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Omicron Surges Across the World While Vaccines Struggle to Contain It

Although it’s not yet clear how dangerous the Omicron variant of COVID-19 is, it’s clearly very infectious as rates are rising in the United States and worldwide.

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Omicron Surges Across the World While Vaccines Struggle to Contain It

Although it’s not yet clear how dangerous the Omicron variant of COVID-19 is, it is clearly very infectious, and rates are rising in the U.S. and worldwide. Here’s a look at that and other related stories.

Omicron Currently 2.9% of All COVID-19 Cases in the U.S.

Now that public health officials are looking for it, they’re finding cases in the U.S. of the Omicron variant, although Delta is still dominant. According to the Centers for Disease Control and Prevention (CDC), Omicron makes up 2.9% of all cases while Delta, 96.7%. The 2.9% figure is up from 0.4% the previous week. Although the data is not confirmed, Omicron does not seem associated with severe disease, at least not yet, but does appear to be more infectious than Delta and other variants.

The CDC has also announced models suggesting a massive wave of Omicron infections as early as January. The worst-case scenario is a fresh wave of Omicron on top of Delta and influenza, which would overwhelm health systems and slam communities, particularly ones with low vaccination rates. A second model suggests a smaller Omicron surge in the spring. The models are based partially on from Denmark, Norway, and the U.K.

“I’m a lot more alarmed. I’m worried,” said Marcus Plescia, M.D., chief medical officer for the Association of State and Territorial Health Officials.

Source: BioSpace

At this time, early data indicates that people who are fully vaccinated and have received a booster are largely protected against severe disease and death from Omicron. Only about 55 million people in the U.S. have gotten the booster shots out of 200 million fully vaccinated.

Plescia added, “The hope is that it is going to be less severe, but the concern is that the numbers could be so great, even if proportionally less people have to be hospitalized, the numbers are much higher, and a lot of people are going to be really sick and overwhelm things.”

J&J Vaccine Less Effective Against Omicron

A study out of South Africa finds that the Johnson & Johnson vaccine offered almost no protection against the Omicron variant in a laboratory experiment. It provides some defense, mainly by stimulating immune cells. The laboratory assays were performed on blood plasma samples from people who had a single shot of the J&J vaccine or two of the PfizerBioNTech vaccine. They all lost some effectiveness against Omicron, but the J&J shot seemed weak. These types of laboratory tests evaluate antibody responses but do not take into account other components of the immune system, such as T cells.

“Omicron does indeed exhibit substantial immune escape from antibodies,” said Penny Moore, Ph. D., a professor of virology at Johannesburg’s University of The Witwatersrand. “The situation, I think, is even more alarming for the J&J vaccine—there was no detectable neutralization in our assay.”

Mathai Mammen, M.D., Ph. D., head of research & development for J&J’s Janssen pharmaceutical unit, stated that the company is “confident in the robust humoral and cell-mediated immune responses elicited” by its vaccine.

Similarly, a study of the University of Hong Kong, also performed on serum, found that China’s Sinovac vaccine did not produce sufficient antibodies against Omicron. The group established serum antibodies from 25 fully vaccinated people with Sinovac’s CoronaVac and another group of 25 who received two doses of Pfizer-BioNTech’s vaccine. None of the Sinovac vaccine participants demonstrated neutralizing antibodies. The Pfizer-BioNTech vaccine group did, but it dropped significantly to 20% from 24% in the laboratory test.

About 40% of COVID-19 Cases are Asymptomatic

It’s challenging to say how many people are asymptomatic for COVID-19, because people with no symptoms don’t generally get tested for the disease. But a study published in JAMA Network Open evaluated 95 studies from January 2020 to February 2021 published on populations globally, including about 30 million people. The data found that more than 60% of confirmed cases in people under 20 were asymptomatic, almost 50% in the 20 to 39 age range, and 32% in people 40 to 59. And a third, 33%, were asymptomatic in people over the age of 60.

“Across the board, it showed that among the elderly, two-thirds had symptoms, and among the 20- to 30-year-olds, about two-thirds didn’t have symptoms,” said Alan Wells, M.D., medical director of UPMC Clinical Laboratories and professor of pathology at the University of Pittsburgh School of Medicine, who was not involved with the study. “That’s what we see in a lot of respiratory viruses.”

Myocarditis Risk Much Higher from COVID-19 Than from Vaccines

A study out of the U.K. confirmed what experts have been saying about the risk of myocarditis—heart inflammation—from the COVID-19 vaccines: the risk is higher from the disease than the vaccines. The study found an additional 2 cases of myocarditis per 1 million people after one dose of the AstraZeneca/Oxford vaccine; one additional case per 1 million with the Pfizer-BioNTech; and six cases per 1 million after one dose of the Moderna. However, a positive COVID-19 test was associated with a significantly higher risk of heart inflammation.

COVID-19 Patients May Fall Under Americans with Disabilities Act

In updated guidance by the Equal Employment Opportunity Commission (EEOC), employees with COVID-19 may be protected under the Americans With Disabilities Act (ADA). This appears to primarily apply to so-called long-haul COVID, suggesting that these individuals may qualify for disability resources. To qualify, a person would have to demonstrate at least one of the following: an “actual” disability that limits a major life activity; a “record” of disability that demonstrates the person’s impairment; be “regarded as” an individual of disability, which means an employer takes some action against the individual because they perceive the staffer has a disability.

Pfizer-BioNTech Surpassing AstraZeneca-Oxford for Vaccines for Poorer Countries

Early in its vaccine development program, AstraZeneca and the University of Oxford indicated much of their focus on distributing their COVID-19 vaccine would be toward poorer countries. And the global COVAX program reflected that. However, it appears that the Pfizer-BioNTech vaccine is replacing the AstraZeneca-Oxford shots as the preferred vaccine for the less-wealthy states.

So far, COVAX has delivered more than 600 million shots to almost 150 countries. Of them, 220 million are AstraZeneca-Oxford while about 160 million are Pfizer-BioNTech. But in the first quarter of 2022, Pfizer-BioNTech is expected to take over per data from Gavi, a vaccine alliance that co-manages COVAX with the World Health Organization (WHO). A spokesperson for Gavi indicated that 470 million doses of the Pfizer-BioNTech shots had been delivered or were ready for delivery versus about 350 million of the AstraZeneca-Oxford shots.

One of the issues is that India, one of the top manufacturers of the AstraZeneca-Oxford shot to poorer countries, has been struggling to secure doses. The U.S. is primarily donating Pfizer-BioNTech shots to the program. However, the obstacle there is that the Pfizer-BioNTech shot requires more stringent cold chain transportation and storage than the AstraZeneca-Oxford vaccine, which is a bottleneck for many poorer countries. There also appears to be a risk of shortages of specialized syringes necessary for the Pfizer-BioNTech shot.

BioSpace source:

https://www.biospace.com/article/omicron-surges-in-u-s-and-the-world-and-other-covid-19-news

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Report: Pfizer, NIH Discussing Study of Longer Paxlovid Dosing Regimen

With increasing concerns about COVID-19 reinfection, Pfizer and the National Institutes of Health are discussing potential studies regarding a longer treatment…

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Report: Pfizer, NIH Discussing Study of Longer Paxlovid Dosing Regimen

With increasing concerns about COVID-19 reinfection, Pfizer and the National Institutes of Health are discussing potential studies regarding a longer treatment period with the antiviral medication, Paxlovid.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and scientific adviser to the White House, said the plan for the new studies could come over the next few days, Reuters reported this afternoon. During a White House briefing on COVID-19, Fauci pointed out that the rising cases of COVID-19 driven by an Omicron sub-variant are increasing the use of Pfizer’s Paxlovid. So far, more than 660,000 courses of Paxlovid have been administered across the U.S., Reuters said.

However, there is a growing concern that some patients are not shaking the virus as quickly as expected following a treatment regimen of the antiviral. Some continue to experience symptoms, or see a recurrence of their COVID-19 symptoms, following treatment with Paxlovid, Reuters said. Currently, there is no clear indication on the number of patients who are experiencing such a recurrence, or whether or not it is due to the variant type of COVID-19. But, the numbers appear to be enough to warrant such a conversation between America’s top infectious disease expert and Pfizer.

Paxlovid was granted Emergency Use Authorization from the U.S. Food and Drug Administration in December. It was granted EUA for the treatment of high-risk adults and pediatric patients 12 years and older who have been diagnosed with COVID-19 and are at serious risk of hospitalization. A combination of nirmatrelvir and ritonavir tablets, during clinical trials, Paxlovid significantly reduced the risk of hospitalization or death by 89% compared to placebo in non-hospitalized, high-risk adults with COVID-19 within three days of symptom-onset. However, even then, there were cases of a recurrence of symptoms in some clinical trial patients.

Pfizer Chief Executive Officer Albert Bourla has suggested that those patients who experience a recurrence of symptoms should undergo a second round of treatment with Paxlovid. As BioSpace previously reported, Bourla said if symptoms reoccur, “then you give a second course, like you do with antibiotics, and that’s it.”

However, the FDA has balked at that suggestion. Dr. John Farley, director of the FDA’s Office of Infectious Diseases, argued that there is no evidence of benefit for a longer course of treatment, such as 10 days instead of the current five days of administration, or a second five-day round of treatment.

Mark Van Scyoc/Shutterstock

While Pfizer may undertake these additional studies, as BioSpace reported earlier Wednesday, the pharma giant has so far reportedly resisted requests to use Paxlovid in combination studies. The nonprofit Drugs for Neglected Diseases Initiative said that Pfizer rejected a January request to offer doses of Paxlovid to be used in a study alongside an inhaled steroid in Africa.

Also Wednesday, Indianapolis-based Eli Lilly said studies have confirmed that bebtelovimab, the company’s monoclonal antibody against COVID-19, is effective against all variants of the SARS-CoV-2 virus, including BA.2, which is currently the dominant strain in the U.S., Seeking Alpha reported.

 

BioSpace source:

https://www.biospace.com/article/pfizer-nih-in-talks-to-begin-study-of-longer-paxlovid-dosing-regimen

 

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Missouri Bill Prevents Doctors Being Disciplined If They Prescribe Ivermectin Or Hydroxychloroquine

Missouri Bill Prevents Doctors Being Disciplined If They Prescribe Ivermectin Or Hydroxychloroquine

Authored by Naveen Athrappully via The…

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Missouri Bill Prevents Doctors Being Disciplined If They Prescribe Ivermectin Or Hydroxychloroquine

Authored by Naveen Athrappully via The Epoch Times (emphasis ours),

Missouri lawmakers passed legislation that prevents state licensing boards from disciplining doctors who prescribe ivermectin and hydroxychloroquine.

Missouri Gov. Mike Parson signs a bill in Jefferson City, Mo., on May 24, 2019. (Summer Balentine/AP Photo)

Sponsored by Rep. Brenda Kay Shields (R-Mo.), HB 2149 also bars pharmacists from questioning doctors or disputing patients regarding the usage of such drugs and their efficacy.

With a convincing 130–4 vote in the House, HB 2149 passed both chambers on May 12 and currently heads to the office of Gov. Mike Parson to be potentially signed into law.

The board shall not deny, revoke, or suspend, or otherwise take any disciplinary action against, a certificate of registration or authority, permit, or license required by this chapter for any person due to the lawful dispensing, distributing, or selling of ivermectin tablets or hydroxychloroquine sulfate tablets for human use in accordance with prescriber directions,” reads the draft of the bill (pdf).

It adds, “A pharmacist shall not contact the prescribing physician or the patient to dispute the efficacy of ivermectin tablets or hydroxychloroquine sulfate tablets for human use unless the physician or patient inquires of the pharmacist about the efficacy of ivermectin tablets or hydroxychloroquine sulfate tablets.”

Critics of the bill have noted that the Food and Drug Administration (FDA) has not given approval for usage of the drugs. Ivermectin and hydroxychloroquine have been divisive drugs and politically polarized throughout the pandemic.

“But, nevertheless, the Missouri legislature has chosen to ‘own the libs’ by issuing a gag order against every pharmacist in this state from offering their medical opinion on taking either one of those medications—even if it could kill their patient,” wrote former Democratic nominee Lindsey Simmons in a May 12 Twitter post.

Although 22 countries across the world have approved the use of ivermectin in treating COVID-19, the FDA maintains that the current data show the drug to be ineffective. Large doses can be dangerous, it says.

A recent study published in the International Journal of Infectious Diseases analyzed a national federated database of adults that compared ivermectin with the FDA-approved COVID-19 medication, remdesivir.

After using propensity score matching and adjusting for potential confounders, ivermectin was associated with reduced mortality vs remdesivir,” researchers wrote. “To our knowledge, this is the largest association study of patients with COVID-19, mortality, and ivermectin.”

According to The Associated Press, Missouri state Rep. Patty Lewis, a Democrat, agreed to the bill to satisfy a group of conservatives in the Senate. She added that the bill will not change anything significantly as medical boards do not engage in punishing doctors who prescribe drugs legally.

Tyler Durden Wed, 05/18/2022 - 23:25

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“They Shut Us Down”: Michigan Businesses Sue Whitmer For Losses Due To COVID Lockdowns

"They Shut Us Down": Michigan Businesses Sue Whitmer For Losses Due To COVID Lockdowns

Authored by Steven Kovac via The Epoch Times (emphasis…

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"They Shut Us Down": Michigan Businesses Sue Whitmer For Losses Due To COVID Lockdowns

Authored by Steven Kovac via The Epoch Times (emphasis ours),

A coalition of five bowling alleys and family entertainment centers is suing Michigan’s Gov. Gretchen Whitmer, a Democrat, for losses incurred due to her mandatory COVID-19 shutdowns in 2020.

Michigan Gov. Gretchen Whitmer listens to Democratic presidential candidate Sen. Kirsten Gillibrand (D-N.Y.) in Clawson, Mich., on March 18, 2019. (Paul Sancya/AP)

Michigan Dept. of Health and Human Services director Robert Gordon is also a defendant in the case.

The plaintiffs allege that the shutdowns imposed by Whitmer and Gordon were a “taking” of their businesses without just compensation in violation of both the state and the U.S. Constitution.

The case has been winding its way through the federal courts since January 2021.

Fred Kautz runs the lane oiler at Kautz Shore Lanes in Lexington, Mich., on May 13, 2022. (Steven Kovac/The Epoch Times)

The coalition lost the first round of the legal battle when the U.S. District Court for the Western District of Michigan ruled against it.

Oral arguments were recently held before a three-judge panel of the US Court of Appeals Sixth Circuit.

Plaintiff’s chief counsel David Kallman told The Epoch Times after the appeals court hearing, “The oral arguments from both sides were vigorous. The judges asked a lot of questions. It was the kind of proceeding that makes you proud to be a lawyer.

“Even the defense acknowledges that we are presenting ‘novel’ arguments.

“Michigan is the only state in the nation where a governor’s public health emergency powers were overturned as unconstitutional.

“If we lose in the court of appeals, we will take this case to the U.S. Supreme Court.”

Scott Bennett, executive director of the Independent Bowling and Entertainment Centers Association, told The Epoch Times,

“The governor’s actions were devastating to our industry.

“Things went from ‘two weeks to slow the spread’ to indefinite shutdowns.”

Bennett said that the forced closures were not based on solid scientific proof that bowling alleys and family entertainment centers would spread the virus any more than the Walmart stores or the GM plants that were allowed to remain open.

“They were allowed to operate with hundreds and even thousands of people in them but we had to shut down. We feel our industry was unfairly singled-out.

“We cannot stand for a repeat of such arbitrary treatment and don’t want the people of Michigan to forget what was done to them.”

With the recent uptick in COVID cases and the approaching mid-term elections, Bennett said his members that survived the 2020 shutdowns feel like it can happen all over again.

“It’s like operating day-to-day with a hammer held over your head. The uncertainty is altering business plans. The value of our businesses is dropping through the floor,” Bennett said.

Brian and Mindy Hill work the counter at their bowling alley in Imlay City, Mich. on May 13, 2022. (Steven Kovac/Epoch Times)

Fred Kautz, the proprietor of Kautz’s Shore Lanes in Lexington, Michigan, started working in the family business when he was 13.

The business has 12 bowling lanes, a bar, an arcade, a restaurant, and living quarters upstairs.

“We’ve owned this place for 42 years. For me and my family, it’s more than a place to work. It’s a way of life. And it has become an institution in our community—a real gathering place,” said Kautz.

He said he is still smarting from what happened after Whitmer’s executive actions were ruled unconstitutional by the Michigan Supreme Court in the fall of 2020.

“We got a little reprieve. We thought we were in the clear until she came back with another round of forced closures, this time under the authority of the Michigan Department of Public Health.

The first 30 days knocked us right on our butts. But we were willing to cooperate, to do our part. We were all scared and we did not want to see harm come to anybody.

We lost a lot of money at the time. We are coming back slowly, but our overall revenue is still down 20 percent from pre-pandemic days. That’s hard to make up.

“In the spring of 2020, I tried to do what was recommended and go along. Never again!

“If my Dad was still alive, he’d have never closed at all,” said Kautz.

Brian and Mindy Hill, owners of I.C. Strikes, a 16-lane bowling alley, bar, and snack bar in Imlay City said their business was hit hard by the shutdowns.

Brian was the town barber for 25 years, before purchasing the bowling alley where he learned to bowl as a child.

“We took over in December 2018. We’d saved up money to buy this place and make some upgrades. When COVID hit, we were forced to close down. It took all the money we saved for improvements just to survive,” said Brian.

The Hills said they never thought they’d see the day when their own government could do something like that to them.

Mary Bacon, assistant manager of Jump City, a family recreation center, cleans an arcade machine in Imlay City, Mich., on May 13, 2022. (Steven Kovac/The Epoch Times)

They shut us down. They took away our livelihood with no end date in sight. Then they wanted to loan us money. Think about that. They first put us in a situation where we had zero income to pay our previous debt. And then they wanted to loan us more money.

“Lots of small business people lost their businesses but kept their debt. It ruined them,” said Brian.

The Hills did apply for and receive a Small Business Administration loan at 3.25 percent interest for 30 years, and they participated in the Paycheck Protection Program which helped their business survive.

Up the road from the Hill’s bowling alley is Jump City, a large indoor recreation center offering an array of bouncy houses and arcade games for children.

Assistant manager Mary Bacon told The Epoch Times, “We lost a lot of business. We were forced to close for 15 months and had to make our payments with no income.”

Bacon remembers the morning of March 16, 2020, when many area businesses were gearing up for big St. Patrick’s Day celebrations.

“By afternoon everybody had to close. All that food went to waste.

“The shutdown was supposed to be for a couple of weeks. Nobody foresaw it would drag on for a year and three months.

“Oh, they said we could open again, but they so severely restricted the number of customers that we lost all of our big birthday parties. With so few kids allowed in, we couldn’t operate. We were losing too much money.”

Bacon said people are coming back to the center but are still scared, even though the games and bouncy houses are continuously cleaned and sanitized.

Navaeh Smalstig, 8, climbs out of a bouncy house at Jump City in Imlay City, Mich., on May 13, 2022. (Steven Kovac/The Epoch Times)

Before the pandemic, Danny Brown owned a roller rink in Grand Blanc and Owasso, two south-central Michigan towns.

“The lockdowns forced us to sell the Owasso rink for less than half of what we paid for it. We will be trying to make up our loss for years to come.”

Brown, who is a plaintiff in the lawsuit, told The Epoch Times, “To keep going I had to decide to triple our debt. Since the shutdown, I am three-quarters of a million dollars deeper in debt.

“Small businesses put everything on the line. All of our personal and family money. I am personally responsible for our debt. If I die my children will have to pay it.”

Brown said Michigan’s government acted without a real understanding and regarded the state’s small businesses as “nonessential throwaways.”

“One of the reasons we filed suit is to push the government to think differently,” he said.

According to Brown, family entertainment centers like skating rinks, bowling alleys, arcades, pool halls, miniature golf, and go-cart tracks have been nearly wiped out.

“A few years ago, there were 3,500 roller skating rinks in the United States. Now there are 700. There were five rinks in Genesee County, now there are two.” he said.

Brown attributes the decrease to years of ongoing government mandates and interference that led up to the COVID-19 lockdowns.

“They took, they stole our businesses!” he said.

Donn Slimmen, another plaintiff in the case, owns Spartan West Bowling in the west Michigan resort town of Ludington.

“The lockdown just about killed us. It was 14 to 15 months of agony. Our bank payments and utility bills didn’t stop. We went from being two to three months behind to more months behind.

“We entered into survival mode. We ate a lot of pork and beans and hotdogs. We’re still trying to work ourselves out of the hole. By the end of this summer, we might be solvent again.

“We were lucky to survive. We are still hanging on by threads,” said Slimmen.

Along with 16 bowling lanes, Slimmen operates a full-service restaurant.

It’s never come back. Pre-pandemic, we’d serve 200 customers at an ordinary Friday fish fry. Now our best night is 100.

“Our restaurant went from a thriving seated-guest business to a take-out operation grossing only two to three percent of the seated sales.

“We were spending $400 to take in proceeds of $100.

“The politicians and bureaucrats don’t understand. They never cleaned a toilet seat or climbed into a bowling machine to fix it,” said Slimmen.

Slimmen blames Gov.Gretchen Whitmer for the plight of his community and the state.

“You didn’t see Republican governors closing businesses. Their states did so much better.

“Drive through downtown Ludington or Muskegon and look at all the boarded-up storefronts. So many places are out of business. Michigan is in terrible shape,” Slimmen said.

The Tomassoni family has been in the bowling business for 84 years in the western Upper Peninsula town of Iron Mountain, Michigan.

We had to close bowling and our banquet facility a total of 161 days in two different periods of time in 2020. After the second shutdown, we could operate at 25 percent occupancy and only during restricted hours. No wedding receptions, no special events. It was a disaster.

“It ripped my heart out. I am so bitter towards my government,” said owner Pete Tomassoni.

Tomassoni’s business suffered further because of its proximity to Wisconsin which is only minutes away.

“Wisconsin closed for just 30 days. For the most part, they were wide open. That really hurt us.

“Our governor was picking and choosing which of our state’s businesses could operate. To force a business to close with no notice and without proven science is straight out wrong.

“I think that she came down so hard on small business because we, by and large, lean to the right.

“The state dangled the threat of yanking business licenses to keep people in line.

“Some of our businesses tried to defy the state and stayed open

Tyler Durden Wed, 05/18/2022 - 21:25

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