Mod­er­na bags an­oth­er US CD­MO to help with fill-fin­ish work for its vac­cine amid boost­er push

Mod­er­na has en­list­ed an­oth­er CD­MO to ramp up Covid-19 vac­cine man­u­fac­tur­ing ca­pa­bil­i­ty in its ef­fort to pro­vide 3 bil­lion dos­es in 2022.

Juan An­dres

Start­ing in Q3, Ther­mo Fish­er Sci­en­tif­ic will car­ry out fill-fin­ish, la­bel­ing and pack­ag­ing ser­vices to sup­port Mod­er­na at the CD­MO’s Greenville, NC site, the com­pa­ny said in a re­lease.

“Ther­mo Fish­er has been a crit­i­cal part­ner in sup­ply­ing raw ma­te­ri­als for our COVID-19 vac­cine and we are now pleased to fur­ther ex­pand our re­la­tion­ship as an im­por­tant man­u­fac­tur­ing part­ner as well,” said Juan An­dres, Mod­er­na’s chief tech­ni­cal op­er­a­tions and qual­i­ty of­fi­cer, in a state­ment. “The ad­di­tion of Ther­mo Fish­er to our net­work will sup­port our ef­forts to scale up our man­u­fac­tur­ing abil­i­ty.”

Mod­er­na has al­so reached an agree­ment with Lon­za to es­tab­lish a new pro­duc­tion line at the com­pa­ny’s Geleen, Nether­lands site, which will add an ad­di­tion­al 300 mil­lion dos­es per year in ca­pac­i­ty.

The pro­duc­tion in Geleen will help Mod­er­na halve the dosage of its vac­cine for pe­di­atric use and as boost­ers against vari­ants. Mod­er­na has stud­ied low­er-dose ver­sions of its jab to help stretch out the sup­ply. So far, dos­es have con­sist­ed of 100 mi­cro­grams, but Mod­er­na has al­so teamed with ROVI in Grana­da, Spain, to sup­ply 600 mil­lion 50 mi­cro­gram dos­es per year. Both of those pacts will be op­er­a­tional be­fore the end of 2021, the com­pa­ny said in the re­lease.

ROVI and France’s Re­ci­pharm have al­ready been per­form­ing fill-fin­ish ser­vices for Mod­er­na’s vac­cine in Eu­rope. These moves are the lat­est an­nounce­ments in a rapid ramp-up in pro­duc­tion.

Last week, Mod­er­na and Sam­sung Bi­o­log­ics inked a deal for fill-fin­ish du­ties at its In­cheon, South Ko­rea plant. Mod­er­na’s al­so pledged to dou­ble its Mass­a­chu­setts lab space for a 50% in­crease in man­u­fac­tur­ing, dou­ble man­u­fac­tur­ing at Lon­za’s Visp, Switzer­land site and Rovi’s Spain fa­cil­i­ty. In April, Sanofi signed on with Mod­er­na to pro­duce its vac­cine. That marked the third com­pa­ny Sanofi part­nered with to pro­duce the Covid-19 shot af­ter its own at­tempts failed. The French drug­mak­er is al­so pro­duc­ing Pfiz­er-BioN­Tech and J&J’s jab at its man­u­fac­tur­ing sites, in­clud­ing the one in Ridge­field, NJ.

Catal­ent — a Mod­er­na part­ner — and Ster­ling are work­ing to­geth­er to pro­vide more ul­tra-low tem­per­a­ture freez­ers for the CD­MO to pre­serve high­ly tem­per­a­ture-sen­si­tive ma­te­r­i­al used in vac­cines.

Mean­while, Mod­er­na’s pledged 50o mil­lion dos­es to CO­V­AX ear­ly last month. Those dos­es will be sold at the low­est tiered price, and go to 92 of the low­est in­come coun­tries by the end of next year. Ac­cord­ing to the agree­ment, 34 mil­lion of those dos­es are set to be de­liv­ered in Q4. Gavi, the vac­cine al­liance has al­ready shipped 49 mil­lion Covid-19 vac­cines do­nat­ed from Pfiz­er, As­traZeneca and the Serum In­sti­tute of In­dia.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

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By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Ex­e­lead inks deal to man­u­fac­ture lipid nanopar­ti­cles for Pfiz­er/BioN­Tech vac­cine

For the two leading Covid-19 vaccines, mRNA is the star of the show — and the microscopic lipids used to transport that therapy into cells have taken a much less visible backseat. But that doesn’t mean that delivery tech isn’t in high demand, and now another CDMO is chipping in to help Pfizer/BioNTech’s shot along.

Indianapolis-based Exelead will add 50 positions to handle the increased workload tied to the Pfizer/BioNTech deal, which was spun from another project the two companies discussed in 2020, before the Covid-19 vaccines were widely available, the partners said.

No­var­tis cuts jobs at Swiss plant as a UK fa­cil­i­ty sits in a hold­ing pat­tern with 200 po­si­tions on the line — re­ports

Swiss drugmaker Novartis launched an ambitious workforce restructuring plan back in 2018 with plans to cut more than 2,000 jobs across the supply chain. Now the aftershocks of that decision are still being felt with one of the company’s facilities in its native country set to close.

Novartis will close its facility in Locarno, Switzerland, with around 50 positions set to be terminated, according to Reuters.

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Ju­bi­lant Hol­lis­ter­Sti­er plots out ex­pan­sion at WA ster­ile in­jecta­bles plant amid work on Covid-19 vac­cines

The dire need for manufacturing capacity and a pledge of a rapid ramp up of vaccines and treatments to battle Covid-19 have left companies scrambling to expand internally, and CDMOs are bringing home serious revenue as a result. That’s meant a bowl of cash to work with, and now a Washington CDMO is splashing out a new expansion.

Jubilant HollisterStier is expanding its sterile injectable manufacturing capacity at its Spokane, WA site to keep up with demand surrounding the Covid-19 vaccine push, the company said this week.