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NYC covid-19 death toll rivals fatality rate during 1918 flu epidemic, researchers say

Health & BeautyAug 14. 2020Robert Redfield, director of the Centers for Disease Control and Prevention, left, and Rep. Jamie B. Raskin (D-Md.) greet one another with an elbow bump after July 31 hearing. (Kevin Dietsch/AP) 

By The Washington Post · Lenny Bernstein, Brady Dennis · NATIONAL, HEALTH, POLITICS, SCIENCE-ENVIRONMENT, HEALTH-NEWS 
The increase in deaths in New York City during the early months of the covid-19 pandemic rivals the death toll there at the peak of the 1918 flu pandemic, according to an analysis published Thursday.

The comparison, published online in the medical journal JAMA Network Open, found that the number of deaths from all causes was roughly equal during the two peak months of the flu epidemic and the first 61 days of the current outbreak.

The H1N1 flu pandemic eventually killed 50 million people a century ago, about 675,000 of them in the United States. The current pandemic has claimed at least 748,000 lives worldwide, about 163,000 of them in the United States, according to a tally kept by The Washington Post.

“For anyone who doesn’t understand the magnitude of what we’re living through, this pandemic is comparable in its effect on mortality to what everyone agrees is the previous worst pandemic,” said Jeremy Faust, an emergency physician at Brigham and Women’s Hospital in Boston who led the team that conducted the data review.

(The AIDS epidemic has killed more than 700,000 people in the United States since it began in 1981.)

There were 31,589 deaths from all causes in New York during the peak period of the flu epidemic, nearly the same as the 33,465 tallied in the 61 days after the first death on March 11 of this year, the analysis shows.

New York in 1918 had a smaller population of 5.5 million people, so the death rate of 287 per 100,000 “person-months” was greater than the 202 of the current covid-19 pandemic. Person-months is a way of measuring the number of deaths in a population during a specific period of time.

But the current outbreak has seen a more dramatic rise in “excess deaths” – the number of fatalities above what would be expected in a normal year. With better medical care, public health, hygiene and medicines such as antibiotics, New York typically has about half the death rate of a century earlier – about 50 per person-month instead of 100. So the current outbreak has quadrupled the death rate, while the flu pandemic nearly tripled it.

The Post has reported that the United States recorded about 37,100 excess deaths in March and the first two weeks of April, nearly 13,500 more than were attributed to covid-19, the disease caused by the novel coronavirus, during that time. The report was based on an analysis of federal data conducted for The Post by a research team led by the Yale School of Public Health.

The findings on Thursday brought the latest reminder of the startling human cost that the current pandemic has inflicted in recent months – and not just in New York, but around the nation. 

“This is the greatest public health crisis that’s hit this nation in a century,” Robert Redfield, director of the Centers for Disease Control and Prevention, said during an interview with WebMD, noting that years of underinvestment in public health infrastructure had left the United States “unprepared” for the pandemic and its still-growing toll

Redfield said the mounting fatalities will make covid-19 “clearly” one of the leading causes of death in the country by the year’s end.

Still, Redfield said he is optimistic that a vaccine could be ready for production before the end of the year, as a particularly dangerous flu season looms. He was similarly hopeful that the high rate of infections in the country would drop if Americans systematically wear masks, maintain social distancing, practice good hygiene and avoid large gatherings.

“You do those four things, it will bring this outbreak down,” he said. “But if we don’t do that, as I said last April, this could be the worst fall from a public health perspective we’ve ever had.”

Also on Thursday, presumptive Democratic presidential nominee Joe Biden called for an immediate nationwide mask mandate that would require everyone in the country to wear face coverings when outside for the next three months.

Doing so would save the lives of at least 40,000 people, he said in brief remarks in Delaware that followed a lengthy briefing on the coronavirus crisis.

“Every single American should be wearing a mask when they’re outside for the next three months at a minimum,” Biden said, emphasizing each word. “Every governor should mandate it.”

Biden described that simple act as a civic responsibility, comparing it with giving blood or donating food to those in need. Although masks can be uncomfortable, he said, they are key to getting life back to normal.

“Be a patriot. Protect your fellow citizens,” he said. “Step up. Do the right thing.”

President Donald Trump, who earlier this year expressed doubt about the value of masks, has since endorsed their use. “Maybe they’re great and maybe they’re just good, and maybe they’re not so good,” Trump said Thursday during a White House coronavirus briefing. “But frankly, what do you have to lose?”

But he slammed Biden’s proposal. “He thinks it’s good politics I guess,” the president said. 

“I trust the American people and their governors very much,” he said. “I trust the American people and the governors want to do the right thing to make the smart decisions. Joe doesn’t, Joe doesn’t. Joe doesn’t know too much.”

Trump accused Biden of “playing politics from the sidelines” and called the former vice president’s plan “regressive,” “anti-scientific” and “very defeatist.”

In few places are the looming worries about the months ahead more immediate than in the nation’s public schools, where families and administrators alike face a series of excruciating decisions. 

Southern states such as Louisiana, Georgia, Arkansas and Texas have some of the earliest back-to-school start dates in the country. Parents, educators and elected officials have watched these early districts closely for clues on whether it’s safe to send teachers and students back into classrooms nationwide – even as the Trump administration has insisted that schools need to return to in-person learning.

So far, the news is not encouraging.

In Georgia, more than 900 students and staff in the Cherokee County School District have been ordered to quarantine after school officials reported nearly 60 students and staff had tested positive for covid-19.

Days after a photo went viral showing students packed into a hallway at North Paulding High School in suburban Atlanta, the district confirmed at least 35 new infections, according to WXIA-TV, which obtained a letter sent to parents.

In central Georgia, people in at least seven schools in the Houston County School District had tested positive for the coronavirus as of late Wednesday, the Macon Telegraph reported.

In Louisiana’s Livingston Parish, at least 150 students and staff have been forced to quarantine after positive cases emerged there, according to the Advocate of Baton Rouge.

Schools that opened even earlier have seen similar outcomes: A Mississippi school that resumed classes the first week of August reported one infected student; within two weeks, 116 students were sent home to quarantine.

If schools remain in limbo, so too do millions of American businesses and workers who are navigating a wave of unemployment and bankruptcies. 

AMC Theatres, the country’s largest movie theater chain, announced Thursday it will resume operations next week after a five-month shutdown, becoming the latest service-sector giant to reopen to the public at a time when infections remain high throughout the United States.

More than 100 AMC theaters in at least 19 states will start screening movies again starting Aug. 20, the company said in a statement. To lure customers back in, all tickets that day will be 15 cents – a campaign AMC is branding “Movies in 2020 at 1920 Prices.”

Guests and workers will be required to wear masks at all times, and auditoriums will operate at 30 percent capacity or less, depending on local restrictions. The company said it will also make hand sanitizer available and regularly disinfect its facilities.

The pandemic has forced AMC into a dire financial position. It furloughed more than 600 corporate employees in the spring, and in June, after reporting a $941.5 million drop in first-quarter revenue, the company warned in a financial filing that it had “substantial doubt” about its ability to stay afloat.

Meanwhile, about 960,000 workers filed for unemployment insurance last week, which marks the first time that initial claims dipped below 1 million since mid-March, when the pandemic first took hold and stay-at-home orders vacated workplaces.

The drop in jobless claims comes as the economy takes prominence in the presidential election. Trump has been touting the numbers of jobs that have been regained in the past three months, even though the unemployment rate and weekly claims remain around historic highs.

U.S. stocks also came close to making financial history Thursday, soaring toward record highs before slipping in late-day trading.

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Russia unveils coronavirus vaccine, claiming victory in global race

Health & BeautyAug 12. 2020

By The Washington Post · Isabelle Khurshudyan, Carolyn Y. Johnson · WORLD, HEALTH, EUROPE, HEALTH-NEWS 

MOSCOW – Russian President Vladimir Putin claimed Tuesday that Russian scientists achieved a breakthrough in the global vaccine race, announcing that the country has become the first to approve an experimental covid-19 vaccine and that his own daughter has already taken a dose.

Officials have pledged to administer the possible vaccine to millions of people this summer and fall – including tens of thousands of teachers and front-line health-care workers in the coming weeks before even finishing clinical trials – with the formula developed by the Gamaleya Institute in Moscow.

https://www.washingtonpost.com/video/c/embed/7446a98d-9276-4687-9394-dc2118c25289?ptvads=block&playthrough=false

But Russia’s hard charge toward a potential vaccine has raised alarm among global health experts that the country is jumping dangerously ahead of critical, large-scale testing that is essential to determine whether a possible covid-19 protection is safe and effective. Few details of the Gamaleya research have been made public or underwent peer review.

Russia’s Health Ministry did not respond to requests for comment, and the Gamaleya Institute referred an interview request to the ministry.

Konstantin Chumakov, a member of the Global Virus Network, an international coalition working on viral threats, said “it is scientifically impossible to prove efficacy” without widespread trials, known as Phase 3.

“Using it in general population before the results of Phase 3 trials are fully studied is a gamble,” he said. “A Russian roulette, if you will.”

The vaccine is named Sputnik V, a reference to the first orbital satellite, which was launched by the Soviet Union in 1957 and set off the global space race. The name also evoked how Putin’s government has seen the vaccine race as a point of national pride and competition on a global scale, with labs in the United States, Europe, China and elsewhere are also in the hunt for a potential vaccine.

“Of course, what counts most is for us to be able to ensure the unconditional safety of the use of this vaccine and its efficiency in the future. I hope that this will be accomplished,” Putin said at a meeting with government members Tuesday, adding that one of his two daughters had received the potential Gamaleya vaccine. He didn’t identify which daughter.

Russian labs race to find a vaccine by fall, but concerns raised about fast-track methods

The aggressive strategy from a country eager to declare a victory amid one of the worst outbreaks in the world has been criticized by outside scientists who worry that shots could be harmful or give people a false sense of security about their immunity. China has already authorized one vaccine for use in its military, ahead of definitive data that it is safe and effective.

“This is changing the rules. This is cutting corners,” said J. Stephen Morrison, senior vice president at the Center for Strategic and International Studies. “It’s a major development, and it starts with Putin. He needs a win.

“It’s hearkening [back to] the Sputnik moment,” he added. “It’s harking back to the glory days of Russian science, it’s putting the Russian propaganda machine into full gear. I think this could backfire.”

– – –

The international jockeying to find a vaccine has sharpened concerns about vaccine nationalism, in which countries’ need to declare victory over the pandemic could bypass long-standing safeguards to protect people from unproven medical products by ensuring that their benefits outweigh the risks.

For Russia, leading the vaccine race is an avenue for greater geopolitical clout. But the country is also looking to avoid appearing dependent on Western powers, with whom relations are historically poor, analysts said.

Last month, security officials from the United States, Britain and Canada accused hackers linked to a Russian intelligence service of trying to steal information from researches working to produce coronavirus vaccines in those countries.

Russian officials denied that, and Kirill Dmitriev, head of the Russian Direct Investment Fund that bankrolled the country’s vaccination effort, dismissed international scrutiny of Russia’s own vaccine efforts as political.

“For countries, it’s difficult to acknowledge that, ‘How is it possible that Russia, which has been always shown as this backward, authoritarian country, can do this?'” Dmitriev said last week.

Dmitriev said Russia has received preliminary applications for more than 1 billion doses of the vaccine from 20 countries and is prepared to manufacture more than 500 million doses of the vaccine per year in five countries.

Russia’s move could potentially increase political pressure on other countries to take a similar bet on an unproven vaccine.

That’s a huge concern because any adverse effects from the vaccine are far less likely to be transparently reported if it is given outside of a rigorous trial. There’s also concern, Morrison said, that people will be coerced to take an unproven and potentially dangerous vaccine to keep their jobs.

“We’re seeing, in all countries, the tension between the political need to demonstrate to the public you’re doing something useful and the scientific hesitancy to only act when a vaccine is shown to be safe and effective,” said Mark Poznansky, director of the Vaccine and Immunotherapy Center at Massachusetts General Hospital.

– – –

At a congressional hearing this month, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases testified that it would be problematic if countries made a vaccine available before extensive testing.

“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best,” Fauci said.

Driven by the urgency of the pandemic, countries around the world are placing massive advance orders for vaccines and spending billions of dollars to help companies scale up production before they are proven safe and effective.

The risk is mainly a financial one – if the vaccines do not succeed in large-scale clinical trials, they will not be used.

The leading Russian vaccine candidate has so far been tested in small, early clinical trials designed to find the right dose and assess any safety concerns. It was given to scientists who developed it, in self-experimentation that is unusual in modern science, as well as to 50 members of the Russian military and a handful of other volunteers.

Dmitriev said Russia will go ahead with Phase 3, a larger trial involving thousands of participants normally considered an essential precursor to receive regulatory approval. Parallel trials are planned in Saudi Arabia, the United Arab Emirates and possibly Brazil and the Philippines, he said.

The southern Brazilian state of Paraná announced that it will begin producing the possible Russian vaccine in November.

Russia also intends to start using the potential vaccine on willing front-line medical workers and teachers, who will be asked to document how they’re feeling.

But while Russian officials have repeatedly assured that the vaccine is safe, Dmitriev was unable to say whether it was tested on someone already infected with the coronavirus. Some vaccines, such as one developed for dengue fever and used in the Philippines, can make the disease more severe.

“We will have tens of thousands of people already vaccinated like this in August,” Dmitriev said.

The World Health Organization still lists the Gamaleya vaccine as being in Phase 1.

WHO spokesman Tarik Jasarevic said at a briefing in Geneva that, “We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine.”

“But again,” he continued, “prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data.”

– – –

Most of what outside scientists know about the experimental vaccine is from secondhand sources and not from published medical studies. Dmitriev acknowledged that while that may be unusual elsewhere, Russia is traditionally secretive in its scientific endeavors.

The results from Phases 1 and 2 will be published by the end of this month, he said, adding that the delay was waiting for formal registration.

“You have to think a little bit about the Russian system; after Sputnik was flying for five days, only on day five did Russia acknowledge that there is a satellite flying,” he said.

Russia’s vaccine uses two doses to deliver different harmless cold viruses, or adenoviruses, that have been engineered to carry into cells the gene for the spiky protein that studs the outside of the coronavirus.

The approach was inspired by the Ebola vaccines Gamaleya developed in 2015 and 2018. But while Putin boasted earlier this year that Russia’s Ebola vaccine “proved to be the most effective in the world,” the WHO still lists it as a “candidate vaccine” on its website.

Adenoviruses are also being used by scientists at the pharmaceutical giant Johnson & Johnson, the Chinese company CanSino Biologics and the University of Oxford in their vaccine candidates.

But those other efforts have published data on how vaccines perform in animals that range from mice to monkeys, and also presented data from early human trials showing the severity of any reactions, ranging from soreness at the injection site to fevers.

The CanSino vaccine uses one of the same harmless viruses the Russians are using in its vaccine, and its results have been disappointing to some scientists.

Dmitriev said his personal confidence in Russia’s vaccine was so high that he, his wife and his parents, both over the age of 70, were test subjects. He said just his wife reported a mild fever the first night of the injection.

“It’s not some crazy Russians using some crazy not proven stuff,” Dmitriev said. “Adenovirus existed with humans for thousands of years, and we made a bet on this proven platform because we understand that it takes very little time to develop, given the challenges.”

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Many workers don’t get new paid sick leave, because of ‘broad’ exemption for providers, report finds

Health & BeautyAug 12. 2020

By The Washington Post · Eli Rosenberg · NATIONAL, BUSINESS, HEALTH, HEALTH-NEWS 

WASHINGTON – A government watchdog said in a new report out Tuesday that the Labor Department “significantly broadened” an exemption allowing millions of health-care workers to be exempted from paid sick leave as part of the law Congress passed in March to help workers during the coronavirus pandemic.

Congress passed the Families First Coronavirus Response Act back in March to ensure workers at small and medium sized companies were able to take paid leave if they or a family member became sick with coronavirus. The law exempts health-care providers as well as companies with more than 500 employees.

But an Office of the Inspector General report noted that a move by the Labor Department to more broadly expand how they categorize health care providers ended up leaving far more workers without a guarantee of paid sick leave than the agency’s estimate of 9 million.

While existing federal statutes define health care workers as doctors, someone practicing medicine or providing health care services, the Labor Department’s exemption from paid sick leave included anyone employed at a doctor’s office, clinic, testing facility or hospital, including temporary sites. The report also found the agency also exempted companies that contract with clinics and hospitals, such as those that produce medical equipment or tests related to Covid-19, the OIG found.

The report also suggested that the Labor Department is not doing enough to enforce the paid-sick-leave provisions, as well as its existing laws on pay and overtime issues.

In an effort to be socially distant, the federal agency acknowledged it has been foregoing fact-finding, on-site investigations, where an investigator examines all aspects of whether an employer is complying with federal labor laws. Instead the agency has been using so-called conciliations, which are telephone-only reviews limited to looking into a single issue affecting one or a few employees, with no fact-finding.

Critics of the Labor Department more hands-off approach to the pandemic have seized on the report as another indication of the ways in which the Trump administration has abandoned its commitments to worker safety.

“The Inspector General’s report makes clear that the Department of Labor went out of its way to limit the number of workers who could take emergency paid leave,” Rep. Robert Scott, D-Va., the chairman of the House Education and Labor Committee, said in a statement. “This absence of meaningful enforcement of our nation’s basic workplace laws creates a major risk to workers who are already vulnerable to exploitation amid record unemployment.”

Before the pandemic, limited or full on-site investigations, a more robust way the agency looked into pay and overtime issues, made up about 53 percent of its inquiries. But since March 18, only 19 percent of those inquiries have been on-site investigations.

Actions taken to enforce the sick leave provisions in the Families First Coronavirus Response Act have skewed even further away from investigations: 85 percent have been resolved through conciliation.

The agency’s Wage and Hour Division responded to the OIG’s findings, noting that they were “developing and sharing models for conducting virtual investigations,” and they also pledged to maintain a backlog of delayed on-site investigations to be tackled when it was safer to conduct those reviews.

But critics suggest the pandemic alone is not sufficient excuse for the drop-off in investigations, some aspects of which could be done remotely.

“These numbers just look so different than the numbers that I’m used to seeing in terms of conciliations versus investigations,” said Sharon Block, a senior Obama administration labor department official. “It really does jump out. That 85 percent is just a really big number.”

The issue about expanding who gets to opt out of offering paid sick leave has been the subject of complaints, according to the OIG report, as well as a federal lawsuit filed by New York Attorney General Letitia James. That lawsuit argued that the Department of Labor overstepped its authority by defining health-care providers in such broad terms, saying it could be skewed to include workers like teaching assistants or librarians at universities, employees who work in food services or tech support at medical schools, and cashiers at hospital gift shops and cafeterias.

Federal Judge Paul Oetken, of New York’s Southern District, struck down Department of Labor’s definition, as well as three other provisions last week – but confusion remains about whether his ruling applies only to employers in New York.

In an internal response to the OIG report, that predates the New York ruling, the Labor Department said that it agreed with many of the OIG’s recommendations and that it would continue to use its definition of health-care providers until the resolution of the federal lawsuit.

The Department of Labor did not reply to requests for comment about whether it planned to contest the judge’s ruling, or the other findings in the report.

The Inspector General pointed to other ways that the Department is not doing enough to adjust to the challenges of the post-pandemic world.

The OIG report said that while the agency’s Wage and Hour Division referenced the coronavirus in an operating plan in late May, it pointed out that the division “focuses more on what the agency has already accomplished rather than thinking proactively and describing how it will continue to ensure FFCRA compliance while still maintaining enforcement coverage,” the report noted.

The DOL did not provide any goals about the enforcement nor provide any requirements for tracking and reporting the new violations created by the FFCRA.

“With the predicted surge of covid-19 cases nationwide in upcoming months as more Americans return to work and as a consequence, an anticipated increase in complaint call volume to WHD, it would be expedient of the agency to devise a detailed plan as to how it intends to address this issue,” the OIG noted.

The report is the latest to spotlight the Trump administration’s employer-friendly approach to worker safety and protections.

The Occupational Safety and Health Administration, the part of the Department of Labor which investigates and is charged with upholding worker safety, has been criticized by workers and advocates for failing to issue citations for worker safety issues during the pandemic in significant numbers. It had only issued four citations out of more than 7,900 coronavirus-related complains according to figures from July 21.

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AstraZeneca to send Japan 120 million doses of vaccine

Health & BeautyAug 09. 2020

By Syndication Washington Post, The Japan News-Yomiuri · No Author · BUSINESS, WORLD, ASIA-PACIFIC 
The Japanese government has reached a supply deal with British drugmaker giant AstraZeneca for 120 million doses of a coronavirus vaccine when it is available. 

Health, Labor and Welfare Minister Katsunobu Kato said at a news conference Friday that Japan is to receive the vaccine as early as next year, with 30 million doses to be supplied by March, should AstraZeneca succeed in developing the drug.

AstraZeneca, which is developing the vaccine in collaboration with the University of Oxford, is in the final stages of clinical trials and is aiming to commercialize the vaccine in September.

The company will begin clinical trials in Japan this month to confirm the safety and effectiveness of the vaccine when it is administered to Japanese, he said. 

The firm has yet to decide whether the vaccine will be administered once or twice per person. The vaccine supply is sufficient for at least 60 million people.

“We will continue discussions with other vaccine manufacturers as well,” Kato said at the news conference.