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.

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”