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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

President Joe Biden (AP Photo/Susan Walsh)

Biden signs law re­quir­ing more de­clas­si­fi­ca­tions on Covid-19's ori­gins

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.