FDA au­tho­rizes Pfiz­er, Mod­er­na Covid-19 vac­cines for chil­dren as young as 6 months

More than 18 months af­ter adults were able to start re­ceiv­ing Pfiz­er-BioN­Tech’s and Mod­er­na’s Covid-19 vac­cines, kids as young as six months are on the verge of be­ing able to get in­oc­u­lat­ed against the pan­dem­ic virus.

The FDA au­tho­rized the Pfiz­er-BioN­Tech and Mod­er­na vac­cines Fri­day morn­ing un­der EUA af­ter the agency’s out­side ad­vi­sors unan­i­mous­ly fa­vored (21-0) ad­min­is­ter­ing the shots. Par­ents and care­givers just have to wait for the CDC to sign off be­fore the youngest of Amer­i­ca’s kids can get the vac­cine.

Un­like the orig­i­nal adult emer­gency green­light, kids will take a three-dose pri­ma­ry se­ries of the Pfiz­er-BioN­Tech shot. Mod­er­na’s shot will be de­liv­ered as two dos­es. The vac­cines have reaped bil­lions of dol­lars for the com­pa­nies in the past year and a half and have helped ce­ment mR­NA tech­nol­o­gy in bio­phar­ma R&D.

All states but Flori­da have al­ready or­dered the Covid-19 vac­cine for chil­dren, ac­cord­ing to news re­ports.

“We are grate­ful to all the par­ents and care­givers who made to­day’s au­tho­riza­tion pos­si­ble by choos­ing to en­roll their chil­dren in our COVID-19 vac­cine clin­i­cal tri­al,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

Ef­fi­ca­cy of Pfiz­er’s three-dose se­ries was de­ter­mined by 376 kids who re­ceived the vac­cine and 179 who re­ceived place­bo in a group of chil­dren aged 6 to 23 months. One Covid-19 case oc­curred in the vac­cine arm and two in the place­bo arm. In the 2- to 4-year age range, 589 re­ceived the Pfiz­er vac­cine and 271 kids got the place­bo. Two cas­es oc­curred in the vac­cine group and five in the place­bo group.

Dur­ing the ad­vi­so­ry com­mit­tee meet­ing on Wednes­day, ad­vi­sors had a few reser­va­tions giv­en the two-dose da­ta ap­peared to show lit­tle ef­fi­ca­cy, but the ex­perts sup­port­ed the over­all risk-ben­e­fit ra­tio.

Paul Of­fit

One ad­vi­sor, Paul Of­fit, di­rec­tor of the vac­cine ed­u­ca­tion cen­ter at the Chil­dren’s Hos­pi­tal of Philadel­phia, said those low lev­els of ef­fi­ca­cy af­ter the sec­ond vac­cine dose were con­cern­ing, and not­ed the vac­cine may end up be­ing a four-dose se­ries.

Ef­fi­ca­cy of Mod­er­na’s vac­cine se­ries was 36.8% for the 2 to 5 age group and 50.6% for kids 6 to 23 months of age. Those re­spons­es oc­curred when Omi­cron was pre­dom­i­nant. In the 2 to 5 age group, 4.6% of kids with the vac­cine end­ed up get­ting the pan­dem­ic dis­ease af­ter the sec­ond dose, com­pared to 7.1% of the kids on place­bo.

A Kaiser Fam­i­ly Foun­da­tion sur­vey in May found that just 18% of par­ents with chil­dren un­der age 5 were “ea­ger” to get their kid vac­ci­nat­ed right away. About 38% of par­ents said they would wait to see how the vac­cine is work­ing for oth­er peo­ple, and 27% of par­ents said they will “def­i­nite­ly not” take their kids to get vac­ci­nat­ed against SARS-CoV-2. And just over one in 10 said they would on­ly get their child vac­ci­nat­ed if they were re­quired to do so.

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.

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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!

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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.

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#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.

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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.

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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.

Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.