Friday, February 10, 2023

University of Sydney scientists make ‘crazy’ Covid-19 discovery

The COVID public health emergency is coming to an end, and even thought you might not have been following protocols recently, this will still affect you and your wallet.
Australian scientists have made an incredible discovery that could change the way we view Covid — and could explain why some people suffer serious illness with the virus, or even death, while others never get sick or appear symptomless.

University of Sydney researchers discovered a protein in the lung that blocks Covid infection and forms a natural protective barrier in the human body.

The naturally occurring protein, LRRC15, works by attaching itself to the virus, stopping Covid particles from binding with more vulnerable cells - as well as reducing the chance of infection.

The research offers a promising pathway to develop new drugs to prevent Covid or deal with fibrosis in the lungs.

The study led by Professor Greg Neely found that this new receptor acts by binding to the virus and sequestering it which reduces infection.

“For me, as an immunologist, the fact that there’s this natural immune receptor that we didn’t know about, that’s lining our lungs and blocks and controls viruses, that’s crazy interesting,” Professor Neely said.

“We can now use this new receptor design broad acting drugs that can block viral infection or even suppress lung fibrosis.”

How it works

The Covid-19 virus infects humans by using a spike protein to attach to a specific receptor in our cells. It primarily uses a protein called the angiotensin-converting enzyme 2 (ACE2) receptor to ender human cells.

Lung cells have high levels of ACE2 receptors, which is why the Covid-19 virus often causes severe problems in this organ.

Like AEC2, LRRC15 is a receptor for Covid meaning the virus can bind to it. But unlike ACE2, LRRC15 does not support infection.

It can however stick to the virus and immobilise it.

Researchers believe patients who died from Covid did not produce enough of the protein, or produced it too late to make a difference.

“We think it acts a bit like Velcro, molecular Velcro, in that it sticks to the spike of the virus and then pulls it away from the target cell types,” another researcher Dr Lipin Loo said.

The breakthrough comes as millions of Australians are now eligible for a fifth Covid vaccine within a fortnight.

The Australian Technical Advisory Group on Immunisation has recommended that all people aged 18 and over receive a top-up jab, no matter how many doses they’ve already received, as long as they have not been infected with the virus in the last six months.

Up to four million Australians are estimated to have been struck down with Covid-19 just in the past four months.

More than 2600 Australians have died with the virus since October. Around 800 of those deaths were aged care residents.


Can Plant Extracts Effectively Inhibit SARS-CoV-2—The Results of a Portugal Review Study Look Promising

Can natural products be used as a means of combating COVID-19? Afterall, plant-based chemistry has been at work in Traditional Chinese Medicine (TCM) for centuries, based on plants: long the source of individual molecules and extracts capable of inhibiting/neutralizing several microorganisms, including viruses.

In fact, natural extracts have demonstrated potential efficacy against various pathogens in the coronavirus families, although that fact isn’t touted much by mainstream media in the West. But plenty of misinformation associated with this topic continues to circulate across cyberspace. There are reasons medical products are tightly regulated at the national level.

Only after careful and systematic research demonstrating safety and effectiveness will such natural products be authorized by relevant authorities. In that spirit, recently, a group of collaborating scientists from Portugal, affiliated with the Mountain Research Institute and the Catholic University of Portugal (Center for Biotechnology and Fine Chemistry), investigated select plant metabolites and their potential therapeutic value targeting SARS-CoV, the virus behind COVID-19.

Of particular interest to the Portugal-based scientists, represented by corresponding author Lillian Barros, Ph.D., a biotech engineer with a focus on biotechnology and food chemistry, was a couple of molecules associated with Traditional Chinese Medicine (TCM) as the world’s biggest population depends heavily on this approach targeting COVID-19.

What are the primary strategies to inhibit or stop SARS-CoV-2, the virus behind COVID-19?

Researchers have determined a couple pathways for therapy to work, including 1) inhibiting of SARS-CoV-2 penetration by preventing SARS-CoV-2 S-ACE2 binding interactions and 2) the inhibiting of protease enzymes such as Mpro (main protease), 3CLpro (3C-like protease) and PLpro (papain-like protease).

Enter this investigation into plant metabolites targeting SARS-CoV-2

The study team centered their investigation on select plants associated with TCM, for example, and the derived molecules that can actually bind with glycoprotein and consequently stop membrane fusion included A) luteolin (11 µM) and TGG (tetra-O-galloyl-β-D-glucose, 5.0 µM), both taken from TCM that do bind with spike glycoprotein. The team looked at other plant-based molecules.

The study team used the SCOPUS database and associated software to better understand a relation between plants and SARS-CoV02. They report about 1504 documents surfaced based on targeted keywords from 2020 to 2022. Selecting output with at least one of the chosen search terms, the team used specialized software to organize output by relevance and relationship.

What’s interesting about plant-based molecules potentially capable of stopping what’s known as cysteine proteases?
It turns out that SARS-CoV-2 thrives thanks to an enzyme called 3CLpro, responsible for the processing of proteins essential for the novel coronaviruses thriving. Hence why, drugs such as Paxlovid fall in the class of 3CLpro inhibition.

Other inhibitors involving both PLpro and 3CLpro identified by the researchers include chalcones, especially chalcone 6 as well. Some properties associated with plans inhibit PLpro with more effectiveness—such as polyphenol compounds taken from the leaves of the paper mulberry tree native to eastern Asia.

Overall, the team reported in their paper published in MDPI that of the compounds studied, Papyriflavonol A shows superior ability to inhibit PLpro enzyme. While one compound could inhibit both the relevant proteins—PLpro and 3CLpro: Salvia miltiorrhiza Bunge-derived lipophilic tanshinones.

The researchers analyze the plant-based metabolites’ potential for contributing to regimen targeting SARS-CoV-2, including several other examples.

What’s a takeaway?

The scientific literature suggests a definite therapeutic value associated with certain plant extracts, including ones involved in TCM, targeting SARS-CoV-2, the virus behind COVID-19. The Portuguese researchers document a particular interest in bioactive molecules such as alkaloid compounds as well as phenolic substances from chalcones and flavonoids to tannins and lignins to glycosides.

Likely, with targeted focus and investment in this plant-based medicinal approach, companies focusing on this area could offer substantially safe and effective, not to mention economical treatments against COVID-19. But would this fit into the biopharmaceutical business model?




Thursday, February 09, 2023

CDC Retrospective Cohort Study: Janssen COVID-19 Vaccines Increases Risk of Guillain–Barré syndrome

Mounting evidence suggests that the COVID-19 vaccines can, on rare occasions, lead to a rare autoimmune condition associated with Guillain–Barré syndrome (GBS). Associated with muscle weakness, this typically virus-originated disease can lead to paralysis, and even death in a minority of cases. GBS has been associated with other vaccines, but it is typically a rare occurrence, and the public benefit of vaccines according to health authorities such as the Center for Disease Control and Prevention (CDC) outweigh rare risks such as GBS.

Recently, physician-scientists affiliated with both the CDC and the Food and Drug Administration (FDA) analyzed in a retrospective cohort study whether COVID-19 vaccines, including Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Johnson & Johnson/Janssen (Ad26.COV2.S) associated with GBS in the period of 21 or 42 days post the vaccination. Tapping into and analyzing data associated with the CDC’s Vaccine Adverse Event Reporting System (VAERS), the investigators analyzed and verified cases of GBS after the COVID-19 jab in Americans aged 18 and above. The CDC and FDA team have gone on the record with this study result that the Janssen COVID-19 vaccine (Ad26.COV2.S) associates with an increased risk of Guillain-Barré syndrome.

Importantly, the study authors report that based on this observational study, there is no association between mRNA COVID-19 vaccination and GBS. The investigators do acknowledge that VAERS is subject to underreporting.

The Condition

With rapid-onset muscle weakness triggered by the immune system damaging the peripheral nervous system, Guillain–Barré Syndrome most often impacts both sides of the body. Typically starting with changes in sensation or pain often in the back along with muscle weakness, it can also start in the hands and feet and spread up the arms or upper body. These symptoms can last for hours or even weeks and during an acute phase, the disease can lead to hospitalization and death. About 15% of acute cases involve a debilitation of breathing muscles leading to the need for mechanical ventilation. The condition may lead to potentially deadly abnormalities associated with heart rate and blood pressure.

GBS occurs throughout the world with a median annual incidence of 1.3 cases per population of 100 000, with men being more frequently affected than women. GBS is considered to be an autoimmune disease triggered by a preceding bacterial or viral infection. About 3,000 to 6,000 cases are diagnosed annually in America.

Study Data

This retrospective cohort study was conducted using US VAERS reports submitted during December 2020 to January 2022. GBS case reports verified as meeting the Brighton Collaboration case definition for GBS in US adults after COVID-19 vaccination were included.

Represented by corresponding author Winston E. Abara, CDC, the study team reported in JAMA that they found a total of 295 validated GBS reports post the COVID-19 jab. What was the average age of individuals afflicted with GBS post the vaccination? Average age was 59 years, and males represented 57.3% of the study subjects.

Out of all the injured, 275 representing 93.2% of the total were hospitalized, while 209 of the incidents happened within 21 days of the subject receiving the COVID-19 vaccine. Another 253 of the safety incidents occurred within 42 days post the COVID-19 vaccine jab.

GBS was more frequently reported within 21 days after Ad26.COV2.S than after BNT162b2 (RRR = 11.40; 95% CI, 8.11-15.99) or mRNA-1273 (RRR = 9.26; 95% CI, 6.57-13.07) vaccination.

The CDC and FDA team have gone on the record with the study results that the Janssen COVID-19 vaccine (Ad26.COV2.S) associates with an increased risk of Guillain-Barré syndrome.


Bivalent COVID Vaccines Perform Worse Against Variant Now Dominant in United States

The new COVID-19 vaccines don’t work as well against XBB.1.5, the virus variant that’s now dominant in the United States, according to multiple studies.

In one of the papers, researchers found the vaccines boosted neutralizing antibodies, believed to be a measure of protection, but that the antibody levels declined to previous levels within three months.

Compared to the antibody responses to BA.5, the responses to XBB.1.5 were reduced 20-fold.

“Following bivalent mRNA boosting, responses to XBB.1.5 increase but remain low and wane within 3 months back to pre-boost levels. These data suggest that once a year boosters with the current mRNA vaccines may not provide adequate protection for an entire year for those at high risk of complications of COVID-19,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at the Beth Israel Deaconess Medical Center and a co-author of the preprint study (pdf), told The Epoch Times via email.

The Moderna and Pfizer vaccines both utilize messenger RNA, or mRNA, technology. The updated versions of the vaccines are bivalent, targeting the Wuhan variant and a sublineage of the BA.4 and BA.5 strain. The new versions were cleared as boosters in the fall of 2022 despite no clinical data being available. They are poised to replace the original vaccines.

Other studies have also found that the bivalents induce a better response than the old, monovalent boosters, but that the response is reduced against XBB.1.5 or its parent, XBB, which comes from BA.2 lineages.

Researchers with Pfizer and Pfizer partners, for instance, reported recently that the antibody levels were the lowest against XBB.1.5, and were particularly low among people without evidence of prior infection. Similarly, researchers with the U.S. National Institutes of Health and other institutions concluded (pdf) that “the lowest titers were observed against XBB.1” and researchers with the U.S. Centers for Disease Control and Prevention (CDC) detected (pdf) “low activity” against XBB.1. And Japanese scientists also observed a reduction in neutralizing power.

A group of Chinese researchers, who reported evidence that XBB.1.5 can more easily evade protection, said that the circulation of the strain “needs to be closely monitored, and the development of effective neutralizing antibodies and vaccines against XBB.1.5 is urgently needed.”

“Based on its genetic characteristics and growth rate estimates, XBB.1.5 is likely to contribute to increases in case incidence globally. There is moderate-strength evidence for increased risk of transmission and immune escape. From reports by several countries, no early signals of increases in severity have been observed,” the World Health Organization stated in a risk assessment (pdf), though it acknowledged that the low number of cases caused by the strain does not enable a confident assessment of severity.

New York officials claimed in January that XBB.1.5 “may be more likely to infect people who have been vaccinated or already had COVID-19,” later adding that they meant compared to prior variants. When asked for evidence to back up the claim, a spokesperson declined to provide any.

Authorization Revoked as XBB Becomes Dominant
Regulators have not yet altered authorizations or approvals for vaccines, but the U.S. Food and Drug Administration (FDA) yanked authorization for Evusheld, a monoclonal antibody treatment, because it said the drug wouldn’t work against XBB.1.5 and other emerging subvariants.

XBB.1.5, an Omicron subvariant like BA.5, was estimated to be behind 66.4 percent of the COVID-19 cases in the United States in the week ending Feb. 4, according to genomic sequencing and other data.

BA.5 was the dominant strain until late 2022, when it was displaced by BQ.1.1 and BQ.1. Those Omicron subvariants make up about a quarter of the cases.

The bivalent vaccines were cleared in part because the vaccines had been performing increasingly worse against Omicron and its subvariants. Regulators chose not to wait for clinical data despite widespread warnings that authorizing the shots without the data would further undermine confidence in the COVID-19 vaccines.

The FDA met with its advisory panel in January but none of the vaccine makers that made presentations during the meeting, including Pfizer and Moderna, presented clinical efficacy data. Officials from the companies alleged that testing data indicated the vaccines work against XBB.

CDC Data

CDC researchers, drawing from testing data, estimated similar vaccine effectiveness (VE) against XBB and BA.5.

For people aged 18 to 49, for instance, the relative effectiveness against symptomatic infection was estimated at 52 percent two to three months after a bivalent booster against the latter and 48 percent against the former.

Relative effectiveness means effectiveness beyond the initial shots, which provide little protection against symptomatic infection.

“‘Generally, VE against symptomatic infection is similar for the two sub lineages and across age groups,” Dr. Ruth Link-Gelles, a CDC researcher and co-author of the report, told the FDA’s advisory panel.

“We’re continuing to monitor this as XBB.1.5 continues to increase nationally,” she added.

Researchers drew from the Increasing Community Access to Testing program, which provides free COVID-19 testing at CBS, Walmart, and other places.




Wednesday, February 08, 2023

California ‘Quietly’ Drops Student COVID-19 Vaccine Mandate

While California’s government is celebrated by some for its commitment to contain and combat COVID-19, many critics have suggested the various governmental and public units, from state offices to universities and school districts, went too far during the COVID-19 response, representing an overreach of constitutional norms and mores. While Gavin Newsom, the Governor of the state, announced a universal COVID-19 vaccination policy by October 2021 (it would eventually apply to 6.7 million public and private school children), the Golden State became one of the first states where school districts proactively pushed universal COVID-19 mandates for children as soon as the Pfizer-BioNTech mRNA vaccine BNT162b2 was formally approved (albeit there was nothing usual about how the controversial vaccine was approved).

Now with the science clearly pointing to the reality that the COVID-19 mRNA vaccines are not only non-sterilizing but also lack breadth in response to various mutations and durability, the Los Angeles Times and other media report that the state has quietly dropped the student COVID-19 vaccine mandate as the state emergency is planned to end February 28. The national public health emergency is scheduled to end by May 11.

Apparently, the mandate was put on hold in April 2022 by the Governor, as was a bill that was to eliminate any exemptions for personal beliefs, writes Howard Blume for the Los Angeles Times.

A confluence of forces converges to make such mandates not even practical anymore, admits the mainstream media.

Most notable is the fact, writes Blume, that SARS-CoV-2 “has evolved to a less deadly, more manageable, and treatable stage. Although COVID-19 remains widespread — and people continue to die from it — the availability of vaccines and antiviral treatments has lessened the effects — offering relief to what had been an overwhelmed public health system.”

In California, Newsom plans to end the state of emergency on Feb. 28, ending a three-year period of history for the Golden State.

It's still taboo to express any critical views of the COVID-19 vaccine products in the mainstream press. On the topic of these products, Blume and contributing writers Adam Beam and Times staff writer Taryn Luna reassure the reader that the move to cease any mandates doesn’t mean that the state rejects the COVID-19 vaccines. In fact, the state’s health department declared:

“COVID-19 immunization is an important tool for keeping our kids healthy and schools open,” the department statement said. “Health officials strongly recommend immunization of students and staff against COVID-19 to prevent hospitalization and other serious complications, including death. Widespread vaccination has contributed to keeping California children in school to learn and to strengthen social connections. Turnkey mobile vaccination services remain available for any K-12 school within the state.”

The Reality

The truth is that the current COVID-19 vaccines, softening the sharp, deadly edges of the COVID-19 pandemic, most definitely exhibited attributes of early state or “Version 1.0” products.

Because the world found out the COVID-19 vaccines were not preventing the contagion from spreading, a movement grew against inoculation mandates by the spring of 2021. It didn’t make much sense if the products didn’t halt the infection in the first place and, thereby stop the transmission of the virus.

That aside, the positioning for the benefits shifted at the time to a reduction in the probability of serious infection and hospitalization, even death. In fact, across many different real-world studies evaluated by TrialSite over the past couple of years, the evidence suggests that the COVID-19 vaccines did serve to induce surges of immune protection during surges of the pandemic, slowing down hospitalization and saving lives.

But two other elements further weakened the prospect of these COVID-19 vaccine products as permanent fixtures on the vaccination schedule in addition to the fact that they were not sterilizing in impact. First, is their lack of breadth, in that as the SARS-CoV-2 virus mutated from Delta into Omicron and various subvariants, increasingly, the pathogen evaded the vaccine’s neutralizing impact, while also and in relation to a mutating RNA virus the durability of the vaccine was questionable. This is why boosters were required, and since the release of the first COVID-19 vaccines to the market in mid-December 2020, up to five doses have been administered, two in the primary series and up to three boosters including the most recent bivalent Omicron BA.4/BA.5 booster does.

The market has resoundingly rejected this product despite intense and ongoing promotional edicts from the government, echoed by health systems. As of this writing, only about 15% of all persons eligible have opted to take the shot.

The whole strategy in response to COVID-19 should be evaluated carefully. For example, early treatment (now emphasized once pharmaceutical products were approved) was de-emphasized when front-line providers produced various approaches in the clinics during the pandemic.

One such approach was the ICAM protocol, which was purportedly saving hundreds of lives out of one Florida-based health system. Involving the use of blood thinners and certain steroids, (both later shown to help) TrialSite learned that once the CEO became aware of the protocol it was canceled. TrialSite brought significant attention to the effort worldwide. Sources conveyed that a contract between Pfizer and the health system precluded the latter from its employees developing any regimen for SARS-CoV-2, even though it was in the middle of a deadly pandemic.

Assuming these declarations are authentic, Pfizer leveraged its position in the pandemic quite ruthlessly to lock in behaviors it deemed appropriate. The message to health systems: If you want access to the COVID-19 vaccines via clinical trials, sign this adhesion-style contract. Of course, there is evidence that Pfizer enforced this approach worldwide via all sorts of unorthodox contracts with draconian clauses. See “Pfizer’s Power in the COVID-19 Vaccine Space.”

Moving forward, state agencies, school districts, and other units of government will likely back out of any hardline COVID-19 vaccine stances now, including relevant mandates, as the science irrefutably reveals the limitations of the current batch of COVID-19 vaccines.

Importantly, this is not to minimize intention for and even the protective results, albeit short-lived, at the time, and in many cases, their influence as a medical tool, along with other approaches during the pandemic, only expresses what the reality is on the ground.


Study finds way to help children overcome peanut allergy

This is rather old hat. Systematic desensitization has been known to psychologists for decades and its application to peanut allergy also goes back at least a decade. Good that someone is still working on it though

Consuming small, sequential doses of boiled peanuts help overcome children’s allergic reactions, according to a new study.

The research, published in the journal Clinical & Experimental Allergy, found that 80 per cent of children with peanut allergy become desensitised to eating peanuts following the trial.

Since up to three per cent of children in Western countries are grappling with peanut allergies, scientists, including those from Flinders University in the US, say the new clinical trial can help develop a novel treatment to reduce the risk of accidental peanut exposure and improve quality of life for peanut-allergic children.

Their new study is based on previous findings that heat affects the protein structure and allergic properties of peanuts, making them potentially less likely to cause severe allergic reactions.

Scientists tested whether a therapy delivering small, increasing doses of boiled peanuts, followed by roasted peanuts, may help children overcome their peanut allergies.

“Small and increasing doses of boiled nuts were first given to children to partially desensitise them, and when they showed no signs of an allergic reaction, increasing doses of roasted peanuts were then provided to increase their tolerance in the next stage of treatment,” study co-author Tim Chataway said in a statement.

Researchers asked 70 peanut-allergic children of ages six to 18 to consume peanuts boiled for 12 hours for 12 weeks, 2 hour boiled peanuts for 20 weeks, and roasted peanuts for 20 weeks.

Scientists found that 56 of the 70 (80 per cent) participants became desensitized to a daily target dose of consuming 12 roasted peanuts without allergic reactions.

While treatment-related adverse events were reported in over 60 per cent of the participants, only 3 withdrew from the trial as a result, the study noted.

“Our clinical trial shows promising early signs in demonstrating that boiling peanuts may provide a safe and effective method for treating peanut-allergic children with sequential doses of boiled and roasted peanuts over an extended period of time,” says Luke Grzeskowiak, another author of the study, said.

However, scientists caution that this method of therapy may not work for everyone, but add that they are in the process of better understanding what factors can influence how people respond to treatment.

While these findings hold “great promise”, researchers add that the results also require confirmation in a larger definitive clinical trial.




Tuesday, February 07, 2023

Adherence to Healthy Lifestyle Prior to Infection and Risk of Post–COVID-19 Condition

There is an old, old fallacy here. Sure: Healthy people survived Covid better but why was that? Was a healthy lifestyle the crucial factor? This article cannot tell us that. It could well be that people who adopted a heathier lifestyle were healthier to start with. And the converse -- that sickly people are unable to adopt many aspects of a healthy lifestyle (such as vigorous exercise) -- is undoubtedly true. So was it lifestyle that protected from Covid in the study below? Maybe, maybe not

It doesn't prove anything by itself but I have a very unhealthy lifestyle and Covid has not touched me at all -- and I am 79, in a high-risk group. So the report below will not influence anything I do

Siwen Wang et al.

Question Is a healthy lifestyle (healthy body mass index, never smoking, high-quality diet, moderate alcohol intake, regular exercise, and adequate sleep) prior to SARS-CoV-2 infection protective of post–COVID-19 condition (PCC)?

Findings In this prospective cohort study of 1981 women who reported a positive SARS-CoV-2 test from April 2020 to November 2021, adherence to a healthy lifestyle prior to infection was inversely associated with risk of PCC in a dose-dependent manner. Compared with those who did not have any healthy lifestyle factors, those with 5 or 6 had half the risk of PCC.

Meaning Preinfection healthy lifestyle was associated with a substantially decreased risk of PCC.


Importance Few modifiable risk factors for post–COVID-19 condition (PCC) have been identified.

Objective To investigate the association between healthy lifestyle factors prior to SARS-CoV-2 infection and risk of PCC.

Design, Setting, and Participants In this prospective cohort study, 32 249 women in the Nurses’ Health Study II cohort reported preinfection lifestyle habits in 2015 and 2017. Healthy lifestyle factors included healthy body mass index (BMI, 18.5-24.9; calculated as weight in kilograms divided by height in meters squared), never smoking, at least 150 minutes per week of moderate to vigorous physical activity, moderate alcohol intake (5 to 15 g/d), high diet quality (upper 40% of Alternate Healthy Eating Index–2010 score), and adequate sleep (7 to 9 h/d).

Main Outcomes and Measures SARS-CoV-2 infection (confirmed by test) and PCC (at least 4 weeks of symptoms) were self-reported on 7 periodic surveys administered from April 2020 to November 2021. Among participants with SARS-CoV-2 infection, the relative risk (RR) of PCC in association with the number of healthy lifestyle factors (0 to 6) was estimated using Poisson regression and adjusting for demographic factors and comorbidities.

Results A total of 1981 women with a positive SARS-CoV-2 test over 19 months of follow-up were documented. Among those participants, mean age was 64.7 years (SD, 4.6; range, 55-75); 97.4% (n = 1929) were White; and 42.8% (n = 848) were active health care workers. Among these, 871 (44.0%) developed PCC. Healthy lifestyle was associated with lower risk of PCC in a dose-dependent manner. Compared with women without any healthy lifestyle factors, those with 5 to 6 had 49% lower risk (RR, 0.51; 95% CI, 0.33-0.78) of PCC. In a model mutually adjusted for all lifestyle factors, BMI and sleep were independently associated with risk of PCC (BMI, 18.5-24.9 vs others, RR, 0.85; 95% CI, 0.73-1.00, P = .046; sleep, 7-9 h/d vs others, RR, 0.83; 95% CI, 0.72-0.95, P = .008). If these associations were causal, 36.0% of PCC cases would have been prevented if all participants had 5 to 6 healthy lifestyle factors (population attributable risk percentage, 36.0%; 95% CI, 14.1%-52.7%). Results were comparable when PCC was defined as symptoms of at least 2-month duration or having ongoing symptoms at the time of PCC assessment.

Conclusions and Relevance In this prospective cohort study, pre-infection healthy lifestyle was associated with a substantially lower risk of PCC. Future research should investigate whether lifestyle interventions may reduce risk of developing PCC or mitigate symptoms among individuals with PCC or possibly other postinfection syndromes.


Do mask mandates work?

This week there was an update to a Cochrane review, which studies the way physical interventions can interrupt or reduce the spread of respiratory viruses. The review, which Tom Jefferson is the lead author of, looks at evidence from 78 randomised trials with over 610,000 participants. In other words, this review is exactly the sort of higher-quality evidence you want when making healthcare decisions.

The review’s fifth update looked at handwashing, antiseptic use, social distancing and barriers such as masks, gloves, gowns and visors.

Given past controversies, it’s worth looking at what the review says about the effects medical or surgical masks have on the way respiratory diseases spread.

Interestingly, 12 trials in the review, ten in the community and two among healthcare workers, found that wearing masks in the community probably makes little or no difference to influenza-like or Covid-19-like illness transmission. Equally, the review found that masks had no effect on laboratory-confirmed influenza or SARS-CoV-2 outcomes. Five other trials showed no difference between one type of mask over another.

This is the second update of the review since the start of the pandemic. The first update was delayed by seven months due to unexplained editorial decisions. It was too late when it came out in November 2020 to make a difference to national Covid policy; by then, activism, low-quality observational evidence and government policy had set the agenda for mask mandates, and the damage had been done.

Often these government policies relied on observational studies on mask usage and the spread of Covid. But there are lots of flaws in observational evidence. For example, in the absence of a study protocol setting out methods before the study is done, it is possible to shift the dates of an observational analysis to suit the rise and fall in infections. So if you time your analysis near the peak of infections, the results will favour mask interventions as the infection rate quickly decreases.

But when we pointed out in November 2020 the troubling lack of robust evidence on face masks and the problems with observational studies, we were shouted down, removed from Facebook and put on the government’s secret watchlist.

What many also failed to notice at the time was that studies that look at individuals – as opposed to populations – can lead to erroneous policy decisions. Studies which involve individuals frequently track people who have specifically chosen to wear a mask. But policies on mandatory masks are very different – they involve lots of people who don’t like wearing masks every day, and many people who won’t wear one at all. A study which only looks at keen mask-wearers will not reflect how people comply on a population level.

The Cochrane review findings report relatively low adherence to mask-wearing, which is similar to what happens in the real world. With better adherence and higher quality masks (and if you are careful when you step out the door), you might reduce your risk in specific settings by a small amount. However, when you scale up any potential small benefits to those who step out the door regularly, the effect doesn’t stack up as a population-based intervention.

Mandates that affected the whole population never made sense. Moreover, even in high adherence populations such as Japan, they have not stemmed an inevitable rise in infections. Part of the problem may be that during the pandemic the government had to be seen to be doing something. Interventions like handwashing and vaccines are invisible, but masks acted as a visible sign of compliance.

What we have witnessed in this pandemic are strong beliefs about what works and what doesn’t. At times, it’s been more like a football match, with cheerleaders on either side goading the opposition. Several policies such as mask mandates, restrictions, and unproven interventions now seem absurd in hindsight. And as the culture of fear has lifted, the population has become all too aware of their detrimental effects.

We failed to follow an evidence-based approach during the pandemic. We are now left with the human, social and economic aftermath of evidence-free policies.




Monday, February 06, 2023

Vitamin D and Covid

Journal article:

Protective Effect of Vitamin D Supplementation on COVID-19-Related Intensive Care Hospitalization and Mortality: Definitive Evidence from Meta-Analysis and Trial Sequential Analysis

Christiano Argano et al.


Background: The COVID-19 pandemic represents one of the world’s most important challenges for global public healthcare. Various studies have found an association between severe vitamin D deficiency and COVID-19-related outcomes. Vitamin D plays a crucial role in immune function and inflammation. Recent data have suggested a protective role of vitamin D in COVID-19-related health outcomes. The purpose of this meta-analysis and trial sequential analysis (TSA) was to better explain the strength of the association between the protective role of vitamin D supplementation and the risk of mortality and admission to intensive care units (ICUs) in patients with COVID-19.

Methods: We searched four databases on 20 September 2022. Two reviewers screened the randomized clinical trials (RCTs) and assessed the risk of bias, independently and in duplicate. The pre-specified outcomes of interest were mortality and ICU admission.

Results: We identified 78 bibliographic citations. After the reviewers’ screening, only five RCTs were found to be suitable for our analysis. We performed meta-analyses and then TSAs. Vitamin D administration results in a decreased risk of death and ICU admission (standardized mean difference (95% CI): 0.49 (0.34–0.72) and 0.28 (0.20–0.39), respectively). The TSA of the protective role of vitamin D and ICU admission showed that, since the pooling of the studies reached a definite sample size, the positive association is conclusive. The TSA of the protective role of vitamin D in mortality risk showed that the z-curve was inside the alpha boundaries, indicating that the positive results need further studies.

Discussion: The results of the meta-analyses and respective TSAs suggest a definitive association between the protective role of vitamin D and ICU hospitalization.


Look back in anger at government Covid folly

Remember this joke: a teenager kills his parents and appeals to the courts for mercy as an orphan? The Australian Medical Association backed lockdown restrictions back in the day but is now complaining about the growing backlog in elective surgery. Here’s a question. Had the vast sums thrown at Covid been redirected to the leading killer diseases, using the standard quality-adjusted life year metric, how many million deaths would have been averted around the world over the next decade? The lockdown harms are showing up in excess death counts, job losses, supply chain chaos, rising cost of living, and have locked in generational poverty and inequality in and across nations. Historical illiteracy is now a job requirement for ‘experts’. Germany has burnt 17.25 million masks past their expiry date, while stockpiling more for future emergencies. Recalling Margaret Thatcher’s comment on the trouble with socialism, politicians don’t learn from mistakes made with other people’s money. The media too lived down to their description as stenographers with amnesia. The state dictated every aspect of peoples’ lives, down to the most ridiculous, absurd and intimate details. With no known cure for blind faith in governments, people embraced compliance with draconian directives from politicians proffering iron fists as a magic bullet.

Lockdowns were a euphemism for a wholesale shutting down of social and economic activities and putting entire populations under house arrest. Neither based in science and best-practice medicine, nor commensurate with the age-stratified threat from the virus, they lasted on and off for two years with constantly shifting goalposts. As early as February-March 2020, data told us that elderly people with comorbidities were the most vulnerable. In a modern-day version of sacrificing virgins to appease the viral gods, the young have lost many more years of their life to buy a few more lonely, miserable months for the infirm old. A study in the Proceedings of the National Academy of Sciences showed that lack of household exposure to kids increased Covid hospitalisation of grown-ups by 27 per cent and ICU admission by 49 per cent. They should have said: ‘Don’t be a Granny killer. Leave that to us.’

The UK Influenza Preparedness Strategy 2011 encapsulated the prevailing consensus on masks: ‘there is very little evidence of widespread benefit from their use in [the community and household] setting’. The lack of observed differences can be seen in a series of comparative charts in Ian Miller’s Unmasked: The Global Failure of Covid Mask Mandates (2022). Governments ‘nudged’ the public to exert peer pressure as a tool of social coercion, backed by sometimes brutal police action against pockets of resistance and protest. Mask mandates reflected and perpetuated the reign of fear and demonstrated broad compliance with the effort of governments to exercise population-wide social control. A highly visible symbol of collectivist compliance, masks became Mao suits for the face. The degree of coercion deployed to increase vaccine uptake would not have been possible without the ground having first been prepared with lockdowns and masks.

Japan has extraordinarily high levels of public compliance with government directives and mask wearing is all pervasive. Using Our World in Data figures, Japan hit 80 per cent full vaccination on 9 December 2021 when its Covid daily death rate was 0.01 per million. This had risen to 3.43 per million on 9 January 2023. Total deaths had increased from 18,370 to 63,777 over that period. Thus 2.5 times as many people died with Covid in the 13.5 months after full vaccination than in the 21.3 months before 80 per cent full vaccination. Yet they still refuse to entertain the notion that vaccines might be the problem, not the solution. The continued hold of the ‘safe and effective’ vaccine mantra, and face mask efficacy for controlling the coronavirus is cause for despair in official cussedness and public gullibility. The transient effectiveness of vaccines has necessitated boosters every few months. Often vaccine rollouts coincided with upsurges in infections and deaths, suggesting negative efficacy. Newer studies show successive doses are less effective and repeated doses may be driving infections by damaging immune function. When vaccines began to be administered at the end of 2020, 1.9 million people had died with Covid globally. Another 4.8 million have died since then. Added to the growing toll of vaccine injuries, this has discredited officials and experts who claimed the vaccines would prevent infection, transmission, severe illness and death. Yet all that matters to zealots is how many arms are jabbed and how often.

With help from the media, social media (thank you, Elon Musk, for the Twitter Files) and police, people were frightened, shamed and brutalised into submission to arbitrary and authoritarian diktats. Governments deployed state propaganda to instil fear of the disease and shame all effort to question edicts. Turning the debate from a scientific discourse into a moral imperative facilitated the demonisation and denigration of critical voices on the lethality of the virus, the effectiveness and ethics of lockdowns, masks and vaccine mandates, and the harms inflicted by these interventions. Calls have grown for an immediate suspension of vaccinations until the unusually strong correlation with excess deaths, heart problems and female reproduction are properly investigated. Instead, suspicions become only stronger that regulators have become vaccine-enablers first, more committed to defend vaccines from criticism than protect people from harmful vaccines. The media switched from exposing official lies to amplifying them. One dispiriting lesson of the last three years is people will ‘live happily ever after’ as long as the media ignores how governments trample our freedoms while claiming to keep us safe.

On every major point of contention in managing the pandemic, the Great Barrington Declaration was right. Fearmongers-in-chief like Neil Ferguson, Anthony Fauci (whose omniscience deserted him during deposition) and their local ‘useful idiots’ were wrong. The common sense distilled into the few words of the Declaration was an uncommon virtue. The three scientist-authors – from Harvard, Oxford and Stanford! – were taken down savagely and belittled as ‘fringe epidemiologists’. This malfeasance was compounded by the cowardice of political leaders hiding behind ‘Follow the Science’ that mistook a slogan for policy and let loose upon democratic societies previously unimaginable acts and scenes of censorship, coercion and brutality which have gradually eroded trust in authorities and institutions. Recovery and healing will be difficult without accountability, punishment and robust institutional guardrails against repeating episodes of the abuses.




Sunday, February 05, 2023

Inside the Secret Government Meeting on COVID-19 Natural Immunity

Natural immunity downplayed. EVERYONE should be vaccinated

Four of the highest ranking U.S. health officials—including Dr. Anthony Fauci—met in secret to discuss whether or not naturally immune people should be exempt from getting COVID-19 vaccines, The Epoch Times can reveal.

The officials brought in four outside experts to discuss whether the protection gained after recovering from COVID-19—known as natural immunity—should count as one or more vaccine doses.

“There was interest in several people in the administration in hearing basically the opinions of four immunologists in terms of what we thought about … natural infection as contributing to protection against moderate to severe disease, and to what extent that should influence dosing,” Dr. Paul Offit, one of the experts, told The Epoch Times.

Offit and another expert took the position that the naturally immune need fewer doses. The other two experts argued natural immunity shouldn’t count as anything.

The discussion did not lead to a change in U.S. vaccination policy, which has never acknowledged post-infection protection. Fauci and the other U.S. officials who heard from the experts have repeatedly downplayed that protection, claiming that it is inferior to vaccine-bestowed immunity. Most studies on the subject indicate the opposite.

The meeting, held in October 2021, was briefly discussed before on a podcast. The Epoch Times has independently confirmed the meeting took place, identified all of the participants, and uncovered other key details.

Dr. Jay Bhattacharya, a professor of medicine at Stanford University who did not participate in the meeting, criticized how such a consequential discussion took place behind closed doors with only a few people present.

“It was a really impactful decision that they made in private with a very small number of people involved. And they reached the wrong decision,” Bhattacharya told The Epoch Times:

Fauci and Murthy decided to hold the meeting, according to emails The Epoch Times obtained.

“Would you be available tonight from 9-9:30 for a call with a few other scientific colleagues on infection-induced immunity? Tony and I just discussed and were hoping to do this sooner rather than later if possible,” Murthy wrote in one missive to Fauci, Walensky, and Collins.

All three quickly said they could make it.

Walensky asked who would be there.

Murthy listed the participants. “I think you know all of them right?” he said. Walensky said she knew all but one person. “Sounds like a good crew,” she added.

During the meeting, Offit put forth his position—that natural immunity should count as two doses.

At the time, the CDC recommended three shots—a two-dose primary series and a booster—for many Americans 18 and older, soon expanding that advice to all adults, even though trials of the boosters only analyzed immunogenicity and efficacy among those without evidence of prior infection.

Research indicated that natural immunity was long-lasting and superior to vaccination. On the other hand, the CDC published a paper in its quasi-journal that concluded vaccination was better.

Osterholm sided with Offit, but thought that having recovered from COVID-19 should only count as a single dose.

“I added my voice at the meeting to count an infection as equivalent to a dose of vaccine! I’ve always believed hybrid immunity likely provides the most protection,” Osterholm told The Epoch Times via email.

Hybrid immunity refers to getting a vaccine after recovering from COVID-19.

Some papers have found vaccination after recovery boosts antibodies, which are believed to be a correlate of protection. Other research has shown that the naturally immune have a higher risk of side effects than those who haven’t recovered from infection. Some experts believe the risk is worth the benefit but others do not.

Hotez and Iwasaki, meanwhile, made the case that natural immunity should not count as any dose—as has been the case in virtually the entire United States since the COVID-19 vaccines were first rolled out.

Iwasaki referred to a British preprint study, soon after published in Nature, that concluded, based on survey data, that the protection from the Pfizer and AstraZeneca vaccines was heightened among people with evidence of prior infection.

She also noted a study she worked on that found the naturally immune had higher antibody titers than the vaccinated, but that the vaccinated “reached comparable levels of neutralization responses to the ancestral strain after the second vaccine dose.” The researchers also discovered T cells—thought to protect against severe illness—were boosted by vaccination.

There’s a “clear benefit” to boosting regardless of prior infection, Iwasaki, who has since received more than $2 million in grants from the National Institutes of Health (NIH), told participants after the meeting in an email obtained by The Epoch Times. Hotez received $789,000 in grants from the NIH in fiscal year 2020, and has received other grants totaling millions in previous years. Offit, who co-invented the rotavirus vaccine, received $3.5 million in NIH grants from 1985 through 2004.

Hotez declined interview requests through a spokesperson. Iwasaki did not respond to requests for comment.

No participants represented experts like Bhattacharya who say that the naturally immune generally don’t need any doses at all.

In public, Hotez repeatedly portrayed natural immunity as worse than vaccination, including citing the widely criticized CDC paper, which drew from just two months of testing in a single state.

In one post on Twitter on Oct. 29, 2021, he referred to another CDC study, which concluded that the naturally immune were five times as likely to test positive compared to vaccinated people with no prior infection, and stated: “Still more evidence, this time from @CDCMMWR showing that vaccine-induced immunity is way better than infection and recovery, what some call weirdly ‘natural immunity’. The antivaccine and far right groups go ballistic, but it’s the reality.”

That same day, the CDC issued a “science brief” that detailed the agency’s position on natural immunity versus the protection from vaccines. The brief, which has never been updated, says that available evidence shows both the vaccinated and naturally immune “have a low risk of subsequent infection for at least 6 months” but that “the body of evidence for infection-induced immunity is more limited than that for vaccine-induced immunity.”

Evidence shows that vaccination after infection, or hybrid immunity, “significantly enhances protection and further reduces risk of reinfection” and is the foundation of the CDC’s recommendations, the agency said.

Several months later, the CDC acknowledged that natural immunity was superior to vaccination against the Delta variant, which was displaced in late 2021 by Omicron. The CDC, which has made misleading representations before on the evidence supporting vaccination of the naturally immune, did not respond to a request for comment regarding whether the agency will ever update the brief.

Iwasaki had initially been open to curbing the number of doses for the naturally immune—”I think this supports the idea of just giving one dose to people who had covid19,” she said in response to one Twitter post in early 2021, which is restricted from view—but later came to argue that each person who is infected has a different immune response, and that the natural immunity, even if strong initially, wanes over time.

Osterholm has knocked people who claim natural immunity is weak or non-existent, but has also claimed that vaccine-bestowed immunity is better. Osterholm also changed the stance he took in the meeting just several months later, saying in February 2022 that “we’ve got to make three doses the actual standard” while also “trying to understand what kind of immunity we get from a previous infection.”

Offit has been the leading critic on the Vaccines and Related Biological Products Advisory Committee, which advises U.S. regulators on vaccines, over their authorizations of COVID-19 boosters. Offit has said boosters are unnecessary for the young and healthy because they don’t add much to the primary series. He also criticized regulators for authorizing updated shots without consulting the committee and absent clinical data. Two of the top U.S. Food and Drug Administration (FDA) officials resigned over the booster push. No FDA officials were listed on invitations to the secret meeting on natural immunity.

Fauci and Walensky, two of the most visible U.S. health officials during the pandemic, have repeatedly downplayed natural immunity.

Fauci, who said in an email in March 2020 that he assumed there would be “substantial immunity post infection,” would say later that natural immunity was real but that the durability was uncertain. He noted the studies finding higher antibody levels from hybrid immunity.

In September 2021, months after claiming that vaccinated people “can feel safe that they are not going to get infected,” Fauci said that he did not have “a really firm answer” on whether the naturally immune should get vaccinated.

“It is conceivable that you got infected, you’re protected—but you may not be protected for an indefinite period of time,” Fauci said on CNN when pressed on the issue. “So I think that is something that we need to sit down and discuss seriously.”

After the meeting, Fauci would say that natural immunity and vaccine-bestowed immunity both wane, and that people should get vaccinated regardless of prior infection to boost their protection.

Walensky, before she became CDC director, signed a document called the John Snow Memorandum in response to the Great Barrington Declaration, which Bhattacharya coauthored. The declaration called for focused protection of the elderly and otherwise infirm, stating, “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk.”

The memorandum, in contrast, said there was “no evidence for lasting protective immunity to SARS-CoV-2 following natural infection” and supported the harsh lockdown measures that had been imposed in the United States and elsewhere.

In March 2021, after becoming director, Walensky released recommendations that the naturally immune get vaccinated, noting that there was “substantial durability” of protection six months after infection but that “rare cases of reinfection” had been reported.

Walensky hyped the CDC study on natural immunity in August 2021, and the second study in October 2021. But when the third paper came out concluding natural immunity was superior, she did not issue a statement. Walensky later told a blog that the study found natural immunity provided strong protection, “perhaps even more so than those who had been vaccinated and not yet boosted.”

But, because it came before Omicron, she said, “it’s not entirely clear how that protection works in the context of Omicron and boosting.”

Walensky, Murthy, and Collins did not respond to requests for interviews. Fauci, who stepped down from his positions in late 2022, could not be reached.

Murthy and Collins also portrayed natural immunity as inferior. “From the studies about natural immunity, we are seeing more and more data that tells us that while you get some protection from natural infection, it’s not nearly as strong as what you get from the vaccine,” Murthy said on CNN about two months before the meeting. Collins, in a series of blog posts, highlighted the studies showing higher antibody levels after vaccination and urged people to get vaccinated. He also voiced support for vaccine mandates.

Some other countries offered the naturally immune benefits.

Just days after U.S. officials heard from the experts, Israel announced that people who presented serological proof of prior infection could get a “green pass,” which was required in the country to enter certain venues, for six months. Some European Union countries said the naturally immune only needed a single dose, instead of two, to receive a digital certificate, enabling free movement within the bloc. The United Kingdom’s travel pass was available to people who tested positive for COVID-19 if the test was within the previous 180 days.

But U.S. policy on vaccines, which has been the basis for vaccination mandates across sectors such as education and health care, was not altered at all in the wake of the meeting.

“I think it’s because the opinions were sort of generally diverse, so there wasn’t a clear, unified message that came out of that,” Offit told The Epoch Times, adding via email that there was “generally a divide among participants about how to think about this,” with “no firm conclusions.”

Bhattacharya said that the discussion happened too late, asserting it was already clear in 2020 that natural immunity protected against both severe disease and reinfection.

“The fact that the head of the CDC and the surgeon general both seem to have ignored these basic scientific facts is a scandal,” he said. “And it resulted in countless Americans losing their jobs for nothing.”

In 2022, the CDC did say that people who recovered from COVID-19 could wait up to three months after infection to get vaccinated, stating that reinfection “is less likely in the weeks to months after infection” and that waiting “might result in an improved immune response to vaccination.”

Over time, some other U.S. policies came to acknowledge natural immunity. Walensky in April 2022 (pdf), for instance, when ordering the end of a public health policy called Title 42, said that she was doing so because deaths and hospitalizations in the Omicron era were lower “due, in part, to widespread population immunity.”

A connecting footnote stated, “In addition to vaccine-induced immunity, studies have consistently shown that infection with SARS-CoV-2 lowers an individual’s risk of subsequent infection and an even lower risk of hospitalization and death.” SARS-CoV-2 causes COVID-19.

In August 2022, the CDC eased its COVID-19 guidelines, stating in part that “persons who have had COVID-19 but are not vaccinated have some degree of protection against severe illness from their previous infection.”

And on Jan. 26, the FDA convened Offit and the other advisers on the vaccine advisory committee to consider various vaccine-related issues. Among them? Whether the naturally immune should be advised to only get one shot, even if they’ve never been vaccinated before.