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FDA panel recommends approval of Pfizer’s Covid vaccine for emergency use

If the FDA adopts the recommendation it would mark a pivotal moment in the Covid-19 pandemic, which has killed roughly 290,000 in the U.S. in less than a year.

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A key Food and Drug Administration advisory panel voted 17 to 4 with one member abstaining on Thursday to recommend the approval of Pfizer and BioNTech’s coronavirus vaccine for emergency use, the last step before the FDA gives the final OK to broadly distribute the first doses throughout the United States.

If the FDA accepts the nonbinding recommendation from the Vaccines and Related Biological Products Advisory Committee — which is expected — it would mark a pivotal moment in the Covid-19 pandemic, which has infected more than 15.4 million people and killed roughly 290,000 in the U.S. in less than a year.

The committee plays a key role in approving flu and other vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does.

The FDA could grant emergency use authorization of Pfizer’s vaccine as early as Friday, James Hildreth, a member of the committee, told NBC’s “Weekend Today” on Saturday. An emergency use authorization, or EUA, generally allows a drug or vaccine to be administered to a limited population or setting, such as to hospitalized patients, as the agency continues to evaluate safety data.

It’s unclear whether the FDA will authorize Pfizer and BioNTech’s vaccine for use in certain groups. Some people, including pregnant women and young children, will likely have to wait to get the vaccine in the U.S. until Pfizer can finish trials on those specific groups. The FDA said Tuesday that there is currently insufficient data to make conclusions about the safety of the vaccine in children under age 16, pregnant women and people with compromised immune systems. Regulators in Canada, the U.K. and Bahrain have all cleared the vaccine for use by most adults.

The committee recommended emergency authorization of the vaccine for people who are 16 years old and older. Prior to the vote, some experts in the meeting argued to limit its recommendation to people who are at least 18, saying the safety data on 16- and 17-year olds was “thin.”

“I would like to just join that lineup of people who are advocating for that. .. I think the data is very thin and it’s inadequate to really say we have safety given the low incidents of disease,” Dr. Mark Sawyer, a voting member of the panel and infectious disease expert at the University of California San Diego School of Medicine, said at the meeting.

An EUA isn’t the same as a full approval, which can typically take months. Pfizer has submitted only two months of follow-up safety data, but the agency usually requires six months for full approval.

In a statement after the vote, Pfizer CEO Albert Bourla said the company was “pleased” with the vote, “and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the U.S. in an effort to help combat this devastating pandemic.”

U.S. officials say they are prepared to distribute the vaccine within 24 hours of authorization. Initial doses will be limited as manufacturing ramps up, with officials predicting it will take months to immunize everyone in the U.S. who wants to be vaccinated. Pfizer has said it plans to ship 50 million vaccine doses this year, enough to inoculate 25 million people. The vaccine is expected to be distributed in phases, with the most critical U.S. workers and vulnerable people getting it first. The Centers for Disease Control and Prevention has provided states with an outline that recommends prioritizing health-care workers and nursing homes first, but states can distribute the vaccine as they see fit.

U.S. officials plan to continue watching for any adverse reactions to Pfizer’s vaccine in the health-care workers and nursing home residents who receive it, Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Disease, said during the agency’s meeting Thursday. Officials will use a text-messaging system, called v-safe, which is intended to provide early indications about possible adverse reactions from the vaccines.

The U.K., which authorized Pfizer’s vaccine for emergency use last week, began mass inoculations on Tuesday. The vaccine there is being given to front-line health workers, nursing home workers and those over age 80 before being given more widely among the U.K. population.

Pfizer’s vaccine uses messenger RNA, or mRNA, technology. It’s a new approach to vaccines that uses genetic material to provoke an immune response. Late-stage clinical trial data shows the vaccine is 95% effective in preventing Covid, is safe and appears to fend off severe disease. To achieve maximum effectiveness, the vaccine requires two doses taken about three weeks apart.

The FDA has indicated it would authorize a Covid-19 vaccine that’s safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the CDC.

Two days before the meeting, the FDA published documents on its website that said trial data submitted by Pfizer was consistent with recommendations put forth by the agency for emergency use. It also confirmed that the vaccine was highly effective and did not raise any major safety concerns, adding that more safety data is still needed on the vaccine in children, pregnant women and people with compromised immune systems.

During the meeting, FDA vaccine reviewer Dr. Susan Wollersheim noted the trial data showed a “numerical imbalance” in cases of Bell’s palsy, a condition that causes a temporary weakness or paralysis of the muscles in the face. She said there were four cases in the vaccine group and none in the placebo group. While the frequency of cases was not above that of the general population, the FDA recommended further surveillance if the vaccine is authorized for more broad use.

Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, presenting potential logistical challenges for rural areas and inner cities that may not have good health-care infrastructure. By comparison, Moderna has said its vaccine can be stored for up to six months at minus 4 degrees Fahrenheit.

President Donald Trump’s coronavirus vaccine czar, Dr. Moncef Slaoui, has said the U.S. should be able to distribute enough coronavirus vaccine doses to immunize 100 million Americans, nearly a third of the U.S. population, by the end of February. He has said the entire U.S. population could be vaccinated against Covid-19 by June.

Pfizer said last week its full-scale production lines in the U.S. and Europe are now complete and it is “confident” it will be able to supply the targeted doses.

— CNBC’s Noah Higgins-Dunn and Will Feuer contributed to this report.

Source: https://www.cnbc.com/2020/12/10/pfizer-covid-vaccine-fda-panel-recommends-approval-for-emergency-use.html

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Airbnb says first-quarter revenue rose 5% as vacationers return to travel

Airbnb’s net loss tripled, but the company expects its adjusted margin to improve in the second half of the year as travel restrictions ease up.

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Airbnb CEO Brian Chesky attends the Cannes Lions on June 20, 2016, in Cannes, France.

Richard Bord | Getty Images

Airbnb said revenue increased 5% in the first quarter, beating analysts’ estimates, as the rapid pace of vaccinations led to more travel. The company’s net loss tripled because of debt repayments and restructuring costs.

Here’s how the company did:

  • Earnings: Loss of $1.95 per share
  • Revenue: $886.9 million, vs. $714.4 million as expected by analysts, according to Refinitiv.

The increase in year-over-year revenue followed a 22% decline in the fourth quarter.

The coronavirus pandemic considerably curtailed rental activity on Airbnb, but the business appears to be recovering as vaccines becomes more widely available and governments lift travel restrictions. The company reported 64.4 million nights and experiences booked, up 39% from the fourth quarter and up 13% year over year. Analysts polled by FactSet had expected 62.5 million nights and experiences booked.

Booking nights dropped in every quarter last year compared with the same period in 2019.

Gross booking value, Airbnb’s way of tracking host earnings, service fees, cleaning fees and taxes, totaled $10.3 billion, up 52% year over year and above the $7.87 billion FactSet consensus.

Airbnb’s net loss tripled as it repaid debt for loans it took out early in the pandemic, and as the company continued to pay restructuring fees following layoffs. It also had a $113 million impairment related to office space in San Francisco.

Its average daily rate rose 25% from the prior quarter to $160, reflecting an increase in the amount customers are spending for homes and experiences. Airbnb pointed to strength in bookings in North America, along with complete homes and locations outside cities, all of which tend to bring higher rates. The company said 24% of nights booked came from stays of at least 28 days, compared with 14% in 2019.

“The two trends I do think are going to invert are we are going to see a recovery of urban travel and a recovery of cross border,” Airbnb CEO Brian Chesky said on a conference call with analysts. “This has been our bread and butter before the pandemic, and I think those are significant tailwinds for us.”

Chesky talked about the potential to offer deals to travelers who can be flexible about when they travel.

“There’s a lot of other opportunities for us, I think, to point demand to where we have available supply, which will allow us to steadily increase occupancy,” he said.

Cancellation rates are now considerably lower than in 2020 but remain higher than they were in 2019, said Dave Stephenson, the company’s finance chief.

The company issued general commentary on the quarters ahead, saying that in the second quarter its adjusted earnings margin before interest, taxes, depreciation and amortization could break even or be slightly positive. That margin was -7% in the first quarter, and it should be higher in the second half of the year than the first half, Airbnb said in a letter to shareholders.

“We expect revenue in Q2 2021 to be significantly higher than that of Q2 2020, given the impact of Covid- 19 on the prior year period, and to be at a similar level to that of Q2 2019,” the company said. “In Q2 2021, we expect the positive momentum of recovery experienced in Q1 2021 to be partially offset by the continued uncertainty of travel restrictions and lockdowns in EMEA.”

The company said it’s too soon to say whether the recovery in the first half of the year will keep the same pace in the second half.

“Although we have seen booking lead times start to lengthen when compared with Q4 2020, we continue to have limited visibility for growth trends in the second half of 2021,” Airbnb said. “With the increased availability of vaccines and the easing of some travel restrictions, there has been greater willingness by guests to search for and book travel later in the year. Offsetting this is the difficulty in predicting factors such as future Covid-19 outbreaks or travel restrictions globally, which impact the actual rate at which guests complete their stays (at which point we recognize revenue).”

Airbnb reported financials for the second time as a public company, having completed its IPO in December. Airbnb shares have fallen about 8% since the start of 2021, while the S&P 500 is up about 10% over the same period.

WATCH: Airbnb CEO on the campaign to attract more hosts as demand surges

  • Earnings: Loss of $1.95 per share
  • Revenue: $886.9 million, vs. $714.4 million as expected by analysts, according to Refinitiv.

Source: https://www.cnbc.com/2021/05/13/airbnb-abnb-earnings-q1-2021.html

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Disney misses on subscriber expectations, parks revenue still hurt by Covid restrictions

Disney+ had been bolstering the company’s success as it was losing out on business from Covid restrictions, but it seems the rapid growth is starting to slow.

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In this handout photo provided by Walt Disney World Resort, guests stop to take a selfie at Magic Kingdom Park at Walt Disney World Resort on July 11, 2020 in Lake Buena Vista, Florida.

Matt Stroshane | Walt Disney World Resort | Getty Images

Disney reported second quarter results Thursday, posting lower-than-expected revenue and subscriber counts for its streaming service.

The company’s stock dipped around 3.5% in after-hours trading.

  • Earnings per share: 79 cents vs 27 cents expected in a Refinitiv survey of analysts
  • Revenue: $15.61 billion vs $15.87 billion expected in the survey

Streaming

The company missed on subscriber estimates for Disney+, coming in at 103.6 million paid subscribers. It was expected to post 109 million, according to FactSet.

The streaming service had been bolstering the company’s success as it was losing out on business from Covid restrictions, but it seems the rapid growth is starting to slow. Still, the company reiterated its plans to see between 230 million to 260 million subscribers to Disney+ by 2024.

“This quarter’s numbers were exactly as we projected internally, so no disappointment here,” CEO Bob Chapek told CNBC’s Julia Boorstin.

Average monthly revenue per user dipped 29% year over year to $3.99, which the company attributed to the launch of Disney+ Hotstar. The service has lower average monthly revenue per paid subscriber than traditional Disney+ in other markets, pulling down the overall average for the quarter.

Disney CFO Christine McCarthy said on the company’s earnings call that excluding Hotstar, average revenue per paid Disney+ subscriber would have been $5.61 in the quarter.

Average monthly revenue per paid subscriber grew slightly for Disney’s other direct-to-consumer platforms, ESPN+ and Hulu.

The company said it now has around 159 million total subscribers across its streaming services as of the end of the second quarter. Revenue for Disney’s direct-to-consumer business grew 59% to $4 billion, which has helped offset losses in other segments affected by the pandemic.

Disney announced it is also extending its MLB contract through 2028 and that it signed an eight-year soccer deal with LaLiga.

Parks

Revenue at Disney’s parks, experiences and products segment fell 44% to $3.2 billion, as many of its theme parks were either closed or operating at reduced capacity and its cruise ships and guided tours were suspended.

The company said the outbreak cost this division around $1.2 billion in lost operating income during the latest quarter.

Disney recorded a one-time $414 million charge during the quarter for impairments and severance for the planned closure of an animation studio and Disney-branded retail stores, and severance paid to workers at its parks and and resorts businesses.

Disney reopened its two California-based parks on April 30, so any revenue garnered over the last few weeks is not reflected in the fiscal second-quarter results. However, the parks’ reopening could boost expectations for the fiscal third quarter.

“We are very encouraged by the initial guest response,” McCarthy said, adding that forward-looking bookings are strong as coronavirus case counts decline and vaccines ramp up.

Additionally, the Centers for Disease Control and Prevention said earlier Thursday fully vaccinated people no longer need to wear a face mask or stay six feet away from others in most settings, whether outdoors or indoors. Chapek pointed toward the new guidance as good news for the company, saying in the earnings call it will be a bigger catalyst for growth and attendance.

“I think in relatively short order you’re going to see our attendance go up significantly,” Chapek later told CNBC.

As of Thursday, Disney’s Paris-based theme park is the only location that has not reopened to the public.

Content sales and licensing revenues fell 36% for the quarter to $1.9 billion. The award-winning “Nomadland” was Disney’s only theatrical release in the U.S. over the quarter (it debuted simultaneously on Hulu). “Raya and the Last Dragon,” Disney’s latest animated feature, also debuted in some theaters internationally. It was made available on Disney+ Premier Access for $30.

Several Marvel titles are on the horizon, such as “Black Widow,” “Eternals,” “Shang-Chi and the Ten Rings,” and “Spider-Man: No Way Home” as well as “Cruella,” “Jungle Cruise,” “Free Guy,” “Encanto” and “West Side Story.”

The company said that “Shang-Chi and the Ten Rings” and “Free Guy” will be released first in theaters, with an exclusive 45-day window. Disney said earlier Thursday its blockbuster film “Jungle Cruise” will debut in theaters and on Disney+ Premier Access on July 30.

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Source: https://www.cnbc.com/2021/05/13/disney-dis-q2-2021-earnings.html

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As much as $365 billion wiped off cryptocurrency market after Tesla stops car purchases with bitcoin

Tesla CEO Elon Musk said Tesla would suspend car purchases using bitcoin, wiping off billions of dollars of value from the cryptocurrency market.

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Artur Widak | NurPhoto | Getty Images

GUANGZHOU, China — Hundreds of billions of dollars were wiped off the entire cryptocurrency market after Tesla CEO Elon Musk tweeted that the electric vehicle maker would suspend car purchases using bitcoin.

At around 6:06 a.m. Singapore time on Thursday when Musk made the announcement, the value of the whole cryptocurrency market stood at around $2.43 trillion, according to data from Coinmarketcap.com.

Around 8:45 a.m., the market capitalization had dropped to around $2.06 trillion, wiping off around $365.85 billion. The market has pared some losses. Since Musk’s tweet, the cryptocurrency market had seen $165.75 billion wiped off its value at around 9:22 a.m. Singapore time.

In February, Tesla announced in a regulatory filing that it had purchased $1.5 billion worth of bitcoin and planned to accept the cryptocurrency for payments.

Musk cited environmental concerns on Thursday and said Tesla is “concerned about rapidly increasing use of fossil fuels for Bitcoin mining and transactions, especially coal, which has the worst emissions of any fuel.”

Bitcoin is not issued by a single entity like a central bank. Instead, it is maintained by a network of so-called “miners.” These miners use purpose-built computers that require a lot of energy to solve complex mathematical puzzles in order for bitcoin transactions to go through. Bitcoin’s energy consumption is larger than some individual countries.

At around 9:34 a.m. Singapore time, bitcoin was down over 12%, dipping below the $50,000 mark for the first time since Apr. 24, according to CoinDesk data. Despite the recent pullback, bitcoin is still up over 400% in the last 12 months.

Other cryptocurrencies ether and XRP were also sharply lower.

Musk has been a big proponent of digital currencies including bitcoin and dogecoin, helping to drive their prices higher in recent months.

The Tesla CEO said the company will not be selling any bitcoin and intends to use it for transactions “as soon as mining transitions to more sustainable energy.”

Bitcoin has garnered interest in the last year as companies such as Square and Tesla announced bitcoin purchases and large institutional investors entered the cryptocurrency space. Major investment banks like Goldman Sachs and Morgan Stanley have also sought ways to allow their wealthy clients to get bitcoin exposure.

Around 8:45 a.m., the market capitalization had dropped to around $2.06 trillion, wiping off around $365.85 billion. The market has pared some losses. Since Musk’s tweet, the cryptocurrency market had seen $165.75 billion wiped off its value at around 9:22 a.m. Singapore time.

Source: https://www.cnbc.com/2021/05/13/bitcoin-btc-price-falls-after-tesla-stops-car-purchases-with-crypto.html

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