Pfiz­er and Mod­er­na are on track to de­liv­er a com­bined 220 mil­lion dos­es of their mR­NA vac­cines in the US by the end of March, the com­pa­nies told a con­gres­sion­al com­mit­tee, set­ting them up to of­fer enough shots to vac­ci­nate 300 mil­lion Amer­i­cans by the end of Ju­ly — a goal Pres­i­dent Joe Biden has out­lined in re­cent days.

John Young

Pre­vi­ous­ly, sup­ply wasn’t sup­posed to reach that lev­el un­til Sep­tem­ber.

Both drug­mak­ers say the new goal re­flects sig­nif­i­cant ex­pan­sions in their man­u­fac­tur­ing ca­pac­i­ty. And J&J said it could come in with mil­lions of its one-shot vac­cine if the FDA au­tho­rizes that third op­tion fol­low­ing an ad­comm sched­uled lat­er this week.

In a pre­pared tes­ti­mo­ny, Pfiz­er CBO John Young not­ed that it’s al­ready shipped around 40 mil­lion dos­es of its BioN­Tech-part­nered vac­cine so far. Thanks to im­prove­ments and ex­pan­sions, by mid-March it could be sup­ply­ing 13 mil­lion dos­es per week; for com­par­i­son, the week­ly num­bers were around 4 to 5 mil­lion in ear­ly Feb­ru­ary.

At Mod­er­na, Pres­i­dent Stephen Hoge tells a sim­i­lar sto­ry:

We have dou­bled our month­ly de­liv­er­ies since late 2020, and we are aim­ing to dou­ble them again by April to more than 40 mil­lion dos­es per month. Based on this progress scal­ing up man­u­fac­tur­ing, we re­cent­ly agreed to move up our de­liv­ery time­line: we now are aim­ing to de­liv­er a sec­ond hun­dred mil­lion dos­es by the end of May and a third hun­dred mil­lion dos­es by the end of Ju­ly.

Stephen Hoge

Break­ing down the mul­ti­ple steps it takes to make an mR­NA vac­cine, he adds that Mod­er­na is in the process of on­board­ing a sec­ond fill-fin­ish part­ner with a US fa­cil­i­ty that, like Catal­ent, would be putting mR­NA-1273 in­to vials. — Am­ber Tong

EMA to con­sid­er ex­pand­ing remde­sivir au­tho­riza­tion

Gilead’s remde­sivir is au­tho­rized in Eu­rope for Covid-19 pa­tients re­quir­ing oxy­gen, but the EMA is look­ing in­to ex­pand­ing that ac­cess.

Eu­ro­pean reg­u­la­tors have start­ed con­sid­er­ing whether or not remde­sivir, sold un­der the brand name Vek­lury, should be used in cas­es where pa­tients don’t need sup­ple­men­tal oxy­gen. The EMA’s CHMP body will is­sue an opin­ion on the mat­ter some­time be­fore the sum­mer af­ter Gilead sub­mit­ted new da­ta, reg­u­la­tors said Mon­day.

Remde­sivir was first au­tho­rized on the con­ti­nent back in Ju­ly, and any po­ten­tial en­dorse­ments by the EMA will have to be for­mal­ly OK’ed by the Eu­ro­pean Com­mis­sion.

The drug end­ed up the win­ner of the Covid-19 treat­ment race, de­spite some deep skep­ti­cism over its ef­fec­tive­ness. Gilead re­ceived full ap­proval for Vek­lury in the US last Oc­to­ber, with a la­bel for treat­ment in adults and chil­dren old­er than 12 in Covid-19 cas­es that re­quire hos­pi­tal­iza­tion.

But that green light came less than a week af­ter a WHO study said the drug had lit­tle, if any, ef­fect on im­prov­ing mor­tal­i­ty rates, re­duc­ing the amount of pa­tients need­ing ven­ti­la­tors or short­en­ing hos­pi­tal stays. That led to the UN or­ga­ni­za­tion rec­om­mend­ing against its use in No­vem­ber, cit­ing the lim­it­ed da­ta and high costs as­so­ci­at­ed with the drug.

Remde­sivir has al­ready brought in a for­tune for Gilead, hav­ing net­ted near­ly $2 bil­lion in sales in last year’s fourth quar­ter alone. The drug­mak­er has priced a five-dose reg­i­men of Vek­lury at $3,120. — Max Gel­man

BioN­Tech stock is keep­ing Biden ad­vis­er Er­ic Lan­der out of cer­tain Covid-19 vac­cine dis­cus­sions

Er­ic Lan­der

A Sen­ate con­fir­ma­tion isn’t the on­ly hur­dle stand­ing be­tween Er­ic Lan­der and his new job as Pres­i­dent Joe Biden’s top sci­en­tif­ic ad­vis­er.

There’s al­so the stock he owns in BioN­Tech — worth be­tween $500,000 and $1 mil­lion — and a port­fo­lio of oth­er bio­phar­ma com­pa­nies that he plans to di­vest if con­firmed, Ax­ios re­port­ed.

While Lan­der, the found­ing di­rec­tor of the Broad In­sti­tute, is al­ready ad­vis­ing the Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy, he’s re­cused from “par­tic­u­lar mat­ters re­lat­ed to any stocks he holds pend­ing di­vesti­ture, in­clud­ing any such mat­ters re­lat­ed to COVID vac­cines,” a White House spokesper­son told the out­let.

He dis­closed his stock own­er­ship in pa­per­work made pub­lic on Mon­day. Among the oth­er drug­mak­ers he has a stake in are Co­di­ak Bio­Sciences, an ex­o­some play­er he co-found­ed. The biotech has al­so in­di­cat­ed plans to de­vel­op a Covid-19 vac­cine. — Am­ber Tong

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

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

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.