Covid-19 News

Estimating dose-response relationships for vitamin D with coronary heart disease, stroke, and all-cause mortality: observational and Mendelian randomisation analyses

DEFINE_ME

Summary

Background

Randomised trials of vitamin D supplementation for cardiovascular disease and all-cause mortality have generally reported null findings. However, generalisability of results to individuals with low vitamin D status is unclear. We aimed to characterise dose-response relationships between 25-hydroxyvitamin D (25[OH]D) concentrations and risk of coronary heart disease, stroke, and all-cause mortality in observational and Mendelian randomisation frameworks.

Methods

Observational analyses were undertaken using data from 33 prospective studies comprising 500 962 individuals with no known history of coronary heart disease or stroke at baseline. Mendelian randomisation analyses were performed in four population-based cohort studies (UK Biobank, EPIC-CVD, and two Copenhagen population-based studies) comprising 386 406 middle-aged individuals of European ancestries, including 33 546 people who developed coronary heart disease, 18 166 people who had a stroke, and 27 885 people who died. Primary outcomes were coronary heart disease, defined as fatal ischaemic heart disease (International Classification of Diseases 10th revision code I20-I25) or non-fatal myocardial infarction (I21-I23); stroke, defined as any cerebrovascular disease (I60-I69); and all-cause mortality.

Findings

Observational analyses suggested inverse associations between incident coronary heart disease, stroke, and all-cause mortality outcomes with 25(OH)D concentration at low 25(OH)D concentrations. In population-wide genetic analyses, there were no associations of genetically-predicted 25(OH)D with coronary heart disease, stroke, or all-cause mortality. However, for the participants with vitamin D deficiency (25[OH]D concentration <25 nmol/L), genetic analyses provided strong evidence for an inverse association with all-cause mortality (odds ratio [OR] per 10 nmol/L increase in genetically-predicted 25[OH]D concentration 0·69 [95% CI 0·59–0·80]; p<0·0001) and non-significant inverse associations for stroke (0·85 [0·70–1·02], p=0·09) and coronary heart disease (0·89 [0·76–1·04]; p=0·14). A finer stratification of participants found inverse associations between genetically-predicted 25(OH)D concentrations and all-cause mortality up to around 40 nmol/L.

Interpretation

Stratified Mendelian randomisation analyses suggest a causal relationship between 25(OH)D concentrations and mortality for individuals with low vitamin D status. Our findings have implications for the design of vitamin D supplementation trials, and potential disease prevention strategies.

Funding

British Heart Foundation, Medical Research Council, National Institute for Health Research, Health Data Research UK, Cancer Research UK, and International Agency for Research on Cancer

Quote from Mark U

What if the flu vaccine - received by all the people who did not get the Covid vaccine - was a main driver for the higher death rate in that group?

Big Pharma international now is running two large FUD propaganda streams.

1) Flue vaccines give other health benefits like less dementia...Reality high numbers of GBS sick are left behind...Nobody needs a flu vaccine as we now know Ivermectin works also for flu. This is what they wanted to stay under the carpet

2) Everywhere we see long Covid again! >20% get it on all TV news etc..

Drivers behind this. Clerks (profs, phds..) that made their position based on FM/R/J/B membership and not by skills, science merits. Even teh worst study find a maximum of 5% long Covid after 2 months.

Newest trick. The count psychological lock down damaged people as long Covid victims!! Most of these fake studies are database based what is not allowed for assessing symptoms!!!

Why even some vaccinated parents aren't planning to rush to give kids Covid shot

“I’m not opposed to vaccinating them in the future, maybe, but right now my husband and I are not comfortable with the data,” one parent said.

Sarah Beth Burwick, a lawyer in Los Angeles, said she and her husband both got their Covid-19 vaccinations at “the earliest possible opportunity” and their two children received all of their childhood vaccinations “on the schedule, without even questioning it."

But she's not planning to rush out to get the children, ages 5 and 2, vaccinated against Covid, even though one of them could be eligible as soon as next week.

There would need to be information out there to convince us it was necessary first," Burwick, 37, said. “I would say I think it’s unnecessary. And I’m uncomfortable with how quickly it’s rolling out with such a small study."

As the Food and Drug Administration prepares in the coming days to authorize emergency use of the Pfizer-BioNTech vaccine for children ages 5 to 11, some parents say they don't plan to be first in line to get their children vaccinated.

It’s not that they are skeptical of vaccines as a rule — pointing out that they got the Covid vaccination themselves and have previously immunized their kids against other diseases — but they have fears, questions and hesitation about giving the Covid vaccination to their children immediately.

They have concerns about the size of the vaccine trial for children, the amount of long-term safety data available, and the potential for side effects (including the rare heart condition myocarditis). They also question whether the vaccine should be given to children when the risk of serious complications from Covid in kids remains low.

Michelle Goebel, 36, an engineer and mother of three in Carlsbad, California, said she, her husband and their parents have all been vaccinated against Covid “because we understand the age-stratified risk

Her children, ages 9, 6 and 3, are fully up to date with their vaccinations, she said, and “even got their flu shots last week.” But she is not ready to vaccinate her children if a Covid vaccine for them were to be given emergency use authorization.

“I’m not opposed to vaccinating them in the future, maybe, but right now my husband and I are not comfortable with the data,” she said. “I need more numbers. I want to see any reported reactions as the numbers increase. I think I would like at least a year out from the trial data to follow up with those original participants to just make sure nothing popped up basically.”

Just over 1,500 children ages 5 to 11 received the vaccine in the Pfizer trial (another 750 received a placebo).

Side effects of the vaccination included sore arms, fever and muscle aches. However, the FDA said that Pfizer’s trial wasn’t large enough to detect extremely rare side effects, including myocarditis that’s been observed after the second dose, particularly in younger men and teenage boys. There were no cases of myocarditis in the trial of young children.

Goebel said she takes particular issue with California's plan to become the first U.S. state to require Covid vaccinations for children to attend schools in person, potentially impacting millions of students.

“I’m totally for approving a vaccine for them and making it a parental and pediatrician choice based on a child’s risk profile or comorbidities,” she said, but she believes “our state is rushing it when we don’t mandate flu vaccines for kids.”

Bryan Longmire, a parent in southeast Texas, told NBC affiliate KBMT he wouldn’t want to put anything in his child’s body “that wasn’t completely necessary

He said that while making vaccines available at school is a good idea for some parents, he hopes it remains an option for families.

“If it gets to the point where they try to institute a mandate or anything like that, then I’ll probably have issues with that,” Longmire said. “It’s to each their own. Do whatever you have to do to protect your family and if you feel that a vaccine is necessary for that, then I think it’s fine.”

More than 1.9 million children ages 5 to 11 have tested positive for the coronavirus, and more than 8,400 have been hospitalized, officials said. Nearly 100 have died.

Polling suggests an uphill battle to convince parents about the vaccine for young children. Only a third of parents said they would immediately seek vaccinations for kids 5 to 11, according to Kaiser Family Foundation polling.

And whether children receive a dose of a Covid vaccine will often depend on where they call home, as Centers for Disease Control and Prevention data analyzed by NBC News revealed that stark regional disparities in vaccination rates for children already eligible are deepening across the country.

Dr. Paul Offit, a vaccine researcher at the Children’s Hospital of Philadelphia and a member of the FDA advisory committee that voted Tuesday to recommend Pfizer-BioNTech’s Covid vaccine for emergency use authorization for those ages 5 to 11, acknowledged the difficulty of the decision.

Quote from THHuxleynew

The ONS survey does antigen tests

Thanks for confirming that you did post nonsense (PCR).

But you fail again. We exactly know that at least 55% of OK population already had contact with Cov-19. This can be calculated from the last exact data based on spike antibodies. Today spike has no value due to vaccines.

What ONS does is basically FUD. The Roche test seems not to work for Delta (see vaccine report) . Further it just looks for the early (after 4 weeks) antibody and not for the > 10 others. We also know that people with natural immunity do not develop high numbers of antibodies. 30% of them despite symptoms has even no short time spike antibodies.

So ONS basically knows nothing as the method is not adequate

What they should do would take far more time. Look at the overall neutralizing capacity of sample blood.

Quote from Fm1

But she's not planning to rush out to get the children, ages 5 and 2, vaccinated against Covid, even though one of them could be eligible as soon as next week.

There would need to be information out there to convince us it was necessary first," Burwick, 37, said. “I would say I think it’s unnecessary. And I’m uncomfortable with how quickly it’s rolling out with such a small study."

Lawyers can afford it..and may be have time to think.

Pfizer just made a fake study among 1500 children. Pfizer cheated away serious events. Classically this was a phase a trial. Classical this would need an other 5 years to market for adults. With children its 10 years here it was 3 months...

I will soon call Dr Mengele a good friend as Pfizer outpaces him by magnitudes!

Quote from THHuxleynew

Thus validating the "quick and simple" vaccine strategy of targeting S but not N proteins. Variants can easily modify n proteins to evade natural immunity there.

I don't disagree if your talking short term immunity but we see that as fleeting. By attacking the N protein you effectively eliminate the spike from mutating. All mutations of çoncern appear on the N protein of the spike. The mutations are sugar based and should be an easy target.

Quote from Fm1

Why even some vaccinated parents aren't planning to rush to give kids Covid shot

“I’m not opposed to vaccinating them in the future, maybe, but right now my husband and I are not comfortable with the data,” one parent said.

Here in Toronto we have what is called the GTHL, a hockey league for kids who play at a higher level and who can afford the much(!) higher costs, compared to house league and 'select' hockey.

Any kid 12 and over has to have had 2 covid vaccines to play. Many hockey parents are enraged at this level of coercion, using our favourite national sport to get kids vaccinated. When the covid vaccines are approved for kids 5 to 11 years of age by Health Canada (I can tell that HC is just itching to approve them!), are mandates also going to apply to them? Are parents going to cave into that pressure, so their kids can play hockey? At least, for now, kids 5 to 11 can play GTHL hockey without vaccines. Too bad however that unvaccinated parents wanting to watch their kids play are not allowed into certain arenas! Sick!

In the Swiss overview statistics the vaccine deaths have disappeared... Guess why...

Delta deaths week 42-41 double vaxx :: 13 average deaths/day 3.86 (may go slightly up due to later corrections)

Conclusion:: We have at least half of deaths now from double vaxx....

If the FM/R mafia doesn't like the data - it just disappears...

(The reports are in German... if somebody likes to see them I can upload them)

Speaking of hockey, I heard this on local talk radio just now: A hockey player in a 'beer league' just called in to the station. His hockey group has about 50 players, almost entirely in their 50s and 60s. You have to be double vaccinated to play. No surprise there, unfortunately. However, they did have a surprise. Some players were getting sick and (literally) tired. So they all had to get tested for Covid. 15 of the 50 players tested positive for Covid. They were shocked! Such is the level of misinformation from Health Canada and the media, that people think that the vaccination is providing substantial protection from infection. One of the players who tested positive (in late September) sadly died three weeks later.

Quote from Mark U

15 of the 50 players tested positive for Covid.

Sad to see how many people can be converted to idiots within a short phase of time. There is a fair chance that without vaccine nobody would have died...or the same person due to preconditions...

Quote from Mark U

Oh lordy. The study was not about geographic death rate gaps, nor how they changed from pre to post pandemic.

It is not, but as it happens geographic death rate gaps follow precisely gaps in vaccination rates. This gives us a handy way to compare historic data to the data from vaccinated and unvaccinated populations. It shows that the vaccinated people are expected to die from other causes at a lower rate. They always have. If they died at the same rate as unvaccinated people, the vaccine would probably be killing them.

You can do the same analysis by looking at other gaps. Not just geographic, but also wealth versus poverty, insured versus not-insured, Democrats versus Republicans, and various other social difference between large groups. The former groups have better health, better longevity, and higher rates of vaccination.

Quote from Mark U

That's what you say. But the CDC is implying there is indeed a health benefit (again, supposedly apart from Covid) to getting a Covid vaccine : "The lower mortality risk after COVID-19 vaccination suggests substantial healthy vaccinee effects (i.e., vaccinated persons tend to be healthier than unvaccinated persons)"

That conclusion makes no sense. The person who wrote that is either wrong, or they misstated the case. The lower mortality is 100% predictable, and the reasons for it are obvious. There is no doubt that vaccinated people tend to be healthier, but that is not a vaccine effect. People who keep themselves in good health (insofar as a person can do that) are the same people who got vaccinated. I am not an expert in social science but I know that much.

That conclusion is a logical fallacy: confusing cause and effect, or questionable cause.

Fallacy: Confusing Cause and Effect

Quote from Mark U

So they all had to get tested for Covid. 15 of the 50 players tested positive for Covid. They were shocked! Such is the level of misinformation from Health Canada and the media, that people think that the vaccination is providing substantial protection from infection.

The vaccination does provide substantial protection from infection. More than 15 would probably be sick without the vaccine, and they would probably be sicker. The vaccine does not provide perfect protection. No authoritative source says is does. They all say it reduces infection, not that it eliminates it.

What you are doing here, with that paragraph, is spreading misinformation. What you say here is nonsense, and it is contradicted by every legitimate source of information. You are doing what you falsely accuse these sources of doing.

Quote from JedRothwell

What you are doing here, with that paragraph, is spreading misinformation.

Quote from JedRothwell

No one is being forced into anything. You are free to refuse any vaccine. No one is being censored. You damn well know that, and you are lying through your teeth.

Quote from JedRothwell

Of course COVID-19 vaccines make you immune to COVID-19! You develop antibodies, and the virus cannot infect you. That's why they reduce the likelihood of infection by 95%.

And this is the misinformation you did spread...

Quote from JedRothwell

Not just geographic, but also wealth versus poverty, insured versus not-insured, Democrats versus Republicans, and various other social difference between large groups. The former groups have better health, better longevity, and higher rates of vaccination.

I do not mean that the U.S. population neatly splits into two groups. I meant that when you find a large group that had better health in 2018, you can predict it will have a higher vaccination rate in 2021. To take an imaginary example, suppose you found that baseball fans were significantly healthier than football fans in 2018. They would probably be more vaccinated today. They might not split along any of the other lines I listed. Baseball fans might be wealthy or poor, Democrats or Republicans with the same distribution as the general population.

(That's imaginary. I have no idea whether baseball fans are healthier or how they vote.)

The Doctrine of the Original Antigenic Sin and How COVID-19 Vaccinated are Potentially Spreading the Virus and Nullifying the Case for Vaccine Mandates: Vaccinating Our Children May End Up Killing Them

The Doctrine of the Original Antigenic Sin and How COVID-19 Vaccinated are Potentially Spreading the Virus and Nullifying the Case for Vaccine Mandates: Vaccinating Our Children May End Up Killing Them

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. by Paul Elias Alexander, PhD Is

trialsitenews.com

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

by Paul Elias Alexander, PhD

Is the case for COVID-19 vaccine mandates now dead? Is the doctrine of the ‘Original Antigenic Sin’ (OAS) in full display now due to the sub-optimal, non-sterilizing, imperfect COVID-19 vaccine? We should have known that we never ever try to vaccinate our way out of a pandemic while in a pandemic. We should have also known that if the initial priming (exposure to a pathogen e.g. to SARS-CoV-2) of the immune system (OAS) to a pathogen is sub-optimal and biased, then that sub-optimal initial priming deranges and biases the immune response long-term and guides all future immunological responses to that pathogen (OAS). That this initial priming if deranged and is wrong, will severely stagger and hobble our immune response for the rest of our lives. Are we setting our populations and dangerously our children, up for disaster, with this imperfect and sub-optimal immune priming with vaccines that do not stop infection or transmission in the first place? A COVID-19 vaccine that only reduces symptoms, thus allowing the host to stay alive (an evolutionary future it did not have) while capable of transmitting? Are we about to rob our children of their robust, durable, potent natural innate immunity with these imperfect leaky vaccines, and immunity that has always protected them and helps reduce the infectious pressure and helps contribute to population herd immunity? With vaccines that have been shown to be harmful (adverse effects and deaths post vaccine, CDC’s VAERS database). I argue we could potentially kill many children with these vaccines because we simply have not done the proper safety tests and studies for the proper duration of follow-up so as to ‘exclude harms’. If we have not conducted the proper studies, how could we justify the safety of these vaccines? To do so is dangerous and reckless as it deceives the public and parents. We do not know what will happen to our healthy children long-term. This is potentially catastrophic if COVID vaccination is allowed to happen in our children. These public health officials at CDC, NIH, NIAID etc. like Fauci and Walensky have not prosecuted their case, have made no case as to why our children warrant these vaccines. None! They are seeking to vaccinate healthy children with near statistical zero risk. With only the opportunity for harm.

Is there an example to explain how the immune system could be primed wrong initially and lead to sub-optimal responding long-term? Dan Stock explains this via a potential localized Th 1 natural killer CD8+ cytotoxic T cell down-regulation biased toward Th 2 systemic antibody responding due to vaccination (mediated by CD 4+ helper T cells). Exposure and subsequent exposure (including boosting) will have a deranged immune system that is ‘responding wrong’ to continue along this path (deranged responding), the end result being the host accumulating viral load in the respiratory tract unable to clear it effectively due to a down-regulated CD 8+ cytotoxic T cell response (sub-optimal initial priming/learning). In other words, a minimized local respiratory tract CD 8 + T cell cytotoxic response where it is needed, with a heightened systemic circulation antibody response where it is not optimally needed, the result being the host becoming infected with virus replicating, and the host becoming progressively ill and potentially shedding/spreading pathogen to the unvaccinated (and vaccinated). I am no virologist or immunologist (and I am open to correction) but this is one explanation that could at least partly explain what we are witnessing now whereby vaccinated persons are becoming infected, developing severe symptoms, being hospitalized, and also dying (especially from the Pfizer vaccine based on existing evidence).

Read et al. also provided us a roadmap to these vaccine and immune system challenges in their treatise on Marek’s disease in chickens in their seminal PLOS paper in 2015. Challenges whereby vaccines may boost and enhance the fitness of more virulent strains. They asked a simple question: Could some vaccines drive the evolution of more virulent pathogens? We say ‘yes’! This can be explained by natural selection which selects out or culls pathogen strains/variants that are so lethal or “hot” that they could kill their hosts if they survive and, thus, inadvertently, kill themselves. Marek’s disease effect and vaccination may well be at play here (moderating symptoms while not stopping infection or transmission, this being a danger to the unvaccinated (and vaccinated)). Can we extrapolate Marek disease vaccines to current COVID-19 vaccines?

We should have also understood, at least the virologists and immunologists and vaccine developers that the COVID-19 vaccines would drive antibodies against the spike glycoprotein ‘only’, while our natural exposure infection immune response will be broad, robust, durable, long-term, and against the spike (S) protein, the membrane protein, the nucleocapsid (N) protein, and all the epitopes on the viral ball and all conserved parts of the virus, and as such not susceptible to mutations on the spike (receptor binding domain). That no COVID-19 vaccine immunity could be equal to or better than naturally acquired immunity. This should have never even been in question. Assertions otherwise by the CDC, NIH, NIAID or vaccine developers are outright falsehoods and means to deceive the public.

We should have known that we could never achieve ‘zero COVID’ as this is a mutable respiratory pathogen, and you can never get ahead of it with a vaccine and particularly given there is an animal reservoir. Viruses are ubiquitous and omnipresent, and respiratory infections are an unescapable part of social life. This is a very different pathogen and approach than small-pox which did not have an animal reservoir. Robert Malone stated “The idea that if you have a workplace where everybody’s vaccinated, you’re not going to have virus spread is totally false…a total lie…the vaccinated are actually the “super-spreaders” that everyone was told about in the beginning of the pandemic”. Malone further states “if the government isn’t going to disclose to you what the [vaccine] risks are, and they’re not going to disclose to you what’s really going on because they think that you can’t handle the news … this is called the noble lie.”

Thus, are we closer to understanding now that vaccinating for COVID-19 under tremendous infectious and vaccine pressure (and ecological pressure) would drive immune escape? That this was indeed a recipe for disaster. Could COVID-19 vaccines be enhancing the evolution of variants/mutants that are more infectious and capable of spreading much faster and with greater lethality? Are these COVID-19 vaccines sub-optimally priming the immune system for long-term skewed deranged responding? Could the use of ‘imperfect’ sub-optimal vaccines enhance the progression of variants that place unvaccinated persons at elevated evolutionary risk of very severe illness, including death? Is this Marek 2.0?

Is this beyond a theoretical risk now and actually an unfolding materializing risk? Could the vaccination program be driving emergence of ‘hotter’ COVID variants? Much faster spread? Could the host be harboring far greater viral load due to the vaccination? Could this result in greater infections and mortality in the vaccinated and unvaccinated hosts whereby we are placing the unvaccinated at extensive risk of severe illness? “Natural selection will remove highly lethal pathogens if host death greatly reduces transmission.” Yet have we reversed this by enhancing the natural selection fitness of more infections and lethal strains, by extending the survival of the host and not stopping infection, increased viral replication, or spread? These questions raise serious concern if all or any are credible as we currently vaccinate against COVID-19, for we may actually be creating a disaster for our populations. All these very troubling potentially devastating questions apply to any move now and in the future by Anthony Fauci of NIAID and Francis Collins of the NIH and Rochelle Walensky of the CDC to vaccinate our children with this safety untested, leaky, non-neutralizing, non-sterilizing vaccines.

Can they (CDC, NIH, FDA, and vaccine developers Pfizer, Moderna etc.) admit this now based on the accumulated evidence? That if, and I dare say ‘if’ these vaccines were developed, that were not to have been forced and coerced but made available and accessed by people only based on ethical informed consent after being explained the benefit and the risks. Only then and with no mandates. None! Is the case for vaccine mandates now dead? In my opinion, it is, as there is no good sound scientific or medical justification for it

Texas A&M Discovered Inhaled Therapeutic Targeting COVID-19: A Possible Blockbuster?

Texas A&M Discovered Inhaled Therapeutic Targeting COVID-19: A Possible Blockbuster?

Texas A&M University Health Science (Texas A&M Health) and the University of Texas MD Anderson Cancer Center report progress on a recent Phase 2

trialsitenews.com

Texas A&M University Health Science (Texas A&M Health) and the University of Texas MD Anderson Cancer Center report progress on a recent Phase 2 clinical trial testing PUL-042. PUL-042 is an inhaled therapeutic that might provide broad protection against several life-threatening respiratory infections. The two organizations collaborated with the study sponsor, Houston-based biotechnology company Pulmotect, Inc. to perform the trial. Results show that the investigational product shows promising efficacy targeting COVID-19.

TrialSite offers a brief breakdown of the updates of this promising nasal therapy for SARS-COV-2, the virus behind COVID-19. Recently, Lindsey Hendrix writing for Texas A&M University Health Science Center, shared promising updates.

What is the company’s hypothesis?

The inhaled version of an investigational product called PUL-042 stimulates the innate immune system of the lungs, protecting against a wide variety of respiratory pathogens. The scientists behind it think PUL-042 could be directed against all existing and future variants of the COVID-19 virus, as well as future pandemics. Based on the promising results from this trial and remarkable activity in pre-clinical models, PUL-042 also has potential for use in other patient populations.

What is PUL-042

Pulmotect’s lead investigational product, PUL-042 is a clinical-stage inhaled therapeutic that stimulates the innate immune system in the lungs to provide immediate and effective protection in animal models against all major classes of pathogens, the company reports on its website.

The company positions the drug as a first in its class, a synergistic combination of two toll-like receptor agonists. The therapy triggers the innate immune system of the surface of the lungs to inhibit and kill a wide range of respiratory pathogens.

What is the science behind targeted therapy?

Pulmotect describes on its website that when microbes (including viruses) land on the epithelial cells of the lung lining, they are destroyed on-contact by antimicrobial peptides and reactive oxygen species (ROS), which are released by epithelial cells.

Activation of the innate immune system also triggers a response from the adaptive immune system. In preclinical models, the company reports that PUL-042 demonstrates protection against a broad range of respiratory pathogens in preclinical models, including the coronaviruses that cause MERS and SARS.

With robust pre-clinical protection shown against multiple pathogens even in models with immunocompromised animals and favorable tolerability demonstrated in clinical trials to date, PUL-042 could offer a broad-spectrum therapy for responding to epidemics and pandemics including current and future SARS-CoV-2 variants and it has potential use for multiple other indications.

So, to summarize, the innate immune system represents the human body’s first line of defense against invading pathogens. When germs and foreign substances enter the body, the innate immune system responds quickly to fight them off. PUL-042, the first drug in its class, is composed of two small synthetic molecules and works by stimulating specific innate immune receptors in the lung lining within minutes. Protection only lasts for about three to five days, but it can be repeatedly administered once every few days.

A Texas A&M discovery

PUL-042 was discovered by Magnus Hӧӧk, a distinguished professor at the Texas A&M Health Institute of Biosciences and Technology, and Dr. Burton Dickey, chair of the pulmonary department at MD Anderson Cancer Center.

“The lungs are the point of entry for many viruses and bacteria. By activating the innate immune defense of the lungs, PUL-042 can provide effective protection against a wide range of deadly pathogens,” Hӧӧk said. “We believe that if we had this therapy available in December of 2019, we could have prevented the COVID-19 pandemic and avoided the 6 million lives lost.”

What are the results from recent Phase 2 clinical trial?

Results from a recent phase 2 clinical trial conducted through Houston-based biotechnology company Pulmotect, Inc. showed that it may be an effective treatment for COVID-19 and other respiratory illnesses.

Patients in the trial treated with inhaled PUL-042 showed improvement in cough and shortness of breath more quickly than those who received a placebo treatment. According to this venture founded in 2007, participants in this study experienced fewer hospitalizations and intensive care admissions.

The study randomized 101 patients with early diseases in the United States. The sponsor reported the investigational product was “well tolerated when administered as a single dose on Day 1, Day 3, and Day 6 of the trial with 28 days of patient follow up.”

In a recent press release, the company shared that two of the study patients were hospitalized with deterioration from pre-treatment of two or more points on the Ordinal Scale for Clinical Improvement. A total of three (3) patients were hospitalized due to progressing COVID-19, two in the placebo group—both required intensive care treatment for 5 days and 9 days, and one patient in the study drug group was hospitalized for four days. They did not require intensive care.

Note this data is not peer-reviewed yet, so cannot be cited as a certainty.

Clinical Trials Attracts DoD Funding

The Food and Drug Administration approved Pulmotect to begin two human clinical trials of PUL-042 last year, one focused on protection and another on treatment for COVID-19. Funding support for the trials was provided by the U.S. Department of Defense.

The company announced back in January 2021 that it received $6 million to conduct two clinical trials.

Broad Antiviral Applicability?

According to Dr. Colin Broom, CEO of Pulmotect “We have not found a virus PUL-042 cannot work against in the lungs, in animal studies.” Broom continued “As an easily administered inhaled therapy, PUL-042 could have value in reducing the impact of COVID-19 irrespective of the development of further variants. It also has potential utility for other patient populations which we plan to explore, including immunosuppressed cancer patients.”

The Sponsor

Houston-based Pulmotect was founded by Hӧӧk and colleagues at Texas A&M to commercialize this intellectual property. The biopharma develops products that boost the innate immune system to protect against a wide range of lung infections.

Formed in 2007, according to Crunchbase, Pulmotect has raised at least $28.4 million.

About Texas A&M Health Center

Part of Texas A&M University, Texas A&M Health Center offers health professions research and education in a range of categories from biomedical sciences to medicine and dentistry, and pharmacy. The academic medical center was established in 1999 as an independent institution of the Texas A&M University System—receiving accreditation in December 2002.

New Inhaled Therapeutic Shows Promising Results Against Most Known Respiratory Infections

The drug developed by Texas A&M and University of Texas MD Anderson Cancer Center scientists could be an effective treatment for COVID-19 and other illnesses.

today.tamu.edu

New Drug Boosts Immune System Against World's Deadliest Infectious Diseases - TMC News

Researchers at the Texas A&M Health Science Center (TAMHSC) and the University of Texas MD Anderson Cancer Center have developed a new therapy to stimulate the…

www.tmc.edu

Biden blinks!

Covid-19 live updates

White House suggests flexibility in vaccine deadline for federal workers, contractors

https://www.washingtonpost.com/nation/2021/10/28/covid-delta-variant-live-updates/

The White House coronavirus response coordinator, Jeff Zients, indicated that the Biden administration could be flexible as it enforces the president’s executive order requiring federal workers and government contractors to vaccinate their workers.

No causal effect of school closures in Japan on the spread of COVID-19 in spring 2020

No causal effect of school closures in Japan on the spread of COVID-19 in spring 2020 - Nature Medicine

School closures in municipalities in Japan at the start of the COVID-19 pandemic showed no significant reduction in cases compared with case counts in…

www.nature.com

Abstract

Among tool kits to combat the coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2, school closures are one of the most frequent non-pharmaceutical interventions. However, school closures bring about substantial costs, such as learning loss. To date, studies have not reached a consensus about the effectiveness of these policies at mitigating community transmission, partly because they lack rigorous causal inference. Here we assess the causal effect of school closures in Japan on reducing the spread of COVID-19 in spring 2020. By matching each municipality with open schools to a municipality with closed schools that is the most similar in terms of potential confounders, we can estimate how many cases the municipality with open schools would have had if it had closed its schools. We do not find any evidence that school closures in Japan reduced the spread of COVID-19. Our null results suggest that policies on school closures should be reexamined given the potential negative consequences for children and parents.

Discussion

We identify the effect of school closures on the spread of COVID-19 using matching methods. Our results suggest that the effect of school closures on COVID-19 cases in Japan in early 2020 is not significantly different from zero. Ref. 45 comes to the same conclusion based on different data from Japan and a different method.

Our research design does not enable us to elucidate the mechanisms underlying the empirical findings. That said, we provide a few conjectures. First, many treated municipalities did not comply with the treatment in the sense that many schools that were closed nevertheless provided spaces for children whose parents worked such as playing fields, gyms, classrooms and libraries. For instance, schools made these facilities available to families in 63.6% of the treated municipalities as of 17 March and 59% as of 16 April (Supplementary Information; main analysis, 16 March and 16 April). Furthermore, children may interact with each other outside of school19,26,36,41. Second, as past studies have demonstrated19,36,40,54, even in control municipalities, children may be less susceptible to SARS-CoV-2 and less likely to transmit the virus to others, including teachers, parents and neighbors. Moreover, students attending in-person schooling were engaged in stringent mitigation strategies such as physical distancing and enhanced hygiene. Limiting the amount of contact between children by shutting down schools may thus have not had a large impact on reducing the spread of COVID-19.

We admit some limitations of our study. Although we are confident in the internal validity of our findings, we are less sure about their external validity (Supplementary Information). Japan, like New Zealand and South Korea, fared relatively well with regard to COVID-19 cases compared to some countries such as Italy, Spain and the United States. It is possible that school closures only have a discernible effect on COVID-19 cases once the reproduction number (within a school environment) passes a certain threshold. Likewise, we analyze the effectiveness of school closures in the initial months of the coronavirus pandemic, but community transmission has become notably worse in many countries (including Japan) since spring 2020. New variants of SARS-CoV-2 (for example, the alpha and delta variants), which have each increased transmissibility, may also be more or less affected by school closures. Another possibility is that citizens’ behavior (for example, social distancing, wearing masks and washing hands) and school measures (for example, disinfecting classrooms, placing transparent dividers between students, splitting classes into smaller groups that meet separately and ventilation) intended to limit the spread of COVID-19 may be less strict in some countries compared to Japan, which could increase the risk of opening schools.

With these caveats in mind, we offer both empirical and methodological contributions to the existing literature. Empirically, we find no evidence that school closures in Japan caused a significant reduction in the number of coronavirus cases. These null results concerning the supposed benefits of closing schools suggest that policymakers should be cautious when considering similar policies in the future, especially given the substantial costs such policies can have for the well-being of both children and parents. Our recommendation is that governments should monitor SARS-CoV-2 infection rates and school closures at a granular level (for example, municipality or school district) in real time (for example, daily). Methodologically, we pay attention to causal inference by using matching techniques and exploiting features of Japanese municipalities that enable us to identify the effect of school closures independent of other NPIs. Our hope is that our study can inspire other researchers to use causal inference methods to rigorously test the generalizability of our findings to other settings.

A nice find from the Swiss Covid report!

All phases with high a CoV-19 case load also show high load of rhinovirus (light blue). Since week 17 also RSV (yellow-brown)is strongly showing up. With alpha almost no other virus have been found. Influenza was just a tiny flash around week 6.

Quote from Wyttenbach

All phases with high a CoV-19 case load also show high load of rhinovirus (light blue). Since week 17 also RSV (yellow-brown)is strongly showing up. With alpha almost no other virus have been found. Influenza was just a tiny flash around week 6.

And the reason is...

I'm sure W is clever enough to work it out - but I don't think he will do so - he prefers his idee fixee.

Throughout the lockdowns non-COVID respiratory diseases were also strongly suppressed. Immunity to them reduced. this winter, they are all coming back, only more than usual.