Category: Covid-19

Page 733«..1020..732733734735..740750..»

Live Updates: Covid-19 News – The New York Times

September 30, 2020

Heres what you need to know:Staff members at the Westminster-Canterbury senior living community waiting in line for a rapid test in Virginia Beach, Va.. A shortage in testing supplies has forced the facility to rely on an outside lab that charges $100 per test.Credit...Julia Rendleman for The New York Times

After months of enduring a dearth of protective medical gear and staggering death tolls from the coronavirus pandemic, nursing home operators and employees across the United States experienced something close to elation as rapid-result test machines paid for by the federal government began arriving last month at 14,000 residential facilities that serve the elderly.

The hand-held testing devices, which spit out results in as little as 15 minutes, were intended to quickly diagnose and isolate patients, and alter the deadly calculus of a contagion that has taken the lives of 77,000 nursing home residents and workers, more than 40 percent of the nations fatalities from Covid-19.

But the initial sense of relief has been overtaken by frustration as nursing homes have discovered that they must pay for test kits on their own, and that the machines are markedly less accurate than lab-based diagnostics.

Because the devices come with a modest starter-set of test supplies that only last a few weeks, facilities, many of them buffeted by financial losses from the pandemic, must pay roughly $32 for each additional test. In communities with high rates of infection, a typical nursing home can churn through hundreds of tests a week.

Many nursing home operators also say they have been overwhelmed by new federal reporting rules, fines and financial incentives that are associated with the program. Facilities can be fined up to $10,000 for failing to meet daily reporting rules that sometimes conflict with those from state or local health agencies, raising questions about the free machines, which cost about $300.

My initial happiness over the machines has quickly turned to disillusionment, said Ben Unkle, the chief executive of Westminster-Canterbury on Chesapeake Bay, which operates a skilled nursing center in coastal Virginia. At the moment were in testing hell.

Shortages in testing supplies have forced Mr. Unkle to rely on an outside lab that charges $100 a test, an expense that he estimates will add $875,000 to the $1 million in pandemic-related losses that the nonprofit provider expects this year. Rather than the 15-minute turnaround, the lab results take up to four days to arrive, complicating efforts at infection control.

As far as Im concerned, this is an unfunded mandate that is not giving us the data we need fast enough to improve either care or protection, Mr. Unkle said.

New York City officials announced on Tuesday a significant uptick in the citywide daily rate of positive coronavirus tests, which was in part attributable to a rise in cases in nine ZIP codes in Brooklyn and Queens some in predominantly Orthodox Jewish communities that have largely ignored public health guidance, like wearing masks.

In a news conference, Mr. de Blasio announced a daily rate of 3.25 percent, the highest it had been since June. It was a relatively low number compared with other parts of the country, but cause for real concern, the mayor said. On Monday, he reported that the daily rate was 1.93 percent; for weeks it had generally held between 1 and 2 percent on most days.

The uptick in the city comes at a particularly crucial moment, as the city tries to fully reopen public schools this week for in-person learning to hundreds of thousands of students and to resume indoor dining.

The mayor has said that he will automatically shut down classrooms which are all slated to be open by Thursday if the test positivity rate exceeds 3 percent over a seven-day rolling average. On Tuesday, Mr. de Blasio said the seven-day average was 1.38 percent and that he would not seek to change those guidelines to target specific areas that had seen an uptick. The city had not seen an increase in cases in schools in the nine ZIP codes in question.

According to the citys health officials, if schools are forced to close, it could take weeks for them to reopen. The president of the citys teachers union said that if the rates do not drop this week, the city should move to close as many as 80 public schools in ZIP codes where the virus is surging. Random student testing is set to begin Thursday, which could also drive down the rate.

The goal is to be under 3 percent in a way that is consistent, Mr. de Blasio said, cautioning that the city was not yet near that point. Public health experts have said cases in schools are inevitable and not necessarily cause for alarm if they are detected quickly.

Over the past two weeks, the cases in the nine ZIP codes account for 25.6 percent of the citys cases, despite the fact that the population in those areas make up only 7.4 percent of the citys population, according to information provided by the citys Health Department.

As part of new enforcement measures in those areas, the city will move to fine anybody who refuses to wear a mask, said Mr. de Blasio, a Democrat. Members of the citys test and trace program, the Sheriffs Office and the New York Police Department, among others, will help with enforcement, he said.

If city officials didnt see improvement in numbers by the end of the day, the city was weighing possible additional options, Mr. de Blasio said, including business closures in certain areas, and a wide-scale closure of institutions like yeshivas and child care, and limits on gatherings.

Community leaders have faulted the city for a lack of engagement with the Orthodox, and particularly Hasidic, communities, which have a longstanding distrust of secular authorities and a particular dislike for Mr. de Blasio. City officials said on Tuesday that they had made extensive outreach efforts recently in the affected communities, which included distributing masks to synagogues, speaking to area leaders and passing out literature about the dangers of the virus.

Indoor dining would begin on Wednesday, the mayor said, but added that officials would watch and see if the move resulted in a further increase in cases.

If anything looks problematic, well talk to the state and decide together if any adjustments need to be made, he said.

Shortly afterward, Gov. Andrew M. Cuomo, a Democrat, said that city officials would have to get approval from the state in order to enact any major restrictions. He also said that clusters identified by the state in Brooklyn, as well as Rockland and Orange counties in the Hudson Valley region, required movement to stamp out the embers right away.

A cluster problem is caused by a lack of compliance, Mr. Cuomo said on Tuesday. Why was there a lack of compliance? Because the local government failed to do its compliance job.

He called on local governments to take stronger action to enforce social-distancing rules. But in response to a question about the status of indoor dining, he said I dont believe were at the point of rolling back anything.

The governor did warn that without local officials and communities taking more steps, the clusters could quickly turn into a wider outbreak. A cluster today can be community spread tomorrow, he said.

Mr. Cuomo has previously said that reaching a 2 percent positivity rate would make him nervous, and that surpassing a 3 percent rate would cause the alarm bells to go off.

All the clusters, he said on Tuesday, had an overlap with large Orthodox Jewish communities and that he would meet with religious leaders to discuss better compliance to mask-wearing and public health guidelines.

Mr. Cuomo also said Tuesday that travelers from Colorado are now required to quarantine for 14 days upon arrival, joining a long list of other states and territories. Arizona and Virginia were removed in the weekly update.

Travelers to Connecticut and New Jersey are also now subject to a 14-day quarantine if they are coming from those same places, though compliance is voluntary in New Jersey and there is a testing alternative in Connecticut.

The day after Florida surpassed 700,000 coronavirus cases, Dr. Anthony S. Fauci, the nations top infectious disease expert, called the recent move by the governor to lift state restrictions on bars and restaurants very concerning.

Nows the time, actually, to double down at bit, Dr. Fauci said Monday on ABCs Good Morning America. And I dont mean close. When I say that, people get concerned that were talking about shutting down. Were not talking about shutting anything down. Were talking about common-sense type of public health measures.

He also expressed reservations about the lack of mask usage, saying Florida and other states were asking for trouble by allowing people to congregate without masks. Gov. Ron DeSantis of Florida, a Republican and Trump ally, refused on Friday to mandate mask usage in the state, insisting that such a decision should be left up to local governments.

At a news conference on Tuesday, Mayor Carlos Gimenez of Miami-Dade County discussed a weekly call he had earlier in the day with Dr. Fauci and Dr. Deborah L. Birx. Mr. Gimenez said that on the call, Dr. Birx, too, appeared to be deeply concerned with the governors decision.

He added that Dr. Birx noted that the virus positivity rate in Miami-Dade remains higher than it was in May. As of Tuesday, the average 14-day positivity rate in the county was 4.44 percent.

She was heartened by the steps that we took, but she was somewhat concerned about the loosening of the rules, he said.

In the last week, the state has been experiencing a relatively low number of new cases a day, on average about one-fifth the seven-day average number of new cases a day it reported at its peak on July 17.

As of Monday, Florida was meeting 36 percent of a testing target developed by Harvard Global Health Institute researchers that measures the minimum amount of testing necessary to mitigate the disease. The state had a positivity rate of 11 percent for the total number of tests processed over the two-week period ending Monday, according to data analyzed by The New York Times. Positive rates should be at or below 5 percent for at least 14 days before a state or country can safely reopen, according to the World Health Organization.

On Friday, Mr. DeSantis removed state restrictions for restaurants and many other businesses. He has also pushed the states largest school district, in Miami-Dade County, to open classrooms to in-person learning, despite concerns from parents and teachers.

Over the weekend, Tallahassee police broke up a large party near Florida State Universitys campus where about 700 cars were parked and blocking travel lanes, and more than 1,000 people gathered outside. The university has been trying to contain the spread of the virus on campus, where 1,448 students and 31 employees have tested positive since Aug. 2, including 51 people last week. Over a seven-day period ending Monday, Leon County, which includes Tallahassee, has reported 501 new cases, according to a Times database.

While other universities have suspended and expelled students for attending parties against campus policies, Mr. DeSantis last week called those measures dramatically draconian and called for creating a bill of rights for college students. The return of students to campus and the parties that come with them have been blamed for some of the recent outbreaks across the country.

On Good Morning America, Dr. Fauci was asked whether he agreed with W.H.O. projections that global deaths, which surpassed one million this week, might double before vaccines could bring the virus under control.

Ive got to be careful, he replied, noting that such predictions, imprecise by nature, might inappropriately ring alarms. But youve got to take it very seriously, he said of a possible doubling in worldwide deaths. The numbers globally are very serious.

SPORTS ROUNDUP

After an auspicious beginning to the N.F.L. regular season played during a pandemic, the league got news of its first coronavirus outbreak after Week 3s games. The Tennessee Titans suspended all in-person activities Tuesday after three players and five members of the teams personnel tested positive, the first such outbreak to hit a team since training camps began in late July. The Minnesota Vikings, who hosted the Titans on Sunday, also shut down in-person activities. Both clubs are working closely with the N.F.L. and the N.F.L.P.A., including our infectious disease experts, to evaluate close contacts, perform additional testing and monitor developments, the league said in a joint statement with the players union. All decisions will be made with health and safety as our primary consideration. We will continue to share updates as more information becomes available.

After weeks of indecision and discussion, FIFA is planning to order soccer clubs to release players who have been called up for World Cup qualification games next week, a move that is very likely to lead to a furious backlash from teams, leagues and player unions fearful of the risks of international travel during the pandemic. The FIFA demand will come after weeks of unsuccessful talks to find a compromise that addresses concerns about committing players to intercontinental travel amid a global rise in cases, and will apply most notably to South American national teams eager to recall their overseas-based players for the first round of qualifying matches for the 2022 World Cup.

A new scientific report confirms that cats and dogs can be infected by the novel coronavirus, and that neither animal is likely to get sick. Cats, however, do develop a strong, protective immune response.

There is still no evidence to suggest that pets have passed the virus to humans, although cats do shed the virus and infect other cats.

Infected dogs in the study didnt produce the virus in their upper respiratory tracts and didnt shed it at all, although some other studies have found different results. Neither the cats nor the dogs in the study showed any illness.

Scientists say that while millions of humans have been infected with the virus worldwide and 1 million have died, there are only a handful of reports of pets that have become infected naturally.

So why havent cats infected humans if they shed the virus? It might be because the number of humans who have contracted the virus is so large, and they are the ones giving it to cats, said Angela M. Bosco-Lauth, one of the authors of the study. Another possible reason is that infection in everyday life is very different from infection in the lab, where scientists inserted pipettes in the nasal cavities of cats and dogs to give them the virus.

Or, Dr. Bosco-Lauth said, cat infection with the virus could be relatively common without humans noticing, because of a lack of symptoms.

Researchers advise keeping cats indoors, particularly if a human in a household has become infected, because they could spread it to other cats.

Long before the coronavirus, the Indian Health Service, the U.S. government program that provides health care to the 2.2 million members of tribal communities, was plagued by shortages of funding and supplies.

Now the pandemic has exposed those weaknesses as never before, contributing to the disproportionally high infection and death rates among Native Americans and fueling new anger about what critics say has been decades of neglect from Congress and successive administrations in Washington.

Hospitals waited months for protective equipment, some of which ended up being expired, and had far too few beds and ventilators to handle the flood of Covid-19 patients. The agency failed to tailor health guidance to the reality of life on poverty-wracked reservations.

The virus has killed more than 500 people in the Navajo Nation in the southwestern United States, giving it a death rate higher than New York, Florida and Texas. It has infected more than 10 percent of the small Choctaw tribe of Mississippi.

A New York Times analysis found that the coronavirus positivity rate for Indian Health Service patients in Navajo Nation and the Phoenix area was nearly 20 percent from the start of the pandemic through July, compared with 7 percent nationally during the same period. It is now down to about 14 percent in both areas, nearly three times higher than the current nationwide rate.

Almost alone in the Western world, Sweden refused to impose a coronavirus lockdown last spring, as the countrys leading health officials argued that limited restrictions were sufficient and would better protect against economic collapse.

It was an approach that transformed the country into an unlikely ideological lightning rod. Many scientists blamed it for a spike in deaths, even as many libertarians critical of lockdowns portrayed Sweden as a model.

For their part, the Swedes admit to making some mistakes, particularly in nursing homes, where the death toll was staggering. Now, though, the question is whether the countrys current low caseload compared with sharp increases elsewhere shows that it has found a sustainable balance, or whether the recent numbers are just a temporary aberration.

With a population of 10.1 million, Sweden averaged just over 200 new cases a day for several weeks, though in recent days that number has jumped to about 380, and critics say the country should test more. The per capita rate is far lower than nearby Denmark or the Netherlands (if higher than the negligible rates in Norway and Finland). Sweden is also doing far better, for the moment, than Spain, with 10,000 cases a day, and France, with 12,000.

In response to the recent outbreaks, many European countries are imposing new restrictions, but avoiding total lockdowns. In essence, some experts say, they are quietly adopting the Swedish approach.

Today, all of the European countries are more or less following the Swedish model, combined with the testing, tracing and quarantine procedures the Germans have introduced, but none will admit it, said Antoine Flahault, director of the Institute of Global Health, in Geneva. Instead, they made a caricature out of the Swedish strategy. Almost everyone has called it inhumane and a failure.

The president of the University of Notre Dame, the Rev. John I. Jenkins, has issued a public apology after coming under criticism for not wearing a mask or adhering to social distancing guidelines during the Supreme Court nomination ceremony over the weekend at the White House for Judge Amy Coney Barrett.

I failed to lead by example, Father Jenkins, who is also a philosopher trained in theology and a member of Notre Dames philosophy department, said in a letter on Monday to the Notre Dame community. I especially regret my mistake in light of the sacrifices made on a daily basis by many, particularly our students, in adjusting their lives to observe our health protocols.

The move by Father Jenkins points to the challenges some public figures face as they promote virus-mitigation efforts. He has repeatedly urged students and staff to hew to social-distancing guidelines but was seen in videos and photographs shaking hands with others and not wearing a mask at the Rose Garden event on Saturday for Judge Barrett, who is a professor at Notre Dame.

In his written apology, Father Jenkins said he was given a rapid coronavirus test upon arriving at the White House. He said he and others were told after receiving negative results that it would be safe to remove their masks. Still, he said following that guidance was a mistake.

In August, Notre Dame became one of the first major universities to resume in-person classes, but had to shift to virtual learning for two weeks this month in response to a spike in coronavirus cases. While Notre Dame has switched again to in-person classes, Father Jenkins said he had decided to quarantine in an abundance of caution after returning to the campus from the White House.

In other news around the United States:

In the six months since Covid-19 brought the United States to a standstill, the opioid epidemic has taken a sharp turn for the worse. Last year, after aggressive efforts to expand access to treatment, Vermont saw its first decrease in opioid-related deaths since 2014; that year, the governor devoted his entire State of the State Message to what he called a full-blown heroin crisis gripping Vermont. But the state saw 82 opioid overdoses through July of this year, up from 60 during the same period last year.

In New York City, a principal prepared for the first day of school at Brooklyns Public School 9, where Sandra Santos-Vizcaino the first New York City public-school teacher to die of the coronavirus was once a beloved third-grade teacher. Nearly half of families across the city have opted their children out of in-person classes altogether through at least the end of November, a statistic that reflects both the pervasive fear felt by many city parents and skepticism of the citys reopening plan.

After months of keeping tens of thousands of theme park workers on furlough with full health-care benefits in hopes that a light at the end of the pandemic tunnel would appear, Disney announced it would eliminate 28,000 theme park jobs in the United States, or about 25 percent of its domestic resort work force. The job cuts will come from Disneys theme parks in California and Florida.

Katina Brenn, the school superintendent in Colby, Kan., knows what is supposed to be done when students are exposed to the virus: Quarantine them at home for 14 days.

But what if its a quarter of the school?

Colby is a small town in western Kansas, with fewer than 300 students in its close-knit high school. When a girl on the volleyball team tested positive recently, the whole team was sent home to quarantine. Then a football player was exposed, raising concerns about the rest of the squad. Soon, the school was facing having to quarantine as many as 75 students.

The town pushed back. The parents were upset, Ms. Brenn said. They want their kids to get an education.

She said she heard from parents who were worried that the way things were going, their children would have to be quarantined again and again when someone they knew was potentially exposed and in Colby, everybody knows everybody.

The pandemic, once mainly an urban problem, has surged across the Great Plains and Upper Midwest in recent weeks, reaching previously unscathed small towns and rural areas. North Dakota, South Dakota and Wisconsin now lead the nation in new cases per capita, and the figures for states like Kansas are as bad as they have ever been.

No one has yet died of Covid-19 in Thomas County, which includes Colby, but there have been 163 coronavirus cases so far among the population of 7,700, and one-third of those cases are new and considered currently active. And the hub of the community is Colby High.

Ms. Brenn said having the schools open for in-person learning was vital, so parents could go to work and keep the town running.

At a recent county meeting, officials agreed to roll back restrictions and allow students who were not directly exposed to a known case and who had no symptoms to return to school.

Parents really want their children to be at school, Ms. Brenn said, adding that the school system had taken precautions like hula hoops laid out on gym floors to enforce spacing between students during physical education classes. Were really trying to keep our kids safe, she said. We think that their schools are their safe place.

An independent association of health workers in Venezuela reported this week that at least 200 doctors, nurses and health care technicians across the country have died after contracting the coronavirus.

The count by Mdicos Unidos Venezuela involves a rare effort to provide greater visibility into how the virus is evolving in Venezuela. Officially, Venezuelas government says the virus has killed only 12 health workers.

In what critics contend is also a gross undercount, Venezuela officially had 73,528 cases and only 614 deaths as of Monday, far lower than any other large country in Latin America either on a per capita or absolute basis. Neighboring Colombia has reported 818,203 cases and 25,641 deaths.

Public health experts say the Venezuelan governments repressive measures in response to the pandemic are hampering efforts to accurately assess its impact. Security forces have detained at least 12 doctors and nurses in Venezuela for speaking publicly about the virus, according to medical unions.

Venezuelas health ministry did not immediately respond to a request for comment.

Dr. Jaime Lorenzo, the director of Mdicos Unidos, said the exodus of thousands of health workers from Venezuela in recent years had also constrained efforts to mitigate the spread of the virus in the country.

The personnel we have left are getting sick as they deal with fatigue and a lack of protective equipment, Dr. Lorenzo said.

Health care workers have been hit hard by the virus around the world. In a survey of countries in the Western Hemisphere, including the United States, the Pan American Health Organization found that the virus had killed more than 2,500 health workers, the group said this month.

Global roundup

Israels second national lockdown is likely to last at least a month and perhaps much longer, Prime Minister Benjamin Netanyahu said on Tuesday, as the countrys soaring infection rate of around 8,000 confirmed new cases a day remained among the highest in the world.

In my opinion, it wont be less than a month, and it could take much more time, Mr. Netanyahu said during a Facebook Live video session.

The lockdown came into effect in mid-September, on the eve of the Jewish New Year holiday, and was tightened on Friday after Mr. Netanyahu warned that without immediate measures, Israel would reach the edge of the abyss. Israelis must remain within 1,000 meters of their homes unless they are going to authorized places of work or seeking essential supplies or services, and outdoor gatherings are limited to 20 people.

But synagogues were allowed to hold indoor prayers for limited numbers of worshipers during Yom Kippur, the holiest day in the Jewish calendar, which fell on Sunday night and Monday, and large gatherings of ultra-Orthodox worshipers were captured on video in several locations.

The number of seriously ill virus patients has surpassed 800, a number that government and health officials had long cited as the maximum that Israels hospitals could cope with in their current capacity.

Israel reported 234 virus deaths over the last week, which works out to 2.6 per 100,000 people, exceeding the per capita death rate for that period in the United States.

In other developments around the world:

The authorities in Germany announced a number of new rules to try to halt rising cases while keeping the economy, schools and day care centers open. Group gatherings will be capped at 50 in bars and rented spaces, with a recommendation that private parties be capped at 25. Bars, restaurants, hairdressers and others will be fined a minimum of about $58 if patrons dont leave required contact data.

Ontario, the most populous province in Canada, on Monday reported 700 new infections, its highest one-day total. Premier Doug Ford said the province was beginning a second wave that would be worse than the first, but he resisted calls by experts for more stringent health measures. In the neighboring province of Quebec, which has also experienced a surge in infections, Premier Franois Legault said on Monday that Montreal, Quebec City and the administrative region of Chaudire-Appalaches would be designated as red zones for four weeks starting on Thursday. Home visits will be mostly banned and movie theaters, libraries, museums, bars and casinos will be closed. Restaurants will be limited to takeout service, but schools will remain open.

Here is the original post:

Live Updates: Covid-19 News - The New York Times

On the road with Operation Warp Speed, the U.S. COVID-19 vaccine effort – Science Magazine

September 30, 2020

Operation Warp Speed leaders Moncef Slaoui (second from right) and Gen. Gustave Perna (second from left) speak with Cincinnati physicians Carl Fichtenbaum (far right) and Odell Moreno Owens (far left) during a visit to one of the sites for the efficacy trial of Modernas COVID-19 vaccine candidate.

By Jon CohenSep. 29, 2020 , 3:45 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

CINCINNATIA hospital at the University of Cincinnati (UC) sits on a street named after Albert Sabin, who famously developed a vaccine against polio that has helped rid most of the world of this once widely feared disease. A unit at the hospital now has a similarly ambitious goal as it participates in the U.S. effort to find a vaccine against COVID-19. Last week, on 25 September, the leaders of Operation Warp Speedthe Trump administration program that has committed $10 billion to this visionflew in from Washington, D.C., for a tour. After learning that the hospital had in about 3 weeks enrolled 130 participants in the multisite phase III efficacy trial of one experimental vaccine, the first question Warp Speeds scientific director, Moncef Slaoui, asked was, Do you have a good representation of diverse populations?

This was one several recent visits to trial sites and vaccine manufacturing plants by Slaoui and his Warp Speed co-leader, Gen. Gustave Perna. The four-star general had on his camouflaged Army uniform and combat boots, but Slaoui, who formerly headed the vaccine division of GlaxoSmithKline (GSK), wore casual slacks, an open-collared shirt, and penny loafers without socks. He aimed to put people at ease on the tour, encouraging them to discuss uncomfortable, even taboo, topicsrace, politics, regulations, and risks. Perna made small talk with the clinical staff, but largely kept to himself.

The nationwide efficacy trial, which compares a COVID-19 vaccine made by Moderna with a placebo, struggled at first to enroll Black and Latino participants, in part because the contract research organizations that make up three-fourths of the nearly 100 trial sites had few contacts with those communities. But the UC site and others at academic centers, which are part of the COVID-19 Prevention Trials Network (CoVPN) organized by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), have a long history of working with minority communities to recruit participants for clinical trials. And the clinicians running this UC site explained to Slaoui that about half of their enrolled participants in the Moderna trial are either Black or Latino, a close match to the citys breakdown. (According to the U.S. Census Bureau, Cincinnatis 300,000 residents are 50% white, 43% African American/Black, and nearly 4% Hispanic/Latino.)

Moderna tracksand makes publicthe demographics of the enrolled participants week by week. During the week before UC started its enrollment for the 30,000-person trial, participants recruited by the other sites were 67% white and only 9% Black/African American and 17% Latino/Hispanic. Carl Fichtenbaum, a coprincipal investigator at the UC site, at a 1 September conference call with fellow CoVPN investigators, NIAID Director Anthony Fauci, and Surgeon General Jerome Adams suggested sites put a cap on the number of white participants they could recruit. I asked the question, What is more important, getting to 30,000 as fast as we can or ensuring the trial is representative of our country and the pandemic? Fichtenbaum recalls. The cap was instituted, and for the week of 21 September, enrollees at all Moderna trial sites were 42% Latino/Hispanic, 30% African American/Black, and 7% white. Cumulatively, as of the day of the Warp Speed leaders visit to UC, 31% of 27,232 participants in the Moderna trial were from diverse communities.

The UC team says its recipe for successful minority participation includes relying on trial recruiters from diverse communities, ads that reach out to those groups specifically, and Spanish speakers who are on the clinical team. We understand the history of Cincinnatiand the history of the problems of our city and the lack of inclusion, Fichtenbaum says. The hospital, he stresses, not only has long treated the underserved, but has embedded roots.

Margaret Powers-Fletcher, coprincipal investigator at the UC vaccine site, noted that many misunderstandings circle around the Moderna vaccine. On one extreme, Powers-Fletcher was asked whether the vaccine was bankrolled by Bill Gates as an attempt to microchip the population. But, more commonly, people want to know about Modernas unusual vaccine technology. The vaccine contains messenger RNA (mRNA), which codes for the surface protein of the virus that causes COVID-19. Explaining this opens the door for a deeper conversation, she says. It gives us the opportunity to not only talk about what mRNA is, but to dispel other myths associated with vaccine.

Slaoui adds that having diversity in the trials will build engagement and trust that translates into wider use of a COVID-19 vaccine that ultimately gets approved. The vaccine that stays on the shelf, if people are not accepting it, is of no use, he says.

Odell Moreno Owens, a Black clinician who heads the Cincinnati-based nonprofit Interact for Health, joined the tour and raised several provocative concerns. One is that Warp Speed now supports efficacy trials of four different COVID-19 vaccines, and the public sometimes has difficulty separating them. A few weeks ago, an international trial of a COVID-19 vaccine candidate made by AstraZeneca and the University of Oxford was put on hold after a serious side effect occurred in a recipient. (Regulators in the United Kingdom and Brazil determined this wasnt connected to the vaccine and allowed the trials there to resume, but the United States has yet to follow suit.) The ripple effect in the community was, I told you so, I told you so, Owens says. Thats going to be a big issue.

It is a real challenge to be able to communicate about these vaccines and their safety and engaging people to use them. Its exacerbated by all the lights that are on this, Slaoui replies. Unfortunately, the world we live in, this period of time and all the politics around it exacerbates the anxiety that exists.

Jaasiel Chapman, the trials community liaison for the Black community and a native of the city, says theres no escaping the divisiveness. People feel like this pandemic has become so politicized and that people want to win elections, rather than save our livesthats definitely one thing that we have gotten out in the community, he says. They feel the government has never cared about us before, so now theyre just trying to rush through a vaccine to kill us. So thats been difficult. There are a lot of doubts in the community.

Much as Slaoui would like to sidestep the politics, they have cast a shadow over him, too. On 25 September, the day of the UC tour, he issued a video that lambasted Senator Elizabeth Warren (DMA) for suggesting at a Senate hearing that he had conflicts of interest because of his investments in companies making COVID-19 vaccines. You dont know me personally and you are publicly accusing me of being greedy, of being corrupt, and of doing this to enrich myself, seethed Slaoui, who was unusually named to co-lead Warp Speed as a government contractor, not as a federal employee. Sitting at a desk with a Warp Speed logo behind him, Slaoui stressed that he had gone to great lengths to separate his finances from the vaccine effort, only holding on to GSK stock because they are his nest egg for retirement. I cannot make any benefit from taking this role and my commitment is to helping the American people fight this epidemic. It is mathematically impossible for me to enrich myself, he said. I didnt hesitate to join the role even though Im a registered Democrat because this pandemic is bigger than any one of us. Its bigger than me and its bigger than you. Please stop distracting me and Operation Warp Speed.

Warp Speeds main vaccine concern, as Slaoui repeatedly stressed during the UC visit, was safety. Cincinnati physician James Powell, who heads a project for the National Medical Associationwhich represents Black physicians and patientsto increase minority awareness about participating in clinical trials shared this worry. He told Slaoui hes particularly concerned about safety when a vaccine moves from a 30,000-person trial to millions of people in the real world.

Slaoui says that to best balance potential benefits versus risks the vaccines will at first go into people at the highest risk of severe disease. He also endorsed a push by the U.S. Food and Drug Administration (FDA)which the Trump administration is reportedly challengingto add a safety measure to vaccine approvals that could slow down the process. Independent boards that monitor the vaccine trials take scheduled looks at the data, and if they see an efficacy signal or dangerous side effects, they can recommend stopping a trial early. An early sign of efficacy, in turn, could lead manufacturers to seek whats known as an emergency use authorization (EUA).

There is widespread concern that politics might influence the issuance of a vaccine EUA, because critics says President Donald Trump and his allies pushed too aggressively for similar authorizations for two unproven COVID-19 treatments, hydroxychloroquine and convalescent plasma. Although Slaoui and other scientific advisers to the administration have said its highly unlikely a vaccine candidate will prove safe and effective in October, before the 3 November presidential election, Trump has repeatedly floated this idea. FDA officials have insisted that politics will not influence their decisions, and they recently proposed a regulation that would not consider an EUA until at least 2 months after the last participant in a trial is fully vaccinated.

Near the end of the visit, Powell asks how many Black investigators are taking part in the Warp Speed trials and how many sites are at historically black colleges and universities (HBCUs).

The answer is, Not enough, Slaoui says. (Two HBCU presidents recently joined COVID-19 vaccine trails and called for their students and faculty to participate, too, but the request also produced some backlash.)

As he says his goodbyes, Slaoui praises the people who participate in the COVID-19 vaccine trials. Its a very generous act. And he laments what he called the unintended consequence of the communication thats happening on the political side of things, which he says was making people afraid of vaccines.

The only way to counter that is to be transparent and explain, Slaoui says. And we need everybodys help. So thank you very much for being here.

See the rest here:

On the road with Operation Warp Speed, the U.S. COVID-19 vaccine effort - Science Magazine

More Than 1 Million People Have Died From COVID-19 Worldwide : Goats and Soda – NPR

September 30, 2020

Relatives at a mass burial of pandemic victims at the Parque Taruma cemetery in Manaus, Brazil, mourn a family member. Andre Coelho/Getty Images hide caption

Relatives at a mass burial of pandemic victims at the Parque Taruma cemetery in Manaus, Brazil, mourn a family member.

The coronavirus pandemic has now killed at least 1 million people worldwide. That's according to a tally maintained by Johns Hopkins University. This sobering milestone was reached just nine months after the first reported fatality in China last January. And public health experts believe the actual toll the recorded deaths plus the unrecorded deaths is much higher. What's more, in the five worst-off countries, the trend line remains worrisome. Here's how they line up and why Argentina could soon join their ranks.

1. United States

Take the United States, which currently leads the world in terms of both total number of dead and total number of infected over the course of the pandemic. While several Northeastern states that were clobbered by the virus early on managed to use social distancing and masking to push down their new cases by early spring, states in other regions then quickly moved to reopen. This fueled an even bigger wave of deaths across wide swaths of the U.S. throughout the summer. Since then many states have managed to bring down their numbers as well as the overall U.S. daily death count. Yet it remains far higher than it was in July. Also, most recently, daily deaths have actually begun rising again largely driven by increasing transmission in various states in the Great Plains and the South.

2. Brazil

Brazil, the second-biggest driver of the worldwide death toll, is also trouble once again. Led by a president who repeatedly downplayed the threat from the coronavirus, Brazil's initial response was chaotic at best, enabling a surge in deaths all through July and August. About a month ago, the daily death count began dropping. But more recently that progress seems to have stalled.

3. India

The trajectory has been even more unremittingly terrible in India, which has the third-highest death toll. Since May, when the government largely lifted a strict lockdown, infections and deaths have been on a virtually uninterrupted upward spiral. One caveat is that when these cases are measured as a share of India's population, India actually ranks fairly low. That's in marked contrast with both Brazil and the United States. Also, over the past several weeks India's daily death count appears to have hit something of a plateau. Still, the total number of people dying there remains extremely high with an average of about 1,100 deaths each day over the past week.

4. Mexico

Mexico, too, is struggling. It doesn't just follow the U.S., Brazil and India when it comes to highest total deaths over the entirety of the pandemic. Over the past two weeks, all four countries have also had the highest number of average daily deaths.

5. United Kingdom

The United Kingdom ranked fifth when it comes to total death toll is faring only slightly better. New infections have risen to their highest level there since early May. And while the death toll remains much lower, it has begun creeping up again. More alarming, however, is the situation in European neighbors Spain and France, where both daily new cases and daily new deaths have recently increased markedly, putting both countries in the top 10 on those measures over the past two weeks.

Could Argentina be far behind?

Meanwhile, countries such as Argentina offer a reminder that the full contours of the pandemic's impact won't be clear until it's over. Three months ago Argentina seemed to be doing comparatively well. That's one reason it still doesn't quite rank among the top 10 countries in terms of total deaths over the entirety of the pandemic. But since June, Argentina has seen a steady increase in infections and fatalities. And over the past two weeks its daily new death count has ranked fifth-highest in the world with little sign of slowing down.

Link:

More Than 1 Million People Have Died From COVID-19 Worldwide : Goats and Soda - NPR

COVID-19 Daily Update 9-29-2020 – West Virginia Department of Health and Human Resources

September 30, 2020

TheWest Virginia Department of Health and Human Resources (DHHR) reportsas of 10:00 a.m., September 29, 2020, there have been 557,869 total confirmatory laboratory results receivedfor COVID-19, with 15,692 total cases and 345 deaths.

DHHR has confirmed the deaths of a 70-year old male from LoganCounty, a 70-year old male from Putnam County, a 79-year old female fromWyoming County, a 73-year old male from Berkeley County, an 81-year old femalefrom Putnam County, an 84-year old female from Putnam County, a 73-year oldmale from Monroe County, and a 78-year old female from Taylor County.

"We must remember that each ofthese West Virginians have families and friends who are left to grieve theirloss, said Bill J. Crouch, DHHR Cabinet Secretary. We join with them in sharingtheir grief.

CASESPER COUNTY: Barbour(78), Berkeley (1,009), Boone (227), Braxton (13), Brooke (114), Cabell (843),Calhoun (25), Clay (36), Doddridge (26), Fayette (629), Gilmer (48), Grant(161), Greenbrier (127), Hampshire (108), Hancock (150), Hardy (91), Harrison(382), Jackson (270), Jefferson (436), Kanawha (2,704), Lewis (38), Lincoln(171), Logan (620), Marion (284), Marshall (179), Mason (143), McDowell (87),Mercer (425), Mineral (174), Mingo (377), Monongalia (2,035), Monroe (151),Morgan (55), Nicholas (105), Ohio (374), Pendleton (53), Pleasants (18),Pocahontas (59), Preston (157), Putnam (576), Raleigh (526), Randolph (252),Ritchie (13), Roane (52), Summers (55), Taylor (127), Tucker (34), Tyler (16),Upshur (84), Wayne (403), Webster (8), Wetzel (56), Wirt (12), Wood (374),Wyoming (118).

Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR. As case surveillance continues at the localhealth department level, it may reveal that those tested in a certain countymay not be a resident of that county, or even the state as an individual inquestion may have crossed the state border to be tested.Suchis the case of Mineral County in this report.

Pleasevisit the dashboard located at http://www.coronavirus.wv.gov for more information.

Free COVID-19 testinglocations are available today in Barbour, Fayette, Kanawha, and Putnam counties,and Wednesday in Fayette, Kanawha, Logan, Monongalia, Putnam, and Waynecounties:

Barbour County, September29, 10:00 AM 2:00 PM, Barbour County Fairgrounds, 115 Fairgrounds Way, Belington,WV

Fayette County, September29, 10:00 AM 2:00 PM, J.W. and Hazel Ruby WV Welcome Center, 55 Hazel RubyLane, Mt. Hope, WV

Kanawha County, September29, 3:00 PM 7:00 PM, George Washington High School, 1522 Tennis Club Road, Charleston,WV

Putnam County, September29, 9:00 AM 1:00 PM, Teays Valley Church of God, 185 Connection Point, ScottDepot, WV

Fayette County, September30, 4:00 PM 7:00 PM, Gateway Center, 2 Greyhound Lane, Smithers, WV

Kanawha County, September30, 3:00 PM 7:00 PM, George Washington High School, 1522 Tennis Club Road, Charleston,WV

Logan County, September30, 10:00 AM 2:00 PM, Old 84 Lumber Building, 100 Recovery Road, Peach Creek,WV

Monongalia County, September30, 9:00 AM 4:00 PM, West Virginia University, Student Recreation Center,2001 Rec Center Drive, Morgantown, WV

Putnam County, September30, 1:00 PM 5:00 PM, Old Buffalo High School, 81 High School Road, Buffalo,WV

Wayne County, September30, 9:00 AM 1:00 PM, Wayne County Health Department, 217 Kenova Ave, Wayne,WV 25570

Testing is available to everyone,including asymptomatic individuals. For upcoming testing locations, pleasevisit https://dhhr.wv.gov/COVID-19/pages/testing.aspx.

Read more here:

COVID-19 Daily Update 9-29-2020 - West Virginia Department of Health and Human Resources

Hidden immune weakness found in 14% of gravely ill COVID-19 patients – Science Magazine

September 30, 2020

A new study may help explain why men, like this patient in an Italian intensive care unit, are more likely than women to develop life-threatening COVID-19.

By Meredith WadmanSep. 24, 2020 , 2:00 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.

From the first months of the COVID-19 pandemic, scientists baffled by the diseases ferocity have wondered whether the bodys vanguard virus fighter, a molecular messenger called type I interferon, is missing in action in some severe cases. Two papers published online in Science this week confirm that suspicion. They reveal that in a significant minority of patients with serious COVID-19, the interferon response has been crippled by genetic flaws or by rogue antibodies that attack interferon itself.

Together these two papers explain nearly 14% of severe COVID-19 cases. That is quite amazing, says Qiang Pan- Hammarstrm, an immunologist at the Karolinska Institute.

Tadatsugu Taniguchi, a pioneering interferon scientist and emeritus professor at the University of Tokyo, calls the discoveries remarkable. He says they highlight the critical role of type I interferons in SARS-CoV-2 infection and the development of potentially lethal COVID-19.

Co-author Isabelle Meyts, a pediatric immunologist at the University Hospitals Leuven, was struck by one papers finding that rogue antibodies underlie COVID-19 in 10% of gravely ill patients: There has never been any infectious disease explained at this level by a factor in the human body. And its not an isolated cohort of Europeans. Patients are from all over the world, all ethnicities. Another finding, that 94% of the patients with interferon-attacking antibodies were male, also helps explain why men face higher risk of severe disease.

The paired studies have immediate practical implications. Synthetic interferons, long used to treat other diseases, might help some at-risk patients, as might other therapies aimed at removing the damaging antibodies. A common kind of antibody test could be readily developed and return answers in hours. Those found to be at high risk of developing severe COVID- 19 could take precautions to avoid exposure or be prioritized for vaccination, says Elina Zuniga, an immunologist who studies interferons at the University of California, San Diego.

The findings also raise a red flag for plasma donations from recovered patients. Because it may be rich in antibodies to the virus, convalescent plasma is already given to some patients to fight the infection. But some donations could harbor the interferon-neutralizing antibodies. You should eliminate these patients from the pool of donors, Zuniga says. You definitely dont want to be transferring these autoantibodies into another person.

Type I interferons are made by every cell in the body and are vital leaders of the antiviral battle early in infection. They launch an immediate, intense local response when a virus invades a cell, triggering infected cells to produce proteins that attack the virus. They also summon immune cells to the site and alert uninfected neighboring cells to prepare their own defenses.

In one study, Jean-Laurent Casanova, an infectious disease geneticist at Rockefeller University, and his team examined blood samples from 987 gravely ill patients from around the world. In 10.2% of the patients, the researchers identified antibodies that attacked and neutralized the patients own type I interferon. A subgroup of affected patients had extremely low or undetectable blood levels of this interferon. Lab studies confirmed the antibodies knocked the interferon out of action and cells exposed to the patients plasma failed to fend off invasion by the new coronavirus.

At least 10% of critical COVID-19 is an autoimmune attack.

None of the 663 people in a control group with mild or asymptomatic SARS-CoV-2 infection had those damaging antibodies. The antibodies were also scarce in the general population, showing up in only 0.33% of more than 1200 healthy people tested. What this means is that at least 10% of critical COVID-19 is an autoimmune attack against the immune system itself, Casanova says.

The preponderance of male patients was a surprise, because women have higher rates of autoimmune disease. Our favorite hypothesis is that it is an X-linked recessive trait, Casanova says. Women with two X chromosomes are protected and men, with one, are not. Supporting that suspicion, one woman with a rare condition that silences one X chromosome was among the severely ill patients with autoantibodies.

If these striking results hold up, they might also help explain the increased vulnerability of older people to severe COVID-19: Half the gravely ill patients with autoantibodies were older than 65.

The second paper found genetic flaws in patients that led to the same end result: a grossly inadequate interferon response to SARS-CoV-2 infection. The team sequenced DNA from 659 critically ill COVID-19 patients and from 534 controls with mild or asymptomatic disease. They examined 13 genes, chosen because flaws in them impair the bodys production or use of type I interferon; mutations in the genes underlie life-threatening influenza or other viral illnesses. The researchers found that 3.5% of the critically ill patients harbored rare mutations in eight of those genes. In patients for whom blood samples were available, interferon levels were vanishingly small. No members of the control group carried any of the mutations. This is the first paper to pin down indisputably disease-causing mutations underlying severe COVID-19, Pan-Hammarstrm says.

But its probably the tip of the iceberg, says Paul Hertzog, an interferon expert at the Hudson Institute of Medical Research. Many other damaging mutations, interferon related and not, may influence the development of severe COVID-19, he says.

Zuniga notes that none of the patients who made antibodies against interferon or had the mutations had a history of life-threatening viral illnesses requiring hospitalization. This suggests that we are more reliant on type I interferons to protect ourselves against SARS-CoV-2 versus other viral infections, she says. That makes it important to try therapies aimed at boosting type I interferon responses.

Dozens of randomized clinical trials are now deploying interferons against SARS-CoV-2. One, led by Tom Wilkinson at the University of Southampton, reported promising findings in a small group of hospitalized COVID-19 patients. But synthetic interferons wont help patients who harbor mutations that prevent interferons from working, or those with antibodies that attack them.

Some researchers caution that the interferon-neutralizing antibodies could be a consequence, rather than a cause, of severe COVID-19. Its possible that they develop during the disease, says Miriam Merad, an immunologist at the Icahn School of Medicine at Mount Sinai. That would explain why the patients hadnt faced life-threatening viral infections before, she says.

But Casanova, who has made a career of discovering mutations that confer susceptibility to infectious diseases, says there is a strong case for causality. He points out that preexisting blood samples from a handful of patients showed they had the antibodies in their blood before contracting SARS-CoV-2. He argues that, in response to infection, its unlikely that the body could quickly generate the high levels of anti-interferon antibodies his team saw.

Yanick Crow, a clinical geneticist at the University of Edinburgh who studies interferon signaling, calls the antibody paper shocking, in part because men were so much more likely than women to carry the rogue antibodies. Tests screening for the antibodies can and should be rapidly developed, he says, and will quickly reveal whether the new findings hold up. Given tens of millions of cases worldwide, he says, 10% is such a high figure and the implications are very important.

*Correction, 25 September, 11 a.m.:A previous version of this story mistakenly reversed the words "cause" and "consequence" when introducing a quote from Miriam Merad. This has been corrected.

Continued here:

Hidden immune weakness found in 14% of gravely ill COVID-19 patients - Science Magazine

COVID-19 Daily Update 9-28-2020 – West Virginia Department of Health and Human Resources

September 30, 2020

The West VirginiaDepartment of Health and Human Resources (DHHR) reports as of 10:00a.m., September 28, 2020, there have been 552,844 totalconfirmatory laboratory results received for COVID-19,with 15,512 total cases and 337 deaths.

DHHR has confirmed the deaths of a 70-yearold male from Kanawha County, a 77-year old female from Taylor County, and a 92-yearold male from Berkeley County. Please join with me in sending our deepestcondolences to these families as they grieve the passing of their loved ones,said Bill J. Crouch, DHHR Cabinet Secretary.

CASES PERCOUNTY: Barbour(66), Berkeley (1002), Boone (220), Braxton (13), Brooke (113), Cabell (823),Calhoun (25), Clay (36), Doddridge (25), Fayette (622), Gilmer (45), Grant(161), Greenbrier (127), Hampshire (108), Hancock (149), Hardy (90), Harrison(369), Jackson (266), Jefferson (433), Kanawha (2,688), Lewis (38), Lincoln(169), Logan (620), Marion (274), Marshall (178), Mason (142), McDowell (84),Mercer (418), Mineral (175), Mingo (377), Monongalia (2,021), Monroe (149),Morgan (55), Nicholas (104), Ohio (373), Pendleton (53), Pleasants (17),Pocahontas (59), Preston (157), Putnam (566), Raleigh (521), Randolph (252),Ritchie (13), Roane (51), Summers (55), Taylor (127), Tucker (29), Tyler (16),Upshur (81), Wayne (398), Webster (8), Wetzel (55), Wirt (12), Wood (366),Wyoming (118).

Please note thatdelays may be experienced with the reporting of information from the localhealth department to DHHR. As case surveillance continues at the local healthdepartment level, it may reveal that those tested in a certain county may notbe a resident of that county, or even the state as an individual in questionmay have crossed the state border to be tested. Such is the case of Gilmer and Hancock counties in thisreport.

Please visit thedashboard located at http://www.coronavirus.wv.gov for more information.

Free COVID-19 testinglocations are available today in Boone, Cabell, Kanawha, Taylor, and Waynecounties and Tuesday in Fayette and Putnam counties:

Putnam County, September29, 9:00 AM 1:00 PM, Teays Valley Church of God, 185 Connection Point, ScottDepot, WV

Testing is available to everyone, including asymptomaticindividuals. For upcoming testing locations, please visit https://dhhr.wv.gov/COVID-19/pages/testing.aspx.

Read more:

COVID-19 Daily Update 9-28-2020 - West Virginia Department of Health and Human Resources

Investigational COVID-19 vaccine well-tolerated and generates immune response in older adults – National Institutes of Health

September 30, 2020

News Release

Tuesday, September 29, 2020

A Phase 1 trial of an investigational mRNA vaccine to prevent SARS-CoV-2 infection has shown that the vaccine is well-tolerated and generates a strong immune response in older adults. A report published today in the New England Journal of Medicine describes the findings from the study, which was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. SARS-CoV-2 is the virus that causes COVID-19 disease.

The experimental vaccine, mRNA-1273, was co-developed by researchers at NIAID and Moderna, Inc. of Cambridge, Massachusetts. The Phase 1 trial began on March 16, 2020, and was expanded to enroll older adults about one month later. Older adults are more vulnerable to complications of COVID-19 and are an important population for vaccination. Understanding how the vaccine affects older adults is a critical part of measuring its safety and efficacy.

The trial was conducted at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, Emory University in Atlanta, and NIAIDs Vaccine Research Center (VRC) clinic at the NIH Clinical Center in Bethesda, Maryland. Julie Ledgerwood, D.O., deputy director and chief medical officer at the VRC, oversaw the study at the NIH site. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate for this trial. This trial is supported by the Infectious Diseases Clinical Research Consortium (IDCRC) through NIAID.

In its expansion to include older adults, the trial enrolled 40 healthy volunteers: 20 adults ages 56 to 70 years, and 20 adults ages 71 years and older. Ten volunteers in each age group received a lower dose of the vaccine (25 g), and 10 volunteers in each age group received a higher dose (100 g). After approximately one month, volunteers then received a second dose of the same vaccine at the same dosage. Throughout the study, volunteers attended clinic visits to track their responses to the vaccine and assess safety.

Overall, the researchers found that the investigational vaccine was well-tolerated in this older age group. Although some volunteers experienced some transient adverse effects, including fever and fatigue after vaccination, the researchers found that they also exhibited a good immune response to the vaccine: the blood of vaccinated volunteers contained robust binding and neutralizing antibodies against SARS-CoV-2. Importantly, the immune response to the vaccine seen in older volunteers was comparable to that seen in younger age groups.

The study will continue to follow the older volunteers for approximately a year after second vaccination to monitor the long-term effects of the vaccine. According to the researchers, these Phase 1 trial results further support testing of the investigational vaccine in older adults in an ongoing large Phase 3 trial.

For more details on the trial, please see NIAIDsMarch 16 press release, NIAIDsMarch 27 statement, or visit ClinicalTrials.gov and search identifierNCT04283461.

Anderson et al. Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults. New England Journal of Medicine DOI: 10.1056/NEJMoa2028436 (2020).

Dr. John Beigel, associate director for Clinical Research in NIAIDs Division of Microbiology and Infectious Diseases, and Dr. Barney Graham, deputy director of NIAIDs Vaccine Research Center, are available for comment.

NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

###

Read the original:

Investigational COVID-19 vaccine well-tolerated and generates immune response in older adults - National Institutes of Health

Tennessee Titans’ COVID-19 outbreak – What we know about the positive coronavirus tests; will NFL games be postponed? – ESPN

September 30, 2020

The NFL has its first COVID-19 team outbreak. At least nine members of the Tennessee Titans have produced confirmed positive test results in the past four days, a rash of coronavirus infections that could potentially have spread during Sunday's game against the Minnesota Vikings at U.S. Bank Stadium.

The Titans have closed their practice facility until at least Saturday, while the Vikings have closed theirs until they have further test results. Decisions on both teams' Week 4 games are pending.

Here's what we know at the moment, with appropriate context. We will continue to update as news develops.

Jump to:Timeline for return to facilitiesCould games get postponed?

Yes. On Saturday, Titans linebackers coach Shane Bowen returned a confirmed positive test. The Titans received the results before they departed Nashville for Minneapolis, and Bowen was held back from making the trip.

We don't know. What we do know is that the entire Titans traveling party was tested Saturday, as they would ordinarily be. The Titans had those results by Sunday morning. All were negative, meaning every coach, player and staff member was eligible for Sunday's game.

1 Related

The Titans stayed Saturday night at the JW Marriott, adjacent to the Mall of America in Bloomington, Minnesota, according to ESPN's Courtney Cronin. League protocol requires all members of the traveling party to have their own rooms and also prohibits them from "congregating, visiting or mingling with individuals outside of the Traveling Party once they have arrived in the game city."

On Sunday, they defeated the Vikings 31-30. The team flew home after the game ended.

Correct. The protocols call for daily testing on every day except game day. Neither the league nor the NFL Players Association (NFLPA) has explained explicitly why, but timing is likely a substantial part of the answer. Results for polymerase chain reaction (PCR) tests, performed on the morning of a game by nasal swab, probably wouldn't be returned in time for kickoff.

Point of care (POC) tests have quicker results -- PCR tests are usually returned overnight, whereas POC tests can be returned on the same day, and even before kickoff after a morning test -- but are not as accurate. At this time, POC tests are only used to help confirm initial positive tests, and the NFL doesn't yet trust them on their own. And the NFL likely didn't want to sideline a player or coach based only off a POC test.

All Tier 1 and Tier 2 employees from the Titans and Vikings, which includes players and coaches, were tested Monday morning. Of the eight Titans who returned confirmed positive tests, three were players and five were employees. They have not been identified. None were displaying symptoms, according to ESPN's Dan Graziano. No members of the Vikings returned positive tests.

Most officials travel home on the night of the game or the next morning. Per their protocol, they are tested twice per week -- once in their hometowns and once on the day before games. Referee Clete Blakeman's crew worked this game and will be tested daily this week. None of those officials will work a game in Week 4.

No. General guidance from public health officials suggests it can take up to five to seven days for an infection to register in a test. That's why the Titans' facility is closed through at least Saturday. The NFL/NFLPA protocol calls for increased monitoring for eight days for anyone who had close contact with someone who returned a confirmed positive test.

The protocols follow CDC guidelines: within 6 feet apart for at least 15 minutes of an infected individual. The league identified 48 close contacts to monitor, based on contact tracing of the eight confirmed positive individuals, according to Graziano. It's unclear if those are all members of the Titans, or if some are members of the Vikings.

That includes contact during a game as well as data recorded by mandatory proximity devices worn by all team employees before and after the game. Per the protocol, "Tier 1, Tier 2, Tier 2M and Tier 3 Individuals will also be required to wear Kinexon Proximity Recording tracking devices at all times while engaged in team activities (including in the Club facility, during practices, and during team travel)."

2:41

Dianna Russini explains the possible origin of the Titans' coronavirus outbreak and why she doesn't anticipate Tennessee playing its Week 4 game against Pittsburgh.

If the Titans passed the infection to the Vikings, then yes. Games are the one point in the NFL week where social distancing is impossible, and the period when it's most likely that an infected person will breathe on others. That's part of the reason the NFL has insisted on coaches and other non-players wearing masks on the sideline.

The absence of game-day testing also heightens the risk. A POC test Sunday morning might have caught at least some of the positive results the Titans eventually recorded Monday.

They were. As of Tuesday morning, there were only four players on the NFL's COVID-19 list. Only seven players, and another 29 non-players, had returned positive results during the four testing periods from Aug. 12 through Sept. 19.

But as Zachary Binney, an epidemiologist at Oxford College of Emory University, said earlier this month: "An outbreak really can happen at any time." It's fair to wonder if this will prompt a shift to game-day testing.

We know the Titans won't return before Saturday at the earliest. The Vikings' return depends on whether they receive any confirmed positive results.

It's complicated. Here is a flow chart for symptomatic and asymptomatic positive tests.

At the moment, both are still scheduled to play Sunday. That could change in the coming hours and days, however. One possibility, according to ESPN's Adam Schefter, is to move the Titans' game Sunday in Nashville against the Pittsburgh Steelers from Sunday to Monday. The Titans' game could also easily be moved to Week 7, if the NFL moves the Steelers' Week 7 game against the Baltimore Ravens into Week 8, when both have byes. A potential rescheduling of the Vikings' game at the Houston Texans is less obvious.

The NFL formed an independent committee made up of unaffiliated former league officials to advise commissioner Roger Goodell on equity and fairness in these situations. One immediate question is whether it's fair for the Titans to play the Steelers on Sunday if they have been away from their team facility, and thus unable to practice, all week.

See the rest here:

Tennessee Titans' COVID-19 outbreak - What we know about the positive coronavirus tests; will NFL games be postponed? - ESPN

New and old local restaurants are casualties of the COVID-19 pandemic – East Idaho News

September 30, 2020

Golden Corral pic courtesy Google maps

IDAHO FALLS Losing everything and starting over seems to be a recurring theme for Jacob and Senessa Tiffany of Idaho Falls.

They opened Kiwi Loco at 3198 South 25th East in March after a year-long remodel project. Everything was going great for several weeks until the COVID-19 pandemic began impacting eastern Idaho.

The Tiffanys did everything they could to stay afloat, but lack of customers and drastic price increases for supplies made it difficult to stay open.

We were paying $30 for a box of gloves. Then all this hit and we were paying $150, Senessa says. It turned into a nightmare.

The new business ultimately became a casualty of the outbreak and closed for the last time on Aug. 31 after five months of business.

We spoke to Senessa as they were opening in March. She told us about the wildfire that had destroyed their home in Paradise, California in November 2018. Idaho Falls became a place for them to start a new life together.

RELATED | Couple who lost home in fire now own thriving business

Senessa was ecstatic the last time we spoke with her, but now theyre going to be starting from scratch all over again and our conversation this time around has a much different tone.

Its tragic what (the pandemic) has done to small businesses, Senessa says. A lot of people are suffering. How can you survive when prices are getting jacked up five times the original amount?

And its not just new restaurants with fledgling customer bases. More than a few longtime restaurants are seeing major declines as well due to COVID-19.

Golden Corral in Pocatello is one of those longtime restaurants. It closed its doors for the last time Sept. 13 after 19 years of business.

At the onset of the virus, owner-operator Pam Casey says they set up a kiosk that provided gloves for customers to wear while they dished up their food. Some people were OK with that, while others were not, Casey says, but once Idaho State University closed down, business was never the same.

On March 16, everything went away. We went from doing a pretty substantial volume to doing $10,000 a week. That doesnt cut it in an 8,500-square-foot restaurant with a heavy-duty bank payment, Pams husband, Jeff, says. After trying to stay open for a while, we decided just a few weeks ago we couldnt do it anymore.

The restaurant had many loyal customers, some of whom had been eating there since the beginning. Despite the long history of financial success, Jeff says the pandemic was a severe blow.

People dont like buffet restaurants when a virus is going around, and even with the precautions we took people still werent interested in coming in, he says.

The financial loss didnt just impact the Caseys. One of the most difficult aspects of the closure has been laying off employees, Jeff says, many of which have significantly contributed to the businesss success over the years.

The working relationship with his employees is what hes going to miss most of all.

Despite everything thats happened, Senessa Tiffany says it still could have been much worse. Theyve almost sold all the Kiwi Loco equipment and will likely break even.

She says the silver lining through all of this is the increased time with her kids and the support of the community. She has no plans to leave eastern Idaho and says shed rather go through a tragedy here than anywhere else.

We love it here. We have a great group of friends and a great community, Senessa says.

Senessa started doing eyelash extensions out of her home for friends and neighbors once her business closed. The response has been great, she says, and shes hoping to build up a bigger clientele. Her new goal is to go to esthetician school and be a one-stop-shop for skincare.

The situation isnt as tragic for the Caseys. They own a Golden Corral in Twin Falls, which will remain open. They also own some other businesses in the Boise area, including Caf Ol.

Chip Schwarze, President of the Idaho Falls Chamber of Commerce, says COVID-19 has fundamentally changed the way people do business. Many business owners have been forced to adapt and drastically change their business model to stay open.

While COVID-19 has negatively impacted some restaurants, Schwarze says its been a banner year for others.

I loved watching Pachangas here in downtown Idaho Falls, Schwarze says. When everybody was shut down, they were preparing packages where people could go home and cook their own Mexican (food). It fundamentally changed the way they did business because they adapted to a bad situation, and were seeing businesses do that across the board.

The impact of COVID-19 on the local economy will be long-lasting, he says, but in the long run, he believes the local economy will recover and eventually struggling businesses will thrive again.

I think our economy in eastern Idaho is going to continue with its rebound and were going to see it blossom over the next six to eight months and come back stronger and better than ever, Schwarze says.

Read more here:

New and old local restaurants are casualties of the COVID-19 pandemic - East Idaho News

COVID-19: Bar owners tell Richland County commissioners state rules are crippling their businesses – Richland Source

September 30, 2020

MANSFIELD -- Tom Zellner told Richland County commissioners on Tuesday it feels like Ohio Gov. Mike Dewine has singled out the bar business in the battle against COVID-19.

"What's sad is we feel that we've been targeted," saidZellner, a partner in The Warehouse Tavern in downtown Mansfield."Why us? What did we do so wrong?"

Zellner, joined by other local bar/restaurant owners, presented a petition signed by 32 local owners, seeking an end to restrictions imposed by the governor at the end of July that ban alcohol sales after 10 p.m. and order bars closed at 11 p.m.

That's been our guiding light as we navigate the uncharted waters of this pandemic. If you think we've been good stewards, consider a membership today. 100% of your support goes to our reporting efforts.Above all, thank you for taking this journey with us. Stay safe, stay healthy.

"There is no science behind the State of Ohio's magic time of 10 p.m. that shows COVID-19 cases increase after that hour," Zellner said. "These current restrictions have been catastrophic to many businesses in our region and if they continue, we fear will lead to the closure of many more businesses in our county."

The local owners, most of whom have state-issued licenses allowing them to remain open until 2:30 a.m., indicated gross revenue losses ranging between 20 and 60 percent since DeWine imposed the restrictions through the state's Liquor Control Commission.

"These restrictions and time constraints are literally destroying our businesses," Zellner said, adding he and his partners chose to open a downtown bar in recent years during a time when local business was booming with momentum.

Bars and dine-in restaurants were among the "non-essential' businesses ordered closed by DeWine in March when the pandemic reached Ohio. They were later allowed to re-open in mid-May at limited capacity.

On July 30, in announcing the time restrictions, DeWine said alcohol consumption tended to lower patrons' inhibitions, leading to a lack of social distancing.

"The problem is, bars, by their nature, lend themselves to a revolving door of people in close contact, oftentimes indoors. Patrons either stay at one location, sometimes for hours or bar hop. Either way, they interact with many different people -- especially the younger crowd, DeWine said at the time.

Bar owners, however, said their employees are trained not to over-serve customers.

"We've been controlling those inhibitions as bar owners for years. I mean, have we not? So I don't understand why we can't do that in this current environment," said Ben Hoggard, general manager and executive chef at the Hudson & Essex in downtown Mansfield.

Bar owners said DeWine's rules have led to more dangerous habits such as people ordering multiple drinks just before 10 a.m. or leaving the bar at 10 p.m., purchasing alcohol, and engaging in large house parties with less monitoring than they would have had at the bar.

Commissioners Marilyn John, Darrell Banks and Tony Vero listened with sympathetic ears, agreeing with the local business owners, but saying DeWine has not been responsive to their questions and concerns since the pandemic began.

"These decisions are being made in one office in Columbus. They're not being made by anybody sitting at this table or anybody in this room," John said.

After the meeting, Commissioner Tony Vero sent an email to DeWine's administration, including the petition that asks for the restrictions to be lifted immediately or at least on Nov. 1 when the Liquor Commission is scheduled to review the order.

In his email, Vero called the governor's rule "capricious" and said DeWine has offered no accompanying science to support it.

Above is a chart showing the rate of positive Ohio COVID-19 tests since the pandemic began.

"These (bar owners) are struggling to survive under an order issued at the end of July where the slight bump (not curve) occurred in Ohio in late April 2020. They also question (as do all three Richland County commissioners) how such a prohibition can remain in place while 1/10 of 1% of Ohios population has an active COVID-19 diagnosis," Vero wrote in the email.

"To date, 0.139% of the state of Ohio has such a diagnosis, and that has remained fairly unchanged (actually a small decrease) since the state finally started publishing recovery figures several months ago," Vero wrote.

Bar owners and commissioners agreed DeWine is not being truthful when he says the state is "98 percent" re-opened.

"I think it's very disingenuous," Vero said during the meeting. "And it's a disservice to owners of these types of establishments who are losing revenue. (DeWine) owes to them to provide them something tangible and quantifiable as to why (the restrictions) exists. And I have yet to see it since the end of July."

Also on Tuesday, commissioners:

-- approved a $305,620 project, using federal CARES Act funds, to digitize and create microfilm of records for county Clerk of Courts Lin Frary's office, using Kofile, the same company doing a similar project for the county recorder's office. The project will include records from 1900 to 1996, which is when the office began to become computerized. It will allow residents and others to search records online, reducing the need to visit the courthouse to obtain public records.

-- approved a mitigation project that will allow Dayspring to move forward with plans on replacing the slate roof at the century-old facility while also seeking a state historical grant to fix the roof at the laundry building, the oldest building on the county home property.

Read the original here:

COVID-19: Bar owners tell Richland County commissioners state rules are crippling their businesses - Richland Source

Page 733«..1020..732733734735..740750..»