Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee to dis­cuss Pfiz­er/BioN­Tech boost­ers for all adults; US buys up $1B in GSK/Vir mAbs

About a week af­ter Pfiz­er asked reg­u­la­tors to ex­pand its Covid-19 boost­er shot EUA to in­clude all adults, the CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices has sched­uled a meet­ing to dis­cuss the idea.

ACIP will meet this Fri­day, and is ex­pect­ed to give an of­fi­cial rec­om­men­da­tion soon af­ter, The As­so­ci­at­ed Press re­port­ed on Tues­day.

Pfiz­er and BioN­Tech’s boost­er shot is cur­rent­ly au­tho­rized for those 65 years and old­er, or at high-risk of a Covid in­fec­tion, in­clud­ing health care work­ers and oth­ers with oc­cu­pa­tion­al haz­ards. Be­fore de­cid­ing on those lim­i­ta­tions, the FDA’s ad­vi­so­ry com­mit­tee on Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts (VRB­PAC) round­ly re­ject­ed Pfiz­er/BioN­Tech boost­er shots for all in­di­vid­u­als old­er than 16 by a 16-2 vote.

Pfiz­er says its new sub­mis­sion is based on the re­sults from a Phase III tri­al show­ing a rel­a­tive vac­cine ef­fi­ca­cy of 95% for those who re­ceived a boost­er com­pared to those who did not. That study was con­duct­ed with 10,000 vol­un­teers in the US, Brazil and South Africa when the Delta vari­ant was the preva­lent strain.

Though Mod­er­na’s boost­er dose is cur­rent­ly lim­it­ed to the same pop­u­la­tion as Pfiz­er’s, the FDA has au­tho­rized “mix-and-match” boost­er dos­es for those who are el­i­gi­ble. Peo­ple who re­ceived the J&J vac­cine are el­i­gi­ble to re­ceive a boost­er of any type af­ter two months.

Some states aren’t wait­ing for the gov­ern­ment to au­tho­rize boost­er shots for all adults. States like Arkansas, Col­orado and New Mex­i­co have opened up mR­NA boost­er vac­cine el­i­gi­bil­i­ty for all adults, CBS News re­port­ed re­cent­ly. — Nicole De­Feud­is 

US buys $1B worth of GSK and Vir’s mon­o­clon­al an­ti­body treat­ment

The US gov­ern­ment has now con­tract­ed to pur­chase ap­prox­i­mate­ly $1 bil­lion worth of Glax­o­SmithK­line and Vir’s mon­o­clon­al an­ti­body treat­ment for ear­ly Covid-19, the com­pa­nies said Wednes­day.

The lat­est gov­ern­ment con­tract is worth $651.1 mil­lion and cov­ers around 300,000 dos­es, ac­cord­ing to the Wall Street Jour­nal.

The gov­ern­ment has now dis­trib­uted more than 175,000 dos­es na­tion­wide, and GSK/Vir say in­clud­ing the con­tracts an­nounced to­day, GSK and Vir have re­ceived bind­ing agree­ments for the sale of more than 750,000 dos­es of sotro­vimab world­wide. Dis­tri­b­u­tion of the treat­ment, known as sotro­vimab, was re­cent­ly hand­ed over to the US gov­ern­ment too. — Zachary Bren­nan

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

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

Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,600+ biopharma pros reading Endpoints daily — and it's free.