Covid-19 man­u­fac­tur­ing roundup: Mod­er­na inks deal for boost­er shots with Japan; Sput­nik Light could be man­u­fac­tured in Kaza­khstan — re­port

Mod­er­na, Take­da and the Japan­ese gov­ern­ment have teamed up to dis­trib­ute 50 mil­lion dos­es of Mod­er­na’s vac­cine — in­clud­ing a boost­er shot if it’s au­tho­rized — in 2022. That dou­bles the to­tal vac­cines signed on from 2021, bring­ing the num­ber to 100 mil­lion dos­es for Japan.

Mod­er­na is re­spon­si­ble for the man­u­fac­tur­ing and sup­ply of the jab, while Take­da is re­spon­si­ble for the im­port, reg­u­la­to­ry, de­vel­op­ment and dis­tri­b­u­tion ac­tiv­i­ties.

“We thank the MHLW and Take­da for their sup­port and for part­ner­ing with us to bring our mR­NA Covid-19 vac­cine to Japan,” Mod­er­na CEO Stéphane Ban­cel said in a re­lease. “We re­main com­mit­ted to mak­ing our vac­cine avail­able around the world as we seek to ad­dress the pan­dem­ic.”

Thurs­day, Mod­er­na al­so an­nounced a new sup­ply agree­ment with Tai­wan for an­oth­er 20 mil­lion dos­es of its vac­cine and vari­ant boost­er shots. That de­liv­ery will be­gin in 2022, and the deal in­cludes an­oth­er 15 mil­lion dos­es in 2023.

Tai­wan and Mod­er­na al­ready had a deal for 5 mil­lion dos­es to be de­liv­ered in 2021.

Sput­nik Light could be man­u­fac­tured in Kaza­khstan — re­port

As Kaza­khstan lags be­hind in its vac­ci­na­tion roll­out, the coun­try is look­ing in­to the pos­si­bil­i­ty of man­u­fac­tur­ing Rus­sia’s Sput­nik Light vac­cine in-coun­try, Reuters re­port­ed Mon­day.

The coun­try has al­ready pro­duced dos­es of the Sput­nik V vac­cine, the dou­ble-jab ver­sion. It al­so has re­ceived im­ports from Rus­sia. Pres­i­dent Kassym-Jo­mart Tokayev or­dered his cab­i­net to in­ves­ti­gate the pos­si­bil­i­ties of im­port­ing and pro­duc­ing do­mes­tic jabs. Just 15.5% of its pop­u­la­tion is ful­ly vac­ci­nat­ed.

A re­view of Rus­sia’s man­u­fac­tur­ing process found is­sues with the vial fill­ing pro­ce­dures last month, the World Health Or­ga­ni­za­tion ruled. Sput­nik V and Sput­nik Light, the sin­gle-dose ver­sion, both await emer­gency use list­ing from the WHO af­ter an Oc­to­ber 2020 sub­mis­sion.

Lithua­nia, Nor­way make an even vac­cine swap

Due to the con­cerns sur­round­ing rare, but se­ri­ous blood clots, Nor­way has opt­ed out of us­ing the J&J Covid-19 vac­cine. So in or­der to keep its vac­ci­na­tion roll­out on sched­ule, it’s agreed to trade 100,000 dos­es of the shot to Lithua­nia in ex­change for the same num­ber of Pfiz­er dos­es, Reuters re­port­ed Wednes­day.

The trade comes as de­mand is high for the sin­gle-dose jab in Lithua­nia, Prime Min­is­ter Er­na Sol­berg said in a state­ment.

Nor­way’s vac­cine roll­out is go­ing well: 75.4% of its res­i­dents above the age of 18 have re­ceived a first dose. Near­ly 40% have re­ceived both dos­es.

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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