The EMA has rec­om­mend­ed that the EU au­tho­rizes As­traZeneca and Ox­ford’s Covid-19 vac­cine, even as they’re in deep dis­pute over its de­liv­ery.

The agency said reg­u­la­tors based their as­sess­ment on com­bined re­sults from four clin­i­cal tri­als in the UK, Brazil and South Africa, in­volv­ing 24,000 peo­ple in to­tal, that sug­gest the vac­cine had a 60% ef­fi­ca­cy.

Ear­li­er in the day the EU made pub­lic their (heav­i­ly redact­ed) sup­ply con­tract, which of­fi­cials de­scribe as a bid to fos­ter trans­paren­cy and ac­count­abil­i­ty in the vac­cine roll­out. It comes af­ter Eu­ro­pean Com­mis­sion pres­i­dent Ur­su­la von der Leyen di­aled up the pres­sure on As­traZeneca, as­sert­ing that its de­ci­sion to re­duce sup­plies to the EU a breach of “bind­ing or­ders” in the con­tract.

Key part of the con­tract on what the EU and #As­traZeneca are at odds over – the ‘Best Rea­son­able Ef­forts’ clause.

AZ says it’s not bind­ing on the num­bers of the vac­cines, in­stead it’s based on best ef­forts.

EU says it is bind­ing pic.twit­ter.com/pcaebp­sczB

— Gavin Lee (@Gavin­LeeB­BC) Jan­u­ary 29, 2021

As­traZeneca no­ti­fied the bloc last week that it will be de­liv­er­ing far few­er dos­es to mem­ber coun­tries than it had promised to, blam­ing pro­duc­tion prob­lems at a Bel­gian fac­to­ry.

The cuts, which amount­ed to a 60% re­duc­tion from 80 mil­lion to 31 mil­lion de­liv­ered dos­es by March, trig­gered fiery back­lash from the EU, which was al­ready deal­ing with de­lays of the Pfiz­er/BioN­Tech vac­cine and lags in vac­ci­na­tion. Skep­ti­cal of As­traZeneca’s ex­pla­na­tion, of­fi­cials had sus­pect­ed that As­traZeneca sold vac­cines in­tend­ed for Eu­rope to oth­er coun­tries at a high­er price.

The EU has al­so de­mand­ed that the phar­ma gi­ant send dos­es pro­duced in the UK to make up for the short­age — some­thing the British gov­ern­ment has pub­licly op­posed.

“We want to pub­lish it to­day,” von der Leyen told Eu­ronews af­ter the EU post­ed the con­tract. “This is busi­ness sen­si­tive da­ta, that’s clear. But ba­si­cal­ly: we want to cre­ate trans­paren­cy on these is­sues that I have just touched on. We know ex­act­ly what is in the con­tract, which is why it is im­por­tant to us that it is now made pub­lic.”

Un­der a con­tract signed in Au­gust, the EU has agreed to pur­chase 300 mil­lion dos­es of the ade­n­ovirus-based vac­cine, which was co-de­vel­oped by As­traZeneca and Ox­ford. They al­so se­cured rights to or­der 100 mil­lion more dos­es.

No­var­tis jumps in to man­u­fac­ture Pfiz­er/BioN­Tech vac­cine

Af­ter its own shots at de­vel­op­ing a Covid-19 treat­ment came up short, No­var­tis is ready to lend a hand to the more suc­cess­ful pro­grams.

Its first move is to fill vac­cine vials with bulk mR­NA ac­tive in­gre­di­ent made by BioN­Tech un­der a con­tract man­u­fac­tur­ing agree­ment, be­fore ship­ping it back for dis­tri­b­u­tion.

While not No­var­tis’ first in­volve­ment in the vac­cine hunt, it would be the lat­est ex­am­ple in a glob­al health cri­sis that’s cat­alyzed a string of un­usu­al pacts be­tween bio­phar­ma ri­vals, all pledg­ing to do what they can to help end the pan­dem­ic.

CEO Vas Narasimhan told Bloomberg on Thurs­day that No­var­tis is “in con­ver­sa­tions with a range of dif­fer­ent play­ers” to see about help­ing man­u­fac­ture their prod­ucts — every­thing from mon­o­clon­al an­ti­bod­ies to vac­cines. He didn’t name any of the po­ten­tial part­ners.

Un­der the deal with Pfiz­er and BioN­Tech, No­var­tis plans to start pro­duc­tion at a fa­cil­i­ty in Stein, Switzer­land in Q2 and have the first ship­ment in Q3.

“We have pro­duc­tion ca­pac­i­ty across our net­work that we’re will­ing to make avail­able,” he said.

Lim­it­ed sup­ply has been a con­sis­tent is­sue for drug­mak­ers, who be­gan scal­ing up man­u­fac­tur­ing while their vac­cines or treat­ments were still in clin­i­cal tri­als. But with as­tro­nom­i­cal de­mand from all cor­ners of the world and plen­ty of pre-or­ders in place, com­pa­nies like As­traZeneca can find them­selves in the hot seat scram­bling to sat­is­fy every cus­tomer.

Ear­li­er this week, Sanofi an­nounced that it would make a plant in Frank­furt avail­able to as­sist Pfiz­er and BioN­Tech in their pro­duc­tion, while its own Glax­o­SmithK­line-part­nered pro­gram gets back on track. Mer­ck KGaA is re­port­ed­ly al­so con­sid­er­ing sev­er­al ways to help fel­low Ger­man play­er BioN­Tech in­crease out­put, in­clud­ing open­ing up its “fill and fin­ish” ca­pa­bil­i­ties.

For No­var­tis, Narasimhan sug­gest­ed every­thing is on the ta­ble. Ad­di­tion­al dis­cus­sions sur­round mR­NA pro­duc­tion, ther­a­peu­tic pro­tein pro­duc­tion as well as raw ma­te­r­i­al pro­duc­tion, the com­pa­ny not­ed in a re­lease.

“The ear­ly stages of scal­ing up from a few tens of thou­sands of dos­es to hun­dreds of mil­lions of dos­es in gen­er­al is a chal­leng­ing scale-up,” he said in an in­ter­view with Bloomberg. “It’s not sur­pris­ing that we have some bumps in the road. What’s im­por­tant right now is that we man­age pub­lic ex­pec­ta­tions ap­pro­pri­ate­ly, and then I think the sup­plies will start to come through.”

The Swiss phar­ma gi­ant has ex­tend­ed its ten­ta­cles in a few dif­fer­ent di­rec­tions to tack­le Covid-19, pitch­ing Jakafi for se­vere pa­tients, hav­ing its AveX­is gene ther­a­py sub­sidiary man­u­fac­ture a vac­cine de­vel­oped by two Mass­a­chu­setts hos­pi­tals, back­ing Mol­e­c­u­lar Part­ners’ pre­clin­i­cal pro­gram in a $231 mil­lion deal, and lat­er bet­ting on a stem cell ther­a­py from Mesoblast.

Jakafi and the Mesoblast pro­gram flopped in late-stage stud­ies, though the oth­er two are still on­go­ing.

Ger­many rec­om­mends against giv­ing As­traZeneca/Ox­ford vac­cine to el­der­ly

As­traZeneca’s vac­cine shouldn’t be giv­en to el­der­ly peo­ple over the age of 65, an ex­pert pan­el in Ger­many has rec­om­mend­ed.

While the head of the coun­try’s vac­cine reg­u­lar ex­pects the EU au­tho­riza­tion — ex­pect­ed im­mi­nent­ly — to come with­out any age re­stric­tions, Ger­many’s of­fi­cial rec­om­men­da­tion will be to on­ly of­fer it to peo­ple aged 18 to 64, un­like the mR­NA jabs from Pfiz­er/BioN­Tech and Mod­er­na.

“There are cur­rent­ly in­suf­fi­cient da­ta avail­able to as­sess the vac­cine ef­fi­ca­cy from 65 years of age,” the com­mit­tee’s draft res­o­lu­tion read. It was made avail­able by the Ger­man health min­istry on Thurs­day.

With­in the Phase III tri­als, 341 peo­ple old­er than 65 were vac­ci­nat­ed but on­ly one be­came in­fect­ed — of­fer­ing lit­tle ev­i­dence of its ef­fi­ca­cy in this high-risk pop­u­la­tion.

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

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.