Covid-19 roundup: EU be­gins re­view­ing Mod­er­na vac­cine; Cure­Vac and EU agree to 405M-dose deal

A day af­ter an­nounc­ing their vac­cine is high­ly ef­fec­tive at pre­vent­ing Covid-19, Mod­er­na said Eu­ro­pean reg­u­la­tors have be­gun a rolling re­view of the prod­uct for ap­proval.

The news sets Mod­er­na’s mR­NA-1273 vac­cine to be one of the first Covid-19 vac­cines au­tho­rized on both sides of the At­lantic, with CEO Stéphane Ban­cel an­tic­i­pat­ing in an in­ter­view Sun­day that the FDA will OK both their vac­cine and the vac­cine co-de­vel­oped by Pfiz­er and BioN­Tech in ear­ly or mid-De­cem­ber. Nei­ther com­pa­ny has yet sub­mit­ted to the US agency.

Al­though the sec­ond com­pa­ny to re­lease piv­otal da­ta on a vac­cine, Mod­er­na is the third to be­gin a rolling re­view at the EMA. As­traZeneca and BioN­Tech, both based in Eu­rope, an­nounced in ear­ly Oc­to­ber that reg­u­la­tors have be­gun a rolling re­view of the vac­cine. Mod­er­na said they sub­mit­ted doc­u­ments on Oct 14.

De­signed to speed ap­provals, rolling re­views give the EMA an ear­ly look at cer­tain pre­clin­i­cal, clin­i­cal and man­u­fac­tur­ing da­ta, but the agency doesn’t is­sue de­ci­sions un­til piv­otal re­sults are in. As­traZeneca is hop­ing to re­lease such da­ta be­fore the end of the year, which would like­ly po­si­tion them as the third Covid-19 vac­cine com­pa­ny to do so.

It’s un­clear how long the EMA may take to re­view a vac­cine. The EMA has op­er­at­ed through­out the pan­dem­ic more de­lib­er­ate­ly than their Amer­i­can coun­ter­part. The FDA, for ex­am­ple, au­tho­rized remde­sivir three days af­ter Phase III re­sults came out and near­ly two months be­fore the EMA did.

EMA of­fi­cials, though, in­di­cat­ed last month that they would have been will­ing to au­tho­rize a vac­cine that’s less than 50% ef­fec­tive, the FDA’s bar. Both Pfiz­er and Mod­er­na say their vac­cines are more than 90% ef­fec­tive.

Ban­cel said Sun­day he an­tic­i­pat­ed an FDA ad­vi­so­ry hear­ing on their vac­cine on Dec 7 or Dec 14, with an EUA com­ing a few days lat­er. He pre­dict­ed a sim­i­lar time­line for Pfiz­er-BioN­Tech, with the two vac­cines po­ten­tial­ly shar­ing a sin­gle ad­comm.

Ja­son Mast

Cure­Vac and EU agree to 405 mil­lion-dose deal

Mod­er­na and Pfiz­er/BioN­Tech were the first com­pa­nies to show piv­otal da­ta for their vac­cines, but the third ma­jor mR­NA com­pa­ny, Cure­Vac, is look­ing to be­come the ar­se­nal of Eu­rope.

Al­ready fi­nanced with a €300 mil­lion in­vest­ment from the Ger­man gov­ern­ment and a €75 mil­lion loan from the Eu­ro­pean In­vest­ment Bank, Cure­Vac an­nounced yes­ter­day that they have signed an agree­ment to pro­vide the EU with 405 mil­lion dos­es of their mR­NA vac­cine.

Cure­Vac’s close op­er­a­tions with Eu­ro­pean of­fi­cials stood in con­trast to its com­peti­tors, with Mod­er­na re­ly­ing heav­i­ly on US gov­ern­ment cash and Pfiz­er pro­vid­ing the fund­ing and clin­i­cal and man­u­fac­tur­ing ex­per­tise to ad­vance BioN­Tech’s vac­cine. The bulk of their man­u­fac­tur­ing will oc­cur in Eu­rope as well, with the com­pa­ny an­nounc­ing plans this morn­ing to es­tab­lish a Eu­ro­pean-based net­work of fac­to­ries that can pro­duce 300 mil­lion dos­es in 2021 and 2022.

Cure­Vac did not say on what time­line they will de­liv­er the 405 mil­lion dos­es to Eu­rope.

The new deal will add to the up to 300 mil­lion dos­es Pfiz­er and BioN­Tech agreed to sell to the EU and the 300 mil­lion-dose deal Sanofi and GSK signed back in Sep­tem­ber. Mod­er­na is still in dis­cus­sions with the Eu­ro­pean Com­mis­sion, with of­fi­cials re­port­ed­ly look­ing to ne­go­ti­ate the price down to be­low $25 per dose.

Ur­su­la von der Leyen

“This is the fifth con­tract with a phar­ma­ceu­ti­cal com­pa­ny for our COVID-19 vac­cine port­fo­lio. And we are work­ing on a sixth one, with Mod­er­na,” Eu­ro­pean Com­mis­sion pres­i­dent Ur­su­la von der Leyen said in a state­ment. “We hope to fi­nalise the con­tract soon.”

Cure­Vac is still in Phase I of clin­i­cal test­ing. They have talked about re­ceiv­ing ap­proval by the third quar­ter of 2021 and tout­ed a vac­cine that’s sta­ble at re­frig­er­a­tor tem­per­a­tures as a key ad­van­tage over oth­er mR­NA ap­proach­es.

Af­ter Mod­er­na, Pfiz­er news, World Health Or­ga­ni­za­tion cau­tions long road ahead

The world now has da­ta to sug­gest two vac­cines are high­ly ef­fec­tive against Covid-19, but WHO of­fi­cials cau­tioned Mon­day that proof a vac­cine works is just one small step in a long path to­ward end­ing the pan­dem­ic.

Ed­ward Kel­ly

“It’s not vac­cines that save peo­ple,” Ed­ward Kel­ly, di­rec­tor of the WHO’s work on ser­vice de­liv­ery and safe­ty, told re­porters, ac­cord­ing to The Wash­ing­ton Post. “It’s vac­ci­na­tions that will ac­tu­al­ly save peo­ple.”

And it will take a long time to vac­ci­nate the globe. As com­pa­nies and of­fi­cials have warned, dos­es will be in short sup­ply for the fore­see­able fu­ture; Mod­er­na and Pfiz­er ex­pect to make enough to vac­ci­nate be­tween 800 mil­lion and a bil­lion peo­ple next year, but the world pop­u­la­tion num­bers more than 7 bil­lion.

More­over, the cold chain re­quire­ments for each vac­cine will lim­it how wide­ly they can be dis­trib­uted in less de­vel­oped ar­eas of the world. Mean­while, wealthy coun­tries and par­tic­u­lar­ly the US have bought much of the ear­ly sup­ply of vac­cine, leav­ing low and mid­dle in­come parts of the world wait­ing.

These fac­tors, along with lin­ger­ing un­knowns about how long the vac­cines last and the still-surg­ing lev­els of virus, un­der­score the need to con­tin­ue mea­sures such as so­cial dis­tanc­ing and test­ing, of­fi­cials said.

“A vac­cine on its own will not end the pan­dem­ic,” WHO Di­rec­tor-Gen­er­al Tedros Ad­hanom Ghe­breye­sus said.

Pfiz­er be­gins pi­lot pro­gram to dis­trib­ute its vac­cine

A week af­ter read­ing out long-await­ed in­ter­im Phase III re­sults from their Covid-19 vac­cine tri­al, Pfiz­er and BioN­Tech are talk­ing dis­tri­b­u­tion.

The vac­cine, which Pfiz­er and BioN­Tech said is more than 90% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19, must be shipped in -70 de­grees Cel­sius (-94 de­grees Fahren­heit) tem­per­a­tures to re­main sta­ble, then used with­in 5 days of be­ing thawed. De­liv­ery pos­es a ma­jor chal­lenge, with some coun­tries say­ing they can’t af­ford to build the dis­tri­b­u­tion sys­tem re­quired to han­dle the vac­cine.

To test the wa­ters, Pfiz­er has launched a pi­lot de­liv­ery pro­gram in Rhode Is­land, Texas, New Mex­i­co and Ten­nessee, ac­cord­ing to Reuters. The four states were cho­sen for their dif­fer­ences in size, di­ver­si­ty of pop­u­la­tions, in­fra­struc­ture, and ur­ban and rur­al set­tings, the news agency re­port­ed.

“We are hope­ful that re­sults from this vac­cine de­liv­ery pi­lot will serve as the mod­el for oth­er U.S. states and in­ter­na­tion­al gov­ern­ments, as they pre­pare to im­ple­ment ef­fec­tive COVID-19 vac­cine pro­grams,” Pfiz­er said, per Reuters.

The pi­lot states won’t get dos­es ear­li­er than oth­er states or have spe­cial con­sid­er­a­tion, ac­cord­ing to Pfiz­er. The phar­ma said it plans on fil­ing for an EUA around the third week of No­vem­ber, once it has the nec­es­sary safe­ty da­ta to ap­proach reg­u­la­tors.

Ding Sheng, di­rec­tor of the Bei­jing-based Glob­al Health Drug Dis­cov­ery In­sti­tute, told Bloomberg that pro­duc­tion of Pfiz­er and BioN­Tech’s can­di­date is “cost­ly” and re­quires cold-chain trans­porta­tion. Philip­pines’ health sec­re­tary Fran­cis­co Duque told Reuters that the cold chain re­quire­ment is “hefty,” and that the coun­try does “not have such fa­cil­i­ty.”

Pfiz­er has de­signed “ther­mal ship­pers” that can be stored at room tem­per­a­ture and keep the vac­cine cold for 10 days if re­plen­ished with dry ice, which they say will lessen the bur­den on coun­tries.

The US struck a $1.95 bil­lion deal for 100 mil­lion dos­es of Pfiz­er and BioN­Tech’s vac­cine, with the op­tion to ac­quire an­oth­er 500 mil­lion down the road. Last week, the drug­mak­ers fi­nal­ized a deal with the EU for 200 mil­lion dos­es, with the op­tion for 100 mil­lion more lat­er on, though the par­ties didn’t dis­close the cost.

Mod­er­na said its can­di­date — which in­ter­im re­sults have shown to be 94.5% ef­fec­tive — can be kept for months at -20 de­grees Cel­sius (-4 Fahren­heit) and at re­frig­er­a­tor tem­per­a­tures for up to 30 days. — Nicole De­Feud­is 

Eli Lil­ly teams with Sam­sung Bi­o­log­ics to mass pro­duce its Covid-19 an­ti­body

Be­lea­guered by ques­tions about how safe­ly it can make its Covid-19 neu­tral­iz­ing an­ti­body, Eli Lil­ly has pulled out a card they placed at the be­gin­ning of the pan­dem­ic.

Sam­sung Bi­o­log­ics dis­closed yes­ter­day that they signed an agree­ment back in May to mass-pro­duce its an­ti­body and, af­ter de­lays in se­cur­ing raw ma­te­ri­als, had re­cent­ly be­gun pro­duc­tion, Reuters re­port­ed.

The FDA re­cent­ly au­tho­rized the an­ti­body, known as bam­lanivimab, for mod­er­ate and mild cas­es of Covid-19 — a huge pop­u­la­tion at a time when the US is record­ing 100,000 cas­es.

Ex­perts such as ex-FDA chief Scott Got­tlieb have warned for months that the US was un­der-in­vest­ing in the in­fra­struc­ture to mass pro­duce the mon­o­clon­al an­ti­bod­ies in de­vel­op­ment at Lil­ly, Re­gen­eron and else­where.

Lil­ly has said they can make 1 mil­lion dos­es by the end of this year, with 300,000 of those ear­marked for the US. But they’ve been dogged by qual­i­ty con­trol ques­tions at one of the plants churn­ing out the drug. Al­though they au­tho­rized the an­ti­body ear­li­er this month, the FDA stip­u­lat­ed that Lil­ly would have to hire out­side con­sul­tants to test batch­es and con­firm the qual­i­ty con­trol da­ta.

It was not im­me­di­ate­ly clear whether the Sam­sung pro­duc­tion was baked in­to pre­vi­ous dose es­ti­mates from Lil­ly or would add new ca­pac­i­ty. The Big Phar­ma has talked about ramp­ing up pro­duc­tion next year as new plants came on­line. In Sep­tem­ber, they an­nounced a man­u­fac­tur­ing col­lab­o­ra­tion with Am­gen.

Lil­ly’s Covid-19 an­ti­body will not be the first Sam­sung has agreed to help mass pro­duce. The South Ko­re­an com­pa­ny has al­so signed agree­ments with Vir Biotech­nol­o­gy to pro­duce the neu­tral­iz­ing an­ti­body they are co-de­vel­op­ing with Glax­o­SmithK­line. — Ja­son Mast

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