Covid-19 roundup: Emer­gen­t's er­ror costs J&J a vac­cine batch; Pfiz­er head says EU re­stric­tions slow vac­cine dis­tri­b­u­tion process

J&J has run in­to a snag in pro­duc­tion of its Covid-19 vac­cine af­ter its qual­i­ty pa­trol spot­ted prob­lems with one batch of drug sub­stance.

The is­sue — which the New York Times re­port­ed was due to a mix-up be­tween the vec­tors used in J&J and As­traZeneca’s vac­cines — sent J&J in­to trou­ble-shoot­ing mode. The com­pa­ny said it’s send­ing ad­di­tion­al ex­perts in man­u­fac­tur­ing, tech­ni­cal op­er­a­tions and qual­i­ty to su­per­vise on­site at Emer­gent’s Bayview fa­cil­i­ty, which was once tout­ed for its ca­pac­i­ty to rapid­ly scale man­u­fac­tur­ing.

In a state­ment, J&J didn’t con­firm whether the batch would in­deed trans­late to 15 mil­lion dos­es, as the Times re­port­ed. It in­stead em­pha­sized that the Emer­gent site has not yet been au­tho­rized by the FDA to make the ac­tive in­gre­di­ents of its one-shot, ade­n­ovirus vec­tor-based vac­cine, and that it’s on track to de­liv­er a to­tal of 1 bil­lion dos­es by 2021.

But while a board mem­ber has pre­vi­ous­ly pre­dict­ed they would de­liv­er a to­tal of 100 mil­lion dos­es to the US by April, J&J is now push­ing that goal to the end of May. Through April, they ex­pect to have 24 mil­lion dos­es, on top of the 20 mil­lion al­ready in arms.

“This batch was nev­er ad­vanced to the fill­ing and fin­ish­ing stages of our man­u­fac­tur­ing process,” the com­pa­ny added. “This is an ex­am­ple of the rig­or­ous qual­i­ty con­trol ap­plied to each batch of drug sub­stance.”

Emer­gent, which had inked a $480 mil­lion deal to sup­ply J&J’s Covid vac­cine for the next two years, had been known as the mak­er of an an­thrax vac­cine pri­or to the pan­dem­ic.

Billed as a cen­ter for in­no­va­tion in ad­vanced de­vel­op­ment and man­u­fac­tur­ing (CIADM), the Bayview site was built as part of a part­ner­ship with BAR­DA to speed de­vel­op­ment and pro­duc­tion of vac­cines or treat­ments for pan­dem­ic re­sponse.

Pfiz­er head says EU re­stric­tions slow vac­cine dis­tri­b­u­tion process

The Eu­ro­pean Union has seen a short­age in Covid-19 vac­cine avail­abil­i­ty, and Pfiz­er head Dan­ny Hen­drikse wants it to be known that new EU re­stric­tions won’t make end­ing that short­age any eas­i­er.

The VP of glob­al sup­ply spoke out against new EU rules about the free move­ment of goods across bor­ders, say­ing that it made it more dif­fi­cult for the com­pa­ny to ex­port the vac­cine.

“Ul­ti­mate­ly what we would like our col­leagues to do is to fo­cus on mak­ing and dis­trib­ut­ing the vac­cine,” he told the UK’s Tele­graph. “The com­po­nents don’t just come from Eu­rope, but from all over the world.”

Pfiz­er told EU lead­ers that the amount of time it takes to make the vac­cine has been cut in half from 110 days to 60, thanks to an in­crease of pro­duc­tion at its Bel­gium plant. But that batch is start­ed in the US, with DNA plas­mids.

The news comes on the back of Ger­many’s sus­pen­sion of the As­traZeneca vac­cine for pa­tients un­der the age of 40 due to a rare, but fa­tal, blood clot called ve­nous throm­bo­sis. The clot was par­tic­u­lar­ly present in young women, a re­port said. EU’s med­ical reg­u­la­tor said that there was no ev­i­dence to sup­port the de­ci­sion to stop us­ing the vac­cine, how­ev­er.

Pfiz­er and BioN­Tech con­firm high ef­fi­ca­cy, no se­ri­ous safe­ty con­cerns af­ter sec­ond Covid-19 vac­cine dose

Six months af­ter Pfiz­er and BioN­Tech’s Phase III clin­i­cal tri­al par­tic­i­pants re­ceived the sec­ond dose of their Covid-19 vac­cine, the com­pa­nies have an­nounced that there are no se­ri­ous safe­ty con­cerns.

Of the 927 con­firmed symp­to­matic cas­es, 850 of the cas­es were in the place­bo group and 77 were in the group giv­en BNT162b2, good for a vac­cine ef­fi­ca­cy of 91.3%, ac­cord­ing to a re­lease. Six-month re­sults al­so showed 100% ef­fi­ca­cy in pre­vent­ing se­vere dis­ease.

Vac­cine safe­ty has now been eval­u­at­ed in 44,000 par­tic­i­pants ages 16 and up. Sci­en­tists have deemed the vac­cine 100% ef­fec­tive in South Africa, where the B.1.351 vari­a­tion is preva­lent.

“The high vac­cine ef­fi­ca­cy ob­served through up to six months fol­low­ing a sec­ond dose and against the vari­ant preva­lent in South Africa pro­vides fur­ther con­fi­dence in our vac­cine’s over­all ef­fec­tive­ness,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

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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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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Man­u­fac­tur­ing woes con­tin­ue for Au­robindo af­ter FDA's warn­ing let­ter

An active pharmaceutical ingredient site in India has been handed a warning letter from the FDA, following an August 2021 inspection.

AuroLife Pharma’s Hyderabad site, which is part of the Aurobindo group of companies, was handed the letter in November. It’s the latest in a string of manufacturing woes the company has battled as of late.

Unit 1 of its Hyderabad site was inspected, and received an official action initiated notice from the FDA. “The company believes that this will not impact the existing business from this facility,” it said in a filing.

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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