FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden ad­min­is­tra­tion’s goal of kick­ing off its boost­er shot dri­ve for the en­tire US pop­u­la­tion this week is not quite go­ing as planned.

First, Pfiz­er ap­plied for ap­proval of a sup­ple­men­tal ap­pli­ca­tion for the boost­er shots, but since last Fri­day’s ad­comm re­view­ing them, the plan has de­volved in­to an EUA, which the FDA is­sued late Wednes­day evening.

The pop­u­la­tion that is now el­i­gi­ble for the boost­er, six months af­ter re­ceiv­ing the first pair of Pfiz­er-BioN­Tech vac­cines, al­so nar­rowed from what Pfiz­er ap­plied for (every­one who’s el­i­gi­ble for the ini­tial Pfiz­er shots) to just those who are 65 or old­er, or at high-risk of a Covid in­fec­tion, in­clud­ing health care work­ers and oth­ers with oc­cu­pa­tion­al haz­ards.

“Af­ter con­sid­er­ing the to­tal­i­ty of the avail­able sci­en­tif­ic ev­i­dence and the de­lib­er­a­tions of our ad­vi­so­ry com­mit­tee of in­de­pen­dent, ex­ter­nal ex­perts, the FDA amend­ed the EUA for the Pfiz­er-BioN­Tech COVID-19 Vac­cine to al­low for a boost­er dose in cer­tain pop­u­la­tions such as health care work­ers, teach­ers and day care staff, gro­cery work­ers and those in home­less shel­ters or pris­ons, among oth­ers,” act­ing FDA com­mis­sion­er Janet Wood­cock said in a state­ment.

The agency said it’s re­ly­ing on an analy­sis from Pfiz­er show­ing that over the last two months, the in­ci­dence of Covid-19 was high­er among the tri­al par­tic­i­pants who com­plet­ed their pri­ma­ry vac­cine se­ries ear­li­er, com­pared to par­tic­i­pants who com­plet­ed it lat­er.

“The FDA de­ter­mined that the rate of break­through COVID-19 re­port­ed dur­ing this time pe­ri­od trans­lates to a mod­est de­crease in the ef­fi­ca­cy of the vac­cine among those vac­ci­nat­ed ear­li­er,” the agency said.

And for those re­ceiv­ing the boost­ers due to high risk of se­vere Covid-19 and in­sti­tu­tion­al or oc­cu­pa­tion­al ex­po­sure risk, they must be adult, 18 through 64 years of age, which ex­cludes the 12-18 age group for which the vac­cine is ei­ther au­tho­rized or ap­proved.

The EUA fol­lows close de­bate and dis­agree­ment among vac­cine ex­perts ad­vis­ing the FDA, and the FDA’s own in­ter­nal vac­cine ex­perts.

The FDA’s ad­comm on vac­cines round­ly re­ject­ed the Pfiz­er/BioN­Tech boost­er shots for all in­di­vid­u­als old­er than 16 by a 16-2 vote Fri­day af­ter­noon. Soon af­ter, how­ev­er, the agency posed a new ques­tion to com­mit­tee mem­bers on lim­it­ing boost­er use to the 65-and-old­er pop­u­la­tion and in­di­vid­u­als at high risk of dis­ease due to oc­cu­pa­tion­al ex­po­sure or co­mor­bidi­ties (which is what the agency in­evitably went with).

That ques­tion, com­ing rough­ly 45 min­utes af­ter the first, passed through the ad­comm with a unan­i­mous 18-0 vote. This vote cen­tered on an EUA — not the sBLA for which Pfiz­er had ap­plied. While CBER head Pe­ter Marks al­lowed the ad­di­tion­al ques­tion and vote, which were not on the agen­da, top CBER of­fi­cial Mar­i­on Gru­ber ques­tioned the move. Gru­ber and her deputy Phil Krause are re­tir­ing soon, at least in part due to the ad­min­is­tra­tion’s over-step­ping its bounds on the boost­er de­ci­sion, they wrote in the Lancet last week.

Krause al­so ques­tioned Pfiz­er at the ad­comm on cer­tain sta­tis­ti­cal dis­crep­an­cies that showed its vac­cine’s ef­fi­ca­cy plum­met­ed to about 60%, where­as his analy­sis through a dif­fer­ent math­e­mat­i­cal process us­ing cas­es per per­son-years re­sult­ed in 93% ef­fi­ca­cy. These dis­parate fig­ures, Krause said, came from the same num­ber of cas­es in a study by Kaiser Per­ma­nente.

The CDC’s ACIP com­mit­tee will meet Thurs­day to dis­cuss its rec­om­men­da­tion on who specif­i­cal­ly should ac­cess boost­ers.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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James Dentzer, Curis CEO

FDA lifts par­tial hold on Curis' lym­phoma study — shares spike

Four months after the FDA put two clinical trials from Curis on clinical hold, the FDA is now apparently content with how the biotech will change up managing one of the studies.

The Massachusetts oncology biotech put out word early Thursday that the federal regulator lifted a partial clinical hold of the company’s Phase I/II study of emavusertib in lymphoma, following a new data package that the biotech recently submitted to the agency. Shares of the biotech $CRIS, hovering just above penny stock territory, shot up more than 55% in early trading before settling at close to a 30% share price boost.

Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”