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Wednesday, January 19, 2022

How does Omicron spread so fast? High viral load isn’t the answer

 In countries around the world, Omicron has rapidly surged past other variants to become the dominant SARS-CoV-2 strain. Now, two studies show that the variant has achieved success despite causing viral levels in the body that are similar to — or lower than — those of its main competitor, the Delta variant1,2.

The results suggest that Omicron’s hyper-transmissibility does not stem from the release of large amounts of virus from infected people. Instead, the best explanation for its lightning-fast spread is its ability to evade SARS-CoV-2 immunity caused by either vaccination or past infection, says Emily Bruce, a virologist at the University of Vermont in Burlington.

The studies have not yet been peer reviewed.

Heavy load

Previous research has hinted that, compared with infections earlier in the pandemic, Delta-variant infections lead to a higher ‘viral load’, the amount of virus in an infected person. This is often measured using a polymerase chain reaction (PCR) test, which provides an index of the quantity of viral RNA in the body.

To compare the viral loads linked to the ever-changing cast of SARS-CoV-2 variants, Yonatan Grad, an infectious-disease specialist at the Harvard T. H. Chan School of Public Health in Boston, Massachusetts, and his co-authors drew on data from the National Basketball Association, the organization responsible for professional basketball in North America1. The league conducts frequent COVID-19 testing of its players and personnel.

The researchers studied PCR-test results of nose and throat swabs collected from infected individuals and found that those who had Delta had a slightly higher peak viral load than did those with Omicron. “I was really not expecting to see that,” says Grad. After all, in only two months, Omicron replaced Delta as the dominant cause of US COVID-19 cases.

Benjamin Meyer, a virologist at the University of Geneva in Switzerland, says he too was stunned by Grad’s results. “Naturally, you’d think that higher transmissibility must cause a higher viral load,” he says.

Meyer and his colleagues took the study a step farther: rather than measuring only viral RNA, they also measured the number of infectious virus particles on swabs collected from a separate group of almost 150 infected people2. This more stringent method found no significant difference between the viral loads of vaccinated individuals infected with Omicron and those infected with Delta.

Isolation exit

The findings have implications for government policies on isolation after infection. Meyer’s team examined samples from people who had been vaccinated but nonetheless became infected with Delta. They found that about half of the samples still held infectious virus five days after the individuals tested positive. Grad and his colleagues found that five days after an initial positive test for Omicron, about half of tested individuals had viral loads high enough that they were probably still infectious.

Such results are concerning, Grad says, because guidelines published by the US Centers for Disease Control and Prevention (CDC) allow people infected with the virus to end their isolation five days after either testing positive or experiencing their first symptoms. The guidelines specify that people who have exited isolation must continue to wear a mask around others for five more days, but do not require a negative COVID-19 test to end isolation. The CDC did not respond to Nature with any comment by press time.

Omicron has made public-health decisions all the more difficult, Grad says. He and his colleagues also found more variability in viral load in individuals infected with Omicron than in people infected with Delta. “That means there’s no clear ‘one size fits all’ approach,” he says.

doi: https://doi.org/10.1038/d41586-022-00129-z

https://www.nature.com/articles/d41586-022-00129-z

Blood thinner could be used to treat and stop transmission of COVID-19

 Patients at four hospitals in NSW and Victoria are set to undergo treatment with a cheap, readily available drug that scientists believe can dramatically improve outcomes for those infected with COVID-19.

Heparin is a common blood thinner that has been in use for decades. Australian National University researchers are coordinating multiple studies aiming to prove it is effective in preventing severe disease among coronavirus patients when inhaled directly into the lungs.

ANU Professor Frank van Haren simulates administering inhaled heparin.

ANU Professor Frank van Haren simulates administering inhaled heparin.CREDIT:KATE GERAGHTY

ANU study lead Professor Frank van Haren said initial results indicate the drug could be “a promising treatment” and also “a possible preventative against the virus” with breathing and oxygen levels improving in 70 per cent of patients after they inhaled a course of heparin.

“If it is as effective as our early results suggest, it could have a major impact in our fight against COVID,” Professor van Haren said.

Researchers around the world are tracking hospital patients infected with SARS-CoV-2 in 13 countries who were given doses of inhaled heparin, which is administered through an inhaler similar to the ones used to treat asthma.

When the study began, Australia did not have enough people infected with COVID-19 to test the drug on patients here, but now trials are beginning at St George Hospital in Kogarah, the John Hunter Hospital in Newcastle, Sydney’s Royal North Shore Hospital and St Vincent’s Melbourne.

Patients ill with COVID-19 will be given heparin to inhale as early results show it reduces the severity of the disease.

Patients ill with COVID-19 will be given heparin to inhale as early results show it reduces the severity of the disease. CREDIT:KATE GERAGHTY

A randomised, peer reviewed study of 98 patients, to be published in the British Journal of Clinical Pharmacology on Thursday, found heparin was safe, with no concerning side effects among patients who inhaled a therapeutic dose of the drug.

While the larger, ongoing international study would provide a “definitive” answer about the treatment’s efficacy, Professor van Haren said the new safety findings were crucial.

“It’s super important to know that the new treatment and new way of giving something is actually safe, that it doesn’t do any harm,” he said. “There is still an urgent need for an effective treatment of COVID-19.”

Co-author Professor Clive Page, from King’s College London, who is co-leading the global studies, said inhaled heparin had antiviral properties “which work by binding to the spike proteins the coronavirus uses to enter the cells of the body.”

“Inhaled heparin effectively stops the virus infecting cells in the lungs and could also stop people from getting the virus from others,” Professor Page said.

“It also works as an anti-inflammatory drug; the medicine has the ability to calm everything down when the body is mounting an exaggerated response to the virus.”

Professor van Haren said he hoped the drug’s efficacy could be proven quickly, saying it could be used widely within months if early results held up – easing the strain on hospitals by reducing the number of patients needing to be admitted to intensive care units.

“Most COVID experts agree that vaccination alone is not going to stop the pandemic. This could really assist in poorer countries where vaccination is challenging and we think it could help frontline workers who could use it as a preventative measure,” he said.

Professor van Haren said the team was now collecting more evidence that inhaled heparin worked and that “once we have this evidence, heparin via inhalation, could be an option to treat COVID-19 patients, everywhere, within months”.

Heparin, which is normally administered via injection, is a blood thinner used to treat and prevent blood clots across the world and is widely available.

https://www.smh.com.au/politics/federal/blood-thinner-could-be-used-to-treat-and-stop-transmission-of-covid-19-20220119-p59pfa.html

Omeros: Has Responded to FDA Letter

Omeros Corporation (Nasdaq: OMER) today confirmed that earlier this month the company submitted to the U.S. Food and Drug Administration (FDA) its response to the Agency’s Complete Response Letter (CRL) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The response comprises a comprehensive briefing package drafted in close collaboration with external clinical, regulatory and legal experts that addresses in detail the points raised by FDA in its CRL for narsoplimab. Omeros concurrently requested a Type A meeting with FDA to resolve any outstanding items.

Narsoplimab is the first drug candidate submitted to FDA for approval in HSCT-TMA. It has Breakthrough Therapy and Orphan designations in both HSCT-TMA and IgA nephropathy.

https://finance.yahoo.com/news/omeros-confirms-submission-response-fda-225200222.html

WHO says no evidence that COVID boosters are needed for healthy children, young adults

 The World Health Organization's (WHO) chief scientist Soumya Swaminathan said Tuesday that there is no current evidence that suggests healthy adolescents or children need COVID-19 vaccine booster doses

Speaking at a news briefing, Swaminathan explained that more research is necessary on the shots going forward, and that the agency had been making decisions based on current science

"There is no evidence right now that healthy children or healthy adolescents need boosters. No evidence at all," she said.

Swaminathan said a panel would meet later this week to consider the question of how countries should be giving out boosters "with the view to reducing deaths." 

The vaccines, she noted, provide levels of protection against severe disease

"That's the outcome we're most interested in: protection against death. Against omicron, many of the vaccines have shown a reduction in efficacy against infection. And, that's why we see a lot of breakthrough infections. But, these are mostly not resulting in severe disease," Swaminathan explained. 

She noted that while there "is some waning which occurs over a period of time" and a "slight drop" in protection, the aim is to protect the most vulnerable and those at highest risk of severe disease and death.

In the U.S, the Food and Drug Administration (FDA) has authorized boosters of the Pfizer-BioNTech vaccine for emergency use in children as young as 12 years old.

The FDA also announced at the beginning of the month that people ages 12 and up can get Pfizer booster shots after only five months, compared to the previous six-month interval. 

Data from the Centers for Disease Control and Prevention shows that more than 81 million eligible Americans have received a booster shot thus far.

https://www.foxnews.com/health/who-no-evidence-covid-boosters-needed-healthy-children-young-adults

Betting Omicron has peaked, Johnson drops COVID-19 rules in England

 British Prime Minister Boris Johnson announced the end of COVID-19 measures introduced to curb the rapid spread of the Omicron variant in England as he looks to live with the virus after a peak in cases.

Britain was the first country to limit international travel over the Omicron variant, raising alarm bells about its mutations, and in December introduced work-at-home advice, more mask-wearing and vaccine passes to slow its spread.

But while cases soared to record highs, hospitalisations and deaths have not risen by the same extent, in part due to Britain's booster rollout and the variant's lesser severity.

Johnson's approach to avoid lockdowns and live with the virus contrasts with a zero tolerance approach to COVID-19 in China and Hong Kong, and tougher restrictions in many other European countries.

"Many nations across Europe have endured further winter lockdowns ... but this government took a different path," Johnson told lawmakers, saying the government had got the toughest decisions right and that numbers going into intensive care were falling.

"Our scientists believe it is likely that the Omicron wave has now peaked nationally ... because of the extraordinary booster campaign, together with the way the public have responded to the Plan B measures, we can return to Plan A."

Johnson said that none of the so-called Plan B measures would remain, as face masks would not be legally enforced anywhere, COVID passes would not be mandatory and advice to work from home would end.

Johnson has faced criticism for his handling of the pandemic overall, and Britain has reported 152,513 deaths, the seventh highest total globally.

Scotland, Wales and Northern Ireland have followed their own anti-coronavirus measures, generally with tougher restrictions, but have also begun to ease them.

PANDEMIC 'NOT OVER'

Johnson hopes to reset his agenda following furore over the lockdown gatherings at his office, which has some in his party plotting to remove him.

Johnson admitted he attended a party in the garden of his Downing Street office and residence in May 2020 while social mixing was banned.

The lifting of Plan B measures, along with Johnson's navigation of Omicron without resorting to a stringent lockdown, could help him appease vocal opponents of restrictions in his own caucus amid the party unrest.

He said that if data supported it, he may end the legal requirement for people to self-isolate if they test positive before the regulation lapses in March.

"But to make that possible, we must all remain cautious during these last weeks of winter," he said, warning of continued pressure on hospitals.

"The pandemic is not over."

A third of Britain's 15 million cases have been reported since the onset of Omicron. By contrast, Britain has reported 5 per cent of its COVID deaths since the variant was identified in late November.

"The idea was by really trying to put a lot of impetus on the booster programme, it would be possible ride it out without the most coercive methods," Professor Francois Balloux of University College London's Genetics Institute, told Reuters.

"In terms of morbidity and mortality, I think it could be seen as probably the right decision."

https://www.channelnewsasia.com/world/betting-omicron-has-peaked-johnson-drops-covid-19-rules-england-2445351

UnitedHealth: Omicron-Driven Cost Impact Cushioned by Healthcare Deferrals

 UnitedHealth Group Inc on Wednesday said added costs of testing and treatment related to the recent surge in COVID-19 cases are being offset by postponements of non-urgent healthcare procedures, and the health insurer maintained its 2022 profit forecast.

The comments should help allay investor concerns that the steep rise in COVID infections and hospitalizations driven by the Omicron variant of the virus in recent weeks would significantly drive up medical costs for health insurers.

Adding to those concerns was a Biden administration initiative requiring insurers to reimburse Americans for up to eight at-home rapid COVID-19 tests per month, while setting no limit for tests, including at-home tests, that insurers must cover if they are ordered or administered by a healthcare provider.

UnitedHealth, however, said severity in Omicron cases is "seemingly lower" with patients staying in hospitals for shorter periods compared to last year.

The costs are further offset by deferral of non-urgent healthcare procedures at hospitals, the company said. Many hospitals have put off elective procedures while they deal with a surge in Omicron patients.

"Activity over the past several weeks shows primary care visits having declined about 10% and an even higher rate of decline in specialist visits," Chief Financial Officer John Rex said.

Shares of the industry bellwether were up about 1%, lifting those of rivals Anthem Inc, Humana Inc and Cigna Corp.

Company executives reiterated the 2022 enrollment target for Medicare Advantage (MA) health plans during a conference call, easing some concerns that strong competition in the sector would hamper membership growth.

"UNH directly addressed the two primary sources of investor uncertainty going into the call - increased MA competition and impact from Omicron - favorably," Stephens analyst Scott Fidel said.

Humana earlier this month slashed its 2022 growth forecast for Medicare Advantage plans, citing higher-than-expected terminations in a highly competitive market.

UnitedHealth stuck with its 2022 adjusted profit forecast of between $21.10 and $21.60 per share. It also reported adjusted fourth-quarter earnings that topped Wall Street estimates by 17 cents a share.

https://money.usnews.com/investing/news/articles/2022-01-19/health-insurer-unitedhealth-profit-rises-84-on-optum-strength

U.S. to distribute 400 million free N95 masks at CVS, Walgreens in COVID fight

 The U.S. government will make 400 million non-surgical "N95" masks from its strategic national stockpile available for free to the public starting next week, a White House official said, as the Biden administration tries to curb the COVID-19 pandemic.

Snug-fitting N95 face masks, so-called because they filter at least 95% of particulate matter from the air, will be shipped to pharmacies and community health centers this week, the official said, and available for pickup late next week.

The U.S. government is leveraging the "federal retail pharmacy program," it used for vaccines, the White House said, as well as federally funded health clinics that serve minority groups hit hard by COVID infections and deaths.

Retail chain CVS CVS.N, which has nearly 10,000 U.S. pharmacy locations including within Target TGT.N stores, and Walgreens WBA.O, which has over 9,000 stores, plan to distribute free masks, company spokespeople said.

The move comes after President Joe Biden and his team faced criticism for not doing enough to foster masking or bolster testing as the Omicron variant rages across the country, and hospitalizations hit a new record.

The administration also made free rapid home tests available via a website that launched officially on Wednesday.

"This is the largest deployment of personal protective equipment in U.S. history," the official said about the masks, which retail for $1 to $2 online.

Multi-layered masks like the N95 that form a seal around the nose and mouth are considered especially effective at preventing virus spread. Last week the U.S. Centers for Disease Control and Prevention (CDC) recommended that Americans wear the "the most protective mask" that they can.

Consumer demand for N95s and other more protective masks has spiked in recent days.

MASK SUPPLY

Hospitals have recovered from the desperate N95 shortages of the early pandemic, but several executives told Reuters that healthcare supply chains remain fragile.

On Dec. 29, there were 747 million N95s in the U.S. government's Strategic National Stockpile, 59 times pre-pandemic levels, according to the U.S. Department of Health and Human Services.

U.S. mask makers told Reuters they have the machines to make millions of N95s each month.

3M MMM.N, the largest manufacturer of N95 respirators in the United States, has the capacity to make more than 2 billion of those masks a year at factories in South Dakota, Nebraska and elsewhere in the world, spokesperson Jennifer Ehrlich said.

3M has "already supplied the federal and state governments with hundreds of millions of N95s that are in stockpiles for this purpose, and we will replenish them as needed," she said.

https://www.nasdaq.com/articles/u.s.-to-distribute-400-million-free-n95-masks-at-cvs-walgreens-in-covid-fight