Covid-19 roundup: Duke de­mands Covid vac­cine — or else; FDA re­sumes Eli Lil­ly's mAb use in 22 states af­ter pause for vari­ant uptick

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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Covid-19 roundup: J&J boost­er shot da­ta show promise; CD­C's ACIP meet­ing this week to dis­cuss Pfiz­er boost­ers

J&J revealed a summary of new Covid-19 vaccine data today, including new results showing booster shots may help with protection.

A Phase III study (ENSEMBLE 2) looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against symptomatic Covid-19, with the following levels of protection:

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

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

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.