Nearly 37,000 Americans died of COVID-19 in November, the most in any month since the dark early days of the pandemic, engulfing families in grief, filling newspaper obituary pages and testing the capacity of morgues, funeral homes and hospitals.

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EMT Giselle Dorgalli, second from right, looks at a monitor while performing chest compression on a patient who tested positive for coronavirus in the emergency room at Providence Holy Cross Medical Center in the Mission Hills section of Los Angeles last month.  Jae C. Hong/Associated Press

Amid the resurgence, states have begun reopening field hospitals to handle an influx of patients that is pushing health care systems – and their workers – to the breaking point. Hospitals are bringing in mobile morgues. And funerals are being livestreamed or performed as drive-by affairs.

Health officials fear the crisis will be even worse in coming weeks, after many Americans ignored pleas to stay home over Thanksgiving and avoid people who don’t live with them.

“I have no doubt that we’re going to see a climbing death toll … and that’s a horrific and tragic place to be,” said Josh Michaud, associate director of global health policy at the Kaiser Family Foundation. “It’s going to be a very dark couple of weeks.”

November’s toll was far lower than the 60,699 recorded in April but perilously close to the next-highest total of almost 42,000 in May, according to data compiled by Johns Hopkins University. Deaths had dropped to just over 20,000 in June after states closed many businesses and ordered people to stay at home.

The fast-deteriorating situation is particularly frustrating because vaccine distribution could begin within weeks, Michaud said.

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FDA commissioner says he won’t guarantee emergency approval of virus vaccines

WASHINGTON — The Food and Drug Administration will not automatically authorize emergency use of coronavirus vaccines before completing a rigorous independent review, despite heightened expectations that two vaccine candidates will be available to Americans this month, Dr. Stephen Hahn, FDA commissioner, told McClatchy in an interview Tuesday.

The interview came hours before Hahn met with White House chief of staff Mark Meadows, according to an administration official, amid calls from President Donald Trump for the FDA to “act quickly” in the approval process.

The FDA is entering one of the most consequential periods in its history after two companies, Pfizer and Moderna, submitted requests for authorization of emergency use of their COVID-19 vaccine candidates. Public advisory meetings have been scheduled, and FDA scientists are reviewing internal company data “around the clock” preparing to deny or approve the applications within a matter of weeks, Hahn said.

“The urgency of the situation is a pressure that I think is substantial on all of us,” he said in the phone interview. “Our career staff recognize that and are working with great speed. But also we’ve maintained a commitment to using data and science, and we will continue to do that.”

Their reviews will not be based on public statements from the companies that say both vaccine candidates, which use similar biological platforms, demonstrated up to 95% effectiveness in advanced clinical trials.

Company results will have to be independently verified, and their safety profiles will be rigorously vetted despite company assurances that the FDA’s safety data milestones have been achieved, Hahn said.

The prospect of imminent vaccines has provided a light at the end of a dark tunnel to Americans facing uncontrolled spread of the pandemic disease and record cases, hospitalizations and deaths.

“The bottom line is we can’t determine at this point, despite the very optimistic reporting in the press and what we’ve heard,” Hahn said. “I couldn’t tell you at this point either way about authorization or not.”

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FDA chief called to White House as Trump pushes to rush vaccine approval

WASHINGTON — The head of the agency responsible for approving any COVID-19 vaccine for the U.S. was summoned to the White House on Tuesday as an increasingly frustrated President Trump complained approval wasn’t coming faster.

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Food and Drug Administration commissioner Dr. Stephen Hahn, shown in August, said in a statement, “We will make sure that our scientists take the time they need to make an appropriate decision,” referring to vaccine approvals. Alex Brandon/Associated Press

White House Chief of Staff Mark Meadows called in Stephen Hahn, the head of the Food and Drug Administration, for a meeting as the agency weighed whether to allow emergency use of the first vaccines that could help defeat the coronavirus.

Trump has been livid with the FDA for not moving faster on the vaccine, blaming it in part for his reelection loss. He has also leveled unfounded claims that drug companies deliberately delayed vaccine development to hinder his chances.

Tuesday’s meeting came as the FDA weighed whether to authorize two experimental vaccines that have been raced through development. Many Americans already harbor concerns about the potential impact of political pressure on vaccine development, and public health officials have been trying to provide reassurance that the approval process has been free from influence.

The White House did not immediately respond to requests for comment about the purpose of the meeting meeting with the FDA’s Hahn. But many aides to the president recognize that it would look bad for Trump to lose Hahn on the cusp of vaccine authorization. And some expressed concern Tuesday that the White House meeting was even happening, for fear that it could undercut efforts to frame the vaccine as a positive part of Trump’s legacy.

But the president has been fuming since he lost his reelection bid and believes that, had a pair of drug companies released data showing that their vaccines were effective before Election Day, he would have have won. He has complained repeatedly about not getting the credit he believes he deserves for the vaccine development.

Hahn said the FDA will thoroughly review each vaccine and not be rushed before making it available to the public.

“We will make sure that our scientists take the time they need to make an appropriate decision,” Hahn said, in a statement provided by the FDA. “It is our job to get this right and make the correct decision regarding vaccine safety and efficacy.”

An FDA spokesman said the agency must review “thousands of pages of technical information” provided by vaccine developers to ensure the shots were studied and manufactured properly.

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CDC advisers to vote Tuesday on who will be first in line for a vaccine

No national testing strategy for the coronavirus ever came out of the federal government. Nor was there a nationally led strategy for procuring protective equipment – states were told to buy supplies on their own.

But on Tuesday, a little-known federal advisory committee is expected to provide some of the pandemic’s most consequential directions to states, 10 months after the first case of COVID-19 was reported in the United States. The directions are to prioritize health care workers and residents of long-term care facilities to get the first shots of coronavirus vaccine in the initial rollout, once federal regulators authorize one, because the vaccine initially will be in extremely short supply.

Those priority groups, totaling about 24 million people, have been broadly supported by the advisory group in recent meetings. Tuesday’s formal vote would affirm the recommendations to Robert Redfield, director of the Centers for Disease Control and Prevention, that health care personnel and nursing home residents be first in line, in what is known as phase 1a. That, in turn, helps states scrambling to meet a Friday deadline for vaccine distribution planning.

The advisory group will also make recommendations at later meetings for priority groups in the next phases, which include essential workers and older adults. An ongoing debate about the ranking of priority groups is likely to intensify as the Food and Drug Administration gets closer to clearing a vaccine later this month.

What the independent committee is likely to recommend may differ from what some Trump administration officials want, according to three federal health officials who spoke on the condition of anonymity to share internal deliberations.

Redfield; Deborah Birx, the coordinator of the White House coronavirus task force, and Adm. Brett Giroir, the top testing official at the Department of Health and Human Services, for example, have recently emphasized the importance of prioritizing older Americans, whereas the committee members have held firm on giving preference to health care workers.

Recommendations from the advisory group are sent to Redfield, who also informs Health and Human Services Secretary Alex Azar. If the recommendations are approved, they will become official CDC recommendations on immunization in the United States.

Michael Pratt, an HHS spokesman, said Azar is committed to following the process and “has insisted that science and data drive the process for vaccines and therapeutic development, and will do so for vaccine allocation and distribution.” He added: “Doctors will make their recommendations, and ultimately the governors will make a determination of what works best for their communities based on input they receive and the circumstances on the ground.”

U.S. officials anticipate having about 40 million doses of vaccines from Pfizer and biotech firm Moderna by the end of the year, enough to immunize 20 million people, a fraction of the U.S. population of 330 million. Operation Warp Speed, the administration’s initiative to speed vaccine and therapeutics development, plans to send the first batch of 6.4 million doses of Pfizer’s vaccine to communities nationwide within 24 hours of FDA clearance, with the expectation that shots will be administered quickly.

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UN urges countries to fight misinformation on vaccines, build trust

UNITED NATIONS — The head of the world’s largest humanitarian network is urging governments and institutions to combat “fake news” about COVID-19 vaccines and start building trust about the importance of vaccinating people.

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International Federation of Red Cross President Francesco Rocca speaks to media at the Kastanies border checkpoint on the Greek-Turkish border, Thursday, March 5. AP Photo/Giannis Papanikos

Francesco Rocca, president of the International Federation of Red Cross and Red Crescent Societies, says “to beat this pandemic, we also have to defeat the parallel pandemic of distrust.”

He says there is “a growing hesitancy about vaccines in general, and about a COVID vaccine in particular” around the world, pointing to a recent Johns Hopkins University study in 67 countries that found vaccine acceptance declined significantly in most countries from July to October this year.

In a quarter of countries, Rocca said, the study found that the acceptance rate for a vaccine against the coronavirus was near or below 50 percent, with Japan dropping from 70 percent to 50 percent acceptance, and France dropping from 51 percent to 38 percent acceptance.

He stressed the lack of trust “is by no means a Western phenomenon,” citing the federation’s research in recent months in eight African countries showed a steady decline in the perceptions of the risk of COVID-19 infection.

Why health officials are terrified of a pandemic Christmas

Americans heard the pleas to stay home. They were told what would happen if they didn’t. Still, millions traveled and gathered during last week’s Thanksgiving holiday, either doubting the warnings or deciding they would take their chances.

Now, like any partygoer waking from a raucous weekend – feeling a bit hung over and perhaps a tinge of regret – the nation is about to face the consequences of its behavior and will need to quickly apply the lessons before heading into the doubleheader of Christmas and New Year’s.

Health experts point to several key takeaways: Many states were overwhelmed by unexpected surges in testing – with many families hoping a negative result might make their planned gatherings a little safer. Some airports were not prepared for the huge crowds that had not been seen since the beginning of the pandemic, making it difficult for travelers to maintain social distancing.

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Amanda Perrone shops for Christmas decorations on Black Friday, at Corky’s Garden Path Greenhouse in Scott Twp., Pa. on Friday, Nov. 27. Christopher Dolan/The Times-Tribune via AP

But perhaps the most obvious lesson: Public health messaging needs to be retooled, as whole swaths of the country are simply tuning out the warnings from officials and experts.

“We have to rethink how we’re communicating. Blaming people, yelling at them, stigmatizing them – clearly it’s not working,” said Angela Rasmussen, a virologist at Georgetown Center for Global Health Science and Security. “We have to show compassion and empathy. Understand where people are coming from and persuade them to do otherwise.”

As bad as the country’s infections and hospitalizations are now, they will probably worsen in coming weeks because of the millions of interactions that occurred over Thanksgiving, experts say.

In recent days America’s infection curve has already become a sheer mountain-climber’s cliff with record-breaking case numbers and hospitalizations. If people travel and gather for Christmas as they did this past week, they project, the country’s already catastrophic situation could reach levels where hospitals are forced to choose which patients to save and which to let die, and where lockdowns become unavoidable realities of everyday life.

“What concerns me is that Thanksgiving is an American holiday,” said Melissa Nolan, an epidemiologist at the University of South Carolina. “Christmas is an international holiday – it’s celebrated around the world. So if Thanksgiving is an indicator of how much travel we can expect at Christmas, I think that is very concerning.”

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Tokyo taking steps to limit coronavirus cases

TOKYO — Tokyo Gov. Yuriko Koike is asking senior citizens 65 or older and those with underlying health conditions not to use the government’s GoTo discount campaign to travel in and out of Tokyo.

New cases in Tokyo and other major cities have spiked in recent weeks, with serious cases rapidly filling hospitals and impacting the treatment of other patients.

Koike says she is focusing on how to stop serious cases and prevent the medical systems from collapsing.

Koike issued a request for restaurants serving alcohol, bars and karaoke chains to close early until mid-December. Aichi, Osaka and Hokkaido have taken similar steps.

Prime Minister Yoshihide Suga’s government has been criticized for being slow to curb social and economic activity. Suga hasn’t taken tougher steps beyond basic safety precautions and wearing masks.

Japan managed to avoid a high number of cases with stay at home and business closure requests under a non-binding state of emergency in the spring. Some experts say it’s time to scale back business activity and urged the government to act quickly to avoid another state of emergency.

The health ministry says Japan has nearly 149,000 confirmed coronavirus cases and more than 2,100 deaths.

Pfizer, BioNTech apply for emergency approval of vaccine in Europe

Pfizer Inc. and partner BioNTech SE sought regulatory clearance for their Covid-19 vaccine in the European Union, putting the shot on track for potential approval there before the end of the year.

The European Medicines Agency said on Tuesday it could issue an opinion within weeks, with a meeting on the assessment scheduled for Dec. 29 at the latest. Submitted on Monday, the formal application caps a rolling review process that started on Oct. 6 and allowed Europe’s drugs regulator to examine data on the vaccine as it emerged.

Governments around the world are eager to start vaccinating their populations to curb the pandemic. Rival Moderna Inc. requested clearance in the U.S. and Europe on Monday. The U.K. invoked a special rule to allow its regulator to bypass its EU counterpart and may be the first to sign off on the Pfizer-BioNTech product. The U.S. isn’t far behind, with a Food and Drug Administration panel set to meet on Dec. 10 to discuss the vaccine.

BioNTech can start shipping the first doses “within hours” after regulatory clearance, Chief Financial Officer Sierk Poetting said at a press conference. BioNTech shares rose 2.3% in German trading.

In November, a study of almost 44,000 people showed the shot prevented 95% of symptomatic coronavirus cases.

If the EMA concludes that the benefits of the Pfizer-BioNTech shot outweigh its risks, it will recommend granting a conditional clearance that could enable the shot to be rolled out in Europe before the end of the year, the companies said in a statement. The agency said it would work “over the Christmas period” on the assessment.

Pfizer and BioNTech also started regulatory submissions in other countries including Australia, Canada and Japan, they said. The partners have signed deals to deliver hundreds of millions of doses of the vaccine, including an agreement with the EU for 200 million doses, with an option for an additional 100 million.

A conditional clearance is issued when European authorities want to get a drug to patients quickly without waiting for as comprehensive a data package as would normally be required for standard authorization. It’s valid for one year and can be renewed — and eventually converted into a standard approval.

Lockdowns working to stem virus surge in France

ROUEN, France — Lockdowns that are forcing millions of people to once again stay home — cutting them off from families and friends, shuttering businesses they invested in, university classes that fed their minds and the nightspots where they socialized — has begun to turn back the coronavirus resurgence in France.

Still, in the country that passed the bleak milestone of 52,000 dead in November, the costs to mental health have been considerable.

With numbers now falling for COVID-19 patients in intensive care, psychiatrists are facing a follow-up wave of psychological distress. Health authorities’ surveys point to a surge of depression most acute among people without work, those in financial hardship and young adults.

The Rouvray Hospital Center in the Normandy town of Rouen is among places where psychiatrists are on the front line of the pandemic’s mental-health fallout. They are fearful that a growing crisis of depression, anxiety and worse may be on the horizon as more livelihoods, futures and hopes are lost to the pandemic.

Associated Press journalists spent 10 hours in the sprawling 535-bed facility, the day after French President Emmanuel Macron laid out a blueprint stretching into mid-January for the gradual lifting of lockdown restrictions.

“Being alone between four walls is terrible,” one patient says. “The halting of life like this, it reverberates on people. It is not good.”

Advocate says pandemic has increased risk of violence, human trafficking

UNITED NATIONS — Nobel Peace Prize laureate Nadia Murad says the COVID-19 pandemic has increased trafficking of women and gender-based violence, leaving the health and safety of women “on the line.”

The 27-year-old activist, who was forced into sexual slavery by Islamic State fighters in Iraq, says curfews, lockdowns and travel restrictions imposed by governments to slow the spread of the virus “have had unintended consequences on women worldwide.”

Murad said domestic tensions have intensified in confined living spaces, and stay-at-home orders “are increasing human trafficking farther underground, out of sight of law enforcement.”

A member of Iraq’s Yazidi minority, Murad was among thousands of women and girls who were captured and forced into sexual slavery by Islamic State extremists in 2014. Her mother and six brothers were killed by Islamic State fighters. She became an activist on behalf of women and girls after escaping and finding refuge in Germany, and shared the Nobel Peace Prize in 2018.

Vietnam confirms first local transmission of virus in 89 days

HANOI, Vietnam — Vietnamese authorities are conducting intensive contact tracing after the country’s first confirmed local transmission of the coronavirus in 89 days.

State media says a 32-year-old man in Ho Chi Minh City tested positive for the coronavirus on Monday after visiting a flight attendant who was undergoing self-quarantine following his return from Japan two weeks ago. The flight attendant tested positive on Saturday, the Tuoi Tre newspaper said.

Health authorities ordered 137 people who had been in close contact with the man to stay in a central quarantine facility and shut down an English center where the man works as a teacher.

Vietnam’s borders remain closed in an attempt to keep out the virus. Only limited international flights are operating to repatriate Vietnamese nationals and transport foreign diplomats and experts.

The country has reported 1,347 coronavirus cases, including 35 deaths.

California considers stay-at-home orders after hospitalizations skyrocket

SACRAMENTO, Calif. — California could see a tripling of hospitalizations by Christmas and is considering stay-home orders for areas with the highest case rates as it tries to head off concerns that severe coronavirus cases could overwhelm intensive care beds, officials said Monday.

“The red flags are flying in terms of the trajectory in our projections of growth,” said Gov. Gavin Newsom. “If these trends continue, we’re going to have to take much more dramatic, arguably drastic, action.”

Hospitalizations have increased 89% over the past 14 days and nearly 7,800 coronavirus patients were hospitalized as of Monday. About 12% of Californians testing positive are likely to need hospital care within the next two to three weeks.

The biggest concern is intensive care cases, which have increased 67% in the past two weeks. If that continues, it would push ICU beds past capacity by mid-December.

That statistic is likely to drive state-mandated stay-at-home orders in 51 of California’s 58 counties that already are seeing the most restrictions on business activities, said Dr. Mark Ghaly, the state’s secretary of health and human services.


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