Stéphane Bancel, Getty

Mod­er­na tur­bocharges its sup­ply chain, up­ping com­mit­ment to 3B dos­es per year for a fu­ture where boost­ers are like­ly

With both As­traZeneca and J&J fac­ing ma­jor hur­dles in their glob­al Covid-19 vac­cine roll­outs, the bur­den has fall­en on Mod­er­na and Pfiz­er/BioN­Tech to step up their games in terms of pro­duc­tion. Now, look­ing at a fu­ture in which boost­ers and vari­ant vac­cines will like­ly be need­ed, Mod­er­na is adding ar­mor to its sup­ply chain.

Mod­er­na is now plan­ning to pro­duce up to 3 bil­lion dos­es in 2022, dou­bling ca­pac­i­ty at con­tract sites in Switzer­land and Spain run by Lon­za and Rovi, re­spec­tive­ly, and in­creas­ing drug sub­stance man­u­fac­tur­ing by 50% at its US fa­cil­i­ties. The ex­pan­sions will al­so al­low Mod­er­na to now pro­duce be­tween 800 mil­lion and 1 bil­lion dos­es in 2021, the com­pa­ny said.

The ac­tu­al num­ber of dos­es will de­pend on the man­u­fac­tur­ing split be­tween 100-mi­cro­gram vac­cine dos­es and po­ten­tial­ly low­er-dose boost­ers and pe­di­atric vac­cines, the com­pa­ny said. The fi­nan­cial terms of the ex­pan­sion weren’t dis­closed, but Mod­er­na said it is fund­ing the move out of pock­et.

“We said ‘what can we do for the world?’ and we ba­si­cal­ly went back to our board and said ‘we need to do mas­sive in­vest­ment,'” Ban­cel told End­points News. “We need to aim to in­crease our ca­pac­i­ty for next year so that we can make sure we can vac­ci­nate and boost every­body.”

While com­peti­tors Pfiz­er, As­traZeneca, Sanofi and J&J have all reached agree­ments with Co­v­ax, the glob­al ini­tia­tive aimed at eq­ui­table ac­cess to COVID-19, Mod­er­na has not. Ban­cel would not dis­cuss the terms of a po­ten­tial deal with the coali­tion Wednes­day, on­ly say­ing that his com­pa­ny is “very ac­tive” in the fi­nal dis­cus­sions.

De­spite the pa­per agree­ments with oth­er com­pa­nies, Co­v­ax has fall­en well short of its goals,  dis­trib­ut­ing just over 40 mil­lion dos­es to date.

On top of fin­ished dos­es, Mod­er­na will al­so stock­pile a “safe­ty stock”  of raw ma­te­ri­als and fin­ished drug sub­stance used in the vac­cine as a means of avoid­ing raw sup­ply short­ages. That’s been a run­ning is­sue for Mod­er­na, re­cent­ly lead­ing it cut the num­ber of dos­es it planned to send to Cana­da by April in half. It’s al­so trou­bled oth­er vac­cine mak­ers, in­clud­ing No­vavax and In­dia’s Serum In­sti­tute.

To­day, the team at Mod­er­na is set to get CEOs of the com­pa­nies that sup­ply raw ma­te­ri­als on the phone, and lay out just what their ex­pec­ta­tions are for the next year, Ban­cel said. The cur­rent short­ages could not have been pre­dict­ed, but if this boost in man­u­fac­tur­ing is to be suc­cess­ful, Ban­cel said it is vi­tal to pre­vent the next one.

“We’re still tight on raw ma­te­ri­als, be­cause a lot of peo­ple around the world are us­ing them,” Ban­cel said.

Aid­ing its am­bi­tious dis­tri­b­u­tion plan is new da­ta un­veiled to­day show­ing the vac­cine can be vi­able with a three-month re­frig­er­at­ed shelf life. That could be a big deal since Mod­er­na’s shot is on­ly ap­proved for re­frig­er­a­tion of up to one month and sev­en months in a stan­dard freez­er. The ex­tend­ed shelf life could be cru­cial for de­liv­er­ing and ad­min­is­ter­ing the vac­cine suc­cess­ful­ly to small­er lo­ca­tions with­in coun­tries in which re­frig­er­a­tion is sparse and freez­ers are a rar­i­ty.

As it looks to ex­pand its part­ner­ship with two of its pri­ma­ry con­tract man­u­fac­tur­ers, Mod­er­na has al­so added some pro­duc­tion heft in re­cent months. French drug­mak­er Sanofi en­tered an agree­ment ear­li­er this week with Mod­er­na to help man­u­fac­ture 200 mil­lion dos­es of the com­pa­ny’s Covid-19 vac­cine at its Ridge­field, NJ site. That will be­gin in Sep­tem­ber.

New Jer­sey CD­MO Catal­ent an­nounced on April 6 that it was up­ping pro­duc­tion ca­pac­i­ty of the vac­cine in its Bloom­ing­ton, IN bi­o­log­ics fa­cil­i­ty through its new high-speed vial fill­ing line. Those dos­es are ex­pect­ed to be ready in May.

“We said look, we have a cer­tain re­spon­si­bil­i­ty as a com­pa­ny and we will in­vest ag­gres­sive­ly … so that next year we can have a big im­pact,” Ban­cel said. “If you think about it, look at the pop­u­la­tion of the plan­et, you see that 70% of peo­ple want the vac­cine, which is what we’re see­ing in polls across the world, and if we can make 3 bil­lion vac­cines, that will be, for a com­pa­ny that just launched its first prod­uct a few months ago, ex­tra­or­di­nary.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

One work­er at a Lat­vian man­u­fac­tur­er is dead af­ter a fire breaks out at fa­cil­i­ty

A press release referred to it as simply, “the incident.” But a fire at an Olainfarm site in Latvia last week has left one person dead, and injured another, the company announced Monday.

Just before midnight Nov. 26, a fire broke out in the production building of JSC Olainfarm,  as the result of an “accident,” a company spokesperson said in an email to Endpoints News. The two victims were both company employees, and the causes of the accident are still being determined.

Fu­ji­film Diosynth dumps an­oth­er $454M in­to its sup­ply chain, this time at a fa­cil­i­ty in the UK

Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the “beating heart” of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

As first Omi­cron case in US crops up, re­searchers won­der: Which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

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