Colleges take COVID testing way too far and spread hysteria

 Universities are supposed to be bastions of critical thinking, reason and logic. But the COVID policies they have adopted — which have derailed two years of students’ education and threaten to upend the upcoming spring semester — have exposed them as nonsensical, anti-scientific and often downright cruel.

Some of America’s most prestigious universities are leading the charge.

At Georgetown University, fully vaccinated students are randomly tested for COVID weekly. A positive PCR test, which can detect tiny amounts of dead virus, sends asymptomatic students to a room in a designated building where they spend 10 days in confinement. Food is dropped off once a day at the door.

I spoke to several holed-up students. One told me she would sometimes call a friend to come and wave at her through the window, just to see a human face. “Everyone’s just fed up at this point,” another said. “People walk around the library and yell at you if you drink a sip of water. And it was during finals.”

Given the fact that the Centers for Disease Control and Prevention has recently changed its quarantine period from 10 days to five, I reached out to Georgetown’s chief public health officer, Dr. Ranit Mishori. She told me that Georgetown still uses a 10-day quarantine.

Amherst College requires students to double mask if they don’t use a KN95.

CHINE NOUVELLE/SIPA/Shutterstock

Near-zero risk

Students are the lowest-risk population on planet Earth. Over the last six months, the risk of a person in the broader age group (15-24) dying of COVID or dying with COVID (the CDC does not clearly distinguish) was 0.001%. All or nearly all of those deaths were in a very specific subgroup: unvaccinated people with a medical comorbidity. But despite Georgetown’s strict vaccination, masking, testing and quarantine requirements, the university announced late last month that all events, “including meetings with visitors, will need to be held virtually or outdoors.”

At Princeton University, fully vaccinated students are not allowed to leave the county unless they’re on a sports team. They’re also testing all students twice a week, usurping the scarce testing supply from vulnerable communities for low-risk young people.

At Cornell, masks are still the rule — and even recommended outdoors. At Amherst, students must double mask if they don’t use a KN95. In nearby Boston, at Emerson College, students are tested twice a week and have stay-in-room orders. The college instructs students to “only leave their residence halls or place of residence for testing, meals, medical appointments, necessary employment, or to get mail.” Seriously.

At these institutions of higher learning and thousands more, science is supposedly held in the highest esteem. So where is the scientific support for masking outdoors? Where is the scientific support for constantly testing fully vaccinated young people? Where is the support for the confinement of asymptomatic, young people who test positive for a virus to which they are already immune on a campus of other immune people?

The data simply do not justify any of it.

According to the CDC, the risk of a fully vaccinated adult ending up in the hospital for COVID was 1 in 26,000 for the week ending Nov. 27. Who was that one person? Not a college student. One analysis of breakthrough infections found that the average age of a vaccinated person being hospitalized is 72 years, and the average age of a vaccinated person dying of COVID is 80.

The data clearly tell us that the risk of a breakthrough COVID infection resulting in severe illness is extremely rare. When it does occur, it is profoundly skewed toward septuagenarians and octogenarians.

Princeton University is also testing all students twice a week, usurping the scarce testing supply from vulnerable communities for low-risk young people.

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From the beginning of this pandemic, the risk of COVID to young people has always been extremely low, a finding public-health officials have downplayed instead of acknowledged. According to the American Academy of Pediatrics, children have represented 0.00%-0.27% of all COVID-19 deaths.

In other words, a total of 803 American children have died from COVID or with COVID over the last two years. That’s fewer than the total deaths from both influenza and RSV infection in a typical year pre-pandemic. A recent study of children in Germany found that no healthy child between the ages of 5 and 17 died of COVID during a 15-month period when nearly all were unvaccinated.

And yet there is very much a public-health crisis facing young people that’s been created by these draconian COVID policies — the result of depriving young Americans of the basic enjoyment of life and the benefits of human connection.

A study conducted by The Jed Foundation, a nonprofit that combats suicide among young people, found that in 2020, 31% of parents said their child’s mental health was worse than before the pandemic. There has been a surge in hospital visits for self-harm, a surge that was particularly acute among adolescent girls. The Surgeon General recently declared a mental health crisis among young people globally, citing 25% of youth experiencing depressive symptoms and 20% experiencing anxiety symptoms.

Omicron’s mild touch

Last week, the CDC reported that weekly deaths in people age 18-29 decreased to zero from one in 5 million the week prior.

That’s lower than the number of deaths from car accidents, suicide and firearms in young people. So why are we imposing a kind of martial law on students to ever so slightly reduce the chance that they develop a mild illness?

For the past two years, this country has imposed extensive, and often unnecessary, restrictions on over 54 million school-age children, even though they are the least likely group to suffer serious consequences of a COVID infection. We have damaged their education, kept them from seeing human faces and treated them as vectors without a right to a normal childhood.

Children are required to wear masks in schools in some states.

JAMES ARTHUR GEKIERE/Belga/Sipa

At the very same moment schools are getting more extreme in their COVID policies, nature has handed us what appears to be a gift. Omicron is a far milder version of COVID that is rapidly displacing the more dangerous Delta variant and conferring cross immunity. A University of Hong Kong study found that Omicron is one-tenth as infective in lung cells compared with the Delta variant, which explains why Omicron results in far less severe illness. According to South African Health Minister Dr. Joe Phaahla, only 1.7% of COVID cases were hospitalized in the second week of the Omicron-dominant wave, compared with 19% the same week of the Delta wave.

But despite all evidence, fear of Omicron is driving more harmful policies imposed on society’s lowest-risk people.

One knee-jerk reaction to the more mild Omicron virus has been to push boosters on young people, despite no supporting clinical data and serious concerns of myocarditis complications. That’s exactly why FDA’s expert advisers voted against boosting young people by a 16-2 vote on Sept. 17. (Just yesterday, the FDA ignored their recommendation and approved the Pfizer booster for kids as young as 12.)

Current data actually tip the risk to benefit analysis in favor of not boosting young healthy people. A recent Israeli study in the New England Journal of Medicine noted zero COVID deaths among double-vaccinated people 16-29 years old without a booster. You can’t lower a risk of zero any further with a booster. But the risk of myocarditis in young people is quite real.

 A new study published last week by Kaiser Permanente Northwest researchers found that as many as 1 in 1,860 men 18-24 years old developed myocarditis after the second shot.

Schools like Emory, Tulane, Wake Forest and Johns Hopkins, my own university, which are requiring boosters in healthy young people, are venturing into uncharted waters. They are risking health complications in young people for the sake of beating back mild and asymptomatic infections.

Cornell University recommends that its students wear masks at all times, including outdoors.

AP

Students speak out

Students from around the country have reached out to me, outraged at excessive policies imposed upon them. They were afraid to be identified in this essay for fear of retaliation. And for good reason. Students have been punished, suspended and even expelled for violations of draconian masking and socializing policies.

It’s time for them to speak out.

Students, parents and university donors should voice their concerns and ask good questions, such as: Will boosters be required every 3-6 months in perpetuity? How many healthy college students have died from COVID? If I have circulating antibodies from prior COVID illness, will the university recognize those antibodies as countries in Europe do?

Concerned citizens should challenge medical dogma with data.

It’s time to learn to live with COVID by using common-sense practices: If you’re sick, stay home. If you’re around someone vulnerable, be careful. If you’ve been exposed, wear a real, quality, N95 mask. For the young who have natural or vaccinated immunity, it’s a mild virus that will circulate for the rest of their lives.

I worked at the Georgetown hospital for five years as a resident. One crucial lesson my mentors there hammered into me was: Treat the person, not the lab result. When students return to campus later this month — as I hope they will to alleviate a worsening mental-health crisis — college administrators need to heed this essential advice.

Dr. Marty Makary is a professor at the Johns Hopkins School of Medicine in Baltimore and the author of “The Price We Pay: What Broke American Health Care and How to Fix It.”

https://nypost.com/2022/01/04/colleges-take-covid-testing-too-far-and-spread-hysteria/

COVID Affects Executive Functioning in Young to Middle-Age Adults: Study

 People who have had prior SARS-CoV-2 infection report significantly more symptoms of cognitive dysfunction and specifically executive dysfunction than people in the general population with no such infection, according to new data published on the preprint server medRxiv.

Researchers, led by Peter A. Hall, PhD, with the University of Waterloo in Waterloo, Canada, found that COVID infection is associated with executive dysfunction among young and middle-aged adults, including for those not exposed to intubation or hospitalization.

The findings, published online January 2, have not been peer-reviewed.

The study included a representative cohort of 1958 community-dwelling young and middle-aged adults. It used a balanced proportion of infected and uninfected people to estimate the link between SARS-CoV-2 infection and cognitive/executive dysfunction.

The authors note that the survey was conducted from September 28 to October 21, 2021, when the primary variant in Canada was Delta.

The research was a cross-sectional observational study with data from the ongoing Canadian COVID-19 Experiences Survey (CCES). It included equal representation of vaccinated and vaccine-hesitant adults between age 18 and 54 years. COVID-19 symptoms ranged from negligible to life-threatening cases requiring hospitalization.

Half in the cohort (50.2%) received two vaccine shots; 43.3% had received no shots; and 5.5% received one shot, but were not intending to receive a second shot.

Dose-Response Relationship

According to the paper, those with prior COVID-19 infection, regardless of symptom severity, reported a significantly higher number of symptoms of executive dysfunction than their non-infected counterparts (Mechanical Adjustment [M_adj] = 1.63, SE = 0.08, 95% CI, 1.47 - 1.80; P = .001).

The researchers also found a dose-response relationship between COVID-19 symptom severity and cognitive dysfunction. Those with moderate and very/extremely severe COVID-19 symptoms were linked with significantly greater dysfunction.

"This reinforces what we're hearing about — that COVID is not 'one and done.'  It can have lasting and quite subtle and damaging effects on the human body," William Schaffner, MD, infectious disease specialist with Vanderbilt University School of Medicine in Nashville, Tennessee, told Medscape Medical News.

Measuring executive functioning — including the ability to make sound decisions — is something other studies haven't typically addressed, he said.

Men were likely to report more cognitive dysfunction symptoms than women (β = 0.15, P < .001). Younger adults (25-39 years) were more likely to experience cognitive dysfunction than those age 40-54 (β = 0.30, P < .001).

Schaffner said it was troubling that young people are more likely to experience the dysfunction.

"When we think of 'brain fog' we think of older persons who are already predisposed to have more memory lapses as they get older," he said.

The link between cognitive dysfunction and COVID-19 infection has been shown in other studies, but many have not used representative samples and have not compared results to noninfected controls in the general population, the authors write.

Executive dysfunction was measured using four questions from the Deficits in Executive Functioning Scale. Respondents were asked how often they have experienced these scenarios in the past 6 months:

• "I am unable to inhibit my reactions or responses to events or to other people."

• "I make impulsive comments to others."

• "I am likely to do things without considering the consequences for doing them."

• "I act without thinking."

"This makes it even more important that we talk about vaccination," Schaffner said, "because clearly the more seriously ill you are, the more likely this sort of thing is likely to happen and vaccines have been shown time and again to avert hospitalizations and more serious illness.

"It also makes more important the monoclonal antibody treatments we have and the antivirals, which will prevent the evolution of mild disease into something more serious," Schaffner said.

This research was supported by a grant from the Canadian Institutes for Health Research (CIHR), Institute for Population and Public Health. The study authors and Schaffner have disclosed no relevant financial relationships.

https://www.medscape.com/viewarticle/966015

COVID Vaccine Booster Efficacy Against Infection May Fade Quickly

 Real-world data from the U.K. showed that efficacy of a third dose of a COVID-19 vaccine waned significantly at the 10-week mark, leaving boosted individuals at risk of infection with Omicron.

In a December 23 U.K. Health Security Agency (HSA) technical briefing, vaccine efficacy against symptomatic infection generally fell to around 40% some 2.5 months after a booster dose.

Meaghan Kall, a PhD candidate and an epidemiologist at the HSA, tweeted that this effect "is not seen with Delta."

For its analysis, the agency assessed 147,597 Delta cases and 68,489 Omicron cases from November 27 to December 17.

It found that for those with a Pfizer primary series and booster, efficacy against symptomatic disease was 70% immediately after the third dose but fell to 45% at 10 weeks or longer.

Those who had a Pfizer primary series but a Moderna booster saw protection against symptomatic disease hover around 70% to 75% for up to 9 weeks post-boost.

For those with a primary series of AstraZeneca, efficacy peaked at 60%, 2 to 4 weeks after either a Pfizer or Moderna booster, then fell to 35% with Pfizer and 45% with Moderna by around 10 weeks.

The report didn't include data on vaccine efficacy against severe disease, including hospitalization and death, because the number of Omicron cases admitted to the hospital following a positive test was too small to create an estimate, tweeted Freja Kirsebom, PhD, of HSA.

Still, "based on experience with previous variants, we do expect [vaccine efficacy] against the more severe outcomes such as hospitalization to be substantially higher than [vaccine efficacy] against symptomatic infection," Kirsebom noted.

Data from Israel also has suggested waning efficacy after a booster dose, though that country's data pertain to the Delta variant. Last week, the expert panel advising the Israeli government recommended a fourth vaccine dose given at least 4 months after a third shot for certain groups: those ages 60 and up, immunocompromised people, and healthcare workers.

Data from the Israeli advisory committee shared with the New York Times showed a doubling in the rate of infection with Delta among people ages 60 and up within 4 or 5 months of the third shot, but it did not offer specific numbers. There was no clear indication of reduced efficacy against severe disease, according to the news report.

Peter Hotez, MD, PhD, of Baylor College of Medicine in Houston, has been advocating for a fourth shot of a COVID-19 vaccine for U.S. healthcare workers, who were among the first to receive their booster doses starting in September. They are about to face a substantial increase in exposure risk due to the Omicron wave, leading Hotez to write in a Los Angeles Times op-ed that "We must take quick action to prevent instability in our health system. If there are data to support its safety and impact, an emergency fourth shot might be offered to those healthcare workers now several months out from their booster shot. Doing so could reduce the risk of breakthrough symptomatic infection and keep these individuals on the job."

The HSA report did offer some good news -- additional confirmation of other early findings of reduced illness severity with Omicron. It found about a 60% reduced risk of hospital admission with Omicron compared with Delta (HR 0.38, 95% CI 0.30-0.50) based on 70 hospital admissions with Omicron and 3,884 with Delta.

A separate updated HSA risk assessment put infection severity in the lowest-risk "green" category based on these findings and three other analyses:

• An Imperial College London analysis showed about a 45% reduced risk of hospitalization
• An analysis from Scotland showed about a 70% reduced risk of hospitalization
• An analysis from South Africa showed about an 80% reduced risk of hospitalization

Kall cautioned that the findings have low confidence because these are early analyses with small numbers of hospitalizations, limited follow-up time, minimal adjustment for previous infection, and limited spread into the most vulnerable age group.

Still, she called this "very good news, and needed after many weeks of doomsday predictions. This will significantly cut the number of expected hospitalizations & deaths."

https://www.medpagetoday.com/special-reports/exclusives/96412

Are We Testing for Omicron Wrong?

 If confirmed in follow-up research and if the diagnostics industry can pivot quickly enough, findings from a South African study could make COVID-19 testing a lot easier for patients and healthcare workers, as the SARS-CoV-2 Omicron variant becomes the dominant source of infection.

In a manuscript posted to the medRxiv preprint server on Friday, researchers from the University of Cape Town reported that saliva samples yielded more accurate results in PCR analyses when Omicron was involved compared with those collected via nasal swabs.

When patients carried the Delta variant, on the other hand, nasal swabs were more accurate, according to the group, led by Diana Hardie, MBChB, MMedPath, who also heads the diagnostic virology laboratory at Groote Schuur Hospital.

The findings came from an analysis of 382 patients tested at Groote Schuur from August through this month, with viral whole-genome sequencing performed on isolates from those with positive results. Just over 300 were tested prior to Omicron's emergence, with 31 testing positive for the Delta variant. Another 74 arrived at the hospital after Omicron became common, of whom 36 were positive for that variant.

All patients had both saliva and mid-turbinate nasal samples taken for RT-PCR analysis. The "gold standard" for positivity in the study was detection of SARS-CoV-2 RNA with either swab.

For the Delta variant, the positive percent agreement for each sampling method, in comparison with this "gold standard," was 71% for saliva and 100% for the nasal swabs. But this was reversed for Omicron, with 100% agreement between saliva samples and the gold standard, but only 86% for nasal swabs.

Nasal swabs have been the standard for COVID-19 screening and diagnosis ever since the virus was discovered, but that may no longer be appropriate in an Omicron-dominated pandemic landscape, the authors concluded.

"These findings suggest that the pattern of viral shedding during the course of infection is altered for Omicron with higher viral shedding in saliva relative to nasal samples resulting in improved diagnostic performance of saliva swabs," Hardie and colleagues wrote.

They noted, as have others, that Omicron is distinguished by "more than 50 distinct mutations." These seem to have resulted in increased infectivity, but they could also affect other aspects of the virus's behavior, including the tissues it may prefer to infect.

With that in mind, Hardie's group pointed to a recent lab study from Hong Kong (as yet unpublished but highlighted in a press release) indicating that Omicron is less likely to lodge in the lung compared with earlier variants. This not only suggests that Omicron is less lethal, but also that the many mutations confer "altered tissue tropism."

However, while saliva sampling may be easier to perform than nasal swabbing, the researchers noted that it's not as simple as spitting in a cup. At Groote Schuur, patients were instructed to swab the inside of the mouth -- both cheeks, above and below the tongue, the gums, and hard palate -- for a total of at least 30 seconds. They were also told not to eat, drink, smoke, or chew anything for at least 30 minutes beforehand.

Another point to consider is that, in the U.S. and most other countries, testing has been predicated primarily on nasal swabs. Although some saliva-based tests have been authorized and are commercially available, the vast majority of currently accessible kits for healthcare use and for at-home self-testing rely on nasal swabs. It would likely take months to retool the supply chain to prioritize saliva sampling -- by which time Omicron may have been supplanted by another variant with its own unique characteristics.

Disclosures

Study authors declared they had no relevant financial interests.

Note that manuscripts posted to preprint servers such as medRxiv have not undergone peer review and thus the results and interpretations should be taken with caution.

Primary Source

medRxiv

Source Reference: Marais G, et al "Saliva swabs are the preferred sample for Omicron detection" medRxiv 2021; DOI: 10.1101/2021.12.22.21268246.

https://www.medpagetoday.com/infectiousdisease/covid19/96385

Entera Bio Shares Rise After Concluding FDA Meeting on Osteoporosis Treatment

 Entera Bio Ltd. said it has concluded its end-of-Phase 2 meeting with the U.S. Food and Drug Administration on EB613, its oral formulation of human parathyroid hormone for the treatment of osteoporosis.

Entera Bio shares were up 19% to $3.85 in premarket trading.

The company said the meeting defined the path for Phase 3 development of EB613, confirming that a fracture study won't be necessary and that lumbar spine bone mineral density at 12 months can be the primary endpoint.

The meeting followed completion of its Phase 2 clinical trial, which met its endpoints, including increases in lumbar spine, femoral, neck and hip bone mineral density versus placebo after six months of treatment, and demonstrated a safety profile consistent with subcutaneous PTH.

Based on FDA feedback at the meeting, Entera said that it is currently proceeding with its plans for a Phase 3 registration study of EB613 this year.

The company said the FDA confirmed that a comparison of Entera's EB613 dosed at 2.5 mg versus subcutaneous PTH with a lumbar spine BMD increase at 12 months as the primary endpoint for the trial would be acceptable. The company may rely on marketed drugs as part of a 505(b)(2) regulatory approval pathway. The FDA's 505(b)(2) new drug application pathway helps avoid unnecessary duplication of studies already performed on previously approved drugs.

If approved, EB613 would be the first oral anabolic agent for the treatment of osteoporosis. Entera said it expects to begin enrollment in its Phase 3 study in 2022.

https://www.marketscreener.com/quote/stock/ENTERA-BIO-LTD-40311507/news/Entera-Bio-Shares-Rise-After-Concluding-FDA-Meeting-on-Osteoporosis-Treatment-37462592/

Bharat Biotech gets approval to test nasal COVID-19 shot as booster - report

 

India's drug regulator on Wednesday granted approval to Bharat Biotech for conducting late-stage trials of its nasal COVID-19 vaccine to be used as a booster shot, according to a Mint report, which cited ANI.

The vaccine maker submitted the late-stage trial application to the Drugs Controller General of India (DCGI) in December, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.

"DCGI's Subject Expert Committee has granted 'in principle' approval to Bharat Biotech for the conduct of 'Phase III superiority study and Phase III booster dose study' for its intranasal COVID vaccine and has asked it to submit protocols for approval," according to the report on Wednesday.

Bharat Biotech and DCGI did not immediately respond to Reuters requests for comment.

As a precautionary measure in light of rising Omicron coronavirus variant cases across the country, India approved the administration of COVID-19 booster shots on Christmas, with healthcare and frontline workers set to receive them from Jan. 10.

The country is yet to approve the use of Bharat Biotech's intranasal vaccine, BBV154. In August, BBV154 received regulatory approval for mid- to late-stage trials. Local media had reported the mid-stage trial has completed.

India's inoculation drive so far has been dominated by a domestically produced version of the AstraZeneca COVID-19 shot by Serum Institute of India and Bharat Biotech's inactivated vaccine Covaxin, both administered through injections.

On Wednesday, the country reported 58,097 new coronavirus cases, twice the number seen only four days ago, taking its total caseload to over 35 million.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Bharat-Biotech-gets-approval-to-test-nasal-COVID-19-shot-as-booster-report-37466624/

Indian health experts urge preparations for new wave of COVID-19

 

New COVID-19 cases in India surged to 58,097 on Wednesday, a doubling of the daily tally over the past four days, as health experts called for preparations to ensure hospitals are not overwhelmed by a new wave of patients.

While doctors fretted, politicians, including Prime Minister Narendra Modi, appeared less concerned by the rising case numbers with many of them holding rallies ahead of assembly elections in several states.

Infections have been increasing sharply in cities, with the fast-spreading Omicron variant of the virus becoming dominant in places like New Delhi, authorities said.

India has confirmed nearly 2,000 cases of the variant with many more expected, lending an urgency to calls for hospitals to get ready.

"With infections expected to be skyrocketing we need: clear communication about self-care to prevent panic-driven trips to the hospitals," Bhramar Mukherjee, professor of epidemiology at the University of Michigan, wrote on Twitter.

"Scale up hospital capacity and optimise care to those who really need it," she said.

New Delhi's premier All India Institute of Medical Sciences cancelled a winter holiday for staff between Jan. 5 and 10. Many doctors and nurses have contracted the virus in recent days.

"Ensure maximum preparedness against a possible surge in cases," the health ministry told state authorities on Tuesday.

Authorities, especially in Delhi, have repeatedly said only those who actually need round-the-clock monitoring should go to hospital while others should recover at home.

Delhi tightened up virus mitigation measures on Tuesday, ordering people to stay on the weekends, in addition to a night curfew.

Many other cities have announced curfews but politicians have not called off their election rallies, at which few people wear masks.

Such gatherings last March and April helped the Delta coronavirus variant infect millions of people in India, killing tens of thousands of them.

Delhi Chief Minister Arvind Kejriwal said on Tuesday he had tested positive a day after attending an election rally where none of the people on a dais, including him, could be seen wearing a mask.

Modi will on Wednesday attend the inauguration of various projects in Punjab state, his latest visit to several states holding elections in coming weeks.

Health ministry officials have said COVID-safety measures such as mask-wearing and social distancing apply to all, including politicians, though few seem to heed the advice.

India has had more than 35 million cases, the second highest tally after the United States

The health ministry reported 534 new deaths on Wednesday, taking that toll to 482,551.

https://www.marketscreener.com/news/latest/Indian-health-experts-urge-preparations-for-new-wave-of-COVID-19--37466456/