# U.S. sets record one-day death toll from coronavirus as FDA committee meets to review Pfizer/BioNTech vaccine

• Concerns are mounting that rich countries are hogging vaccines

The U.S. set fresh records for single-day fatalities from the coronavirus illness COVID-19 and hospitalizations, as a U.S. regulatory advisory committee gathered to offer its verdict on the vaccine developed by Pfizer Inc. and its German partner BioNTech SE.

The committee, a group of independent experts, started their meeting at 9 a.m ET and is expected to discuss the data generated in a late-stage trial all day, before taking a vote on whether to recommend the Food and Drug Administration grant the vaccine emergency use authorization.

Dr. Stephen Hahn, FDA commissioner, told NBC that the agency’s initial assessment is that “this is a vaccine that does meet our criteria.. But we do want to hear from the vaccine advisory committee.”

“We’ll have to see what the scientific and medical discussion is today. But our plan is to take their recommendations into account for our decision making and make a decision shortly thereafter… We intend to act quickly,” he said.

See now:What to expect from the FDA’s important COVID-19 vaccine meeting Thursday

The vaccine has already been authorized by the U.K., Canadian and Bahrain governments and the U.K. started inoculating high-risk people this week. Hahn noted that the U.S. is the only country that requires public vetting of data before moving ahead with an EUA, which he said is “very important for transparency.

‘It is not just a formality,” he said. “We take this very seriously, in terms of having the transparency around our process. It is why we have outside experts, because issues, medical issues, scientific issues, could be raised that need to be addressed. But again, we’ll make that final decision.”

The U.S. suffered 3,053 fatalities from COVID-19 on Wednesday, according to a New York Times tracker, the most since the start of the outbreak and more than the 2,977 people who died in the terrorist attacks on Sept. 11, 2001. The previous record was 2,885 set just last week. Another 218,473 cases were recorded, boosting the daily average to 209,835 for the last week.

See:Dr. Atul Gawande on COVID-19: ‘It’s never too late to save another 100,000 lives’

There was a record 106,688 COVID-19 patients in U.S. hospitals on Wednesday, according to the COVID Tracking Project, breaking the record of 104,590 set a day earlier. During the spring pandemic peak, hospitalizations held below 60,000 patients.

Experts have warned that cases, hospitalizations and deaths will likely spike in the coming weeks after millions of Americans traveled for Thanksgiving, against the advice of public health officials. There are concerns that wave will be followed by another, even worse one, if people travel and mix with other households over the Christmas and Hanukkah holidays.

Read:The U.S. is getting closer to COVID-19 vaccine distribution, but only about half of Americans say they’re ready to get the shots

The U.S. continues to lead the world by reported cases at 15.4 million and fatalities at 289,450 people, according to data aggregated by Johns Hopkins University, or more Americans than died in combat in both world wars of the 20th century.

Barbara Ferrer, public health director in Los Angeles County, said Wednesday the more than 8,000 people who have died of COVID-19 in her district are ““an incalculable loss to their friends and their family as well as our community” as she struggled to hold back tears at a daily briefing, the Washington Post reported. Ferrer noted that current rising death tolls are projected to continue.

In other news:

• Pfizer
PFE,
-0.51%
 and BioNTech
BNTX,
+4.85%
 said documents relating to their COVID-19 vaccine were “unlawfully accessed” after a cyberattack on Europe’s medicines regulator, MarketWatch’s Lina Saigol reported. The European Medicines Agency, or EMA, which authorizes the use of medicines across the European Union, had earlier disclosed that it had been targeted in a cyberattack. “The agency has swiftly launched a full investigation, in close cooperation with law enforcement and other relevant entities,” the EMA said in a brief statement. It added that it couldn’t provide additional details whilst the investigation is ongoing. BioNTech said that documents included in its regulatory submission, which had been stored on an EMA server, had been accessed.

• There are growing concerns that wealthy nations are hogging COVID-19 vaccines at the expense of poorer ones. The People’s Vaccine Alliance, a group that includes Amnesty International, Frontline AIDS, Global Justice Now and Oxfam, said nearly 70 low-income countries will only be able to vaccinate one in 10 people next year unless governments and drug companies act now to make sure enough doses are produced. “By contrast, wealthier nations have bought up enough doses to vaccinate their entire populations nearly three times over by the end of 2021 if those currently in clinical trials are all approved for use,” Amnesty International said in a statement. Canada tops the chart with enough vaccines to vaccinate each Canadian five times. Rich nations representing just 14% of the world’s population have bought up 53% of all the most promising vaccines so far, it said.

• A Singapore so-called cruise to nowhere that was ended after a passenger tested positive for coronavirus was a false alarm, the Guardian reported. The cruise was launched in an effort to revive the battered cruise sector with ships unable to sail during the pandemic. Nearly 1,700 passengers were isolated in their cabins on Wednesday, after the 83-year old male passenger tested positive for COVID-19. But the man did not have the virus, after three more tests conducted on land proved negative, the government said.

• Japan set a record for daily cases of COVID-19 on Thursday at 2,954, the Japan Times reported. At least 12 new deaths were counted, including five in Hokkaido. Tokyo confirmed a record of 602 new cases, surpassing the previous record of 584 set last Saturday.

Read now:Children probably won’t get a COVID-19 vaccine before the next school year — here’s why

Latest tallies

The number of confirmed cases of COVID-19 worldwide climbed above 68.9 million on Thursday, the Johns Hopkins data show, and the death toll is 1.57 million. At least 44 million people have recovered from COVID-19.

Brazil has the second highest death toll at 178,995 and is third by cases at 6.7 million.

India is second worldwide in cases with 9.8 million, and third in deaths at 141,772.

Mexico has the fourth highest death toll at 111,655 and 12th highest case tally at 1.2 million.

The U.K has 62,663 deaths, the highest in Europe and fifth highest in the world, and 1.8 million cases, or seventh highest in the world.

Read also:Leading epidemiologist on why the virus has spread in a ‘surprisingly enduring’ way in Italy, and how Germany managed lower deaths

China, where the virus was first discovered late last year, has had 93,898 confirmed cases and 4,748 deaths, according to its official numbers.

What’s the economy saying?

New applications for U.S. unemployment benefits jumped last week to a nearly three-month, owing to an increase in layoffs after a record surge in coronavirus cases as well as to filing delays after the Thanksgiving holiday, MarketWatch’s Jeffry Bartash reported.

Initial jobless claims surged by 137,000 to 853,000 in the seven days ended Dec. 5, the Bureau of Labor Statistics said Thursday. Economists polled by MarketWatch had forecast new claims to total a seasonally adjusted 720,000.

Another 427,609 applications for benefits were filed through a temporary federal-relief program that expires at the end of the year.

See now: Fight over workplace lawsuits trips up COVID relief — more than 100 organizations have lobbied on the issue

While jobless claims have correctly reflected the rise and decline in unemployment during the pandemic, a government watchdog agency also found the number of distinct individuals applying for or collecting benefits has been inflated by fraud, double counting and other problems.

Read:Jobless claims inflated, GAO finds

The Bureau of Labor Statistics plans to take steps to improve the data, but for now the claims report is not considered entirely accurate. Economists say to pay attention to the direction of claims instead of the totals.

“The jump in weekly unemployment claims was partially due to a rebound from lower claims during Thanksgiving week, but the trend of more Americans losing jobs is clearly rising over the last month,” said Robert Frick, corporate economist at Navy Federal Credit Union.

“Given Covid-19 cases and deaths are now regularly setting new highs, these reports put into question job growth in December, especially given the rapid slowdown in growth in November,” he added.

What are companies saying?

• Moderna Inc.
MRNA,
-0.30%
has dosed the first participants in a Phase 2/3 study of its COVID-19 vaccine candidate in adolescents aged 12 to less than 18. The study is being conducted in collaboration with Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The biotech is aiming to generate data in the spring of 2021 that will support the use of the vaccine in that age group, Chief Executive Stéphane Bancel said in a statement. The trial will be randomized and include a control group and the company is aiming to enroll 3,000 participants in the U.S. who will be monitored for 12 months after the second dose.

• RH Inc.
RH,
-4.45%
reported third-quarter adjusted profit and sales that beat Wall Street estimates but said it will continue to see pandemic-related supply disruptions interfering with demand for its products. RH, formerly known as Restoration Hardware, posted better-than-expected sales and profit. Demand was hindered by limiting capacity in its restaurants, lower demand for its contract division due to a continued pullback in spending for hotels and others in the hospitality industry, and lower sales in its outlets, RH said. Revenue growth lagged due to “higher-than-anticipated demand and disruptions across our global supply chain as a result of the virus,” the company said in a letter to shareholders. The “recent spike of virus infections and shelter-in-place orders continue to negatively impact our manufacturing partners, and we are now forecasting product supply to catch up to demand in the second half of 2021,” the company said. Supply constraints will limit demand and revenue growth for the remainder of this year, but RH expects that unfilled orders will provide “an $80 (million) to $100 million positive impact to revenue growth in fiscal 2021,” it said. RH plans to open more stores next year, including its “guesthouse” in New York City, but said it would not give firm opening dates because of the pandemic

• Starbucks Corp.
SBUX,
+4.36%
reiterated its guidance for next year and said that it is counting on a “significant rebound” for 2021. At its virtual investor day, Starbucks said it is anticipating a “continued recovery” from the effects of the pandemic, and expects a GAAP per-share profit between $2.34 and $2.54 and adjusted EPS between $2.70 and $2.90 in fiscal 2021. Analysts polled by FactSet expect adjusted EPS around $2.81. For fiscal 2022, Starbucks said it expects “outsized” growth in its adjusted EPS of at least 20%, and a growth rate between 10% and 12% for the two fiscal years thereafter. The 2023 and 2024 guidance compared with a previous guidance of a 10% growth rate for these years. “The recent disruption of the global pandemic has accelerated certain shifts in consumer behavior, and Starbucks has quickly adapted its business for the short- and long-term implications,” the company said.

• Hospital operator Tenet Healthcare Corp.
THC,
+18.76%
has agreed to acquire a portfolio of up to 45 ambulatory surgery centers from SurgCenter Development for $1.1 billion in cash, plus the assumption of $18 million of debt. The centers will be operated by Tenet’s United Surgical Partners International unit, which will own up to 60% of each center. The deal is expected to close by year-end. The deal “will enhance our overall business mix and further diversify our earnings profile by accelerating our shift toward lower cost of care, consumer-friendly, faster-growing assets for Tenet, USPI and our physician and health system partners,” Chief Executive Ron Rittenmeyer said in a statement. The portfolio consists of top-quality, physician-owned facilities which have generated strong growth and recovery from COVID-19, he said. Tenet is expecting the deal to generate double-digit returns on invested capital within 3 years of closing, and provide a roughly 28% boost to 2021 EPS