Global Statistics

All countries
527,813,178
Confirmed
Updated on May 23, 2022 9:07 am
All countries
483,888,360
Recovered
Updated on May 23, 2022 9:07 am
All countries
6,300,800
Deaths
Updated on May 23, 2022 9:07 am
Monday, May 23, 2022

Global Statistics

All countries
527,813,178
Confirmed
Updated on May 23, 2022 9:07 am
All countries
483,888,360
Recovered
Updated on May 23, 2022 9:07 am
All countries
6,300,800
Deaths
Updated on May 23, 2022 9:07 am
Molderizer and Safe Shield

Merck prepares new study on their $425M Covid drug; COVAX begins rollout but huge disparities still loom – Endpoints News

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Mer­ck spent $425 mil­lion to buy out On­coIm­mune in No­vem­ber, pre­sum­ably un­der the be­lief that they could scale up their drug for se­vere Covid-19 and get it through the FDA on the strength of a Phase III tri­al the small­er biotech com­plet­ed in Sep­tem­ber.

The FDA threw a wrench in those plans. The agency told Mer­ck last week that the 203-per­son study wasn’t suf­fi­cient to show the drug was ef­fec­tive. Now, Bloomberg re­ports, Mer­ck is prepar­ing an ad­di­tion­al Phase III study, one that will push re­sults — and any chance of ap­proval — back to the end of the year.

It’s an­oth­er Covid-19 set­back for Mer­ck, a Big Phar­ma long known for elite re­search, par­tic­u­lar­ly in in­fec­tious dis­ease; two years ago, they de­vel­oped the first vac­cine for Ebo­la. The com­pa­ny joined the pan­dem­ic fight late, and the var­i­ous tech­nolo­gies they’ve de­vel­oped have since stum­bled. They axed their two vac­cine pro­grams af­ter dispir­it­ing ear­ly re­sults, and they’ve said lit­tle about an Emory-de­vel­oped oral an­tivi­ral they li­censed and put in Phase III.

The FDA’s de­ci­sion is par­tic­u­lar­ly sur­pris­ing giv­en how the Mer­ck-On­coIm­mune buy­out came about. Bloomberg re­port­ed that Op­er­a­tion Warp Speed chief Mon­cef Slaoui bro­kered the deal af­ter the small biotech said their drug re­duced the risk of res­pi­ra­to­ry fail­ure or death in a Phase III tri­al. HHS then gave Mer­ck a con­tract for $356 mil­lion to sup­ply 100,000 dos­es by June.

“It’s not that the agency wasn’t im­pressed by the da­ta, be­cause they were,” Nicholas Kart­so­nis, Mer­ck’s clin­i­cal in­fec­tious dis­ease chief told Bloomberg. “They just want more of it, and more com­fort that if we’re in­deed go­ing to bring this for­ward, that the da­ta gets repli­cat­ed.”

CO­V­AX be­gins roll­out but huge dis­par­i­ties still loom

CO­V­AX, the WHO and Gates-backed vac­cine-shar­ing pro­gram, has had a rocky start, edged out in the hunt for vac­cines by the wealth­i­est coun­tries in the world. As shots rolled out in the US, the UK, and Eu­rope, CO­V­AX large­ly stood on the side­lines: At the end of Feb­ru­ary, more than 100 of the world’s poor­est coun­tries had yet to re­ceive a sin­gle dose.

The pro­gram, though, is be­gin­ning to set bench­marks. They post­ed their first round of glob­al vac­cine al­lo­ca­tions on Tues­day, sched­ul­ing 237 mil­lion dos­es of the As­traZeneca-Ox­ford vac­cine to ship to 142 na­tions by the end of May. The first ones be­gan on Mon­day, af­ter 600,000 dos­es land­ed in Ghana and 500,000 dos­es in Côte d’Ivoire.

The al­lo­ca­tions still amount to drops in the buck­et com­pared to the roll­out in the US alone, where more than 500 mil­lion dos­es have been se­cured in the same time pe­ri­od. Pres­i­dent Biden said Tues­day that the US would have enough vac­cines for its en­tire el­i­gi­ble adult pop­u­la­tion by May —  a bench­mark most of the world may not hit for years.

In ad­di­tion to shots from As­traZeneca, a com­pa­ny that pri­or­i­tized glob­al scale and ac­cess, CO­V­AX will soon be­gin to see shots from oth­er ma­jor de­vel­op­ers. Just over 1 mil­lion Pfiz­er-BioN­Tech vac­cines are in­clud­ed in the first al­lo­ca­tion and No­vavax, which has yet to be au­tho­rized any­where but re­cent­ly showed its vac­cine was high­ly ef­fec­tive in the UK and mod­er­ate­ly ef­fec­tive in South Africa, has pledged 1.1 bil­lion dos­es.

NIH pulls plug on con­va­les­cent plas­ma in pa­tients

The NIH is singing last rites on con­va­les­cent plas­ma.

More than a year af­ter doc­tors around the coun­try be­gan band­ing to­geth­er to get con­va­les­cent plas­ma off the ground as an emer­gency, stop­gap treat­ment for a new, emer­gency virus — and six months af­ter for­mer Pres­i­dent Trump pushed the FDA au­tho­rize it — the NIH has halt­ed its tri­al in con­va­les­cent plas­ma for mod­er­ate pa­tients af­ter a da­ta safe­ty and mon­i­tor­ing board found it had lit­tle ef­fect.

The study, called C3PO and launched in Au­gust, was one of the best hopes for prov­ing con­va­les­cent plas­ma could be an ef­fec­tive treat­ment for Covid-19. Al­though oth­er stud­ies, in­clud­ing the Mayo Clin­ic’s con­tro­ver­sial ex­pand­ed ac­cess pro­gram, fo­cused on se­vere pa­tients, re­searchers be­lieved it should work bet­ter the ear­li­er it was ad­min­is­tered. Small­er stud­ies from oth­er coun­tries bol­stered that be­lief.

The study had en­rolled 511 out of a planned 900 pa­tients. It showed the ther­a­py was safe but un­like­ly to help the group stud­ied.

The FDA al­ready be­gan to roll back its con­tro­ver­sial EUA for con­va­les­cent plas­ma last month, in the face of new ev­i­dence point­ing to its in­ef­fec­tive­ness in hos­pi­tal­ized pa­tients. They said it would on­ly be used in hos­pi­tal­ized pa­tients with ear­ly-stage dis­ease or an im­paired abil­i­ty to make their own an­ti­bod­ies.

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



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