Two senior FDA vaccine regulators are stepping down

Two senior Food and Drug Administration officials responsible for reviewing Covid-19 vaccine applications are leaving the federal agency this fall, an agency spokesperson confirmed Tuesday.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause will exit the agency in October and November, respectively, according to a letter shared with CNBC by FDA spokeswoman Stephanie Caccomo.

“Thank you so much to Marion and Phil for all that they have contributed and continue to contribute to the agency, and thanks so much to each of you for all that you do every day,” FDA top vaccine regulator Dr. Peter Marks said in the letter.

The news was reported earlier by the biotech website BioCentury.

Their announced plans to depart come as the Biden administration prepares to begin offering Covid vaccine booster shots to the general public the week of Sept. 20. Some health experts saw the move as premature and political, especially because the FDA hasn’t finished reviewing data on boosters yet.

Endpoints News, a biotech industry publication, reported that the officials are leaving because they’re frustrated that the Centers for Disease Control and Prevention and its advisory committee are involved in decisions they think should be up to the FDA.

The final straw was when the White House got ahead of the agency on booster shots, according to Endpoints News, citing a former senior FDA leader.

When asked at a briefing later Tuesday whether the departures will affect trust in the FDA, White House Covid czar Jeff Zients said the decision to distribute boosters was made by a number of senior health officials, including acting FDA Commissioner Dr. Janet Woodcock.

“As our medical experts laid out, having reviewed all the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot,” he said.

Amazon pushes deworming drug falsely touted as Covid treatment

This picture shows the tablets of Ivermectin drugs in Tehatta, West Benga, India on 19 May on 2021.

Soumyabrata Roy | NurPhoto | Getty Images

Amazon is directing users to an anti-parasitic drug falsely claimed to be a treatment for Covid-19.

The drug, called ivermectin, is typically used to treat or prevent parasites in animals. In recent weeks, it has become the latest false cure for Covid-19, prompting warnings from the Food and Drug Administration and the Centers for Disease Control and Prevention.

When CNBC searched for the term “iv” on Amazon, the website’s auto-complete function suggested a range of ivermectin products, including “ivermectin pills,” “ivermectin paste” and “ivermectin injectable.” The auto-complete search results are a sign that enough people have been searching for “ivermectin” that Amazon’s search algorithm was automatically trained to put it at the top of suggested results.

When CNBC searched for the term “iv” on Amazon, the website’s auto-complete function suggested a range of ivermectin products, including “ivermectin pills,” “ivermectin paste” and “ivermectin injectable.”

User reviews on some of the products appeared to make reference to false claims that ivermectin is a treatment for Covid-19. One review read, “Yes I used it for that. Two doses, completely gone. This stuff absolutely works. The rumors are true.”

On a separate ivermectin listing, one reviewer provided dosing directions and included a link to a website promoting Covid misinformation, including that ivermectin is “safe and effective” for treating Covid-19.

Amazon spokesperson Craig Andrews told CNBC in a statement: “Amazon’s autocomplete responses are driven by customer activity. We are blocking certain autocomplete responses to address these concerns.”

A few hours after this story was published, Amazon added a notice to searches for “ivermectin for humans,” which notes that the FDA advises against the use of ivermectin to treat or prevent Covid-19. It instructs users to visit the FDA website for more information.

The same notice also appears on searches for “ivermectin covid.”

Ivermectin can be used by humans in small doses to treat parasites such as head lice, but it is most commonly used by veterinarians to deworm large animals. While it has been referred to as a “wonder drug” for treating some parasitic illnesses, it has not been shown to be effective against Covid-19 or other viruses.

Nevertheless, it has gotten a lot of attention, including in some Facebook groups and Reddit communities, NBC News reported.

Prescriptions written for ivermectin are up 24-fold compared with before the pandemic, according to the CDC. Normally, about 3,600 prescriptions are written for ivermectin per week. “Since early July 2021, outpatient ivermectin dispensing has again begun to rapidly increase, reaching more than 88,000 prescriptions in the week ending August 13, 2021,” the CDC said.

Earlier this month, the FDA put out an advisory that warned Americans not to ingest ivermectin.

Amazon has previously faced scrutiny over the sale of products with misleading coronavirus claims on its marketplace. Last February, amid a rise in products with suspect coronavirus claims, the company added a notice to searches for “coronavirus,” “Covid-19,” “n95 mask” and other terms that directed users to the CDC for more information about prevention and treatment of the disease.

Amazon has struggled to remove books and other products containing coronavirus misinformation. A recent study by University of Washington researchers found that more than 10% of Amazon search results show products that promote health misinformation. Researchers examined books, e-books, audiobooks, apparel and dietary supplements.

CDC advises unvaccinated people against travel over Labor Day weekend

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention.

Chip Somodevilla | Getty Images

CDC director Dr. Rochelle Walensky advised unvaccinated people against traveling over the upcoming Labor Day weekend as the U.S. battles back a surge in Covid-19 hospitalizations caused by the highly contagious delta variant.

“Given where we are with disease transmission right now, we would say that people need to take their own these risks into their own consideration as they think about traveling,” Walensky said during a White House Covid briefing Tuesday, noting that people who are fully vaccinated and wear masks can travel. “If you are unvaccinated, we would recommend not traveling.”

Health systems across the U.S. have been dealing with record hospitalizations in recent weeks, with several states like Washington, Mississippi and Florida all hitting record levels of new Covid cases and hospitalizations.

The current seven-day average of new Covid infections in the U.S. is 129,418 cases per day, a decrease of 10% from the prior week’s seven-day average, Walensky said.

The seven-day average for Covid hospitalizations stands at about 11,500 hospitalizations per day, a decrease of about 5% from last week’s seven-day average, she said, citing data collected by the Centers for Disease Control and Prevention.

Covid deaths have risen by just 2.3% over the previous week to a seven-day average of 896 deaths per day, she said.

Walensky also recommended spending time outside with other vaccinated family members over the Labor Day weekend, and to mask up when indoors, especially when in public, to help prevent transmission.

“Throughout the pandemic, we have seen that the vast majority of transmission takes place among unvaccinated people in closed indoor settings,” Walensky said. “Masks are not forever, but they are for now.”

Social Security trusts to run out of money sooner than expected due to Covid

VALERIE MACON | AFP | Getty Images

The Social Security trust fund most Americans rely on for their retirement will run out of money in 12 years, one year sooner than expected, according to an annual government report published Tuesday.

The outlook, aggravated by the Covid pandemic, also threatens to shrink retirement payments and increase health-care costs for older Americans.

The Treasury Department oversees two Social Security funds: The Old-Age and Survivors Insurance and the Disability Insurance Trust Funds. Those programs are designed to provide a source of income respectively to former workers who have retired at the end of their careers or to those who cannot work due to a disability.

Officials said that the Old-Age and Survivors trust fund is now able to pay scheduled benefits until 2033, one year earlier than reported last year. The Disability Insurance fund is estimated to be adequately funded through 2057, eight years earlier than in the report published in 2020.

Though the two funds are separate under law, the Treasury Department said the hypothetical combined funds would be able to pay scheduled benefits on a timely basis until 2034.

Senior administration officials said in a press briefing Tuesday afternoon that a spike in deaths among retirement-age Americans in 2020 helped keep the programs’ costs lower than projected. They added that the ultimate, long-term impact of the coronavirus is less clear as costs and revenues return to their extended forecasts. 

The Treasury Department said it estimates the level of worker productivity and thus GDP is assumed to be permanently lowered by 1% even as they are projected to resume their pre-pandemic trajectories.

Nevertheless, the financial outlook for Social Security and Medicare, two of the nation’s preeminent safety net programs, has deteriorated over the past year as Covid hastened retirements and caused a contraction in the size of the U.S. labor force.

There was no change from last year’s projection that the Medicare’s hospital insurance fund would be depleted in 2026. At that point, doctors, hospitals and nursing homes would not receive their full compensation from Medicare and patients would likely bear the responsibility for any cuts to coverage.

“The finances of both programs have been significantly affected by the pandemic and the recession of 2020,” the Treasury Department said in materials released Tuesday. The combined effects of a dive in employment, interest rates, earnings and GDP, as well as higher mortality for the next few years “all significantly impact the outlook of the programs.”

In their entirety, the funds act as pillars upholding the retirement plans of tens of millions of Americans, current and future. Americans have for decades come to assume that the programs they spent years contributing to in payroll taxes would in turn provide for them.

The programs have become so popular that they are often dubbed the “third rail” of U.S. politics — simply too dangerous to touch. Treasury Secretary Janet Yellen struck that tone in a statement released Tuesday.

“Having strong Social Security and Medicare programs is essential in order to ensure a secure retirement for all Americans, especially for our most vulnerable populations,” she said. “The Biden-Harris Administration is committed to safeguarding these programs and ensuring they continue to deliver economic security and health care to older Americans.”

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But the future of that model is now in the middle of a slow-moving crisis: Within the past two years, the program has started to draw down its assets in order to pay retirees all benefits promised.

In other words, Social Security’s costs in the form of monthly payments to retirees now exceed the income it takes in from U.S. workers. Projected to soon consistently operate in the red, the program’s reserve fund would be depleted around 2033.

If Congress does not act by that time, Social Security law would cut benefit checks for retirees by about 20% across the board. For a demographic that has planned on those payments, and usually has few other avenues of income, a 20% reduction could prove disastrous and threaten to throw many Americans into poverty.

Social Security has long known it faces a simple math problem: With thousands of baby boomers retiring every day, there is an insufficient number of younger people entering the workforce to offset the cost.

To make matters worse, Americans’ life expectancy is increasing and birth rates are declining.

By Social Security’s estimates, the number of Americans 65 or older will increase to more than 79 million by 2035, up from the current 54 million, according to Census data. Meanwhile, the number of births in the U.S. declined last year by 4% from 2019, double the average annual rate of decline of 2% since 2014, the CDC said in May.

The U.S. birth rate is now so low that the nation is “below replacement levels,” meaning more people die every day than are being born, the CDC said. 

Supreme Court is asked to block it from taking effect

Pedestrians walk past the U.S. Supreme Court in Washington, D.C., U.S., on Sunday, June 20, 2021.

Stefani Reynolds | Bloomberg | Getty Images

A group of abortion providers and advocates including Planned Parenthood is asking the Supreme Court to temporarily block the enforcement of a Texas law that would ban most abortions after as early as six weeks of pregnancy.

Petitioners say the law, which is set to take effect Wednesday, would essentially overturn the precedent set by Roe v. Wade, the landmark 1973 case that enshrined the right for women to choose to have an abortion.

S.B. 8 was signed into law in May by Republican Gov. Greg Abbott. It prohibits doctors from performing or inducing abortions if they have “detected a fetal heartbeat for the unborn child,” except in medical emergencies.

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The law does not let state officials enforce those rules, but rather empowers any individual to file civil lawsuits against anyone who provides abortions or “aids or abets” them after the detection of a heartbeat. Those lawsuits can yield at least $10,000 in “statutory damages” per abortion.

If allowed to take effect, the law “would immediately and catastrophically reduce abortion access in Texas, barring care for at least 85% of Texas abortion patients” and likely forcing many providers to close down, said the emergency request for an injunction filed Monday.

That application was filed directly to conservative Justice Samuel Alito, who handles requests from the Lone Star State. It was submitted days after a lower appeals court refused to block the implementation of the law.

Alito asked the respondents — a group of Texas officials including Attorney General Ken Paxton — to respond to the appeal by Tuesday at 5 p.m. ET.

“In less than two days, Texas politicians will have effectively overturned Roe v. Wade,” said Center for Reproductive Rights CEO Nancy Northup, whose organization helped file the Supreme Court request, in a statement Monday.

The Supreme Court, which in the wake of former President Donald Trump’s administration comprises a 6-3 conservative majority, is already scheduled to hear arguments in a potentially pivotal abortion case from Mississippi. That state has asked the justices to reconsider existing precedent that stops states from banning abortions that occur prior to fetal viability.

This is developing news. Please check back for updates.

Ram, Dodge, Lexus, Mitsubishi get top scores for new vehicle quality in J.D. Power study

2019 Ram 1500

Mack Hogan/CNBC

Ram trucks topped J.D. Power’s ranking of new vehicles by quality for the first time ever. Across the industry, the annual study showed drivers complained the most about new high-tech features, such as infotainment systems.

Dodge landed in second place, with Lexus and Mitsubishi tied for third for new vehicle quality. Toyota’s luxury Lexus brand was the highest-ranked luxury vehicle brand, followed by Hyundai’s Genesis. Ram and Dodge trucks are both produced by Stellantis, formerly Fiat Chrysler.

J.D. Power’s annual Initial Quality Study is considered an important measure within the auto industry. The firm surveys thousands of new car owners and scores auto brands based on the number of problems reported per 100 vehicles within the first 90 days of ownership. Problems can range from sluggish smartphone connectivity to engine troubles and bad paint.

The 2019 Lexus LS 500h

Mack Hogan | CNBC

The average number of problems per 100 vehicles stood at 162, a 2% improvement from the prior year. The Nissan Maxima had the best score of any single model in the study, with 85 problems reported per 100 new vehicles.

The top problem reported by owners pertained to Android Auto or Apple CarPlay connectivity, which significantly worsened as automakers implemented new wireless connectivity for the phone mirroring features. It was the first time since 2011 that voice recognition was not the top problem in the study.

Quality laggards included Chrysler in last place, behind Audi and Tesla.

Tesla isn’t officially part of the study because it doesn’t give J.D. Power access to customer data; the automakers’ permission is legally required in 15 states. However, J.D. Power researchers were able to rank Tesla in their quality study starting last year, basing their unofficial score on surveys from owners in the other 35 states.

Vice president of automotive quality at J.D. Power, Dave Sargent, said Tesla owners reported problems that had more to do with the build quality, fit and finish of its vehicles rather than the technology inside them. Examples included body panel gaps, paint issues, wind noise, interior squeaks and rattles.

Only one battery electric vehicle, an electric version of the Mini Cooper, ranked above average on the list, Sargent said.

Generally the problems owners reported with battery-powered vehicles were not directly attributable to the fact that they were EVs, he said, meaning they didn’t have issues with their new electric vehicles’ battery or electric motors in the first 90 days of ownership.

“These vehicles, because they are being offered generally to people who are very tech savvy, tend to be loaded up with latest features and those do not always go well on any vehicles,” Sargent said, adding he believes the vehicles will get better.

With seven top-ranked vehicles, Hyundai placed as the top overall automaker in the study. Toyota was second with six vehicles, followed by BMW and Nissan at four. General Motors and Stellantis had two.

Nearly 1 million Covid booster shots have already been administered in U.S.

Nurse Mary Ezzat administers a Pfizer COVID-19 booster shot to Jessica M. at UCI Medical Center in Orange, CA, on Thursday, August 19, 2021.

Jeff Gritchen | MediaNews Group | Orange County Register via Getty Images

Nearly 1 million Covid-19 booster shots have already been administered in the U.S. since health officials authorized administering extra shots of Pfizer or Moderna’s vaccines to people with weakened immune systems on Aug. 12, according to data compiled by the Centers for Disease Control and Prevention.

So far, about 955,000 fully vaccinated people have received an additional dose of a Covid vaccine, according to data collected by the CDC. That number includes those who had previously received two doses of Pfizer or Moderna’s vaccines or one dose of Johnson and Johnson’s, the agency said.

It’s unclear if all of those people were considered immunocompromised.

In approving the booster shots in people with weak immune systems, which includes cancer, HIV patients and organ transplant patients, CDC officials cited several small studies that showed they didn’t produce an adequate immune response after receiving two doses of Pfizer or Moderna’s vaccines. FDA and CDC officials didn’t approve booster doses of J&J’s vaccine earlier this month, saying they were waiting on more data.

Some Americans were already finding ways to get additional doses of the Covid vaccines on their own prior to the formal approval with some even going as far as receiving the extra shots from different companies – a practice known as “mixing and matching.”

The CDC and Food and Drug Administration are currently reviewing whether to administer booster shots to the general population.

President Joe Biden said the U.S. plans to widely distribute Covid booster shots beginning the week of Sept. 20, pending clearance from FDA and CDC scientists.

The CDC’s Advisory Committee on Immunization Practices debated the need for boosters Monday, saying the data supporting wide distribution was limited.

Dr. Helen Keipp Talbot, a voting member of the CDC advisory group, told the committee Monday that many hospitals in the south are already administering third doses in health-care workers and patients.

New Jersey officials said Monday more than 36,000 extra doses have been administered to the immunocompromised, frontline health-care workers and seniors so far.

State health commissioner Judy Persichilli said the state is looking to identify more people who qualify for a third dose.

“Nationally we think about 3% of the population is immunocompromised, so we’re really asking particularly medical directors in long-term care to do a deep analysis of those medical records and identify individuals who should be queued up to get that third dose right now,” she said.

–CNBC’s Bob Towey and Nate Rattner contributed to this report.

Zoom faces headwinds as businesses reopen, CFO says as stock dips 15%

Investors got a peek into post-pandemic Zoom on Monday after the video-calling software company reported better-than-expected second-quarter earnings. However, the company struggled with tough year-over-year comparisons as offices reopen and live events return.

Zoom shares were down more than 15% Tuesday morning.

The company’s executives explained the slower growth, even as it delivered its first $1 billion quarter.

“What we’re seeing … is headwinds in our mass markets, so these are individual consumers and small businesses. And, as you say, they are now moving around the world. People are taking vacations again, they’re going to happy hours in person,” Zoom CFO Kelly Steckelberg told CNBC’s “Squawk Box” on Tuesday morning.

“As we came through the back half of Q2, we started to see some additional churn there and that’s what’s evidenced in our guidance for the rest of the year and that’s what I think you’re seeing in the reaction to the stock,” she added.

Zoom’s guidance for the current quarter predicted strong growth from its direct and channel businesses, with weakness in the online business because of challenges among smaller customers and consumers.

Despite the stock dip, analysts remained confident in the company’s growth within its enterprise efforts.

“Listen, we still believe Zoom is a very good franchise with a tremendous amount of growth in its future, but we expect the market will need to rationalize a different level of growth post-pandemic into their valuation expectations,” JPMorgan’s Sterling Auty said.

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Shoe maker Allbirds files for IPO and reveals continued losses

Allbirds shoes consist of wool, and the laces consist of recycled plastic bottles.

The sustainable shoe maker Allbirds said Tuesday that it has lost money since its inception and expects it will continue to be unprofitable for the foreseeable future, as it prepares to debut on Wall Street through an initial public offering.

Allbirds said it has applied to list its Class A common stock on the Nasdaq exchange, under the ticker symbol “BIRD.”

The news follows direct-to-consumer darling Warby Parker earlier this month revealing in an SEC filing that it has seen rising sales, but also widening losses over the past three years. The eyeglass maker is preparing to go public, but through a direct listing.

Allbirds is hoping to cash in on increasing demand, especially among younger shoppers, for products that are sustainably sourced. It launched an activewear line earlier this month, expanding its product assortment beyond its popular wool sneakers.

But the company has yet to turn a profit, which could worry potential investors.

Allbirds’ net loss totaled $14.5 million in 2019 and grew to $25.9 million in 2020, according to documents filed with the Securities and Exchange Commission. For the six-month period ended June 30, Allbirds reported a loss of $21.1 million.

Its revenue, meantime, has grown to $219.3 million in 2020 from $193.7 million in 2019. For the six-month period ended June 30, revenue was $117.5 million.

Digital sales totaled $194.6 million, representing a whopping 89% of total sales. More people shopped online last year due to the Covid pandemic, and Allbirds has been a beneficiary of the shift toward comfort and casual dressing.

The company counted 27 locations around the world as of June 30. But it plans to make a much bigger push in bricks-and-mortar retail in the future. Allbirds noted it is in the “early phase of a ramp towards hundreds of potential locations in the future.”

This story is developing. Please check back for updates.

UNICEF worried about the future for women and children

Afghans continue to wait at Kabul International Airport as thousands of Afghans rush to flee the Afghan capital of Kabul, on August 18, 2021.

Anadolu Agency | Getty Images

The executive director of UNICEF, Henrietta Fore, has told CNBC that the agency’s “deepest concern” following the withdrawal of U.S. and allied troops from Afghanistan is the impact on children’s and women’s rights and education. 

Speaking exclusively to CNBC Friday, Fore said some of the other big challenges on the ground in Afghanistan include unaccompanied children and continuing immunization programs for preventable diseases. 

“We are very worried about the status of women and children … we need the women as teachers, as healthcare workers, in children’s hospitals as doctors; we need the women to be able to work in the society. We are, as yet, unclear in some areas if that’s going to be allowed,” she said. 

Her comments came as the U.S. and its allies finished their evacuation efforts from Kabul airport, effectively ending a two-decade war sparked by the terrorist attacks of Sept. 11, 2001. 

Fore said that ensuring all children’s access to education in the country is another key focus for UNICEF, the United Nations agency responsible for the protection and development of children and their rights. 

Fore told CNBC that even before the current crisis they had been “working with elements of the Taliban in various parts of the country,” and that in some areas schools are currently open with girls and boys going to school. 

“In the past 20 years, we have had a very large gain in education, so we’ve tripled the number of schools,” she added. “We used to have 1 million children going to school [in Afghanistan]; now there are 10 million children, and more than 4 million are girls, we don’t want to go backwards 

Asked if UNICEF had been reassured by the Taliban that schools would remain open, Fore said the agency was hoping it would be the case. 

“The Taliban is not monolithic. So each district, each area, each school, is different. And so we talk to all of the relevant authorities and we are encouraging it, but we can use everyone’s advocacy about the importance of going to school for both girls and boys, because boys now are subject to recruitment into many of the local militia,” she said. 

“We want boys in school and we want girls in school, we want the future of Afghanistan’s, well their young people, to have a chance.”

Fore became executive director of the agency in 2018. She said the organization was also “particularly worried” about the high numbers of unaccompanied children in Afghanistan, since recent events unfolded. 

“Many have been separated from their families. Some have been in the airport area, either just outside the gate or inside the gate,” she said. 

Nilofar Bayat, captain of the Afghan wheelchair basketball team, arrives at Torrejon Air Base outside Madrid, Spain, on Aug. 20, 2021, with her compatriots after being evacuated from Kabul.

Mariscal | Pool | Reuters

“The real protection crisis [is] to try to get these children back with their families. Have their families gone on planes and they’ve been left behind? Or have they been sent over the fence and their families are still in Kabul?” 

Immunization programs 

Fore also said that protecting the ongoing health programs for preventable diseases was an important focus for UNICEF, as immunization rates in Afghanistan had dropped significantly. 

“So that means that polio vaccinations, measles vaccinations, all the things that we try to keep at bay, that are preventable diseases, we need to get them started again,” she stressed. 

Asked about the criticism the U.S. has received following the withdrawal of troops from the country, Fore said, “I will leave blame to others.” 

“We are just working so hard to try to reach the needs of the people. I can tell you that people are just terrified. They’re worried about the future, they don’t know what lies ahead. They’re not sure where they’re going to get their food, is the shop open, the banks are closed, you know, salaries aren’t moving. They’re just trying to survive, and so that’s what we’re focused on, just survival of these people,” she added. 

UNICEF has a 65-year history of working in Afghanistan and Fore told CNBC it is continuing to plan for the long term in the country. The agency recently launched a $192 million appeal to address the escalating crisis. 

“[it] is a lot of money, but we think we’re going to need it in Afghanistan. And we’re going to need it in the coming months and years. So we’re planning to stay and stay by the side of the many Afghan children who need us,” she said.