CanSino Biologicss experimental COVID-19 vaccine is one of at least four using an adenovirus that some worry could increase HIV susceptibility.

By Jon CohenOct. 19, 2020 , 6:30 PM

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

Certain COVID-19 vaccine candidates could increase susceptibility to HIV, warns a group of researchers who in 2007 learned that an experimental HIV vaccine had raised in some people the risk for infection with the AIDS virus. These concerns have percolated in the background of the race for a vaccine to stem the coronavirus pandemic, but now the researchers have gone public with a cautionary tale, in part because trials of those candidates may soon begin in locales that have pronounced HIV epidemics, such as South Africa.

Some approved and experimental vaccines have as a backbone a variety of adenoviruses, which can cause the common cold but are often harmless. The ill-fated HIV vaccine trial used an engineered strain known as adenovirus 5 (Ad5) to shuttle into the body the gene for the surface protein of the AIDS virus. In four candidate COVID-19 vaccines now in clinical trials in several countries, including the United States, Ad5 similarly serves as the vector to carry in the surface protein gene of SARS-CoV-2, the viral cause of the pandemic; two of these have advanced to large-scale, phase III efficacy studies in Russia and Pakistan.

In todays issue ofTheLancet, four veteran researchers raise a warning flag about those COVID-19 vaccine candidates by recounting their experience running a placebo-controlled AIDS vaccine trial dubbed STEP.An interim analysis of STEP found that uncircumcised men who had been naturally infected with Ad5 before receiving the vaccine became especially vulnerable to the AIDS virus. The vaccine, made by Merck, had been the leading hope for what was then a 20-year search for a shot that could thwart HIV. But after the STEP results appeared, the field went into a tailspin. It took a decade to recover, says one of the co-authors of theLancet correspondence, Lawrence Corey of the Fred Hutchinson Cancer Research Center.

Corey, who now co-leads the COVID-19 prevention network in the United States that is testing vaccines at the behest of the National Institutes of Health, says he and his co-authors went public because Ad5-based COVID-19 vaccines may soon be tested in populations with high HIV prevalence and thus a greater risk of accidental infection during a clinical trial. If I were in a sub-Saharan African country and making a decision as to what I would want for my country for a general population use of a SARS-CoV-2 vaccine, I dont see why I would pick an Ad5 vector [vaccine] when there are many other alternative choices, Corey says.

The backfire in STEPwhich evaluated the efficacy of the Merck vaccine in people at high risk of HIV infection in the Americas and Australiaalso appeared in a second study, dubbed Phambili, of the same vaccine. It was taking place simultaneously in South Africa and was stopped early because of the STEP data.

Precisely how Mercks Ad5 vaccine increased the risk of HIV transmission in STEP and Phambili remains murky. The Lancet editorial spells out several possibilities, including dampening of HIV immunity, enhancing replication of the AIDS virus, or setting up more target cells for it.

In addition to the Ad5 COVID-19 vaccine candidates, several other leading vaccines, including ones made by Johnson & Johnson and AstraZeneca/the University of Oxford, use different adenoviruses as vectors. Theres no evidence that any of those adenoviruses increases the risks of an HIV infection.

I dont see why I would pick an Ad5 vector [vaccine] when there are many other alternative choices.

Of the Ad5-based COVID-19 vaccine candidates, from China-based CanSino Biologics, has developed the furthest. In a Lancet report in May, researchers from the company recognized the controversial possibility of their vector increasing the risk of HIV infection and said they would watch for it in the candidates trials. CanSinos COVID-19 vaccine is being tested in efficacy trials in Russia and Pakistan that together hope to enroll more than 40,000 people, and the company is discussing starting studies in Saudi Arabia, Brazil, Chile, and Mexico.

China has already approved a CanSino vaccine against Ebola that uses the Ad5 vector. Yu Xuefeng, CanSinos CEO, tells Science the risk of increased HIV susceptibility may be limited to Ad5 vaccines that produce an AIDS virus protein. Theres no clear answer yet, Yu says. We certainly havent seen anything with the Ebola vaccine. The companys Ebola vaccine was tested in a population in Sierra Leone that, he notes, had a relatively high HIV prevalence, making it more likely to have detected the problem if it existed.

Russias Gamaleya Research Institute has a COVID-19 vaccine candidate that uses a combination of Ad5 and Ad26 vectors; its now in an efficacy trial in that country.

Last week, ImmunityBio received approval from the U.S. Food and Drug Administration to begin human trials of its COVID-19 vaccine, which uses Ad5 as a vector. The first trial will take place in Newport Beach, California, but Patrick Soon-Shiong, the companys CEO, says he also hopes to test it in South Africa, where he grew up and went to medical school.

He calls the STEP study results very, very fuzzy and stresses that ImmunityBios Ad5 has four deleted genes that reduce the immune responses it triggers. Its 90% muted, he says.

ImmunityBio is discussing the risks with scientists and regulators in South Africa of a trial there to test its modified Ad5 COVID-19 vaccine. The informed consent process for that proposed study would tell participants about potential risks given the previous STEP and Phambili results.

Soon-Shiong emphasizes that his companys experimental COVID-19 vaccine, unlike every other candidate that uses an adenovirus vector, presents two different SARS-CoV-2 genes and mighttherefore offer more protection from infection or disease. Why only test this in wealthy enclaves of Southern California, he asks? Why not South Africa? Why not for the underserved people of the world?

Pediatrician Glenda Gray, who heads the South African Medical Research Council and was the protocol chair of Phambili, has taken part in several discussions with the ImmunoBio team.When [Soon-Shiong] contacted South Africa, we were obviously quite concerned, Gray says. All of us who were in Phambili and quite traumatized by what happened asked whether there was an appetite to do something in South Africa.

But after several months of deliberations, the South Africans concluded that regulators should consider a small trial of the vaccine there in people at low risk of HIV infection, Gray says. We decided not to throw the baby out with the bath water just yet, she adds. If it does go ahead in South Africa, there has to be huge consultation with communities, and we have to make doubly sure that the participants understand what happened in the past.

Gray says South Africa appreciates ImmunoBios offer to allow the country to manufacture the product. Were in the middle of a COVID-19 epidemic in South Africa, and we dont know if well ever get access to the current suite of vaccines produced elsewhere, she says.

The decision to move forward, she insists, has to be left to South African scientists, regulators, and ethics committees. Its incredibly patronizing for people to determine what science is good or bad for other countries, she says. Everyone knows about Phambili and STEP, and the scientists understand that theres an important need to be cautious.

Gray, who has co-authored papers about HIV vaccines with Corey and the other three authors of the Lancet correspondence, says there are no easy answers. What if this vaccine is the most effective vaccine? she asks. If this works out to be an important vaccine, well have some experience with it.

See more here:

Could certain COVID-19 vaccines leave people more vulnerable to the AIDS virus? - Science Magazine

The Ondo State Government has said 12 new cases of the Covid-19 infection have been recorded in the state.

Two of the number are health workers from Akoko South East local government area.

The Acting Commissioner for Health in the State, Jibayo Adeyeye, gave the details while addressing journalists in Akure on Wednesday.

According to him, four cases were recorded in Akoko South-East, three from Akure South, one from Ile Oluji/ Okeigbo; one from Ose, one from Owo, one from Idanre and one in Okitipupa.

He also noted that seven of them were asymptomatic.

He said Ondo has a total of 1651 confirmed COVID-19 cases; with 25 active confirmed cases and 36 deaths.

In spite of this, the Governor of the state, Oluwarotimi Akeredolu, has approved the resumption of all schools in the state on Monday, 19th of October, 2020.

He, however, directed that all schools must abide by the COVID-19 preventive guidelines released by the Ondo State Inter-ministerial Committee to ensure the safety of staff and students.

Chairperson of the Inter-ministerial Committee on Coronavirus (COVID-19), who is also the Vice-Chancellor, University of Medical Sciences, Ondo, Adesegun Fatusi, said that the governor had also instructed the Ondo State Inter-ministerial Committee to conduct periodic monitoring visit to schools and any school found not to be complying with the COVID-19 guidelines should be shut.

The guidelines include: Notices with the message, No Mask, No Entry, must be boldly displayed at the entrance of the school and at strategic spots throughout the school compound; Infrared thermometer must be made available and used to assess the temperature of each staff, student, and visitors at the point of entry into the schools.

Hand washing devices with an adequate and constant source of running water and soaps must be available in schools and all individuals must wash their hands when entering the schools. Alternatively, hand sanitisers with an alcohol content of not less than 70% may be used.

All individuals with high temperature or who show any form of illness must not be allowed into the school: written guidelines must be available in that regard.

Seats in the classrooms and staff rooms must be separated with a minimum space of two metres or 6 feet (two arms length).

A COVID-19 monitoring team must be established in each school with the responsibility for monitoring and ensuring full compliance of all staff and students with the above-stated guidelines.

Civil society organisations, which monitored the just concluded governorship election in the state, observed widespread non-compliance with COVID-19 protocols as directed by the Independent National Electoral Commission.

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Heres what you need to know:New Jersey Gov. Phil Murphy is advising residents against non-essential out-of-state travel.Credit...Noah K. Murray/Associated Press

Coronavirus cases in New Jersey, an early epicenter of the pandemic, are on the rise again, doubling over the last month to an average of more than 900 new positive tests a day, a worrisome reversal of fortune for a state that had driven transmission rates to some of the nations lowest levels.

After an outbreak several weeks ago in a heavily Orthodox Jewish town near the Jersey Shore, cases are now rising in counties across the state, driven, officials say, by indoor gatherings.

The states health commissioner has said there are signs of widespread community spread for the first time since New Jersey successfully slowed the spread of a virus that has claimed the lives of more than 16,000 residents. A small, densely packed state, New Jersey has the highest virus fatality rate in the country.

Gov. Philip D. Murphy said Monday that residents should refrain from all but necessary out-of-state travel.

The numbers are up, Mr. Murphy said. Theyre up up and down the state.

Under a quarantine policy adopted by New Jersey, New York and Connecticut, New Jersey now exceeds the threshold an average of 10 cases for every 100,000 residents for seven days used to determine which states should be included in the travel advisory. Thirty-eight other states are on the list.

The uptick comes as other parts of the Northeast and states across the country are confronting similar surges of infections and hospitalizations as the pandemic stretches into its eighth month, with a death toll that now exceeds 219,000, according to a New York Times database.

Mr. Murphy, who has been conservative in allowing the state to reopen, said he would consider targeted shutdowns to curb the spread, as Connecticut and New York have done, but he suggested that would not cure the problem.

As the coronavirus pandemic erupted this spring, two professors at Stanford University Dr. Jay Bhattacharya and Dr. Scott W. Altas bonded over a shared concern that lockdowns were creating economic and societal devastation.

Now Dr. Atlas is President Trumps science adviser, a powerful force inside the White House. And Dr. Bhattacharya is one of three authors of the so-called Great Barrington Declaration, a scientific treatise that calls for allowing the coronavirus to spread in order to achieve herd immunity the point at which enough people have been infected to stall transmission of the pathogen.

The Centers for Disease Control and Prevention and leading experts have recently concluded, using different scientific methods, that as many as 90 percent of Americans are still vulnerable to infection.

While Dr. Atlas and administration officials have denied advocating the herd immunity approach, they have praised the ideas in the declaration. The message is aligned with Mr. Trumps vocal opposition to lockdowns on the campaign trail, even as the country grapples with renewed surges of the virus.

The central proposition is that to contain the coronavirus, people who are not vulnerable should immediately be allowed to resume life as normal while those at high risk are protected from infection.

Under that scenario, younger Americans should return to workplaces, schools, shops and restaurants, while older Americans would remain cloistered from the virus as it spreads, recipients of such services as grocery deliveries and medical care.

It argues that eventually so many younger Americans will have been exposed, and presumably will have developed some immunity, that the virus will not be able to maintain its hold on the communities.

The manifesto does not contain details on how the strategy would work in practice, nor do its authors have expertise in implementing public health programs. Dr. Anthony S. Fauci, the governments top infectious disease expert, dismissed the declaration as unscientific, dangerous and total nonsense, as well as unethical, particularly for multigenerational families and communities of color.

The idea has alarmed and angered other public health researchers. On Wednesday, about 80 published a manifesto of their own, the John Snow Memorandum (named after a legendary epidemiologist), saying that this approach would endanger one-third of the U.S. population who have conditions that put them at high risk from severe Covid-19, and result in perhaps a half-million deaths.

I think its wrong, I think its unsafe, I think it invites people to act in ways that have the potential to do an enormous amount of harm, said Dr. Rochelle Walensky, an infectious disease expert at Harvard University and one of the signatories to the Snow memo. You dont roll out disease you roll out vaccination.

President Trump attacked Dr. Anthony S. Fauci, the governments top infectious disease expert, in a conference call on Monday with campaign aides, calling the doctor a disaster and saying, People are tired of hearing Fauci and these idiots, all these idiots who got it wrong.

He continued his criticism of Dr. Fauci, the overwhelmingly popular director of the National Institute of Allergy and Infectious Diseases, after landing in Arizona for the first of two scheduled rallies in the state, which is experiencing a rise in coronavirus cases.

Speaking to reporters after deplaning Air Force One, Mr. Trump called Dr. Fauci a very nice man but complained that he loves being on television and has made a lot of bad calls. Asked why he didnt fire Dr. Fauci, Mr. Trump said, Hes been there for about 350 years. I dont want to hurt him.

At a campaign rally on Monday in Arizona, where polls show that the president is trailing Mr. Biden, Mr. Trump also faulted the news media for excessive coverage of the coronavirus.

Theyre getting tired of the pandemic, arent they? Mr. Trump said in Prescott, in central Arizona. You turn on CNN. Thats all they cover. Covid, Covid, pandemic, Covid, Covid.

The attack on Dr. Fauci comes as the United States has seen more coronavirus cases over 8 million and more deaths nearly 220,000 than any other nation in the world. The presidents advisers have tried to get him to lay off the infectious diseases specialist, who remains popular.

Dr. Fauci pushed back against complaints that he had flip-flopped over the use of masks, saying that admitting a mistake after examining further data shows honesty.

The conflict began Sunday night on the CBS News program 60 Minutes, when Dr. Fauci said it was absolutely no surprise that President Trump got sick with the coronavirus, given his lax attitude toward social distancing guidance.

I was worried that he was going to get sick when I saw him in a completely precarious situation: crowded, no separation between people and almost nobody wearing a mask, Dr. Fauci said in the CBS interview. He was referring to an event at the White House in September to announce the nomination of Amy Coney Barrett for the Supreme Court.

When I saw that on TV, I said, Oh, my goodness, nothing good can come out of that thats got to be a problem, Dr. Fauci said. Sure enough, it turned out to be a super-spreader event.

Numerous people who attended the event later tested positive for the coronavirus, including the president.

Dr. Fauci, who has often been at odds with the president, sharpened his stance against an ad run by Mr. Trumps re-election campaign that appeared to show the doctor praising the presidents handling of the coronavirus. Dr. Fauci said his words were taken out of context, and that their use in the ad was inappropriate because he never endorses candidates.

I got really ticked off, he said.

Mr. Trumps attacks on Dr. Fauci led Senator Lamar Alexander of Tennessee to become the latest Republican to distance himself from the president. Dr. Fauci is one of our countrys most distinguished public servants, said Mr. Alexander, who is retiring this year. He has served six presidents, starting with Ronald Reagan. If more Americans paid attention to his advice, wed have fewer cases of Covid-19, and it would be safer to go back to school and back to work and out to eat.

The National Academy of Medicine honored Dr. Fauci on Monday with the academys first Presidential Citation for Exemplary Leadership, citing his distinguished service as a trusted adviser to six U.S. presidents during public health crises and steady leadership during the Covid-19 pandemic.

In his acceptance speech, Dr. Fauci said that to inspire public trust and confidence in vaccines, people needed to hear consistent messages from the government, not conflicting ones.

A judge in Wisconsin, the site of the one of the worst outbreaks of a resurgent coronavirus, has upheld an executive order by Gov. Tony Evers that limits public gatherings to 25 percent of a building or rooms capacity.

This critically important ruling will help us prevent the spread of this virus by restoring limits on public gatherings, said the governors office in a statement. This crisis is urgent. Wisconsinites, stay home.

The ruling means in rural Wisconsin, many restaurants, taverns, and supper clubs with no maximum capacity set by local authorities will be limited to ten patrons dining-in at a time, according to the Tavern League of Wisconsin, which requested a temporary injunction on Emergency Order #3 from the circuit court judge.

The state has reported more than 22,500 new coronavirus cases in the last week, according to a New York Times database, putting Wisconsin behind only North Dakota, South Dakota and Montana in terms of new infections per capita.

The Tavern League, which sued for relief against the executive order, represents about 5,000 small businesses, according to Scott Stenger, who heads the leagues government affairs outreach. We dont take suing anybody lightly, let alone the governor of our state, Mr. Stenger said. Its not something wed do before.

Mr. Stenger said the league had not been consulted ahead of time about the emergency order, and did not have an opportunity to help craft regulations that might better help eateries and bars across the rural parts of the state stay open while still taking precautions to protect their customers.

The issue is especially acute in rural areas of Wisconsin, where there are often no set capacity limits for restaurants and taverns. By default, those businesses will be limited to ten patrons.

Without economic assistance from the state, or from Congress, Mr. Stenger said that more of his members will likely go out of business.

California will have its own independent panel of experts review any federally approved coronavirus vaccines before they are administered to residents, Gov. Gavin Newsom said on Monday.

Of course we wont take anyones word for it, he said in a news briefing. He emphasized that the second set of eyes on potential vaccines is part of Californias broader efforts to make sure that vaccines get equitably distributed to communities that are most vulnerable.

While Mr. Newsom acknowledged that the vaccine approval process has been politicized, he said, It doesnt matter who the next president is, were going to maintain our vigilance.

The announcement came after Gov. Andrew M. Cuomo of New York said that his state would also review vaccines approved by the federal government although Mr. Cuomo tied the move to doubts raised when President Trump suggested that he would reject tougher F.D.A. guidelines. Frankly, Im not going to trust the federal governments opinion, Mr. Cuomo said in late September.

On Sunday, Mr. Cuomo, as head of the bipartisan National Governors Association, posed additional questions about how the Trump administration will ensure that states are able to get and distribute vaccines.

Mr. Newsom said that his state is working with the federal government on its vaccination plans, but that experts from Californias prestigious academic and health care institutions are helping to figure out expected logistical challenges. They include where to store vaccines that must be kept cold, how to notify people about when to get their second shots and how to guarantee that rural communities have access to vaccines.

Mr. Newsom cautioned against being overly exuberant about the prospect of widespread vaccination; he said that wont happen until next year. This vaccine will move at the speed of trust, he said.

Californias new case rates have stayed relatively low, even as the state has expanded testing and gradually lifted restrictions on businesses. Still, the governor implored residents not to let their guard down as the holidays approach.

Countries across Europe announced new restrictions on Monday in an effort to halt a strong second wave of the virus, as the global tally of cases passed 40 million. Cases have been detected in nearly every country around the world, and at least 1.1 million people have died.

Officials are desperate to avoid a second economically damaging blanket lockdown, and are instead seeking to tighten restrictions in a more precise fashion. Heres the latest.

Ireland will be imposing its highest level of restrictions starting on Wednesday night, Prime Minister Michael Martin announced on Monday. Nonessential businesses will be mandated to close, restaurants and pubs will be limited to takeout, and people will not be allowed to travel more than five kilometers (three miles) from their homes. Schools and construction sites will remain open, however, the public broadcaster RTE reported. The restrictions, which will remain in effect for six weeks, come after the country set new daily case records four times in the past week. If we pull together over the next six weeks we will be able to celebrate Christmas in a meaningful way, Mr. Martin said.

In Spain, the region of Navarre announced on Monday the countrys most drastic regional measures yet to contain the second wave. As of Thursday, Navarre will stop its residents from leaving their region except for work or emergency reasons. It will also close for 15 days its bars and restaurants, and force all shops, sports venues and other establishments to close by 9 p.m. The measures come after Navarre reported an average of 945 cases per 100,000 inhabitants over the past 14 days, three times the national average.

Austria, which reported 1,121 daily cases of the virus on Monday, announced new limits on the number of people who could meet privately starting Friday: six indoors and 12 outdoors. The country has reported nearly 10,000 cases in the past week, more than at any time in March, when the government imposed a nationwide lockdown. The restrictions were lifted over the summer as numbers dropped and the country sought to attract tourists, an important source of income for the alpine nation.

In Italy, Prime Minister Giuseppe Conte announced that mayors will have the power to close streets or squares where people tend to gather after 9 p.m., while restaurants, bars and pubs will be allowed to serve seated customers up to six per table until midnight. Drinking outside of restaurants or bars will be permitted only until 6 p.m., and gaming and betting halls will close at 9 p.m. Italy has so far fared better than its European counterparts, but infections have been rising in recent weeks, with a record 11,705 new cases reported on Sunday.

France imposed a nightly curfew in nine cities, including Paris, over the weekend, and asked people throughout the country to limit gatherings to six people to halt an alarming spike in cases. On Monday, the office of President Emmanuel Macron announced that the first lady, Brigitte Macron, was in quarantine after being exposed to someone who had tested positive. Ms. Macron has not shown any symptoms, the office said in a statement.

Slovenias government declared a 30-day state of emergency after cases of the virus more than doubled in the past week, Reuters reported. The government will ban movement between regions that have been most affected by the pandemic and introduce a nightly curfew beginning at 9 p.m. starting Monday, Interior Minister Ales Hojs said at a news conference. Mr. Hojs said that all public and religious events would be banned, and that the number of people allowed to gather would be reduced to six from 10. Slovenia has reported 4,845 coronavirus cases in the past week, a spike from 2,255 cases the week before.

Britain has reported an average of nearly 17,000 new cases a day over the past week, according to a New York Times database, with almost a thousand new daily cases in Wales.

Wales will enter a national lockdown starting Friday night, the countrys first minister, Mark Drakeford, announced on Monday. The firebreak lockdown, which will last until Nov. 9, will require residents to remain at home and force pubs, restaurants and nonessential shops to close. Mr. Drakeford said there are no easy choices in front of us and called the lockdown our best chance of regaining control of the virus and avoiding strain on the National Health Service.

About 2.3 million of the 3.1 million people in Wales were already living under local lockdowns. and the country has effectively shut its borders to travel from other parts of Britain.

And officials in Bucharest, the Romanian capital, announced that schools, theaters and indoor dining will be closed for at least two weeks, and that masks will become mandatory in all public spaces. The city reported on Sunday that the virus rate over the previous 14 days had exceeded three cases per 1,000 residents, a red line for imposing stricter rules. After keeping the virus largely in check during the initial months of the pandemic, Romania has seen cases triple over the past month. While the schools will switch to online learning, there is deep concern that many students lack tablets and other necessary materials.

As the Trump administration has pressed publicly for top-speed development and approval of a coronavirus vaccine, while researchers and public health experts warned of the dangers of rushing the process, the idea of getting the vaccine as soon as it is available is losing appeal for many Americans, especially Black Americans, recent surveys show.

In a STAT-Harris poll of about 2,000 people, conducted Oct. 7-10 and published Monday, 58 percent of respondents said they would get vaccinated right away, down from 69 percent who said the same in August.

The decline was twice as steep among Black respondents: just 43 percent said in October that they would get the vaccine, down from 65 percent in August.

Rob Jekielek, managing director of The Harris Poll, which has been asking the question throughout the pandemic, said two news events appeared to have played a role in the falloff: the back-and-forth between the Food and Drug Administration and the White House over vaccine guidelines, and President Trumps Covid-19 diagnosis and treatment.

The politicization of the process is having a huge negative effect, especially with Black Americans, he said in an interview.

Pew Research Center polls that framed a question on the issue somewhat differently also found growing hesitation over a vaccine: About 51 percent of adult respondents said in September that they would definitely or probably get a vaccine if one were available, down from 72 percent who said the same in May. The surveys included more than 10,000 respondents and had a margin of sampling error of plus or minus 1.6 percentage points.

Its pretty clear the public is concerned about the pace of the vaccine approval process and have outstanding questions about safety, said Alec Tyson, associate director of Pew Research.

Polls conducted for CNN by the market research firm SSRS asked, If a vaccine to prevent coronavirus infection were widely available at a low cost, would you, personally, try to get that vaccine, or not? Sixty-six percent of respondents said yes in May; just 51 percent did in October. The polls margin of error was plus or minus 3.3 percentage points.

And in an ABC News/Ipsos poll last month, 64 percent of respondents said they would take a safe and effective coronavirus vaccine, down from 74 percent in May. Those polls had a margin of error of 4.9 points.

For months, as New York City struggled to start part-time, in-person classes, fear grew that its 1,800 public schools would become vectors of coronavirus infection.

But nearly three weeks into the in-person school year, early data from the citys first effort at targeted testing has shown the opposite: a surprisingly small number of positive test results.

Out of 15,111 staff members and students tested randomly by the school system in the first week of its testing regimen, the city has gotten back results for 10,676. There were only 18 positives: 13 staff members and five students.

And when officials put mobile testing units at schools near Brooklyn and Queens neighborhoods that have had new outbreaks, only four positive cases turned up out of more than 3,300 tests conducted since the last week of September.

New York City is facing fears of a second wave of the virus brought on by localized spikes in Brooklyn and Queens, which have required new shutdown restrictions that included the closure of more than 120 public schools as a precaution.

On Monday, Mayor Bill de Blasio said that city continued to see a leveling off in those areas and officials had seen particular progress in central Queens, the mayor said. But he did not provide data for those areas.

Across the city, the seven-day average positivity rate was at 1.62 percent, the mayor said. When he first announced an uptick in cases about three weeks ago, the positivity rate was 1.38 percent.

Shortly afterward on Monday, Gov. Andrew M. Cuomo said that data in different hot spot areas across the state where he had imposed restrictions by zones would continue to be reviewed, and that the state would announce changes to the zones on Wednesday. Zone sizes could be made larger or smaller, he said, adding that we have total flexibility in these zones.

Statewide, the daily positivity rate was 1.21 percent, he said, while the red zones, which have the most severe restrictions in place, had a positivity rate of 3.31 percent. Hospitalizations statewide, which have been steadily increasing in recent weeks, are 934.

But for now, at least, New York Citys sprawling system of public schools, the nations largest, is an unexpected bright spot as the city tries to recover from a pandemic that has killed more than 20,000 people and severely weakened its economy.

In September, New York became the first big urban district to reopen schools for in-person learning.

Roughly half of the citys students have opted for hybrid learning, where they are in the building some days, but not others. The approach has enabled the city to keep class sizes small.

Over the last two weeks, Catholic leaders in New York have voiced their deep disapproval with Gov. Andrew M. Cuomo over his decision to sharply limit attendance at houses of worship in areas that are seeing a surge of new coronavirus cases.

The governors decision was largely aimed at trying to rein in congregants in Orthodox Jewish synagogues in New York City and in Orange and Rockland Counties, where some members have flouted social distancing and mask regulations.

But it also affected other houses of worship, including about two dozen parishes in the diocese covering Queens and Brooklyn, where Catholic officials have sued Mr. Cuomo in federal court, insisting that they have been abiding by the rules and should not be punished.

Weve gone above and beyond what they have recommended and mandated, said Dennis Poust, a spokesman for the New York State Catholic Conference. So if theres an animus, its coming from his end, not our end.

Leaders of the Diocese of Brooklyn and the Archdiocese of New York have also criticized the restrictions, which have closed nonessential businesses and limited occupancy in so-called red zones to 25 percent of building capacity or a mere 10 people, whichever is lower.

To have all of the steps weve taken be ignored, and to face the prospect of indefinite unreasonable restrictions placed upon our churches is just not fair! Cardinal Timothy M. Dolan wrote in a blog post last week. Why are churches being singled out? Why especially are those houses of worship that have been exemplary, strict and successful in heeding all warnings, being shut down again?

GLOBAL ROUNDUP

Polands deputy prime minister and de facto leader, Jaroslaw Kaczynski, is going into quarantine after learning that he had been in contact with someone infected with the coronavirus, a government spokesman said, adding that Mr. Kaczynski, who is 71, feels well and will continue performing his duties from home.

Mr. Kaczynski did not wear a mask when he handed out an award at a ceremony last week, and briefly took off his mask when he was sworn in as deputy prime minister on Oct. 6.

Poland largely resisted the first wave of the pandemic with an early lockdown that began in March. But after it reopened all its schools for in-person instruction in early September, case counts started climbing, and the country is now battling a major surge of infections and hospitalizations. Poland has reported 49,950 new cases in the last seven days, according to a New York Times database, and 175,766 in all, with more than 3,500 Covid-19-related deaths.

With hospital beds filling up, there is particular concern about the damage that the virus could sow in Poland, which has a relatively weak health care system and one of the lowest ratios of doctors and nurses to residents in the European Union.

To deal with the surge, the government is transforming the national stadium in Warsaw into a field hospital. The health minister, Adam Niedzielski, said on Monday that temporary Covid-19 hospitals would also be set up in other major cities, and that he was in discussions with private hospitals about making more beds available. Mr. Niedzielski warned that if the virus continued to spread at its current pace, the country could soon be facing as many as 20,000 new cases a day.

In other developments around the world:

Restrictions on nonessential travel between the United States, Canada and Mexico will be extended until Nov. 21, Chad Wolf, the acting secretary of Homeland Security, announced on Monday. We are working closely with Mexico & Canada to identify safe criteria to ease the restrictions in the future & support our border communities, Mr. Wolf wrote on Twitter. In the past seven days, Canada has reported 16,284 cases, which works out to 44 per 100,000 people; Mexico, 33,724 cases, or 27 per 100,000; and the U.S., 396,305 cases, or 119 per 100,000.

Officials in Melbourne, Australia, announced some easing of one of the worlds strictest lockdowns, allowing residents to travel up to 25 kilometers from their homes and up to 10 people from two households to socialize outdoors. Dan Andrews, the premier of the state of Victoria, drew a contrast between the situation there and in Britain, where there have been fewer restrictions despite a surge in cases. Back in August and at our peak, we reported 725 daily cases. At the same time, the U.K. recorded 891, he said in a statement. Today, as Victoria records two new cases, the U.K. hit 16,171. And as we continue easing our restrictions, they are being forced to increase theirs.

Twenty-five crew members aboard a livestock carrier docked at a port in Western Australia have tested positive for the coronavirus. The ship, the Al Messilah, has 52 crew members, and the authorities warned that further positive test results were possible.

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Live Covid-19 Updates: The Latest Globally - The New York Times

Many families are starting to have tough conversations about whether or not to gather together for Thanksgiving amid the coronavirus pandemic.

Thanksgiving weekend is usually one of the busiest travel holidays in the U.S. But this year, Dr. Anthony Fauci is urging families to scale back their holiday plans.

It is unfortunate because thats such a sacred part of American tradition the family gathering around Thanksgiving, Fauci told CBS Evening News last week. But that is a risk.

Dr. Carlos del Rio, a professor of global health and epidemiology at Emory University in Atlanta, says transmission between family members is high because we tend to be maskless and congregate in indoor common spaces.

Earlier this month, Dr. Deborah Birx warned that COVID-19 transmission is different than in the spring as people move indoors, humidity drops and respiratory droplets stay in the air longer.

Birx added that in Utah, public health officials traced 80% of coronavirus infections to small gatherings where people let down their guard, The CT Mirror reports.

Seeing family members outside of your bubble may appear safe because they are people you are familiar with, he says. But that doesnt mean you should get too comfortable, he says.

People are going to be getting together with people that they feel comfortable with when the reality is there could be transmission happening, he says.

And even if you all live under one roof, COVID-19 transmission is still possible. For example, del Rio says he and his wife live together but work at different hospitals, thus risk of infection persists in their bubble.

For travel, flying may be pretty safe, he says, because of the cleaning measures airlines are taking. Many airlines are filtering the air and making masks mandatory, he says.

What may be a little more challenging is the pre-boarding process, he says, such as taking a taxi or ride-share to the airport, security lines and just being in the airport.

If you plan to gather for the holidays, he says to keep it to less than 10 people and try to make sure everyone is healthy. Its okay to share food, he says, but keep social distancing in effect while eating. Avoid hugging and being in close proximity, he advises.

And if you can, get a coronavirus test beforehand, he says.

If you can get people tested, I think that's useful, he says. But again, remember, a test helps you identify who's infected, not necessarily who's not.

The Centers for Disease Control and Prevention recently released guidance on holiday gatherings and what Americans need to do to stay safe while traveling, hosting or attending a Thanksgiving get-together.

Del Rio says the CDCs precautions, such as correctly wearing a face mask and social distancing, during travel and gathering can be taken to lessen the risk.

Ashley Lockeproduced and edited this interview for broadcast withTodd Mundt.Serena McMahonadapted it for the web.

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A Doctor Weighs In As Families Discuss Thanksgiving Plans And COVID-19 Risk - Here And Now

While critics of wide scale testing, including President Donald Trump have asserted that surges in cases can be explained by increased testing, health experts say that a jump in confirmed cases is usually caused by more people getting sick.

And those experts, who have long urged that testing is a critical tool in the fight against the pandemic, say that the lack of aggressive and consistent testing has contributed to the viruss spread.

If we really wanted to get things under control, frequent testing of almost everybody would be one way to do it and were, of course, nowhere near that, Marc Lipsitch, a professor of epidemiology at the Harvard T.H. Chan School of Public Health, said. Were doing infrequent testing of almost no one.

There are several reasons why states arent conducting enough tests, experts say, including the diminished fear of the virus on the part of some people, who are increasingly getting tired of wearing masks, practicing social distancing and seeking Covid-19 tests.

The initial level of fear is not at the level that it was, said Melissa Nolan, an assistant professor of epidemiology at the University of South Carolina, which has resorted to offering students T-shirts and raffles as an incentive for testing. Testing fatigue and mask-wearing fatigue is real.

Without widespread testing, cities and states dont have the ability to track who has the virus and who is at risk of getting it, experts say.

There's still a dearth of testing, Lipsitch said, pointing to colleges and sports as areas that are able to operate through the pandemic due to aggressive testing policies. In places with higher resources, such as universities, you can actually figure out where people are getting exposed and infected.

Nigel Chiwaya is a deputy data editor for NBC News.

Joe Murphy is a data editor at NBC News Digital.

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Covid-19 testing lags as cases increase across the United States - NBC News

WASHINGTON In North Carolina last week, President Trump told voters at a campaign rally not to fear Covid-19 because theyd soon have access to a coronavirus cure. The experimental treatment, he told supporters the next day in Iowa, made him feel like Superman. In Florida, he told seniors theyd soon have access, for free, to the antibody therapy hed received during his own bout with the virus two weeks before.

Its a significant shift. Trump campaigned for months on the dubious pledge that a vaccine would be available before a very special date, an open nod to Election Day. But as its become clear drug companies wont help Trump deliver on a key campaign promise by Nov. 3, hes largely dropped the aggressive vaccine rhetoric. Instead, hes begun to campaign on equally lofty boasts of a Covid-19 cure-all even though the treatments remain unproven and unavailable to the general public.

We have to get em approved, and I want to get em to the hospitals where people are feeling badly, Trump said in a recent video. Thats much more important to me than the vaccine.

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Trumps pivot to touting therapeutics underscores his desperation to claim that his government is making significant progress in combating the pandemic. And it is an attempt, too, to turn his own Covid-19 diagnosis from a weakness into a strength, bolstering the dangerous arguments that Americans shouldnt fear the virus or let it dominate their lives.

Clearly, theres been a shift in what the President talks about, said Walid Gellad, a physician and health policy professor at the University of Pittsburgh. That may just be a factor of the personal experience, although clearly its also related to the reality of the vaccine. I dont know which of those it is.

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Trumps latest comments have stoked additional fear among public health experts and scientists that Americans will take the presidents advice and largely ignore the pandemic unfolding around them. Even as Trump campaigns regularly in front of thousands of mostly unmasked supporters, case rates are spiking across the country. Over 700 Americans still die of Covid-19 each day.

Even amid the spikes, Trump has argued that Americans should return to business as usual, given the existence of the experimental therapies.

Public health experts are still urging people to continue to follow social distancing guidelines and to wear masks in public. With the weather growing colder, Americans spending more time indoors, and the holiday travel season approaching, experts including Tony Fauci, the governments leading infectious disease researcher, warn that failure to adhere to basic public health guidelines could have deadly consequences.

Trump has fixated particular on a treatment hes referred to as Regeneron in fact, an as-yet-unnamed cocktail of antibodies being developed by Regeneron, a New York drug manufacturer. Trumps effusiveness even led the Lincoln Project, a coalition of Republicans opposed to his re-election bid, to publish a fake commercial mocking Trump for hawking an unproven cure.

Youve got to open up your businesses, open up your schools, Trump said at a campaign rally in North Carolina on Thursday. We have incredible therapeutics, we have incredible drugs, we have, in my opinion, a cure. Because I took something, Regeneron, it was highly sophisticated stuff. The antibodies, and Eli Lilly makes an incredible drug.

Its unclear whether Americans are taking his words to heart. Trumps message, however, is clearly out of step with reality, given skyrocketing case rates and a corresponding increase in Covid-19 hospitalizations.

I have not seen any polling on whether this latest fusillade of claims regarding that great drug Regeneron has convinced anyone that there are cures out there, period, let alone readily available ones for the population, said Peter Bach, a doctor and health policy researcher at Memorial Sloan-Kettering Cancer Center in New York. I cant remember how many times the boy had to cry wolf before he was ignored, but I am sure the president has exceeded that number by now, probably by severalfold.

Trumps tone regarding new Covid-19 therapies has exceeded even his prior effusiveness regarding vaccines: Since his release, Trump has attempted to convince Americans theyll soon have access to the same level of treatment he received at Walter Reed.

We have Regeneron, we have a very similar drug from Eli Lilly, and theyre coming out, and were trying to get them on an emergency basis, Trump said in a video posted to Twitter on Oct. 7, in which he said contracting coronavirus may have been a blessing from God. Weve authorized it, Ive authorized it, and if youre in the hospital and youre feeling really bad, I think were going to work it so that you get em, and youre going to get em free.

The promises ignore key context: The president is among a small handful of people around the world whove received access to the Regeneron antibody therapy outside the setting of a clinical trial. The Food and Drug Administration has not yet issued an emergency use authorization for either therapy in fact, one trial testing Eli Lillys antibody treatment for hospitalized patients was recently paused following a potential safety concern.

As with other once-touted Covid-19 treatments, however, Gellad said the presidents enthusiasm could do more harm than good, especially when it comes to the publics perception of the FDA. Trump has already telegraphed that his administration will soon issue emergency authorizations for both the Regeneron and Eli Lilly antibody therapies. If the FDA does so, it might appear that Trumps rhetoric influenced the decision even if the agencys scientists didnt factor in the presidents eagerness. The scenario has already played out twice in 2020, Gellad said: First over the malaria drug hydroxychloroquine and again over the use of blood plasma from recovered Covid-19 patients.

The perception, and the reality, is that theres a lot of political interference, whether its addressing hydroxychloroquine, plasma, antibodies, or vaccines, Gellad said. In reality, all of these drugs might fit the criteria for what FDA would have done probably anyway.

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For Trump, Covid-19 therapeutics are the new vaccines - STAT - STAT

Approximately seven months after the coronavirus sparked social distancing measures and concerns about hospital capacity, new medical records data help shed light on the magnitude of the drop in hospital admissions and the more recent rebound in hospitalizations. These new data provide additional information to help assess the economic impact of the COVID-19 pandemic on hospitals and insurers and also provide more information to help assess the extent to which people are still delaying or forgoing care. We analyze trends in total hospital admissions and then separately analyze non-COVID-19 admissions by patient sex, age, and region. We calculate actual admissions as a share of total predicted admissions in 2020 based on trends from past years. Key findings include:

This new analysis is based on electronic medical record (EMR) data from Epic Health Research Network (EHRN) and includes all inpatient hospital admission volume from Dec 31, 2017 to August 8, 2020, involving patients who either were discharged or died, as of September 13, 2020. Data are aggregated weekly and pooled from 27 health care organizations in the United States, representing 162 hospitals that span 21 states and cover 22 million patients. These states represent 67.0% of COVID-19 cases as of September 23, 2020 and also represent 66.5% of the U.S. population. Predicted volume was calculated using historical data from Dec 31, 2017 to Jan 25, 2020. COVID-19 admissions were identified as admissions with either a documented COVID-19 diagnosis (U07.01) or other respiratory diagnosis involving a patient who either had tested positive or presumptive positive for COVID-19 or received a COVID-19 diagnosis within 14 days of the admission.

Several recent studies show that, beginning in March 2020, social distancing measures, concerns over hospital capacity, and fears of contracting COVID-19 led to sharp declines in health care spending. Across all health care services, not including pharmaceutical drugs, expenditures were down 38% in April 2020, compared to April 2019. More recently, overall spending on health care has started to rebound and, by June, spending was only 10% lower than the previous year.

An earlier EHRN analysis of EMR data found similar patterns for emergency department visits for acute myocardial infarctions and stroke, with sharp declines followed by increases that brought those emergency department visits roughly back to expected rates. In late March to early April, the incidence of these conditions as reported in hospital emergency department records was down by 45% for AMIs and 38% for strokes.By the end of May, the weekly incidence of acute myocardial infarction admissions had returned to approximately 92% of the pre-pandemic trend (prior to March 13, 2020). Similarly, the incidence of emergency department visits for stroke returned to approximately 87% of the historical trend. Analysis of EMR data for breast, cervical, and colon cancer screenings showed an even sharper decline beginning in early March followed by an increase in screenings; even so, screening rates have remained far below 2019 levels. By mid-June, weekly volumes for these cancer type screenings remained roughly 30-35% lower than their pre-COVID-19 levels.

A recent analysis of outpatient office visits published by the Commonwealth Fund found that visits fell nearly 60% by early April and then increased, plateauing as of July at 10% below the pre-pandemic baseline. Another analysis of outpatient visits that included data through May 15, 2020 found that non-COVID-19 outpatient visits dropped by almost 40 percent by mid-April and then started to increase by mid-April. An analysis of data from 18 states that was published by the Health Care Cost Institute found similar patterns for childhood vaccinations and cancer screenings. A study published in September in Health Affairs used data from a national medical group specializing in hospital medicine to analyze hospital admissions. That study reported similar patterns to ourswith all medical admissions in April having declined by 34.1%, and by June/July they were 8.3% lower relative to baseline volume.

Our analysis of EMR data shows a precipitous drop in hospital admissions starting the week of March 14, 2020, falling to a low of roughly 70% of predicted admissions by the week of April 11 (Figure 1)just four weeks after the March 13, 2020 national emergency proclamation. Admissions gradually began to increase soon after that date and, by July 11, admissions were back to approximately 95% of their predicted level. More recently, total admissions dipped slightly and are now at about 90% of predicted levels.

The lost admissions between March 8 and August 8, 2020 account for 6.9% of the total number of admissions predicted during the 2020 calendar year. If the number of admissions remains at about 90% of predicted admissions (as they were on August 8) through the end of the year, total admissions will be 10.5% below predicted volume for the entire year. If there are new restrictions on non-emergency procedures in the latter part of 2020, the share of lost admissions likely will be higher.

Implications for hospital finances

This drop in admissions was not something that hospitals could have anticipated at the beginning of the year and suggests revenue losses that may be difficult for some hospitals to weather. Hospitals financial strength differs widely. One recent study found that the median hospital had enough cash on hand to pay itsoperating expenses for 53 days in 2018, but the 25thpercentile hospital only had enough cash on hand for 8 days. Smaller hospitals and rural hospitals are among those most likely to face financial challenges in the wake of revenue loss related to COVID-19. These hospitals may be more likely to close or merge if they do not have the financial resources to make up for declines in revenue caused by the declines in admissions shown in our data.

Hospitals and other health care providers have qualified for various types of federal assistance during the coronavirus pandemic. However, much of this money was not targeted to safety net hospitals operating on narrow margins. Most notably, hospitals and other Medicare and Medicaid providers received grants from the $175 billion provider relief fund that is being distributed by the Department of Health and Human Services (HHS). Hospitals qualified for grants that were the equivalent to a minimum of 2% of revenue and on average received grants that amounted to about 5.6% of revenue. Hospitals that qualified for additional grants either qualified by seeing a high number of COVID-19 inpatients by June 10 or were childrens hospitals, rural hospitals and/or safety net hospitals. About $30 billion remains available for future grant allocations as of October 8, 2020. It is unclear how the Department of Health and Human Services will allocate that money. How declines in admissions translates into lost hospital revenue depends on the type of admissions that were missed and which insurers paid for those admissions. Private insurers typically reimburse at higher rates than Medicare or Medicaid, and reimbursement widely varies by type of admission.

Hospitals and other providers that participate in traditional Medicare were also eligible for loans through the Medicare Accelerated and Advance Payment Programs, which are designed to help hospitals facing cash flow disruptions during an emergency. About 80% of the $100 billion in loans went to hospitals. Repayment for the loans was originally set to begin in August, but Congress later delayed when repayments would begin and extended the period for repayment.

Hospitals are also receiving a 20% increase in inpatient reimbursement for COVID-19 patients during the current public health emergency. The Congressional Budget Office estimated that this change will increase Medicare spending by about $3 billion. Hospitals may also be eligible for loans being distributed by the Treasury department, the Federal Reserve, and Small Business Administration.

Implications for insurer finances

Health insurers, in contrast, may be benefiting financially from this decline in hospital admissions. Many insurers have been reporting large profits despite voluntarily eliminating cost sharing for patients with COVID-19. The Affordable Care Acts (ACA) Medical Loss Ratio limits the share of premiums that insurers can keep for overhead and profit. This means that beneficiaries get a refund check from their insurer if it did not spend a sufficient share of premiums on health care costs for beneficiaries. Using preliminary data reported by insurers to state regulators and compiled by Market Farrah Associates, KFF estimated insurers will be issuing a total of about $2.7 billion in rebates across all markets in 2020nearly doubling the previous record high of $1.4 billion last year.

We used EMR data from EHRN to look specifically at non-COVID-19 admissions by patient sex, age and region. By looking specifically at non-COVID-19 admissions, we can more easily assess declines in the use of health care due to voluntary and mandatory delays in non-emergency care. This analysis does not include specific diagnoses or procedures to assess which types of admissions had the steepest declines. Declines in certain types of admissionssuch as car crashesmay be explained by changes in habits due to the coronavirus pandemic. However, as discussed earlier in this paper, declines in cancer screenings suggest that the overall decline in admissions is also a sign of patients delaying or foregoing preventive care and therefore not starting necessary treatments. Some cancer treatments were also delayed earlier in the pandemic, although those treatments may now have resumed in many cases.

Non-COVID-19 admissions by sex

Non-COVID-19 admissions for both male and female patients dropped to about 60% of predicted admissions in April 2020 and then increased to roughly 85-90% of predicted admissions by the summer (Figure 2). On an absolute level, admissions for female patients remained about 20% higher than for male patients (data not shown). Much of this differential is likely due to womens admissions for childbirth.

Non-COVID-19 admissions by age

We stratified the EHRN admissions data by age to assess trends in non-COVID-19 admissions for patients age 65 and older compared to younger patients. We found that admissions for patients age 65 and older was just 50-55% of predicted levels in April 2020, compared to 65-70% of predicted levels for younger patients (Figure 3). Admissions among patients age 65 and older have not rebounded as quickly as younger patients. Admissions for patients age 65 and older were at roughly 80% of their predicted level in late July and early August, while admissions for patients under age 65 were at approximately 90% of predicted levels during the same time period. Individuals age 65 and older may be more reluctant to schedule non-emergency procedures given that they are at higher risk of serious illness if infected with the coronavirus.

The slower return to normal among older patients may lead to a change in hospitals payer mix. While patients age 65 and older typically have Medicare, the majority of younger patients have private insurance, which typically reimburses at a higher rate than Medicare. If hospitals experience an increase in the share of patients with private insurance, that could help mitigate some of the revenue declines they are likely to see from a drop in overall admissions.

Non-COVID-19 admissions by region

We next examined how non-COVID-19 admission trends differed across geographic regions, using the regions defined by the U.S. Census Bureau. To give a sense of the geographic distribution of our dataset, admissions from the Northeast, Midwest, South, and West regions account for 22%, 37%, 28%, and 13% of overall admissions, respectively. Hospitals in the Northeast experienced the steepest decline in non-COVID-19 admissions, with those admissions decreasing to a low of roughly 50% of predicted admissions the week of April 11 (Figure 4). Admissions in the Northeast have since increased and were at 87% of predicted levels in early August. Hospitals in the Midwest followed a similar pattern but did not experience quite as steep an initial decline in admissions. In the South, where the number of cases increased in some states during the summer, there has been less of a rebound in non-COVID-19 admissions and those admissions were about 82% of predicted levels in early August. Hospitals in the West did not experience as large a decline in admissions, but also have not experienced as large of a rebound. By early August, admissions in the West were at about 83% of predicted levels.

This new analysis from the Epic Health Research Network provides additional insights into patterns of hospital admissions during the COVID-19 pandemic. This adds to a body of research showing the steep decline in admissions in the spring followed by a more recent rebound in admissions. By looking at the patterns in non-COVID-19 admissions, we can see how changes in behavior had a differential impact by region, age, and sex. If overall hospital admissions remain at or above 90% of predicted admissions, hospital revenues may stabilize at a somewhat sustainable level. However, if the coronavirus begins to spread more rapidly later in the fall and non-emergency procedures are once again delayed, it could have serious consequences both for hospitals financial stability and the health of patients.

Tyler Heist, Ph.D., and Sam Butler, M.D., are with the Epic Health Research Network. Karyn Schwartz, M.P.H., is with KFF.

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Trends in Overall and Non-COVID-19 Hospital Admissions - Kaiser Family Foundation

(KTIV) -- There were 508 new, confirmed cases in Iowa from 10 a.m. Sunday to 10 a.m. Monday,according to the state's dashboard.

At 10 a.m. Saturday, health officials reported 107,062 total positive cases across the state, that number rose to 107,570 by 10 a.m. Monday.

The state's website says out of those who have tested positive, 82,056 have recovered. That's an increase of 275 recoveries in the last 24 hours.

The state reported six additional deaths within this time frame, putting the state's death toll to 1,534.

According to the state's latest report, there are 480 Iowans hospitalized due to the virus. Of those hospitalizations, 113 are in the ICU and 45 are on ventilators.

In Iowa, 2,876 new tests were given for a total of901,746 people that have been tested for COVID-19.

As of 9 a.m. Monday, the Siouxland District Health Department reported 49 new COVID-19 cases in Woodbury County. This brings the county's total number of positive cases up to 6,748.

The SDHD has reported no new virus-related deaths, keeping the county's death toll to 89.

To date, 5,022 of the county's cases have recovered.

A total of 64 people are currently hospitalized with COVID-19 in Woodbury County. Forty of those are county residents.

Buena Vista County, where Storm Lake is located, has had one new COVID-19 case, bringing its total cases to 2,195. Of those cases, 1,939 of them have recovered.

So far, the county has had 12 total COVID-19 deaths.

Clay County, where Spencer is located, has reported three new virus cases, with its total now at 482. Of those cases, 294 have recovered

Clay County has confirmed four total virus-related deaths.

State health officials say Dickinson County reported two new cases, bringing their total positive cases to 684. Officials say 479 of those cases have recovered.

Dickinson County has had seven virus-related deaths.

Plymouth County's total positive cases have risen from 1,531 to 1,535 in the last 24 hours. Officials say 1,046 of those cases have recovered.

Plymouth County has reported one additional virus-related death, bringing its death toll up to 25.

As of Oct. 19, the state health department says Sioux County reported four new cases bringing their total to 2,286. Officials say 1,392 of those cases have recovered.

Sioux County has had no additional virus-related deaths, keeping its death toll to 11.

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Oct. 19: Iowa reports 508 new COVID-19 cases, 275 recoveries and 6 deaths - KTIV

The Gallatin City-County Health Department reported Monday there were 15 county residents hospitalized for COVID-19.

Health Officer Matt Kelley said he believes it to be the highest number of people reported to be hospitalized for COVID-19 in a day since the pandemic began. The number refers to Gallatin County residents hospitalized for COVID-19, and includes residents who may be hospitalized in a different county or state.

Birgen Knoff, Bozeman Health system director of clinical practice, said Monday their numbers can change quickly. For example, on Monday morning the health system had 13 patients hospitalized for COVID-19. By the afternoon, that number dropped to 11 patients.

The health department reported 41 new COVID-19 cases on Monday, 57 on Sunday and 59 on Saturday, continuing a trend of increasing case counts in recent weeks. Kelley said last week that the increase in cases there were 175 new cases from Tuesday to Thursday was pressuring the countys contact tracing ability.

It wasnt long ago that we had two to three, maybe four people in the hospital with coronavirus, Kelley said Monday. To have that sort of shift to the norm being seven, eight and nine, and now were up to 15, that is concerning.

Kelley said his concern is compounded by high hospitalization rates in other parts of Montana. According to data from the Montana Department of Public Health & Human Services, both Billings Clinic and Benefis Hospitals in Great Falls had between 70% and 90% of beds occupied as of Oct. 19.

Kelley said the situation elsewhere in Montana limits Bozemans options should hospitalizations increase.

In normal times, if youve got a big surge in Bozeman, Billings would be a primary place that youd get some relief from that, Kelley said.

Knoff said they have transfer agreements with other health systems, but Bozeman Health has not taken on a significant number of patients via transfer agreements recently. Knoff said they created plans to deal with a surge at the beginning of the pandemic that include increasing the number of beds beyond their normal capacity.

On Monday, Bozeman Health had roughly half of its capacity filled, Knoff said.

We feel really good right now about our capacity to take on additional patients with acute care needs, Knoff said.

The health department reported last week a {span}seven-day rolling average for the rate of positive cases{/span} of 10.9% on Thursday, and a seven-day rolling average of daily cases of 42.1 per 100,000 residents. Both were increases from the previous week. The department is seeing increasing cases from all areas of the county in different age categories, Kelley said, and the situation is not getting any better.

Kelley said that the high rate of cases in Bozeman is a specific concern for long-term care facilities.

The more cases you have in the community the harder it is to protect those long-term care facilities, Kelley said. The people who are working in those facilities live in those communities they go out in the world the same as all the rest of us.

To see what else is happening in Gallatin County subscribe to the online paper.

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Gallatin County health official concerned by increase in COVID-19 hospitalizations - The Bozeman Daily Chronicle

ANN ARBOR, MI - Washtenaw County has seen one of the states biggest one-week increases of COVID-19, according to data released on Monday, Oct. 19.

The county went from 200 cases the week of Oct. 4-10 to 433 new cases the week of Oct. 11-17 - the second largest increase in the state. Washtenaw Countys has had an average of 16.83 new cases a day during the past week, per the Harvard Institute.

The countys accelerated rate of COVID-19 transmission has moved it from the yellow zone to orange, based on a metric developed by the Harvard Global Health Initiative to assess coronavirus risk levels.

To date, Washtenaw County has reported 4,229 laboratory confirmed COVID-19 cases, along with 631 probable cases, according to Washtenaw County Health Department data. Thats an increase from the 4,028 the county reported on Friday, Oct.16, including 47 cases that were reported in the past 24 hours.

Eleven percent of cases have resulted in hospitalization, while 119 people from the county have died.

The county had a weekly testing positivity rate of 1.9% as of Oct. 15.

Countywide, 3,484 people have recovered from the coronavirus, which means they are alive 30 days after the start of the virus, per the health department.

Washtenaw Countys increase is similar to neighboring counties like Livingston County, which saw the states third largest increases from week to week, from 85 the week of Oct. 4-10 to 162 new cases the week of Oct. 11-17.

Livingston County reported 68 COVID-19 cases over the weekend. A total of 14 recent COVID-19 cases from the area can be attributed to individuals who attended services at Brighton Assembly of God, after attending services at the church on Oct. 4, Oct. 7 and Oct. 11

Washtenaw Countys daily cases are the closest to Jackson Countys 16.94 new cases a day, with an average of 16.83 new cases a day, per the Harvard Institute.

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Monday, Oct. 19, coronavirus data by Michigan county: 70 of 83 counties are trending up

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One of Michigans largest weekly COVID-19 case increases is in Washtenaw County - MLive.com

SIOUX FALLS, S.D. (KELO) Heres a look at the top stories as of 4 p.m.

Active COVID-19 cases set another record in South Dakota on Monday, based on data from the state Department of Health.

On Monday, 567 new coronavirus cases were announced, bringing the states total case count to 33,836. Total recovered cases are now at 25,125. But active cases, which passed 8,000 for the first time on Sunday, are up to 8,388.

Only eight counties are listed as having moderate community spread; the other 58 counties in South Dakota are listed as having substantial community spread.

Sioux Falls Mayor Paul TenHaken says people in the region need to do more to slow the spread of coronavirus.

We are in a tense spot and we need you to do more, TenHaken said.

He stressed the importance of social distancing and hand hygenine as COVID-19 cases surge in the state.

Wear a dang mask, TenHaken said while referencing a letter sent from mayors of several South Dakota towns with a request to residents.

Sioux Falls Police said a suspect accused of firing a gun at officers died of a gunshot to the head, but the origin of that shot isnt known yet.

The South Dakota Department of Criminal Investigation is looking into the incident.

Two Sioux Falls Police Officers responded to a call about a person who would not leave an apartment. They found the suspect in a hallway just before the suspect fired at one of the officers.

Both officers are on administrative leave.

Snow has fallen across KELOLAND on Monday. Get the latest forecast from the KELOLAND Live Doppler HD StormCenter in the video player below.

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First@4: Active COVID-19 case record in S.D.; Region in a tense spot; Shooting investigation - KELOLAND.com

Topline

At the request of Senate Democrats, the government's top watchdog agency will investigate whether the Trump administration's reported interference with agencies handling the Covid-19 outbreak violated federal policies, NBC first reported Monday, following months of reports of tension between President Trump and medical experts.

Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, speaks at a White ... [+] House Coronavirus Task Force briefing on April 22.

The Government Accountability Office agreed to investigate whether the Trump administrations reported interference with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) violated the agencies scientific credibility and communication policies.

Sen. Elizabeth Warren (D-Mass.), Sen. Gary Peters (D-Mich.) and Sen. Patty Murray, (D-Wash.) on Sept. 8 sent a letter to the Government Accountability Office urging it to investigate if the CDC and FDAs scientific integrity had been undermined and if the policies in place are being implemented based on agency recommendations.

The senators claimed the Trump administration has repeatedly pressured the CDC and FDA to change their messaging to align with Trumps political priorities, according to ABC News which obtained a copy of the letter.

The senators pointed to reports that political appointees at the Department of Health and Human Services (HHS) updated the CDC websites asymptomatic testing guidelines without approval and reports the White House pressured the CDC to downplay the risk of coronavirus transmission in schools to put pressure on schools to physically reopen.

Trump administration officials have repeatedly said the White House has followed the advice of doctors and scientists and denied claims the coronavirus response has been politicized.

Since the start of the pandemic, there have been reports the president and his administration have downplayed the severity of the virus and interfered with the recommendations of scientists and doctors. Earlier this month, 30 senators sent a letter to the HHS Inspector General calling for an investigation into allegations of political interference with public health research and guidelines from the CDC and FDA. They noted the Senate recently introduced the Science and Transparency Over Politics (STOP) Act which would create a Pandemic Response Accountability Committee to investigate political pressure on HHS agencies decisions.

There has been tension between Trump and leading infectious disease expert Dr. Anthony Fauci for months. In an interview with 60 Minutes on Sunday, Fauci said he was absolutely not surprised Trump contracted Covid-19 and said he was worried the president would get sick after he saw him in a completely precarious situation of crowded, no separation between people, and almost nobody wearing a mask. Fauci was referring to the Sept. 26 White House event celebrating the nomination of Judge Amy Coney Barrett to the Supreme Court, which Fauci called a super-spreader event. Fauci also acknowledged the White House has limited his media appearances. The next day, Trump reportedly called Fauci a "disaster" who has been around for "500 years, on a campaign call and referred to him and other health officials as "idiots," according to Reuters. Trump reportedly claimed Americans are tired of hearing about the pandemic and ready to move on, even though cases are spiking and medical experts have warned cases may increase this winter.

Senate Dems ask government watchdog to investigate 'political pressure' on FDA, CDC (ABC News)

Fauci Says Hes Absolutely Not Surprised Trump Contracted Covid-19 (Forbes)

Trump Calls Dr. Fauci Disaster, Says He Would Fire Him It Werent For Negative Press (Forbes)

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Watchdog To Investigate Whether Trump Interfered With Health Agencies' Covid-19 Response - Forbes

Patients get tested for COVID-19 in India, one of 30 countries that took part in the Solidarity trial.

By Kai KupferschmidtOct. 16, 2020 , 3:45 AM

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

One of the worlds biggest trials of COVID-19 therapies released its long-awaited interim results yesterdayand theyre a letdown. None of the four treatments in the Solidarity trial, which enrolled more than 11,000 patients in 400 hospitals around the globe, increased survivalnot even the much-touted antiviral drug remdesivir. Scientists at the World Health Organization (WHO) released the dataas a preprint on medRxivlast night, ahead of its planned publication in The New England Journal of Medicine.

Yet scientists praised the unprecedented study itself and the fact that it helped bring clarity about four existing, repurposed treatments that each held some promise against COVID-19. Its disappointing that none of the four have come out and shown a difference in mortality, but it does show why you need big trials, says Jeremy Farrar, director of the Wellcome Trust. We would love to have a drug that works, but its better to know if a drug works or not than not to know and continue to use it, says WHOs chief scientist, Soumya Swaminathan.

The prospects of two of the four treatmentsthe malaria drug hydroxychloroquine and the HIV drug combination ritonavir/lopinavirhad faded after another large study, the United Kingdoms Recovery trial,showed they did not increase survivalin June. After analyzing that study and its own data up until then, WHO decided to drop both from the study.

There was still hope for remdesivir and for interferon-beta, which had initially been given in combination with ritonavir/lopinavir but was tested as a standalone drug after the Recovery data came out. But neither of those treatments lowered mortality or delayed the moment patients needed ventilation to help them breathe. The results in these two treatment arms are likely to be the most scrutinized.

Remdesivir, which attacks a specific enzyme in several RNA viruses and was previously tested against Ebola, was initially seen as a promising candidate. In a U.S. trial with more than 1000 COVID-19 patientspublished last week, those who received remdesivir had a shorter recovery time than patients in the control group, but there was no significant difference in mortality. Two smaller trials found few significant benefits. Remdesivir received an emergency use authorization from the U.S. Food and Drug Administration (FDA) in May for severe COVID-19 patients that was later expanded to include all patients.

But the Solidarity trial suggests the drug does little in severe cases. Of 2743 hospitalized patients who received the drug, 11% died, versus 11.2% in a control group of roughly the same size. The difference is so small it could have arisen by chance.

When the authors pooled Solidaritys data with those from the three other trials, they found a slight reduction in mortality that wasnt statistically significant either. This absolutely excludes the suggestion that remdesivir can prevent a substantial fraction of all deaths, the authors write. The confidence interval is comfortably compatible with prevention of a small fraction of all deaths but is also comfortably compatible with prevention of no deaths.

This trial doesnt help remdesivir, thats for sure, says Eric Topol, director of the Scripps Research Translational Institute. Its not a dead duck as much as hydroxychloroquine, but it certainly is not the hope that was initially signaled.

But the drugs manufacturer, Gilead Sciences, casts doubt on the study. The trial design prioritized broad access, resulting in significant heterogeneity in trial adoption, implementation, controls and patient populations, the companysays in a statement, and consequently, it is unclear if any conclusive findings can be drawn from the study results.

Gilead received the manuscript about Solidarity on 28 September, according to WHO. On 8 October, before the results became public, the company signed a$1 billion deal with the European Commissionfor a 6-month supply of the drug.

Solidaritys most disappointing results, however, are those for interferon-beta, Topol says. Mortality among the 2050 people who received that drug (either alone or in combination with lopinavir/ritonavir) was 11.9%, versus 10.5% in the control group. Prior studies have suggested interferon can only help if given early, however, and not once patients have been hospitalized. So I think thats still an open question, Topol says.

Treating COVID late is very difficult, Benjamin tenOever, a virologist at the Icahn School of Medicine at Mount Sinai, wrote in an email toScience. At this point in the disease the issue is more about inflammation and clotting, which is likely why these four drug regimens showed little value.

The silver lining may be that the trial itself, unprecedented in several ways, succeeded. Set up in a short time in March as the pandemic engulfed the world, it used a simple protocol that allowed doctors in overstretched hospitals anywhere to randomize their patients to whatever study drug was available or to standard care. To get four different drug strategies nailed down, and in this short period of time and across the world, is just fantastic, Topol says. I give them a lot of praise for getting us these results with extraordinary velocity. I think that Recovery and the Solidarity trial between them have set the standard of the scale thats required in order to give you clear answers, Farrar adds.

To get four different drug strategies nailed down, and in this short period of time and across the world, is just fantastic.

The biggest hurdle was the long time it took to get regulatory approval for the study in some countries, says WHOs Marie-Pierre Preziosi. Regulators, as well as the ethics committees for that matter, need to rethink their approaches in pandemics and need to be much more ready to cope with this because sometimes the duration for authorization is really not appropriate.

Still, the trial has ramped up to more than 11,000 patients from 30 countries, including Argentina, Peru, India, the Philippines, and Spain, with more slated to join. About 2000 patients are now included every month. For the moment, the remdesivir arm will continue to get more precise evidence, says John-Arne Rttingen, CEO of the Research Council of Norway, who heads the executive group of Solidaritys steering committee. But new drugs will be added, he says.

As early as next week, Solidarity participants could start to receive acalabrutinib, a cancer drug that inhibits an enzyme that plays an important role in the human immune system. The hope is to soon include targeted therapies such as monoclonal antibodies as well because they are more likely to be successful than repurposed drugs. Trying to find off-target benefits from FDA-approved drugs is not a great strategy (although arguably the best we can do under these conditions), tenOever wrote.

Solidarity built on experience from the 201416 Ebola epidemic in West Africa, says Ana Maria Henao Restrepo, who heads the Research and Development Group at WHO. Back then, there were many debates about whether it was even ethical to do randomized clinical trialswhich withhold a potential therapy from patients in control groupsduring a deadly outbreak. Now, you dont see any debate on that question, she says. The community, all of us, we have moved, we have learned a lot since West Africa.

The studys global reach has important benefits, says Nahid Bhadelia, a physician at Boston Medical Center. Conducting a trial in many places simultaneously means more patients can be included, leading to faster results but also to more robust data, she says. Youre including many different types of subgroups and populations in different parts of the world.

Another advantage: The 1300 participating doctors worldwide will have a sense of ownership of the results, Henao Restrepo says. When they see the results inThe New England Journal of Medicine, [they will] say, Ive contributed to that and I understand why that drug works or doesnt work. I know, I trust it, she says. That is different from some Northern Hemisphere group publishing, and they say: Somewhere in a rich country they did a trial and now we all have to believe the results.

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Remdesivir and interferon fall flat in WHO's megastudy of COVID-19 treatments - Science Magazine