COVID-19 Novel Coronavirus pandemic

[raisedbywolves]

My husband was a Strategic Planner, I worked in Emergency Management for the final four years of my career, and we live in South Florida. We have food (real, frozen, shelf and c-rats), meds, paper goods & medical supplies, water, batteries, fuel, guns and ammo (Saleen! ) to last about 3 weeks if we have to shelter in place. We have a go bag and a full tank of gas if we have to evacuate. We're good, we have a comprehensive emergency management plan. Written, distributed, tested.

Yeah, I think this is one of the times living in hurricaneville helps us.

[curiouscat]

I didn't know where to put this, but damn you covid-19!
I can't go grocery shopping, because I'm afraid of the virus and I'm for damn sure not taking my four month old around people that won't wear masks.
My damn husband won't buy me frozen meals to eat while he's gone. I don't know how to cook. We're running out of money. We constantly eat out, because he doesn't want to cook when he gets home and I've been semi-lazy.
I'll admit dealing with baby isn't hard. I only have to feed and change him. Otherwise, he's sleeping or on his playmat.
I don't really want to learn how to cook, because I'm afraid I'll get salmonella or e. coli poisoning. I have been buying Publix ready to pop into oven meals.
So now I'm placing an instacart order for them to deliver groceries so I don't have to buckle my child into his carseat and go to the grocery store. I know I can do curbside, but it's a hassle. They give a one hour window and who knows when the baby wants to start screaming.

[Boston Babe 73]

I didn't know where to put this, but damn you covid-19!
I can't go grocery shopping, because I'm afraid of the virus and I'm for damn sure not taking my four month old around people that won't wear masks.
My damn husband won't buy me frozen meals to eat while he's gone. I don't know how to cook. We're running out of money. We constantly eat out, because he doesn't want to cook when he gets home and I've been semi-lazy.
I'll admit dealing with baby isn't hard. I only have to feed and change him. Otherwise, he's sleeping or on his playmat.
I don't really want to learn how to cook, because I'm afraid I'll get salmonella or e. coli poisoning. I have been buying Publix ready to pop into oven meals.
So now I'm placing an instacart order for them to deliver groceries so I don't have to buckle my child into his carseat and go to the grocery store. I know I can do curbside, but it's a hassle. They give a one hour window and who knows when the baby wants to start screaming.

Learning to cook can be fun. You just start out with simple stuff and move on from there. You could also go with a service like "Freshly That delivers to your door and is pre cooked. All you have to do is heat it up. I wish there were more I could do for you. Maybe watch a couple of easier cooking shows and you'll lose a bit of that fear. I'm with you on grocery shopping. I only go ever two weeks or so and always in the early morning to avoid people.

[Nic B]

I didn't know where to put this, but damn you covid-19!
I can't go grocery shopping, because I'm afraid of the virus and I'm for damn sure not taking my four month old around people that won't wear masks.
My damn husband won't buy me frozen meals to eat while he's gone. I don't know how to cook. We're running out of money. We constantly eat out, because he doesn't want to cook when he gets home and I've been semi-lazy.
I'll admit dealing with baby isn't hard. I only have to feed and change him. Otherwise, he's sleeping or on his playmat.
I don't really want to learn how to cook, because I'm afraid I'll get salmonella or e. coli poisoning. I have been buying Publix ready to pop into oven meals.
So now I'm placing an instacart order for them to deliver groceries so I don't have to buckle my child into his carseat and go to the grocery store. I know I can do curbside, but it's a hassle. They give a one hour window and who knows when the baby wants to start screaming.

I hate cooking. I prefer something fresh out of the fridge or something frozen I can pop in the microwave. I wanted to do curbside but Walmart wouldn't do that for any frozen stuff so we had to go inside.

Walmart has this really good Atkins omelet I am obsessed with. It is just ham and cheese but I put some ketchup on it, so yummy. I also buy those personal prepackaged salads....I love the chicken Caesar and the Sante Fe kind (though I use my own dressing, vinagarette instead of the kind it comes with.

[JohnLanders]

https://www.kcra.com/article/harriso...id-19/33314321

Harrison Barnes of the Sacramento kings has been tested positive for COVID-19

SACRAMENTO, Calif. —

Harrison Barnes announced Tuesday he tested positive for COVID-19, making him the fourth Sacramento Kings player confirmed to have contracted the virus.

Barnes posted on Twitter that prior to the team leaving last week for Orlando, he tested positive for coronavirus. He said he's been primarily asymptomatic and is feeling well.

"I'm quarantined and am abiding by the safety protocol until I'm cleared for action," Barnes said on Twitter. "I hope to join my team in Orlando when it is safe to do so!"

Before heading to join his team in Orlando, Barnes will need to test negative for coronavirus twice in a row, and then pass separate NBA protocols.

Jabari Parker, Buddy Hield and Alex Len also tested positive for COVID-19 in June. Hield and Parker are already in Orlando, but Len has not yet arrived.

The Kings confirmed July 5 that they shut down their practice facility after a member of their traveling party tested positive for COVID-19.

[JohnLanders]

https://www.yourcentralvalley.com/ne...-for-covid-19/

FRESNO, California (KSEE/KGPE) — A Porterville man was arrested and charged with mail fraud and introducing a misbranded drug and sold a package of herbal mixtures dubbed the “Emergency D-Virus Plan of Care,” which he claimed treated COVID-19, according to U.S. Attorney McGregor W. Scott.

According to the indictment, Huu Tieu, 58, was the president and CEO of Golden Sunrise Pharmaceutical Inc. and Golden Sunrise Nutraceutical Inc., both headquartered in Porterville.

Scott said from at least April 25 to July 9, through his companies, Tieu marketed and sold a package of herbal mixtures dubbed the “Emergency D-Virus Plan of Care,” which he claimed treated COVID-19. In materials posted on the companies’ websites and Facebook pages and in emails to the media, Tieu made a series of false statements about the Emergency D-Virus Plan of Care, including:

That one of the mixtures in the product, called “ImunStem,” was the first dietary supplement in the United States to be FDA approved as a prescription medicine to treat serious or life-threatening conditions and had specifically been approved to treat COVID‑19. In reality, the FDA has never approved any Golden Sunrise product for any intended use and, on at least two occasions, has told Tieu in writing that ImunStem is not FDA approved; and
That ImunStem was designated as a Regenerative Medicine Advanced Therapy (RMAT) under the 21st Century Cures Act. In reality, the FDA never granted an RMAT designation to any Golden Sunrise product, denied Tieu’s request for an RMAT designation for ImunStem in 2017, and reiterated that denial to Tieu in writing in 2019.

According to the indictment, Tieu made these misrepresentations for the purpose of soliciting customers, both patients and health care professionals, to acquire Golden Sunrise products so that he could submit reimbursement claims to the patients’ insurers, including Medicare and Medi-Cal. Tieu dispensed his products to customers in the Porterville area and also shipped the products to other parts of California and the United States.

According to Scott on May 8, an undercover investigator with the Tulare County District Attorney’s Office met with Tieu in person, telling him her mother was 68 and very sick with COVID-19. The investigator asked Tieu if she should take her mother to the hospital. Tieu responded, “No. You cannot go in there,” and instead, encouraged her to use Golden Sunrise products.

If convicted, Tieu faces a maximum statutory penalty of 20 years in prison and a $250,000 fine on the mail fraud counts and three years in prison and a $10,000 fine on the misbranding counts.

[JohnLanders]

Here is a Report of a COVID-19 Party On Lake Erie

[JohnLanders]

[JohnLanders]

[JohnLanders]

https://dailyvoice.com/new-york/suff...sitive/790806/

A spike in COVID-19 cases in Suffolk County has been traced back to a Fourth of July party where attendees failed to adhere to state guidelines for stopping the spread of the virus.

New York Gov. Andrew Cuomo said on Tuesday, July 14 that state and local contact tracing efforts found that 35 percent of people who attended the event became infected with the virus after not social distancing or wearing face coverings.

The 35 percent of party-goers represented more than a third of everyone who was in attendance at the bash. State officials did not release the name of the town where the party was held.

Long Island has seen a rise in positive cases in recent days from those being tested for COVID-19. The infection rate on Long Island over the past three days is as follows:

Saturday, July 11: 0.9 percent;
Sunday, July 12: 1.5 percent;
Monday, July 13: 2.0 percent.
Long Island’s infection rate on Monday, July 13 was the highest in the state, ahead of the Capital Region (1.7 percent), New York City (1.4 percent), and the Finger Lakes (1.4 percent).

"New Yorkers showed incredible courage and resiliency throughout this pandemic, and nowhere is their work more evident than in the numbers we release every day, including in New York City, once a global hotspot," Cuomo said.

"However, the success of our efforts depends on citizens' willingness to comply with state guidance, socially distance, wear masks and wash their hands, and rising cases around the country continue to threaten our progress.”

In the past 24 hours, there have been 102 new positive COVID-19 cases reported, bringing the total to 42,214 during the pandemic. Nassau reported 69 new cases of the virus, for a total of 42,423 positive cases.

"It's also clear based on contact tracing that many of the new cases in New York are a result of a lack of compliance during the July 4 weekend and illustrate how quickly the virus spreads, with one party, for example, infecting more than a third of attendees," Cuomo said.

"I cannot be more clear: Look at what's happening in the rest of the country — if we are not smart, if we don't wear masks and socially distance, cases will spike,” he said. “No one wants to go back to the hell we experienced three months ago, so please stay vigilant."

Click here to sign up for Daily Voice's free daily emails and news alerts.

[JohnLanders]

https://www.kmov.com/news/five-peopl...105a73aa3.html

CASS COUNTY, Mo. (KMOV.com) -- Five people tested positive for COVID-19 after attending the same party over the Fourth of July weekend in Cass County, officials say.

The party happened on July 3 at a home between Harrisonville and Garden City near MO-7 Highway.

According to the health department, the party did not have a specific guest list, so contacting those who attended and who were possibly exposed is difficult.

Anyone who attended is asked to quarantine for 14 days and monitor themselves for COVID-19 symptoms.

If symptoms appear, individuals are asked to call their primary care provider or the Cass County Health Department at 816-673-4618.

[JohnLanders]

https://www.news5cleveland.com/news/...f-state-travel

MEDINA, Ohio — The Medina County Health Department is advising residents to wear masks and to practice social distancing following a surge of COVID-19 cases.

According to health officials, Medina County saw 74 cases during the 7-day period of July 6 to 13, which is the highest number of cases for a 7-day time period since the pandemic began.

Officials say that the positives cases did not come from congregate living areas such as nursing home or from testing events. The new cases have been traced to graduation parties, weddings, other group gatherings and out-of-state travel.

The health department asks residents to practice social distancing, wear a mask, avoid groups of 10 or more and wash your hands.

Health officials said that while residents are probably tired of hearing about washing your hands to help stop the spread of coronavirus, each thing you do creates a layer of protection that when combined, goes a long way in helping keep you, your family and the community healthy.

When it comes to schools, health officials say districts “are all grappling with how to incorporate as many layers as possible into each environment. This won’t be easy, and it won’t be perfect. Every district will make those tough individual choices for their schools, and parents will in turn make those choices for their own families.”

The health department asks residents to act with the entire community’s well-being in mind.

Additional Coronavirus information and resources:
See complete coverage on our Coronavirus Continuing Coverage page.

Rebound Northeast Ohio News 5's initiative to help people through the financial impact of the coronavirus by offering one place to go for information on everything available to help and how to access it. We're providing resources on:

Getting Back to Work - Learn about the latest job openings, how to file for benefits and succeed in the job market.

Making Ends Meet - Find help on topics from rent to food to new belt-tightening techniques.

Managing the Stress - Feeling isolated or frustrated? Learn ways to connect with people virtually, get counseling or manage your stress.

[JohnLanders]

https://www.nbcphiladelphia.com/news...party/2468901/

A Montgomery County youth sports coach had contact with players and attended a 4th of July party while infected with COVID-19, according to county commissioner Dr. Valerie Arkoosh.

Dr. Arkoosh spoke about the person, whose gender or identity was not revealed, while discussing contact tracing during a COVID-19 news conference Wednesday afternoon.

The county's contact tracing team had shared the story of "a youth sports league coach, who tested positive for COVID-19, and was coaching during the infectious period, coached several games," Arkoosh said. "And this individual acknowledged that they did not always maintain social distance and did not always wear a mask."

“So because of that, working with the president of the league, the Office of Public Health recommended that 12 players and all three coaches that were involved be quarantined for a 14-day period,” Dr. Arkoosh said.

Montgomery County officials learned through contact tracing that the person also attended a 4th of July party during the infectious period.

“So because of that, working with the president of the league, the Office of Public Health recommended that 12 players and all three coaches that were involved be quarantined for a 14-day period,” Dr. Arkoosh said.

Montgomery County officials learned through contact tracing that the person also attended a 4th of July party during the infectious period.

[curiouscat]

Can someone explain to me in stupid people terms why you should self quarantine for two weeks? Why that specific number? Also, why even though you might've been more than 6 feet from a co-worker and not show symptoms, why you should get tested if they tested positive. I'm trying to explain to my husband and his dumbass mother why she should be tested. Nothing is getting through to them.

[JohnLanders]

Can someone explain to me in stupid people terms why you should self quarantine for two weeks? Why that specific number? Also, why even though you might've been more than 6 feet from a co-worker and not show symptoms, why you should get tested if they tested positive. I'm trying to explain to my husband and his dumbass mother why she should be tested. Nothing is getting through to them.

The sad part is that some of these people believe in COVID-19 conspiracy theories if thats the case here. You can shove entire virology, microbiology and immunology class on non biology majors and they will take Hydroxychloroquine like its their Kool-Aid at this point.

[JohnLanders]

https://www.usnews.com/news/entertai...heory-is-aired

NEW YORK (AP) — The Sinclair Broadcast Group said Saturday it is pulling from the air an edition of its “America This Week” program that discusses a conspiracy theory involving Dr. Anthony Fauci and the coronavirus.

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Sinclair spokesman Michael Padovano said Sinclair hopes to add context and other viewpoints and still air the controversial segment on the next week's edition of “America This Week."

Meanwhile, Fauci, the nation's top infectious disease expert, talked in detail in a new podcast about the “serious threats” and hate mail directed his way.

“America This Week” is hosted by Eric Bolling, a former Fox News Channel personality, and sent to stations Sinclair owns in 81 markets. The show it initially distributed for this weekend's show featured an interview with Judy Mikovits, maker of the widely discredited “Plandemic” video, and her lawyer, Larry Klayman.

Mikovits, an anti-vaccine activist, said she believed that Fauci manufactured the coronavirus that causes COVID-19 and shipped it to China. There has been no evidence that the virus was produced in a lab, much less any of Fauci's involvement.

Bolling did not push back on the claim, or show any evidence of checking its veracity. He followed up with a segment interviewing radiologist Dr. Nicole Saphier, a Fox News contributor, who said she thought Fauci “in no way, shape or form has been involved in the manufacture of this virus.”

During the segment, first revealed by Media Matters for America, a chyron on the bottom of the screen read “Did Dr. Fauci create coronavirus?"

Bolling told CNN Business that he wasn't even aware of the “Plandemic” video before his bookers arranged for Mikovits' appearance. He told CNN that “frankly, I was shocked when she made the accusation.” He said he brought Saphier on to challenge what he called a “hefty” charge.

The 26-minute “Plandemic” video emerged this spring and promoted a series of questionable, false and potentially dangerous theories. Online platforms Facebook, YouTube and Twitter took actions to slow its distribution.

Kelly McBride, a senior vice president and ethics expert for the Poynter Institute, a journalism think tank, said Saturday that such controversial theories should only be presented if accompanied by thorough reporting on their accuracy.

“One has the responsibility to vet the information that they're putting in front of an audience,” McBride said. “There's no way to put information out like that responsibly because it's so far-fetched.”

Before pulling the episode, Sinclair had tweeted that it did not endorse Mikovits' theory. But the company said, “We're a supporter of free speech and a marketplace of ideas and viewpoints, even if incredibly controversial.”

A hero to some for his blunt talk about COVID-19, Fauci has been the target of criticism by President Donald Trump and his supporters. It was revealed this spring that he was given security after receiving threats, and he talked about it in some detail on “The Axe Files” podcast with former Obama aide David Axelrod this past week.

Fauci said he's seen a side of society that is disturbing, with a far greater level of anger than he heard in the 1980s when he was working to combat HIV.

Fauci says he is receiving “not only hate mail, but actual serious threats against me."

“I mean against my family, my daughters, my wife,” he said. "There are people who get really angry at thinking that I’m interfering with their life because I’m pushing a public health agenda.”

When it comes to hate mail and serious threats against him and his family, Fauci said, “I don't really see how society does that.”

“I could understand, very well, that you have to be careful because of the negative consequences of things like shutting down,” he said. “That's understandable, which is the reason we're all trying to open up America again in a way that is safe, that we can do it in a measured fashion. But the hostility against public health issues is difficult to not only understand, but difficult to even process."

[raisedbywolves]

Can someone explain to me in stupid people terms why you should self quarantine for two weeks? Why that specific number? Also, why even though you might've been more than 6 feet from a co-worker and not show symptoms, why you should get tested if they tested positive. I'm trying to explain to my husband and his dumbass mother why she should be tested. Nothing is getting through to them.

You should self quarantine for two weeks because this is the potential incubation period during which you could become sick from the exposure. I believe they say you could get sick anywhere from 2-14 days after being exposed. During this time you are potentially infectious yourself, but might not be showing symptoms. If you quarantine, you keep from passing the virus to others, even if you aren't showing symptoms.

As for the social distancing, that is the best we can do (and wear masks), but it's not foolproof. Plus, in a work situation, I guarantee you that people can't stay socially distanced at all times.

[JohnLanders]

https://ktla.com/news/local-news/l-a...d-19-briefing/

Los Angeles Mayor Eric Garcetti said Wednesday that people without symptoms should continue to get tested for COVID-19, despite new guidelines put out by the U.S. Centers for Disease Control and Prevention this week.

?I very strongly disagree with what the CDC put out saying that there should not be testing of people without symptoms,? the mayor said.

The CDC changed its COVID-19 testing guidelines to say some people without symptoms may not need to be tested, even if they?ve been in close contact with someone who has the virus. Previously, the CDC had said testing was appropriate for people with recent or suspected exposure, even if they were asymptomatic.

?This is a devastating virus. Never forget that,? Garcetti said. ?If it doesn?t kill you, it can leave you with long-term damage.?

L.A. was the first big city to offer widespread testing to non-symptomatic people, the mayor said, allowing 30% of cases to be caught that way.

?Often it?s those silent spreaders that have done the most damage,? he said. ?We will not stop providing tests for those who don?t have symptoms.?

The change in federal testing guidelines was a result of pressure from the upper ranks of the Trump administration, a federal health official said, and Dr. Anthony Fauci, a key White House coronavirus task force member, said he was not part of the meeting when the new guidelines were discussed.

L.A. County public health officials said Wednesday that the COVID-19 case rate has continued to drop and is now at fewer than 200 cases per 100,000 residents. And, the mayor said COVID-19 hospitalizations are at an all-time low since the beginning of the pandemic.

But health officials continue to stress the importance of maintaining physical distance, regular hand-washing and wearing masks to help slow the spread of the virus until there is a vaccine.

A new vaccine trial is coming to L.A. County, officials announced Wednesday, and those interested in participating can sign up online.

And, the city of L.A. is working to accelerate research into rapid, at-home COVID-19 tests, which will dramatically ramp up testing capacity, according to Garcetti.

The county reported 1,642 new coronavirus cases on Wednesday, bringing the total to 235,286. Additionally 58 new deaths were reported, raising the death toll countywide to 5,663.

Garcetti also announced Wednesday that Los Angeles would make all city services contactless and digital.

?This directive is a critical step to not only modernize government, but to keep us safe as we open up city services, or the city services that have stayed open and they don?t put you at risk,? the mayor said. ?So this is about saving time and money. This is about keeping you safe and healthy. And this is about increasing the quality and reimagination of the service you get from the city.?

City officials are working on creating a universal login for services including payment, direct assistance, public counter permits and library services.

Garcetti also said last week that the L.A. Al Fresco program that provides outdoor dining permits will be extended through the end of 2020.

[JohnLanders]

Here is an update on Covid

[JohnLanders]

https://losangeles.cbslocal.com/2020...-becomes-sick/

LOS ANGELES (CBSLA/AP) — Late-stage studies of AstraZeneca’s COVID-19 vaccine candidate are on temporary hold while the company investigates whether a patient suffered a serious side effect or an unrelated illness.

In a statement issued Tuesday, the company said its “standard review process triggered a pause to vaccination to allow review of safety data,” stating that a patient experienced a “potentially unexplained illness.” The health news site STAT first reported the pause in testing, stating that the impacted patient was in the United Kingdom.

An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies in the U.S., which late last month began recruiting 30,000 people for the vaccine’s largest study. That trial includes participants in the Los Angeles area in a study being conducted by the Lundquist Institute, in partnership with the National Institutes of Health and AstraZeneca.

“This is an historic occasion for the nation, for the county of Los Angeles and particularly for the Lundquist Institute,” Dr. David Meyer, president and chief executive of the institute, said Friday when a Long Beach man became the first in that trial to receive the vaccine.

It was not immediately clear what the impacts of the pause would be on that trial.

The vaccine, developed by Oxford University, is also being tested in thousands of people in Britain and in smaller studies in Brazil and South Africa.

Temporary holds of large medical studies are not unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing. AstraZeneca pointed out that it was possible the problem could be a coincidence; illnesses of all sorts could arise in studies of thousands of people.

“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,” the company statement said.

Dr. Ashish Jha of Brown University said via Twitter that the significance of the interruption was unclear but that he was “still optimistic” that an effective vaccine will be found in the coming months.

“But optimism isn’t evidence,” he wrote. “Let’s let science drive this process.”

The development came the same day that AstraZeneca and eight other drugmakers issued an unusual pledge, vowing to uphold the highest ethical and scientific standards in developing their vaccines.

Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech. Those two vaccines work differently than AstraZeneca’s, and the studies already have recruited about two-thirds of the needed volunteers.

During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important phase of study for picking less common side effects and establishing safety.

The trials also assess effectiveness by tracking who gets sick and who doesn’t between patients getting the vaccine and those receiving a dummy shot.

The announcement follows worries that President Donald Trump will pressure the U.S. Food and Drug Administration to approve a vaccine before it was proven to be safe and effective.

The U.S. has invested billions of dollars in efforts to quickly develop multiple vaccines against COVID-19, but public fears that a vaccine is unsafe or ineffective could be disastrous — derailing the effort to vaccinate millions of Americans.

Representatives for the FDA did not immediately respond to requests for comment.

AstraZeneca’s U.S.-traded shares fell more than 6% in after-hours trading following reports of the trial being paused.

https://www.cnbc.com/2020/09/08/coro...-election.html

White House coronavirus advisor Dr. Anthony Fauci said Tuesday a coronavirus vaccine probably won’t be ready by the U.S. presidential election even as the Centers for Disease and Prevention asks states to ready distribution facilities by Nov. 1.

At a health conference, Fauci said it’s more likely a vaccine will be ready by “the end of the year” as drug companies Moderna and Pfizer race to complete patient enrollment for their late-stage vaccine trials by the end of September.

“It’s unlikely we’ll have a definitive answer” by the Nov. 3 election, the director of the National Institute of Allergy and Infectious Diseases said at the Research! America 2020 National Health Research Forum.

The comments are also at odds with President Donald Trump, who suggested at a press conference Monday that a vaccine could be ready for distribution by Election Day.

“We could have a vaccine soon, maybe even before a very special day. You know what day I’m talking about,” Trump told reporters.

Infectious disease experts and scientists have said they worry the vaccine approval process in the U.S. could be polluted by politics, not science.

The CDC has asked governors and health departments to prepare to distribute a vaccine as soon as Nov. 1, just two days before the election. Dr. Stephen Hahn, commissioner of the Food and Drug Administration, has also said the agency is prepared to bypass the full federal approval process in order to make a vaccine available as soon as possible.

Earlier Tuesday, nine drugmakers released a public letter pledging to “uphold the integrity of the scientific process” as they work toward potential global regulatory filings and approvals of the first Covid-19 vaccines.

“We saw it critical to come out and reiterate our commitment,” Pfizer CEO Albert Bourla told NBC’s “TODAY” on Tuesday. “We will develop our product, develop our vaccine using the highest ethical standards.”

On Thursday, Health and Human Services Secretary Alex Azar also tried to alleviate concerns about the review process, insisting the government’s Nov. 1 deadline for states is not linked to the presidential election.

“It has nothing to do with elections. This has to do with delivering safe, effective vaccines to the American people as quickly as possible and saving people’s lives,” Azar said on “CBS This Morning.” “Whether it’s Oct. 15, whether it’s Nov. 1, whether it’s Nov 15, it’s all about saving lives but meeting the FDA standards of safety and efficacy.”

Dr. Moncef Slaoui, who is leading the Trump administration’s Operation War Speed initiative, told NPR a vaccine ready for public distribution in November is “extremely unlikely.”

The FDA has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces the risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the CDC. Hahn said the FDA wouldn’t authorize a vaccine that’s not safe, even if it is fairly effective.

Fauci said Tuesday the trial results will also be reviewed by the Data and Safety Monitoring Board, an independent group of medical experts who observe patient safety and treatment data. He added he “wouldn’t be surprised” if the U.S. had more than one vaccine.

In the meantime, he said, the U.S. coronavirus response still needs to improve.

He called the coronavirus outbreak in the U.S. a “mixed bag” as new cases fall in the southern region of the country and cases surge in states such as Montana, the Dakotas, Michigan, Minnesota and Iowa.

“When you look at the country as a whole, we need to be doing much better than we’re doing,” he told told PBS’ Judy Woodruff at the conference.

[JohnLanders]

https://losangeles.cbslocal.com/2020...-becomes-sick/

LOS ANGELES (CBSLA/AP) ? Late-stage studies of AstraZeneca?s COVID-19 vaccine candidate are on temporary hold while the company investigates whether a patient suffered a serious side effect or an unrelated illness.

In a statement issued Tuesday, the company said its ?standard review process triggered a pause to vaccination to allow review of safety data,? stating that a patient experienced a ?potentially unexplained illness.? The health news site STAT first reported the pause in testing, stating that the impacted patient was in the United Kingdom.

An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies in the U.S., which late last month began recruiting 30,000 people for the vaccine?s largest study. That trial includes participants in the Los Angeles area in a study being conducted by the Lundquist Institute, in partnership with the National Institutes of Health and AstraZeneca.

?This is an historic occasion for the nation, for the county of Los Angeles and particularly for the Lundquist Institute,? Dr. David Meyer, president and chief executive of the institute, said Friday when a Long Beach man became the first in that trial to receive the vaccine.

It was not immediately clear what the impacts of the pause would be on that trial.

The vaccine, developed by Oxford University, is also being tested in thousands of people in Britain and in smaller studies in Brazil and South Africa.

Temporary holds of large medical studies are not unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing. AstraZeneca pointed out that it was possible the problem could be a coincidence; illnesses of all sorts could arise in studies of thousands of people.

?We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,? the company statement said.

Dr. Ashish Jha of Brown University said via Twitter that the significance of the interruption was unclear but that he was ?still optimistic? that an effective vaccine will be found in the coming months.

?But optimism isn?t evidence,? he wrote. ?Let?s let science drive this process.?

The development came the same day that AstraZeneca and eight other drugmakers issued an unusual pledge, vowing to uphold the highest ethical and scientific standards in developing their vaccines.

Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany?s BioNTech. Those two vaccines work differently than AstraZeneca?s, and the studies already have recruited about two-thirds of the needed volunteers.

During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important phase of study for picking less common side effects and establishing safety.

The trials also assess effectiveness by tracking who gets sick and who doesn?t between patients getting the vaccine and those receiving a dummy shot.

The announcement follows worries that President Donald Trump will pressure the U.S. Food and Drug Administration to approve a vaccine before it was proven to be safe and effective.

The U.S. has invested billions of dollars in efforts to quickly develop multiple vaccines against COVID-19, but public fears that a vaccine is unsafe or ineffective could be disastrous ? derailing the effort to vaccinate millions of Americans.

Representatives for the FDA did not immediately respond to requests for comment.

AstraZeneca?s U.S.-traded shares fell more than 6% in after-hours trading following reports of the trial being paused.

https://www.cnbc.com/2020/09/08/coro...-election.html

White House coronavirus advisor Dr. Anthony Fauci said Tuesday a coronavirus vaccine probably won?t be ready by the U.S. presidential election even as the Centers for Disease and Prevention asks states to ready distribution facilities by Nov. 1.

At a health conference, Fauci said it?s more likely a vaccine will be ready by ?the end of the year? as drug companies Moderna and Pfizer race to complete patient enrollment for their late-stage vaccine trials by the end of September.

?It?s unlikely we?ll have a definitive answer? by the Nov. 3 election, the director of the National Institute of Allergy and Infectious Diseases said at the Research! America 2020 National Health Research Forum.

The comments are also at odds with President Donald Trump, who suggested at a press conference Monday that a vaccine could be ready for distribution by Election Day.

?We could have a vaccine soon, maybe even before a very special day. You know what day I?m talking about,? Trump told reporters.

Infectious disease experts and scientists have said they worry the vaccine approval process in the U.S. could be polluted by politics, not science.

The CDC has asked governors and health departments to prepare to distribute a vaccine as soon as Nov. 1, just two days before the election. Dr. Stephen Hahn, commissioner of the Food and Drug Administration, has also said the agency is prepared to bypass the full federal approval process in order to make a vaccine available as soon as possible.

Earlier Tuesday, nine drugmakers released a public letter pledging to ?uphold the integrity of the scientific process? as they work toward potential global regulatory filings and approvals of the first Covid-19 vaccines.

?We saw it critical to come out and reiterate our commitment,? Pfizer CEO Albert Bourla told NBC?s ?TODAY? on Tuesday. ?We will develop our product, develop our vaccine using the highest ethical standards.?

On Thursday, Health and Human Services Secretary Alex Azar also tried to alleviate concerns about the review process, insisting the government?s Nov. 1 deadline for states is not linked to the presidential election.

?It has nothing to do with elections. This has to do with delivering safe, effective vaccines to the American people as quickly as possible and saving people?s lives,? Azar said on ?CBS This Morning.? ?Whether it?s Oct. 15, whether it?s Nov. 1, whether it?s Nov 15, it?s all about saving lives but meeting the FDA standards of safety and efficacy.?

Dr. Moncef Slaoui, who is leading the Trump administration?s Operation War Speed initiative, told NPR a vaccine ready for public distribution in November is ?extremely unlikely.?

The FDA has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces the risk of getting influenza by 40% to 60% compared with people who aren?t inoculated, according to the CDC. Hahn said the FDA wouldn?t authorize a vaccine that?s not safe, even if it is fairly effective.

Fauci said Tuesday the trial results will also be reviewed by the Data and Safety Monitoring Board, an independent group of medical experts who observe patient safety and treatment data. He added he ?wouldn?t be surprised? if the U.S. had more than one vaccine.

In the meantime, he said, the U.S. coronavirus response still needs to improve.

He called the coronavirus outbreak in the U.S. a ?mixed bag? as new cases fall in the southern region of the country and cases surge in states such as Montana, the Dakotas, Michigan, Minnesota and Iowa.

?When you look at the country as a whole, we need to be doing much better than we?re doing,? he told told PBS? Judy Woodruff at the conference.

[JohnLanders]

https://abcnews.go.com/Politics/stan...ry?id=72926212

A group of 78 researchers and doctors from Stanford Medical School took aim this week at Dr. Scott Atlas, the expert President Donald Trump recently added to the White House pandemic response task force, for embracing and peddling what they described as "falsehoods and misrepresentations of science" in his public musings about the coronavirus.

Atlas, a neuroradiologist by training with no background in treating infectious diseases, joined the president's medical advisory staff last month. Before doing so, he made frequent appearances on Fox News, where he often cast doubt on the efficacy of wearing masks and pushed for schools to reopen with in-person learning ? positions in line with Trump's own public sentiments.

In a "Dear Colleagues" letter penned Wednesday, the Stanford experts wrote that they have a "moral and ethical responsibility" to push back on Atlas' controversial claims about mitigating the spread of the coronavirus, which they characterized as "opinions and statements [that] run counter to established science" and "undermine public health authorities and the credible science that guides effective public health policy."

ABC News has reached out to Atlas through the White House for comment.

The rebuke from experts at Stanford's medical school, where Atlas was once chief of neuroradiology, marked a significant backlash against one of the president's top advisors. At a White House press briefing in August, Trump introduced Atlas as a new member of the coronavirus task force, calling him "a very famous man who is also highly respected."

In their letter, however, the Stanford experts tick through a set of widely accepted medical conclusions in conflict with Atlas' public statements and alleged private policy suggestions.

MORE: The new doctor in Trump's pandemic response briefings: Scott Atlas agrees with him on masks, opening schools
Without explicitly tying their list to Atlas' past statements, the set of conclusions -- which are based on a "preponderance of data," according to the letter -- include information about the use of face masks, asymptomatic spread and the risk posed to children.

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Their last point, for example, denounces the use of natural "herd immunity," the notion of allowing the disease to tear through the population to build up natural immunity, as "not a safe public health strategy."

Last month, the Washington Post reported that Atlas advocated for the administration to embrace natural herd immunity, citing five unnamed sources. Atlas vehemently denied the report.

"There is no policy of the President or this administration of achieving herd immunity. There never has been any such policy recommended to the President or to anyone else from me. That's a lie," Atlas said in a statement released by the White House.

PHOTO: President Donald Trump introduces Dr. Scott Atlas during a news conference in at the White House, Aug. 12, 2020.
Nichiolas Kamm/AFP via Getty Images
Nichiolas Kamm/AFP via Getty Images
President Donald Trump introduces Dr. Scott Atlas during a news conference in at the White House, Aug. 12, 2020.
President Donald Trump introduces Dr. Scott Atlas during a news conference in at the White House, Aug. 12, 2020.
Atlas doubled down on his defense to CNN's Michael Smerconish on Sunday.

"It's not just a lie, it's an overt lie, it's a disgusting lie, and it's a harmful statement to make. I have never advised the president to push a herd immunity strategy," he said.

MORE: Pfizer may win the COVID vaccine race. But distributing it could be another matter.
Even so, both Trump and Atlas have pushed the concept of letting the virus circulate widely -- at least among young health people -- without using the term "herd immunity." Last month, the president expressed interest in exploring the option of allowing the disease to spread quickly and allow the populace to build up resistance.

"Well, once you get to a certain number, you know, we use the word 'herd,' right, once you get to a certain number, it's going to go away," Trump said on Fox News. "So -- you know -- it doesn't have to be..."

Atlas has also drawn ire for controversial statements about returning children to schools. He has questioned whether children can transmit the virus and complained that the U.S. is "the only country ? this hysterical about opening schools."

MORE: 5 unanswered medical questions about coronavirus
The Stanford experts noted that, "while infection is less common in children than in adults, serious short-term and long-term consequences of Covid-19 are increasingly described in children and young people."

They concluded their letter by emphasizing the need to exercise "science-based decision-making," and warning that any policy proposals that fall short of that standard could undermine progress in combatting the disease.

"Failure to follow the science ? or deliberately misrepresenting the science," the letter continues, "will lead to immense avoidable harm."

Atlas is a senior fellow at Stanford's conservative Hoover Institution.

[JohnLanders]

[JohnLanders]

https://ktla.com/news/nationworld/as...n-u-k-patient/

Oxford University announced Saturday it was resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended following a reported side-effect in a U.K. patient.

In a statement, the university confirmed the restart across all of its U.K. clinical trial sites after regulators gave the go-ahead following the pause on Sunday.

“The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator, the MHRA, the trials will recommence in the U.K.,” it said.

The vaccine being developed by Oxford and AstraZeneca is widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world.

British Health Secretary Matt Hancock welcomed the restart, saying in a tweet that it was “good news for everyone” that the trial is “back up and running.”

The university said in large trials such as this “it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.”

It said globally some 18,000 people have received its vaccine so far. Volunteers from some of the worst affected countries — Britain, Brazil, South Africa and the U.S. — are taking part in the trial.

Although Oxford would not disclose information about the patient’s illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed severe neurological symptoms that prompted the pause. Specifically, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.

The university insisted that it is “committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.”
Related Content

AstraZeneca pauses COVID-19 vaccine study after ‘potentially unexplained’ illness

Pauses in drug trials are commonplace and the temporary hold led to a sharp fall in AstraZeneca’s share price following the announcement Tuesday.

The Oxford-AstraZeneca study had been previously stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine.

During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety. The trials also assess effectiveness by tracking who gets sick and who doesn’t between patients getting the vaccine and those receiving a dummy shot.

Dr. Charlotte Summers, a lecturer in intensive care medicine at the University of Cambridge, said the pause was a sign that the Oxford team was putting safety issues first, but that it led to “much unhelpful speculation.”

“To tackle the global COVID-19 pandemic, we need to develop vaccines and therapies that people feel comfortable using, therefore it is vital to maintaining public trust that we stick to the evidence and do not draw conclusions before information is available,” she said.

Scientists and others around the world, including experts at the World Health Organization, have sought to keep a lid on expectations of an imminent breakthrough for coronavirus vaccines, stressing that vaccine trials are rarely straightforward.

Italy’s health minister, Roberto Speranza, welcomed the resumption of the vaccine trial, but warned that prudence was still necessary.

“Science is at work to give the world efficient and secure treatments and vaccines,” he said. “In the meantime, the key continues to be our behavior.”

Italy, which was ground zero for Europe’s outbreak, is one of the main countries investing in the AstraZeneca vaccine.

Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech.

[JohnLanders]

https://ktla.com/news/nationworld/as...n-u-k-patient/

Oxford University announced Saturday it was resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended following a reported side-effect in a U.K. patient.

In a statement, the university confirmed the restart across all of its U.K. clinical trial sites after regulators gave the go-ahead following the pause on Sunday.

?The independent review process has concluded and following the recommendations of both the independent safety review committee and the U.K. regulator, the MHRA, the trials will recommence in the U.K.,? it said.

The vaccine being developed by Oxford and AstraZeneca is widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world.

British Health Secretary Matt Hancock welcomed the restart, saying in a tweet that it was ?good news for everyone? that the trial is ?back up and running.?

The university said in large trials such as this ?it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.?

It said globally some 18,000 people have received its vaccine so far. Volunteers from some of the worst affected countries ? Britain, Brazil, South Africa and the U.S. ? are taking part in the trial.

Although Oxford would not disclose information about the patient?s illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed severe neurological symptoms that prompted the pause. Specifically, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.

The university insisted that it is ?committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.?
Related Content

AstraZeneca pauses COVID-19 vaccine study after ?potentially unexplained? illness

Pauses in drug trials are commonplace and the temporary hold led to a sharp fall in AstraZeneca?s share price following the announcement Tuesday.

The Oxford-AstraZeneca study had been previously stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine.

During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety. The trials also assess effectiveness by tracking who gets sick and who doesn?t between patients getting the vaccine and those receiving a dummy shot.

Dr. Charlotte Summers, a lecturer in intensive care medicine at the University of Cambridge, said the pause was a sign that the Oxford team was putting safety issues first, but that it led to ?much unhelpful speculation.?

?To tackle the global COVID-19 pandemic, we need to develop vaccines and therapies that people feel comfortable using, therefore it is vital to maintaining public trust that we stick to the evidence and do not draw conclusions before information is available,? she said.

Scientists and others around the world, including experts at the World Health Organization, have sought to keep a lid on expectations of an imminent breakthrough for coronavirus vaccines, stressing that vaccine trials are rarely straightforward.

Italy?s health minister, Roberto Speranza, welcomed the resumption of the vaccine trial, but warned that prudence was still necessary.

?Science is at work to give the world efficient and secure treatments and vaccines,? he said. ?In the meantime, the key continues to be our behavior.?

Italy, which was ground zero for Europe?s outbreak, is one of the main countries investing in the AstraZeneca vaccine.

Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany?s BioNTech.