Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Mon­cef Slaoui hasn’t start­ed mak­ing plans for his sum­mer va­ca­tion next year. But he of­fers high odds that all Amer­i­cans will be able to do that in the not too dis­tant fu­ture.

In an in­ter­view with a pair of sym­pa­thet­ic pod­cast­ers at the con­ser­v­a­tive Amer­i­can En­ter­prise In­sti­tute, Slaoui pro­vides an ed­u­ca­tion to lis­ten­ers on how any drug or vac­cine can be sped through tri­als. And he leaves the door wide open to the no­tion that the lead­ing vac­cine de­vel­op­ers can demon­strate ef­fi­ca­cy and safe­ty in a com­pelling fash­ion as ear­ly as Oc­to­ber — or as late as the end of this year.

But Slaoui says he is quite con­fi­dent that based on what he knows now, there’s good rea­son to be hope­ful that vac­cines will be avail­able in suf­fi­cient quan­ti­ty to cov­er all the at-risk pop­u­la­tion in the US — up to 40 mil­lion peo­ple — by the end of Feb­ru­ary. And he’s look­ing for sev­er­al vac­cines to cross the fin­ish line, so that the ex­perts can choose which are the most like­ly to work based on de­mo­graph­ics and risk.

Slaoui’s po­si­tion on this will be close­ly fol­lowed. He end­ed a 30-year stint at GSK as chair­man of the vac­cines group, top­ping it off with the high­ly suc­cess­ful Shin­grix pro­gram. With his switch to OWS, Slaoui di­vest­ed his Mod­er­na shares — jump­ing from the board of one of the lead­ing vac­cine de­vel­op­ers to OWS — but kept his GSK stock, which trig­gered some crit­i­cism that he’s still clear­ly deeply re­sent­ful about.

For crit­ics, it’s all fod­der for dis­cus­sion as every­one fo­cus­es in on the high­ly po­tent top­ic of whether Pres­i­dent Trump will force through a vac­cine an­nounce­ment — herald­ing a suc­cess­ful piv­otal tri­al — in time to in­flu­ence the elec­tion. And like every ex­pert in the gov­ern­ment, from FDA com­mis­sion­er Stephen Hahn to NI­AID di­rec­tor An­tho­ny Fau­ci, Slaoui says the sci­ence will be all that mat­ters.

Draw­ing from a tran­script of the call, here’s Slaoui de­scrib­ing in de­tail how vac­cine de­vel­op­ment is done:

We’re run­ning very large tri­als be­cause they al­low us to reach ef­fi­ca­cy faster, not be­cause there’s an elec­tion, be­cause there’s thou­sands of peo­ple dy­ing every day. And the da­ta will be de­fined by the num­ber of cas­es. There is no date. It’s im­pos­si­ble to give you a date. I have been asked about dates, and I didn’t feel any pres­sure what­so­ev­er to say da­ta will de­fine the date. When we have the num­ber of cas­es re­quired and then we have an in­de­pen­dent da­ta safe­ty mon­i­tor­ing board in­de­pen­dent­ly look in­to the da­ta and says we need to con­tin­ue, we need to stop be­cause this is not work­ing, or we need to stop be­cause this is work­ing too well, it’s un­eth­i­cal to con­tin­ue, we now need to start to give the vac­cine to the place­bo arm in the tri­al and to oth­er peo­ple to con­sid­er, then that will be the end. So the end of the tri­als is com­plete­ly in­de­pen­dent of the op­er­a­tion or any­body in­volved in the op­er­a­tion. It’s ac­tu­al­ly great aca­d­e­m­ic ex­perts, whose names are un­known to the pub­lic who are look­ing in­to that da­ta. And this is how all clin­i­cal tri­als are al­ways done. That is how clin­i­cal tri­als are done.

So when will we know?

So the da­ta will dic­tate, the facts will dic­tate. We may have the end point in Oc­to­ber. We may have it in No­vem­ber 4th, who knows? We may have it in De­cem­ber 15th. That’s the an­swer, and to be hon­est, on a per­son­al ba­sis, I would re­sign in­stant­ly if I was forced to do some­thing that I thought would be in­ap­pro­pri­ate.

From the pod­cast­ers: What’s your time­line? Or what’s your thought on that?

I hope we will have enough dos­es of vac­cines in the first two months of 2021 to im­mu­nize the at risk pop­u­la­tions in the US, vac­cines that could have shown ef­fi­ca­cy and ap­proved in­de­pen­dent­ly by the FDA. And I’m talk­ing about maybe the 30 to 40 mil­lion most sus­cep­ti­ble peo­ple in the US across maybe De­cem­ber, Jan­u­ary, Feb­ru­ary.

And then and I think that should de­crease dra­mat­i­cal­ly the bur­den of this dis­ease on so­ci­ety in gen­er­al. Be­cause, as you know, most of the bur­den of the dis­ease is on a high risk pop­u­la­tion. Plus the sec­ondary ef­fect of over­whelm­ing the hos­pi­tal sys­tems, et cetera, which has an im­pact on oth­er pop­u­la­tions for oth­er rea­sons. And I think, from there on, it’s go­ing to be a grad­ual process that will be a bal­ance be­tween the ben­e­fits/risks that the vac­cines will have shown and the risk of par­tic­u­lar sub­pop­u­la­tion.

For in­stance, frankly, im­mu­niz­ing the pe­di­atric pop­u­la­tion, tod­dlers, et cetera, will be some­thing that should be re­al­ly far be­cause they have 70 or 80 years to live. And we need prob­a­bly there to use plat­form tech­nolo­gies that are well un­der­stood in the long range, such as pro­tein based vac­cines, et cetera. We are for­tu­nate that most­ly in that pop­u­la­tion the dis­ease bur­den is very, very low. And so, I think there will be a gra­di­ent of views. But prob­a­bly be­tween the first quar­ter and the sec­ond quar­ter of 2021, the most at risk pop­u­la­tions will have been, I hope, im­mu­nized. And life, I would ex­pect… I hope next sum­mer I can have a va­ca­tion, nor­mal va­ca­tion.

What­ev­er hap­pens to his va­ca­tion plans, one thing seems cer­tain. Mil­lions of peo­ple will be ar­gu­ing over the de­vel­op­ment time­line right un­til the elec­tion is de­cid­ed.

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

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

Endpoints Premium

Premium subscription required

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

The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,100+ biopharma pros reading Endpoints daily — and it's free.

J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,100+ biopharma pros reading Endpoints daily — and it's free.

Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Roche and Genen­tech re­searchers plot $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Roche and Genentech have committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Researchers from both Roche and its big South San Francisco hub — mixing teams from gRED and pRED this time — will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

Am­gen, As­traZeneca speed to­ward fil­ing next-gen an­ti­body for asth­ma af­ter un­cork­ing full late-stage da­ta

On the hunt for a novel competitor to Sanofi and Regeneron’s Dupixent in severe asthma, Amgen and AstraZeneca posted “exciting” results from their next-gen antibody late last year. Now, the partners are showing their hands, and the results look good enough for approval.

Amgen and AstraZeneca’s tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared with SOC alone, according to full data from the Phase III NAVIGATOR study presented Friday at the virtual American Academy of Allergy, Asthma & Immunology meeting. And those significant results were consistent regardless of patients’ baseline eosinophil counts.