President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month af­ter word first broke of the Trump Ad­min­is­tra­tion’s plan to rapid­ly ac­cel­er­ate the de­vel­op­ment and pro­duc­tion of a Covid-19 vac­cine, the White House has se­lect­ed the five vac­cine can­di­dates they con­sid­er most like­ly to suc­ceed, The New York Times re­port­ed.

Most of the names in the plan, known as Op­er­a­tion Warp Speed, will come as lit­tle sur­prise to those who have watched the last four months of vac­cine de­vel­op­ments: Mod­er­na, which was the first vac­cine to reach hu­mans and is now the fur­thest along of any US ef­fort; J&J, which has not gone in­to tri­als but re­ceived around $500 mil­lion in fund­ing from BAR­DA ear­li­er this year; the joint As­traZeneca-Ox­ford ven­ture which was grant­ed $1.2 bil­lion from BAR­DA two weeks ago; Pfiz­er, which has been work­ing with the mR­NA biotech BioN­Tech; and Mer­ck, which just en­tered the race and ex­pects to put their two vac­cine can­di­dates in­to hu­mans lat­er this year.

Paul Hud­son

No­tably ab­sent from that list is Sanofi. The French vac­cine gi­ant has worked with BAR­DA since the agency’s ear­ly days and re­ceived $30 mil­lion in fund­ing ear­li­er this year for its re­com­bi­nant DNA Covid-19 vac­cine ef­fort. The omis­sion comes af­ter CEO Paul Hud­son caused an in­ter­con­ti­nen­tal stir last month when he said that the US would get the “right to the largest pre-or­der” of their vac­cine be­cause the fed­er­al gov­ern­ment had backed the project at-risk, al­though the com­pa­ny lat­er walked back some of those com­ments.

A cou­ple oth­er much-hyped vac­cine ef­forts were left out, in­clud­ing those from No­vaVax and In­ovio. In­vestors, who had sent their stocks cloud-bound dur­ing the pan­dem­ic, quick­ly took note of their ex­clu­sion, sink­ing shares 12% and 11%, re­spec­tive­ly.

It’s pos­si­ble, though, that oth­er names may arise. Bloomberg re­port­ed late yes­ter­day that the White House had se­lect­ed 7 dif­fer­ent can­di­dates, al­though they were able to give on­ly the names of the five that the Times re­port­ed.

A for­mal an­nounce­ment is ex­pect­ed to be made lat­er this month, the New York Times re­port­ed. A spokesper­son for HHS, which over­sees the vast bulk of the gov­ern­ment’s vac­cine and drug re­sponse, de­clined to com­ment.

The new win­now­ing ap­pears to be part of the third phase of the project, which was for­mal­ly an­nounced in a press re­lease on May 15. HHS said at the time that 14 dif­fer­ent vac­cine can­di­dates had been se­lect­ed out of the 100-plus in de­vel­op­ment but, with the ex­cep­tion of bil­lion­aire physi­cian Patrick Soon-Sh­iong, none of the mak­ers of those can­di­dates said whether they were part of the project and nei­ther did the gov­ern­ment.

Ac­cord­ing to HHS, those 14 can­di­dates would then be cut down to 8 dif­fer­ent can­di­dates and, fi­nal­ly, to 3-5 can­di­dates that will pro­ceed to “large-scale ran­dom­ized tri­als.” These can­di­dates are al­so those that, in part­ner­ship with the gov­ern­ment, will go in­to large-scale man­u­fac­tur­ing be­fore they’ve been ful­ly test­ed or au­tho­rized — a cru­cial step for as­sur­ing that when a vac­cine is proven, it can al­so be rapid­ly de­ployed.

The com­pa­nies will al­so like­ly get ad­di­tion­al fund­ing, the New York Times re­port­ed, on top of the rough­ly $2.2 bil­lion al­ready al­lo­cat­ed be­tween Mod­er­na, J&J, and As­traZeneca. BAR­DA re­ceived $6.5 bil­lion un­der the CARES Act, al­though that fund is not ex­clu­sive­ly for vac­cines.

The ad­min­is­tra­tion has not pub­licly set goal­posts for the op­er­a­tion, but in late April Bloomberg quot­ed an of­fi­cial at 300 mil­lion dos­es by Jan­u­ary and most state­ments have giv­en a sim­i­lar range. NI­AID chief An­tho­ny Fau­ci said on Tues­day “by the be­gin­ning of 2021 we hope to have a cou­ple of hun­dred mil­lion dos­es.”

Ken Fra­zier Mer­ck

That time­line would be or­ders of mag­ni­tude faster than the or­di­nary pace of vac­cine de­vel­op­ment, which can of­ten take at least a decade, and some vi­rol­o­gist and vac­cine de­vel­op­ers have ques­tioned how at­tain­able it is. That group in­cludes Mer­ck CEO Ken Fra­zier, who told FT that a 12-18 month time­line for a vac­cine was “very ag­gres­sive” and “not some­thing I would put out there that I would want to hold Mer­ck to.”

Much of the work to reach that goal is al­ready un­der­way. As­traZeneca’s agree­ment with BAR­DA called for the com­pa­ny to pro­vide 300 mil­lion dos­es to the US, start­ing in Oc­to­ber, and Mod­er­na signed an agree­ment with Swiss CMO Lon­za to pro­duce a bil­lion dos­es per year, with the first batch­es com­ing in Ju­ly.

The se­lect­ed can­di­dates cov­er at least three dif­fer­ent tech­nolo­gies, in­clud­ing mR­NA from Mod­er­na and BioN­Tech and ade­n­ovi­ral vec­tors from J&J and As­traZeneca. Mer­ck has two can­di­dates, one that us­es a vec­tor called VSV and an­oth­er that us­es a measles virus vec­tor. It was not clear which can­di­date was se­lect­ed by the gov­ern­ment, al­though the VSV one has al­ready been backed by $38 mil­lion from BAR­DA and the agency put sev­er­al hun­dred mil­lion dol­lars be­hind an Ebo­la vac­cine from Mer­ck that used the same plat­form.

The fur­thest along of the ef­forts are As­traZeneca and Mod­er­na, both of which are now in Phase II. Fau­ci said in an in­ter­view with JA­MA on Tues­day that Mod­er­na could move in­to a glob­al, 30,000-per­son Phase III tri­al next month.

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

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Covid-19 has roiled clin­i­cal tri­al plans around the world, rais­ing con­cerns over the in­dus­try’s fu­ture on new drug ap­provals

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.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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