Covid-19 roundup: Mod­er­na of­fers vac­cine to work­ers, con­trac­tors and board mem­bers; Claim­ing 79% vac­cine ef­fi­ca­cy, Sinopharm shoots for full Chi­na OK

Mod­er­na is mov­ing its peo­ple — work­ers, con­trac­tors as well as board mem­bers — to the front of the vac­cine line in the US, of­fer­ing them a chance to get their two shots un­der emer­gency use au­tho­riza­tion.

The move will pro­vide an ad­di­tion­al lay­er of Covid-19 pro­tec­tion, the Cam­bridge, MA-based biotech said, as its staff is con­duct­ing es­sen­tial ser­vices in de­vel­op­ing, man­u­fac­tur­ing and de­liv­er­ing a vac­cine that pro­tects against the dis­ease caused by coro­n­avirus.

Health au­thor­i­ties have been in­formed, ac­cord­ing to the com­pa­ny, and it will shoul­der all costs. It added:

The pro­gram will ex­tend to adult house­hold mem­bers of our team to re­duce the risk of ab­sen­teeism and dis­rup­tion due to a COVID-19 in­fec­tion in an adult house­hold mem­ber. Par­tic­i­pa­tion in the pro­gram is con­fi­den­tial and en­tire­ly vol­un­tary.

Per Mod­er­na’s most re­cent an­nu­al re­port, it has around 830 full-time em­ploy­ees, al­though the num­ber has al­most cer­tain­ly gone up as it ex­pand­ed its man­u­fac­tur­ing op­er­a­tions. The board has eight di­rec­tors, led by chair­man Noubar Afeyan. It’s un­clear how many con­trac­tors will be of­fered the vac­cine.

Un­der Op­er­a­tion Warp Speed, the US has pre-or­dered 200 mil­lion dos­es of the Mod­er­na vac­cine for the gen­er­al pub­lic, enough to vac­ci­nate 100 mil­lion peo­ple — with the el­der­ly, health­care and oth­er es­sen­tial work­ers tak­ing pri­or­i­ty. — Am­ber Tong

In a first for Chi­nese de­vel­op­ers, Sinopharm says vac­cine is 79.34% ef­fec­tive

It’s been ad­min­is­tered to hun­dreds of thou­sands of peo­ple, and we fi­nal­ly have a num­ber on how ef­fec­tive it is: Sinopharm says one of its in­ac­ti­vat­ed vac­cines showed 79.34% ef­fi­ca­cy in an in­ter­im analy­sis across Phase III tri­als.

In a brief state­ment, Sinopharm said that the shot — de­vel­oped by its sub­sidiary Bei­jing Bi­o­log­i­cal Prod­ucts In­sti­tute — didn’t break out the num­ber of cas­es ac­crued in its tri­al or de­tail how many cas­es were in the vac­cine arm ver­sus place­bo. What it did say was that the re­sults reached the stan­dards of the WHO and guid­ance is­sued by Chi­na’s drug reg­u­la­tors, and that it’s of­fi­cial­ly filed for mar­ket­ing ap­proval.

It al­so dis­closed that the vac­cine in­duced a se­ro­con­ver­sion rate of 99.52%.

The state­ment marked the first pub­lic dis­clo­sure by any Chi­nese de­vel­op­er of late-stage da­ta of their vac­cines, where spo­radic re­leas­es by coun­tries and in­sti­tu­tions have led to con­fu­sion. The Unit­ed Arab Emi­rates, for in­stance, had found that the Bei­jing Bi­o­log­i­cal Prod­ucts In­sti­tute vac­cine is 86% based on an in­ter­im analy­sis on its own da­ta ear­li­er this month.

Tak­en at face val­ue, the 79.34% num­ber puts Sinopharm just be­tween vac­cines de­vel­oped by As­traZeneca/Ox­ford and the fron­trun­ners at Pfiz­er/BioN­Tech and Mod­er­na, which had pub­lished da­ta sug­gest­ing 62%, 95% and 94% ef­fi­ca­cy, re­spec­tive­ly, for the ap­proved reg­i­mens. But the im­por­tance of any da­ta de­pends al­so on the study de­sign, vol­un­teer de­mo­graph­ic, num­ber of cas­es, cri­te­ria for defin­ing cas­es and many oth­er fac­tors.

Along with a cou­ple oth­ers, the vac­cine has al­ready been cleared for emer­gency use in state-owned en­ter­prise em­ploy­ees and stu­dents trav­el­ing over­seas as well as med­ical and avi­a­tion work­ers, among oth­ers. — Am­ber Tong

Chi­na’s Fo­s­un to man­u­fac­ture 200M dos­es of BioN­Tech vac­cine

A Chi­na-based man­u­fac­tur­er has inked a deal to pro­duce 200 mil­lion dos­es of the Pfiz­er-BioN­Tech Covid-19 vac­cine.

Oth­er de­tails were scarce, but the Shang­hai Fo­s­un Phar­ma­ceu­ti­cal Group will es­tab­lish a joint ven­ture with Ger­many’s BioN­Tech as the world rush­es to get vac­cines in­to arms and quell the spread of the pan­dem­ic.

First re­port­ed by Caix­in, the fi­nan­cial mag­a­zine, Fo­s­un de­clined to com­ment on the re­port or the terms of the deal, and it’s un­clear how long it will take to pro­duce the 200 mil­lion dos­es.

The joint ven­ture is a fur­ther ex­pan­sion of the Covid-19 part­ner­ship be­tween Fo­s­un and BioN­Tech, which be­gan back in March. Pri­or to Wednes­day’s deal, the two groups had so far on­ly agreed on the dis­tri­b­u­tion and com­mer­cial­iza­tion of vac­cines man­u­fac­tured in Eu­rope.

Fo­s­un has said pre­vi­ous­ly it would buy at least 100 mil­lion dos­es of the vac­cine for use in main­land Chi­na in 2021 if it gains reg­u­la­to­ry ap­proval in the coun­try. — Con­ner Mitchell

Arc­turus launch­es Phase II vac­cine tri­al, but an­a­lysts are skep­ti­cal

As Arc­turus Ther­a­peu­tics charges full speed in­to a Phase II tri­al for its sin­gle-dose Covid-19 vac­cine in Sin­ga­pore, some an­a­lysts say weak Phase I/II da­ta point to an un­cer­tain path ahead.

US-based Arc­turus got cleared on Mon­day by the Sin­ga­pore Health Sci­ences Au­thor­i­ty to launch a Phase II tri­al of its can­di­date, ARCT-021, de­vel­oped with Duke-NUS Med­ical School in Sin­ga­pore. The tri­al will en­roll up to 600 par­tic­i­pants, and de­ter­mine an op­ti­mal reg­i­men to head in­to Phase III, ac­cord­ing to the com­pa­ny. The Phase II will eval­u­ate both sin­gle and “prime-boost” dos­ing reg­i­mens.

Baird an­a­lysts, though, called the Phase I/II re­sults “lack­lus­ter,” and wrote in a note to in­vestors that they are “skep­ti­cal of the path for this mR­NA vac­cine in COVID-19.”

Arc­turus’ stock $ARCT was down 54.04% on Tues­day morn­ing, at $42.48 per share.

The rea­son for their con­cern is that ARCT-021 achieved “mod­est” neu­tral­iz­ing an­ti­body in­duc­tion across dos­es and ages, com­ing in at the low­er end of the range of healthy con­va­les­cent sera. Pfiz­er/BioN­Tech’s jab, for ex­am­ple, achieved two- to four-fold nAb in­duc­tion above healthy con­va­les­cent sera. Ac­cord­ing to Arc­turus, nAb titers in con­va­les­cent sera ranged from 12 to 1818 in the Phase I/II study.

“We see lit­tle mech­a­nis­tic ba­sis by which a mR­NA vac­cine that achieves less­er nAb in­duc­tion than peers would some­how show com­pa­ra­ble pro­tec­tion from COVID-19 dri­ven en­tire­ly by T-cell in­duc­tion, giv­en how much nAb and T-cell in­duc­tion should be dri­ven by sim­i­lar means of mR­NA trans­la­tion/anti­gen pre­sen­ta­tion with­in trans­duced cells,” Baird’s Mad­hu Ku­mar and Robert Paler­mo wrote.

Arc­turus called the Phase I/II re­sults fa­vor­able, and said it’s plan­ning a glob­al Phase III launch in Q2 2021.

Eng Eong Ooi

“The Phase 1/2 study re­sults, to­geth­er with re­cent­ly gen­er­at­ed pre­clin­i­cal da­ta, in­di­cate that ARCT-021 leads to a po­tent im­mune re­sponse to SARS-CoV-2, and demon­strates a dif­fer­en­ti­at­ed bi­o­log­i­cal pro­file where­by the im­mune re­sponse in­creas­es in the weeks fol­low­ing vac­ci­na­tion,” Eng Eong Ooi, a Duke-NUS pro­fes­sor and mem­ber of Arc­turus’ Vac­cine Plat­form Sci­en­tif­ic Ad­vi­so­ry Board, said in a state­ment.

Arc­turus’ vac­cine push is be­ing led by Joseph Payne, who was oust­ed from the com­pa­ny over two years ago by what he called a “dys­func­tion­al board.” Last month, he bagged a $45 mil­lion lim­it­ed re­course loan from Sin­ga­pore’s Eco­nom­ic De­vel­op­ment Board, and inked an agree­ment with the coun­try for up to $175 mil­lion in dose pur­chas­es. If the can­di­date is ap­proved, Arc­turus will re­pay Sin­ga­pore’s EDB through sales roy­al­ties. If it isn’t ap­proved, the board is will­ing to for­give the loan. — Nicole De­Feud­is

Ger­many hits snags in Pfiz­er/BioN­Tech vac­cine dis­tru­bu­tion

In the rush to get jabs in arms, Ger­many is ex­pe­ri­enc­ing some dis­tri­b­u­tion pains.

Ac­cord­ing to a Reuters re­port, some Bavar­i­an dis­tricts are send­ing back 1,000 dos­es of Pfiz­er and BioN­Tech’s vac­cine can­di­date fol­low­ing doubts they were prop­er­ly re­frig­er­at­ed. A spokesman for the Licht­en­fels dis­trict said the dos­es may have be­come too warm in their de­liv­ery cool box­es, per Reuters.

Pfiz­er/BioN­Tech’s mR­NA can­di­date must be kept at about -70 de­grees Cel­sius tem­per­a­tures — cold­er than Antarc­ti­ca — to re­main sta­ble. They’re be­ing shipped in spe­cial­ized box­es with dry ice, and must be kept at 2 to 8 de­grees Cel­sius af­ter they’re tak­en out of freez­er stor­age to re­main vi­able for up to five days.

Up­on ar­rival in Licten­fels and oth­er north­ern Bavar­i­an dis­tricts, tem­per­a­ture log­gers showed some in­ter­im tem­per­a­tures of up to 15 de­grees Cel­sius, Reuters re­port­ed.

“BioN­Tech com­ment­ed and said that the vac­cine was prob­a­bly okay, but prob­a­bly okay is not enough,” Licht­en­fels Dis­trict Ad­min­is­tra­tor Chris­t­ian Meiss­ner told Reuters TV.

Au­thor­i­ties have ex­pressed con­cern over Pfiz­er/BioN­Tech’s cold chain re­quire­ments, and some coun­tries have said they can’t af­ford the in­fra­struc­ture that would be nec­es­sary to dis­trib­ute the vac­cine. Mod­er­na an­nounced last month that their vac­cine can be stored at 36 de­grees to 46 de­grees Fahren­heit for up to 30 days, and should be sta­ble for 12 hours at room tem­per­a­ture.

Mean­while, in the Vor­pom­mern-Rü­gen dis­trict, 8 work­ers in an el­der­ly care home mis­tak­en­ly re­ceived five times the rec­om­mend­ed dose of Pfiz­er’s vac­cine, four of whom have since been hos­pi­tal­ized for flu-like symp­toms, ac­cord­ing to Reuters.

Pfiz­er and BioN­Tech inked a deal to dou­ble the US’ dose or­der last week, promis­ing a full 200 mil­lion dos­es to Op­er­a­tion Warp Speed by Ju­ly 31, 2021. — Nicole De­Feud­is

Brazil VP Hamil­ton Mourao takes un­proven Covid-19 treat­ment hy­drox­y­chloro­quine

Months af­ter the FDA yanked its emer­gency use au­tho­riza­tion for Pres­i­dent Don­ald Trump’s so-called “mir­a­cle” Covid-19 treat­ment hy­drox­y­chloro­quine, Brazil­ian Vice Pres­i­dent Hamil­ton Mourao is re­port­ed­ly tak­ing the un­proven drug.

Ac­cord­ing to Reuters, Mourao is in “good” con­di­tion and is self-iso­lat­ing at home af­ter test­ing pos­i­tive on Sun­day.

The FDA is­sued an EUA for hy­drox­y­chloro­quine in March, which be­came part of rou­tine care for Covid-19 pa­tients at hos­pi­tals na­tion­wide. But by June, the NIH had stopped a larg­er study be­cause in­ter­im re­sults showed the drug didn’t im­prove pa­tient out­comes. The FDA re­voked its EUA, cit­ing a lack of both ben­e­fits and risks.

“We hope this clear re­sult will help prac­ti­tion­ers make in­formed treat­ment de­ci­sions and re­searchers con­tin­ue their ef­forts pur­su­ing oth­er pos­si­ble safe and ef­fec­tive treat­ments for pa­tients suf­fer­ing with this dis­ease,” James Ki­ley of the NIH’s Na­tion­al Heart, Lung, and Blood In­sti­tute said in a state­ment at the time.

Brazil has the third-high­est amount of Covid-19 cas­es in the world, be­hind on­ly the US and In­dia, at 7.48 mil­lion cu­mu­la­tive cas­es. In the last 24 hours, the coun­try has re­port­ed 18,479 new cas­es. — Nicole De­Feud­is

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

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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