Covid-19 roundup: As Omi­cron spreads, African biotech re­port­ed­ly close to re­pro­duc­ing Mod­er­na's vac­cine, while WHO cre­ates pan­dem­ic pre­ven­tion body

The emer­gence of the Omi­cron vari­ant over the hol­i­day has reignit­ed the fo­cus on vac­cine eq­ui­ty, and in its ef­forts to bring more shots to Africa, one South African biotech is re­port­ed­ly close to re­pro­duc­ing Mod­er­na’s mR­NA shot.

Afrigen Bi­o­log­ics and Vac­cines is speed­ing to­ward its piv­otal tri­als, the Wash­ing­ton Post re­port­ed Sun­day, though it’s do­ing so with­out Mod­er­na’s recipe. The biotech re­port­ed­ly has fin­ished se­quenc­ing the Mod­er­na vac­cine and plans to soon com­pare its own recre­ation to Mod­er­na’s jab.

A key dif­fer­en­tia­tor, how­ev­er, is Afrigen is at­tempt­ing to make a vac­cine that will not re­quire freez­ing in stor­age — hope­ful­ly low­er­ing costs and en­abling bet­ter ac­cess for African coun­tries.

Though Mod­er­na has said it will not seek dam­ages dur­ing the course of the pan­dem­ic, the biotech has thus far re­fused to share its in­tel­lec­tu­al prop­er­ty. Mod­er­na has al­so pledged up to $500 mil­lion to build an mR­NA man­u­fac­tur­ing site in Africa to even­tu­al­ly make up to 500 mil­lion vac­cine dos­es each year.

As a re­sult, Afrigen’s de­vel­op­ment process is large­ly made up of pub­licly avail­able in­for­ma­tion and help from out­side ad­vi­sors. If Mod­er­na shares its for­mu­la, Afrigen could have the con­ti­nent’s first mR­NA shot with­in a year, man­ag­ing di­rec­tor Petro Terblanche told the Post. With­out it, the process could take up to three years.

Ear­li­er this year, Afrigen joined an mR­NA tech trans­fer hub es­tab­lished with both the WHO and CO­V­AX to try to boost vac­ci­na­tion rates in Africa. With wealthy na­tions hav­ing bought up most of the ear­ly sup­ply, vac­ci­na­tion of the con­ti­nent’s 1.2 bil­lion peo­ple re­mains at just 6%, per the Post, com­pared to 60% in the US, 70% in France and 77% in Chi­na.

Mean­while, the WHO is step­ping up pres­sure on rich coun­tries in a new state­ment out Mon­day morn­ing. The or­ga­ni­za­tion called out vac­cine do­na­tion ef­forts to Africa, say­ing that in or­der for the con­ti­nent to reach 70% im­mu­niza­tion, “the qual­i­ty of do­na­tions needs to im­prove.”

“The ma­jor­i­ty of the do­na­tions to-date have been ad hoc, pro­vid­ed with lit­tle no­tice and short shelf lives,” the state­ment read in part. “This has made it ex­treme­ly chal­leng­ing for coun­tries to plan vac­ci­na­tion cam­paigns and in­crease ab­sorp­tive ca­pac­i­ty. To achieve high­er cov­er­age rates across the con­ti­nent, and for do­na­tions to be a sus­tain­able source of sup­ply that can com­ple­ment sup­ply from AVAT and CO­V­AX pur­chase agree­ments, this trend must change.”

WHO seeks to es­tab­lish per­ma­nent pan­dem­ic pre­ven­tion task force

As the Omi­cron vari­ant con­tin­ues its spread, the WHO is putting to­geth­er a new task force to strength­en pan­dem­ic pre­pared­ness and re­sponse.

Dur­ing the sec­ond spe­cial ses­sion of the World Health As­sem­bly on Sun­day, the or­ga­ni­za­tion said it is plan­ning on es­tab­lish­ing a new ne­go­ti­at­ing body to bet­ter co­or­di­nate re­spons­es to fu­ture pan­demics. The first meet­ing of the pan­el will take place no lat­er than next March 1, and each of the six WHO re­gions will get a seat at the ta­ble in ei­ther a co-chair or vice chair post.

Should every­thing go well at the first meet­ing, the WHO said a sec­ond meet­ing will take place on or be­fore Aug. 1, af­ter which a pro­pos­al will be sub­mit­ted to en­shrine the body in the WHO’s con­sti­tu­tion.

In ad­di­tion to high­light­ing con­tin­ued in­equities and spurring WHO ac­tion, the Omi­cron vari­ant is al­so cre­at­ing lo­gis­ti­cal night­mares for trav­el­ers and gov­ern­ments, as the WTO post­poned a meet­ing in Gene­va over virus con­cerns, the body said in a state­ment. The in-per­son meet­ing had been sched­uled to run Tues­day through Fri­day in Gene­va.

Among the top­ics ex­pect­ed to have been dis­cussed were waivers for Covid-19 treat­ments, vac­cines and ther­a­peu­tics, which has proved a thorny is­sue through­out the pan­dem­ic. The Biden ad­min­is­tra­tion has sup­port­ed tem­porar­i­ly waiv­ing patents since May, while the EU said last week it will con­sid­er a “tar­get­ed” waiv­er af­ter lengthy op­po­si­tion.

The waiv­er was first pro­posed by South Africa and In­dia in Oc­to­ber 2020.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

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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.

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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.

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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.

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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.

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.

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.

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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.

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