Covid-19 roundup: As­traZeneca gets EMA thumbs up for vac­cine amid bit­ter feud with EU; No­var­tis jumps in to man­u­fac­ture Pfiz­er/BioN­Tech vac­cine

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.

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.

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