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    Scientists question FDA on 'scant' J&J booster data and speedy review

    Syringes and a box of Johnson & Johnson vaccine.
    Paul Hennessy | SOPA Images | LightRocket | Getty Images

    Members of the Food and Drug Administration’s key advisory committee on vaccines criticized the speed with which the agency was reviewing Johnson & Johnson’s Covid booster trials as well as the lack of verified data presented before the panel Friday.
    Their comments came before the panel of outside experts unanimously voted to recommend the company’s booster shots for all individuals over 18. J&J submitted its booster data to the FDA 10 days before the Vaccines and Related Biological Products Advisory Committee’s meeting.

    Agency officials acknowledged in their presentations that they had not yet verified all the data submitted by J&J.

    “Is there an option of saying it’s a little early? There are a number of issues that are still outstanding,” committee member Dr. Cody Meissner asked FDA offiicals. “There are a lot of uncertainties at this point, making it hard to vote for or against this tonight.”
    FDA medical officer Dr. Timothy Brennan told the advisory committee that one of the trial’s examining the side effects of J&J’s booster had just 17 participants ages 18 to 55. Brennan said the trial’s sample size prevented him from drawing any conclusions on the data, but noted that the figures appeared to be show fewer side effects after the booster than after the first dose.
    Brennan’s presentation also said the data from J&J had not been confirmed. J&J reported that 47% of the 17 participants reported headache, while 26% reported fatigue and 21% reported muscle pain after getting a booster.
    “What puzzled me was, in the briefing documents and in their presentations today, they spoke repeatedly about data not being verified by the FDA,” committee member Dr. Archana Chatterjee said of J&J. “And the question I had around that is [what is] the reason for bringing this before VRBPAC without being able to verify the data.”

    CNBC Health & Science

    Committee Chair Dr. Arnold Monto explained that the lower performance of J&J’s vaccine compared with Pfizer and Moderna’s played a role in the rapid pace of the review.
    “There is a public health imperative here,” Monto said, “because what we’re seeing is this is a group with overall lower efficacy than we have seen with the mRNA vaccines, so there is some urgency to do something.”  
    Dr. Peter Marks, director of the FDA’s center for biologics and research, asked that the panel move forward with the meeting before addressing any members’ outstanding concerns. He said the FDA reviewed immunogenicity data on thousands of participants from J&J before Friday’s meeting, a process that ordinarily would’ve taken months to complete.
    “I would suggest we work our way through the process, go through the questions, and if at the end of the day the feeling of the committee is that this is not ready, I think we can have some comments after that would go along the lines of what could be done to make this acceptable in the future,” Marks said.  
    Although committee member Dr. Michael Nelson said J&J’s data was “a little bit immature and somewhat scant in multiple areas,” he said he thought the safety and efficacy data they had so far was enough to support emergency use in the U.S. 

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    Disability attorney says Walmart's firing of Down syndrome woman is part of a pattern

    A disability rights attorney described a pattern of Walmart refusing to accommodate employees with disabilities in a legal filing on Friday.
    The filing is the latest development in a legal battle between Walmart and the U.S. Equal Employment Opportunity Commission.
    A jury in federal court found that Walmart wrongfully fired Marlo Spaeth, a longtime employee with Down syndrome, in July.
    Walmart and the EEOC are now waiting for a judge to decide whether the nation’s largest private employer will face tighter supervision.

    Exterior view of a Walmart store on August 23, 2020 in North Bergen, New Jersey. Walmart saw its profits jump in latest quarter as e-commerce sales surged during the coronavirus pandemic.
    VIEW press | Corbis News | Getty Images

    The firing of Marlo Spaeth, an employee with Down syndrome who worked at Walmart for nearly 16 years, was not a one-time incident, but rather part of the retailer’s pattern, a disability rights attorney said in a court filing Friday.
    In the document, attorney Monica Murphy describes how she has represented six Wisconsin residents with disabilities, over the past five years, who have faced similar discrimination at Walmart. She said Walmart refused to accommodate these workers and instead took away their hours or forced them to take unpaid leave. Murphy is an attorney for Disability Rights Wisconsin, a nonprofit group with a mission of protecting the rights of people with disabilities. 

    Several other court filings on Friday told the stories of other Walmart employees with disabilities who were fired from their jobs. They included lawsuits filed by the workers’ families and a jury verdict in another discrimination lawsuit that awarded more than $5 million in damages to a former Walmart employee. The employees lived in other states, including Maine, Oklahoma and South Dakota.
    The filings are the latest development in a legal battle between Walmart and the U.S. Equal Employment Opportunity Commission. The federal agency has taken up the case of Spaeth, who worked for more than a decade folding towels, tidying aisles and helping customers as a Walmart associate at a Wisconsin Supercenter. Attorneys for the EEOC argued that Walmart wrongfully fired Spaeth rather than making reasonable accommodations for her disability.
    A jury in federal court found in July that Walmart violated federal law. Jurors ordered the company to pay more than $125 million in damages — one of the highest in the federal agency’s history for a single victim. The damages were reduced by the judge to $300,000, the maximum allowed under the law.
    Walmart and the EEOC are now waiting for a judge to decide whether the nation’s largest private employer will face tighter supervision or be forced to make changes to its corporate policies.
    Walmart said it is reviewing Friday’s filings. In a statement, the company’s spokesman said Walmart’s leaders and managers “take supporting all our associates seriously and for those with disabilities, we routinely accommodate thousands every year.”

    In a motion filed earlier this month, Walmart attorneys pushed back against the EEOC’s calls for additional supervision. They argued that Walmart did not violate the Americans with Disabilities Act and that the EEOC had no evidence that the company would violate it in the future.
    The ADA requires employers to make reasonable accommodations for workers and customers.
    Murphy describes in her filing several other cases that closely resemble Spaeth’s case. Like Spaeth, she said the employees had worked for Walmart for years. When Walmart began using a computerized scheduling system at their stores, they faced a sudden change to their work schedules and the company refused to adjust their hours.
    Among them, she said she represented two employees with disabilities who worked for Walmart for 16 years. They were taken off work when they told Walmart they could not work 8-hour shifts. Murphy said they filed and settled their claims at the Wisconsin Equal Rights Division and the two employees never returned to work.
    She is currently representing a Walmart employee in a pending case in Wisconsin’s Equal Rights Division. The 11-year employee was fired by Walmart, after struggling to adjust to her new schedule from the computerized system. Walmart terminated her, saying she had excessive absenteeism.

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    Risk of mRNA Covid booster causing heart inflammation in young adults continues to worry scientists, Dr. Ofer Levy says

    Dr. Ofer Levy, a voting member of the FDA’s vaccine advisory panel, spoke with CNBC’s “Closing Bell” after the committee unanimously recommended the agency approve J&J’s Covid boosters.
    The panel previously recommended the FDA approve boosters from Moderna and Pfizer for anyone 65 and older, among other high-risk groups.
    Some committee members have voiced concern about authorizing third mRNA doses for people 12 and up due to the risk of two rare heart inflammation conditions.

    The risk of mRNA Covid booster shots causing heart inflammation in young adults continues to worry top scientists weighing whether to approve third doses for anyone over 12, Dr. Ofer Levy, a voting member of the Food and Drug Administration’s advisory panel, said Friday.
    Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital, spoke just hours after the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously recommended giving second shots to all recipients of Johnson & Johnson’s single-dose Covid vaccine over 18 years old.

    The panel previously recommended the FDA approve boosters from Moderna and Pfizer for all seniors and other high-risk groups. But some committee members have voiced concern about authorizing third mRNA doses for people 12 and up due to the risk of two rare heart inflammation conditions, myocarditis and pericarditis.
    “As we go into younger and younger age groups, they’re less and less at personal risk of severe Covid, and on the other hand, somewhat more at risk of this inflammatory heart condition with the mRNA vaccine,” Levy told CNBC’s “Closing Bell.” “So it’s a risk benefit analysis, and that’s why you’re seeing that deliberation.”
    Though uncommon, myocarditis has been found mostly in male adolescents and young adults who received a vaccine from Pfizer or Moderna, according to the Centers for Disease Control and Prevention. Cases typically arise within days of vaccination, usually after the second dose, and subside with medicine and rest, the CDC said.
    Unlike mRNA vaccines from Pfizer and Moderna, J&J’s Covid shot is not associated with a risk for heart inflammation, the CDC says. Over 15 million Americans have received their primary vaccine dose from J&J.
    Data suggests both two-dose mRNA options are comparatively more effective, but J&J submitted a study to the FDA that showed a second dose enhanced protection against symptomatic infection from 72% to 94%.

    CNBC Health & Science

    But as U.S. health officials consider rolling out boosters to younger age groups, Israel has already begun administering boosters to anyone over 12. Data presented to the committee indicated that Israel might already be starting to see herd immunity, he added.
    “The priority is to keep people out of the hospital, keep them alive,” Levy said. “But if we can get a level of immunity that reduces the chance that you even get infected or spread to anybody else, that’s wonderful because that can get us towards herd immunity.”

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    Grayscale Investments close to filing application for spot bitcoin ETF, source says

    Grayscale Investments plans on filing an application to convert the world’s biggest bitcoin fund into a spot ETF early next week, according to a person with knowledge of the matter.
    The application begins a 75-day review period, said the source, who declined to be identified because the New York-based company hasn’t disclosed its plans.

    Michael Sonnenshein, chief executive officer of Grayscale Investments LLC, speaks virtually during a Crypto Summit Feb. 25, 2021.
    Daniel Acker | Bloomberg | Getty Images

    Grayscale Investments plans on filing an application to convert the world’s biggest bitcoin fund into a spot ETF early next week, according to a person with knowledge of the matter.
    The investment firm had intended to file its application to the Securities and Exchange Commission as soon as the agency allowed efforts by competitors for a futures-based bitcoin ETF, said the person. That happened late Friday.

    The Grayscale application begins a 75-day review period, said the source, who declined to be identified because the New York-based company hasn’t disclosed its plans.
    If approved, Grayscale’s ETF would be another step in the legitimization of the nascent crypto asset class. Bitcoin has proven resilient, approaching all-time highs over $60,000 on Friday, even after setbacks including being banned by China last month.
    The bitcoin-futures ETF’s impending debut, while significant, is considered an inadequate step by some crypto investors because it would be linked to derivative contracts traded on the Chicago Mercantile Exchange rather than actual bitcoin.
    Grayscale’s spot Bitcoin application, however, represents an investment that is backed by bitcoins, not derivatives tied to it.

    Grayscale has a significant chunk of the world’s bitcoin holdings in storage for its trust known by the GBTC ticker. GBTC had $38.7 billion in assets under management as of Friday.

    The company, a pioneer in crypto investing which enabled institutional investors like Ark Invest’s Cathie Wood to bet on bitcoin, originally publicly filed for an ETF in January 2017. It withdrew the application in October of that year after the SEC indicated that it wasn’t yet comfortable with the bitcoin market.
    Grayscale’s move could be an attempt to force the SEC’s hand. If they are comfortable with bitcoin futures, regulators should also be comfortable with the underlying market, the thinking goes, according to the source.
    Of course, the SEC could still choose to delay or reject the Grayscale application.
    Last month, Grayscale’s CEO publicly criticized the SEC’s apparent preference for futures-based ETFs, calling it a “shortsighted” move that could harm investors.

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    Michael Burry of ‘The Big Short’ asked about shorting crypto days before bitcoin hit $60,000

    Andrew Toth | FilmMagic | Getty Images

    “The Big Short” investor Michael Burry inquired about ways to bet against bitcoin just before the world’s largest cryptocurrency hit a six-month high to breach the $60,000 level.
    “Ok, I haven’t done this before, how do you short a cryptocurrency,” Burry said in a Wednesday tweet. “Do you have to secure a borrow? Is there a short rebate? Can the position be squeezed and called in? In such volatile situations, I tend to think it’s best not to short, but I’m thinking out loud here.”

    Bitcoin topped $60,000 on Friday, notching its highest level since April 17. Investors and analysts are optimistic that U.S. regulators could give the green light to the first bitcoin futures exchange-traded fund as soon as next week. Such a move would give mainstream investors exposure to the crypto market, which allows for even greater acceptance of digital assets on Wall Street.
    The famed investor has been a vocal critic of cryptocurrencies, taking issue with their wild volatility and speculative trading activities. He previously compared bitcoin to the 2007 housing bubble, which he had bet against and profited from immensely.
    “MSCI says there is $7.1 trillion in market cap tied to stocks of companies holding crypto. But MSCI also says only 79 people of 6,500 corporate board members have crypto expertise. This is, as they say, a feature, not a bug,” he said in a now-deleted tweet Thursday.

    Over the past week, Burry also called meme token Shiba Inu “pointless.”
    Burry was one of the first investors to call and profit from the subprime mortgage crisis. He was depicted in Michael Lewis’ book “The Big Short” and the subsequent Oscar-winning movie of the same name. Burry now manages about $340 million at Scion Asset Management.

    Burry said in an email exclusively to CNBC that he’s not shorting cryptocurrencies, but that he does believe they are in a bubble.
    The investor routinely deletes and makes private his Twitter account under the handle @michaeljburry. Over the past week, he reactivated his account and made it public. In his recent tweetstorm, he commented on a range of topics from taxing the rich, to the Federal Reserve and former President Donald Trump. It appeared that Burry deleted his account again Friday.

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    Stocks making the biggest moves midday: J.B. Hunt, Charles Schwab, Virgin Galactic, 23andMe and more

    Signage at 23andMe headquarters in Sunnyvale, California, U.S., on Wednesday, Jan. 27, 2021.
    David Paul Morris | Bloomberg | Getty Images

    Check out the companies making headlines in midday trading.
    J.B. Hunt Transport Services — Shares of J.B. Hunt jumped 8.7% after the company beat estimates on the top and bottom lines for the third quarter. The Arkansas-based shipping company earned $1.88 per share on $3.14 billion in revenue for the quarter. Analysts surveyed by Refinitiv were looking for $1.77 per share on $3.01 billion of revenue.

    Paper stocks — Shares of paper and packaging providers were the biggest decliners in the S&P 500 after KeyBanc noted box shipment data released Friday was flat for the third quarter, on a yearly basis. International Paper lost 4.5%, and WestRock fell 5.6%. Packaging Corporation of America fell 3.9.
    Goldman Sachs — Shares of Goldman Sachs jumped 3.8% after the bank’s third-quarter earnings crushed expectations. Goldman reported earnings of $14.93 per share on revenue of $13.61 billion. Analysts expected earnings of $10.18 per share on revenue of $11.68 billion, according to Refinitiv. The firm’s investment banking revenue surged nearly 90%.
    PNC Financial — The bank stock slipped 1.7% despite PNC beating estimates on for adjusted earnings per share and revenue for the third quarter. The company’s net interest income for the third quarter did come in below estimates, according to StreetAccount.
    Charles Schwab — Shares of the brokerage firm gained 3.6% after it reported quarterly earnings that beat analysts’ estimates. Schwab recorded 84 cents per share, compared to estimates of 81 cents per share, and beat on revenue at $4.57 billion, compared to $4.52 billion.
    Virgin Galactic — Shares of the space tourism company tanked 16.8% after the company delayed its spaceflight tests to 2022. Bank of America lowered its price target for Virgin Galactic to $20 a share from $25 per share and maintained its underperform rating on the stock, citing “increased uncertainty and lack of clarity” from the company around the change.

    Corsair Gaming — Corsair shares dropped 8.1% after the maker of video game-related peripheral products said supply chain issues were hurting sales but that 2021 will still be a “strong growth year.”
    Alcoa Corp — Shares of the aluminum producer jumped 15.2% following the company’s third-quarter results. Alcoa earned $2.05 per share excluding items on $3.11 billion in revenue. Analysts surveyed by Refinitiv were expecting the company to earn $1.80 per share on $2.93 billion in revenue.
    23andMe — Shares of the DNA genetic testing company surged 16.9% after EMJ Capital’s Eric Jackson said it’s one of his stock picks and should be seen as a therapeutics company as well as a subscription service, which could bode well for future growth.
     — CNBC’s Jesse Pound, Yun Li, Pippa Stevens and Hannah Miao contributed reporting

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    91% of people with health savings accounts make this mistake

    Just 9% of health savings account owners invest a portion of their funds, according to the Employee Benefit Research Institute. The rest, 91%, hold cash.
    Ideally, savers would treat HSAs like a retirement account, by investing for future health costs in old age.
    However, HSA investing may not be available to everyone. Doing so would mean paying out of pocket for short-term health expenses to let money grow.

    The Good Brigade | DigitalVision | Getty Images

    The vast majority of health savings account owners aren’t investing their money — and it’s likely shortchanging them over the long term.
    Just 9% of accountholders were investing a portion of their HSA balance in 2020, according to an Employee Benefit Research Institute study published Thursday. The remainder — 91% — held their full balance in cash.

    HSA owners can invest money in mutual funds (one that tracks the S&P 500 stock index, for example) and other options that are generally available to retirement savers.
    More from Personal Finance:Social Security benefits are getting biggest boost in 40 yearsThe best and worst states for older adults to work and live71% of older investors worry rising inflation will hurt savings
    The low share of invested accounts is alarming, as it indicates many people aren’t taking full advantage of HSAs, according to Paul Fronstin, director of EBRI’s health research and education program. Some may have valid reasons for not doing so, though, he said.
    “For the same reason you’re hopefully investing your 401(k) in mutual funds, you can do the same thing in your HSA,” Fronstin said.
    HSA savers who have the means to invest at least a portion of their money will generally see their savings grow at a more rapid rate and therefore have more money to cover health costs in their older years — when they’re more likely to need care, Fronstin said.

    The average retired couple age 65 in 2021 may need roughly $300,000 saved, after taxes, to cover health-care expenses in retirement, according to Fidelity Investments.
    Investors also more likely to keep pace with or beat health-care inflation. Savings held fully in cash would likely erode in value relative to the cost of future care, Fronstin said.
    In 2020, the average account containing investments other than cash grew by $3,420, whereas the average non-invested account grew by $170, according to EBRI. (Account contributions may account for some of this difference.)

    Not available to everyone

    HSAs are tax-advantaged savings accounts. They enjoy a unique benefit relative to retirement accounts, in that savings are never taxed if used for qualified medical expenses. (Retirement savings are taxed upon contribution or withdrawal, depending on account type.)
    The accounts are only available to people with a high-deductible health plan. These health plans have grown more popular with private-sector employers over the last decade, and HSA use has swelled.
    There were about 31 million accounts as of June, around five times more than in 2011, according to Devenir, an HSA provider. They held $93 billion, up from about $12 billion a decade ago.

    The share of invested accounts is growing, but slowly. In 2015, 4% of HSAs had at least some savings invested, according to EBRI.
    “It’s trending up at a snail’s pace,” Fronstin said.
    Of course, not everyone necessarily has the means to invest.
    Doing so would mean paying out-of-pocket for short-term health expenses (potentially hundreds or thousands of dollars) in order to keep HSA funds invested and allow more runway for investment growth.
    One strategy that may help such savers: Hold enough cash in an HSA to cover you annual health deductible and invest the remainder, Fronstin said.

    There are other valid reasons you might not invest HSA savings.
    For example, some HSA administrators may not even offer investments to users; many also require a minimum balance (perhaps $1,000 or $2,000) before users can start investing.
    The latter requirement could pose a problem for a large share of account holders — about 40% of accounts finished 2020 with less than $500, according to EBRI.

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    Fed's Barkin backs tapering plans and expresses concern about inflation

    Richmond Fed President Thomas Barkin told CNBC on Friday that he’s on board with reducing the amount of economic help the central bank is providing.
    Officials have indicated that tapering of bond purchases could start as early as November.
    Barkin noted that he sees “risk on the inflation side” that he is monitoring.

    Richmond Federal Reserve President Thomas Barkin said Friday he’s on board with reducing the amount of economic help the central bank is providing as concerns grow about inflation.
    With the Fed indicating that it’s likely to start pulling back on its monthly bond purchases, Barkin said that seems reasonable, and he’s leaning toward beginning the process in November. Minutes from the September Fed meeting indicated that officials want to start tapering either next month or in December.

    “If we do decide to taper at the next meeting, we’re going to have a discussion on which of those two dates, I’m sure, and my instinct would be if you’re going to decide it, go ahead and move,” he told CNBC’s Steve Liesman during a live “Squawk Box” interview. “But I’m certainly going to be open to debates on both sides.”
    Fed officials have indicated they’ve met their inflation goal of 2%, though the full and inclusive employment part of the mandate remains elusive despite significant progress.
    Like many of his colleagues, Barkin pointed to temporary factors like supply chain problems that have pushed car prices higher as a major factor in driving inflation, which is running around a 30-year high.
    But he also conceded that it’s been a bigger problem that he expected.
    “I do think there’s risk on the inflation side, and I’m watching that very carefully,” he said.

    The minutes showed that the pace of bond purchases likely will slow by about $15 billion each month — $10 billion in Treasurys and $5 billion in mortgage-backed securities.
    Fed officials have stressed that even after the start of tapering, it will be some time before interest rate hikes begin. Market pricing currently is for the first increase to come in July 2022, with another likely before the end of the year, according to the CME’s FedWatch tracker.
    Barkin said he would base his rates decision on two factors — whether inflation is going to stay elevated or come back to its norm of around 1.5% to 2% of the past 25 years or so, and how close the labor market is to full employment.
    “Is the labor market going to be this tight over the next six months? Is inflation going to come down or not?” he said. “Different answers to those questions in my mind would lead me to different points of view on when we would start to increase rates.”
    He also was asked his position on whether Fed officials should be allowed to own individual stocks, but declined to answer pending an inquiry Chairman Jerome Powell is leading into best practices. Several officials have come under fire for trading stocks, and two regional presidents have resigned following controversies over their activities.

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