Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

Af­ter a two-month hold on mil­lions of dos­es of the J&J vac­cine, the FDA will an­nounce that it is re­leas­ing 10 mil­lion dos­es and trash­ing 60 mil­lion that were made at a trou­bled Bal­ti­more plant, The New York Times scooped on Fri­day morn­ing.

Emer­gent BioSo­lu­tions re­port­ed that the dos­es were con­t­a­m­i­nat­ed af­ter drug ma­te­r­i­al in­tend­ed for the As­traZeneca vac­cine came in close con­tact with me­dia pre­pared for a J&J run. As a re­sult, the dos­es were held from dis­tri­b­u­tion, caus­ing a shake­up in ear­ly avail­abil­i­ty.

Lat­er, a Form 483 from the FDA re­vealed im­prop­er de­con­t­a­m­i­na­tion meth­ods from staff and oth­er un­san­i­tary con­di­tions like paint chip­ping on the walls and mold grow­ing in the build­ing.

An­oth­er 60 mil­lion dos­es of As­traZeneca’s could be­come avail­able as well. The FDA has not de­ter­mined whether Emer­gent can re­sume pro­duc­tion again, sev­er­al out­lets re­port­ed. — Josh Sul­li­van

EMA up­dates As­traZeneca vac­cine warn­ings, con­tin­ues re­view of my­ocardi­tis and peri­cardi­tis for mR­NA vac­cines

The Eu­ro­pean Med­i­cines Agency said Fri­day that it has con­clud­ed that peo­ple who have pre­vi­ous­ly had cap­il­lary leak syn­drome must not be vac­ci­nat­ed with As­traZeneca’s Covid vac­cine Vaxzevria.

“The Com­mit­tee car­ried out an in-depth re­view of 6 cas­es of cap­il­lary leak syn­drome in peo­ple who had re­ceived Vaxzevria. Most of the cas­es oc­curred in women and with­in 4 days of vac­ci­na­tion. Three of those af­fect­ed had a his­to­ry of cap­il­lary leak syn­drome and one of them sub­se­quent­ly died. As of 27 May 2021, more than 78 mil­lion dos­es of Vaxzevria had been ad­min­is­tered in the EU/EEA and the UK,” EMA said.

The agency al­so said it’s con­tin­u­ing its re­view of my­ocardi­tis (in­flam­ma­tion of the heart mus­cle) and peri­cardi­tis (in­flam­ma­tion of the mem­brane around the heart) in a small num­ber of peo­ple fol­low­ing vac­ci­na­tion with Covid vac­cines, in­clud­ing the one from Pfiz­er.

As of the end of May 2021, cas­es of my­ocardi­tis re­port­ed in the EEA from Eu­dravig­i­lance data­base were 122 (Pfiz­er’s Comir­naty), 16 (Mod­er­na’s vac­cine) and 38 (As­traZeneca’s Vaxzevria) and 0 for J&J. The ex­po­sure in the EEA for each vac­cine was around 160 mil­lion dos­es for Comir­naty, 19 mil­lion dos­es for Mod­er­na, 40 mil­lion for Vaxzevria and 2 mil­lion for Janssen.

And as of the end of May 2021, EMA said cas­es of peri­cardi­tis re­port­ed in the EEA data­base were 126 (Comir­naty), 18 (Mod­er­na), 47 (Vaxzevria) and 1 (Janssen).

“For Comir­naty and COVID-19 Vac­cine Mod­er­na the PRAC is re­view­ing cas­es of my­ocardi­tis and peri­cardi­tis in the con­text of a safe­ty sig­nal, un­der an ac­cel­er­at­ed timetable (fi­nal­i­sa­tion ex­pect­ed in Ju­ly),” EMA said.

The CDC on Thurs­day, at an FDA ad­vi­so­ry com­mit­tee meet­ing on vac­ci­nat­ing chil­dren, al­so pre­sent­ed its find­ings on my­ocardi­tis and peri­cardi­tis fol­low­ing mR­NA vac­ci­na­tion, not­ing 488 to­tal re­ports for the Pfiz­er-BioN­Tech vac­cine and 301 re­ports for Mod­er­na through the end of May. CDC found that of the re­ports, the me­di­an age af­ter the first dose was 30, and 24 for the sec­ond dose, with more males than fe­males re­port­ing my­ocardi­tis and peri­cardi­tis. CDC said 15 are still hos­pi­tal­ized and three are in the in­ten­sive care unit.

While the slides show no sta­tis­ti­cal sig­nal yet, CDC’s ACIP has sched­uled a meet­ing for next Fri­day to fur­ther up­date the da­ta, and dis­cuss its eval­u­a­tion of my­ocardi­tis fol­low­ing mR­NA vac­ci­na­tions, as well as to as­sess the ben­e­fit-risk bal­ance. — Zachary Bren­nan

Pfiz­er has emer­gency plan to pro­duce an­oth­er vac­cine in months, if need­ed

Dur­ing the G7 sum­mit Thurs­day, Pfiz­er CEO Al­bert Bourla an­nounced that if a new vac­cine were need­ed, the com­pa­ny has a process to en­sure it could be de­vel­oped with­in 100 days. He al­so re­in­forced that ac­cord­ing to his com­pa­ny’s da­ta, none of the ex­ist­ing vari­ant strains have es­caped pro­tec­tion from the vac­cine.

“I re­peat: none,” he said. “Not one.”

Pfiz­er sci­en­tists are al­so pur­su­ing an oral treat­ment against Covid-19, the ini­tial re­sults of which Bourla called “promis­ing.” If things go ac­cord­ing to plan, the com­pa­ny could ap­ply for ap­proval by the end of 2021.

The Group of Sev­en is ex­pect­ed to do­nate 1 bil­lion Covid-19 vac­cine dos­es to low-in­come coun­tries, British Prime Min­is­ter Boris John­son said Thurs­day.

The news came just a few hours af­ter Pres­i­dent Joe Biden an­nounced that the US was set to do­nate at least 500 mil­lion Pfiz­er-BioN­Tech shots, Reuters re­ports. The group is ex­pect­ed to agree to the do­na­tion dur­ing the three-day sum­mit at Car­bis Bay in Eng­land.

Eng­land is ex­pect­ed to do­nate 100 mil­lion of those shots, 80 mil­lion of which will go to CO­V­AX,  John­son has said.

Both coun­tries have rolled out suc­cess­ful vac­ci­na­tion cam­paigns. Near­ly 52% of the to­tal US pop­u­la­tion, and 61.5% of adults have re­ceived at least one dose of the vac­cine. In Eng­land, 77% of adults have re­ceived a jab.

But one bil­lion dos­es may not be enough. An­na Mar­riott, the glob­al pover­ty or­ga­ni­za­tion Ox­fam’s health pol­i­cy man­ag­er, said that if the best lead­ers can do is do­nate 1 bil­lion dos­es, the sum­mit will have been a fail­ure. Mar­riott called for 11 bil­lion dos­es to end the pan­dem­ic, and called for in­tel­lec­tu­al prop­er­ty waivers, Reuters re­port­ed. Near­ly 4 bil­lion peo­ple are de­pen­dent up­on vac­cines from CO­V­AX, the pro­gram from Gavi, the vac­cine al­liance to pro­vide shots to low- and mid­dle-in­come coun­tries.

The virus has led to the deaths of 3.9 mil­lion peo­ple since its start in Chi­na in 2019. — Josh Sul­li­van

Ger­many de­bates bail­ing on Cure­Vac as the wait con­tin­ues

Ger­man Health Min­is­ter Jens Spahn no longer plans to use Cure­Vac’s Covid-19 vac­cine for the cur­rent vac­ci­na­tion cam­paign, RP On­line has re­port­ed.

EMA ap­proval was orig­i­nal­ly ex­pect­ed by May, but on Tues­day news broke that reg­u­la­to­ry ap­proval of the vac­cine shouldn’t be ex­pect­ed to come be­fore Au­gust.

Chief pro­duc­tion of­fi­cer Flo­ri­an von der Mülbe has blamed de­lays on sup­ply chain is­sues. In Ju­ly 2020, GSK an­nounced it would in­vest $293 mil­lion in the jab and take on man­u­fac­tur­ing re­spon­si­bil­i­ties. — Josh Sul­li­van

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

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Troy Wilson, Kura CEO

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.

A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

Amid geopolitical tensions between the US and China, two Republican senators are calling for a bill that would aim to strike a balance on domestic and foreign inspection requirements from the FDA.

Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Creating Efficiency in Foreign Inspections Act. It contains a bit of rhetoric, highlighting “communist China” not once, but twice in the release, but states that the goal is to even the playing field between foreign and American manufacturers.

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