HHS secretary Alex Azar at the CDC, Oct. 21, 2020 (Alyssa Pointer/Atlanta Journal-Constitution via AP)

Alex Azar, re­fus­ing to ac­knowl­edge elec­tion re­sults, says they're not work­ing with Biden team on vac­cine roll­out

With da­ta now out on two ex­per­i­men­tal vac­cines, the course of the rag­ing US out­break and the suc­cess of the fed­er­al gov­ern­ment’s $18 bil­lion vac­cine ac­cel­er­a­tion pro­gram hinges in part on whether of­fi­cials can suc­cess­ful­ly roll dos­es out to the gen­er­al pub­lic, should they re­ceive FDA au­tho­riza­tion.

It’s a del­i­cate and high­ly tech­ni­cal process, one that of­fi­cials have been game-plan­ning in mil­i­tary table­top style for months. But so far nei­ther those of­fi­cials nor oth­er rep­re­sen­ta­tives from the fed­er­al gov­ern­ment have spo­ken to the ad­min­is­tra­tion that will take over just a month in­to the like­ly roll­out, HHS sec­re­tary Alex Azar said Wednes­day.

Re­fus­ing to ac­knowl­edge the out­come of the No­vem­ber elec­tion, Azar said his agency would not work with pres­i­dent-elect Joe Biden’s team un­til the Gen­er­al Ser­vices Ad­min­is­tra­tion is­sues a let­ter kick-start­ing the process. He said, how­ev­er, that the roll­out is be­ing car­ried out by ca­reer of­fi­cials, en­sur­ing con­ti­nu­ity.

“In the event of a tran­si­tion, all of the in­di­vid­u­als you see here be­sides my­self, all of the peo­ple in­volved in plan­ning at CDC and on the Op­er­a­tion Warp Speed team, these are ca­reer of­fi­cials, so they’re not im­pact­ed by any change in lead­er­ship,” he said at a press con­fer­ence be­side Warp Speed lead­ers Mon­cef Slaoui and Gen­er­al Gus­tave Per­na. “In the event of tran­si­tion, there’s re­al­ly just to­tal con­ti­nu­ity.”

While out­side ex­perts raise red flags over how well cash-strapped states will be able to han­dle a mass vac­ci­na­tion cam­paign, Azar, Slaoui and Per­na tried to project con­fi­dence that of­fi­cials were pre­pared and the roll­out would go smooth­ly.

Oth­ers in and around the gov­ern­ment, though, have been less san­guine. Pfiz­er CEO Al­bert Bourla said this week that he be­lieved dis­tri­b­u­tion would be more or­der­ly than some an­tic­i­pate, but said the state of the pres­i­den­tial tran­si­tion was not “ide­al.” An­tho­ny Fau­ci raised con­cerns on Mon­day that a rough tran­si­tion be­tween Trump and Biden’s ad­min­is­tra­tion could dis­rupt the roll­out.

“We want a smooth process for that,” Fau­ci said on the To­day Show. “And the way you do that is by es­sen­tial­ly hav­ing the two groups speak to each oth­er and ex­change in­for­ma­tion.”

Un­like the White House, ex­ec­u­tives at the lead­ing com­pa­nies de­vel­op­ing Covid-19 vac­cines have pro­vid­ed up­dates to Biden’s team on their progress. CNN re­port­ed that HHS staffers have been in­struct­ed that should a mem­ber of Biden’s team reach out to them, they should con­tact the deputy sur­geon gen­er­al of com­mu­ni­ca­tion and not re­spond.

Slaoui, Warp Speed’s sci­en­tif­ic head, said at the press con­fer­ence that he ex­pect­ed an EUA for both Pfiz­er and Mod­er­na’s vac­cine to come in the mid­dle of De­cem­ber, an es­ti­mate in line with com­pa­ny pre­dic­tions and out­side re­port­ing. He said da­ta from an un­named third vac­cine — like­ly a ref­er­ence to the can­di­date from As­traZeneca and Ox­ford — could fol­low in a few weeks.

Gus­tave Per­na

Should one or both be au­tho­rized, the fed­er­al gov­ern­ment will im­me­di­ate­ly dis­trib­ute some dos­es to all 64 ju­ris­dic­tions it over­sees, Per­na said.

“Up­on re­ceipt of emer­gency use au­tho­riza­tion, all of Amer­i­ca must re­ceive vac­cine with­in 24 hours,” he said. “I think this in­cred­i­bly im­por­tant — fair and eq­ui­table dis­tri­b­u­tion of vac­cine through­out the coun­try. There is no have and have nots.”

The gov­ern­ment ex­pects to ship 40 mil­lion dos­es of vac­cine in De­cem­ber, enough to in­oc­u­late 20 mil­lion peo­ple. States have asked for $8 bil­lion in aid to han­dle those ship­ments and get them in­to arms, but Con­gress has not ap­proved new fund­ing and Azar has re­peat­ed­ly re­buffed the re­quests.

Pfiz­er and Mod­er­na’s vac­cine have dif­fer­ent re­quire­ments for cold-chain stor­age and pre­cise­ly where each vac­cine goes and who should get it will come down to de­ci­sions from the CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices.

Nor­mal­ly that com­mit­tee meets di­rect­ly af­ter an ap­proval is is­sued, but Azar said he is try­ing to have them meet at the same time the FDA ad­vi­so­ry com­mit­tee meets. In Sep­tem­ber, the ACIP raised se­ri­ous con­cerns about the chal­lenges that the roll­out of the Pfiz­er-BioN­Tech vac­cine would pose.

“The com­plex­i­ties of this plan for vac­cine stor­age and han­dling will have ma­jor im­pact in our abil­i­ty to ef­fi­cient­ly de­liv­er the vac­cine,”  Nan­cy Mes­son­nier, di­rec­tor of the CDC’s Na­tion­al Cen­ter for Im­mu­niza­tion and Res­pi­ra­to­ry Dis­eases, said at the time.

The Pfiz­er-BioN­Tech mR­NA can­di­date needs to be stored and shipped at -94 de­grees Fahren­heit and can on­ly be kept at nor­mal fridge tem­per­a­tures for up to 7 days. Pfiz­er and the gov­ern­ment say the “ther­mal ship­pers” they de­vel­oped should mit­i­gate con­cerns. Mod­er­na’s vac­cine can be shipped at -4 de­grees and stored in the fridge for up to a month.

Mon­cef Slaoui (AP)

Slaoui ac­knowl­edged that reg­u­la­tors would on­ly have a cou­ple months fol­low-up on the first two vac­cines when they are like­ly au­tho­rized, but he laid out in stark terms what he saw as the cost of wait­ing now that the virus is surg­ing to record lev­els across the coun­try.

Around 70% of the coun­try, he said, would like­ly have to be im­mu­nized to achieve herd im­mu­ni­ty.

“We have north of 150,000 peo­ple in­fect­ed every day and north of 1,000 peo­ple dy­ing every­day,” he said at a press con­fer­ence. “And wait­ing 2 more months or 4 more months will count in the tens or hun­dreds of thou­sands of more deaths the harm to the pop­u­la­tion that no vac­cine would ever even ap­proach.”

He said, how­ev­er, that they will still col­lect da­ta on the vac­cines af­ter the EUA. That in­cludes short- and long-term safe­ty mon­i­tor­ing, but al­so da­ta on how durable the vac­cines are and how well they pre­vent asymp­to­matic in­fec­tion. Slaoui pre­dict­ed the da­ta will show some but not com­plete pro­tec­tion.

It’s un­clear when Mod­er­na or Pfiz­er will un­blind the stud­ies, but Slaoui said the lat­est it would come is 2 to 3 months af­ter the EUA, when he pre­dict­ed the FDA would for­mal­ly ap­prove both vac­cines.

Still, he said, the US would need more vac­cines to cov­er the pop­u­la­tion and he urged more Amer­i­cans to sign up for on-go­ing and forth­com­ing tri­als on the next wave of can­di­dates. It would not on­ly help the world get an­swers faster, he said, but al­so give you 50/50 odds of get­ting a vac­cine to­mor­row in­stead of in sev­er­al months.

“We now know that vac­ci­na­tion is pos­si­ble — not on­ly it’s pos­si­ble, it’s in­cred­i­bly ef­fec­tive. It’s very like­ly that oth­er vac­cines will al­so be as ef­fec­tive,” he said. “Come and par­tic­i­pate.”

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

Scoop: Google’s GV spear­heads the Spot­light syn­di­cate — back­ing an up­start biotech aimed at ‘de­moc­ra­tiz­ing’ gene edit­ing

CRISPR had no sooner started to shake the very foundations of drug development before its limitations began to loom large. Gene editing could change the world — if only you could get around the hurdles that threatened to trip up every program.

So it’s only natural to see CRISPR 2.0 taking shape before the pioneers can get the lead therapies through development. And who better than Google’s GV venture arm to take the lead spot in a small syndicate backing some scientists with their own unique twist on a solution?

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

Robert Clarke (Kinaset)

Ki­naset launch­es with $40M and a JAK in­hibitor from Vec­tura's old pipeline

Kinaset Therapeutics is joining the search for a better severe asthma treatment, picking up where Vectura left off when it decided to clear house last year.

UK-based Vectura — which took a big hit when its most advanced candidate flopped in a Phase III asthma trial back in 2018 — recently shifted to a CDMO model, offloading all of its R&D programs. Robert Clarke, who’s worked on inhalable therapeutics for 21-plus years, had close contacts at the company and took a look at what they were offering. After doing some research, he was attracted by VR475, a pan-JAK inhibitor.

Stephané Bancel (Endpoints at JPM20)

Mod­er­na cal­i­brates fi­nal Covid-19 vac­cine ef­fi­ca­cy at 94.1% — and to­day it's gun­ning for the EUA

Nearly a year ago, as the coronavirus emerged in China, the NIH and four major companies bet on an unproven genetic technology as the best tool for developing a vaccine to stem the outbreak. Today, a second such vaccine is heading to the FDA.

Moderna said Monday that they will request an emergency use authorization from the FDA after a final analysis showed their mRNA vaccine was 94.1% effective at preventing symptomatic Covid-19. The data confirm the results from an interim analysis and matches efficacy Pfizer and BioNTech showed in a Phase III study, setting the biotech up to potentially nab one of the first two Covid-19 vaccine OKs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,300+ biopharma pros reading Endpoints daily — and it's free.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

Endpoints Premium

Premium subscription required

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