Özlem Türeci, BioNTech co-founder and Uğur Şahin, BioNTech CEO

Third dose bumps up ef­fi­ca­cy of Pfiz­er-BioN­Tech's Covid-19 vac­cine in youngest group of chil­dren to 80%

Pfiz­er and BioN­Tech said Mon­day that they’re ready to ap­proach the FDA this week with ear­ly da­ta for their boost­er shot for Covid-19 vac­cine in the youngest age group (6 months to un­der 5 years), which showed 80.3% ef­fi­ca­cy based on 10 symp­to­matic Covid cas­es iden­ti­fied be­gin­ning sev­en days af­ter the third dose.

“The study sug­gests that a low 3-ug dose of our vac­cine, care­ful­ly se­lect­ed based on tol­er­a­bil­i­ty da­ta, pro­vides young chil­dren with a high lev­el of pro­tec­tion against the re­cent COVID-19 strains,” Uğur Şahin, CEO and co-founder of BioN­Tech said in a state­ment. “We are prepar­ing the rel­e­vant doc­u­ments and ex­pect com­plet­ing the sub­mis­sion process to the FDA this week, with sub­mis­sions to EMA and oth­er reg­u­la­to­ry agen­cies to fol­low with­in the com­ing weeks.”

The vac­cine al­so proved to be as safe as place­bo, Pfiz­er said.

The FDA is like­ly to of­fer a swift EUA to both Pfiz­er’s vac­cine and Mod­er­na’s two-dose Covid-19 vac­cine for this youngest group of chil­dren with­in the next month or so, bar­ring any last-minute con­cerns by FDA staff. Af­ter re­view­ing the ap­pli­ca­tions, the agency said it will hold a joint ad­vi­so­ry com­mit­tee meet­ing for the two vac­cines on June 15. And June 14 will be the new meet­ing date for the FDA and its ad­vi­so­ry com­mit­tee of ex­ter­nal ex­perts to dis­cuss Mod­er­na’s EUA re­quest for 6 years through 17 years of age.

Once the apps are ful­ly sub­mit­ted and the meet­ing dates are fi­nal­ized, the FDA will re­lease its own analy­ses of the Pfiz­er and Mod­er­na da­ta no lat­er than two busi­ness days be­fore each meet­ing.

Late last month, Mod­er­na com­plet­ed the fil­ing of its EUA ap­pli­ca­tion, pre­vi­ous­ly an­nounc­ing that its vac­cine is 51% ef­fec­tive in chil­dren 6 months to 2 years of age and 37% ef­fec­tive in 2- to 5-year-olds. And while that sub-50% ef­fi­ca­cy num­ber may raise eye­brows, FDA’s Pe­ter Marks has said that it’s OK as long as the ef­fi­ca­cy is above 50% for the en­tire range of the ap­pli­ca­tion sub­mit­ted (6 months to 17 year-olds).

Mean­while, Pfiz­er and BioN­Tech’s tri­al is still wrap­ping up, with the pro­to­col spec­i­fy­ing a for­mal analy­sis will be per­formed when at least 21 cas­es have ac­crued from sev­en days af­ter the third dose. Fi­nal vac­cine ef­fi­ca­cy da­ta will be shared once avail­able, Pfiz­er said.

In to­tal, the part­ners’ Phase II/III tri­al in­clud­ed 1,678 chil­dren re­ceiv­ing a third dose of the 3-µg for­mu­la­tion at least two months af­ter the sec­ond dose at a time when Omi­cron was the pre­dom­i­nant vari­ant.

The im­muno­genic­i­ty analy­sis of geo­met­ric mean titer ra­tio and sero-re­sponse rate was con­duct­ed on a sub­set of study par­tic­i­pants one month fol­low­ing the third dose in chil­dren 6 months to un­der 5 years of age, com­pared to the sec­ond dose in the 16- to 25-year-old pop­u­la­tion. Pfiz­er said non-in­fe­ri­or­i­ty was met for both the 6- to 24-month-old pop­u­la­tion and the 2- to un­der 5-year-old pop­u­la­tion for both co-pri­ma­ry end­points.

Three 3-µg dos­es of the Pfiz­er-BioN­Tech vac­cine were well-tol­er­at­ed in this age group, Pfiz­er added, not­ing that the ma­jor­i­ty of ad­verse events were mild or mod­er­ate.

The chil­dren who par­tic­i­pat­ed in the tri­al and re­ceived place­bo are now be­gin­ning to re­ceive their vac­cines.

Ed­i­tor’s note: Up­dat­ed with more in­for­ma­tion on the new FDA ad­vi­so­ry com­mit­tee meet­ing times.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

Endpoints Premium

Premium subscription required

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

Albert Bourla (Photo by JOHN THYS/POOL/AFP via Getty Images)

As boost­er sea­son awaits, US re-ups sup­ply of Pfiz­er Covid-19 vac­cine with new $3.2B deal

The US government said late Wednesday that it will pay Pfizer and its partner BioNTech $3.2 billion upon receipt of the first 105 million Covid-19 vaccine doses, potentially the new Omicron-adapted boosters pending EUA.

Under this agreement, the US government also has the option to purchase up to 195 million additional doses, bringing the total number of potential new doses to 300 million. The US has now spent almost $15 billion on Pfizer’s Covid-19 vaccine.

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,900+ biopharma pros reading Endpoints daily — and it's free.

On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.