Alex Gorsky, J&J CEO (Andrew Harnik/AP Images)

UP­DAT­ED: FDA adds sec­ond warn­ing to J&J's Covid-19 vac­cine on da­ta link­ing it to rare nerve con­di­tion

The J&J Covid-19 vac­cine has been linked to a sec­ond rare but se­ri­ous side ef­fect.

The FDA is­sued a warn­ing Mon­day af­ter­noon that there are da­ta “con­nect­ing the shot to an in­creased risk” of Guil­lain-Bar­ré syn­drome, a rare con­di­tion where the body’s im­mune sys­tem at­tacks its nerves. The FDA said that there were 100 pre­lim­i­nary re­ports of the syn­drome out of the 12.5 mil­lion peo­ple who re­ceived the vac­cine. No such re­la­tion­ship was seen be­tween the Mod­er­na or Pfiz­er-BioN­Tech vac­cines and the au­toim­mune con­di­tion.

Of those 100 cas­es, 95 were se­ri­ous and re­quired hos­pi­tal­iza­tion and that there was one re­port­ed death. The agency not­ed that the vast ma­jor­i­ty of peo­ple with Guil­lain-Bar­ré syn­drome re­cov­er and said there was not yet enough da­ta to es­tab­lish a causal re­la­tion­ship.

The FDA em­pha­sized, as they did when the first rare but se­ri­ous side ef­fect emerged, that the ben­e­fits of the vac­cine “clear­ly” out­weigh the risks. The on­ly sin­gle-dose Covid-19 vac­cine au­tho­rized in the US, the shot was shown to be 85% ef­fec­tive at pre­vent­ing se­vere dis­ease.

But news of the first side ef­fect ap­peared to slow both US and glob­al up­take of the vac­cine, which pub­lic health of­fi­cials had hoped would reach many peo­ple who are less able to ac­cess the two-dose mR­NA shots.

In April, the FDA and CDC paused the roll­out of the vac­cine af­ter da­ta linked it to a rare blood clot­ting dis­or­der. The agen­cies lift­ed the hold 10 days lat­er, ar­gu­ing the ben­e­fits still out­weighed the risks and that, with greater ed­u­ca­tion and aware­ness among physi­cians, the side ef­fects could be caught and man­aged.

The well pub­li­cized side ef­fect, how­ev­er, ap­peared to scare many away from tak­ing the vac­cine. A Reuters analy­sis in June found that half of the EU’s J&J sup­plies had gone un­used. The New York Times turned up sim­i­lar find­ings in the US. The com­pa­ny’s 12.8 mil­lion vac­cines ad­min­is­tered in the US rep­re­sent just 8% of the to­tal Amer­i­cans who have been ful­ly vac­ci­nat­ed and just 7% of the Amer­i­cans who have been ful­ly vac­ci­nat­ed.

The new side ef­fect, while rare and not yet con­clu­sive­ly linked to the vac­cine, may on­ly fur­ther ham­per up­take for a vac­cine that many hoped could pro­vide a cru­cial tool to reach­ing hard-to-reach com­mu­ni­ties and end­ing the pan­dem­ic. It could al­so pro­vide an­oth­er blow to the vi­ral vec­tor plat­form that J&J has built its vac­cine busi­ness around, as the ri­val mR­NA jabs prove both safer and more ef­fi­ca­cious.

J&J’s shot is not the first vac­cine to be linked to Guil­lain-Bar­ré syn­drome. The con­di­tion of­ten ap­pears af­ter vi­ral in­fec­tion, but the 1976 swine flu vac­cine was al­so linked to cas­es among a small num­ber of re­cip­i­ents. In that in­stance, the CDC re­ports, the vac­cine in­creased the like­li­hood of com­ing down with the syn­drome by about 1 in­stance per 100,000 vac­ci­na­tions.

A hand­ful of cas­es of the syn­drome have al­so been linked in Eu­rope to the As­traZeneca-Ox­ford vac­cine, which us­es a sim­i­lar tech­nol­o­gy to J&J’s.

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?”

Endpoints Premium

Premium subscription required

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

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

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

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%.

Endpoints Premium

Premium subscription required

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

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.

Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Califf on ac­cel­er­at­ed ap­provals: Com­pa­nies need to do more work be­fore FDA says OK

As he awaits a tight Senate vote, Rob Califf, President Joe Biden’s nominee to be the next FDA commissioner, is signaling where the agency may move on accelerated approvals if he takes over at FDA.

Building off comments from his Senate confirmation hearing, in which Califf said that he’s “a fan of accelerated approval” but the US needs a better system to evaluate these drugs once they’re on the market, the nominee raised questions about how well the current structure serves patients.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,300+ biopharma pros reading Endpoints daily — and it's free.