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.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Take­da scores a win for a rare type of lung can­cer, gear­ing up for a show­down with J&J

Four months after J&J’s infused drug Rybrevant scored the industry’s first win in a rare type of non-small cell lung cancer (NSCLC), Takeda is following up with an oral option for the small but desperate patient population.

The FDA granted an accelerated approval to Takeda’s oral TKI inhibitor Exkivity (mobocertinib) in metastatic NSCLC patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, the company announced on Wednesday.

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