Category: Corona Virus Vaccine

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Why patients with COVID-19 lose their sense of smell – Alabama NewsCenter

September 8, 2020

There are still many unknowns regarding COVID-19, but one common occurrence among those infected is smell loss. There are many different events that can trigger smell loss, and Dr. Jessica Grayson provides insight as to why this might be happening.

Hyposmia or anosmia, a decreased or complete loss of smell, has been widely reported in patients with COVID-19, often as a symptom noticed early on prior to other symptoms or even as the only symptom present in an otherwise asymptomatic patient.

There have been a significant number of people who have been treated or tested at UAB who have had loss of smell in the setting of their COVID diagnosis, Grayson said. However, given the isolation protocols, most of these have only been diagnosed subjectively.

Grayson, an assistant professor with the UAB Department of Otolaryngology, said post-viral smell loss is the most common reason for loss of smell. Approximately 40 percent of anosmia is due to post-viral causes. More than 200 different viruses can cause alterations in smell and taste due to temporary or long-term injury to the neural structures.

If the nose is congested or full of polyps, then the odorant particulates cannot reach the olfactory fibers, which sense the smell and communicate with the brain, she said. In other instances, the nose looks relatively normal, but there is local inflammation in the olfactory mucosa that leads to adverse effects on smell.

Grayson adds that, apart from COVID-19, some people are born with hyposmia or anosmia. These disorders are typically diagnosed once the person is old enough to communicate that they cannot smell, typically during adolescence. In people suffering with obesity, there is an increased risk of potential smell loss due to benign intracranial hypertension, which causes thinning of the skull base particularly in the region of the cribriform plate because it is already the thinnest region where the olfactory nerves penetrate into the nasal cavity.

Patients with BIH have also been found to suffer from alterations in smell, she said. Trauma, particularly high-velocity head trauma, can cause loss of smell in patients either due to shearing of the olfactory nerves from coup and contrecoup injuries to the head or from direct injury to the olfactory region of the skull base.

Grayson said that surgery in the region of the olfactory mucosa that does not preserve this mucosa can cause smell loss. Tumors arising from the olfactory mucosa, olfactory fibers and anterior cranial fossa can cause smell loss. Neurodegenerative diseases and inflammatory conditions, such as Parkinsons disease and Sjogrens disease, can also negatively affect smell.

Retraining the nose

Although losing the sense of smell can be jarring, Grayson said there are ways to regain that lost sense.

Patients with post-viral smell loss have roughly a 60-80% chance of regaining some of their smell function at one year, Grayson said. However, people with traumatic injuries often do not regain smell.

Smell retraining consists of exposure to certain scents in a repeated nature over many weeks. Patients smell four odor categories flowery, fruity, aromatic and resinous every day for 12 weeks and potentially up to six months.

Studies have shown improvement in smell when patients utilize smell retraining, and some studies have suggested changing the four scents at 12-week intervals, she said. When patients performing smell retraining were compared to patients who were not, there were more patients who had improvement in their sense of smell.

Keen on smelling

Grayson said sense of smell is important for flavoring of food as well as safety reasons.

The ability to smell is important, because if something is burning, the house is on fire, food has gone bad, a gas leak, brakes burning in your car, you need to be able to have that sense, she said. Patients who cannot smell have to have protections in place to prevent bad things from happening, like checking smoke detectors monthly, following expiration dates strictly or having someone else in the home who can smell, or having natural gas detectors.

She said if a person begins to experience a lost sense of smell or taste, COVID-19 testing may be an option.

Right now, if you lose your sense of smell and taste, you can look for COVID testing, if available, she said. However, you can also isolate for 10 days, or 72 hours symptom-free, and follow CDC guidelines.

Grayson said concerned persons can reach out to the Department of Otolaryngology, which can send a smell test.

If we need to do smell retraining based on loss, our team will also get you set up for a follow-up appointment.

This story oriiginally appeared on the University of Alabama at Birminghams UAB News website.

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Why patients with COVID-19 lose their sense of smell - Alabama NewsCenter

University of Iowa reports 175 new COVID-19 cases – UI The Daily Iowan

September 8, 2020

174 students and 1 employee reported they have tested positive for the virus since Friday.

The University of Iowa is reporting new COVID-19 case numbers with 174 students self-reporting they have tested positive since Sept. 4. 1,569 students have tested positive since the beginning of the semester.

One additional employee reported they have tested positive since Sept. 4, for a total of 20 employee cases since the beginning of the semester.

15 students are in quarantine in the residence halls, and 97 are in isolation.

As of Friday, there are 4,356 confirmed positive cases in Johnson County. Iowa City is still listed on the New York Times ranking of metro areas with most COVID-19 cases in the United States in the last two weeks, listed at 13 as of Sept. 7.

Iowa City was listed as the fourth-worst metro in the country on Sept. 4.

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University of Iowa reports 175 new COVID-19 cases - UI The Daily Iowan

Drugmakers seek to reassure public on coronavirus vaccine as concerns grow about political pressure – CNBC

September 6, 2020

Lisa Taylor receives a COVID-19 vaccination from RN Jose Muniz as she takes part in a vaccine study at Research Centers of America on August 07, 2020 in Hollywood, Florida.

Joe Raedle | Getty Images

A group of drugmakers competing to bring a coronavirus vaccine to market plan to issue a public statement as soon as next week that says they will not seek government approval until enough data has been collected to ensure the drugs are safe and effective, CNBC confirmed Saturday.

An early draft of the joint statement promises to prioritize the safety of vaccinated people, according to The Wall Street Journal, which first reported the plans to issue a statement.Pfizer,Johnson & Johnson and Moderna are expected to participate in the pledge, the Journal reported. CNBC has confirmed that Sanofi also plans to participate.

The pledge comes as scientists and public health specialists express concern that the Trump administration is exerting pressure on regulators, especially the Food and Drug Administration, to authorize a vaccine before the Nov. 3 presidential election.

"We believe this pledge will help ensure public confidence in the Covid-19 vaccines that may ultimately be approved and adherence to the rigorous scientific and regulatory process by which they are evaluated," a draft of the statement says, according to the Journal.

The Journal added that the statement says the companies would only seek an emergency use authorization or government licensure based on "substantial evidence of safety and efficacy" from phase three clinical trials. However, top U.S. health officials, including FDA Commissioner Dr. Stephen Hahn and Director of theNational Institute of Allergy and Infectious Diseases Dr. Anthony Fauci, have recently said a phase three trial could be ended early if a vaccine yields strong evidence quickly.

An emergency authorization by the FDA would come as public health specialists express concern that the agency has previously yielded to political pressure. The agency issued an emergency authorization in March for the use of Trump-backed anti-malarial drugschloroquine and hydroxychloroquine in treating Covid-19 patients. But the agency revoked the authorization in June based on emerging evidence that the drugs could cause cardiac complications and increase the risk of death in some Covid-19 patients.

And last month, Hahn walked back comments he made on the benefits of convalescent plasma at a White House press conference in which the emergency authorization of the Covid-19 treatment was announced. Scientists criticized Hahn for overselling the benefits of the treatment, which data suggests are more modest, in remarks that were repeated by administration officials, including President Donald Trump.

"Political considerations should be put aside by Republicans and Democrats," the vaccine manufacturers' draft statement says, according to the Journal.

Regulators and drug companies have been moving at a record pace to bring a vaccine to market that effectively and safely combats the coronavirus, which has infected more than 26.6 million people and killed at least 875,400 people around the world. The stakes are high, as forecasters and epidemiologists warn that the winter could prove to be even more deadly.

The U.S. has invested more than $10 billion in six different vaccine efforts through Operation Warp Speed, the Trump administration's effort to rapidly bring Covid-19 vaccines and treatments to market. Three companies, Moderna, Pfizer and AstraZeneca, are already testing their vaccine candidates in phase three trials.

It's unclear if AstraZeneca plans to participate in the joint pledge, but the company previously released a statement committing tofollow the science and put patients first.

Democratic vice presidential candidate Kamala Harris suggested in an excerpt of an interview with CNN broadcast on Saturday that President Donald Trumpmight use a vaccine to bolster his appeal heading into the election.

"He's looking at an election coming up in less than 60 days and he's grasping for whatever he can get to pretend he can be a leader on this issue when he's not," she told CNN.

She added that she "would not trust Donald Trump" and that she would only be convinced by an outside evaluation of public data on a vaccine's safety and efficacy.

Judd Deere, spokesman for the White House, said in a statement to CNBC that every decision the FDA has made has maintained the agency's "gold standard for safety and been data-driven." He added that it's a "false narrative... that politics is influencing approvals."

"President Trump believes all Americans should have access to proven, safe, and affordable treatment options and the rapid research, development, trials, and scientific approvals are emblematic of President Trump's highest priority: the health and safety of the American people," he said.

Concerns that the political calendar could affect regulatory scrutiny of potential vaccines in the U.S. were heightened after the Centers for Disease Control and Prevention sent a letter to state health officials directing them to expedite the approval process for medical supply company McKesson so it can set up coronavirus vaccination sites by Nov. 1.Health and Human Services Secretary Alex Azar quickly defended the move, saying it had nothing to do with the Nov. 3 presidential election.

Dr. Moncef Slaoui, who is leading Operation War Speed, said last week that the CDC directive was for planning purposes and a vaccine is "extremely unlikely" to be ready for public distribution by November.

"There is a very, very low chance that the trials that are running as we speak" could be ready before the end of October, Slaoui told NPR. "And therefore, there could be if all other conditions required for an Emergency Use Authorization are met an approval. I think it's extremely unlikely but not impossible."

He said he "firmly" believes a vaccine will be available before the end of the year and "in quantities that can immunize patients at the highest risk, which means very old people, 70 years and older, and maybe people that are highly exposed on the first line."

CNBC's Berkeley Lovelace contributed to this report.

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Drugmakers seek to reassure public on coronavirus vaccine as concerns grow about political pressure - CNBC

Labor Day weekend travelers are heading to COVID-19 hot spots like Florida – NBC News

September 4, 2020

Millions of Americans, tired of being pinned down by the pandemic, are expected to hit the road this Labor Day weekend despite a coronavirus crisis that continues to generate more than 30,000 new cases per day and shows little sign of slowing down.

And the destination of choice, according to the travel site TripIt, is a state where the coronavirus crisis continues unabated Florida.

Florida this year is claiming the lions share (plurality) of Labor Day flight reservations, with 12 percent of all plans including a destination in the Sunshine State, the site says.

By comparison, this time last year Floridas share of flight reservations was 4 percent, TripIt reported.

As of Friday, Florida has reported 633,442 confirmed cases of COVID-19 and 11,647 deaths two dismal figures that place it third in the nation for number of cases and fifth in the nation for fatalities, statistics compiled by NBC News show.

Another favorite destination for travelers this weekend? TripIt says Hawaii, a state that is currently experiencing a surge in new cases. United Airlines increased its service to Hawaii after a 50 percent increase in Labor Day weekend bookings, the website said.

But unbeknownst to the travel website, the Hawaii Tourism Authority extended the state's mandatory 14-day quarantine for all arriving passengers until Oct. 1. So if you were hoping to be on Waikiki Beach this weekend, you will have to change your plans.

The fact that so many Americans are ready to travel after months of staying put is worrying for public health experts.

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Dr. Anthony Fauci, the nations leading infectious disease expert, said the new case count has been declining, but the country is still far from the goal of 10,000 or less new cases per day that he had hoped would be reached by September.

Fauci, speaking Wednesday on NBC's "Today," shared a Labor Day weekend warning.

When you have a holiday like Labor Day, we have seen, after Fourth of July, we saw after Memorial Day, a surge in cases, Fauci said. Wear a mask. Keep social distancing. Avoid crowds. You can avoid those kind of surges. You don't want to be someone who's propagating the outbreak. You want to be part of the solution, not part of the problem.

In the two weeks before the Fourth of July holiday, there were 590,741 new confirmed COVID-19 cases, an NBC News analysis of available figures showed. In the two week after that holiday, the number of cases jumped 866,834.

The pattern was different before and after Memorial Day, though. There were 314,108 cases in the two weeks before that holiday and the number actually declined slightly to 293,915 cases in the two weeks after.

But at that point the pandemic was easing in the Northeastern states that were hit hardest early on like New York and New Jersey and starting to take off in Southern and Sun Belt states like Florida, Arizona and Texas. All are led by Republican governors who, at the urging of President Donald Trump, were already in the process of reopening their states.

California, which has a Democratic governor who ignored Trump and took aggressive action early on to deal with the crisis, also saw a big spike when it reopened and now leads the nation with 722,042 cases. In recent weeks, however, the number of new cases and hospitalizations have been in decline.

In a sign of how far New York has come since March and April when it was the nations COVID-19 hot spot, Gov. Andrew Cuomo announced that starting Wednesday malls will be allowed to reopen at 50 percent capacity. Casinos will also be allowed to reopen the same day, but at 25 percent capacity, he said.

Masks and social distancing rules remain in effect in both the malls and casinos. And Cuomo is dispatching state inspectors to the casinos to make sure people there arent gambling with other peoples lives.

Trump was expected later Thursday to release a Labor Day message in which he urges all Americans to wear masks against COVID-19, an issue he helped politicize by refusing at first to wear one himself.

On Trump's watch, the deadly pandemic has claimed nearly 187,000 lives in the U.S., with more than 6.1 million cases recorded both world-leading figures, the latest NBC News numbers show.

The U.S. now accounts for almost a quarter of the more than 26 million cases and about a fifth of the nearly 865,000 deaths worldwide, according to the Johns Hopkins University COVID-19 dashboard.

Meanwhile, baseball fans mourned the death of Hall of Fame pitcher Tom Seaver, who helped lead the so-called Miracle Mets to the New York teams first world championship in 1969, and who was battling dementia when he died Wednesday of COVID-19. He was 75.

And in London, England, the production of the latest Batman movie, titled "The Batman," ground to a halt after a crew member came down with the coronavirus. Actor Robert Pattinson stars in the movie.

In other developments:

First-time jobless claims for the last week of August fell to 881,000, which is the lowest weekly total since the pandemic took off and wrecked the thriving economy that Trump inherited from President Barack Obama. But part of the reason for the dip below the previous two weeks million-plus jobless claims numbers is that the government changed the way it adjusts for seasonal fluctuations in the jobs market. And while Trump has boasted on Twitter of soaring job gains within the past three months, economists say this ignores the inescapable fact that the economy is still nearly 13 million jobs shy of where the country was in February, NBC News reported Thursday.

Iowa Sen. Joni Ernst, a Republican in the midst of an unexpectedly tough reelection battle, was caught echoing a discredited conspiracy theory that government statistics on coronavirus infections and deaths have been inflated while talking to a voter. When asked later about that conversation, Ernst at first said she was just repeating what she had heard. But as the trickle of questions turned into a torrent, Ernst began back-pedaling and later issued a statement which read, in part, Over 180,000 Americans have died because of COVID-19 and what matters is that Iowa gets the resources it needs. Iowa is currently a coronavirus hot spot. The number of cases in Iowa has jumped in recent weeks and health experts suspect part of the reason is that bikers who attended last months massive rally in Sturgis, South Dakota brought more cases home with them. One biker from Minnesota who attended the event has died from COVID-19.

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Labor Day weekend travelers are heading to COVID-19 hot spots like Florida - NBC News

Here’s why it’s unlikely we’ll have a coronavirus vaccine by Election Day – CNN

September 4, 2020

Doctors who are running the clinical trials would know best, and they don't think so.

"Do the simple math," said Dr. Larry Corey of the Fred Hutchinson Cancer Research Center in Seattle, who is leading the team coordinating the clinical trials for federally backed coronavirus vaccines in the US.

"We designed the trial to get to 130, 140 endpoints seven months from starting the trial," Corey told CNN. "The first one started in mid-July."

"Endpoints" are coronavirus infections. What Corey is saying is that the trials are designed to go on until 140 or 150 people catch the coronavirus. The researchers would look to see if people who got the real vaccine were less likely to be among those infected.

But if you add seven months to July, you get February.

That doesn't mean it's impossible to have an answer before then. If one of the vaccines being tested is highly effective, and there is a high rate of infection among the people volunteering in the trials, it's possible many people who got placebo shots would get infected quickly. "If you had a highly effective vaccine, maybe you'd find that five months from designing the trial," Corey said.

But if you add five months to July, you get December.

That still doesn't get us to October.

And there are other obstacles. Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the Food and Drug Administration's Vaccine and Related Biological Products Advisory Committee, said most of the Phase 3 trials underway now aim to enroll 30,000 people each. That's because the people who designed the trials think it will take that many volunteers for them to see 140 or 150 infections.

None is fully enrolled yet, so it's already September and many, if not most, of the volunteers have yet to receive their first dose.

"Then you have to wait two weeks after the second dose to really have full immunity," Offit told CNN.

A highly unlikely -- but not impossible -- timeline

So why is the administration talking about results in November, or even October?

"It's highly unlikely, but it is theoretically possible without doing anything nefarious," said Dr. Ann Falsey, a professor of medicine at the University of Rochester School of Medicine in New York, who is coordinating the clinical trial there for AstraZeneca's candidate coronavirus vaccine.

For instance, if the virus is spreading fast, that would make for a lot of data, very fast. "Unfortunately, there may be a real hotspot and there may be a lot of activity," Falsey told CNN.

And if one of the vaccines being tested is highly effective, it would quickly become clear. People in the placebo group will get infected at a much higher rate than people who got the real vaccine.

"So maybe you get to a definitive answer sooner than you thought you would," she said. "That would be unlikely," she added.

Offit agreed. The trials are not designed to detect symptomless or mild infections, Offit said. "The clinical endpoint is severe disease," he said. That makes it even less likely the trials are going to produce a lot of surprise data ahead of schedule.

And the FDA has already told companies a vaccine has to be at least 50% effective to be considered. That means it will have to lower the risk of death or severe disease by 50%.

Even if volunteers are in a virus hotspot, Offit said, they will have been counseled to be careful. It is an ethical requirement of the trials to caution the volunteers about the risks of becoming infected. "You are telling people to wear face masks and social distance," he said.

"You are not telling them to go to a maskless biker's convention in South Dakota. You want them to protect themselves."

The FDA can't move faster than the data

Normally, the FDA takes a year to approve a vaccine after all the Phase 3 data is submitted, Offit said. An expedited process would take 10 months.

In the case of a pandemic, that process is accelerated, and Operation Warp Speed has been running other needed steps in parallel with the clinical trials, helping companies start manufacturing vaccines even before the trials are over and ordering syringes and other equipment now instead of waiting until the trials are finished, so the FDA could be ready to move much, much sooner.

But the only way there would be enough data to move one of the vaccines in the queue for FDA emergency use authorization would be if one or more of the trials got a surprising amount of data very, very quickly.

Pfizer Chairman and Chief Executive Officer Dr. Albert Bourla thinks that could happen. He said the Phase 3 clinical trial of his company's Covid-19 vaccine has enrolled about 23,000 participants, and some are already getting the second dose of the vaccine.

Pfizer "should be able to have enough events to say if the product works or not" by the end of October, Bourla said Thursday in remarks to to the International Federation of Pharmaceutical Manufacturers and Associations.

The people making that decision are the Data and Safety Monitoring Board. That's an independent group of experts -- separate from the company making the vaccine, separate from the doctors running the clinical trials and separate from the federal government -- who get to peek at the data early.

"They are there to protect the safety and to define the accuracy of the vaccine," Corey said.

If they see a clear signal that the vaccine is unsafe, for instance -- if many people have severe reactions, or if people who get the vaccine are in fact more likely to get infected -- they can stop the trial. They can also stop the trial if they see the vaccine really is not protecting people -- if just as many people who get the real vaccine become infected as those getting a placebo.

And they can stop the trial if it looks like the vaccine is working better than expected. That's why the CDC is asking states to be ready to distribute a vaccine in October or November, Health and Human Services Secretary Alex Azar told CBS This Morning.

"God forbid we get great data and it comes out of the Data and Safety Monitoring Board and the FDA finds that it meets their standards, and we aren't ready to distribute," Azar said. "We need to be ready for all contingencies and that's why the CDC is doing this."

Corey said he doubted anyone on the DSMB would feel any pressure to stop a trial and recommend a FDA review because of pressure -- either political pressure or just the pressure of trying to end a pandemic that has killed 185,000 Americans.

"It's not like they don't understand the responsibility. All of them know how to read," Corey said.

Falsey doesn't think so, either.

"I don't think that the message is that we are going to look at the data in the middle of the trial and if it looks kind of good, we'll go with it," Falsey said. If a vaccine gets fast tracked, it will be because there is definitive evidence, she said.

Offit agrees. He said he trusts the FDA and the approval process. But not everyone does.

"The irony of this is you may, by the end of the year, have a safe vaccine. But you have an administration that hasn't garnered a lot of trust," he said.

"Maybe we will have a safe and effective vaccine but people still won't trust it because they don't trust the way the administration has handled science. That would be the ultimate irony."

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Here's why it's unlikely we'll have a coronavirus vaccine by Election Day - CNN

Coronavirus live updates: CDC tells officials to be ready for vaccine by November; steroids can help severely ill patients – USA TODAY

September 4, 2020

Approving a vaccine in the U.S. usually takes years, but COVID-19 vaccines are moving through in record time. What does that mean? USA TODAY

Clinical trials of a COVID-19 vaccine can be legitimately cut short and could allow a vaccine to become available more quickly than previously expected if results are overwhelming, Dr. Anthony Fauci says. And the CDC is telling some health officials to be ready to start distributing a vaccineby November, according to one report.

Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is confident the experts making thecall on a vaccine would not be swayed by political pressure as Election Day approaches.

The Trump administration announced a nationwide ban on evictions until December to ease financial pressures fueled by the pandemic.The federal edict came down after some states, including California and Nevada, announced similar protections against evictions.

Philadelphia Mayor Jim Kenney apologized on Twitter after a photo of him eating in a Maryland restaurant made the rounds on social media. And Speaker of the House Nancy Pelosi faced criticism forvisiting a hair salon in San Francisco despite the city's current guidelines intended to curb the spread of the coronavirus.

Some significant developments:

Today's numbers:A USA TODAY analysis of Johns Hopkins data through late Tuesday shows four states set records for new cases in a week while two states had a record number of deaths in a week. New case records were set in Iowa, Minnesota, South Dakota and West Virginia. Record numbers of deaths were reported in Arkansas, Hawaii and Guam. The U.S. has 6 million confirmed cases and over 184,000 deaths. Globally, there are 25.8million cases and more than 858,000 people have died.

What we're reading:California, the first state to reach 700,000 confirmed cases of COVID-19,announced a new tiered plan for reopening businesses that some critics say has inequities.

This file will be updated throughout the day. For updates in your inbox,subscribe to theDaily Briefing.

The first COVID-19 death associated with a massive biker rally in Sturgis, South Dakota has been reportedweeks after the event attracted more than 400,000 vehicles anddrew widespread concern from public health officials.

The death was reported by Minnesota Department of Health Infectious Disease Director Kris Ehresmann ata Wednesday briefing.Minnesota South Dakota's neighbor to the east is tracking anongoing outbreak of 50 cases tied to the August event,Ehresmann said. That outbreakonly includes people who attended the event.

A Minnesota man who died was in his 60s and had underlying health conditions. The rally went forward despite fears it could become a super-spread event.South Dakota Gov. Kristi Noem welcomed bikers and the tourist dollars they spend.

Joel Shannon

The CDC is telling some health officials around the country to be ready to start distributing a vaccine to prevent the coronavirus by November, the New York Times reports.

That would be on the early side of what officials have laid out as a best-case scenario:that a vaccine will be ready by the end of the year.A COVID-19 vaccine could be available earlier than expected if ongoing clinical trials produce overwhelmingly positive results, Dr. Anthony Fauci, the nations top infectious disease official, told Kaiser Health News.

"Limited COVID -19 vaccine doses may be available by early November 2020, but COVID-19 vaccine supply will increase substantially in 2021," reads the CDC document.

At least twoclinical trials of 30,000 volunteers are now expected to conclude by the end of the year, but Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.

The federal budget deficit is projected to hit a record $3.3 trillion because ofCOVID-19 costs and the recession, the Congressional Budget Office said Wednesday.

Thats more than triple the 2019 shortfall. The deficit projection was attributed to the coronavirus disruption of the economy and the cost of legislation enacted by Congress in response to the pandemic.

It wasless than a year ago that Federal Reserve Chairman Jerome Powell warned lawmakers that the ballooning federal debt could hamper Congress ability to support the economy in a downturn and that was months before the coronavirus appeared in the U.S.

The federal budget is on an unsustainable path, with high and rising debt, Powell told the Joint Economic Committee in November.

Three Phase 3 trials have started in the U.S. for vaccines against the coronavirus and volunteers have been stepping up to be human guinea pigs to make sure they are safe.

But with seven candidate vaccines now funded by the federal government on their way towards Phase 3, a lot more volunteers will be needed a combined total of at least 210,000.

Half receive the active vaccine and half a placebo. Participants won't know whether they got the actual vaccine until their trial ends in about two years. In the meantime, they are left wondering whether their lack of a sore arm or fever means they received the placebo or just got lucky.

"If I got the placebo, then I will go and get the actual shot when ready," said one volunteer, Dusta Eisenman, 44, of San Jose, California. Want to volunteer? Here's how.

Karen Weintraub

Canada's chief medical officer issued some guidelines Wednesday on having sex in the age of COVID-19.

Dr. Theresa Tam advised Canadians to wear a mask during sexual intercourse and to check for any symptoms beforehand, especially with a new partner.

While COVID-19 is not easily transmittable through bodily fluids, reported Reuters, Tam advises against kissing or any face-to-face contact during sexual intimacy.

"Canadians can find ways to enjoy physical intimacy while safeguarding the progress we have all made containing COVID-19," Tam said.

Seven more Greek houses at Indiana University-Bloomington are being directed to quarantine because of COVID-19,bringing the total up to 30 out of 40 Greek houses as of Wednesday evening.

IU Bloomington reportedan 8.1% positivity rate among students living in fraternity and sorority housing during its mitigation testing, according to a Monday update to its testing dashboard. Residence halls had a 1.63% positivity rate.

All communal living houses are directed to suspend in-person activities other than dining and housing until at least Sept. 14, said IU spokesperson Chuck Carney.

Lydia Gerike, Indianapolis Star

With volunteer ranks thinned by fear of the coronavirus, Kentucky is trying to put some fizz into its recruitment effort for poll workers for November's general election by soliciting for them on beer cans.

Secretary of State Michael Adams' office is working with the Kentucky Guild of Brewers to get out the word on beer labels. The message includes a QR code linked to a site where people can register to vote and apply to be a poll worker.

Last year I testified to the Legislature that we had a poll worker crisis in Kentucky, Adams said in a statement. COVID-19 certainly hasnt helped. We need younger generations to step up and be good citizens, and so we enlisted the help of Kentuckys craft breweries to reach them.

Emma Austin, Louisville Courier Journal

A package of new studies published Wednesday in the Journal of the American Medical Association confirms that patients severely ill with COVID-19 can benefit from steroids. The drugs can save about 1 in 12 patients treated.

Both dexamethasone, which has been approved by the U.S. Food and Drug Administration for use on COVID-19 patients, and hydrocortisone are equally effective, the research found.

Overall, the research found the most severely ill COVID-19 patients, those who are on ventilators, benefited the most, Dr. Todd Rice of Vanderbilt University, who co-wrote the editorial, said in a JAMA interview. Steroids likely tamped down an immune system overreaction.

Patients who were considered mildly ill with COVID-19, those who were hospitalized but not overwhelmed with inflammation, did not benefit from steroids, the studies found. There is a gray area, the researchers admitted, where its hard to determine whether to give steroids to patients who have relatively mild disease at the momentbut seem likely to decline.

Karen Weintraub

First camea shift from classroom instruction to online learning because of the coronavirus. Now comes cyberattacks that could lead to ahaltonline learning.

Floridas largest school district has faced multiple cyberattacks this week that appear to be aimed at disrupting instruction via personal computer, Miami-Dade County Public Schools Superintendent Alberto Carvalho said in a tweet Wednesday.

So far, he said the hackers haven't been able to penetrate the districts servers. The FBI and Secret Service have been asked to investigate.

The Transportation Security Administration is testing a system that matches your ID to your face, avoiding person-to-person contact that could spread the coronavirus.

The system, now part of a pilot program at Washington's Reagan National Airport, is similar to a technology that was tested last year at McCarran International Airport in Las Vegas. However, the new system will allow passengers to insert their ID into the scanner, rather than handing it to a TSA officer.

"In light of COVID-19, advanced health and safety precautions have become a top priority and part of the new normal for TSA," said Administrator David Pekoske in a statement Tuesday.

Pekoske said if the pilot program proves successful, it may be implemented at more airports.

Curtis Tate

Secretary of State Mike Pompeo on Wednesday defended the Trump administrations controversial decision not to participate in a global alliance to develop and distribute a COVID-19 vaccine.

The White House confirmed earlier this week that it would not be part of the vaccine alliance, which is being led in part by the World Health Organization and involves more than 170 other countries. The global effort involves not only developing an effective vaccine but also ensuring it is equitably distributed across the globe.

Pompeo told reporters Wednesdaythe U.S. would not participate in the global vaccine effort because the WHO is too political. The vaccine alliance is being co-led by Gavi, which focuses on providing vaccines to children in poor countries, and other groups. The Trump administration has moved to withdraw the United States from the WHO, arguing it was too soft on China when the novel coronavirus first emerged.

Critics say this decision isolates the United States and risks hindering the worldwide race to find an effective vaccine.

Deirdre Shesgreen

The U.S. government is canceling some of its contracts to buy new ventilators, saying the national stockpile is full after some statesfeared they'd run short on the life-saving machines in the early days of the coronavirus pandemic.

The Department of Health and Human Services said Tuesday that it has nearly120,000 ventilators available for deployment to state and local health officials if needed. The Trump administration had signed nearly $3 billion in contracts to get more ventilators as demand surged in the spring, but the cancellation of some of the contracts was billed as a cost-savings measure as demand was no longer as high.

President Donald Trump faced criticism in Marchfrom some mayors and governors who urged him to use his powers under theDefense Production Act to ramps up production of ventilators.At the time, the national stockpile had only about 16,660 ventilators ready to deploy.

Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY

The COVID-19 Treatment Guidelines Panel, part of the National Institutes of Health, said theres no solid evidence for or against recommending convalescent plasma to treat hospitalized COVID-19 patients.

The statement Wednesday comes less than 10 days after the U.S. Food and Drug Administration issued an emergency authorization for using plasma taken from patients who have recovered from the coronavirus.The panel reviewed data from a preliminary study by the Mayo Clinic and found that while the treatment may be beneficial for non-intubated patients, there was no comparable difference in death rates.

"There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate efficacy and safety of convalescent plasma for COVID-19,"the panel wrote.

Adrianna Rodriguez

The first coronavirus vaccine doses to become available should go to front-line health care workers at the highest risk of being exposed to the virus, with paramedics, firefighters and police also would get priority,according to a draft report released by the National Academies of Science, Medicine and Engineering.

Next on the priority list should be people of all ages with underlying conditions, the report said.A vaccine probably would be in scarce supply initially, with enough doses for only 3% to 4% of the U.S. population, the report said.

Francis Collins, director of the National Institutes of Health, and Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, created the panel that wrote the draft. The panel is made up of doctors, ethicists, public health officials and scientists.

Elizabeth Weise

Philadelphia's mayor apologized after a photo of him eating inside a Maryland restaurant circulated on social media despite a banon indoor restaurant dining in the City of Brotherly Love.A spokesperson for Mayor Jim Kenney confirmed that he dined at a friend's restaurant on the Chesapeake Bay.Kenney justified thedecision by sayingthat he felt the risk was low because Cecil County had fewer than 800 COVID-19 cases.

One vocal critic waschef and restaurant owner Marc Vetri,who criticized the hypocrisy of Kenney dining indoors while restaurants in the city "close, suffer and fight for every nickel." Plans call for city restaurants to partially open beginning Tuesday.

The U.S.Census Bureau is ending in-person counting in some cities, including San Diego,as early as Sept. 18, two weeks before the Sept. 30 deadline, NPR reported."In some areas, nonresponse followup will finish earlier than Sept.30 based on the rates of completion, self-response rates and the number of hours our available workforce can work," the bureau told NPR.

Minnesota's state demographer Susan Brower toldNPR that counting may also be done in two weeks in Minnesota's Hennepin County. The Census Bureau first postponed its spring deadline to Oct. 31 because of the coronavirus pandemic. The deadline changed againlast month to Sept. 30.

All businesses in Maryland will be able to open Friday as the state enters the third phase of its coronavirus recovery plan, Gov. Larry Hogan announced. Up to 100 people will be allowed at indoor venues, or 250 people at outdoor venues.All retail stores as well as churches and houses of worship will be able to increase capacity from 50% to 75%. Local jurisdictions will still be able to decide not to open as much as the state plan allows.

"I want to remind the people of Maryland that moving into Stage 3 does not mean that this crisis is behind us and remind them that we must remain vigilant so that we can keep Maryland open for business," Hogan said at a news conference.

Australias economy has suffered its sharpest quarterly drop since the Great Depression because of the pandemic. Data released on Wednesday confirmedthe country is experiencing its first recession in 28 years.The latest national accounts showed the economy shrank 7% in the June, the biggest contraction since records began in 1959.Combined with a smaller 0.3% drop in the March quarter, the definition of a technical recession two consecutive quarters of contraction has been fulfilled.

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The Trump administration said Tuesday that it is implementing anational four-month moratoriumon residential evictions because ofthe coronavirus pandemic.Relying on a1944 Public Health Service Act thatgives the administration broad quarantine powers, the moratoriumwill run through Dec. 31. Itapplies to individuals earning less than $99,000 a year and who are unable to make rent or housing payments.

"President Trump is committed to helping hard-working Americans stay in their homes and combating the spread of the coronavirus,"White House spokesman Brian Morgenstern told reporters Tuesday.

John Fritze andNicholas Wu

On Facebook:There's still a lot unknown about the coronavirus. But what we do know, we're sharing with you.Join our Facebook group,Coronavirus Watch,to receive daily updates in your feed and chat with others in the community about COVID-19.

In your inbox:Stay up-to-date with the latest news on the coronavirus pandemic from the USA TODAY Network.Sign up for thedailyCoronavirus Watchnewsletter.

Tips for coping:Every Saturday and Tuesday we'll be in your inbox, offering you a virtual hug and a little bit of solace in these difficult times.Sign up forStaying Apart, Together.

Contributing: The Associated Press

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Coronavirus live updates: CDC tells officials to be ready for vaccine by November; steroids can help severely ill patients - USA TODAY

Pfizer expects COVID-19 vaccine results by end of October – KING5.com

September 4, 2020

Dr. Fauci said Pfizer's October timeline for a vaccine is 'unlikely,' but he doesn't believe politics will influence the FDA's decision to approve a vaccine.

WASHINGTON, D.C., USA The CEO of Pfizer said the drug-making company is in a "very advanced stage" of its COVID-19 vaccine trial and believes they should know by the end of October whether their vaccine is safe and effective. But the nation's top infectious disease expert expressed skepticism over that timeline.

The pharmaceutical company has already enrolled 23,000 volunteers in the phase three trial, CEO Albert Bourla said Thursday during a Q&A with the International Federation of Pharmaceutical Manufacturers & Associations, a trade group. The company hopes to get at least 30,000 volunteers enrolled in total.

We expect by the end of October, we should have enough ... to say whether the product works or not, Bourla said.

He added that if the data shows it's safe and effective, they would then "submit immediately" to the FDA for approval.

Dr. Anthony Faucitold CNN that Pfizer's timeline is "conceivable," but "unlikely." He said that most believe vaccine trials won't have enough data until November or December.

"It is conceivable that you could have it by October, though I don't think that that's likely, Dr. Fauci said.

Dr. Fauci also defended the U.S. Food and Drug Administration, stating that he doesn't believe politics could influence the FDA's decision to approve a vaccine.

"I think that we can have some confidence and have faith in what the FDA is saying. They're saying very explicitly that they're going to be making the decision based on the scientific data and we hope that's going to be the case," Dr. Fauci explained.

The federal government last week told states to prepare for a coronavirus vaccine to be ready to distribute by Nov. 1. That timeline raised concern among public health experts about an October surprise" a vaccine approval driven by political considerations ahead of a presidential election, rather than science.

The Pfizer and Moderna vaccine candidates began Phase 3 testing in late July. AstraZeneca announced Monday its vaccine candidate has entered the final testing stage in the U.S. as well.

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Pfizer expects COVID-19 vaccine results by end of October - KING5.com

Column: Controlling COVID-19 will require a global effort – The Daily Tar Heel

September 4, 2020

In a statement earlier this week, the Trump administration confirmed they do not plan on joining the global effort to develop, manufacture and distribute a coronavirus vaccine becausethe World Health Organization is involved. This follows announcements earlier this year that the United States is planning on terminating its diplomatic relationship with the WHO altogether.

The WHO is made up of 194 member states across six regions, and is instrumental in directing and coordinating international health work. They partner with the United Nations, international organizations and individual research institutions to support health initiatives, national health policies and strategies. They are to be partially credited with the eradication of smallpox, the reduction in polio cases and leading the charge against outbreaks like Ebola and dengue.

The organization is funded by several sources, including international organizations, private donors, member states and the United Nations. Member states of the WHO are each required to pay dues, which are calculated relative to each countrys wealth and population. The United States has historically been one of the organizations largest donors, making up 14.67 percent of all voluntary contributions given globally.

As a result, the WHO has been criticized relentlessly due to certain member states having disproportionate financial and political influences within the organization. Trump has been vocal in his belief that Chinese officials pressured the WHO into ignoring their handling of the COVID-19 pandemic, consequently misleading global figures and causing international economic hardship.

Regardless, the possibility of the U.S. terminating its relationship with the WHO and refusing to partake in the development, manufacturing and distribution of a coronavirus vaccine will have devastating international effects. After losing a significant amount of its funding, the WHOs additional health programs will be significantly weakened, such as the movement to stop the rapid spread of HIV or drug-resistant tuberculosis. Global health experts also argue that by refusing to work with the WHO, the move will also effectively kill any international coordination on the COVID-19 response, prolonging the pandemic even further.

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Column: Controlling COVID-19 will require a global effort - The Daily Tar Heel

In a dry run ahead of COVID-19 vaccine, Memphis health officials to administer drive-thru flu shots – Commercial Appeal

September 4, 2020

Memphis and Shelby County residents could get a novel coronavirus vaccine, if and when it comes,at a drive-thru site in Shelby County, the Shelby County Health Department said Thursday.

The health department plans to test how it would distribute and administer a novel coronavirus vaccine at drive-thru sites. To test how that would work, they plan on using the flu vaccine, David Sweat, the chief epidemiologist at the Shelby County Health Department said.

Sweat said the department and Memphis and Shelby County COVID-19 joint task-force would announce more about which sites would be used for the test-run in the coming weeks.

The health department's announcement comes after the Centers for Disease Control and Prevention told U.S. states last week to be ready to distribute a novel coronavirus vaccine by Nov. 1.

At present there are two U.S. vaccine candidates that are in the final trials before a potential approval by the U.S. Food and Drug administration, according to the New York Times vaccine tracker. Those final trials, known as stage three trials, are when thousands of people are given dosages of the vaccine to study its effectiveness and safety.

Those two vaccine candidates one from Moderna and another the trio of Pfizer and a German and Chinese firm could potentially be the first vaccine administered on a broad scale. However, there are many other vaccines in earlier stages of testing.

Samuel Hardiman covers Memphis city government and politics for The Commercial Appeal. He can be reached by email at samuel.hardiman@commercialappeal.com or followed on Twitter at @samhardiman.

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In a dry run ahead of COVID-19 vaccine, Memphis health officials to administer drive-thru flu shots - Commercial Appeal

Fear and dread haunt COVID-19 ‘long-haulers’ – Reuters

September 4, 2020

LONDON (Reuters) - Until March 19 this year, Felicity Callard, a 49 year-old British university professor and lecturer, was fit, active and strong. Now, she says, shes exhausted, frail and scared.

Felicity Callard, a 49-year-old British university professor and lecturer who suffered from the coronavirus disease (COVID-19), is pictured during an interview at her house in London, Britain, September 2, 2020. REUTERS/Matthew Childs

Her mind fills with fears about what kind of damage might have been done to her heart, lungs and brain when she suffered what is classified as a mild case of COVID-19 more than five months ago - and shes terrified it might happen again.

I was absolutely, completely destroyed by this illness, she told Reuters. My life has completely changed. Im basically confined to a kilometre from my house and back - because thats as far as I can walk.

Back in March, she says, she felt more individual control over her health. She was reassured in part by messages that the vast majority of cases are mild, and that good infection control, hand hygiene and social distancing would reduce the risk of contracting COVID-19. Now, however, she feels as though the threat is everywhere.

Callard is one of thousands of people worldwide who are reporting a wide range of ongoing symptoms many months after being diagnosed with COVID-19. Some call themselves COVID long haulers, while others have adopted the term long COVID to describe their condition.

Breathlessness, memory loss, extreme fatigue, headaches, brain fog, muscle pain and swelling joints, are commonly described among multiple recurring symptoms in global online patient advocacy blogs and chatrooms.

And for many, the anxiety, depression and dread are at least as debilitating as the physical frailties.

Thats been the pattern - relapse and remit - for so many of us, said Sandra Edwards, a 46-year-old Briton who now helps run a newly-formed patient advocacy group called LongCovidSOS.

Were in no mans land. We dont know if this is chronic or if it will come to a point where well make a full recovery, she told Reuters. You wake up in the morning and dont know how youre going to feel - not just day by day, but sometimes hour by hour. It slowly chips away at you.

According to LongCovidSOS, data from a symptom tracker app devised by Kings College London scientists shows that 10% of COVID-19 patients are still unwell after three weeks, and up to 5% may continue to be sick for months.

Mentally, you feel abandoned, said Morena Colombi, a 59-year-old from Truccazzano in the Italian province of Milan who was diagnosed with COVID-19 in February and is still suffering symptoms. Even the doctors dont know how to help you.

Maybe one day you get better, and the next day you pay for it, she told Reuters. You can no longer resume your life as before and that makes you depressed.

Til Wykes, a psychology professor at Kings College Londons Institute of Psychiatry, Psychology & Neuroscience (IPPN), notes that uncertainty is a key feature of anxiety. The unknown progression of the disease leaves doctors unsure of how to help, and can make patients feel fearful and alone.

For most illnesses we have an understanding about what will happen first, what will happen next, and what to expect, she said. The problem (with COVID) is that the symptoms come, then seem to be abating, but then they come back again.

After the World Health Organization met groups representing long-term COVID sufferers last month, the WHOs director general Tedros Adhanom Ghebreyesus assured them: We hear you loud and clear.

But he cautioned: We still know relatively little about the long-term effects. We only have less than eight months of experience (of the coronavirus pandemic) to draw on.

Patients like Callard and Edwards say they recognise doctors are dealing with a completely new disease caused by a novel virus, so cant be expected to have all the answers. But they and mental health specialists say the psychological impact of this unpredictability and lack of control make things worse.

Rona Moss-Morris, head of psychology at the IPPN, says evidence from previous disease outbreaks and from studies of patients who have been in critical or intensive care shows a significant impact on levels of anxiety, depression and post-traumatic stress disorder (PTSD).

And its also very frightening for people being at home and not in hospital - and feeling they can barely breathe, for example, she told Reuters.

Were hearing horror stories from people who were in that kind of situation.

Reporting by Kate Kelland in London, with additional reporting by Angelo Amante in Rome. Editing by Alexandra Hudson

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Fear and dread haunt COVID-19 'long-haulers' - Reuters

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