Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

EU mis­tak­en­ly leaves key parts of As­traZeneca Covid-19 con­tract unredact­ed, re­veal­ing costs and So­ri­ot's 'best-ef­fort' claim

Ten­sions be­tween As­traZeneca and the EU re­gard­ing slowed vac­cine roll­out boiled over last week, when the bloc pub­lished a heav­i­ly redact­ed ver­sion of the com­pa­ny’s con­tract fol­low­ing crit­i­cism of its “best-ef­fort” pledges. But ea­gle-eyed in­ter­net sleuths and Ger­man jour­nal­ists found the blacked-out sec­tions could be eas­i­ly re­moved, prompt­ing the EU to pub­licly apol­o­gize.

Among the most note­wor­thy find­ings was that the con­tract it­self is worth £870 mil­lion, or about $1.19 bil­lion for the 300 mil­lion dos­es, in­clud­ing all di­rect and in­di­rect costs. There was al­so a par­tial­ly cut-off sec­tion that de­tailed how even though As­traZeneca is ob­lig­at­ed to sup­ply its dos­es at no prof­it, the com­pa­ny “shall not be re­quest­ed or re­quired to sup­ply the Vac­cine Dose…”

Ger­man mag­a­zine Der Spiegel was the first pub­li­ca­tion to pub­lish the rev­e­la­tions. The au­then­tic­i­ty of the redact­ed por­tions has been con­firmed by End­points News, though any­thing writ­ten af­ter “Dose” could not be re­cov­ered.

The con­tract al­so pro­vid­ed roadmaps for in­stances of es­ti­mat­ed costs ex­ceed­ing the £870 mil­lion fig­ure. There are two plans in place, should the ex­ceed­ed costs be ei­ther high­er or low­er than 20%, but the redac­tions block­ing out the plans them­selves could not be re­moved.

Ad­di­tion­al­ly, the doc­u­ment con­tained a pro­vi­sion for pro­vid­ing ad­di­tion­al dos­es at cost through Ju­ly 1, at which point As­traZeneca could de­ter­mine “in good faith” whether or not the pan­dem­ic was still go­ing on. That backs up re­port­ing from the Fi­nan­cial Times last Oc­to­ber say­ing the com­pa­ny can de­clare the pan­dem­ic over by that time and start mak­ing a prof­it on vac­cines de­liv­ered af­ter that date.

The redac­tion block­ing the pro­vi­sion it­self, how­ev­er, al­so could not be re­moved.

A Eu­ro­pean Com­mis­sion spokesman apol­o­gized to As­traZeneca at a press con­fer­ence Tues­day, say­ing “it was cer­tain­ly not our in­ten­tion for this to hap­pen,” per an EU­Ob­serv­er re­port. He added, “In or­der for those con­tracts to be con­clud­ed with the phar­ma­ceu­ti­cal com­pa­nies, it was agreed that cer­tain con­tracts would re­main con­fi­den­tial.”

The news comes af­ter a rau­cous week of back-and-forth be­tween one of the biggest drug­mak­ers in the world and the Eu­ro­pean gov­ern­men­tal body. As­traZeneca no­ti­fied the bloc late last month that it would de­liv­er more than 60% few­er dos­es than orig­i­nal­ly promised, blam­ing pro­duc­tion prob­lems at a Bel­gian fac­to­ry. That trig­gered fiery back­lash from the EU, which was al­ready deal­ing with de­lays of the Pfiz­er/BioN­Tech vac­cine and lags in vac­ci­na­tion.

Some crit­ics ac­cused As­traZeneca of sell­ing vac­cines in­tend­ed for Eu­rope to oth­er coun­tries at a high­er price. But CEO Pas­cal So­ri­ot main­tained the con­tract was based on a best-ef­fort de­liv­ery clause, a clause that has os­ten­si­bly been con­firmed by the re­moved redac­tions. That could ul­ti­mate­ly shield the com­pa­ny from le­gal ac­tion, as a hand­ful of mem­ber states like Italy and Poland have con­sid­ered su­ing Pfiz­er over sim­i­lar slow­downs.

The par­ties al­so en­gaged in a high­ly pub­lic tit-for-tat over whether or not a meet­ing be­tween the two would oc­cur. The EU had ac­cused As­traZeneca of pulling out of a meet­ing last Wednes­day, but it ul­ti­mate­ly went on as planned de­spite not re­solv­ing much.

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

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Robert Califf (AP Photo/Manuel Balce Ceneta)

FDA au­tho­rizes boost­er dose of Pfiz­er and BioN­Tech's Covid-19 vac­cine in 5- to 11-year-olds

The latest wave of the pandemic — marked by Omicron and its sub-variants — has seen higher hospitalization rates for young children, health agencies have observed. That’s part of the reason why the FDA is authorizing a booster shot for kids between 5 and 11 years old.

Regulators on Tuesday OK’d a single booster dose of Pfizer and BioNTech’s mRNA vaccine for children who received their primary series with the same vaccine at least five months ago. By Pfizer’s count, that makes more than 8 million 5- to 11-year-olds eligible for another dose.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.