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

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

Endpoints Premium

Premium subscription required

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

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

Endpoints Premium

Premium subscription required

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

Petro Terblanche, Afrigen Biologics managing director (Kristin Palitza/picture-alliance/dpa/AP Images)

WHO-backed Afrigen plans a charge to­ward the clin­ic with Africa's first Covid-19 vac­cine

NEW YORK — When vaccines from high-income countries did not arrive in Africa, a local WHO-backed company decided to take the matter into its own hands.

The South Africa-based company Afrigen Biologics and Vaccines has developed the continent’s first mRNA Covid-19 vaccine that will enter clinical trials in early 2023. Afrigen developed the shot by copying publicly available sequencing information about Moderna’s shot after the biotech and Pfizer refused assistance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Covid-19 roundup: Mod­er­na sends in EUA for bi­va­lent teen boost­er; US trim­ming Pfiz­er/BioN­Tech do­na­tions

Though Moderna’s bivalent vaccine to counter the Omicron variant has cleared the initial hurdles in getting FDA authorization, the vaccine maker is moving on to the next step.

On Twitter, the company announced on Friday that it has filed a EUA for its bivalent vaccine for use in adolescents aged 12 through 17 and for smaller children aged six through 11.