Last week, part­ners Pfiz­er and BioN­Tech joined the elite group of CanSi­no, Mod­er­na and Ox­ford who have be­gun hu­man tri­als of their ex­per­i­men­tal Covid-19 vac­cine. On Tues­day, the US-Ger­man part­ners kicked off dos­ing in the Unit­ed States.

The team, which kicked off dos­ing in Ger­many in late April, said the first US par­tic­i­pants had been giv­en a vac­cine from the BNT162 pro­gram in a Phase I/II tri­al. The vac­cine pro­gram in­cludes four ex­per­i­men­tal vac­cines — each with com­bi­na­tion of mR­NA for­mat and tar­get anti­gen — the de­sign of the tri­al will al­low for the eval­u­a­tion of the var­i­ous can­di­dates si­mul­ta­ne­ous­ly so that the safest and po­ten­tial­ly most ef­fi­ca­cious can­di­date can be iden­ti­fied.

“The short, less than four-month time­frame in which we’ve been able to move from pre-clin­i­cal stud­ies to hu­man test­ing is ex­tra­or­di­nary…” said Pfiz­er chief Al­bert Bourla in a state­ment.

The Phase I/II study is set to en­roll up to 360 healthy sub­jects in­to two age co­horts (18-55 and 65-85 years of age) — the sub­jects im­mu­nized in the first por­tion of the study will be healthy adults 18-55 years of age. Old­er adults will on­ly be im­mu­nized with a giv­en dose lev­el of a vac­cine can­di­date, once test­ing in younger adults of­fers ini­tial ev­i­dence of safe­ty and im­muno­genic­i­ty.

From the man­u­fac­tur­ing side, the part­ners are scal­ing up pro­duc­tion. Mil­lions of vac­cine dos­es should be avail­able in 2020, and those num­bers should grow to hun­dreds of mil­lions by next year, the com­pa­nies said.

World lead­ers, bar­ring the US, pledge $8 bil­lion in vac­cine, treat­ment re­search — re­port

Last month, Pres­i­dent Don­ald Trump said he would stop fund­ing the WHO, tak­ing is­sue with the way the or­ga­ni­za­tion has been tack­ling the pan­dem­ic. Now, the Unit­ed States is steer­ing clear of a glob­al ef­fort to sup­port vac­cine and treat­ment de­vel­op­ment.

On Mon­day, world lead­ers vowed to raise $8 bil­lion to kick­start the ef­fort, to build on ef­forts by the World Bank, the Bill and Melin­da Gates Foun­da­tion and wealthy in­di­vid­u­als, Reuters re­port­ed. The event was or­ga­nized by the Eu­ro­pean Union and non-EU coun­tries Britain, Nor­way and Sau­di Ara­bia, and in­clud­ed the par­tic­i­pa­tion of Japan, Cana­da, South Africa and Chi­na, among oth­ers.

A se­nior US ad­min­is­tra­tion of­fi­cial de­clined to tell the wire ser­vice specif­i­cal­ly why the Unit­ed States was not par­tic­i­pat­ing.

The suc­cess­ful de­vel­op­ment of a vac­cine is on­ly the first step — easy ac­cess glob­al­ly will be the next big hur­dle. EU of­fi­cials said that the fund­ing will not strip the re­cip­i­ent phar­ma­ceu­ti­cal com­pa­nies of in­tel­lec­tu­al prop­er­ty on any vac­cine or treat­ment, but com­pa­nies will be ex­pect­ed to com­mit to mak­ing them avail­able at af­ford­able prices.

Many lead­ers stressed that any vac­cine must be made avail­able to every­one. Cana­di­an Prime Min­is­ter Justin Trudeau said it should not just be for rich coun­tries.

“Those who in­vent it, of course, will be fair­ly paid, but ac­cess will be giv­en to peo­ple across the globe by the or­ga­ni­za­tion we choose,” French Pres­i­dent Em­manuel Macron said, ac­cord­ing to the Reuters re­port.

The is­sue of how a vac­cine will be dis­trib­uted across the globe, if proved safe and ef­fec­tive, is para­mount. In a Wall Street Jour­nal opin­ion piece late last month en­ti­tled “Amer­i­ca needs to win the coro­n­avirus vac­cine race,” for­mer FDA chief Scott Got­tlieb warned that “while friend­ly na­tions will try to share a suc­cess­ful prod­uct — to a point — the US can’t re­ly on vac­cines from Chi­na or even Eu­rope be­ing avail­able in Amer­i­ca quick­ly.”

Last week, Bloomberg re­port­ed that the Trump ad­min­is­tra­tion is work­ing on ex­e­cut­ing a multi­bil­lion-dol­lar plan “Op­er­a­tion Warp Speed” to as­sure that 300 mil­lion dos­es (of any po­ten­tial vac­cine) — which should cov­er near­ly the en­tire US pop­u­la­tion — are avail­able by Jan­u­ary, the ear­li­est time­line chart­ed by vac­cine de­vel­op­ers. Al­though the de­tails are sparse, the plan brings phar­ma­ceu­ti­cal com­pa­nies, gov­ern­ment agen­cies and the mil­i­tary to co­or­di­nate test­ing of ex­per­i­men­tal vac­cines and in­volves large in­vest­ments in man­u­fac­tur­ing.

The vac­cine part­ner­ship be­tween Ox­ford, As­traZeneca and Vac­citech — which aims to make 100 mil­lion dos­es by the end of 2020 — in­cludes pro­vi­sions to dis­trib­ute the vac­cine to low and medi­um-in­come coun­tries, al­though the de­tails are sparse.

Sep­a­rate­ly, the Serum In­sti­tute of In­dia that has al­so part­nered with Ox­ford sci­en­tists to mass-pro­duce their vac­cine (with plans to pro­duce up to 60 mil­lion dos­es this year) told Reuters that their first pri­or­i­ty is In­dia and its pop­u­la­tion of 1.3 bil­lion. A ma­jor­i­ty of the vac­cine, at least ini­tial­ly, would have to go to our coun­try­men be­fore it goes abroad,” Serum CEO Adar Poon­awal­la said.

Gilead’s promis­ing Covid-19 an­tivi­ral remde­sivir gets Bangladeshi pro­duc­er — re­port

The com­pa­ny, which has pre­vi­ous­ly pledged to do­nate its ex­ist­ing sup­ply of 1.5 mil­lion in­di­vid­ual dos­es of remde­sivir for use in pa­tients in clin­i­cal tri­als and on a com­pas­sion­ate use ba­sis, has re­port­ed­ly found a new sup­pli­er in the form of one of Bangladesh’s largest drug­mak­ers, Bex­im­co Phar­ma­ceu­ti­cals.

The an­tivi­ral, which failed to pass muster as an Ebo­la ther­a­py, quick­ly rose to promi­nence as a po­ten­tial Covid-19 drug af­ter in­duc­ing a sta­tis­ti­cal­ly sig­nif­i­cant im­pact in help­ing hos­pi­tal­ized Covid-19 pa­tients re­cov­er faster in a ran­dom­ized, place­bo-con­trolled study — the gold-stan­dard for ben­e­fit-risk cal­cu­la­tions. Al­though more da­ta are in­com­ing, the drug was grant­ed emer­gency use au­tho­riza­tion by the FDA on Fri­day.

Apart from the $50 mil­lion the com­pa­ny has al­ready in­vest­ed in de­vel­op­ing the drug, an­oth­er $1 bil­lion is ex­pect­ed to be spent, as Gilead ramps up fur­ther de­vel­op­ment and man­u­fac­tur­ing of remde­sivir in an­tic­i­pa­tion of reg­u­la­to­ry ap­provals, ex­ec­u­tives said in a re­cent con­fer­ence call.

Bex­im­co plans to price the drug at be­tween 5000 and 6000 takas per vial ($59-$71/per vial), Bex­im­co’s Chief Op­er­at­ing Of­fi­cer Rab­bur Reza told Reuters, adding a pa­tient might need any­where be­tween 5 and 11 vials.

“We will on­ly know ex­act­ly how much a pa­tient needs once stud­ies are com­plete,” Reza said, not­ing that pro­duc­tion would be­gin this month, ini­tial­ly for do­mes­tic use.

Mod­els pre­dict Amer­i­can dai­ly death rate to hit 3,000 by June 

As part of the Unit­ed States get ready to ease back in­to nor­mal­i­ty, the Uni­ver­si­ty of Wash­ing­ton’s In­sti­tute for Health Mod­el­ing and Eval­u­a­tion says the coro­n­avirus pan­dem­ic will claim near­ly 135,000 Amer­i­can lives by Au­gust, in part due to states eas­ing their so­cial dis­tanc­ing re­stric­tions.

The pro­jec­tion is grim for the com­ing weeks. IHME pre­dicts that there will be as many as 3,000 deaths per day in by June 1, with a sharp peak hit­ting around mid-May — well ahead of the cur­rent pace of about 1,500 dai­ly deaths.

An­oth­er draft re­port pro­ject­ed Covid-19 cas­es will surge to about 200,000 per day by June 1, with 3,000 deaths ex­pect­ed per day, the Wash­ing­ton Post re­port­ed. The White House and the CDC dis­avowed the re­port, al­though the slides do car­ry the CDC’s lo­go, the Post said, adding that the cre­ator of the mod­el said the num­bers are un­fin­ished pro­jec­tions shown to the CDC as a work in progress.

SEC in­ves­ti­ga­tion trig­gers sus­pen­sion of Mol­e­culin Biotech’s stock

Every few years, a pub­lic health cri­sis (think Ebo­la, Zi­ka) spurred by a rogue pathogen trig­gers a small-biotech ral­ly, as drug­mak­ers emerge from the wood­work with am­bi­tious plans to treat the mount­ing out­break. In most cas­es, that en­thu­si­asm nev­er quite de­liv­ers.

With Covid-19 hav­ing rav­aged much of the globe, the ever op­por­tune biotech is al­ways around the cor­ner.

On Mon­day, Texas can­cer-fo­cused biotech Mol­e­culin said its shares had been placed in a tem­po­rary trad­ing halt fol­low­ing no­ti­fi­ca­tion from the SEC.

The small com­pa­ny, which has a mar­ket cap of about $65 mil­lion, has been mak­ing state­ments in a smat­ter­ing of reg­u­la­to­ry fil­ings and press re­leas­es since March 19 sug­gest­ing its ex­per­i­men­tal drug, WP1122, was a po­ten­tial can­di­date for use in Covid-19 and that it could ex­pe­dite the reg­u­la­to­ry ap­proval of the treat­ment. Be­tween March 18 and May 1st (when the trad­ing sus­pen­sion came in­to ef­fect), the val­ue of the com­pa­ny’s stock has more than dou­bled to $1.o7.

The sus­pen­sion will ter­mi­nate at 11:59 p.m. ET on May 15th, 2020. Mol­e­culin said it be­lieves it will be able to demon­strate the ac­cu­ra­cy and ad­e­qua­cy of its pub­lic dis­clo­sures.

Milken In­sti­tute track­er iden­ti­fies loads more Covid-19 treat­ment and vac­cine can­di­dates in de­vel­op­ment

In ear­ly March, the think tank had tracked 55 treat­ments and 38 vac­cine can­di­dates. Fast for­ward to May 4, those num­bers have jumped to more than 111 vac­cines and 197 treat­ments in the pipeline to treat and pre­vent Covid-19.

Of this bur­geon­ing group, nine vac­cines and more than 50 treat­ments cur­rent­ly are in clin­i­cal tri­als.

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

Over the past 4 months, a group of analysts at GlobalData tracked 322 biopharma companies — biotechs, pharmas, CROs and such — reporting on the trouble Covid-19 has caused for their clinical development plans.

Slightly more than half — 179 — are US operations, with about 1 in 4 scattered throughout Europe and in Canada. And the disruptions are clustered around mid-stage development, though a hefty number of late-stage derailments may well blunt the stream of approvals down the road.