Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

Af­ter mak­ing it clear that the US’ cur­rent mon­key­pox vac­cine sup­ply is in­suf­fi­cient, the FDA on Tues­day au­tho­rized a new route of ad­min­is­tra­tion that should in­crease the num­ber of avail­able dos­es by five-fold.

Daniel Ku­ritzkes

Reg­u­la­tors cleared Bavar­i­an Nordic’s Jyn­neos vac­cine for in­tra­der­mal in­jec­tion in adults old­er than 18. Un­like sub­cu­ta­neous in­jec­tion — the cur­rent method by which vac­cine is de­liv­ered un­der the skin — an in­tra­der­mal jab goes di­rect­ly in­to the skin. It’s be­lieved that this method re­quires less vac­cine, since the der­mis is rich in den­drit­ic cells which spe­cial­ize in tak­ing up for­eign anti­gens and pre­sent­ing them to the im­mune sys­tem, ac­cord­ing to Daniel Ku­ritzkes, chief of in­fec­tious dis­eases at Brigham and Women’s Hos­pi­tal in Boston.

“In re­cent weeks the mon­key­pox virus has con­tin­ued to spread at a rate that has made it clear our cur­rent vac­cine sup­ply will not meet the cur­rent de­mand,” FDA com­mis­sion­er Robert Califf said in a news re­lease.

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

The down­side to in­tra­der­mal in­jec­tion? It’s more dif­fi­cult to per­form cor­rect­ly, William Schaffn­er, a pro­fes­sor in Van­der­bilt Uni­ver­si­ty’s in­fec­tious dis­eases di­vi­sion, told End­points News on Tues­day.

William Schaffn­er

As Schaffn­er put it, in­tra­der­mal in­jec­tion is “a bit of an art form.” It was most com­mon­ly used for tu­ber­cu­lo­sis skin tests; how­ev­er, he not­ed that it’s like­ly the av­er­age nurse now may have nev­er giv­en an in­tra­der­mal in­oc­u­la­tion, or on­ly had brief ex­po­sure. It’s much eas­i­er to stick a nee­dle through the skin for a sub­cu­ta­neous in­jec­tion.

“That’s easy. I can show you how to do that in five min­utes,” Schaffn­er said.

But get­ting it in­to the skin cor­rect­ly takes tech­nique. If it isn’t done prop­er­ly, vac­cine can ei­ther leak out or make its way through the skin, where it may be less ef­fec­tive giv­en the low­er dose, he said.

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

The White House Na­tion­al Mon­key­pox Out­break Re­sponse team will over­see the roll­out of this new strat­e­gy and co­or­di­nate with the CDC, FDA, HHS and lo­cal of­fi­cials, ac­cord­ing to a fact sheet put out on Tues­day. Providers cur­rent­ly have all the sup­plies they need, ac­cord­ing to the White House, and the Biden ad­min­is­tra­tion added that it’s launch­ing a “ro­bust ef­fort to train health care work­ers and providers.”

The 400,000 vials of Jyn­neos vac­cine in the na­tion­al stock­pile should ex­pand to 2 mil­lion dos­es us­ing in­tra­der­mal in­jec­tion.

In ad­di­tion, the FDA au­tho­rized the Jyn­neos vac­cine for in­di­vid­u­als un­der 18 years old who are at high-risk for mon­key­pox in­fec­tion, though ado­les­cents must re­ceive sub­cu­ta­neous in­jec­tion.

To date, HHS has made 1.1 mil­lion dos­es of the Jyn­neos vac­cine avail­able for or­der and has shipped more than 620,000 dos­es. Plus, the Ad­min­is­tra­tion for Strate­gic Pre­pared­ness and Re­sponse an­nounced that it will pro­cure an ad­di­tion­al 5.5 mil­lion vials, which trans­lates to more than 25 mil­lion dos­es via in­tra­der­mal in­jec­tion.

Last week, of­fi­cials said an ad­di­tion­al 150,000 vials will ar­rive two months ahead of sched­ule in Sep­tem­ber.

While Jyn­neos re­mains the on­ly vac­cine in the US specif­i­cal­ly ap­proved for mon­key­pox, HHS has al­so cleared states and ju­ris­dic­tions to or­der the small­pox vac­cine ACAM2000. How­ev­er, the agency pre­vi­ous­ly not­ed that ACAM2000 isn’t rec­om­mend­ed for every­one “due to sig­nif­i­cant side ef­fects.”

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

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Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

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Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

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Robert Califf, FDA commissioner (via AP Images)

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

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Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

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In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

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