• Pfizer is expected to ask the F.D.A. to authorize its #Covid vaccine for children under 5.

    #Pfizer and its partner BioNTech are expected as soon as Tuesday to ask the Food and Drug Administration to authorize a coronavirus #vaccine for children under 5 years old as a two-dose regimen while they continue to research how well three doses work.

    Federal regulators are eager to review the data in hopes of authorizing shots for young children on an emergency basis as early as the end of February, according to multiple people familiar with the discussions, who were not authorized to speak publicly. If Pfizer waited for data on a three-dose regimen, the data would not be submitted until late March and the vaccine might not be authorized for that age group until late spring.

    • Experts question unusual authorization plan for Covid vaccine for kids under 5

      The idea of authorizing use of the first two doses while the third-dose data are pending is being framed as a way to allow parents eager to vaccinate children 4 and under to get a head start on the process, with a third dose to follow after review of the results of that part of the study.

      None of the experts STAT spoke to for this article could recall a precedent for this approach. And several worried going down this path could erode willingness on the part of parents of young children to get them vaccinated.

      [...] “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” said Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s Office of Vaccines. “If the vaccine in this age cohort is a three-dose vaccine, #FDA should review the data from the three-dose series before authorizing the vaccine.”

    • What’s Holding Up the COVID Vaccines for Children Under 5?

      Here’s the good news: Two companies could have data on vaccines in kids under 5 in a matter of weeks. Pfizer has said it’ll have data on three doses “in spring” and Moderna has said it’ll have data by the end of March. If the data looks good, there’s nothing to stop the FDA from authorizing a vaccine for kids of a certain age group, even if an older cohort misses the mark or hasn’t yet gotten the green light. Creech, who is also a principal investigator for Moderna’s pediatric vaccine trials, and Spearman both told me they expect authorization by April or, in a worst-case scenario, May.

    • Moderna to ask FDA to authorize Covid-19 vaccine in children 6 months to 6 years

      #Moderna said the studies — in children aged 6 months to 23 months and 2 to 6 years — showed the vaccine generated similar immune responses as those seen in adults aged 18 to 25 who received two doses of Moderna’s adult Covid vaccine.

      [...] In children 6 months to 2 years cases of Covid were decreased 43.7%; they were decreased by 37.5% in the 2 to under 6 years age group. Moderna said that the efficacy was on par with what would be expected of a two-dose vaccine against the Omicron variant, which predominated during the trial. The Omicron variant contains mutations that allow it to evade immunity built up by both vaccination and prior infection.

    • Pfizer/BioNTech to seek Covid vaccine authorization for children under age 5
      Pfizer va soumettre une demande d’autorisation à la FDA d’ici la fin de la semaine (pour 3 doses, donc), le verdict devrait être rendu mi-juin et permettre une utilisation fin juin.
      Bien meilleure efficacité que le Moderna pour la même tranche d’âge, mais Moderna n’a pas encore publié les résultats avec booster.

      The vaccine was well-tolerated, induced a strong immune response, and was 80.3% effective at preventing Covid infections at a time when the Omicron variant of the SARS-CoV-2 virus was circulating.

  • Rihanna Is Pregnant. Here’s Why the Photo Shoot Is Next-Level. - The New York Times

    The art form known as the “celebrity pregnancy photo shoot” has a new winning entry. Rihanna and ASAP Rocky have announced their first child with the release of a street shot by Miles Diggs, a.k.a., Diggzy, a.k.a., the 20-something photographer named by Vogue as “fashion’s favorite paparazzi.”

    The series of pictures, posted on Instagram and sold to a variety of media outlets, including this one, feature Rihanna in a long pink puffer coat with jeweled gold buttons over extra-long ripped jeans puddling in the street and held up by a gold and leather Chanel chain belt. Her stomach, framed by the coat (which British Vogue identified as vintage Chanel, though Chanel declined to comment) and which is closed by a single button at the breastbone, is covered only by a jewel-encrusted costume jewelry cross on a long pearl necklace. Her hands are tucked into the pockets of her jeans, her hair in loose waves. ASAP Rocky is wearing leather pants, a Carhartt denim jacket, hooded varsity sweater and black beanie.

    In this, the Rihanna snap is the latest stage in a photographic tradition that can be traced back to the Demi Moore pregnancy cover on Vanity Fair in 1991.

    That portrait, featuring the actress cradling her distended stomach, nude save for a giant diamond ring, was so scandalous when released that it was banned from certain stores despite being mailed with a paper covering. The shot started an image-making trend that extended through Cindy Crawford, Britney Spears, Ciara and Gigi Hadid — though all of them were topped by Beyoncé’s 2017 pregnant-while-wearing-lingerie-in-a-bower baby-bump photo shoot. That snap set a new standard for managing the public pregnancy reveal, becoming not only Instagram’s most-liked photo of the year when it reached 11.1 million likes, but also the first of an entire series of high-concept maternity photo shoots dropped by the star.

    Already, according to the online shopping site Lovethesales, searches for “pink padded coats” increased 200 percent in the hours after the photos were posted; for “ripped bluejeans,” 175 percent; and for “pearl necklaces,” 80 percent. (ASAP Rocky also caused a spike for men’s sweater vests, leather trousers and Carhartt jackets.)

    All of which suggests that when it comes to maternity style — not to mention baby kits — this may be just the beginning.

    #Instagram #Influenceuse #Rihanna #Photo_enceinte #Mode

  • Opinion | Neil Young Says ‘No More’ to Spotify - The New York Times

    It’s no surprise to me that the singer-songwriter Neil Young followed through on his threat to pull his music from Spotify in protest of the Covid misinformation spouted by that streaming service’s brightest star, Joe Rogan.

    Young’s move is certainly a grand gesture, but if the goal was to shame Spotify into cleaning up its act, it likely won’t work. There just aren’t enough quality alternatives to force the issue.

    Which brings me back to Neil Young. Sure, I have all kinds of affection for his artistry, dating from my teenage years, so I want to see him succeed. But the impact of leaving Spotify amounts to just the same old huffery and puffery when there’s nowhere else to run to. Good P.R., no doubt, but it has almost no impact.
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    Young — and whoever is next — needs to think hard about how he can find other homes beyond the big platforms and support them with the gift of his music and allow his work to last into eternity. After all, I heard, rock ’n’ roll can never die.

    #Neil_Young #Spotify #Economie_numérique

  • New Research Hints at 4 Factors That May Increase Chances of Long Covid

    If further study confirms the findings, they could lead to ways to prevent and treat the complex condition.


    One of the four factors researchers identified is the level of coronavirus RNA in the blood early in the infection, an indicator of viral load. Another is the presence of certain autoantibodies — antibodies that mistakenly attack tissues in the body as they do in conditions like lupus and rheumatoid arthritis. A third factor is the reactivation of Epstein-Barr virus, a virus that infects most people, often when they are young, and then usually becomes dormant.

    The final factor is having Type 2 diabetes, although the researchers and other experts said that in studies involving larger numbers of patients, it might turn out that diabetes is only one of several medical conditions that increase the risk of long Covid.


  • Jack Dorsey and Marc Andreessen’s Crypto Feud Puts Web3 at Risk - The New York Times

    “You don’t own ‘web3.’ The VCs and their LPs do.”

    Jack Dorsey tweeted this esoteric salvo in late December, not long after he stepped down as the head of Twitter to focus on advancing his Bitcoin ambitions. The post, swiping at the power held by venture capitalists and their limited partners as they try to reorganize the internet around blockchain technology, an effort known as web3, soon set off a public feud among members of the Silicon Valley ruling class. The dispute over what many herald as the next arena of technological revolution has drawn increasingly hard lines. Elon Musk is with Mr. Dorsey; Marc Andreessen is his enemy.

    The web3 revolution, backers say, promises the democratization of commerce and information by building a better internet on blockchain networks — distributed ledger systems that form the basis of Bitcoin and other cryptocurrencies. It theoretically would cut out traditional middlemen and gatekeepers, letting users transact directly and have a greater stake in the programs they use.

    But Mr. Dorsey has a different view. “It will never escape their incentives,” continued his post about the role of venture capitalists in web3. “It’s ultimately a centralized entity with a different label.”

    Tokenisation de l’internet

    Essentially, web3 refers to an internet operating on so-called tokenomics. Tokens are digital units of cryptocurrency, and in web3, developers and users have mutual financial interests and everyone can earn crypto. Users benefit directly from their contributions — creativity, play, engagement or deposits, say. They can also help govern futuristic community-run companies, where they can vote on decisions with tokens created by the particular project.

    Yet big investors also appear attracted to the infinite frontier. Last year, venture capitalists backed about 460 blockchain projects, spending nearly $12.75 billion, up from 155 deals worth $2.75 billion in 2020, per Pitchbook data provided to The New York Times. And the venture arms of crypto exchanges like Coinbase and FTX are some of the biggest deal makers, compounding concerns about corporate concentration. That means major players increasingly control the decentralized entities said to democratize everything for little guys.

    “While cryptocurrency industry insiders promote the ‘democratized’ benefits of digital assets,” Ms. Goldstein testified, “in truth, crypto concentrations of money and power match or surpass those in traditional financial markets.”

    Proponents across the web3 ideological divide have been working to woo lawmakers. Venture capitalists are pushing policy proposals meant to influence officials to embrace web3. Believers in the revolution, like Mr. Selkis of Messari, have compiled lists of politicians to support. But the movement still appears to lack a unified front.

    The debate that Mr. Dorsey sparked last month has continued online, though it appears he has begun to direct his attention elsewhere. On Thursday, he started a Bitcoin legal defense fund for developers who face “legal headaches,” and he said Block would get involved with mining Bitcoin.

    Andreessen Horowitz’s policy team has been looking beyond Washington, publishing proposals for global leaders on how to become “web3 republics.”

    Crypto, however, is not the only issue on every tech billionaire’s mind.

    #Web3 #Tokenisation #Internet #Capital_risque #Cryptomonnaies

  • They Made the Most of the Opioid Crisis. Until They Didn’t. - The New York Times

    By David Enrich

    Jan. 19, 2022, 10:30 a.m. ET

    Crime and Punishment at an Opioid Startup
    By Evan Hughes

    The pharmaceutical industry is enjoying a very good crisis. The rapid development of safe and effective Covid-19 vaccines and treatments has turned drug companies into much-feted heroes. Chipper executives are boasting about saving billions of lives. Shareholders are swimming in profits.

    It is a remarkable turnaround for an industry that had been widely reviled. Prepandemic, pharmaceutical companies were routinely berated for the outrageous prices they charged for drugs developed with taxpayer support. They were hauled before grand juries for their roles in what was, until the onset of Covid-19, the country’s most pressing public health crisis: the opioid epidemic.

    Even as it has been overshadowed by the coronavirus, the opioid crisis has grown worse. In the most recent 12-month period for which data are available, more than 100,000 Americans — a record number — died of overdoses. Many were killed by fast-acting synthetic opioids like fentanyl, which is found in illegal street drugs and prescription painkillers.

    Anyone who has read “Empire of Pain,” Patrick Radden Keefe’s epic exposé of the Sackler family behind Purdue Pharma, is aware of opioid peddlers’ dirty hands. But until I read “The Hard Sell,” about the outrageous behavior of an obscure drug company, I hadn’t appreciated the full extent of the filth or the dark stain the opioid sector has left on the entire industry.

    “The Hard Sell,” by the journalist Evan Hughes, is a fast-paced and maddening account of Insys Therapeutics, whose entire business model seemed to hinge on crookedness. (The book is based in part on a 2018 article Hughes wrote for The New York Times Magazine.) Its sole branded product was Subsys, a fentanyl-based liquid that patients sprayed under their tongues. Insys executives went to extraordinary — and at times criminal — lengths to get their addictive and dangerous drug into as many mouths as possible.

    The company was founded in Arizona by “an Indian-born visionary,” John Kapoor. He was a serial drug company entrepreneur who, despite repeated scrapes with regulators, investors and business partners, managed to emerge, over and over, with his fortune and reputation largely intact. (A judge found one of his early companies to have been, as Hughes puts it, “rife with misconduct,” and the Food and Drug Administration reprimanded it for endangering patient health.)

    Kapoor was cut from a mold that will be familiar to readers of “Bad Blood” or “The Cult of We” (about the Theranos and WeWork debacles, respectively). He was blindly ambitious, with a sympathetic origin story that disguised his broken moral compass. Whereas Elizabeth Holmes would tell people that she started her pinprick blood-testing company because she feared needles, Kapoor claimed to have come up with the idea for Subsys after watching his wife endure excruciating pain as she died from breast cancer.

    Hughes is skeptical about this cover story. The more likely explanation, he suggests, is that Kapoor detected a lucrative opportunity to jump into the booming opioid market with a newfangled narcotic.
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    The innovation with Subsys was not the drug itself — its active ingredient, fentanyl, has been around since 1960 — but the delivery mechanism. An arms race was underway to develop the fastest-acting opioids. Spraying fentanyl molecules under your tongue turned out to be a super-efficient way — “close to the speed of IV drugs administered in a hospital,” Hughes writes — to deliver pain relief.

    Kapoor’s company won F.D.A. approval for Subsys to be used as a treatment for cancer patients. But that was a limited and already crowded market. From the get-go, Insys’ goal was to tap into the much larger pool of people who suffered from a broad range of pain. To do that, Kapoor and his team at Insys borrowed tactics from their rivals and exploited the peculiarities of the pharmaceutical industry.

    The company bought access to pharmacy data that showed which doctors were prescribing lots of fast-acting synthetic opioids. About 170 doctors nationwide were responsible for roughly 30 percent of all prescriptions for these drugs, and Insys dispatched its sales force to persuade this tiny group of like-minded physicians to start prescribing Subsys. (Yes, it is crazy that drug companies are permitted to access this sort of easily abusable data.)

    Allowing for even more precise targeting of amenable doctors, the F.D.A. required drug companies like Insys to closely monitor who was prescribing their drugs. “The purpose of collecting this data was to protect patient safety, but Insys found itself with a marketing gold mine,” Hughes writes. Soon doctors who prescribed Subsys began finding Insys salesmen in their offices, pushing them to write more scripts.

    The Insys sales force initially tried to pitch Subsys on its merits, but there was a problem: Competitors were showering this small band of doctors with free meals, gifts and money. To succeed, Insys needed to play the same game.

    Bribery is frowned upon, so, in addition to being plied with food, booze and fun, the doctors were paid to give speeches about Subsys to small audiences — sometimes to the staffs of their own offices. “The idea was to funnel cash to the speaker so that he would prescribe Subsys in return,” Hughes writes. “If he didn’t live up to his end of the deal, he wouldn’t get paid to speak anymore. It was a quid pro quo.”

    The entire opioid business seems to have been awash in these underhanded tactics; as Hughes notes, “Nothing that Insys did was truly new.” Indeed, what’s most surprising and powerful about “The Hard Sell” is not one company’s criminality — we’ve grown inured to corporations behaving badly — as much as how institutionalized these practices were across the modern drug industry.

    For Insys and its top executives, this was highly profitable. The price of some Subsys prescriptions ran into the tens of thousands of dollars. (When insurance companies began balking at covering these costs, Insys set up a centralized office to secretly file and process paperwork on doctors’ behalf.) Insys went public in 2013 and was the year’s best performing I.P.O., with its shares more than quadrupling.

    By then, even as Wall Street and the business media celebrated Insys, the wheels were beginning to come off.

    Conscientious insiders warned the government about the company’s fraudulent and abusive practices. Soon federal investigators were closing in. Kapoor and his inner circle would be the rare corporate executives to face criminal prosecution. Hughes recounts the chase and trial in dramatic fashion.

    My one big complaint about “The Hard Sell” is that it’s unclear how much damage Subsys did in the context of the broader opioid epidemic. Hughes includes tales of people overdosing and becoming addicted, of lives and families shattered, but I was left unsure whether prescription drugs like Subsys were a root cause of the fentanyl crisis, a contributing factor or a meaningless blip.

    At times I wondered if the answer might be the latter and if Hughes was dodging an inconvenient fact so as not to deflate an otherwise compelling story. If so, he needn’t have worried. Even if Insys turns out to be a footnote in the opioid epidemic, there is value in exposing the world to the scummy underbelly of a powerful industry — especially one that has become the sudden object of so much public gratitude.

    David Enrich is the business investigations editor at The Times. He is the author, most recently, of “Dark Towers: Deutsche Bank, Donald Trump, and an Epic Trail ofDestruction.”

    Crime and Punishment at an Opioid Startup
    By Evan Hughes
    288 pp. Doubleday. $28.95.

    #Opioides #The_Hard_Sell #Insys #Voyous

  • Wordle Is a Love Story - The New York Times

    The word game has gone from dozens of players to hundreds of thousands in a few months. It was created by a software engineer in Brooklyn for his partner.

    J’adore les “belles histoires”

    Josh Wardle, a software engineer in Brooklyn, knew his partner loved word games, so he created a guessing game for just the two of them. As a play on his last name, he named it Wordle.

    But after the couple played for months, and after it rapidly became an obsession in his family’s WhatsApp group once he introduced it to relatives, Mr. Wardle thought he might be on to something and released it to the rest of the world in October.

    On Nov. 1, 90 people played.

    On Sunday, just over two months later, more than 300,000 people played.

    It’s been a meteoric rise for the once-a-day game, which invites players to guess a five-letter word in a similar manner as the guess-the-color game Mastermind. After guessing a five-letter word, the game tells you whether any of your letters are in the secret word and whether they are in the correct place. You have six tries to get it right.

    #Wordle #belle_histoire #Jeu