Covid-19 roundup: FDA ad­dress­es risk of ex­ces­sive bleed­ing af­ter J&J vac­cine; No­vavax vac­cine gets OK in South Ko­rea 

The FDA has added a new risk to the fact sheet for J&J’s Covid-19 vac­cine: im­mune throm­bo­cy­tope­nia, a con­di­tion that can lead to easy or ex­ces­sive bruis­ing and bleed­ing.

Reg­u­la­tors is­sued a let­ter to J&J on Tues­day alert­ing it of the change.

“Re­ports of ad­verse events fol­low­ing use of the Janssen COVID-19 Vac­cine un­der emer­gency use au­tho­riza­tion sug­gest an in­creased risk of im­mune throm­bo­cy­tope­nia (ITP) dur­ing the 42 days fol­low­ing vac­ci­na­tion,” the let­ter states.

While the chance of ex­pe­ri­enc­ing im­mune throm­bo­cy­tope­nia af­ter vac­ci­na­tion is low, the FDA not­ed, in­di­vid­u­als who have a his­to­ry of ITP should con­sult their vac­cine providers be­fore re­ceiv­ing the shot, ac­cord­ing to the up­dat­ed fact sheet. 

Those who have al­ready re­ceived the jab should seek med­ical at­ten­tion right away if they ex­pe­ri­ence un­usu­al or ex­ces­sive bleed­ing, easy or ex­ces­sive bruis­ing, or tiny blood spots un­der the skin be­yond the site of in­jec­tion.

The news comes weeks af­ter the CDC of­fi­cial­ly rec­om­mend­ed that Amer­i­cans re­ceive one of the mR­NA vac­cines over J&J’s vac­cine due to re­newed con­cerns about rare but some­times fa­tal blood clots.

Throm­bo­sis oc­curs when blood clots block blood ves­sels. The FDA and CDC put a hold on J&J’s vac­cine back in April to as­sess the risk of such blood clots but end­ed up lift­ing the pause less than two weeks lat­er af­ter de­cid­ing that the shot’s ben­e­fits still out­weigh the risks. But dur­ing a re­cent ACIP meet­ing, it was re­vealed that there are more cas­es of throm­bo­sis with throm­bo­cy­tope­nia syn­drome (TTS) in those who re­ceived the J&J vac­cine than pre­vi­ous­ly thought

The J&J shot will still be avail­able to those who are un­able or un­will­ing to get an mR­NA vac­cine.

No­vavax vac­cine gets OK in South Ko­rea 

No­vavax has swung an OK for its Covid-19 vac­cine in South Ko­rea, where it will be man­u­fac­tured and mar­ket­ed by SK bio­science, the com­pa­ny an­nounced on Wednes­day.

The shot — which is now the first pro­tein-based Covid vac­cine au­tho­rized for use in South Ko­rea — will be avail­able to adults 18 years and old­er. And SK bio­science al­ready has an ad­vanced pur­chase agree­ment with the gov­ern­ment for 40 mil­lion dos­es, ac­cord­ing to No­vavax.

“No­vavax is proud to bring our COVID-19 vac­cine to South Ko­rea at a crit­i­cal time in the pan­dem­ic as both the Delta and Omi­cron vari­ants have tak­en hold,” CEO Stan­ley Er­ck said in a state­ment.

It’s still un­clear how the vac­cine will fare against the Omi­cron vari­ant, which is spread­ing rapid­ly around the world.

Up­on au­tho­riz­ing the shot at the end of De­cem­ber, the EMA said:

“Tak­en to­geth­er, the re­sults of the two stud­ies show a vac­cine ef­fi­ca­cy for Nu­vax­ovid of around 90%. The orig­i­nal strain of SARS-CoV-2 and some vari­ants of con­cern such as Al­pha and Be­ta were the most com­mon vi­ral strains cir­cu­lat­ing when the stud­ies were on­go­ing. There is cur­rent­ly lim­it­ed da­ta on the ef­fi­ca­cy of Nu­vax­ovid against oth­er vari­ants of con­cern, in­clud­ing Omi­cron,”

The shot — al­so dubbed Nu­vax­ovid in South Ko­rea — has al­so re­ceived au­tho­riza­tion from the WHO, and in In­dia, In­done­sia and the Philip­pines.

But de­spite in­sist­ing for months that the com­pa­ny was just a step or two away from its reg­u­la­to­ry fil­ing in the US mar­ket, No­vavax has still not filed with the FDA.

The com­pa­ny has strug­gled to as­sure reg­u­la­tors of its vac­cine can­di­date’s po­ten­cy and pu­ri­ty, push­ing back the tim­ing of sub­mit­ting its ap­pli­ca­tion to the FDA all sum­mer. On Wednes­day, the com­pa­ny said it was still a month away from fil­ing in the US.

Pfiz­er re­leas­es new da­ta sup­port­ing co-ad­min­is­tra­tion of its Covid-19 vac­cine and Pre­vnar 20

New Phase III da­ta from Pfiz­er sug­gest its Covid-19 vac­cine can be co-ad­min­is­tered with its re­cent­ly ap­proved next-gen pneu­mo­coc­cal vac­cine Pre­vnar 20, ac­cord­ing to the com­pa­ny.

Pre­vnar 20, which was ap­proved back in June, cov­ers all 13 strains that Pre­vnar 13 does, plus 8, 10A, 11A, 12F, 15B, 22F and 33F.

Pfiz­er test­ed the shots in 570 adults, who ei­ther re­ceived both vac­cines at the same time, or ei­ther shot plus a place­bo. Re­spons­es elicit­ed by Pre­vnar 20 for all serotypes were sim­i­lar when giv­en with a dose of the Covid vac­cine or with place­bo, Pfiz­er said. Re­spons­es to a boost­er dose of the Covid vac­cine were al­so sim­i­lar when giv­en with Pre­vnar 20 or place­bo.

The safe­ty pro­file for both shots ad­min­is­tered to­geth­er “gen­er­al­ly re­flect­ed that ob­served with the Pfiz­er-BioN­Tech Covid-19 Vac­cine boost­er dose,” the com­pa­ny said in a state­ment.

“Pfiz­er is stead­fast in its com­mit­ment to ad­dress the bur­den of cer­tain res­pi­ra­to­ry dis­eases while rais­ing aware­ness of the im­por­tance of adult im­mu­niza­tions,” Kathrin Jansen, Pfiz­er’s SVP and head of vac­cine R&D, said in a state­ment.

Pfiz­er isn’t the on­ly drug­mak­er re­search­ing vac­cine com­bi­na­tions. The CDC has al­ready said that it is safe to ad­min­is­ter cur­rent­ly avail­able Covid-19 vac­cines along with the flu shot. Mod­er­na and No­vavax have al­so said they’re work­ing on com­bi­na­tion Covid and flu shots.

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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Bahija Jallal, Immunocore CEO

BREAK­ING: FDA hur­ries up a quick ap­proval for the world's first TCR -- af­ter a 14-year R&D trek

Over the 14 years since Immunocore was spun out of MediGene in a quest to develop a gamechanging cancer med, the biotech has raised record sums and undergone a major shakeup on a long roller coaster ride of valuations for investors. But they survived and thrived and today they’re popping the champagne corks to celebrate an FDA approval of their first TCR drug.

Immunocore flagged the FDA’s green light for tebentafusp Wednesday morning by highlighting a series of firsts.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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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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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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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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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.