Category: Corona Virus Vaccine

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Breaking up in the time of Covid-19 brings new challenges – CNN

October 23, 2020

And while divorcing or going separate ways is rarely easy, couples dissolving their households during Covid-19 are facing new woes.

For marriages and relationships involving the usual strife, the stress of job losses, shared housing, co-parenting and health insurance worries have been exacerbated by the pandemic. That has couples weighing when (not to mention if) it's the right time to bow out.

For many couples married or not the time is now

For Missy, 43, an information technology consultant (we're not using her real name to protect her privacy) the moment she decided it was time to finally end things for good with her partner of nearly 20 years came in April.

The couple married in 2001 and had two children. "Sometime late last year, I started feeling like we'd grown into different people," she said. "And I started to realize that if I was going to choose a person now, it would be someone different than him."

Then the pandemic hit.

"I was working from home since March and was thinking, there's a pandemic, I can't (split up) now," she said. "Where would we live? How would we do this?"

"At the very beginning (of lockdown), I absolutely thought, 'We need to stick together, we have to ride this out,'" Missy said.

But by April, after a fight that was finally the last straw for her, Missy said, she and her ex-husband decided he would move out.

"Don't let Covid be your excuse to stay in a bad relationship," she said. "I am really glad I ended mine when I did."

Coveting a different future

Missy is one of many people pushed to a breaking point and breakup during the pandemic.

For many people forced into closer proximity and more time with their partners, this sense of disillusionment has brought into sharper relief the behaviors and beliefs they can and cannot live with anymore.

"Some people are really planning their escape or their next step in life for their freedom right now," said Kem Marks, founder and chief attorney of Just In Time Legal Solutions in Bessemer, Alabama.

Marks said she fields constant queries from her clients about when they can expect their divorce proceedings to be finalized. "People are coveting this ideal life they never had time to think about or plan before."

Some divorces may be happening faster, thanks to Zoom

"There seems to be the perception the courts are closed or people don't have access to the courts right now, but that's totally false," Martinez said. "The courts are 100% open, and if anything, we are getting into court faster."

Being able to do many things on Zoom video conferencing has saved time, too. "What used to be a five-minute hearing that you'd spend an hour in court waiting for has been eliminated by these Zoom proceedings," Martinez said.

But that hardly means the emotional toll of getting divorced right now isn't taking a toll, she said especially when it comes to formulating parenting plans, with so many uncertainties still surrounding the coronavirus and schooling options.

"I have been doing this for 15 years as a high-conflict parenting litigator, and I have all the stories. But anxiety levels are at an all-time high for most people," she said. "This is some of the most hysterical behavior I've seen in a long time."

"Parents are fighting over virtual or in person, they want to deny time-sharing because of these things," she said. "How you run your household may be very different than how your parenting partner runs their household, and that's been highlighted."

Teetering on the edge

The pandemic has people teetering on the edge more than ever due to both the overall stress of the pandemic and the inequalities that have been further highlighted because of it, said Linda Waite, a professor in the deparment of sociology at the University of Chicago.

"Most professionals have kept their jobs," she said. "They've been able to work at home, most have their kids in schools that are doing a good job at staying on top of things, or maybe they've made learning pods."

The stresses and losses have "fallen disproportionately on people who don't have a lot to begin with," Waite said. "Those are likely to be Blacks and Hispanics, but many Whites, too, with only a high school education."

As a result, for some people, "marriage has gotten more fragile because they're under so much stress."

Couples without kids are also suffering

Couples without kids who are separating or divorcing are also enduring huge losses right now, Waite said.

"If you lose your partner, even if you don't have kids, you still have to find a new place to live," she said, not to mention sharing assets. "And it's very hard to replace a partnership now."

"The pandemic definitely stirred things up," Duprat said. "I think the urgency that the pandemic brings makes people reflect on their deepest goals and what they want."

And what he and his wife found out, he said, is their life goals no longer matched. "We've been together so many years," he said. "And not having each other now at the same time everyone is locked inside or 6 feet apart is going to be difficult."

"It's almost like the pandemic has been a preparation for the tough period ahead of us," he said. "We're both worried about the other one a lot."

Moving forward

Martinez said she encourages her clients to go to individual counseling during a divorce "to deal with the emotional and psychological trauma they've experienced, mostly in parenting situations, since you have to interact with that person forever."

Consider hiring a mediator, too, which can potentially save you thousands of dollars on lawyer fees.

If you have decided it's time to involve a lawyer, Wise recommended scheduling a consultation with a family law attorney, calling several to see which attorney best suits your needs.

While you can expect some things to go more smoothly during the pandemic, other factors may be more difficult.

"In certain cases, it may be harder for some (people) to handle mediations or court appearances virtually," Wise said. "Divorce is an emotional process, and sometimes that human connection of having your divorce attorney in your actual corner can be calming."

"Try to stay as flexible as you can. If you are unavoidably heading for divorce, get your ducks in a row by knowing your financials and what you need your bottom line to be in the future," she said.

"Because of the uncertain economy, if a couple has decided to divorce, I would suggest they move forward quickly at this time," Nankervis stated via email. "The sooner everything is bound contractually, the easier it will be to move forward."

Parenting classes previously offered in person are now offered online, she said, which can be less stressful.

Especially when children are involved, she said, it's important to focus on what's best for your entire family, no matter how mad you are at your ex-partner.

"Even after a divorce, you are still a family," Nankervis said. "It just looks different."

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Breaking up in the time of Covid-19 brings new challenges - CNN

Hospital Bills For Uninsured COVID-19 Patients Are Covered, But No One Tells Them – NPR

October 23, 2020

When Angela Settles' husband, Darius, got sick with COVID-19, he was worried about medical bills. He worked two jobs but had no health insurance. Blake Farmer/WPLN News hide caption

When Angela Settles' husband, Darius, got sick with COVID-19, he was worried about medical bills. He worked two jobs but had no health insurance.

When Darius Settles died from COVID-19 on the Fourth of July, his family and the city of Nashville, Tenn., were shocked. Even the mayor noted the passing of a 30-year-old without any underlying conditions one of the city's youngest fatalities at that point.

Settles was also uninsured and had just been sent home from an emergency room for the second time, and he was worried about medical bills. An investigation into his death found that, like many uninsured COVID-19 patients, he had never been told that cost shouldn't be a concern.

Back at the end of June, Settles and his wife, Angela, were both feeling ill with fevers and body aches. Then Darius took a turn bad enough that he asked his wife to call an ambulance.

"My husband is having issues breathing and he's weak, so we're probably going to need a paramedic over here to rush him to the hospital," she told the operator, according to the 911 recordings obtained by WPLN News.

Darius Settles was stabilized and tested for the coronavirus at the hospital, according to his medical records. The doctor sent him home with antibiotics and instructions to come back if things got worse.

Three days later, they did. And now he also knew he had COVID-19; his test results were in.

But Settles was also between full-time jobs, playing the organ at a church as he launched a career as a suit designer. So he had no health insurance.

His wife, who works for Tennessee State University, says he was worried about costs as he went back to the hospital a second time; she tried to reassure him

"He said, 'I bet this hospital bill is going to be high.' And I said, 'Babe, it's going to be OK.' And we left it alone, just like that," she says.

When he returned to TriStar Southern Hills Medical Center, owned by the for-profit hospital chain HCA, physicians tested his blood oxygen levels, which are usually a first sign that a COVID-19 patient is in trouble. They had dropped to 88%. An X-ray of his lungs "appears worse," the physician wrote in the record.

But the doctor also noted that his oxygen saturations improved, and he was breathing on room air after a few hours in the emergency room. The records show they discussed why he might not want to be admitted to the hospital since he was otherwise young and healthy and didn't note any risk factors for complications.

And when Angela Settles called to check in, he seemed to be OK with leaving despite his persistent struggle to breathe.

He was a COVID-19 patient so, "I could not go up there to see him," she says. "He was saying that I might as well go home."

Angela Settles was surprised since her husband was the one who wanted to go to the hospital in the first place.

At first, she thought the hospital just didn't want to admit a man without insurance who would have trouble paying a big bill. But TriStar Southern Hills admits hundreds of patients a year without insurance more than 500 in 2019, according to a spokesperson.

And in this case, the federal government would have paid the bill. But no one said that when it might have made a difference to Darius Settles.

Message never makes it to patients

TriStar, like most major health systems, participates in a program through the Centers for Medicare and Medicaid Services in which uninsured patients with COVID-19 have their bills covered. It was set up through the pandemic relief legislation known as the CARES Act.

But TriStar doesn't tell its patients that upfront. Neither do other hospitals or national health systems contacted by WPLN News. There's no requirement to, which is one of the program's shortcomings, says Jennifer Tolbert of the Kaiser Family Foundation who studies uninsured patients. (KHN is an editorially independent program of the foundation.)

"This is obviously a great concern to most uninsured patients," Tolbert says. Her research finds that people without insurance often avoid care because of the bill or the threat of the bill, even though they might qualify for any number of programs if they asked enough questions.

Tolbert says the problem with the COVID-19 uninsured program is that even doctors don't always know how it works or that the program exists.

"At the point when the patient shows up at the hospital or at another provider site, it's at that point when those questions need to be answered," she says. "And it's not always clear that that is happening."

Among clinicians, there's a reluctance to raise the issue of cost in any way and run afoul of federal laws. Emergency rooms must at least stabilize everyone, regardless of their ability to pay, under a federal law known as the Emergency Medical Treatment and Labor Act, or EMTALA. Asking questions about insurance coverage is often referred to as a "wallet biopsy," and can result in fines for hospitals or even being temporarily banned from receiving Medicare payments.

Physicians also don't want to make a guarantee, knowing a patient still could end up having to fight a bill.

"I don't want to absolutely promise anything," says Ryan Stanton, an ER physician in Lexington, Ky., and a board member of the American College of Emergency Physicians.

"There should not be a false sense that it will be an absolute smooth path when we're dealing with government services and complexities of the health care system," he says.

"Could I have done more?"

Darius Settles knew he was in bad shape. But he didn't attempt to make a third trip to the hospital. Instead of 911, he called his father, pastor David Settles, and asked his father to come pray for him.

When the elder Settles replied that he was always praying for his son, Darius said, "No, I really need you to pray for me. I need you to get the oil, lay hands on me and pray," David Settles recalls, and so he went, despite concern for getting COVID-19 himself.

He sat by his son's side. Darius' wife made some peppermint tea, and when they put it to his lips, Darius didn't sip. They thought he had fallen asleep. But he was unconscious.

At that point, they called 911 again and the operator instructed them to get Darius to the floor and perform chest compressions until paramedics arrived.

For 11 minutes, Angela Settles pumped her husband's chest, occasionally asking the dispatcher "what's taking so long," the 911 recordings show. Even after help showed up, Darius never revived.

Pastor Settles was back in the pulpit just a few weeks later, preaching on suffering and grief after the death of his son, "whom I watched as the breath left his body," he told his congregation. "The Lord gives, and the Lord takes away."

Darius Settles left behind his own son, who was 6. And his widow's head is still spinning. She says she can't shake a sense of personal guilt.

"Could I have done more?" Angela Settles asks. "That's hard, and I know that he would not want me to feel like that."

She wonders, too, if the hospital could have done more for him. And even after failing to disclose its policy for uninsured COVID-19 patients, it did send her a bill for part of her husband's care. Asked why, a TriStar spokesperson says it was sent in error and does not have to be paid.

This story is from a reporting partnership that includes WPLN, NPR and KHN.

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Hospital Bills For Uninsured COVID-19 Patients Are Covered, But No One Tells Them - NPR

Mexico Government Could Absorb Some Liabilities Arising from COVID-19 Vaccine – Insurance Journal

October 23, 2020

Mexicos government could absorb some liabilities arising from unexpected side effects of COVID-19 vaccines but is not considering creating a fund to do so, a top official said.

As various vaccine candidates make their way through different stages of clinical trials, it is unclear who foots the bill if people in poor countries fall sick from treatments.

If that contingency arises, these funds can be obtained from the treasury, Martha Delgado, the deputy foreign minister in charge of Mexicos international response to the pandemic, told Reuters in an interview.

Under the World Health Organizations (WHO) COVID-19 vaccine plans, known as COVAX, 92 poor countries are eligible to access vaccines at lower or no cost until the end of 2021.

Delgado believes potential side effects will likely be caught during the vaccine trials and by health authorities.

I dont believe the WHO and its entire network of associations would launch (a vaccine) and make available to over 100 countries something that is questionable from the point of view of safety or responsibility, said Delgado.

According to confidential documents reviewed by Reuters and six people familiar with the matter, the WHO has left the issue of financial claims unresolved, as it seeks to ensure that the injections are distributed fairly.

Not participating in COVAX agreements was riskier for Mexico, she said: How much does that risk cost? she asked.

The terms for joining COVAX are the same for all signatories, but if you dont have that agreement, you dont have COVAX, full stop, Delgado said.

The government wants to vaccinate nearly all of Mexicos population against coronavirus by the end of 2021 after reaching deals with pharmaceutical companies Pfizer, AstraZeneca and CanSino, plus with COVAX.

Delgado expects the first vaccine doses to come from the pharmaceutical firms that have promised the earliest deliveries. COVAX has not committed to a date, while Pfizer has offered to start delivering as early as December, she noted.

Delgado had expected vaccinations to begin by April 2021 but now believes it could be sooner.

The worst scenario for Mexico is that our (U.S.) neighbors have a vaccination campaign four months before Mexico, and theres an issue of closed borders because in Mexico theres no vaccination campaign, said Delgado.

We have to align these processes regionally, she added. If we start receiving vaccines in December, perhaps we could also start a vaccination campaign in January or February.

(Reporting by Anthony Esposito and Adriana Barrera; editing by Steve Orlofsky)

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Mexico Government Could Absorb Some Liabilities Arising from COVID-19 Vaccine - Insurance Journal

COVID-19 in South Dakota: 973 total new cases; Death toll rises to 347; Active cases at 9,273 – KELOLAND.com

October 23, 2020

PIERRE, S.D. (KELO) Active cases of COVID-19 in South Dakota surpassed 9,000 on Thursday, as 14 new deaths due to the virus were announced by the state department of health.

The death toll is now at 347 in South Dakota. There have been 124 deaths in October, the deadliest month of the pandemic. The new deaths were 12 women and two men listed in the 60-69 (2), 70-79 and 80+ (11) age ranges. The new deaths were listed in the following counties: Minnehaha (3), Pennington (3), Brookings (2), Davison, Gregory, Lawrence, Lyman, Walworth and Tripp.

On Thursday, 973 new coronavirus cases were announced, bringing the states total case count to 36,017, up from Wednesday (35,044). On Tuesday, the DOH changed its website to not list new total cases on the SD overview tab of its dashboard. KELOLAND News has been counting the number of new total cases since the beginning of the pandemic and will continue to report on the new total cases. There were 948 new PCR cases and 25 new antigen cases announced for 973 new cases Thursday.

Total recovered cases are now at 26,397, up 374 from Wednesday (26,023).

Active cases are now at 9,273, up from Wednesday (8,688) and another record daily amount.

Current hospitalizations are now at 355, up from Wednesday (332). Total hospitalizations are at 2,277, up from Wednesday (2,239).

Total persons tested negative is at 202,429, up from Wednesday (201,206).

There were 2,196 new persons tested reported on Thursday.

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COVID-19 in South Dakota: 973 total new cases; Death toll rises to 347; Active cases at 9,273 - KELOLAND.com

Roche joins the COVID-19 antiviral drug race, betting $350M on a startup – BioPharma Dive

October 23, 2020

Dive Brief:

In the early days of the pandemic, when drugmakers and researchers began a worldwide scramble to repurpose existing drugs to treat people with COVID-19, the antiviral remdesivir, tested against Ebola, emerged as the first successful example.

But the drug, now known as Veklury, has significant limitations. Its benefits chiefly an apparent ability to shorten hospital stays for very sick COVID-19 patients are modest, and were recently called into question by negative results in a large study sponsored by the World Health Organization. The drug is complex and time-consuming to manufacture. And it's given intravenously over multiple days, limiting its potential to be used more broadly.

An oral antiviral, or an infusible drug specifically engineered to stop SARS-CoV-2 from replicating, could solve many of these problems. A pill, for example, is much easier to manufacture and distribute widely. It would also be less burdensome to administer earlier in a patient's disease course, when stopping the virus from spreading might help prevent the progression of COVID-19. And a drug tailor-made for COVID-19 should be more potent than a treatment originally designed for something else.

As time has gone on, multiple drugmakers have brought these types of candidates into human testing. Pfizer began a Phase 1 trial of a novel, intravenously administered antiviral in September. In preclinical tests, the drug showed potential against multiple coronaviruses, which could make it useful in future outbreaks. Merck has an antiviral pill in Phase 2 testing, with data expected shortly. The drug, licensed from biotech Ridgeback Therapeutics, has broad spectrum activity, expanding its future potential, Merck executives have said.

Now Roche is in the mix with AT-527, an experimental pill developed by Atea that interferes with the RNA of multiple viruses, among them SARS-CoV-2. Atea was cleared by the Food and Drug Administration in May to begin testing AT-527 in COVID-19, and raised $215 million from a wide group of investors to back the effort.

Roche will now accelerate that plan, and is envisioning a broad program ahead for the Atea drug, should it prove helpful to hospitalized patients. Positive results in the Phase 2 test could lead to a pivotal study in the first quarter of 2021 that will also include patients who aren't hospitalized. Another Phase 3 test in patients newly exposed to infection could follow.

Under the collaboration, Roche has acquired international rights to the drug and will help accelerate its development, and manufacture and distribute the antiviral overseas. Atea keeps remaining drug rights, though it can request Roche's help with U.S. distribution as well. Roche noted specifically in a statement that AT-527 can be manufactured "quickly and at scale."

The Swiss drugmaker recently cut a similar-type deal with Regeneron to help widely manufacture the biotech's experimental COVID-19 antibody drug, which could soon win an emergency clearance from U.S. regulators. It's also been testing its arthritis medicine Actemra against COVID-19, with mixed results.

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Roche joins the COVID-19 antiviral drug race, betting $350M on a startup - BioPharma Dive

Stressing freedom, vaccine opponents rebranding in virus era – The Westerly Sun

October 23, 2020

Years before this years anti-mask and reopening demonstrations, vaccine opponents were working on reinventing their image around a rallying cry of civil liberties and medical freedom.

Now, boosted by the pandemic and the political climate, their rebranding is appealing to a different subset of society invested in civil liberties and, some health officials say, undercutting public health efforts during a critical moment for vaccines.

A new analysis from several institutions has found that between 2009 to 2019, conversations around civil liberties in the anti-vaccine community had increased, with Facebook pages framing vaccines as an issue of values and civil rights.

Researchers reviewed over 200 Facebook pages supporting vaccine refusal for their paper published in the American Journal of Public Health this month. David A. Broniatowski, the papers lead author, said current protests against government lockdowns and masks took their pages directly from the anti-vaccine playbook.

We couldve seen it coming, said Broniatowski, an associate professor at George Washington Universitys School of Engineering and Applied Science. This was all happening right under our noses, and its continuing to happen.

In recent weeks, protesters gathered in Massachusetts to demonstrate against the governors mandate requiring schoolchildren to receive the influenza vaccine. In Facebook pages and groups touting medical freedom and vaccine choice, the protesters have called the mandate unconstitutional and say it infringes on their rights.

Anita Garcia has been protesting vaccines for years and recently took part in protests against the flu mandate in Massachusetts, where she is from. Garcia is a member of an 866-member Facebook group called Massachusetts for Medical Freedom. She said that with the flu mandate demonstrations, she is seeing protesters turn out to object to what they consider government overreach.

All you can do is try to fight for your freedom, Garcia said. We are for medical freedom, bodily autonomy. Our bodies are ours, not for someone else to govern.

Vaccines, though, save lives 2 to 3 million a year, according to World Health Organization estimates. And vaccines have all but eliminated from American life such childhood diseases as measles, which regularly infected 3 to 4 million people a year in the United States before a vaccine was developed. It was declared eliminated from the United States in 2000, though low vaccination rates in some communities have led to outbreaks in recent years.

Vaccines are encouraged, or in some cases required, because they have been proven safe and protect not only those vaccinated but also others who cant be by slowing the spread of preventable diseases.

Historically, the anti-vaccine community has been known for its concerns around vaccine safety and the debunked theory that vaccines cause autism. Broniatowski and researchers found, though, that civil liberties have emerged as a common narrative among vaccine refusal pages on Facebook, including those who also supported alternative medicine and conspiracy theories about the pharmaceutical industry and billionaire philanthropist Bill Gates.

The rebranding to emphasize liberties is allowing vaccine opponents to exploit American reactions to the pandemic, said Dorit Reiss, a University of California Hastings law professor who specializes in policy issues related to vaccines.

I do think we are seeing an increase in people in support of them just because more people are vulnerable, upset and distrustful, Reiss said. And the anti-vaccine movement knows exactly what to say.

Medical freedom advocates are moving quickly on social media to capitalize around the frustration around the pandemic. During this months vice presidential debate, Democratic Sen. Kamala Harris was asked if she would take a coronavirus vaccine. Harris responded by saying shed take the vaccine if public health professionals recommend it but that if Donald Trump tells us we should take it, Im not taking it.

Shortly after her remark, accounts and pages on Facebook and Twitter that support medical freedom began circulating a text post that said Kamala wont take a vaccine that DJT pushed. Imagine being forced to take a mandated vaccine from a leader you disagree with!! The irony. Do you NOW understand what Medical Freedom means?

You can see the consequences to these groups sowing distrust around vaccines. And they really matter, and they are going to come out in this pandemic, said Mark Dredze, associate professor of computer science at Johns Hopkins University and one of the papers authors.

In May, a poll from The Associated Press-NORC Center for Public Affairs Research found that 31 percent of Americans were unsure if they would get the COVID-19 vaccine once released.

Medical freedom supporters are pushing out their message to a significant portion of Americans who are not anti-vaccine but who are witnessing the politicization of the virus and have concerns about the vaccine, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston.

Children have a fundamental right to access to vaccines, said Hotez, who is also co-director of the Texas Childrens Hospital Center for Vaccine Development. You need a high percentage of vaccine coverage in order to achieve herd immunity to protect all children.

As public health officials fight the pandemic and groups push for the economy to reopen, one expert suggests that health professionals trying to find common ground are going to have to meet people where they are.

You cant have a system that will result in us no longer being able to protect our communities from measles because we allow so much of the choice to occur that vaccine rates plummet, said Ross D. Silverman, professor of health policy and management at Indiana University. There is an alchemy there.

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Stressing freedom, vaccine opponents rebranding in virus era - The Westerly Sun

‘We have to be cautious,’ | Doctors warn Texas is on track for a second wave of COVID-19 – KHOU.com

October 23, 2020

Hospitalizations and new cases of coronavirus across Texas have shown a slow but steady increase since the beginning of October.

HOUSTON New infections of COVID-19 in Texas are slowly increasing, according to the Texas Department of State Health Services.

New hospitalizations are also increasing, again, slowly, but steadily. Hospitalizations hit a three-month low in late September of 3,091, but as of Thursday, have risen to 4,931.

Average new cases are increasing too, since the beginning of October, according to DSHS data. Harris County and the City of Houston are reflecting these same trends.

In the last seven days (Oct. 16 to Oct. 22), Texas reported 4,478 new cases of COVID-19. In the previous seven days (Oct. 9 to Oct. 15), the state reported 3,795, a difference of 683 from one week to the next.

Dr. James McDeavitt, SVP and Dean of Clinical Affairs for Baylor College of Medicine, said hospitals in the Texas Medical Center are beginning to reopen COVID-19 units in anticipation of the rise in cases.

Not because we need them but because theres a hint that the surge might be coming, and we want to be prepared for that," said Dr. McDeavitt.

The question is, will this second surge be more or less severe than the wave Texas saw in July when the state was reporting 10,000 new cases a day?

"The danger of exponential growth of the virus is it starts off slowly, and then all of a sudden, because it multiplies, multiplies, multiplies, it's out of control, so we have to be cautious," Dr. McDeavitt said. I think we are at a very delicate equilibrium, or at the beginning of a new surge.

His concern is that people traveling for the holidays will spread the virus.

Thats like a perfect setup to become a super spreader event," said Dr. McDeavitt.

He wrote an article about the "Holiday Family Bubble," similar to the model the NBA used to protect its players this season: there were zero infections.

"One weak link will breach your bubble. Half-hearted commitments will only lead to a dangerous false sense of security," he wrote.

The tips come with a several guidelines that maximize safety leading up to and during your holiday visits.

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'We have to be cautious,' | Doctors warn Texas is on track for a second wave of COVID-19 - KHOU.com

Explained: Why October is crucial in the race to find a vaccine for Covid-19 – The Indian Express

October 23, 2020

Written by Abhishek De, Edited by Explained Desk | New Delhi | Updated: October 17, 2020 8:09:04 amPeople wearing protective masks wait in line to board a bus in Mumbai on October, 6, 2020. (Reuters Photo: Francis Mascarenhas)

When will an antidote against Covid-19 finally become widely available? The answer to this question may eventually be found this month as a handful of coronavirus vaccine candidates near the end of late stage clinical trials. At least two vaccine frontrunners Pfizer and Moderna Inc are set to release late-stage and Phase 2 results this month.

While experts have said vaccines were likely to reach the general public in the March-April 2021, drugmakers have been more ambitious with their calculations, with some firms like Moderna Inc eyeing the emergency-use authorisation route to launch their shots by year end. In fact, Pfizer may also file for US FDA approval of its vaccine this month itself, Bloomberg reported.

There are 182 vaccine candidates in pre-clinical or clinical trials across the world. Of these, 36 are in clinical trials and nine in final states of human trials. In India, where two vaccines are in phase II trials and the one by Oxford in phase III, the Union Health Ministry has said it was expecting supplies to be available from January next year.

Here is when drugmakers are eyeing release of their Covid-19 vaccines

US biotechnology company Moderna, whose mRNA-1273 vaccine is undergoing phase-3 clinical trials in the United States on 30,000 participants, has said it might seek emergency-use authorisation (EUA) after November 25 once it had enough safety data. During public health emergencies, drug regulators allow the emergency-use authorisation of unapproved medical products or treatments.

November 25 is the time we will have enough safety data to be able to put into an emergency-use authorization file that we would send to the FDA, Moderna CEO Stephane Bancel told Forbes. However, he said approval wouldnt be expected until the late first quarter or early second quarter of 2021.

Recent trial results: Recently, results of phase 1 trials of the mRNA-1273 vaccine showed that it was well-tolerated and generated a strong immune response in older adults (participants over 55 years of age).

The study, published in the New England Journal of Medicine, found that the immune response to the vaccine seen in older volunteers was comparable to that seen in younger age groups. Moreover, the blood of vaccinated volunteers contained robust binding and neutralising antibodies against SARS-CoV-2.

Also in Explained: How will the novel coronavirus behave in winter?

Pfizer Inc, which has jointly developed a candidate with German partner BioNTech SE, plans to distribute its single nucleoside-modified messenger RNA (modRNA) vaccine to Americans before the end of the year if found to be safe and effective, CEO Albert Bourla has said in an interview.

Pfizer has said it would submit data from the late-stage trial of its BNT162b2 vaccine to the FDA by end of October, putting it ahead in the race than Moderna. If the FDA approves the vaccine, the company is prepared to distribute hundreds of thousands of doses this year itself, he said in an interview on CBS television network.

Recent trial results: Two vaccine candidates BNT162b1 or BNT162b2 have gone into human trials so far. According to a report based on early phase clinical trials, published in the journal Nature, both the Pfizer vaccines induced a robust immune response in healthy adults aged 18-55 years. However, the BNT162b2 vaccine generated a lower adverse reaction, making it the safer candidate of the two.

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According to a report in The Times, pharmaceutical giant AstraZeneca could get the required clearances for the Oxford University vaccine candidate by Christmas in the UK. A full vaccine roll-out programme for the masses could take six months or less after approval, the report said. Scientists are hopeful last-stage trial results would at least show that the ChAdOx1 vaccine (also christened AZD1222 and Covishield in India) prevents 50 per cent of infections, the threshold for success.

Recent trial results: On September 9, the vaccine trials were halted after one of the participants in the UK developed an unexplained illness in an adverse event. The participant reportedly had developed a serious spinal inflammatory syndrome called transverse myelitis. Trials, however, resumed in the UK on September 12.

A report on early-stage human trial data of the vaccine candidate showed it had triggered a dual immune response in humans. Made from a weakened version of a common cold adenovirus that causes infections in chimpanzees, the vaccine induced neutralising antibodies that rendered the virus non-infectious in all participants who had been administered a second dose, a paper published in The Lancet said.

Johnson and Johnson, which began a 60,000-person phase III trial of its single-shot JNJ-78436735 vaccine last month, expects to submit results by the end of the year or early 2021. If they are positive, the company said it would seek emergency use authorisation. J&J plans to manufacture as many as 1 billion doses in 2021. The antidote stands out from the rest since it is the first one that could potentially be a single-shot vaccine. Vaccines by Moderna Inc, Pfizer Inc and AstraZeneca all require two shots separated by several weeks.

Recent trial results: Phase 1/2a human trials showed that a single dose of the vaccine induced a strong neutralising antibody response in nearly all participants aged 18 years and older and was generally well-tolerated. Participants aged 65 years of age also showed strong humoral and cellular immune responses.

Nearly two months after Russia became the first country to approve a Covid-19 vaccine (Sputnik V) amid scepticism from the global scientific community, the country is likely to approve another shot as soon as October 15. Named EpiVacCorona, the vaccine is being developed by Vector State Virology and Biotechnology Center. Russia plans to manufacture an initial 10,000 doses, with production expected to begin in November.

Recent trial results: Siberias Vector Institute completed Phase II human trials of the vaccine in September and none of the volunteers showed any side effects except experiencing sensitivity at the injection site, Sputnik news said. The first two phases of clinical trials demonstrated the effectiveness and safety of the EpiVacCorona vaccine, Vectors press department told the Interfax news agency.

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Explained: Why October is crucial in the race to find a vaccine for Covid-19 - The Indian Express

Coronavirus response | Ask the Admin: COVID-19 without a fever – Champaign/Urbana News-Gazette

October 20, 2020

A: I am sorry for your loss. Your question is a great one that points out a common misconception.

Temperature checks are not, and have never been, a good measure for preventing COVID-19. It is one screening metric that can indicate a viral illness, but it is in no way useful as the only measure.

As we saw from the recent outbreak associated with the White House, screening procedures, even those that involve rapid testing, are never intended to replace the more important prevention measures of wearing masks and practicing social distancing.

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Coronavirus response | Ask the Admin: COVID-19 without a fever - Champaign/Urbana News-Gazette

COVID-19 in South Dakota: 621 new total cases; Death toll rises to 330; Active cases at 8,441 – KELOLAND.com

October 20, 2020

PIERRE, S.D. (KELO) Seven new COVID-19 deaths were announced along with more active coronavirus cases and hospitalizations in Tuesdays update from the South Dakota Department of Health.

The death toll increased to 330. There have now been 107 deaths in October, the deadliest month of the pandemic. Of the new deaths, five were men and two were women with one in the 50-59 age range, 2 in the 70-79 age range and four in the 80+ age range.

On Tuesday, 621 new coronavirus cases were announced bringing the states total case count to 34,457, up from Monday (33,836). Total recoveries are now at 25,686, up from Monday (25,125).

Active cases are now at 8,441, up from Monday (8,388) and another daily record high.

Current hospitalizations are at 329, up from Monday (304). Total hospitalizations are at 2,193, up from Monday (2,146).

Total persons tested negative is now at 200,269, up from Monday (198,614).

There were 2,276 new persons tested reported on Tuesday.

The rest is here:

COVID-19 in South Dakota: 621 new total cases; Death toll rises to 330; Active cases at 8,441 - KELOLAND.com

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