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.

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.