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.

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Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The company calls it “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” the Boston Globe reported, quoting a spokesperson.

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John Quisel, Disc Medicine CEO

Disc Med­i­cine goes pub­lic in re­verse merg­er with strug­gling Gem­i­ni Ther­a­peu­tics

After licensing a failed Roche schizophrenia drug last year, Disc Medicine is going public via a reverse merger with Gemini Therapeutics.

The combined company, while still named Disc Medicine, will trade under the stock symbol $IRON, in reference to Disc’s lineup of therapies for blood iron disorders. Alongside the merger, Disc has secured $53.5 million in another financing round, building on the $90 million Series B it raised in September.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

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The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

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Samantha Du, Zai Lab CEO

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Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

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Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.