Paul Mango (Matt Rourke/AP Images)

How Op­er­a­tion Warp Speed clashed with Pfiz­er in the ear­ly days of the pan­dem­ic

Op­er­a­tion Warp Speed, per­haps the bright­est spot in for­mer Pres­i­dent Don­ald Trump’s Covid-19 lega­cy, helped hur­ry the de­vel­op­ment and dis­tri­b­u­tion of Pfiz­er and Mod­er­na’s life­sav­ing Covid-19 vac­cines at a pace nev­er be­fore imag­ined.

Alex Azar

One of the cen­tral fig­ures in and around the now-de­funct OWS was Paul Man­go, for­mer deputy chief of staff at HHS who led the me­dia calls around Covid-19 and worked close­ly with for­mer HHS Sec­re­tary Alex Azar.

Man­go has penned a new book on his time at OWS lead­ing up to the vac­cines, which hits the shelves on May 18.

An ad­vance copy of the book, known as Warp Speed: In­side the Op­er­a­tion That Beat COVID, the Crit­ics, and the Odds, de­liv­ers sev­er­al sur­pris­ing be­hind-the-scenes strug­gles be­tween Warp Speed and Pfiz­er, a com­pa­ny that in­sists it nev­er took any gov­ern­ment sup­port for its Covid-19 vac­cine.

But Man­go’s book ex­plains more of the de­tails on how Pfiz­er’s vac­cine strug­gled at the be­gin­ning, what Pfiz­er did take from OWS, and how the Big Phar­ma was re­liant on the fed­er­al gov­ern­ment for sev­er­al key tasks.

In out­lin­ing the cen­tral is­sues for Warp Speed, Man­go points to Pfiz­er, which sold 100 mil­lion dos­es of its vac­cine for $1.95 bil­lion to the US, as one of three main sources of ten­sion.

When the vac­cines first be­gan rolling out, Man­go ex­plains how Pfiz­er pledged in Sep­tem­ber 2020 that it would like­ly de­liv­er 50 mil­lion dos­es to the US be­fore year’s end.

“As the au­tumn wore on, how­ev­er, Pfiz­er be­gan re­duc­ing the num­bers of dos­es we could ex­pect to re­ceive,” Man­go writes.

The dos­es were even­tu­al­ly de­liv­ered in a trick­le in ear­ly De­cem­ber, Man­go says, but Pfiz­er shift­ed its promise to 22 mil­lion dos­es, and end­ed up on­ly pro­vid­ing 18 mil­lion.

Al­bert Bourla

“Need­less to say, in those ear­ly weeks, when it came to Pfiz­er’s man­u­fac­tur­ing process, we had lit­tle con­fi­dence at all,” Man­go writes.

Pfiz­er has since dis­trib­uted more Covid-19 dos­es than just about any oth­er com­pa­ny and hauled in more than $20 bil­lion in vac­cine sales last year world­wide. Pfiz­er CEO Al­bert Bourla is al­so writ­ing his own book that may ex­plain some of this sit­u­a­tion more. But still, Man­go in­sists that Pfiz­er was the tough­est to deal with.

“Of all the com­pa­nies in which we in­vest­ed, Pfiz­er was both the least trans­par­ent and least col­lab­o­ra­tive. It would not let us ob­serve its man­u­fac­tur­ing process­es for months and then failed to de­liv­er the con­tract­ed amounts of dos­es it promised in No­vem­ber and De­cem­ber of 2020. This erod­ed the cred­i­bil­i­ty of the GEN [Gus­tave] Per­na’s dis­tri­b­u­tion team in the eyes of many gov­er­nors,” Man­go writes.

Sim­i­lar­ly, Man­go, a West Point grad­u­ate who al­so served as chief of staff at CMS, not­ed the “on­ly prob­lem” Warp Speed en­coun­tered among 18 us­es of the De­fense Pro­duc­tion Act to pri­or­i­tize cer­tain sup­plies, was with Pfiz­er.

“It is hard to know for sure, but pol­i­tics may have been at least par­tial­ly be­hind Pfiz­er’s gen­er­al­ly dif­fi­cult stance to­ward OWS, even while de­pend­ing heav­i­ly on our as­sis­tance with pack­ag­ing, dis­trib­ut­ing, and ad­min­is­ter­ing its dos­es,” Man­go writes, adding:

For a long time, Pfiz­er de­clined to an­swer these ques­tions yet voiced frus­tra­tion with not re­ceiv­ing a pri­or­i­ty rat­ing un­der the DPA. We spec­u­lat­ed that the com­pa­ny in­tend­ed to use the DPA to help it man­u­fac­ture vac­cines that would be shipped over­seas, which, in many cas­es, the DPA pro­hib­it­ed. In the late fall, Pfiz­er be­gan to en­counter se­ri­ous raw ma­te­r­i­al and spare parts con­straints. On­ly then did it com­ply with the DPA’s re­quire­ments and re­ceive (in De­cem­ber) a pri­or­i­ty rat­ing.

Pfiz­er did not re­spond to a re­quest for com­ment.

The GAO al­so not­ed in a re­port from last April that the De­part­ment of De­fense worked with all of the com­pa­nies but Pfiz­er to ne­go­ti­ate ad­di­tion­al gov­ern­ment rights re­quir­ing vac­cine de­vel­op­ers to li­cense their IP so that a con­tract man­u­fac­tur­er may pro­duce the vac­cine for ex­clu­sive sale to the gov­ern­ment.

Mon­cef Slaoui (AP)

“Ac­cord­ing to DOD of­fi­cials, DOD was un­able to ne­go­ti­ate with Pfiz­er to in­clude third par­ty man­u­fac­ture as a rem­e­dy in its agree­ment due to the gov­ern­ment’s lack of in­volve­ment in the Pfiz­er vac­cine’s de­vel­op­ment. Pfiz­er of­fi­cials not­ed that Pfiz­er’s agree­ment does not al­low the gov­ern­ment to ‘march-in,’ as that term is de­fined in 35 U.S.C. § 203, and ac­cord­ing to their agree­ment, gov­ern­ment fund­ing was lim­it­ed to pay­ment for dos­es,” the GAO re­port says.

Deb­o­rah Birx

Man­go al­so re­flects on the ten­sion be­tween Mon­cef Slaoui, Warp Speed’s dis­graced chief sci­en­tif­ic ad­vi­sor who has since been let go from sev­er­al biotechs and boards due to sex­u­al ha­rass­ment, and Deb­o­rah Birx, the White House coro­n­avirus task force co­or­di­na­tor.

Where­as Slaoui in­sist­ed on ad­vanc­ing six vac­cine can­di­dates across three dif­fer­ent tech plat­forms, Birx told the team to fo­cus “on on­ly one of these three plat­forms, a tried-and-test­ed tech­nol­o­gy re­ferred to as ‘pro­tein sub-unit’ be­ing uti­lized by two of our vac­cine can­di­date com­pa­nies Novo­vax and Sanofi,” ac­cord­ing to Man­go.

Hind­sight is 20/20, but nei­ther the Novo­vax nor the Sanofi Covid-19 vac­cines have re­ceived an EUA yet.

And where­as Warp Speed helped NIH build Mod­er­na’s Covid-19 vac­cine from the ground up, mak­ing the EUA a mo­men­tous oc­ca­sion, Man­go notes that the Pfiz­er EUA:

Did not have the same emo­tion­al im­pact on our team. It wasn’t even re­al­ly a Pfiz­er vac­cine. Dis­trib­uted by Pfiz­er, BioN­Tech, a small com­pa­ny in Ger­many, ac­tu­al­ly de­vel­oped it. While heav­i­ly sup­port­ed by Op­er­a­tion Warp Speed in many ways, in­clud­ing a $2 bil­lion ad­vanced pur­chase or­der for 100 mil­lion dos­es, Pfiz­er con­sis­tent­ly chose to op­er­ate at arm’s length. So, we did not feel near­ly the per­son­al own­er­ship of Pfiz­er’s suc­cess as we did of Mod­er­na’s.

Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.