Major coronavirus vaccine trial is paused to investigate unexplained illness

https://www.washingtonpost.com/health/2020/09/09/astrazeneca-covid-vaccine-safety-trial/?utm_campaign=wp_main&utm_medium=social&utm_source=facebook&fbclid=IwAR2gomNZclHdUubRHKRqa3u5a6b06VEM2-wwNYFHitq9pK8_5ya8XflTFI0

The halt shows that safety protections are working, experts say

A major coronavirus vaccine trial is on hold as an independent committee investigates whether a case of spinal inflammation in a single British participant is linked to the vaccine — a step that several experts said is a sign of the protections in place to ensure the safety of products ultimately used in millions of healthy people.

The hold on human testing of the vaccine candidate being developed by the pharmaceutical company AstraZeneca and the University of Oxford was confirmed by the company in a statement Tuesday evening, calling it a “routine action.”

“The announcement yesterday about the AstraZeneca vaccine is a concrete example of how even a single case of an unexpected illness is sufficient to require a clinical hold for the trial in multiple counties,” said Francis Collins, director of the National Institutes of Health, at a Senate hearing.

The announcement comes as scientists and a growing numbers of Americans express concern about the politicization of the vaccine approval process during a presidential election campaign. President Trump has made approval of a coronavirus vaccine a cornerstone of his campaign and repeatedly said it could be greenlighted before the Nov. 3 election.

But Collins and other scientists pointed to AstraZeneca’s decision as evidence that scientists, rather than politicians, are running the process. The experts said that it was hard to estimate how long the investigation would take, but that the pause was a good sign and not unexpected in trials of this size and scale, where many thousands of people are closely followed.

Collins testified that while minimal information is available about the adverse event, he has heard it described as transverse myelitis, rare inflammation of the spinal cord that has been associated with vaccinations, but has also been documented in a few cases of covid-19 and can occur in immune system disorders such as multiple sclerosis.

A study in the journal Lupus reported that between 1970 and 2009, there were 37 cases of transverse myelitis associated with various vaccines.

“The event is being investigated by an independent committee, and it is too early to conclude the specific diagnosis,” said AstraZeneca spokesman Brendan McEvoy.

Serious adverse events are closely monitored in clinical trials to determine whether they are likely to be linked to the drug or vaccine being administered. In trials with many thousands of people, sicknesses are likely to occur, and they may have no connection to the drug or vaccine being tested.

Collins also said he was not worried that the delay or even possible elimination of the AstraZeneca vaccine candidate would limit the eventual availability of vaccines to Americans.

“The reason we’re investing not in one, but in six different vaccines is because of the expectation that they won’t all work,” he told members of the Senate Health, Education, Labor and Pensions Committee.

“To have a clinical hold as has been placed on AstraZeneca as of yesterday because of a single serious adverse effect is not at all unprecedented,” Collins said.

He said that if after a thorough investigation, the adverse reaction is traced back to the vaccine candidate, then all the doses of that vaccine being manufactured would be thrown away. The United States has committed up to $1.2 billion to AstraZeneca to support development of the vaccine and to purchase 300 million doses.

A hold on a trial is not common, but is also not cause for alarm — it is a sign the system in place to protect participants is working, said Susan Ellenberg, a biostatistician at the University of Pennsylvania who has served on the independent data safety monitoring boards that investigate such incidents.

“The process is when something unusual develops, they might want to put a hold on things — and given the incredible attention that’s being given to these vaccines, and the recognition of how fast we’re trying to go, I think people are bending over backwards to show safety is really the top priority,” Ellenberg said.

This is the second pause for the trial. An information sheet for study participants from July noted that the trial had been put on hold after a participant developed neurological symptoms, but those were determined to be caused by an “unrelated neurological illness.”

“I think the company is being prudent to stop and look and to determine whether this severe adverse event, whatever it is, was a coincidence that followed vaccination, or was caused by the vaccine,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “The vaccine is designed to prevent covid-19, not everything else” that adults might develop.

The pause came a day after the leaders of nine drug companies signed a highly unusual pledge that they would be guided by science and prioritize safety in their effort to develop a coronavirus vaccine, amid worries that political pressure could lead to an unsafe or ineffective vaccine to be used in millions of healthy people.

“This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts,” Pascal Soriot, the AstraZeneca chief executive, said in a statement. “We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”

“Even if it turns out this is causally related to the vaccine, that doesn’t automatically mean this is something you might not carry on,” said Naor Bar-Zeev, deputy director of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health. “The benefit versus risk needs to be evaluated with the likelihood of each of these things and is clearly context dependent. If there was no covid in the world, you’d not want to take a vaccine.”

But Collins underscored at the hearing that the safety review and pause was just another reason that the United States was spreading its bets so widely, investing in six different vaccines. The United Kingdom has also made purchasing agreements for six vaccines in the final stages of human testing.

At a news conference at 10 Downing Street on Wednesday, United Kingdom chief scientific adviser Patrick Vallance said it was not unusual for a large Phase 3 trial test of effectiveness and safety of vaccines to be paused.

This is precisely why a Phase 3 trial is undertaken, he said.

“A pause is obviously not good,” Vallance said. “But it is sensible to look closely to see what is going on.”

 

 

 

 

A New Front in America’s Pandemic: College Towns

The coronavirus is spiking around campuses from Texas to Iowa to North Carolina as students return.

Last month, facing a budget shortfall of at least $75 million because of the pandemic, the University of Iowa welcomed thousands of students back to its campus — and into the surrounding community.

Iowa City braced, cautious optimism mixing with rising panic. The university had taken precautions, and only about a quarter of classes would be delivered in person. But each fresh face in town could also carry the virus, and more than 26,000 area residents were university employees.

“Covid has a way of coming in,” said Bruce Teague, the city’s mayor, “even when you’re doing all the right things.”

Within days, students were complaining that they couldn’t get coronavirus tests or were bumping into people who were supposed to be in isolation. Undergraduates were jamming sidewalks and downtown bars, masks hanging below their chins, never mind the city’s mask mandate.

Now, Iowa City is a full-blown pandemic hot spot — one of about 100 college communities around the country where infections have spiked in recent weeks as students have returned for the fall semester. Though the rate of infection has bent downward in the Northeast, where the virus first peaked in the U.S., it continues to remain high across many states in the Midwest and South — and evidence suggests that students returning to big campuses are a major factor.

In a New York Times review of 203 counties in the country where students comprise at least 10 percent of the population, about half experienced their worst weeks of the pandemic since Aug. 1. In about half of those, figures showed the number of new infections is peaking right now.

Despite the surge in cases, there has been no uptick in deaths in college communities, data shows. This suggests that most of the infections are stemming from campuses, since young people who contract the virus are far less likely to die than older people. However, leaders fear that young people who are infected will contribute to a spread of the virus throughout the community.

The surge in infections reported by county health departments comes as many college administrations are also disclosing clusters on their campuses.

*Brazos County, Tex., home to Texas A&M University, added 742 new coronavirus cases during the last week of August, the county’s worst week so far, as the university reported hundreds of new cases.

*Pitt County, N.C., site of East Carolina University, saw its coronavirus cases rise above 800 in a single week at the end of August. The Times has identified at least 846 infections involving students, faculty and staff since mid-August.

*In South Dakota’s Clay and Brookings counties, ballooning infections in the past two weeks have reflected outbreaks at the state’s major universities. In McLean County, Ill., the virus has been spreading as more than 1,200 people have contracted the virus at Illinois State University.

*At Washington State University and the University of Idaho, about eight miles apart, combined coronavirus cases have risen since early July to more than 300 infections. In the surrounding communities — rural Whitman County, Wash., and Latah County, Idaho — cases per week have climbed from low single-digits in the first three months of the pandemic, to double-digits in July, to more than 300 cases in the last week of August.

The Times has collected infection data from both state and local health departments and individual colleges. Academic institutions generally report cases involving students, faculty and staff, while the countywide data includes infections for all residents of the county.

It’s unclear precisely how the figures overlap and how many infections in a community outside of campus are definitively tied to campus outbreaks. But epidemiologists have warned that, even with exceptional contact tracing, it would be difficult to completely contain the virus on a campus when students shop, eat and drink in town, and local residents work at the college.

The potential spread of the virus beyond campus greens has deeply affected the workplaces, schools, governments and other institutions of local communities. The result often is an exacerbation of traditional town-and-gown tensions as college towns have tried to balance economic dependence on universities with visceral public health fears.

In Story County, Iowa, a local outcry following a burst of new Iowa State University cases pressured the university on Wednesday to reverse plans to welcome 25,000 football fans for its Sept. 12 opener against the University of Louisiana at Lafayette. In Monroe County, Indiana, the health department quarantined 30 Indiana University fraternity and sorority houses, prompting the university to publicly recommend that members shut them down and move elsewhere.

In Johnson County, where the University of Iowa is located, cases have more than doubled since the start of August, to more than 4,000. Over the past two weeks, Iowa City’s metro area added the fourth-most cases per capita in the country. The university has recorded more than 1,400 cases for the semester.

With a population of roughly 75,000, Iowa City relies on the university as an economic engine. The University of Iowa is by far the community’s largest employer, and its approximately 30,000 students are a critical market. Hawkeye football alone brings $120 million a year into the community, said Nancy Bird, executive director of the Iowa City Downtown District.

When the pandemic first hit in March, the university sent students home and pivoted to remote instruction, like most of the country’s approximately 5,000 colleges and universities. That exodus, heightened by health restrictions, has been an existential challenge for many downtown businesses, Ms. Bird said.

Jim Rinella, who owns The Airliner bar and restaurant, said the 76-year-old landmark across the street from campus “had zero revenue the whole month of April.” May was almost as scant, he said, and in June, he shut down after a couple of employees became infected.

By the time he reopened after July 4, too few students were in town to come close to making up the losses. He and his wife, Sherry, had hoped the campus reopening in August might be a lifeline.

The Rinellas live in Detroit, where they have other businesses, and Mr. Rinella said he was out of town when crowds jammed downtown on the weekend before the Aug. 24 start of classes. He said he immediately called his manager to make sure they were following state and local health rules.

But the photos taken by the local press from outside his establishment and others were damning. In an open letter, the university president lashed out, saying he was “exceedingly disappointed” in the failure of local businesses to keep students masked and socially distanced. Days later, the governor cited high infection rates among young people as she closed bars and restricted restaurants in Johnson County and five other counties with high concentrations of students.

Now The Airliner — where a booth is named for the University of Iowa’s most famous dropout, Tom Brokaw, and a modeling scout is said to have discovered Ashton Kutcher — has to close at 10 p.m. as well as require customers to buy a meal and sit far apart if they want to drink there.

“I’m at a pain point,” Mr. Rinella said. “If my grandfather hadn’t started the place, I’d question whether I want to be in the restaurant business.” A recent lunch hour visit found one customer at the bar drinking a beer.

The rise in local case counts reverberated at the county’s community college, which decided to start its fall semester with continued online instruction. Iowa City’s K-12 schools followed suit, which also meant canceling extracurricular activities, including sports, until students come back to the classroom in person.

“This is one of our last chances for college coaches to see us play or to get recent films sent out to college coaches. For some of us, playing in college is a goal we have been working toward since we were 11 or 12,” Lauren Roman, a 17-year-old high school volleyball player, told the school board last month. She burst into tears as she explained that she has waited since March for college recruiters to see her play. “Some of us really do need that scholarship money.”

“This sucks,” the board vice-president Ruthina Malone, agreed at the same meeting, choking up as she described emails she had received from families of children whose education relies on in-person instruction. But, she told the board, “we do not operate in isolation.” Her husband, she said, is an art teacher who would like nothing more than to teach again in person, and she works at the university.

The pandemic has hurt colleges’ finances in multiple ways, adding pressure on many schools to bring students back to campus. It has caused enrollment declines as students have opted for gap years or chosen to stay closer to home, added substantial costs for safety measures, reduced revenue from student room and board and canceled money-generating athletic events.

Governments have not always stepped into the breach: In Iowa, the state cut $8 million from its higher education appropriation even after the Board of Regents, which oversees the state’s universities, requested an $18 million increase. Over the summer, the University of Iowa announced a salary freeze and other significant cuts. This was before the Big Ten Conference postponed fall competition, erasing more than $60 million from the university’s athletics program.

When the university announced its plans for reopening with a combination of in-person and virtual instruction, it did not mention its finances as a factor, though it froze tuition rather than reduce it, as some universities have done. It also mandated mask wearing inside buildings and said it would test students with symptoms or who had been exposed to the virus.

Still, its decision to hold in-person classes drew criticism from some faculty. “We’re scared for our health and yours,” one group of instructors wrote in an open letter to students in July.

And its decision not to test asymptomatic students unless they had been exposed unnerved some city officials. Dr. Dan Fick, the campus health officer, said the university wanted to avoid a false sense of security.

But Janice Weiner, who represented the City Council in meetings with the business community and campus, questioned the approach. “We have a robust and capable medical community, we have good public health officials, we have everything we need,” she said. “But then the university didn’t require everyone coming back to campus to be tested.”

Iowa City is a blue town in a state with a pro-Trump Republican governor, Kim Reynolds, who has clashed with the state’s cities over masks and Covid policies.

Though the governor in March restricted large gatherings, closed Iowa schools and banned indoor operations of many businesses, she began relaxing those orders in May and has argued that face-mask mandates couldn’t be legally enforced.

Several municipalities have nonetheless passed ordinances requiring face masks, including Johnson County and Iowa City — largely in preparation for the return of students. But because state health rules have become a patchwork, not all returning students come from places where mask wearing is required, said Ms. Weiner. And, she said, the inconsistency offers an excuse to those who don’t want to wear them.

Interviews with students suggested that concern had at least some justification.

“If people get sick, they get sick — it happens,” Mady Hanson, a 21-year-old exercise science major, said last week on campus. She added that she and her family had survived Covid-19 and that she resented the city’s “ridiculous” restrictions.

“We’re all farmers and don’t really care about germs, so if we get it, we get it and we have the immunity to it.”

Both university and city officials said they believe the spike in cases has been a wake-up. “When we look back,” said Dr. Fick, “I think we’ll be proud that when students got the message, a majority stepped up.”

On the City Council, Ms. Weiner was less upbeat.

“There’s not a whole use in placing blame — we have to figure out a way forward,” she said. “But it’s going to take a herculean effort here for our numbers to start to go down.”

 

 

 

The coronavirus and a $12 billion motorcycle rally

https://www.axios.com/newsletters/axios-vitals-9f3757d6-dde4-4b75-a994-9572837e9d3f.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

The coronavirus outbreak tied to the annual motorcycle rally in Sturgis, South Dakota, ended up generating more than $12 billion in public health costs, according to a new discussion paper.

Why it matters: The analysis puts a point on just how bad these superspreader events can be — and the difficulty of preventing them solely with voluntary policies.

Background: The annual rally was held this year over 10 days in August, and included a Smash Mouth concert. The nearly 500,000 attendees came from all over the country, and social distancing and mask-wearing were mostly optional.

By the numbers: The rally led to 266,796 additional cases, or 19% of the new cases in the U.S. between Aug. 2 and Sept. 2., the paper found.

  • The event led to a 35% increase in cases in South Dakota. In counties that are home to the highest number of rally attendees, cases rose by 10.7% compared to counties without any attendees.
  • If each coronavirus case costs $46,000, that’s an additional $12.2 billion added on to the pandemic’s price tag.

The other side: “Overall, I think the ‘Sturgis Effect’ that the authors document is in large part just a Midwest surge that took place during this time period. There is likely still a small Sturgis Effect … but the results are likely biased upward,” tweeted Devin Pope, a professor at the University of Chicago.

The big picture: Given the state of contact tracing in the U.S. (bad), we’ll never know how many coronavirus cases were actually tied to the Sturgis rally.

  • But it’s a reminder that it takes collective action to contain the virus: As Sturgis revelers head back home, this South Dakota-centered outbreak has the potential to infect people who never went anywhere near Sturgis and thought they were doing everything right.

 

 

 

 

How important is the ACA for people who lose their jobs?

https://us3.campaign-archive.com/?u=6ab1fc39a0b1b15521551487c&id=6f9ac3fd86&e=ad91541e82

https://www.nejm.org/doi/full/10.1056/NEJMp2023312

This week’s contributor is Larry Levitt, the Executive Vice President for Health Policy at the Kaiser Family Foundation.

For the first time in an economic downturn, the Affordable Care Act (ACA) exists as a health care safety net for people losing their jobs and employer-provided health insurance. A new study provides some clues as to how well the health care law works for people who lose their jobs and insurance.

The study – by Sumit Agarwal and Benjamin Sommers, published in the New England Journal of Medicine – compares people who lost their jobs before and after the ACA went into effect in 2014 to see if there is a difference in how many people retained health insurance. During the pre-ACA period (2011-2013), there was about a 5% increase in the uninsured rate for people following a job loss. After the ACA went into effect (2014-2016), no such increase occurred. Instead, Medicaid and the marketplaces saw large increases in utilization.

With millions of Americans losing their jobs during the pandemic, the number of people without health coverage has undoubtedly risen. However, by how much is unknown, since we don’t track insurance coverage in real-time like we do employment. Many who have lost jobs may not have had employer-sponsored insurance in the first place, if they worked an industry like food service or retail. And the vast majority of people who are unemployed are classified as on temporary layoff, with employers who may be continuing health benefits for their furloughed workers, at least for now. However, the share of unemployed workers who have permanently lost their jobs is growing.

If the economic crisis persists, the number of people losing job-based health insurance will climb, making the ACA’s role as a safety net more relevant than ever.

 

 

Cartoon – Something that would greatly Prevent Covid 19

U.S. sets record for new coronavirus cases, surpassing 53,000 - The  Washington Post

Cartoon – Federal Coronavirus Response

10 Dilbert Cartoons That Get Project Management Just Right

C.D.C. Tells States How to Prepare for Covid-19 Vaccine by Early November

As President Trump pushes the possibility of a vaccine this year, the C.D.C. has outlined technical scenarios to state public health officials for an unidentified Vaccine A and Vaccine B.

The Centers for Disease Control and Prevention has notified public health officials in all 50 states and five large cities to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups as soon as late October or early November.

The new C.D.C. guidance is the latest sign of an accelerating race for a vaccine to ease a pandemic that has killed more than 184,000 Americans. The documents were sent out on the same day that President Trump told the nation in his speech to the Republican National Convention that a vaccine might arrive before the end of the year.

Over the past week, both Dr. Anthony S. Fauci, the country’s top infectious disease expert, and Dr. Stephen Hahn, who heads the Food and Drug Administration, have said in interviews with news organizations that a vaccine may be available for certain groups before clinical trials have been completed, if the data is overwhelmingly positive.

Public health experts agree that agencies at all levels of government should urgently prepare for what will eventually be a vast, complex effort to vaccinate hundreds of millions of Americans. But the possibility of a rollout in late October or early November has heightened concerns that the Trump administration is seeking to rush the distribution of a vaccine — or simply to hype that one is possible — before Election Day on Nov. 3.

For an administration that has struggled with the logistical challenges of containing the coronavirus, the distribution of millions of vaccines that must be stored in subzero temperatures and provided first to high-risk groups through America’s flawed, fragmented health care system would be a daunting challenge. Even the C.D.C.’s guidance acknowledged that its plan was hypothetical and based on the need to immediately begin organizing the gigantic effort that would be required if the F.D.A. were to allow the use of a vaccine or two this year.

The C.D.C. plans lay out technical specifications for two candidates described as Vaccine A and Vaccine B, including requirements for shipping, mixing, storage and administration. The details seem to match the products developed by Pfizer and Moderna, which are the furthest along in late-stage clinical trials. On Aug. 20, Pfizer said it was “on track” for seeking government review “as early as October 2020.”

Credit…

“This timeline of the initial deployment at the end of October is deeply worrisome for the politicization of public health and the potential safety ramifications,” said Saskia Popescu, an infection prevention epidemiologist based in Arizona. “It’s hard not to see this as a push for a pre-election vaccine.”

Three documents were sent to public health officials in all states and territories as well as officials in New York, Chicago, Philadelphia, Houston and San Antonio on Aug. 27. They outlined detailed scenarios for distributing two unidentified vaccine candidates, each requiring two doses a few weeks apart, at hospitals, mobile clinics and other facilities offering easy access to the first targeted recipients.

The guidance noted that health care professionals, including long-term care employees, would be among the first to receive the product, along with other essential workers and national security employees. People 65 or older, as well as Native Americans and those who are from “racial and ethnic minority populations” or incarcerated — all communities known to be at greater risk of contracting the virus and experiencing severe disease — were also prioritized in the documents.

That’s a positive development, “so it doesn’t just all wind up in high-income, affluent suburbs,” said Dr. Cedric Dark, an emergency medicine physician at Baylor College of Medicine in Texas.

The C.D.C. noted in its guidance that “limited Covid-19 vaccine doses may be available by early November 2020.” The documents were dispatched the same day that Dr. Robert Redfield, director of the C.D.C., sent a letter to governors asking them to prepare vaccine distribution sites by Nov. 1, as McClatchy reported.

The agency also said its plans were as yet hypothetical, noting, “The Covid-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available.” A C.D.C. spokeswoman confirmed that the documents were sent but declined to comment further.

Many of the details listed for the two vaccines — including required storage temperature, the number of days needed between doses, and the type of medical center that can accommodate the product’s storage — match what Pfizer and Moderna have said about their products, which are based on so-called mRNA technology. Neither company responded to requests for comment.

The scenarios, which assume that the two vaccines will demonstrate sufficient safety and effectiveness for an emergency authorization from the F.D.A. by the end of October, noted that Vaccine A, which seems to match Pfizer’s, would have about two million doses ready within this time frame, and that Vaccine B, whose description matches Moderna’s, would have about one million doses ready, with tens of millions of doses of each vaccine ready by the end of the year. Although it’s possible that some promising preliminary data may emerge by the end of October, experts are skeptical.

“The timeline that’s reported seems a bit ambitious to me,” Dr. Dark said. “October’s like 30 days away.”

Trials that test a vaccine’s effectiveness can take years to yield reliable results. It’s possible to draw conclusions sooner “if there is an overwhelming effect” in which vaccinated people appear to be far better protected from disease, said Padmini Pillai, a vaccine researcher and immunologist at M.I.T.

But there can be significant risks in approving a vaccine for broad use in the public before Phase 3 clinical trials involving tens of thousand of participants are completed. Rare but dangerous side effects may only surface over time, after such large numbers of people have received the vaccine.

And data gathered early in a trial might not hold true months down the line. Researchers also need time to test large numbers of people from a variety of backgrounds to determine how well the vaccine works in different populations — including the vulnerable communities identified in the guidelines.

Should any of these snags occur, Dr. Pillai said, “all of this together could diminish public trust in the vaccine.”

James S. Blumenstocksenior vice president of pandemic response and recovery at the Association of State and Territorial Health Officials, confirmed that the three C.D.C. documents were sent to all state and territorial health departments last week. “It is now the time to enhance organizational structure and involve all partners in this planning process going forward,” he said.

Lisa Stromme, a spokeswoman for the Washington State Department of Health, said that her state’s health officials were still at “a very early stage in a planning process,” but were already working toward developing infrastructure that would accommodate the assumptions laid out by the C.D.C.

The C.D.C. documents said that public health administrators should review lessons learned from the 2009 H1N1 pandemic vaccination campaign, which did not have enough doses at the beginning to meet demand.

“It’s good to have a plan out for hospitals and health care systems to prepare” for a potential rollout, said Dr. Taison Bell, a pulmonary and critical care physician at the University of Virginia. But Dr. Bell added that he was concerned that the timeline outlined in the documents “is incredibly ambitious and makes me worry that the administration will prioritize this arbitrary deadline rather than maintaining diligence with following the science.”

The technical comparison of Vaccine A and Vaccine B has some echoes of what was discussed at an Aug. 26 meeting of the Advisory Committee on Immunization Practices of the C.D.C. At the meeting, Dr. Kathleen Dooling, a C.D.C. medical officer, laid out three scenarios: Vaccine A, or the Pfizer vaccine, is approved, Vaccine B, the Moderna vaccine, is approved, or both. The requirement that Pfizer’s vaccine be stored at minus 70 degrees Celsius would mean that it couldn’t be administered at most small sites, she said. The C.D.C. documents noted that orders of Vaccine A would go “to large administration sites only.” The Moderna vaccine requires storage at minus 20 degrees Celsius.

The C.D.C. documents said the vaccine would be free to patients, but that providers might not be reimbursed for administrative costs if the vaccine was given an emergency authorization, rather than a standard approval.

Experts worry that the process is unlikely to go off without a hitch, given the last-minute scramble and the mixed messaging so far. “I think distribution is going to be very tricky for the vaccine, particularly if there is a cold storage requirement,” Dr. Bell said.

There are also likely to be challenges administering both doses of the proposed vaccines, which must be given weeks apart, Dr. Dark said. “How are you going to make sure people get both?”

 

 

 

 

ANALYSIS: ADMINISTRATION’S CORONAVIRUS ADVICE IS SECRET, FRAGMENTED AND CONTRADICTORY

Analysis: Trump administration’s coronavirus advice is secret, fragmented and contradictory

Analysis: Trump administration's coronavirus advice is secret, fragmented  and contradictory – Center for Public Integrity

ANALYSIS: TRUMP ADMINISTRATION’S CORONAVIRUS ADVICE IS SECRET, FRAGMENTED AND CONTRADICTORY

Dr. Deborah Birx speaks to reporters in the rotunda of the State Capitol in Lincoln, Neb., Aug. 14, 2020, after meeting with Gov. Pete Ricketts and community and state health officials. (AP Photo/Nati Harnik)

Private calls and unpublished reports leave many Americans and local officials in the dark.

 

INTRODUCTION

This is a news analysis from the Center for Public Integrity.

From behind a podium and a black mask, Tulsa mayor G.T. Bynum faced the press. It was late July, and one percent of his city had tested positive for COVID-19 since the beginning of the pandemic.

 

A reporter had a question: What did Bynum have to say about the newly leaked White House Coronavirus Task Force document that recommended Tulsa close bars and limit gatherings to 10 people?

The “alleged White House document” was “never officially presented to us … by either the federal government or the state government,” the mayor said. But he was familiar with the document’s recommendations, having read them online. “All of that remains very much on the table.” 

Fast-forward a month, at a press conference that looked exactly like the last, and Bynum still hadn’t received any of the weekly reports from the White House. “It was news to me that there had been eight different reports. I only knew about the one that was leaked to the media,” he said. “That’s all data that, of course, we would like to know.”

Indeed, the White House reports — chock full of local data and recommendations — would be useful for many city leaders, many of whom still don’t know what percentage of coronavirus tests in their metro areas are positive. But Bynum and others didn’t have that information. The White House was sending each state’s report directly to its governor and a select group of other officials instead of distributing the documents widely or posting them publicly.

The nation’s coronavirus response must be “locally executed, state managed, federally supported,” White House officials have said repeatedly. In fact, much of their public health advice has been secret, segmented and inconsistent. Federal guidance isn’t always reaching the local officials it’s meant to support. And scattershot messages mean that average citizens weighing visits to grandparents or countless other daily risks have limited  — and sometimes conflicting — information from the officials they are expected to trust.

 

THE SUMMER OF SECRET WARNINGS

In late June, the White House Coronavirus Task Force began sending reports to governors showing how their states were faring in the pandemic. Dr. Deborah Birx, a leader of the task force, held the documents aloft at a press conference July 8, but they weren’t distributed to reporters. Birx said several states were in the coronavirus “red zone — with high numbers of cases — and should take special precautions, but Vice President Mike Pence delivered the primary message of the press conference: Reopen schools.

Later that month, the Center for Public Integrity obtained a copy of the compiled report for all 50 states and published it, revealing that 18 states were in the red zone. The next morning, presidential adviser Kellyanne Conway suggested Public Integrity, a  30-year-old nonprofit, nonpartisan newsroom, had nefarious motives for disclosing public information: “I don’t know about that particular document, and respectfully the Center for Public Integrity is an outside organization that I’m sure doesn’t support the president’s election,” she told reporters.

A spokesman for Pence, Devin O’Malley, later acknowledged the document’s authenticity. But the White House still didn’t release the reports and stayed mum on why it was keeping them secret. Weeks later, White House spokesman Judd Deere sent an email to Public Integrity that didn’t quite answer the question: “The White House Coronavirus Task Force is providing tailored recommendations weekly to every governor and health commissioner for their states and counties,” he wrote. “Local leaders are best positioned to make on-the-ground decisions for their communities … The United States will not be shut down again.”

Meanwhile, Birx hit the road, zigzagging across the country to meet with governors in person and privately urge some of them to ratchet up virus precautions. On closed-to-the-press conference calls with state and local officials, Birx warned individual cities that they should take “aggressive action” to curb the coronavirus, according to recordings obtained by Public Integrity.

But officials from those cities weren’t always on the calls: Baltimore and Cleveland leaders missed a call in which Birx pinpointed them. And some of them weren’t getting the reports she was referencing. In late August, the most recent White House report the Arkansas Department of Health had was three weeks old. 

Public health experts say the reports should be public. “This is a pandemic,” Harvard epidemiologist Bill Hanage told Public Integrity in July. “You cannot hide it under the carpet.”

Dr. David Rubin, who has provided epidemiological modeling to the task force as director of PolicyLab at the Children’s Hospital of Philadelphia Research Institute, is also befuddled as to why the reports are secret. “I think we’d be in a lot different place today if we had national standards around certain things,” he said. But he doesn’t blame Birx or other scientists working with the White House. “They’re playing the hand that they were dealt.”

 

CUSTOM-MADE OR CONFUSING?

In mid-March, a 4×6” blue-and-white postcard appeared in mailboxes across the nation, emblazoned with “President Trump’s Coronavirus Guidelines for America” and both the White House and Centers for Disease Control and Prevention logos. On the back were a dozen lines of advice, including: “Even if you are young, or otherwise healthy, you are at risk and your activities can increase the risk for others.”

The postcard appeared in the days when the president, vice president, Birx and National Institute of Allergy and Infectious Diseases Director Anthony Fauci together updated the nation daily on television about the state of the coronavirus. The administration had already pressed the mute button on the CDC (though the agency posted guidance online, it wasn’t giving the regular briefings it had in past epidemics), but the White House was still attempting to send out a cohesive public health message.  

Then, as the economy cratered, Trump shifted gears to reopening and pushed responsibility for the pandemic response to the states. After decades of relying on national entities for public health advice and regulation — the CDC, the Food and Drug Administration, the surgeon general and others — America handed responsibility for infectious-disease containment to the states. 

Doing so allows governors to respond to their unique virus conditions, defenders of the administration said. The U.S. needs “a decentralized approach” said Heritage Foundation visiting fellow Doug Badger, because states have police powers to enforce lockdowns and because they are “better suited to responding to this pandemic, where there is great variation between and within states. […] There’s no one-size-fits-all policy.” Indeed, epidemics unfold at different rates in different geographies, and it makes sense to adjust advice based on whether people live close together or far apart, and how widely the virus is spreading in their communities.

But experts say that even though some public health warnings should be specific to local areas, many messages, such as the need to wear masks, should be nationally consistent. Contradictory guidance undermines trust, and the virus exploits the communities with weakest defenses. “Diseases don’t care about national or state borders,” said Jessica Malaty Rivera, Science Communication Lead at the Covid Tracking Project, a volunteer organization collecting pandemic data. “You can’t look at this in a fragmented way otherwise we’re going to continue this fragmented progress.”

 

“Diseases don’t care about national or state borders.”

JESSICA MALATY RIVERA, SCIENCE COMMUNICATION LEAD AT THE COVID TRACKING PROJECT

 

And some think the Trump administration’s advice isn’t as tailored or helpful as it should be. “For weeks, the Trump Administration has been issuing these cookie-cutter reports based on little or no review of existing regulations or conditions on the ground, while failing to pull together a national strategy for COVID-19 testing, contact tracing, and response,” Charles Boyle, a spokesman for Oregon Gov. Kate Brown, wrote in an email. “None of the recommendations in these weekly reports have been paired with the resources or the federal support to implement them.”

In addition, Trump’s desire for state leadership has been selective. After weeks of insisting on a governor-led response, in July Trump Tweeted, “SCHOOLS MUST OPEN IN THE FALL!!!” and threatened to withhold federal funding from school districts that did not open their doors. 

 

WHO DO YOU LISTEN TO?

Splitting public health advice into pieces means that some of those fragments don’t line up. On a private call with state and local leaders earlier this month, Birx said colleges should be testing students as they return to campus, and even be prepared to do 5,000 or 10,000 tests in one day. But the CDC hasn’t endorsed such testing because its effectiveness hasn’t been “systematically studied.”

Nowhere has the fractured advice been more evident than on the topic of how to reopen K-12 schools. The CDC in May issued guidelines, but later replaced them with a more lenient version after the president objected. After insisting schools open their doors, Trump acknowledged that some hot spots may need to delay opening. CDC director Robert Redfield said that schools should go virtual if their areas have more than 5 percent test positivity — a threshold that only 17 states and the District of Columbia met as of Aug. 26 according to a New York Times tracker. Birx has stayed noticeably quiet on the topic. The secret reports from her task force recently endorsed West Virginia’s school reopening guidelines, which say schools must switch to virtual learning if daily new cases in a county exceed 25 per 100,000 residents.

All this leaves local officials with a dizzying set of choices and advice, stuck making the decisions others don’t want blame for.

“This really stinks for local health departments,” said Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials. “Everybody wants to relinquish authority to the local health department. The authority ends up coming and going depending on how hard it is to address the issue. And it just is not fair to them.”

In addition, perhaps due in part to the mixed messaging, whatever advice the White House does have isn’t always followed. In Arkansas, where the task force has recommended that bars close, they remain open. In Georgia, where the task force recommended a state mask mandate, Gov. Brian Kemp sued to block Atlanta from requiring face coverings, though he later relented. In Tennessee in July, Gov. Bill Lee ignored Birx’s suggestion that he close bars, limit indoor dining and mandate masks.

All this has meant that in the first major pandemic in a century, despite the feeble and disjointed efforts of the White House to corral them, the United States were not united, not even in the messages sent to citizens. That has some experts worried about what’s to come in the fall, when the reluctance of some to be vaccinated could mean the nation fails to reach the threshold for herd immunity that would protect everyone. Rivera, of the Covid Tracking Project, is “absolutely terrified” about that possibility; united messaging is key when trying to help people understand the scientific rigor behind a vaccine, she said. “All it takes is one rumor to completely shift public health behavior.”

 

HELP FROM THE FOURTH ESTATE

In Tulsa, Bynum can now see all the White House reports. That’s because Public Integrity published a recent Oklahoma report, and local journalists pressed the governor on why he hadn’t handed it out. Last week he agreed to post all of the state’s White House reports.

In other parts of the country, people still don’t know what White House experts are saying about their states or counties. The federal map of red, yellow and green zones — an easy-to-understand stoplight that could help people quickly decide whether to cross state lines, for example — remains off limits to the public. President Trump resumed daily coronavirus briefings this month, but Birx remains relegated to private calls and local press briefings on her treks across states. The CDC continues its silence; Fauci is recovering from a vocal cord surgery and can’t speak.

For more than a century, Congress has given the federal government a prominent role in helping stop the spread of disease from state to state. Americans can debate whether governors or the president should make the big decisions in this particular pandemic. But neither statute nor scientific wisdom puts limits on the federal government’s ability to dole out health advice. And there is no national security reason to make such advice secret.

 

 

Covid-19 has killed more police officers this year than all other causes combined, data shows

https://www.washingtonpost.com/business/2020/09/02/coronavirus-deaths-police-officers-2020/?utm_campaign=wp_main&utm_medium=social&utm_source=facebook&fbclid=IwAR3KWZcuMmVXy_R7mDh_m58_BLdQkz6rw5iU9nsii950Bx46lwc0nbfC3p4

By one estimate, coronavirus deaths among law enforcement are likely to surpass those of 9/11.

In a speech this week in Pittsburgh, Joe Biden linked the Trump administration’s mismanagement of the coronavirus to its handling of protests and riots with a surprising statistic: “More cops have died from covid this year than have been killed on patrol,” he said.

The Democratic presidential nominee’s claim is true, according to data compiled by the Officer Down Memorial Page and the National Law Enforcement Officers Memorial Fund, two nonprofits that have tracked law enforcement fatalities for decades.

As of Sept. 2, on-the-job coronavirus infections were responsible for a least 100 officer deaths, more than gun violence, car accidents and all other causes combined, according to the Officer Down group. NLEOMF reported a nearly identical number of covid-related law enforcement deaths.

NLEOMF reported a nearly identical number of covid-related law enforcement deaths. It also noted that fatalities due to non-covid causes are actually down year-over-year, undermining President Trump’s claims that “law enforcement has become the target of a dangerous assault by the radical left.”

Both organizations only count covid deaths “if it is determined that the officer died as a result of exposure to the virus while performing official duties,” as the National Law Enforcement Officers Memorial Fund put it. “Substantive evidence will be required to show the death was more than likely due to the direct and proximate result of a duty-related incident.”

In addition to the 100 confirmed coronavirus fatalities listed on the Officer Down website, the nonprofit said it is in the process of verifying an additional 150 officer deaths due to covid-19 and presumed to have been contracted in the line of duty, said Chris Cosgriff, executive director of ODMP, in an email.

“By the end of this pandemic, it is very likely that COVID will surpass 9/11 as the single largest incident cause of death for law enforcement officers,” he wrote. Seventy-one officers were killed in the attacks on the twin towers, one officer was killed on United Flight 93, and more than 300 have passed away since then as a result of cancer contracted in the wake of the attacks, according to ODMP.

At the state level, Texas stands out for having the highest number of law enforcement covid fatalities with at least 21, according to NLEOMF. At least 16 of those represent officers with the Texas Department of Criminal Justice, which manages the state’s correctional facilities. Louisiana has 12 covid-related officer deaths. Florida, New Jersey and Illinois round out the top five with eight each.

According to both organizations, officers in correctional facilities account for a substantial number of covid-related law enforcement deaths, reflecting the dire epidemiological situation in many of the nation’s prisons and jails.

“Corrections officers and Corrections Departments have been hit harder than regular police agencies,” Cosgriff said. According to the Marshall Project, a nonprofit criminal justice news site, more than 100,000 U.S. prison inmates have tested positive for coronavirus and at least 928 have died. There have been an additional 24,000 cases and 72 deaths among prison staff.

ODMP’s tally includes police officers, sheriff’s deputies, correctional officers, federal law enforcement officers and military police officers killed outside of military conflict. NLEOMF’s inclusion criteria are similar.

This year, Trump signed the Safeguarding America’s First Responders Act of 2020, which guarantees law enforcement officers and their survivors federal benefits if the officer is killed or disabled by covid. For legal purposes, the legislation presumes that covid cases among officers were contracted in the line of duty.

 

 

 

 

Unemployment Claims Are ‘Stubbornly High’ as Layoffs Persist

Rise in Unemployment Claims Signals an Economic Reversal - The New York  Times

Just over one million Americans filed new claims for state jobless benefits last week, the latest sign that the economy is losing momentum just as federal aid to the unemployed has been pulled away.

Weekly claims briefly dipped below the one million mark early this month, offering a glimmer of hope in an otherwise gloomy job market. But filings jumped to 1.1 million the next week, and stayed above one million last week, the Labor Department said Thursday.

“It’s devastating how stubbornly high initial claims are,” said Julia Pollak, a labor economist at the employment site ZipRecruiter. “There are still huge numbers of layoffs taking place.”

Another 608,000 people filed for benefits under the federal Pandemic Unemployment Assistance program, which offers aid to independent contractors, self-employed workers and others not covered by regular state programs. That number, unlike the figures for state claims, is not seasonally adjusted.

Other recent indicators also suggest that the recovery is faltering. Job growth slowed in July, and real-time data from private-sector sources suggests that hiring has slumped further in August. On Tuesday, American Airlines said it will furlough 19,000 workers on Oct. 1, the latest in a string of such announcements from major corporations.

“It is worrying because it does signal that these large companies are pessimistic about the state of the recovery and don’t think that we are going to be returning to normal anytime soon,” said Daniel Zhao, senior economist at the career site Glassdoor.

Unemployment filings have fallen sharply since early April, when 6.6 million applied for benefits in a single week. But even after that decline, weekly filings far exceed any previous period. Close to 30 million Americans are receiving benefits under various state and federal programs.

The rate of job losses remains high as government support for the unemployed is waning. A $600-a-week federal supplement to state unemployment benefits expired at the end of July, and efforts to replace it have stalled in Congress. President Trump announced this month that he was using his executive authority to give jobless workers an additional $300 or $400 a week, but few states have begun paying out the new benefit.

Economists warn that the loss of federal support could act as a brake on the recovery. Nancy Vanden Houten, lead economist for the forecasting firm Oxford Economics, estimated that the lapse in extra unemployment benefits would reduce household income by $45 billion in August. That could lead to a drop in consumer spending and further layoffs, she said.

The benefit initiated by Mr. Trump would use federal emergency funds to provide $300 a week in extra payments to most unemployed workers. (States can choose to chip in an additional $100 a week, but few are doing so.) As of Wednesday, 34 states had been approved for grants under the program, known as Lost Wages Assistance.

Arizona, the first state to turn the grants into payments, sent $252.6 million to about 400,000 recipients last week, a sum that included retroactive payments for the first two weeks of August. Texas this week has paid out $424 million and expects to deliver nearly $1 billion more to cover the first three weeks of benefits. A handful of other states are paying benefits or expect to begin doing so within days.

Most, however, said it could take until mid-September or later.

Once the money starts flowing, it may not last long. Mr. Trump’s order authorized spending up to $44 billion, which federal officials said last week would cover four or five weeks of payments. That means jobless workers in many states may receive a lump sum covering several weeks of retroactive benefits, but nothing more without congressional action.

A crowd thronged a temporary unemployment office in Kentucky in June. Adapting computer systems to new benefits has been a crucial factor in processing claims.

On the surface, the new lost wages program looks like the earlier $600-a-week federal supplement, just cut in half. But there are subtle differences: The program has a different funding source (the Federal Emergency Management Agency instead of the Labor Department) and new restrictions (people receiving less than $100 a week in regular benefits don’t qualify).

Those kinds of adjustments would be trivial on a modern computer system. But many state unemployment systems are running on computers that are anything but modern.

In Oklahoma, for example, the unemployment system uses a 40-year-old mainframe computer that turns even minor adjustments into a major programming task. As a result, even though the state was among the first to apply for the $300 benefit this month, it doesn’t expect to begin paying the new benefit until late September.

“The fact that I’m working with a mainframe from 1978 to process claims is just crippling to the agency,” said Shelley Zumwalt, interim executive director of the agency that oversees Oklahoma’s unemployment system. “We are just holding that system together with masking tape and chewing gum.”

When the pandemic hit, Arizona, too, was stuck with archaic computer systems. It built a new system virtually from scratch to begin paying out federally funded emergency benefits, and it was among the last states to do so.

But the approach left Arizona better able to handle curveballs like the new $300 benefit.

“Through that chaos, we created a pandemic unemployment system,” said Michael Wisehart, director of the Arizona Department of Economic Security.

Christy Miller says there are three things that shape her identity: making people laugh, making people strong and lifting heavy objects. She can’t do any of those right now, and she isn’t sure when she will be able to again.

Ms. Miller, 49, is a standup comedian in New York, where comedy clubs have been closed since March. She is also a personal trainer and an amateur power lifter — activities she has had to give up because gyms, too, remain closed in the city.

The $600-a-week supplement to her unemployment pay didn’t just allow her to pay rent and buy food. It also freed up the time and mental energy for her to learn video production, podcasting and other skills to help her survive the pandemic-driven shutdown of her industry.

“I would give up the $600 a week any day for this coronavirus to go away and get back to work,” she said. “But the $600 has allowed me not to be homeless, to learn more computer stuff that I never would have learned or had the time to learn.”

None of those ventures are producing much income yet, though. She saved as much of her unemployment benefits as she could, and has enough to cover rent through the end of the year. But other bills are another matter. And there is little guarantee that her business will bounce back before her savings run out.

“If they don’t fix this pandemic thing, I may have to leave New York because I can’t afford to stay here,” she said.

Kris Fusco is finally back at work. That doesn’t mean her coronavirus worries are behind her.

When Ms. Fusco’s employer — a small, family-owned business in Massachusetts that rents musical instruments to students — laid her off in March, she expected to be out of work for a couple of weeks. That got extended to April, then to June. Eventually one of the owners called her to tell her they didn’t know when they could reopen.

“I said, ‘You do what you need to do to keep your business afloat, and I’m just going to hold on as long as I can,’” she said. Fortunately, her employer called her back shortly after the $600 supplement expired. She returned to work last week, and, despite some nervousness about going into the office with the virus still spreading, she said she was grateful for the paycheck.

But Ms. Fusco, 50, doesn’t know how long her good fortune will last. With many schools still teaching remotely or canceling activities like band, she worries that her company’s business will suffer. Already, she has noticed a large number of instruments being returned.

“It’s very worrisome for me because I can see the snowball effect from Covid-19 all around me,” she said. “It’s always lurking right behind my eyeballs that in six months I might be out of a job again.”