First known U.S. Omicron case found in fully vaccinated overseas traveler

 The United States on Wednesday identified its first known COVID case caused by the Omicron variant, discovered in a fully vaccinated patient who traveled to South Africa, as scientists continue to study the risks the new version could pose.

Public health officials said the infected person, who had mild and improving symptoms, returned to the United States from South Africa on Nov. 22 and tested positive seven days later.

That patient was fully vaccinated but did not have a booster shot, according to Dr. Anthony Fauci, the top U.S. infectious disease official, who briefed reporters at the White House.

The person is in self-quarantine and all of the patient's close contacts have tested negative, he said.

Key questions remain about the new variant, which mutated in ways that health experts think could improve its ability to both spread and evade some of the defenses provided by vaccines. Work is underway to update those vaccines, if necessary.

Omicron has been found in two dozen countries, including several in Europe plus Canada, Australia, Japan, Hong Kong and Israel.

The United States has not yet detected community transmission of Omicron. Across much of the country, COVID transmission remains high but new cases have held fairly steady over the last two weeks, according to a Reuters tally. Three-quarters of all COVID samples in South Africa are now Omicron. 

"The critical thing is, over the next week or so, will we see any community transmission from that case," said Andy Pekosz, virologist at the Johns Hopkins Bloomberg School of Public Health. "That's a critical thing that we want to keep an eye on."

Pekosz said the variant could make the relatively new set of antiviral pills from Merck (MRK.N) and Pfizer (PFE.N) more important by helping to reduce the severity of infections.

Fauci said it could take two weeks or more to gain insight into how easily the variant spreads from person to person, how severe is the disease it causes and whether it can bypass the protections provided by vaccines currently available.

The Biden administration has asked fully vaccinated people to seek booster shots after their initial doses. Sixty percent of Americans are fully vaccinated and about a fifth of those people took boosters, according to the U.S. Centers for Disease Control and Prevention (CDC).

For days, U.S. health officials have said the new variant -first detected in southern Africa and announced on Nov. 25 - was likely already in the United States as dozens of other countries also detected its presence.

"This new variant is a cause for concern but not a cause for panic," Biden said on Wednesday before the Omicron case was announced. A spokesperson, Jen Psaki, said he the president had been briefed by his team on the first known U.S. case.

Benchmark U.S. stock indexes turned negative on the news. The S&P 500 (.SPX) fell by more than 1%, extending to nearly 4% its loss in price terms over the past week. The World Health Organization named the variant as one of concern on Friday.

The United States has barred nearly all foreigners who have been in one of eight southern African countries. On Tuesday, the CDC directed airlines to disclose names and other information of passengers who have been to those countries.

https://www.reuters.com/business/healthcare-pharmaceuticals/us-reports-first-case-omicron-variant-2021-12-01/

Emerging picture from South Africa suggests Omicron could be real cause for concern

New data shows that the Omicron wave is much steeper than the Delta wave that hit South Africa - and hospitalisations are now rising in Gauteng province.

Don't be distracted by headlines that the Omicron variant might be less deadly than Delta. More worrying pictures are starting to emerge from South Africa.

And here's two of them.

The first is data from the South African COVID-19 monitoring consortium on new cases.

Image:Data from the South African COVID-19 monitoring consortium shows the impact of Omicron. Pic: SACMC Epidemic Explorer
These graphs are showing a "sustained increase" (coloured orange) in cases in recent days in most of South Africa's provinces. Out in front, is Gauteng province, home to Johannesburg and South Africa's capital Pretoria.
This is where the Omicron was first documented.
I've been told that data being published later this week will shows that nearly all this increase is likely due to cases of the Omicron variant.
Like labs in the UK, a PCR test for Omicron looks clearly different to the previously dominant Delta variant due to the "S-gene dropout". This is now the typical feature of cases in South Africa's fourth wave.

What's really concerning in these charts is that the Omicron wave is much steeper than the Delta wave that hit South Africa in their winter (in the middle of each chart in red).

Delta was by far the most transmissible variant of COVID seen so far. It also infected millions of South Africans. That, plus 24% of South Africans being vaccinated, should leave a majority of the population with some immunity to infection.

So what you would expect to see then, if a virus as transmissible as delta caused a second wave, is a much slower growth in infections - due to that herd immunity.

But here in South Africa we don't. So either, Omicron is much more transmissible than Delta or it's getting round antibodies from vaccination or previous infection. In all likelihood due to its bevvy of mutations, the new variant is probably doing a bit of both.

Now, this wouldn't be so awful if Omicron isn't a very deadly virus. Quite a few experts have suggested this week that cases from Omicron seem to be mild.

But there's a few problems with this. First, the population of South Africa and Botswana is much younger than Europe's. We know young people are more likely to get mild infections. Secondly, Omicron has only been around at noticeable levels for weeks. And it can take a couple of weeks for cases to end up in hospital.

That's where the second picture comes in. Hospitalisations are now rising in Gauteng province. And given the rise in cases are being driven by Omicron, it's reasonable to assume these admissions are caused by it too.

Image:Hospitalisations are now rising in Gauteng province. Pic: SACMC Epidemic Explorer
There are some caveats here. New outbreaks of new variants when numbers of infections are low (as is the case at the start of this wave in South Africa) can start off very steeply and then slow down. Especially if they're confined to a particular group.

The very steep Delta wave in unvaccinated parts of the north west of England were an example of this. It's also possible the hospitalisation curve doesn't rise as steeply as the curve in cases. This will be a reassuring sign.

But so far there's nothing very reassuring about the data coming out of South Africa.

https://news.sky.com/story/covid-19-emerging-picture-from-south-africa-suggests-omicron-variant-could-be-real-cause-for-concern-12484064

Over half of employers to require Covid vaccines as omicron fears grow

 As President Joe Biden’s nationwide employer vaccine mandate gets held up in court, more employers are considering implementing their own requirements.

The majority of U.S. employers now have, or plan to have, a vaccine mandate as many return-to-work plans are pushed back again, due to concerns about the new omicron Covid variant.

According to a Willis Towers Watson survey of 543 employers, 57% of all organizations said they either require or plan to require vaccinations. Of that, 18% already do and 7% are planning to put a requirement in place.

Another 32% will do so if the Occupational Safety and Health Administration Emergency Temporary Standard takes effect.

Currently, the Biden administration has had to halt implementation and enforcement of its vaccination and testing policy, which required businesses with 100 or more employees to ensure their staff were vaccinated or undergo weekly Covid testing. 

The mandate would cover two-thirds of the private-sector workforce, or more than 84 million workers. 

“This continues to be such a quagmire for employers because of the legal challenges to the ETS,” said John Ho, a labor and employment attorney at the law firm Cozen O’Connor.

“Most of the clients I’m talking to are still in a wait-and-see,” Ho said.

“If rates go back up, employers might get more aggressive,” he added. “Everyone is keeping their eye on the numbers.”

U.S. Covid cases climb heading into the holidays

Average daily case counts are lower than levels seen at this point last year but on the rise. The daily death toll, which typically lags an increase in reported cases, has flattened in recent weeks.

—2021 —2020

Average daily cases

Average daily deaths

Note: Seven-day averages of daily cases and deaths are shown to smooth day-of-week reporting fluctuations and more clearly show the trends.

Source: Johns Hopkins University. As of Nov. 18, 2021.

Even without Biden’s shot mandate, “nothing is precluding employers with moving ahead with their own version,” said Ian Carleton Schaefer, chair of Loeb & Loeb’s New York employment and labor practice.

“As employers are pushing to reopen, they are likely going to get more aggressive with their own policies, regardless of what happens,” he said.

However, the threat of higher employee turnover may be holding some businesses back from pursuing an independent plan, according to Scott Hecker, senior counsel at the Washington, D.C., office of Seyfarth Shaw and a former attorney at the U.S. Department of Labor.

“I’ve talked to clients who have said they can’t lose one person; they are already stretched so thin.” 

In fact, only 3% of employers with vaccination mandates reported a spike in resignations, Willis Towers Watson found, although nearly one-third of those planning mandates are very concerned that it could drive employees away.

“There’s certainly documentation that the threat of departure maybe isn’t borne out when the rubber meets the road,” Hecker said, but “we do have to consider that stats don’t always show the story on the ground.”

Many U.S. companies, including United Airlines, CVS Health and Walmart, already have a vaccine mandate, while others, such as Bank of America, encourage the vaccine but do not require it.

The White House has recommended that private businesses implement their own vaccine and testing requirements, despite the court-ordered pause. And yet, when Google issued its own vaccine mandate, hundreds of employees pushed back.

“The balance of power is in flux now,” added Loeb & Loeb’s Schaefer. “A lot depends on the company, the industry and the geography.”

On the flip side, nearly half of employers said that vaccine mandates could help attract and retain employees, Willis Towers Watson found. (Meanwhile, the number of job listings mandating candidates have a Covid vaccine is surging.)

The survey also found even more employers are planning to require testing and masks for employees returning to the office in addition to vaccine mandates. About 84% said they will offer testing, most on a weekly basis, and 9 out of 10 require or plan to require masks indoors.

Legally, if an employee has a religious or medical issue, they have a right to request a reasonable accommodation, which may be to stay home, according to Ho.

“Many employers were thinking of bringing employees back around the first of the year, now there’s new uncertainty which will push this back further,” said Jeff Levin-Scherz, population health leader at Willis Towers Watson.

Just over one-third, or 34%, of employees are currently working remotely, according to Willis Towers Watson, and that number is expected to drop to 27% in the first quarter of 2022.

About 3 in 10 of the employers surveyed said their organizations have already reached a “new normal” in terms of returning to the workplace and ending pandemic-related policies.

Roughly the same number said they didn’t expect that to happen until well into 2022 or later.

https://www.cnbc.com/2021/12/01/more-employers-will-make-vaccines-mandatory-as-omicron-fears-grow.html

Omicron variant may be more contagious than Delta, warns Hong Kong

 The new Omicron variant of the coronavirus could be more contagious than the prevalent Delta strain, judging by a “surprisingly distant” transmission in a Hong Kong hotel, a top microbiologist warned on Wednesday, as a transit passenger who spent days at the airport became the city’s fourth case.

Medical experts from the University of Hong Kong also urged the public not to wait for a next-generation Covid-19 vaccine against the heavily mutated variant, saying existing shots were still useful.

The HKU team, which on Tuesday night revealed it had successfully isolated the new variant, said it would partner with companies in mainland China to develop a vaccine targeting Omicron.

https://www.scmp.com/news/hong-kong/health-environment/article/3157987/omicron-coronavirus-variant-could-greatly-reduce

South Africa Sees Cases Double As White House Extends Federal Mask Mandate

 Update (1800ET): Now that the first case of the omicron variant has been confirmed in the US (even though Dr. Anthony Fauci insists that all of the case's close contacts have been identified and tested, and that there's no sign of additional cases - at least not right now), the Biden Administration has decided to extend a federal mask mandate through mid-March.

The mandate requires travelers to wear masks on airplanes, trains and buses, and at airports and train stations.

President Biden is expected to share his plans for imposing tighter travel restrictions on foreigners on Thursday. The CDC is reportedly already collecting names to give to local authorities so that their viral status can presumably be tracked.

As European countries from Germany, to Austria to the Netherlands tighten lockdown measures amid a surge in COVID cases (while deaths remain slightly elevated but more subdued), the continent's unelected bureaucrat in chief, European Commission President Ursula von der Leyen, asked during a speech on Wednesday that EU members consider adopting a vaccine mandate. All members should "think about" imposing mandates of their own in a coordinated fashion that's in keeping with the Continent's new approach.

Source: Reuters

Speaking during a news conference, the European Commission chief suggested that member states need mandates to help prevent the spread of cases and a further spike in infections due to the emergence of new variants, such as the omicron strain.

"I think it is understandable and appropriate to lead this discussion now, how we can encourage and potentially think about mandatory vaccination within the European Union," von der Leyen stated, adding that fighting the pandemic requires a "common approach" across the bloc.

Meanwhile, a former president of EU member Ireland published an editorial in Politico Europe Wednesday slamming the WTO's refusal to approve sharing of intellectual property that would allow emerging countries to produce their own vaccines.

Epidemiologists warned us time and again that allowing the virus to spread around the world is a recipe for new mutations to develop and that they will indiscriminately harm us all. This waiver, which has now dominated WTO talks for over a year, is a necessary global solution to end the pandemic. Yet one powerful voice at the WTO has continued to undermine this effort — and that must change.

Isn't it interesting how world leaders talk about vaccine mandates, while simultaneously ensuring that emerging countries will need to purchase their jabs from American pharmaceutical giants? But let's put a pin in that.

South Africa has seen the number of new COVID cases doubled between Wednesday and Tuesday, according to official data released by the same people who issued the first warnings about the omicron variant.

What's more, a top South African health official said the omicron variant would likely still be susceptible to the T-cell response caused by both natural and vaccine-induced causes. But that hasn't stopped the country from seeing a surge in infections and reinfections, which has been particularly notable among the older population, officials said.

Back in Europe, outgoing Chancellor Angela Merkel has proposed new nationwide restrictions on people who haven't been vaccinated.

Coincidentally, the WHO said earlier that indications are that most omicron cases will be mild, not severe. Of course, that's true of delta and all the other strains as well. The organization later said that the world is still "in the midst" of the pandemic.

But the point is - as even some of South Africa's top virology experts discussed earlier this week and over the weekend - that even if omicron does break through natural and vaccine-induced protections, infections will likely be mild in nearly all of these patients, and the body's T-cell response will leave most people protected.

Confirmed cases of the omicron variant remained fewer than 300 (closer to 250 still by midday) while omicron cases were confirmed for the first time in South Korea (which has already imposed travel restrictions on southern African states), Saudi Arabia and Norway. More cases were found in new locations in the UK, Switzerland, Nigeria, Brazil and elsewhere.

No cases have been confirmed in the US, but several have been identified in Canada.

Source: Bloomberg

Here are some other important stories regarding COVID and the omicron variant:

• Poland reported 29K new COVID cases, the highest in almost eight months, and 570 fatalities, on Wednesday. More alarming: the Health Ministry said 25% of the deaths were among vaccinated patients, mostly elderly people with comorbidities. Prime Minister Mateusz Morawiecki called on the nation to get boosters ahead of Christmas. The country has imposed new restrictions on travelers but hasn't confirmed a single case of omicron.
• WHO members voted to start drafting an international agreement to help avoid future pandemics as more cases amid the spread of the omicron variant. The WHO’s members approved a proposal Wednesday that set a deadline of 2024 to try to implement such a measure. They didn’t resolve the biggest disagreement, however: whether the accord should be a legally binding treaty.
• OECD chief economist Laurence Boone says it would cost $50 billion to vaccinate the world, a sum that pales in comparison to the $10 trillion G-20 countries have spent mitigating the impact of the pandemic. Too bad the US-controlled WTO won't share the recipe with the emerging world.
• The EU is preparing to recommend that member states review their travel rules daily. They should pursue a "coordinated approach" and be prepared to impose new controls if necessary.
• Finally, Israel’s coronavirus czar Salman Zarka said the country should look at mandatory vaccination now that the omicron variant has emerged. "Mandatory vaccination needs to be considered, whether through legislation or otherwise, especially given the fact that not only is the pandemic here, but I fear it will get worse," Zarka said on 103FM radio. He said he changed his mind following the appearance of omicron, which has been identified in several Israelis.
• The US is preparing to impose new travel restrictions while the CDC plans to tighten COVID screening and testing at airports around the country by requiring international travelers to have a negative COVID test result from the past 24 hours.
• WHO adds that vaccine makers shouldn't rush to rework their vaccines because they're not sure whether new vaccines are necessary.
• Austrian lawmakers extended a nationwide lockdown for a second 10-day period to suppress the latest wave of coronavirus infections before the Christmas holiday period.

Nigeria, meanwhile, has detected a case of omicron from October, the latest piece of evidence to suggest that the variant has likely already spread around the world. The Netherlands says it has found a case of omicron from two weeks ago. Before this, the earliest known sample of the variant was collected on Nov. 9 in South Africa.

https://www.zerohedge.com/covid-19/eu-chief-insists-we-must-discuss-vaccine-mandate-omicron-confirmed-norway-south-korea

NYC Prisons Face Crippling Staff Shortages As Thousands Defy Mayor's Vaccination Mandate

 Outgoing NYC Mayor Bill de Blasio has been widely criticized for seeming and acting out of touch with New Yorkers. And during his final weeks in Gracie Mansion, the intensely unpopular Democratic candidate may unwittingly handicap the already struggling NYC jail Riker's Island.

To wit, the AP reports that hundreds of city department of corrections' workers might soon be fired after missing a Tuesday deadline to either get vaccinated or see their waiver approved. The city's DoC reported 77% of its staff had gotten at least one vaccine dose as of 1700ET on Monday. That's the lowest rate of any city agency, meaning about 1,900 employees have yet to comply with the mandate or apply for the waiver.

The deadline for compliance was delayed a month for jail workers because of existing staffing shortages.

Jail workers who have applied for religious or medical exemptions can continue to work while their cases are reviewed, officials said. They plan to release data on Wednesday detailing how many workers sought for an exemption. But they already know that the number who have obstinately refused to do either is unsustainably high.

Those who don't comply are supposed to be placed on unpaid leave and asked to surrender any badges or city-issued firearms (or other equipment).

What is the mayor doing about this? Well, in anticipation of the looming mandate, Mayor de Blasio on Monday issued an emergency executive order designed to beef up jail staffing by authorizing a transition to 12 hour from 8 hour shifts. Faced with a revolt over vaccine mandates, the mayor is asking remaining workers to take on more hours in a poorly paid, highly dangerous job.

The workers and their union representatives are unsurprisingly pushing back: The president of the union for jail guards balked at de Blasio's decision to move to 12-hour shifts, calling it "reckless and misguided."

The union said it would sue to block the mandate, the same tactic an NYC police union tried in late October as the vaccine requirement for officers neared. The police union lost and the mandate went into effect as planned.

To be sure, Benny Boscio Jr., the president of the Correction Officers’ Benevolent Association, told the AP that staffing in the city’s jails is as bad or worse than it was in October, when the mayor announced jail workers would have extra time to meet the vaccine mandate.

Resignations and retirements are already piling up, Boscio warned. Asking more able-bodied workers to go on unpaid leave would be like "pouring gasoline on a fire", Boscio said.

"To move forward with placing what little staff we do have on leave tomorrow would be like pouring gasoline on a fire, which will have a catastrophic impact on the safety of our officers and the thousands of inmates in our custody," Boscio said Tuesday.

NYC's jails, which includes the notorious Rikers Island complex, have been plagued by surging violence, self-harm and deaths since the start of the pandemic. At least 14 deaths have been recorded in NYC's jails so far this year, the highest number since 2013.

But de Blasio doesn't seem to care; he's preoccupied with adopting a new plan that would ban horse-drawn carriages and replace them with electric cars. And on Monday he imposed a new vaccination mandate on child-care workers in the city. You almost couldn't make this up.

https://www.zerohedge.com/political/nyc-prisons-face-crippling-staff-shortages-thousands-defy-mayors-vaccination-mandate

Invacare gets FDA warning letter

 Invacare Corp. said it received a warning letter from the U.S. Food and Drug Administration.

The maker of medical equipment used in non-acute care settings said in a U.S. Securities and Exchange Commission filing that the letter related to observations in a Form FDA-483 issued in June following an inspection of the company's Elyria, Ohio, facilities.

The warning letter relates to procedures involving complaint handling, corrective and preventive action and medical device reporting associated with oxygen concentrators.

The FDA issues a Form 483 at the conclusion of an inspection when an investigator observes any conditions that may constitute violations of the Food Drug and Cosmetic Act and related acts.

Invacare said in the filing it intends to respond in a timely manner and work to adequately address the FDA's concerns.

The company said there has been no impact on the its ability to produce and market its products.

https://www.marketscreener.com/quote/stock/INVACARE-CORPORATION-13127/news/Invacare-Gets-Warning-Letter-From-FDA-37182238/