Pfiz­er plans to study a third shot for its Covid-19 vac­cine in the youngest kids, push­ing back its time­line far­ther

Amer­i­can chil­dren un­der the age of five may not be vac­ci­nat­ed un­til mid-2022, as Pfiz­er said Fri­day that it’s go­ing to now test a third dose of its Covid-19 vac­cine in the tri­al.

The de­ci­sion comes as Pfiz­er an­nounced non-in­fe­ri­or­i­ty was not met for chil­dren be­tween the ages of two and five when com­pared to old­er teenagers in the cur­rent tri­al.

Pfiz­er pre­vi­ous­ly said it might ap­ply for an EUA in this youngest pop­u­la­tion by the end of De­cem­ber or ear­ly next year, but now says that if the three-dose study proves suc­cess­ful, Pfiz­er and BioN­Tech ex­pect to sub­mit da­ta to reg­u­la­tors to sup­port an EUA “in the first half of 2022.”

The shift to three dos­es was made af­ter a rou­tine re­view by the ex­ter­nal in­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee, and the tri­al will now eval­u­ate a third dose of 3 µg at least two months af­ter the sec­ond dose in this young age group. Here’s how Pfiz­er ex­plained the non-in­fe­ri­or­i­ty is­sue with the 2- to 5-year-old group in the tri­al:

While the study is on­go­ing and re­mains blind­ed, a pre-spec­i­fied im­muno­genic­i­ty analy­sis was con­duct­ed on a sub­set of the study pop­u­la­tion one month fol­low­ing the sec­ond dose. Com­pared to the 16- to 25-year-old pop­u­la­tion in which high ef­fi­ca­cy was demon­strat­ed, non-in­fe­ri­or­i­ty was met for the 6- to 24-month-old pop­u­la­tion but not for the 2- to un­der 5-year-old pop­u­la­tion in this analy­sis. No safe­ty con­cerns were iden­ti­fied and the 3 µg dose demon­strat­ed a fa­vor­able safe­ty pro­file in chil­dren 6 months to un­der 5 years of age.

Pfiz­er and BioN­Tech are al­so shift­ing to a three-dose reg­i­men for all ages, as the com­pa­nies plan to eval­u­ate a third dose of the 10 µg for­mu­la­tion in chil­dren five to un­der 12 years of age. Ad­di­tion­al­ly, the com­pa­nies have ini­ti­at­ed a low dose sub-study of a third dose of 10 µg or 30 µg in ap­prox­i­mate­ly 600 ado­les­cents aged 12- to 17 to as­sess safe­ty and im­muno­genic­i­ty.

Ini­tial­ly, the Phase I/II/III tri­al, which en­rolled about 4,500 chil­dren aged six months to un­der 12 years in the US, Fin­land, Poland and Spain, was de­signed to eval­u­ate the safe­ty, tol­er­a­bil­i­ty and im­muno­genic­i­ty of the Pfiz­er-BioN­Tech vac­cine on a two-dose sched­ule (ap­prox­i­mate­ly 21 days apart) in three age groups: ages five to un­der 12 years; ages two to un­der five years; and ages six months to un­der two years.

In ad­di­tion to Pfiz­er, Mod­er­na is work­ing on its own Covid-19 vac­cine tri­al for those be­tween the ages of six months and 12.

Stephen Hoge, pres­i­dent of Mod­er­na, said in the com­pa­ny’s Q3 earn­ings call that the com­pa­ny sub­mit­ted da­ta from its Kid­Cove study to the FDA as well as to oth­er coun­tries.

But Hoge not­ed that the com­pa­ny was re­cent­ly no­ti­fied by the FDA that the agency “will re­quire ad­di­tion­al time to eval­u­ate our pro­posed amend­ment due to re­cent analy­sis of the risk of my­ocardi­tis af­ter vac­ci­na­tion in some pop­u­la­tions. The agency ex­pects this eval­u­a­tion may ex­tend un­til Jan­u­ary 2022.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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Sum­i­to­vant sub­sidiaries En­zy­vant and Al­ta­vant merge in­to com­bined com­pa­ny

Two Sumitovant Biopharma entities are merging under one name, effective immediately.

Enzyvant Therapeutics and Altavant Sciences announced they have merged to form a singular entity focused on developing therapies for patients with rare diseases. The combined company will keep the name Enzyvant and along with clinical development will eventually include in-house manufacturing.

Bill Symonds, the current CEO of both Altavant and Enzyvant, is now CEO of the merged company.

Eu­ro­pean Com­mis­sion lays ground­work to un­wind Il­lu­mi­na's $7B+ Grail merg­er

The European Commission has recommended steps that — though not yet final — would require Illumina to “swiftly” unwind its controversial $7.1 billion Grail buyout.

The Commission delivered a “statement of objections” on Monday, detailing the process Illumina would need to take in divesting Grail, its blood testing spinout launched in 2016. Illumina re-acquired Grail back in August, despite criticism from both the FTC and EU.