Covid-19 roundup: WHO rec­om­mends against 'high cost' remde­sivir, dis­ap­point­ing Gilead; EU deals with Pfiz­er/BioN­Tech, Cure­Vac top $10B — re­port

Vek­lury, or remde­sivir, may be the first Covid-19 treat­ment to earn full ap­proval at the FDA, af­ter it won a full-throat­ed en­dorse­ment from Pres­i­dent Trump. But the WHO is tak­ing the op­po­site view.

The UN agency said a pan­el tasked with de­vel­op­ing its guide­lines has rec­om­mend­ed against the use of remde­sivir, an an­tivi­ral Gilead orig­i­nal­ly de­vel­oped for Ebo­la, for Covid-19, cit­ing lim­it­ed da­ta sup­port­ing its ben­e­fits on one hand and “rel­a­tive­ly high cost and re­source im­pli­ca­tions as­so­ci­at­ed” with the in­tra­venous drug on the oth­er.

As a re­sult of that de­ci­sion, the WHO has al­so sus­pend­ed remde­sivir from an of­fi­cial list of med­i­cines de­signed to be a bench­mark for de­vel­op­ing coun­tries — in or­der to sig­nal to those coun­tries that it doesn’t rec­om­mend that they pro­cure the drug (not that they are like­ly to, as de­vel­oped coun­tries have bought up the ma­jor­i­ty of avail­able dos­es).

Gilead hit back by point­ing to stud­ies that sug­gest­ed the drug cut down re­cov­ery times, which had ce­ment­ed ap­provals in the UK, Ger­many, Japan and oth­er coun­tries.

The WHO has been throw­ing cold wa­ter on remde­sivir since a large tri­al com­par­ing remde­sivir and three oth­er treat­ments con­clud­ed that none had sub­stan­tial ef­fect on cer­tain key met­rics for hos­pi­tal­ized Covid-19 pa­tients. The oth­er ther­a­pies in the study were hy­drox­y­chloro­quine, lopinavir and in­ter­fer­on.

But the ex­perts were care­ful to stress that they weren’t say­ing remde­sivir isn’t ef­fec­tive — they just want more clin­i­cal da­ta be­fore they would en­dorse it.

“The ev­i­dence sug­gest­ed no im­por­tant ef­fect on mor­tal­i­ty, need for me­chan­i­cal ven­ti­la­tion, time to clin­i­cal im­prove­ment, and oth­er pa­tient-im­por­tant out­comes,” the WHO wrote in a state­ment.

Gilead had hit back at the SOL­I­DAR­I­TY da­ta, say­ing they ap­pear in­con­sis­tent with “more ro­bust ev­i­dence” from stud­ies such as ones led by the NIH and hint­ing that the WHO’s tri­al may not of­fer con­clu­sive find­ings due to its de­sign.

In re­sponse to the new rec­om­men­da­tions, Gilead still stood firm­ly by remde­sivir.

“We are dis­ap­point­ed the WHO guide­lines ap­pear to ig­nore this ev­i­dence at a time when cas­es are dra­mat­i­cal­ly in­creas­ing around the world and doc­tors are re­ly­ing on Vek­lury as the first and on­ly ap­proved an­tivi­ral treat­ment for pa­tients with Covid-19 in ap­prox­i­mate­ly 50 coun­tries,” Gilead in a state­ment.

With a price tag of $3,120 for US in­sur­ers, an­a­lysts have es­ti­mat­ed a multi­bil­lion-dol­lar wind­fall for Gilead.

EMA on tract to stay in sync with FDA re­gard­ing vac­cine OK

As the FDA pre­pares to wel­come Pfiz­er and BioN­Tech’s EUA fil­ing, the EMA doesn’t ex­pect to be far be­hind.

Ur­su­la von der Leyen, pres­i­dent of the Eu­ro­pean Com­mis­sion, told re­porters that the EMA has sug­gest­ed it could clear a vac­cine for con­di­tion­al ap­proval as soon as the sec­ond half of De­cem­ber. The reg­u­la­tors are in dai­ly con­tact with the coun­ter­parts across the At­lantic in or­der to “syn­chro­nize” as­sess­ment, she added.

Mod­er­na has said that it will ap­ply for an EUA soon, af­ter its vac­cine was shown to be 94.5% ef­fec­tive in Phase III. The FDA is re­port­ed­ly sched­ul­ing an ad­vi­so­ry com­mit­tee for ear­ly De­cem­ber, which it has promised to com­plete be­fore sanc­tion­ing any can­di­date.

EU deals with Pfiz­er/BioN­Tech, Cure­Vac top $10B — re­port

The Eu­ro­pean Union is ready to shell out more than $10 bil­lion for two Covid-19 vac­cines de­vel­oped by Pfiz­er/BioN­Tech and Cure­Vac, Reuters re­port­ed.

While the pre-or­ders have pre­vi­ous­ly been an­nounced, the prices were kept un­der wraps.

For Pfiz­er and BioN­Tech — which are an­gling for the first emer­gency OK in the US and EU af­ter con­clud­ing their mR­NA jab is 95% ef­fec­tive — the EU deal rep­re­sent­ed the largest ini­tial or­der. The first 200 mil­lion dos­es cost $3.7 bil­lion (€3.1 bil­lion), trans­lat­ing to $18.5 per vial; if it grabs the op­tion­al 100 mil­lion, the to­tal deal val­ue would be $5.52 bil­lion.

The US has agreed to buy 100 mil­lion dos­es at $19.5 a pop.

Cure­Vac, mean­while, is so ear­ly in the de­vel­op­ment stage that it doesn’t ex­pect to score reg­u­la­to­ry clear­ance un­til Q3 of next year. The EU is its first cus­tomer, agree­ing to pay 11.84 (€10) per dose, or $2.6 bil­lion to­tal, for an ini­tial sup­ply of 225 mil­lion dos­es.

Ac­cord­ing to Reuters, the Ger­man biotech had ini­tial­ly asked for €12. But the EU might al­so pur­chase 180 mil­lion more dos­es at an undis­closed price.

So far the list of vac­cines that the EU has se­cured ac­cess to have over­lapped large­ly with what Op­er­a­tion Warp Speed has tapped, fea­tur­ing J&J, As­traZeneca, Sanofi/GSK and BioN­Tech/Pfiz­er. It’s al­so com­plet­ed ex­plorato­ry talks with Mod­er­na. No­vavax, a Mary­land-based biotech, has the on­ly OWS can­di­date that the EU has not ex­pressed in­ter­est in ob­tain­ing.

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