Covid-19 roundup: New study sug­gests Mod­er­na vac­cine may be more ef­fec­tive than Pfiz­er against the Delta vari­ant; Pen­ta­gon to re­quire vac­cines for mem­bers of the mil­i­tary 

A study of pa­tients in the Mayo Clin­ic Health Sys­tem across mul­ti­ple states sug­gests those who re­ceived Pfiz­er’s Covid-19 vac­cine are at a two-fold high­er risk of break­through in­fec­tion com­pared to those who got the Mod­er­na vac­cine.

It’s im­por­tant to note that the study, pub­lished Sun­day in the preprint serv­er medRx­iv, has not been peer-re­viewed.

The study be­gan in Min­neso­ta, where re­searchers have been an­a­lyz­ing the ef­fi­ca­cy of the vac­cines on a month­ly ba­sis since Feb­ru­ary 2021. As cas­es in­creased in Ju­ly and the Delta vari­ant be­came more promi­nent, the sci­en­tists mea­sured a 76% ef­fi­ca­cy against in­fec­tion for the Mod­er­na vac­cine, and a 42% ef­fi­ca­cy against in­fec­tion for Pfiz­er’s. Those rates are much low­er than the fig­ures seen through April 2021 (93.3% for Mod­er­na and 86.1% for Pfiz­er).

The abil­i­ty of the vac­cines to pre­vent hos­pi­tal­iza­tion has re­mained “more con­sis­tent­ly high,” ac­cord­ing to the re­searchers. Both had sim­i­lar rates of ICU ad­mis­sion and com­pli­ca­tions.

To val­i­date the find­ings, the sci­en­tists com­pared break­through in­fec­tion rates in oth­er states in the Mayo Clin­ic Health Sys­tem, in­clud­ing Wis­con­sin, Ari­zona, Flori­da and Iowa. In most states, those who re­ceived the Mod­er­na vac­cine were less like­ly to ex­pe­ri­ence a break­through in­fec­tion, ac­cord­ing to the study.

“Con­sid­er­ing all states to­geth­er, mR­NA-1273 con­ferred a two-fold risk re­duc­tion against break­through in­fec­tion com­pared to BNT162b2,” re­searchers said.

They added:

mR­NA-1273 and BNT162b2 were orig­i­nal­ly de­signed, test­ed, and proven to re­duce the bur­den of symp­to­matic dis­ease, hos­pi­tal­iza­tion, and death re­lat­ed to SARS-CoV-2 in­fec­tion. This study fur­ther sup­ports the ef­fec­tive­ness of both vac­cines in do­ing so, even de­spite the evo­lu­tion of more trans­mis­si­ble vi­ral vari­ants.

Pfiz­er said last month that it’s like­ly a third dose may be need­ed with­in six to 12 months af­ter full vac­ci­na­tion. While pro­tec­tion against se­vere dis­ease re­mains high, a de­cline in ef­fi­ca­cy against symp­to­matic dis­ease and the emer­gence of new vari­ants are ex­pect­ed, the com­pa­ny said in a state­ment.

Pen­ta­gon looks to re­quire vac­cines for mem­bers of the mil­i­tary 

The Pen­ta­gon has said it will look to make the Covid-19 vac­cine manda­to­ry for mil­i­tary mem­bers next month.

De­fense Sec­re­tary Lloyd Austin will re­quest that Pres­i­dent Biden make the vac­cine a re­quire­ment in Sep­tem­ber, by which time the shots could have full reg­u­la­to­ry ap­proval, Pen­ta­gon press sec­re­tary John Kir­by said Mon­day.

“I strong­ly sup­port Sec­re­tary Austin’s mes­sage to the Force to­day on the De­part­ment of De­fense’s plan to add the COVID-19 vac­cine to the list of re­quired vac­ci­na­tions for our ser­vice mem­bers not lat­er than mid-Sep­tem­ber,” Biden re­spond­ed.

So far, more than 73% of ac­tive du­ty per­son­nel have re­ceived at least one shot, ac­cord­ing to Kir­by.

“You can con­sid­er this memo, not just a warn­ing or­der to the ser­vices, but to the troops them­selves,” he said.

The news comes as large com­pa­nies — in­clud­ing Wal­mart, Dis­ney, Unit­ed Air­lines and Pfiz­er — move to re­quire the vac­cines for some em­ploy­ees. The De­part­ment of Jus­tice has ruled that such man­dates are le­gal, even for Covid-19 vac­cines that have not yet been ful­ly ap­proved, and re­main sub­ject to emer­gency use au­tho­riza­tions.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

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Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

Amgen VP of R&D David Reese

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A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

Stéphane Bancel, Moderna CEO (Nancy Lane/The Boston Herald via AP Images, Pool)

At­tempt­ing to ride boost­er ad­comm coat­tails, Mod­er­na says its Covid-19 shot is bet­ter than Pfiz­er/BioN­Tech

As the FDA prepares to convene an adcomm to discuss Pfizer/BioNTech’s Covid-19 vaccine boosters later this week, the other major mRNA player is sticking its thumb out and trying to hitch a ride on the corporate media blitz.

Moderna put out a press release Wednesday afternoon pointing to two recently unveiled studies that, the biotech asserts, solidify the need for Covid-19 boosters, leaping into the ongoing debate for the shots. The release comes merely hours after briefing documents for the Pfizer/BioNTech adcomm went public, with Moderna putting forth an argument for why its vaccines are better suited to combat the Delta variant than Pfizer and BioNTech’s jab.