cine eight months af­ter re­ceiv­ing the orig­i­nal shots, ac­cord­ing to Ax­ios. The Biden ad­min­is­tra­tion re­cent­ly an­nounced it would be­gin of­fer­ing boost­er shots to stay ahead of de­clin­ing vac­cine ef­fec­tive­ness.

His com­ments were in di­rect con­tra­dic­tion to re­ports that the White House planned to call for boost­er shots six months fol­low­ing the sec­ond mR­NA jab in­stead.

“If the da­ta tells us dif­fer­ent­ly, we’ll make ad­just­ments ac­cord­ing­ly,” Fau­ci said on ABC’s “This Week”.

Fau­ci’s state­ments come as the US sees an in­crease in Covid cas­es — most­ly due to the in­fec­tious Delta vari­ant. In the last 28 days, Johns Hop­kins Uni­ver­si­ty da­ta show that the US re­port­ed al­most 3.8 mil­lion con­firmed cas­es. — Paul Schloess­er

Got­tlieb ex­pects Pfiz­er Covid-19 vac­cine ap­proval for kids un­der 12 by ear­ly win­ter

For­mer FDA Com­mis­sion­er Scott Got­tlieb said on CBS’s “Face the Na­tion” Sun­day that the Pfiz­er vac­cine could be ap­proved for kids ages 5-12 by late No­vem­ber or ear­ly De­cem­ber of this year.

Got­tlieb, who is on the board of di­rec­tors of Pfiz­er, said that Pfiz­er “is go­ing to be in a po­si­tion… to file da­ta with the FDA at some point in Sep­tem­ber and then file the ap­pli­ca­tion po­ten­tial­ly as ear­ly as Oc­to­ber. So that’ll put us on a time frame where the vac­cine could be avail­able at some point, late fall, more like­ly ear­ly win­ter, de­pend­ing on how long FDA takes to re­view the ap­pli­ca­tion.”

Da­ta on the vac­cine in chil­dren be­tween the ages of 2 and 5 will be avail­able by No­vem­ber, Got­tlieb said. — Paul Schloess­er

Pfiz­er bol­sters mar­ket­ing team to ap­proach vac­ci­na­tion push

Fol­low­ing its full FDA ap­proval, Pfiz­er has made it a pri­or­i­ty to mar­ket its Covid-19 vac­cine, and it’s hir­ing more team mem­bers to pro­mote it.

The drug­mak­er has post­ed sev­er­al po­si­tions on LinkedIn, The Fi­nan­cial Times first re­port­ed, in­clud­ing a se­nior di­rec­tor for its US Covid launch and a se­nior man­ag­er for US Covid con­sumer mar­ket­ing. The jobs are be­ing cre­at­ed among a flur­ry of com­pe­ti­tion from vac­cine mak­ers for boost­er shots.

Boost­ers will be­come avail­able in the US on Sept. 20 for those who are im­muno­com­pro­mised, and have re­ceived ei­ther the Mod­er­na or Pfiz­er-BioN­Tech jab. Pfiz­er de­clined to talk to the FT about the depth or du­ties of the new team, but it’s ex­pect­ed to mar­ket the vac­cine through on­line so­cial me­dia, TV ads and bill­boards. It’s been work­ing with New York-based ad agency Ogilvy. — Josh Sul­li­van

So­cial: Shut­ter­stock

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

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.