Category: Corona Virus Vaccine

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Trump wants a vaccine for Covid-19 before the November 3 election. Is this possible? – The Indian Express

August 26, 2020

By: Reuters | Chicago, New York | Updated: August 26, 2020 11:22:32 pmPresident Donald Trump in Clyde, Ohio, August 6, 2020. (The New York Times: Anna Moneymaker)

US President Donald Trump has said a vaccine for the novel coronavirus could be available before the November 3 presidential election, sooner than most experts anticipate. A COVID-19 vaccine as early as October could become a reality if drugmakers deliver on optimistic timelines for completing large, late-stage clinical trials and regulators allow for its use prior to a full review and approval.

How can US regulators speed up availability of a vaccine?

The US Food and Drug Administration can greenlight medical products during public health emergencies by issuing an emergency use authorisation (EUA) before all the data are in to complete a formal review. The FDA has issued EUAs for many COVID-19 tests and for a few treatments.

On Sunday, the FDA authorised on an emergency basis the use blood plasma from recovered COVID-19 patients as a treatment. The FDA commissioner later corrected data he cited at a news conference that significantly overstated the treatments known ability to save lives.

EUAs are not typically used for vaccines intended for healthy people to prevent infection. That presents a higher bar for approval than treatments for people with life-threatening disease. Nevertheless, the FDA in June released EUA guidance for COVID-19 vaccines. Once it grants an EUA, the agency eventually must issue a formal marketing approval or revoke emergency authorisation.

How much time could an EUA save?

Typical FDA approval reviews take eight months or longer, with a priority review shaving off a couple of months. But the agency has moved quickly during past public health crises. During the 2009 H1N1 swine flu pandemic, it only took two months to get an approved vaccine, but those were based on existing seasonal flu vaccines.

An EUA for a vaccine using a new approach might only save a few weeks, some experts say. The FDA would still need substantial data, said Dr. Kathryn Edwards, former chairwoman of the FDAs vaccine advisory committee and scientific director at the Vanderbilt Vaccine Research Programme.

What they do seem to be telling us is that once you show that your vaccine works that might be a time when an EUA may be used before the paperwork is completed, said Filip Dubovsky, chief medical officer of vaccine maker Novavax Inc.

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Is it risky to use an EUA for vaccines?

The US government decided against an EUA for the H1N1 vaccine after a survey found 64 per cent of Americans would not take it if it had not gone through the formal approval process. Consumer rights watchdog Public Citizen urged regulators not to use an EUA for COVID-19 vaccines, which it says could create the appearance of a rushed review.

The FDA and other US health experts say there must be sufficient safety and efficacy data before a vaccine is authorised for public use.

I certainly would not recommend nor would I ever allow myself to be injected with a vaccine that has not been thoroughly vetted and approved by the FDA, said former FDA associate commissioner Dr. Peter Pitts, president of the Center for Medicine in the Public Interest.

Could Trump pressure the FDA to issue an EUA without sufficient data?

Trump, without citing evidence, on Saturday accused deep state elements in the FDA of holding up vaccines and treatments in order to undermine his reelection prospects. FDA Commissioner Stephan Hahn has denied that assertion. Peter Marks, one of the FDAs top drug reviewers, told Reuters he would resign if he felt the agency was pressured to approve a vaccine before it was ready.

Dr. Jesse Goodman of Georgetown University, a former FDA chief scientist, said a vaccine EUA could undermine public confidence in the agency. He cited pressure around hydroxychloroquine, a treatment pushed by Trump and others in his administration, which received an EUA that was later revoked when data showed a lack of efficacy and safety issues. Were certainly seeing a situation where norms are not being respected government-wide, Goodman said.

Dont miss from Explained | Why the departure of adviser Kellyanne Conway matters for Trump

Which drugmakers have a shot at a viable vaccine before the election?

AstraZeneca Plc in conjunction with Oxford University researchers and Pfizer Inc with partner BioNTech SE have said they could have pivotal data by October. Moderna Inc is not far behind with late-stage data expected as soon as November or December.

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Trump wants a vaccine for Covid-19 before the November 3 election. Is this possible? - The Indian Express

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

August 25, 2020

A judge struck down a state order requiring most Florida schools to open for in-person instruction.

A Florida judge ruled on Monday that the states requirement that public schools open their classrooms for in-person instruction violates the Florida constitution because it arbitrarily disregards safety and denies local school boards the ability to decide when students can safely return.

The ruling was a victory for the American Federation of Teachers, the nations second-largest teachers union, and one of its affiliates, the Florida Education Association. The unions sued Gov. Ron DeSantis and Richard Corcoran, the education commissioner, last month in the first lawsuit of its kind in the country.

The states order required that school districts give students the option to go back to school in person by Aug. 31 or risk losing crucial state funding. An exception was made only for Miami-Dade, Broward and Palm Beach counties, which have been the hardest hit by the coronavirus and plan to start the school year online.

The districts have no meaningful alternative, Judge Charles W. Dodson of the Leon County Circuit Court wrote of the rest of the states schools. If an individual school district chooses safety, that is, delaying the start of schools until it individually determines it is safe to do so for its county, it risks losing state funding, even though every student is being taught.

Later Monday, the state filed an appeal to the ruling, prompting an immediate stay.

This fight has been, and will continue to be, about giving every parent, every teacher and every student a choice, regardless of what educational option they choose, Mr. Corcoran said in a statement.

In Tampa, the states reopening order prevented the Hillsborough County school district from starting the school year with four weeks of online-only instruction, as the school board wanted to do. The Hillsborough board is scheduled to meet on Tuesday, although no vote is expected, a district spokeswoman said. The superintendent, Addison Davis, said in a statement after the ruling that the school system continued to plan to start classes on Aug. 31 with a choice of in-person or online instruction.

During a three-day hearing last week, the unions presented testimony from public health experts and teachers concerned about risking their health. One teacher said he would quit to avoid exposure to the virus. Another, who is quadriplegic, said he could not afford to leave his job, though his doctor had warned him that Covid-19 would threaten his life.

In a pandemic, none of these things are great victories, but it is a reprieve for human life, said Randi Weingarten, the president of the American Federation of Teachers. It is a pushback on reckless disregard of human life. It is a pushback on politics overtaking safety and the science and the well-being of communities.

With a federal eviction moratorium coming to an end in the United States, legal aid lawyers say they are preparing to defend renters in housing court.

The fourth-month moratorium followed by a 30-day notice period, protected about 12 million tenants living in qualifying properties. Local moratoriums in some states have protected others not covered by the federal law.

For tenants, especially those with limited means, having a lawyer can be the difference between being evicted and being able to stay, but tenants in housing courts rarely have legal representation. Surveys in several big cities over the years have found that at least 80 percent of landlords, but fewer than 10 percent of tenants, tend to have lawyers.

The presidents recent executive order on assistance to renters doesnt offer much immediate hope for people facing eviction; it merely directs federal agencies to consider what they could do using existing authority and budgets.

Tenants are not equipped to represent themselves, and eviction court places them on an uneven playing field, said Ellie Pepper of the National Housing Resource Center.

Demand for legal assistance with housing issues is on the rise in states where local moratoriums have ended. Our caseloads havent yet exploded, because the courts just started hearing cases that were pending before the pandemic struck, said Lindsey Siegel, a lawyer with Atlanta Legal Aid. But its coming.

A 33-year-old man was infected a second time with the coronavirus more than four months after his first bout, the first documented case of so-called reinfection, researchers in Hong Kong reported Monday.

The finding was not unexpected, especially given the millions of people who have been infected worldwide, experts said. And the man had no symptoms the second time, suggesting that even though the prior exposure did not prevent the reinfection, his immune system kept the virus somewhat in check.

The second infection was completely asymptomatic his immune response prevented the disease from getting worse, said Akiko Iwasaki, an immunologist at Yale University who was not involved with the work but reviewed the report at The New York Timess request. Its kind of a textbook example of how immunity should work.

People who do not have symptoms may still spread the virus to others, however, underscoring the importance of vaccines, Dr. Iwasaki said. In the mans case, she added, natural infection created immunity that prevented disease but not reinfection.

In order to provide herd immunity, a potent vaccine is needed to induce immunity that prevents both reinfection and disease, Dr. Iwasaki said.

Doctors have reported several cases of presumed reinfection in the United States and elsewhere, but none of those cases have been confirmed with rigorous testing. Recovered people are known to carry viral fragments for weeks, which can lead to positive test results in the absence of live virus.

But the Hong Kong researchers sequenced the virus from both of the mans infections and found significant differences, suggesting that the patient had been infected a second time.

The study is to be published in the journal Clinical Infectious Diseases. The Times obtained the manuscript from the University of Hong Kong.

The mans first case was diagnosed on March 26, and he had only mild symptoms. He later tested negative for the virus twice and had no detectable antibodies after that first bout. He was positive again for the coronavirus on a saliva test on Aug. 15 after a trip to Spain via the United Kingdom. The man had picked up a strain that was circulating in Europe in July and August, the researchers said.

His infections were clearly caused by different versions of the coronavirus, Dr. Kelvin Kai-Wang To, a clinical microbiologist at the University of Hong Kong, said: Our results prove that his second infection is caused by a new virus that he acquired recently, rather than prolonged viral shedding.

Common cold coronaviruses are known to cause reinfections in less than a year, but experts had hoped that the new coronavirus might behave more like its cousins SARS and MERS, which seemed to produce protection lasting a few years.

Its still unclear how common reinfection from the new coronavirus might be, because few researchers have sequenced the virus from each infection.

EDUCATION ROUNDUP

The video call service Zoom reported partial outages on Monday morning, causing problems on the first day of remote classes for many schools in the United States.

Zoom said it began receiving reports of users being unable to start or join meetings at about 8:50 a.m. on the East Coast, as working and school hours began. About two hours later, the company said that it was deploying a fix across our cloud, and at about 12:45 p.m. it said everything should be working properly now.

As the pandemic has kept students out of classrooms and workers out of offices, Zoom has quickly become critical infrastructure for many school districts, companies and local governments. The partial disruption in service, which lasted approximately four hours in some areas, adds another element to the contentious debate over how to safely and effectively resume learning this fall.

The Atlanta school district, which serves about 50,000 students, was among those affected by the outage. And students and professors at Penn State University reported widespread problems on campus on Monday morning, as did Michigans Supreme Court, which has conducted hearings online since the pandemic began.

Another online learning platform, Canvas, also experienced technical issues on Monday. Cory Edwards, a spokesman for the company, said the system had slowed down for about 75 percent of its U.S. customers for about a half-hour on Monday morning. The problem probably resulted from heavy usage as many students returned to school this week, he said.

The website DownDetector, which tracks outages at social media companies and tech companies, showed significant Zoom outages in major cities around the country, including New York, Washington, Atlanta, Chicago, St. Louis and San Francisco. The site reported more than 15,000 outages by about 10 a.m. Eastern time.

Many courthouses also rely on Zoom to conduct hearings, city councils govern through virtual meetings, and the police face reporters in video news conferences.

Here are other key education developments:

Following months of pressure to set up outdoor classrooms in New York City, Mayor Bill de Blasio said Monday that principals can apply by this Friday to create outdoor classes in their schoolyards. The citys public school system, the nations largest, is scheduled to reopen in just under three weeks in a hybrid model, leaving schools little time to move classroom infrastructure outdoors. The city will prioritize 27 neighborhoods badly hit by the virus with schools that do not have usable outdoor space. The mayor said that outdoor learning wont work every day because of bad weather, but that it was still a good alternative for many schools.

The University of Illinois, Urbana-Champaign, became the latest college to find a significant number of students testing positive for coronavirus upon their return to campus, university and county health officials said on Monday. The university said it had recorded 326 positive results since Aug. 15. On its website, the university said that it has conducted more than 87,000 tests since early July, with an average positive rate of .74 percent over the past five days considered quite low. The college began modified in-person instruction on Monday.

More than 730 American colleges and universities have announced at least one case on campus among students, faculty or staff since the beginning of the pandemic, according to a New York Times database. Among the latest: Millikin University in Decatur, Ill., which reported its first case on Monday, the first day of fall classes.

The University of Kansas, where fall classes began Monday in Lawrence, issued 14-day public health bans to two fraternities on Sunday for violating university policies on mask wearing and social distancing. The universitys chancellor said in a statement that Kappa Sigma and Phi Kappa Psi were ordered not to host any event without approval from the university.

The University of Nebraska in Lincoln announced Sunday that students at the Kappa Alpha Theta sorority have been placed under quarantine after five cases were identified.

After tests and temperature checks, 336 Republican delegates representing 50 states, five territories and Washington, D.C., gathered in Charlotte, N.C., on Monday and officially renominated President Trump. It was the only in-person event of either political partys quadrennial convention.

In a surprise speech at the convention, Mr. Trump accused his opponents of using Covid to steal the election, repeating claims that voting by mail was part of plot to cost him the election.

Mr. Trump also criticized Roy Cooper, the Democratic governor of North Carolina, telling the crowd in Charlotte that Mr. Cooper and other Democratic governors had enacted virus restrictions simply to hurt his re-election chances and would lift them after Election Day.

You have a governor who is in a total shutdown mood, he said. I guarantee you on November 4, it will all open up.

Outside of the convention hall, public health officials in Mecklenburg County, which includes Charlotte, continue to fight to contain the spread of the virus, with an average of 1,100 new cases a day over the past week, according to a New York Times database.

Just six representatives from each state and territory are in the room, masked and seated at a distance from one another. Each speaker is required to wear a mask before he or she reaches the podium, and the microphone will be cleaned between speakers, according to a person briefed on the protocols.

Mr. Trump and Vice President Mike Pence spoke to the delegates, and Mr. Trump plans to appear every night during the convention.

Despite the precautions in place inside the convention hall, photographs of crowds gathered by the stage while Mr. Trump spoke showed people not social distancing, some wearing masks and some without.

Authorities in the blockaded Gaza Strip announced the first coronavirus cases transmitted through the community on Monday, raising concerns that the pandemic could spread widely in the densely populated and impoverished coastal enclave.

Before Mondays announcement, authorities had found infections only at quarantine facilities, where all returning travelers were required to quarantine for three weeks and pass two tests before being permitted to leave.

Ashraf al-Qidra, a spokesman for the Hamas-run Health Ministry, told a news conference that four people in the Maghazi refugee camp in central Gaza tested positive for Covid-19, while noting officials were carrying out epidemiological investigations.

Mr. Qidra said that authorities tested the four individuals after learning they had been in contact with a resident of Gaza who tested positive for the disease at the Augusta Victoria Hospital in East Jerusalem.

Salama Maroof, the head of the Hamas-operated government media office, said that the entire territory would be placed under curfew for 48 hours.

We call on everyone to exercise the greatest degree of carefulness, stay in their homes and follow the health measures, he said at the news conference.

Early Tuesday morning, police cars were seen driving around Gaza using loudspeakers to call on residents to remain in their homes.

Experts have warned that Gazas health sector, already devastated by years of war and conflict, lacked the resources to deal with a widespread outbreak.

Gerald Rockenschaub, the head of the World Health Organizations mission, said medical institutions carry only about 100 adult ventilators, most of which are already in use.

As of early Tuesday, 113 virus cases had been recorded in Gaza and only a single fatality. But only about 17,000 tests have been conducted during the pandemic, according to the Hamas-run Health Ministry, meaning some cases could have gone undetected.

The small number of cases relative to the tens of thousands in Israel and the West Bank has largely been seen as a result of the coastal enclaves isolation and Hamass strict quarantine policy for returning travelers.

In other global news:

A tsunami of job cuts is about to hit Europe as companies prepare to carry out sweeping downsizing plans to offset a collapse in business. Government-backed furlough programs that have helped keep about a third of Europes work force financially secure are set to unwind in the coming months. As many as 59 million jobs are at risk of cuts in hours or pay, temporary furloughs or permanent layoffs, especially in industries like transportation and retail, according to a study by McKinsey & Company.

For 40 days, millions of people in Urumqi, the capital of the Xinjiang region in western China, have been unable to leave their homes because of a sweeping lockdown to fight a virus resurgence. Now, with the outbreak seemingly under control but the restrictions still largely in place, many residents say they are being confined to their homes unnecessarily and denied access to critical services like health care. The ruling Communist Party has been widely criticized in recent years for a harsh crackdown on the regions Muslim minority.

The United Nations said Monday that up to 100 million jobs directly reliant on international tourism are at risk because of the pandemic and that revenue generated by the global tourist industry could fall by as much as $1.2 trillion this year. U.N. officials, who have called the pandemic the biggest challenge in the organizations 75-year existence, also said in the report that some of the smallest countries are particularly vulnerable, as tourism represents a large chunk of their economic output.

Bali, Indonesias leading tourist destination, has abandoned its plan to allow foreign tourists starting Sept. 11, Gov. I Wayan Koster announced, and will wait at least until the end of the year before opening to them. Balis economy contracted 11 percent during the second quarter, with about 2,700 tourism workers laid off and another 74,000 on unpaid leave, the governor said.

Prime Minister Jacinda Ardern of New Zealand extended a lockdown in Auckland, New Zealands largest city, until Sunday night. The restrictions had been set to expire on Wednesday, but Ms. Ardern said the extra time was necessary to ensure that a virus cluster had been brought under control. Eight new confirmed or probable cases were announced on Monday, bringing the total to 101.

The first volunteer was inoculated with a made in Italy vaccine on Monday at Spallanzani hospital in Rome, which specializes in infectious diseases. The vaccine is produced by ReiThera, a biotechnology company based near Rome but headquartered in Switzerland.

Health authorities in France said a virus outbreak at a nudist camp in the southern resort town of Le Cap dAgde was very worrying. More than 140 people have tested positive in the town, the Agence Rgionale de Sant (ARS), Frances health agency, said on Sunday, and 310 more are awaiting results.

KEY DATA OF THE DAY

Officials in Connecticut have issued a public health warning for the city of Danbury, urging residents to stay home when possible and limit gatherings after new cases jumped sharply there in the first 20 days of August.

Danbury, a city of about 84,000 people near the New York border, reported 178 new cases in that time, the state said, more than quadruple the figure for the prior two weeks.

The states public health department now recommends that residents not attend large church services or outdoor gatherings, or any gathering indoors with people other than those they live with.

It does worry us that the number has gone up quite a bit, Gov. Ned Lamont said at a news conference on Monday afternoon, referring to the share of positive test results in Danbury. He also urged people to self-quarantine, wear face coverings, social distance and get tested.

In a statement on Friday, officials said that many new cases in Danbury appeared linked to recent domestic and international travel. Connecticut currently requires travelers from dozens of states and two territories to quarantine for 14 days upon arrival.

Danbury was among the states hardest-hit places earlier this year; Connecticuts first confirmed case worked at Danbury Hospital.

Danburys public schools will start the year with distance learning because of the outbreak, the superintendent said in a letter posted to Facebook on Monday.

Elsewhere in the region:

After a cripplingly slow vote count in New Yorks June primary, marred by thousands of disqualified ballots, Gov. Andrew M. Cuomo said on Monday that he would sign a series of executive orders to make it easier for voters to cast valid absentee ballots in November. The orders will require local officials to take steps to be ready to start counting votes ASAP, after the Nov. 3 election. The governor also ordered a redesign of ballot-return envelopes to make it clear where they should be signed, addressing a common reason for disqualification.

New testing sites will be set up at LaGuardia and Kennedy airports for many out-of-state travelers, Mr. Cuomo said.

SPORTS ROUNDUP

When 11 National Football League teams were notified over the weekend that a total of 77 people, including players and staff members, had apparently tested positive, they scrambled to respond, holding players out of practice and rescheduling training sessions.

Then on Monday came word from the testing lab: Never mind.

The results were all false positives, BioReference Laboratories said in a news release on Monday, citing isolated contamination during test preparation at one of its facilities in New Jersey.

All individuals impacted have been confirmed negative and informed, Dr. Jon R. Cohen, BioReferences executive chairman, said in the news release.

N.F.L. officials said on Sunday that the affected clubs were following contact tracing, isolation and rescheduling protocols that were outlined by the league and players association. Among the 11 affected teams were the Minnesota Vikings, Chicago Bears and Buffalo Bills.

Eight Vikings athletes with false positives watched team meetings virtually on Sunday, unable to attend practice. The New York Jets, Cleveland Browns and Bears all rescheduled training sessions before getting the all clear; the Pittsburgh Steelers, Philadelphia Eagles and Detroit Lions held out players who had falsely tested positive.

The leagues regular season is expected to start Sept. 10.

Elsewhere in sports:

Usain Bolt, the Jamaican sprinter who won eight gold medals over the course of three Olympics, will go into quarantine just to be safe as he awaits results from a test, he said in an Instagram post on Monday. He celebrated turning 34 on Friday at a surprise party attended by, among others, his girlfriend, his newborn daughter and the prominent soccer players Raheem Sterling and Leon Bailey. Videos posted by the music news outlet Urban Islandz showed attendees dancing near one another without wearing masks. It was not clear whether any others at the party had tested positive. Jamaica has recently had a spike in cases.

In New York, school-sponsored sports that are considered lower risk, including tennis, soccer, cross country, field hockey and swimming, may practice and play with limits starting Sept. 21 statewide, the governor said Monday. Teams may not travel to play outside of the schools region or contiguous regions or counties until Oct. 19. Sports with more physical contact that are considered higher risk, including football, wrestling, rugby and hockey, may begin practicing with limits but cannot play until a later date or Dec. 31.

U.S. ROUNDUP

Many of the states with the biggest decreases per million people also had some of the countrys worst outbreaks in July.

Experts said that the drop in reported cases could not be attributed to the recent drop in testing volume. They explained that decreased hospitalizations and a lower share of positive tests indicated that the spread had most likely slowed.

A July surge in Florida affected young people in particular. Statewide bar closures following earlier reopenings and local mask mandates are among the policies that have helped reverse the trend, said Mary Jo Trepka, the chair of the Florida International University epidemiology department. Deaths were greater in July for residents under 65 than for those over 90.

And though Florida is doing better now, the state did surpass 600,000 cases on Sunday.

Arizona and Louisiana have also seen cases drop after taking mask mandates and other measures came into force.

Elsewhere in the United States:

Louisiana shut down its coronavirus testing sites on Monday as the state braced for two tropical storms, Marco and Laura, in quick succession. Hospitals and urgent care facilities can still perform tests, said Kevin Litten, a spokesman for the Louisiana Department of Health. The shutdown of the state sites, and any power outages the storms cause, will probably lead to some kind of disruption in data collection, Mr. Litten said, followed by a jump in cases when testing resumes afterward. Similar effects were seen after Tropical Storm Isaias, which disrupted testing in Florida and the Carolinas early this month. Coastal Louisiana is among the hardest-hit areas of a state that has recorded at least 143,000 coronavirus cases and nearly 4,750 deaths, according to a New York Times database.

Joseph R. Biden Jr. and Senator Kamala Harris will be tested regularly for Covid-19 as Election Day approaches, the Biden campaign said on Monday, a day after a senior Biden official said Mr. Biden had not yet been tested. The Biden team said that with the potential of additional events over the remainder of the campaign, it had increased its health protocols. Staff members who interact with Mr. Biden and Ms. Harris will also be tested regularly, and the campaign said it would announce publicly if either candidate ever has a confirmed case of coronavirus.

More here:

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

First Covid-19 reinfection documented in Hong Kong, researchers say – STAT

August 25, 2020

Researchers in Hong Kong on Monday reported what appears to be the first confirmed case of Covid-19 reinfection, a 33-year-old man who was first infected by SARS-CoV-2 in late March and then, four and a half months later, seemingly contracted the virus again while traveling in Europe.

The caseraises questions about the durability of immune protection from the coronavirus. But it was also met with caution by other scientists, who questioned the extent to which the case pointed to broader concerns about reinfection.

There have been scattered reports of cases of Covid-19 reinfection. Those reports, though, have been based on anecdotal evidence and largely attributed to flaws in testing.

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But in this case, researchers at the University of Hong Kong sequenced the virus from the patients two infections and found that they did not match, indicating the second infection was not tied to the first. There was a difference of 24 nucleotides the letters that make up the virus RNA between the two infections.

This is the worlds first documentation of a patient who recovered from Covid-19 but got another episode of Covid-19 afterwards, the researchers said in a statement.

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Experts cautioned that this patients case could be an outlier among the tens of millions of cases around the world and that immune protection may generally last longer than just a few months. They said that ongoing studies tracking patients who had recovered from Covid-19 would help reach more definitive conclusions. They also noted that the mans second case was milder than his first, indicating that his immune system was providing some level of protection, even if it could not prevent the infection entirely.

Theres been more than 24 million cases reported to date, Maria Van Kerkhove, a coronavirus expert at the World Health Organization, said at a briefing Monday, when asked about the Hong Kong report. And we need to look at something like this at a population level.

The question of how long someone is protected from Covid-19 after being infected and recovering looms large.

Studies are increasingly finding that most people who recover from the illness mount a robust immune response involving both antibodies (molecules that can block the virus from infecting cells again) and T cells (which can help clear the virus). This has suggested that people would be protected from another case for some amount of time.

But based on what happens with other coronaviruses, experts knew that immunity to SARS-CoV-2 would not last forever. People generally become susceptible again to the coronaviruses that cause the common cold after a year or even less, while protection against SARS-1and MERS appears to last for a few years.

What we are learning about infection is that people do develop an immune response, and what is not completely clear yet is how strong that immune response is and for how long that immune response lasts, Van Kerkhove said. She added she was still reviewing the Hong Kong case.

The strength and durability of the immune response is also a crucial factor in how long vaccines will be effective for, and for how often people might need a booster dose.

In the Hong Kong case, the man had traveled to Spain and returned to Hong Kong via the United Kingdom. A saliva sample was taken upon arrival in Hong Kong as part of a screening protocol and tested positive for SARS-CoV-2 on Aug. 15.

During his second infection, the man did not have any symptoms. Some patients go through their course of Covid-19 without showing symptoms, but researchers have also hypothesized that secondary cases of the coronavirus will generally be milder than the first. Even if immune systems cant stop the virus from infecting cells, they might still rally some level of response that keeps us from getting sicker. During his first case, the patient had classic Covid-19 symptoms of cough, fever, sore throat, and headache.

Experts said it was also important to consider the immune response the patient generated after his first infection. While most people seem to mount a solid response, there has been indication that some people do not produce neutralizing antibodies those that can block the virus from infecting cells at very high levels, for unclear reasons.

The fact that somebody may get reinfected is not surprising, said Malik Peiris, a virologist at the University of Hong Kong, who is not an author of the paper describing the reinfection but is familiar with the case. But the reinfection didnt cause disease, so thats the first point. And the second thing is that it is important to know whether the patient mounted a neutralizing antibody response to the first infection or not. Because the vast majority of patients in our experience do mount a good neutralizing antibody response. So is this person an outlier or is he likely to be the average person infected?

Even if the Hong Kong case is an outlier, it points to a few implications: For one, people who have recovered from Covid-19 should also be vaccinated, the researchers said. And they should continue following precautions like wearing a mask and physical distancing.

Helen Branswell contributed reporting.

Original post:

First Covid-19 reinfection documented in Hong Kong, researchers say - STAT

They Survived The Ventilator. But Why Does Their COVID-19 Coma Persist? : Shots – Health News – NPR

August 25, 2020

A COVID-19 patient in the intensive care unit at United Memorial Medical Center in Houston on July 28. Go Nakamura/Getty Images hide caption

A COVID-19 patient in the intensive care unit at United Memorial Medical Center in Houston on July 28.

Leslie Cutitta said yes, twice, when clinicians from Massachusetts General Hospital in Boston called asking whether she wanted them to take and then continue extreme measures to keep her husband, Frank Cutitta, alive.

The first conversation, in late March, was about whether to let Frank go or to try some experimental drugs and treatments. The second call was just a few days later. Hospital visits were banned, so Leslie Cutitta couldn't be with her husband or discuss his wishes with the medical team in person. So she used stories to try to describe Frank's zest for life.

"Frank used to joke that he wanted to be frozen, like Ted Williams, until they could figure out what was wrong with him if he died," says Leslie Cutitta. It wasn't a serious end-of-life discussion, but Cutitta knew her husband would want every possible life-saving measure.

So the Cutittas hung on and a small army of ICU caregivers kept working. On April 21, after 27 days on a ventilator, Frank's lungs had recovered enough to remove the breathing tube.

After the removal, it typically takes hours, maybe a day, for the patient to return to consciousness. The body needs that time to clear the drugs that keep the patient sedated and comfortable able to tolerate intubation and mechanical ventilation. But doctors across the U.S. and in other countries have noted a troubling phenomenon associated with some COVID-19 cases: Even after extubation, some patients remain unconscious for days, weeks or longer. There's no official term for the problem, but it's being called a "prolonged" or "persistent" coma or unresponsiveness.

Frank Cutitta, 68, was one of those patients. He just didn't wake up.

"It was a long, difficult period of not just not knowing whether he was going to come back to the Frank we knew and loved," says Leslie Cutitta. "It was very, very tough."

Doctors who are studying the phenomenon of prolonged unresponsiveness are concerned that medical teams are not waiting long enough for these COVID-19 patients to wake up, especially when ICU beds are in high demand during the pandemic.

As Frank's unresponsive condition continued, it prompted a new conversation between the medical team and his wife about whether to continue life support. Although he no longer needed the ventilator, he still required a feeding tube, intravenous fluids, catheters for bodily waste and some oxygen support.

Leslie Cutitta recalls a doctor asking her: "If it looks like Frank's not going to return mentally, and he's going to be hooked up to a dialysis machine for the rest of his life in a long-term care facility, is that something that you and he could live with?"

Leslie Cutitta struggled to imagine the restricted life Frank might face. Every day, sometimes several times a day, she would ask Frank's doctors for more information: What's going on inside his brain? Why is this happening? When might something change?

Their candid and consistent answer was: We don't know.

"Because this disease is so new and because there are so many unanswered questions about COVID-19, we currently do not have reliable tools to predict how long it will take any individual patient to recover consciousness," says Dr. Brian Edlow, a critical care neurologist at Mass General.

Given all the unknowns, doctors at the hospital have had a hard time advising families when a patient has remained unresponsive for weeks, post-ventilator. Some families in that situation have decided to remove other life supports so the patient can die. Edlow can't say how many.

"It is very difficult for us to determine whether any given patient's future will bring a quality of life that would be acceptable to them," Edlow says, "based on what they've told their families or written in a prior directive."

There are lots of theories about why COVID-19 patients may take longer to regain consciousness than other ventilated patients, if they wake up at all. COVID-19 patients appear to need larger doses of sedatives while on a ventilator, and they're often intubated for longer periods of time than is typical for other diseases that cause pneumonia. Low oxygen levels, due to the virus's effect on lungs, may damage the brain. Some of these patients have inflammation related to COVID-19 that may disrupt signals in the brain, and some experience blood clots that have caused strokes.

"So there are many potential contributing factors," Edlow says. "The degree to which each of those factors is playing a role in any given patient is still something we're trying to understand."

One of the first questions researchers hope to answer is how many COVID-19 patients end up in this prolonged, sleeplike condition after coming off the ventilator.

"In our experience, approximately every fifth patient that was hospitalized was admitted to the ICU and had some degree of disorders of consciousness," says Dr. Jan Claassen, the director of neurocritical care at New York's Columbia University Medical Center. "But how many of those actually took a long time to wake up, we don't have numbers on that yet."

An international research group based at the University of Pittsburgh Medical Center expects to have in September some initial numbers on COVID-19 brain impacts, including the problem of persistent comas. Some COVID-19 patients who do eventually regain consciousness still have cognitive difficulties.

To try to get a handle on this problem at Columbia, Claassen and colleagues created a "coma board," a group of specialists that meets weekly. Claassen published a study in 2019 that found that 15% of unresponsive patients showed brain activity in response to verbal commands. A case reported by Edlow in July described a patient who moved between a coma and minimal consciousness for several weeks and was eventually able to follow verbal commands.

This spring, as Edlow observed dozens of Mass General COVID-19 patients linger in this unresponsive state, he joined Claassen and other colleagues from Cornell's Weill Medical College to form a research consortium. The researchers are sharing their data to determine the cause of prolonged coma in COVID-19 patients, find treatments and better predict which patients might eventually recover, given enough time and treatment.

The global research effort has grown to include more than 222 sites in 45 countries. Prolonged or persistent comas are just one area of research, but one that is getting a lot of attention.

Dr. Sherry Chou, a neurologist at the University of Pittsburgh Medical Center, is leading the international effort.

Chou says families want to know "whether a patient can wake up and be themselves." Answering that question "depends on how accurate we are at predicting the future, and we know we're not very accurate right now."

A CT scan of Frank Cutitta's brain showed some residue from blood clots but was otherwise "clean."

"From what they could tell, there was no brain damage," Leslie Cutitta says.

And then on May 4, after two weeks with no signs that Frank would wake up, he blinked. Leslie and her two daughters watched on FaceTime, making requests such as "Smile, Daddy" and "Hold your thumb up!"

"At least we knew he was in there somewhere," she says.

It was another week before Frank could speak and the Cutittas got to hear his voice.

"We'd all be pressing the phone to our ears, trying to catch every word," Leslie Cutitta recalls. "He didn't have a lot of them at that point, but it was just amazing, absolutely amazing."

Frank and Leslie Cutitta at their home in Wayland, where a banner still hangs for his return from the hospital. Jesse Costa/WBUR hide caption

Frank Cutitta spent a month at Spaulding Rehabilitation Hospital. He's back home now, in a Boston suburb, doing physical therapy to strengthen his arms and legs. He says he slurs words occasionally but has no other cognitive problems.

While he was in the ICU, Cutitta's nurses played recorded messages from his family, as well as some of his favorite music from the Beach Boys and Pavarotti. Frank Cutitta says he believes the flow of these inspiring sounds helped maintain his cognitive function.

The Cutittas say they feel incredibly lucky. Leslie Cutitta says one doctor told the family that during the worst of the pandemic in New York City, most patients in Frank's condition died because hospitals couldn't devote so much time and resources to one patient.

"If Frank had been anywhere else in the country but here, he would have not made it," Leslie Cutitta says. "That's a conversation I will never forget having, because I was stunned."

Frank Cutitta credits the Mass General doctors and nurses, saying they became his advocates.

It "could have gone the other way," he says, if clinicians had decided "look, this guy's just way too sick, and we've got other patients who need this equipment. Or we have an advocate who says, 'throw the kitchen sink at him,'" Frank says. "And we happened to have the latter."

Many hospitals use 72 hours, or three days, as the period for patients with a traumatic brain injury to regain consciousness before advising an end to life support. As COVID-19 patients fill ICUs across the country, it's not clear how long hospital staff will wait beyond that point for those patients who do not wake up after a ventilator tube is removed.

Joseph Giacino directs neuropsychology at Spaulding and says he's worried hospitals are using that 72-hour model with COVID-19 patients who may need more time. Even before the coronavirus pandemic, some neurologists were questioning that model. In 2018 the American Academy of Neurology updated its guidelines for treating prolonged "disorders of consciousness," noting that some situations may require more time and assessment.

Some patients, like Frank Cutitta, do not appear to have any brain damage. Whatever caused his extended period of unconsciousness cleared.

Unless a patient has previously specified that she does not want aggressive treatment, "we need to really go slow," says Giacino, "because we are not at a point where we have prognostic indicators that approach the level of certainty that is necessary before making a decision that we should stop treatment because there is no chance of meaningful recovery."

Doctors interviewed for this story urged everyone to tell their loved ones what you expect a "meaningful recovery" to include. If confronted with this situation, family members should ask doctors about their levels of certainty for each possible outcome.

Some medical ethicists are also urging clinicians not to rush when it comes to decisions about how quickly COVID-19 patients may return to consciousness.

"A significant number of patients are going to have a prolonged recovery from the comatose state that they're in," says Dr. Joseph Fins, chief of medical ethics at Weill Cornell Medical College. "This is a time for prudence because what we don't know can hurt us and can hurt patients."

Leslie and Frank Cutitta have a final request: Wear a mask.

"This disease is nothing to be trifled with," Leslie Cutitta says. "It's a devastating experience."

Frank Cutitta worries about all of the patients still suffering with COVID-19 and those who have survived but have lasting damage.

"I'm not considering myself one of those," he says, "but there are many, many people who would rather be dead than left with what they have after this."

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They Survived The Ventilator. But Why Does Their COVID-19 Coma Persist? : Shots - Health News - NPR

U.S. Authorizes Plasma Treatment for Virus, but the Big Prize for the White House Is a Vaccine – The New York Times

August 25, 2020

Trump aides, meeting with lawmakers, reportedly said a vaccine would be approved before the election.

Trump administration officials met with congressional leaders last month and told them they would probably give emergency approval to a coronavirus vaccine before the end of Phase 3 clinical trials in the United States, perhaps as early as late September, according to two people briefed on the discussion.

The move would be highly unusual and would most likely prompt concerns about whether the administration is cutting corners on approvals for political purposes.

The two-hour meeting involving Treasury Secretary Steven Mnuchin; the White House chief of staff, Mark Meadows; House Speaker Nancy Pelosi; and Senator Chuck Schumer, the Democratic leader, took place on the evening of July 30 in Ms. Pelosis conference room.

During the discussion, the people briefed on it said, Mr. Meadows indicated that a vaccine being developed by AstraZeneca and Oxford University was the most likely candidate.

The projected timeline shows the administrations hopes for a major victory against the pandemic before the election. It also suggests that officials have high expectations for the results of overseas drug trials, which began ahead of domestic ones.

Senior administration officials disputed the account, saying Mr. Meadows and Mr. Mnuchin were either being misrepresented or had been misunderstood on every major point.

The AstraZeneca-Oxford team is now conducting Phase 2 and Phase 3 trials in Britain, Brazil and South Africa. Researchers have said they expect results by September, at the earliest. Along with a number of other pharmaceutical companies, AstraZeneca has also begun large-scale trials in the United States, although it began enrolling volunteers only a few days ago.

The Food and Drug Administration typically requires clinical trials with American patients before approving vaccines for use in the United States.

The administration officials comments at the meeting suggest that the White House is significantly more sanguine than its own scientific experts about the prospects for a speedy vaccine against a virus that has killed 176,000 Americans.

In an Aug. 13 briefing with reporters, Francis Collins, the director of the National Institutes of Health, said it would be astounding if vaccine development progressed fast enough for the Food and Drug Administration to approve one by the end of next month. Maybe November, December would be my best bet, he said.

Dr. Anthony S. Fauci, the infectious disease expert who serves on the coronavirus task force, has said early next year is the most likely timing.

President Trump has seen his political fortunes plummet over deep unhappiness among voters about how he and his administration have handled the pandemic, which his Democratic opponent, former Vice President Joseph R. Biden Jr., has made a central focus of his campaign.

A White House spokeswoman did not immediately respond to a request for comment.

One senior administration official who was briefed on the meeting said neither Mr. Meadows nor Mr. Mnuchin had suggested a vaccine could be approved as early as late September. The official was adamant that the administration would not approve a vaccine solely on the basis of foreign clinical trials.

A spokesman for Mr. Meadows disputed that he discussed AstraZenecas prospects. Neither did Mr. Mnuchin, according to the Treasury Department spokeswoman.

Trump hails the F.D.A.s authorization of blood plasma as a treatment, despite the lack of clinical trials.

The Food and Drug Administration on Sunday authorized the emergency use of blood plasma from people who have recovered from coronavirus infections for the treatment of patients hospitalized with Covid-19.

The decision, which was delayed after top federal scientists urged further study of the treatment, was praised by President Trump at a news conference in which he said plasma was very effective, even though no rigorous clinical trials have proven that it works.

The presidents endorsement notwithstanding, convalescent plasma, however promising, has not been proven to work in randomized clinical trials, considered the best way of determining whether a treatment is effective.

Although Mr. Trump said the new approval would dramatically expand access to the treatment, convalescent plasma cannot be easily scaled up into millions of doses like manufactured drugs, because it is derived from blood donations.

Still, many researchers have seen it as a potential bridge until a more effective treatment becomes available, or a vaccine.

On a call earlier in the day with reporters, the commissioner of the Food and Drug Administration, Dr. Stephen M. Hahn, said

that information from studies conducted this year showed that the treatment was safe and had the potential to be helpful. However, he added that the agency would continue working with researchers studying the treatment and update the authorization as appropriate.

But enrollment in randomized trials at least 10 such studies have begun in the United States has faltered, collectively enrolling only a few hundred people.

The agencys decision Sunday was based mostly on an analysis of preliminary data. A previous authorization for the use of chloroquine and hydroxychloroquine was rescinded based on the findings of subsequent studies.

The authorization contains guidance for doctors on which patients should be considered. Dr. Peter Marks, the director of the F.D.A.s center for biologics, evaluation and research, said on the call that those who were treated within three days of being diagnosed, with plasma that contained high levels of antibodies, as compared with lower levels of antibodies appeared to benefit more from this treatment than others. And those that seemed to benefit the most were those who were less than 80 years of age who were not on a respirator.

The F.D.A.s announcement had been expected to come sooner, but an intervention by top scientists, including Dr. Anthony S. Fauci, led to a delay that seemed to have angered Mr. Trump. On the call, Dr. Hahn said that the decision to authorize the treatment was made solely on the basis of the science and the data and on nothing else.

During the Sunday news conference, however, Mr. Trump repeated his unfounded claim that the F.D.A. was deliberately holding up decision-making until after the election, this time citing a deep state.

Then, turning to Alex M. Azar II, the secretary of health and human services, Mr. Trump said there were people in your larger department who can see things being held up and wouldnt mind so much thats my opinion, my very strong opinion and thats for political reasons.

Russia expected congratulations for its vaccine. It has been met with skepticism instead.

It was with great fanfare that President Vladimir V. Putin and other officials announced this month that a billion doses of a Russian vaccine for the coronavirus would soon be rolled out.

But if they imagined themselves taking bows now for saving the world, Russian health officials instead are finding themselves on the defensive.

Some foreign colleagues, who must have felt certain competition and competitive edges of Russias product, have been trying to express opinions that we find totally groundless, the minister of health, Mikhail Murashko, said at a news conference in Moscow.

Skeptics have noted that the vaccine, which the Russians call Sputnik V, has not been tested in the sort of late-stage, large, randomized control trials that are critical in establishing safety and effectiveness. By skipping such trials, Russia may be endangering people to score propaganda points, health experts warn.

If we wanted to take the chance of hurting a lot of people or giving them something that doesnt work, we could start doing this, you know, next week if we wanted to, said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases.

Aleksandr Gintsburg, the director of the Gamaleya Institute, the scientific body that designed the vaccine, said the pushback was merely a fight for market share.

The worlds major powers are racing to produce vaccines that, if successful and accepted by their own citizens and other countries, will bring not just prestige but geopolitical and economic benefits for the winner. The United States has poured billions of dollars into an effort called Operation Warp Speed.

In other developments around the world:

The lockdown in Auckland, New Zealands largest city, will be extended until next Sunday night, Prime Minister Jacinda Ardern announced on Monday. The restrictions had been set to expire on Wednesday. Ms. Ardern said the extra time was necessary to ensure that the virus cluster in Auckland, the largest in the country, had been brought under control. Eight new confirmed or probable cases connected to the cluster were announced on Monday, bringing the total to 101. The prime minister also said masks were now mandatory on public transportation nationwide.

Florida and Texas have joined California in topping 600,000 cases.

Florida and Texas on Sunday became the second and third states to surpass 600,000 reported cases since the beginning of the pandemic, according to a New York Times database. The two states joined California, which crossed that threshold on Aug. 14.

Texas, with more than 6,000 daily cases recorded during the past week, reached 602,144 cases as of Sunday evening. Florida had 600,563 cases.

Texas and Florida, which are the second and third most populous states behind California, experienced a surge of infections this summer after state officials eased lockdown measures.

New cases in all three states, however, have been decreasing in recent weeks, with Florida recording a 40 percent drop in its seven-day average compared with the average two weeks earlier. The decline in Texas has been less dramatic, with a 22 percent decrease during the same period. The caseload decrease in California was 7 percent.

Reported deaths, however, still remain high in all three states. Florida recorded 106 new deaths on Saturday, for a total of 10,324 since the beginning of the pandemic. Texas reported 110 new deaths on Sunday, for a total of 11,760, and California counted at least 164 new deaths over Saturday and Sunday, for a total of 12,152.

A giant motorcycle rally in South Dakota is over. Positive test results are starting to come in.

As bikers prepared to inundate the South Dakota city of Sturgis earlier this month, there were warnings that the motorcycle rally, a two-week event that attracts hundreds of thousands of people annually, could spur the spread of the coronavirus.

In the days since it ended last Sunday, there are troubling signs that it did.

On Tuesday, South Dakota health officials announced that a patron who spent five hours at One-Eyed Jacks Saloon during the rally had since tested positive for the virus. On Thursday, they said an employee of a tattoo parlor who had worked five 16-hour shifts in five days had also tested positive. Then on Friday, the news arrived that another person who patronized three local saloons had also tested positive.

And public health officials in two neighboring states, Minnesota and Nebraska, attributed dozens of cases to the rally and warned people who had attended to monitor themselves for symptoms and get tested.

Even before the first bikers arrived for the rally, cases in South Dakota had slowly been trending upward.

At the beginning of July, the state was averaging 52 cases a day; by Saturday the average over the previous seven days had reached 145, according to a New York Times database. And the state set a record on Saturday with 251 new coronavirus cases.

Gov. Kristi Noem, a Republican, never issued a stay-at-home order and has refused to sign a statewide mask ordinance. She also hosted President Trumps Independence Day rally at Mount Rushmore, a packed event without social distancing and with few masks.

Large gatherings have continued, and have even been encouraged by local officials throughout the state despite repeated incidents.

Attendees at the Sitting Bull Stampede Rodeo in Mobridge in July, a Big & Rich Concert in Sioux Falls at the beginning of August and now the Sturgis motorcycle rally have tested positive for the virus.

In a statement on Sunday, the South Dakota Department of Health said there have been less than 40 cases associated with the rally.

In China, where the pandemic began, life is starting to look normal.

In Shanghai, restaurants and bars in many neighborhoods are teeming with crowds. In Beijing, thousands of students are heading back to campus for the fall semester. In Wuhan, where the coronavirus emerged eight months ago, water parks and night markets are packed elbow to elbow, buzzing as before.

While the United States and much of the rest of the world are still struggling to contain the virus, life in many parts of China has in recent weeks become strikingly normal. Cities have relaxed social distancing rules and mask mandates, and crowds are again filling tourist sites, movie theaters and gyms.

It no longer feels like there is something too frightful or too life-threatening out there, said Xiong Xiaoyan, who works at a paint manufacturer in the southern province of Guangdong.

The scenes of revelry stand in stark contrast to the early days of the pandemic, when China was its center and the government imposed sweeping lockdowns.

Now, after months of travel restrictions and citywide testing drives, locally transmitted cases of the virus in China are near zero, according to official data. On Monday, China reported no new locally transmitted cases for the eighth consecutive day. The 16 new infections it reported were all imported, bringing Chinas total number of confirmed cases to 84,967, with at least 4,634 deaths.

China could still face a Covid-19 resurgence, experts warn, especially as the weather cools and people spend more time indoors.

They still need to be cautious, said David Hui, the director of the Stanley Ho Center for Emerging Infectious Diseases at the Chinese University of Hong Kong. Mass gatherings and mass celebrations should not be encouraged.

As big storms bear down, those in their path are urged to heed the virus in their preparations.

With Tropical Storms Marco and Laura continuing to churn in the Caribbean this weekend, prompting warnings and watches for several countries, Gov. John Bel Edwards of Louisiana has urged residents to be mindful of the pandemic as they make their emergency preparations.

Covid-19 does not become less of a threat because of tropical weather, said Mr. Edwards, who advised people to include face masks and hand sanitizer in their emergency kits.

Still, the governor also announced that state virus testing sites would close on Monday and Tuesday.

The governor declared a state of emergency on Friday, and requested a federal emergency declaration from the White House on Saturday, as he warned that Marco and Laura were forecast to affect the state in quick sequence early this week.

Marco, which was downgraded from a Category 1 hurricane on Sunday night, could still bring dangerous storm surges to the Gulf Coast, and is on track to approach southeastern Louisiana on Monday.

On Sunday, Laura was lashing parts of the Dominican Republic and Haiti with heavy rains and life-threatening flash flooding, the center said. Lauras center is forecast to move near or over Cuba as it crosses the southeastern Gulf of Mexico.

Dennis Feltgen, a meteorologist with the National Hurricane Center, quashed public speculation that the storms would collide and form a single monster storm. They cannot merge, he said. They actually repel each other because of the rotations.

Feel the urge to scream? Maybe these zombies can help.

Many people feel trapped by the coronavirus pandemic. In Japan, some are distracting themselves by screaming inside closed caskets.

During 15-minute shows performed in Tokyo over the weekend, thrill seekers shrieked and trembled in glass caskets as they listened to ghost stories and the roar of chain saws. With nowhere to run, they were menaced by zombies, poked with rubber hands and splashed with water, all for less than $10 in admission.

The event was organized by Kowagarasetai, a horror event production company whose name means Scare Squad. But some customers said they actually left feeling more relaxed.

Updated August 24, 2020

The coffins are a better place to scream than at Japanese theme parks, which have encouraged visitors to keep their mouths shut on roller coasters to prevent virus transmission through droplets. (Please scream inside your heart, the Fuji-Q Highland amusement park suggested in June in a video demonstration by two of its executives, who inspired social media users to try the serious face challenge on their own roller coaster rides.)

Kenta Iwana, founder of Kowagarasetai, said he wanted to give people a way to express themselves without holding back.

There are no places to scream, Mr. Iwana, 25, told Agence France-Presse this summer as he unveiled another one of his socially distanced productions, a drive-in haunted house. In addition to providing people with an emotional outlet, he said, his company creates job opportunities for performers who normally work at theme parks.

Japan, which has been fighting a resurgence of the virus in recent weeks, reported 740 new cases nationwide on Sunday, including 212 in Tokyo. The country has had a total of more than 63,000 cases and almost 1,200 deaths, according to a New York Times database.

Inmates from state prisons have helped California fight fires for decades, playing a crucial role in containing the blazes striking the state with more frequency and ferocity in recent years.

This past week, though, hundreds of inmate firefighters were absent from the fire lines. They had already gone home, part of an early release program initiated by Gov. Gavin Newsom to protect them from the coronavirus.

That has highlighted the states dependence on prisoners in its firefighting force and complicated its battle against almost 600 fires, many of which continued burning across Northern California this weekend.

The virus has exposed countless examples of inequality across the United States, and the use of inmate firefighters shows how the pandemics consequences have reached deep into unexpected corners of society. In California, the presence of inmates has been the difference between having the resources to save homes from wildfires or not.

To critics, the prison program is exploitative and should be replaced with proper public investment in firefighting. To others, it is an essential part of the states response to what has become an annual wildfire crisis.

Across the United States there have been 112,436 infections of inmates and correctional officers, and 825 have died, according to a New York Times database. In four of the six prisons that train incarcerated firefighters, there have been more than 200 infections each among inmates and staff members, according to the database.

The states main firefighting agency is pleading for more personnel, and Mr. Newsom has requested more firefighters from as far away as the East Coast and Australia.

Waits stretch up to 12 hours at Austrias border as vacationers return from the Balkans.

After travelers reported wait times of up to 12 hours at Austrias southern border with Slovenia overnight because of restrictions aimed at slowing the coronavirus, the Austrian authorities loosened the controls on Sunday morning.

An enormous traffic jam had formed as many Central and Western Europeans returned from vacations in the Balkans by car. Those in each vehicle, including people passing through Austria to other countries, were required by the Austrian health authorities to stop and fill out a registration form.

One vacationer from Bavaria, in southern Germany, told the German news media that he had arrived at the congested border at 5:30 p.m. on Saturday and then not been able to enter Austria until 7:30 a.m. on Sunday.

Caught off guard, the Slovenian and Austrian authorities did not provide assistance to stuck drivers, and the atmosphere during the wait grew tense and aggressive, according to Austrian media reports. Before the pandemic, the border was mostly open, with many drivers not even having to slow down when crossing the national border.

On Sunday morning, the governor of the Austrian state of Krnten ordered border police officers to perform only spot checks at the crossing, which quickly reduced the wait time.

Austria reported 265 new coronavirus cases on Friday; Germany, to which many of the travelers caught up in the border delay were returning, recorded 2,034 new cases.

Nearly 40 percent of infections currently registered in Germany are thought to have been brought back by returning vacationers.

Restaurants in New York City, which were devastated by the pandemic shutdown in the spring, remain in crisis as a ban on indoor service continues, despite nearly 10,000 eateries having set up outdoor seating since July.

Though outdoor dining has been a hit with patrons and provided a tenuous lifeline, restaurant owners say they are operating at a fraction of regular seating capacity. Many remain open only because of the federal paycheck protection program, which supports payroll, and because they have not paid full rent in months.

Hanging in the balance is a vital New York City industry that before the pandemic employed more than 300,000 people, including recent immigrants, musicians, artists, writers and actors who help define the city as a cultural hub.

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U.S. Authorizes Plasma Treatment for Virus, but the Big Prize for the White House Is a Vaccine - The New York Times

COVID-19 Daily Update 8-24-2020 – West Virginia Department of Health and Human Resources

August 25, 2020

TheWest Virginia Department of Health and Human Resources (DHHR) reports as of 10:00 a.m., on August 24,2020, there have been 398,479 total confirmatorylaboratory results received for COVID-19, with 9,312 totalcases and 179 deaths.

DHHR has confirmed the death of a 59-yearold male from Lincoln County. We mourn the tragic loss of this West Virginianand send our deepest sympathies to the family, said Bill J. Crouch, DHHRCabinet Secretary.

CASESPER COUNTY: Barbour (33), Berkeley (767), Boone(128), Braxton (9), Brooke (85), Cabell (490), Calhoun (8), Clay (19),Doddridge (6), Fayette (187), Gilmer (18), Grant (133), Greenbrier (98),Hampshire (92), Hancock (118), Hardy (63), Harrison (256), Jackson (190),Jefferson (324), Kanawha (1,225), Lewis (32), Lincoln (115), Logan (439),Marion (208), Marshall (135), Mason (84), McDowell (66), Mercer (276), Mineral(131), Mingo (213), Monongalia (1,060), Monroe (65), Morgan (37), Nicholas(43), Ohio (288), Pendleton (48), Pleasants (14), Pocahontas (42), Preston(135), Putnam (247), Raleigh (325), Randolph (219), Ritchie (3), Roane (25),Summers (18), Taylor (101), Tucker (11), Tyler (15), Upshur (40), Wayne (227),Webster (7), Wetzel (45), Wirt (7), Wood (291), Wyoming (51).

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.Such is the case of Greenbrierand Randolph counties in this report.

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

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COVID-19 Daily Update 8-24-2020 - West Virginia Department of Health and Human Resources

Trump heralds a ‘historic breakthrough’ in the R&D fight against Covid-19 now comes the instant backlash as the FDA provides a controversial assist -…

August 25, 2020

Zheng Wei and William Pan met in a molecular biology study group in college in Guangzhou, China.

In the following decades, the duo transformed from college note-takers to co-founders of Taicang, China-based Connect Biopharmaceuticals. And on Monday, they completed a $115 million Series C to propel their pipeline of immune modulators.

The amount and the type of investors that we have in this round it really is a big boost for the company, said Wei, who most recently served as director of immunology at San Diego-based Arena Pharmaceuticals.

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Trump heralds a 'historic breakthrough' in the R&D fight against Covid-19 now comes the instant backlash as the FDA provides a controversial assist -...

UC Davis Begins Injections in COVID-19 Trial – UC Davis

August 25, 2020

Patients at UC Davis Health on Thursday (Aug. 20) became the first in Sacramento to receive a vaccine candidate for COVID-19, which is part of a major clinical trial involving 30,000 participants worldwide.

The six people who received the injections are part of a late-stage study that will enroll about 200 participants through UC Davis Healths clinical trials program.

Im excited about being able to be afforded the opportunity to help the world tackle this pandemic, said one of the first people vaccinated: Lucas Solano, 27, who enrolled in the trial a few days ago. Its exciting to be one of the people that essentially would take the initiative and be helpful, if this vaccine became approved and distributed worldwide.

The trial headed by Pfizer Inc. and BioNTech is ongoing and still accepting participants.Learn about enrollment criteria and how to sign up.

The research trial, known as a phase 2/3 study, seeks to determine the efficacy and side effects of a single nucleoside-modified messenger RNA (modRNA) candidate from the pharmaceutical companies BNT162 mRNA-based vaccine program.

The vaccine candidate has undergone rigorous evaluation in the United States and Germany and has previously shown significant positive results, according to Pfizer.

UC Davis Health, which includes Sacramentos only academic medical center, is one of only 120 sites taking part in the trial. The pharmaceutical giantPfizer, which has teamed up with the smallerBioNTechof Germany, selected vaccine study sites known for their world-class research experience, infrastructure, and nearby concentrations of known and anticipated positive COVID-19 cases.

UC Davis has played an active role in seeking solutions to combat the coronavirus disease since the UC Davis Medical Centerproviders in February diagnosed and treated thefirst apparent caseof COVID-19 acquired by community spread in the United States.

This is a historic day forUC Davis School of Medicine, Dean Allison Brashear said Thursday. This is a game-changer for our ability to begin to fight the pandemic.

In the randomized trial, half the participants will receive the vaccine and half the placebo. Patients wont know which they are getting and neither will most of the researchers. The study will measure safety, immune response and efficacy data needed for regulatory review.

The vaccine is one of several being developed around the world, at record-setting speed, in efforts to stop the spread of the virus which has killed more than 170,000 people in the United States, including about 12,000 in California.

To ramp up on a vaccination study like this, given the current climate with the virus, is extremely huge, said Chris Kain, a nurse manager and the associate director of theClinical Research Centerwithin theClinical and Translational Science Center. Kaincoordinated with multiple departments before the first participants received their shots.

Its been amazing to see all the teams working together, he said.

UC Davis Health serves a geographical region populated with multiple races and ethnicities, which increases the chances of identifying clinical trial candidates from more diverse backgrounds, compared to other communities in the United States. Latinos and Blacks have been disproportionately affected by the virus and are encouraged to enroll in the study. Health care workers and those who work in settings with a high volume of customers, such as grocery stores, are encouraged to participate.

The trials primary goal is preventing COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization and preventing COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. A secondary goal is preventing severe COVID-19 in those groups.

If the vaccine candidates success continues, Pfizer and its European partner BioNTech have stated they are on track to seek regulatory review as early as October. If regulatory authorization or approval is obtained, the companies plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

See earlier coverage: UC Davis Health to Enroll Participants for Major COVID-19 Vaccine Clinical Trial

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UC Davis Begins Injections in COVID-19 Trial - UC Davis

Coronavirus live updates: First confirmed case of reinfection; WHO says 172 countries on global vaccine plan – CNBC

August 25, 2020

Scientists are expressing some doubts about the Food and Drug Administration's emergency use authorization forconvalescent plasma as a treatment for Covid-19 patients. In a Sunday news briefing, President Donald Trump touted the treatment as a "breakthrough." Former FDA chief Dr. Scott Gottlieb told CNBC that while there was enough data to justify the authorization, the treatment is not a "home run."

Here are some of the biggest developments Monday:

The following data was compiled by Johns Hopkins University:

Read more from the original source:

Coronavirus live updates: First confirmed case of reinfection; WHO says 172 countries on global vaccine plan - CNBC

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