HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week af­ter HHS Sec­re­tary Xavier Be­cer­ra de­clared mon­key­pox a na­tion­al health emer­gency, re­ports have emerged that the US plans to ex­tend its vac­cine sup­ply by opt­ing for a dif­fer­ent route of ad­min­is­tra­tion.

Of­fi­cials are ex­pect­ed to call for in­tra­der­mal in­jec­tion of Bavar­i­an Nordic’s Jyn­neos vac­cine — the on­ly shot ap­proved specif­i­cal­ly for mon­key­pox in the US — as op­posed to sub­cu­ta­neous in­jec­tion, un­named sources told both the New York Times and Wash­ing­ton Post on Tues­day.

HHS did not re­spond to a re­quest for com­ment. Be­cer­ra, FDA com­mis­sion­er Rob Califf, White House mon­key­pox re­sponse co­or­di­na­tor Bob Fen­ton and CDC di­rec­tor Rochelle Walen­sky will par­tic­i­pate in a White House press brief­ing this af­ter­noon “to pro­vide up­dates on the Mon­key­pox re­sponse ef­fort.”

Daniel Ku­ritzkes

It’s be­lieved that ad­min­is­ter­ing the vac­cine via in­tra­der­mal in­jec­tion — a process by which a vac­cine is de­liv­ered di­rect­ly in­to the skin, as op­posed to un­der the skin — re­quires a small­er dose and could ex­tend the US’ sup­ply by five times, ac­cord­ing to the Post. That’s be­cause the der­mis is rich in den­drit­ic cells, which spe­cial­ize in tak­ing up for­eign anti­gens and pre­sent­ing them to the im­mune sys­tem to elic­it an im­mune re­sponse, Daniel Ku­ritzkes, chief of in­fec­tious dis­eases at Brigham and Women’s Hos­pi­tal in Boston, told End­points News.

The down­side? It’s more chal­leng­ing to do cor­rect­ly, ac­cord­ing to William Schaffn­er, a pro­fes­sor in Van­der­bilt Uni­ver­si­ty’s in­fec­tious dis­eases di­vi­sion.

William Schaffn­er

“The best ex­am­ple we have of do­ing this in a wide­spread fash­ion pre­vi­ous­ly is with the, rather now old-fash­ioned, TB tu­ber­cu­lo­sis skin tests,” Schaffn­er told End­points News on Tues­day. “There are still many nurs­es work­ing, and some re­tired, who were ex­pert at do­ing this. It’s a bit of an art form. The av­er­age nurse prob­a­bly in their train­ing may nev­er have giv­en an in­tra­der­mal in­oc­u­la­tion or had on­ly very brief ex­po­sure.”

It’s much eas­i­er to stick a nee­dle through the skin, he added, which is how the vac­cine is ad­min­is­tered cur­rent­ly. But cor­rect­ly get­ting it in­to the skin takes tech­nique. If it isn’t done cor­rect­ly, vac­cine can ei­ther leak out or make its way through the skin, where it may be less ef­fec­tive giv­en the low­er dose.

“The rea­son this isn’t em­ployed more is that it’s not easy,” Schaffn­er said.

This route al­so re­quires a small­er nee­dle, though Ku­ritzkes not­ed they are “rel­a­tive­ly eas­i­ly avail­able.” An­oth­er po­ten­tial hur­dle would be get­ting the reg­u­la­to­ry OK to split up the con­tents of a sin­gle-dose vial.

“There would need to be some ei­ther per­mis­sion from the FDA or po­ten­tial­ly some work from the com­pa­ny that’s pro­duc­ing these to demon­strate that it’s okay to go in and out of the vial sev­er­al times, that you don’t risk con­t­a­m­i­nat­ing the con­tents, or get­ting for­eign ma­te­r­i­al in the sy­ringe from the stop­per,” he said.

Bavar­i­an Nordic, which man­u­fac­tures the Jyn­neos vac­cine, did not re­spond to an in­ter­view re­quest as of press time. Just a few weeks ago, the US or­dered an ad­di­tion­al 2.5 mil­lion dos­es of the liq­uid-frozen vac­cine. Along with two pre­vi­ous or­ders this year for 500,000 and 2.5 mil­lion dos­es, and an or­der back in 2020 for 1.4 mil­lion dos­es, that brings the com­pa­ny’s US com­mit­ment to near­ly 7 mil­lion dos­es to be de­liv­ered through­out this year and next.

The news comes as the New York Times re­ports that about 20 mil­lion dos­es of the mon­key­pox vac­cine have ex­pired in the US’ na­tion­al stock­pile.

The US al­so re­cent­ly act­ed on a $26 mil­lion op­tion for in­tra­venous cours­es of Siga Tech­nolo­gies’ small­pox treat­ment Tpoxx, which could be im­por­tant for pa­tients who can­not swal­low.

“These op­tion ex­er­cis­es for the pro­cure­ment of IV for­mu­la­tion of TPOXX as well as the fund­ing of a post-mar­ket­ing field study for IV TPOXX high­light the grow­ing im­por­tance of a broad-based re­sponse to the sub­stan­tial risks posed by the or­thopox fam­i­ly of virus­es, in­clud­ing small­pox and mon­key­pox,” CEO Phil Gomez said in a state­ment.

Mon­key­pox cas­es in the US are now ap­proach­ing 9,000, ac­cord­ing to the CDC.

While Schaffn­er told End­points back in May that he was “quite con­fi­dent” pub­lic health au­thor­i­ties in the US, Cana­da and Eu­rope would quick­ly bring chains of trans­mis­sions un­der con­trol, he’s since changed his stance.

“Its ca­pac­i­ty to spread has been much more vig­or­ous than many of us an­tic­i­pat­ed when it first start­ed to ap­pear in the West­ern world,” he said.

Ku­ritzkes, how­ev­er, main­tains that a wide­spread vac­ci­na­tion cam­paign in the US is un­like­ly.

“I don’t think it’s like­ly that we’re go­ing to see a vac­ci­na­tion cam­paign any­thing like we saw for COVID, be­cause the vast ma­jor­i­ty of the pop­u­la­tion is not re­al­ly at risk for com­ing in con­tact with mon­key­pox or ac­quir­ing mon­key­pox,” he said.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.