Covid vaccination status for CF members

[Thumbs Up]

Ready to talk about this now? Thanks for bringing it up. There have now been 50 trials including 26 randomized control trials.

FDA-approved drugs, like ivermectin, may be prescribed for an unapproved use (“off-label”) when the physician believes it to be medically appropriate for their patients. The FDA affords clinicians the freedom to prescribe and treat using medications that they deem to be in the best interest of the patient.

The practice of prescribing drugs “off-label” is so common that 1 out of 5 prescriptions dispensed in the U.S. is for an off-label use. The reason why off-label prescriptions are issued so frequently because there might not be an approved drug to treat a specific disease or medical condition. Also, patients may have tried all approved treatments without seeing any benefits.

The NIH COVID-19 Treatment Panel states that, “Providers can access and prescribe investigational drugs or agents that are approved or licensed for other indications through various mechanisms, including Emergency Use Authorizations (EUAs), Emergency Investigational New Drug (EIND) applications, compassionate use or expanded access programs with drug manufacturers, and/or off-label use.”
The panel also recommends that promising, unapproved, or unlicensed treatments for COVID-19 be studied in well-designed, controlled clinical trials. This includes drugs that have been approved or licensed for other indications. It is important to note that there have been multiple published, peer-reviewed controlled clinical trials throughout the world that point to the efficacy of ivermectin in the prevention and treatment of COVID-19.
The panel also stipulates that the treatment recommendations in their guidelines are not mandates; but rather that “the choice of what to do or not to do for an individual patient is ultimately decided by the patient and their provider.”
Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. Doctors may prescribe what they wish as long as they believe themselves to be well-informed and basing their decision on sound medical evidence. It should be noted, however, that individual institutions may set their own standards for off-label prescriptions if they so choose.https://covid19criticalcare.com/iver...on-ivermectin/

https://covid19criticalcare.com/

Weak Guidance on Ivermectin from the World Health Organization (WHO):

The latest guidance from the WHO is out of alignment with many national and local health authorities around the world where ivermectin has been proven to prevent and treat COVID-19. These countries include, Bulgaria, Slovakia, India, Egypt, Peru, Zimbabwe, and Bolivia, and in several regions a growing number of health authorities have advocated for, or adopted ivermectin across Japan, Mexico, Brazil, Argentina, and South Africa and it is now the standard of care in Mexico City.https://www.wfmz.com/news/pr_newswir...ad45532f3.html

[Montanan]

Originally Posted by DomPerignon

They’re using it profusely in India and the Dominican Republic that I know of and it’s working miracles . It cost about 2 cents a dose witch is not a good business model for US or European big pharma.
Just google it .

Interesting subject, a few, small trials have been implemented, none especially noteworthy.

Read the interpretations of each trial in Table 2

https://www.covid19treatmentguidelin...py/ivermectin/

https://www.covid19treatmentguidelin...bles/table-2c/

NIH summary:

Ivermectin
Last Updated: February 11, 2021

Ivermectin is a Food and Drug Administration (FDA)-approved antiparasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies.1 It is also being evaluated for its potential to reduce the rate of malaria transmission by killing mosquitoes that feed on treated humans and livestock.2 For these indications, ivermectin has been widely used and is generally well tolerated.1,3 Ivermectin is not approved by the FDA for the treatment of any viral infection.

Proposed Mechanism of Action and Rationale for Use in Patients With COVID-19
Reports from in vitro studies suggest that ivermectin acts by inhibiting the host importin alpha/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses hijack to enhance infection by suppressing the host’s antiviral response.4,5 In addition, ivermectin docking may interfere with the attachment of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein to the human cell membrane.6 Ivermectin is thought to be a host-directed agent, which may be the basis for its broad-spectrum activity in vitro against the viruses that cause dengue, Zika, HIV, and yellow fever.4,7-9 Despite this in vitro activity, no clinical trials have reported a clinical benefit for ivermectin in patients with these viruses. Some studies of ivermectin have also reported potential anti-inflammatory properties, which have been postulated to be beneficial in people with COVID-19.10-12

Some observational cohorts and clinical trials have evaluated the use of ivermectin for the prevention and treatment of COVID-19. Data from some of these studies can be found in Table 2c.

Recommendation
There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.
Rationale
Ivermectin has been shown to inhibit the replication of SARS-CoV-2 in cell cultures.13 However, pharmacokinetic and pharmacodynamic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans.14,15 Even though ivermectin appears to accumulate in the lung tissue, predicted systemic plasma and lung tissue concentrations are much lower than 2 µM, the half-maximal inhibitory concentration (IC50) against SARS-CoV-2 in vitro.16-19 Subcutaneous administration of ivermectin 400 µg/kg had no effect on SARS-CoV-2 viral loads in hamsters. However, there was a reduction in olfactory deficit (measured using a food-finding test) and a reduction in the interleukin (IL)-6:IL-10 ratio in lung tissues.20

Since the last revision of this section of the Guidelines, the results of several randomized trials and retrospective cohort studies of ivermectin use in patients with COVID-19 have been published in peer-reviewed journals or have been made available as manuscripts ahead of peer review. Some clinical studies showed no benefits or worsening of disease after ivermectin use,21-24 whereas others reported shorter time to resolution of disease manifestations that were attributed to COVID-19,25-28 greater reduction in inflammatory marker levels,26,27 shorter time to viral clearance,21,26 or lower mortality rates in patients who received ivermectin than in patients who received comparator drugs or placebo.21,26,28

However, most of these studies had incomplete information and significant methodological limitations, which make it difficult to exclude common causes of bias. These limitations include:

The sample size of most of the trials was small.
Various doses and schedules of ivermectin were used.
Some of the randomized controlled trials were open-label studies in which neither the participants nor the investigators were blinded to the treatment arms.
Patients received various concomitant medications (e.g., doxycycline, hydroxychloroquine, azithromycin, zinc, corticosteroids) in addition to ivermectin or the comparator drug. This confounded the assessment of the efficacy or safety of ivermectin.
The severity of COVID-19 in the study participants was not always well described.
The study outcome measures were not always clearly defined.
Table 2c includes summaries of key studies. Because most of these studies have significant limitations, the Panel cannot draw definitive conclusions on the clinical efficacy of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide further guidance on the role of ivermectin in the treatment of COVID-19.

[DomPerignon]

Originally Posted by Montanan

Interesting subject, a few, small trials have been implemented, none especially noteworthy.

Read the interpretations of each trial in Table 2

https://www.covid19treatmentguidelin...py/ivermectin/

https://www.covid19treatmentguidelin...bles/table-2c/

NIH summary:

Ivermectin
Last Updated: February 11, 2021

Ivermectin is a Food and Drug Administration (FDA)-approved antiparasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies.1 It is also being evaluated for its potential to reduce the rate of malaria transmission by killing mosquitoes that feed on treated humans and livestock.2 For these indications, ivermectin has been widely used and is generally well tolerated.1,3 Ivermectin is not approved by the FDA for the treatment of any viral infection.

Proposed Mechanism of Action and Rationale for Use in Patients With COVID-19
Reports from in vitro studies suggest that ivermectin acts by inhibiting the host importin alpha/beta-1 nuclear transport proteins, which are part of a key intracellular transport process that viruses hijack to enhance infection by suppressing the host’s antiviral response.4,5 In addition, ivermectin docking may interfere with the attachment of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein to the human cell membrane.6 Ivermectin is thought to be a host-directed agent, which may be the basis for its broad-spectrum activity in vitro against the viruses that cause dengue, Zika, HIV, and yellow fever.4,7-9 Despite this in vitro activity, no clinical trials have reported a clinical benefit for ivermectin in patients with these viruses. Some studies of ivermectin have also reported potential anti-inflammatory properties, which have been postulated to be beneficial in people with COVID-19.10-12

Some observational cohorts and clinical trials have evaluated the use of ivermectin for the prevention and treatment of COVID-19. Data from some of these studies can be found in Table 2c.

Recommendation
There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.
Rationale
Ivermectin has been shown to inhibit the replication of SARS-CoV-2 in cell cultures.13 However, pharmacokinetic and pharmacodynamic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans.14,15 Even though ivermectin appears to accumulate in the lung tissue, predicted systemic plasma and lung tissue concentrations are much lower than 2 µM, the half-maximal inhibitory concentration (IC50) against SARS-CoV-2 in vitro.16-19 Subcutaneous administration of ivermectin 400 µg/kg had no effect on SARS-CoV-2 viral loads in hamsters. However, there was a reduction in olfactory deficit (measured using a food-finding test) and a reduction in the interleukin (IL)-6:IL-10 ratio in lung tissues.20

Since the last revision of this section of the Guidelines, the results of several randomized trials and retrospective cohort studies of ivermectin use in patients with COVID-19 have been published in peer-reviewed journals or have been made available as manuscripts ahead of peer review. Some clinical studies showed no benefits or worsening of disease after ivermectin use,21-24 whereas others reported shorter time to resolution of disease manifestations that were attributed to COVID-19,25-28 greater reduction in inflammatory marker levels,26,27 shorter time to viral clearance,21,26 or lower mortality rates in patients who received ivermectin than in patients who received comparator drugs or placebo.21,26,28

However, most of these studies had incomplete information and significant methodological limitations, which make it difficult to exclude common causes of bias. These limitations include:

The sample size of most of the trials was small.
Various doses and schedules of ivermectin were used.
Some of the randomized controlled trials were open-label studies in which neither the participants nor the investigators were blinded to the treatment arms.
Patients received various concomitant medications (e.g., doxycycline, hydroxychloroquine, azithromycin, zinc, corticosteroids) in addition to ivermectin or the comparator drug. This confounded the assessment of the efficacy or safety of ivermectin.
The severity of COVID-19 in the study participants was not always well described.
The study outcome measures were not always clearly defined.
Table 2c includes summaries of key studies. Because most of these studies have significant limitations, the Panel cannot draw definitive conclusions on the clinical efficacy of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide further guidance on the role of ivermectin in the treatment of COVID-19.

Here’s the Dominican experience

https://dominicantoday.com/dr/covid-...th-ivermectin/

[DomPerignon]

Here’s the India experience

https://johnbwellsnews.com/fda-warns...-care-workers/

[Thumbs Up]

Honduras started handing out Ivermectin for COVID a year ago. Chiapas, Mexico was using it early on, S Africa just lifted it's ban on it. Belize also uses it. I would love to see a risk/ benefit analysis. Tons of info here: https://trialsitenews.com/tag/ivermectin/

FDA Now Cautions Against Ivermectin—the Vested Interests are Circling the Wagons
With mass media synchronization, that is recent ivermectin-based articles from both the New York Times and CNN covering negative news, the U.S. Food and Drug Administration (FDA), the Gold Standard global food and drug regulatory body, has issued a cautionary statement targeting ivermectin. The crux of the agency’s concern includes 1) Ivermectin is an off label treatment; 2) taking large doses of the drug can be harmful; 3) ivermectin should be used for “legitimate” source (e.g. anti-parasitic indication); and 4) animal medications should never be taken by humans. The basis for the agency’s warnings are “multiple reports” of individuals that have received either medical support for taking the drug or hospitalization after self-medication with the type needed for animals. No such data backing those reports is included, however—no warning letters, no examples from county or state health agencies or for that matter tangible reports from hospitals. TrialSite’s suggests that the FDA is reacting to growing interest around America about the drug. Interestingly, as the National Institutes of Health (NIH) declared that there isn’t enough information yet to recommend for or against the use of ivermectin, this now contradicts the FDAs’ more forceful off-label use declaration. The NIH’s stance of course was in the context of physician discretion, consenting patients, etc. As TrialSite suggests, the fix is on, powerful economic and sectoral interests are circling the wagons as drugs, politics and power predicts this particular research pathway doesn’t benefit economic interests during the pandemic and beyond. https://trialsitenews.com/fda-now-ca...ng-the-wagons/

Dr. Pierre Kory testifies to senate committee:https://vimeo.com/490351508

[Lake-Effect]

Originally Posted by Thumbs Up

Ready to talk about this now?

Sure. Since IVM is "approved" for trial or last-hope efforts in the US, where in the US is it being trialled or used, and with what results?


Meanwhile, in the Philippines...

[Montanan]

COVID Passport Update:

The EU Digital Green Certificate aims to establish a system that allows recording the vaccination status, previous COVID-19 infections as well as test results in order to ease travel through the EU area.

Only last Sunday, the EU Internal Market Commissioner Thierry Breton pointed out that the Commission intends to launch the vaccination certificate programme by the middle of June, SchengenVisaInfo.com reports.

https://www.schengenvisainfo.com/new...-certificates/

[Montanan]

Originally Posted by DomPerignon

Here’s the India experience

https://johnbwellsnews.com/fda-warns...-care-workers/

Thank you for the references. Can you provide links to clinical trial publications? I have been trying to find data and have not been able to find any with peer reviewed articles.

Several in vitro lab studies. But those are test tube incubations.

Loads of anecdotal, newspaper stories.

All the best.

[Montanan]

The EU Commission brought forward its proposal for the creation of a Digital Green Certificate in a bid to restore travel amid COVID-19 for those who have been vaccinated against the virus, SchengenVisaInfo.com reports.

The same document can also be used to prove that the holder has recovered from COVID-19. Those who have not been vaccinated, nor have they recovered from the virus, can use the document to present their COVID-19 test results.

By including all three situations in one document, the Commission intends to avoid the discrimination of non-vaccinated persons.

The certificates, a prototype of which was presented by Commissioner Breton during his interview, will include information such as name, birth date, date of issuance, information on the vaccine/test/recovery and a unique scannable identifier of the certificate.

Reference the digital and the paper prototype certificates at the link below:

https://www.schengenvisainfo.com/new...ent-prototype/

As the old American Express advertisement used to say:

Never leave home with out it!

But in this Covid world, perhaps the expression may become:

You can't leave home with out it.

[CatNewBee]

Originally Posted by Montanan

The EU Commission brought forward its proposal for the creation of a Digital Green Certificate in a bid to restore travel amid COVID-19 for those who have been vaccinated against the virus, SchengenVisaInfo.com reports.

The same document can also be used to prove that the holder has recovered from COVID-19. Those who have not been vaccinated, nor have they recovered from the virus, can use the document to present their COVID-19 test results.

By including all three situations in one document, the Commission intends to avoid the discrimination of non-vaccinated persons.

The certificates, a prototype of which was presented by Commissioner Breton during his interview, will include information such as name, birth date, date of issuance, information on the vaccine/test/recovery and a unique scannable identifier of the certificate.

Reference the digital and the paper prototype certificates at the link below:

https://www.schengenvisainfo.com/new...ent-prototype/

As the old American Express advertisement used to say:

Never leave home with out it!

But in this Covid world, perhaps the expression may become:

You can't leave home with out it.

Yes, digital tracking, nothing to do with covid, electronic fancing and surveillance of the population to curb free movement without border controls.
electronic ankle cuffs

[Montanan]

Denmark is working on a Covid Passport and is apparently going to call it a Coronpas.

Here is what I'll propose for Montaña's Corona Certification.

It must be accompanied by a slice of lime, otherwise it will be deemed invalid.

Those that have one will be called a Limey.

If you have one and drive, they will issue you an ankle bracelet.

[Thumbs Up]

Originally Posted by Montanan

Thank you for the references. Can you provide links to clinical trial publications? I have been trying to find data and have not been able to find any with peer reviewed articles.

Several in vitro lab studies. But those are test tube incubations.

Loads of anecdotal, newspaper stories.

All the best.

Originally Posted by Lake-Effect

Sure. Since IVM is "approved" for trial or last-hope efforts in the US, where in the US is it being trialled or used, and with what results?

Here is info about all of the studies. https://ivmmeta.com/
Positive results across 50 studies so far.

[Montanan]

Originally Posted by Lake-Effect

Sure. Since IVM is "approved" for trial or last-hope efforts in the US, where in the US is it being trialled or used, and with what results?


Meanwhile, in the Philippines...

Well that kinds of puts ivermectin back into the ranch supply stores and in the barn and out of the medicine cabinets here in Montana.

"April 05, 2021
MANILA, Philippines — The Department of Health (DOH) and the Food and Drug Administration (FDA) reiterated their position on Monday that they do not recommend using the anti-parasitic drug Ivermectin for COVID-19 care, stating that existing “evidence” does not support such claims.

The agencies cited a study of six trials conducted by the Philippine COVID-19 Clinical Practice Guidelines (CPG) that concluded the drug “did not significantly reduce” the risk of death in patients with moderate to severe cases."

Since The Last Best Place has about 2.5 million head of cattle and just over 1 million people, we have a real anxiety of the Covid pandemic becoming a COWvid pandemic. The more ranchers that get infected by SARS-CoV-2 the more potential for the virus to become Zooanthroponosis [Reverse Zoonotic Disease Transmission] transmitted from humans to animals. Cows are not very compliant as to social distancing, hoof washing and mask wearing.

We Montanans already have been dealing with zombie deer disease outbreaks [a.k.a Chronic wasting disease - CWD]. Damned Deadly Prions. Geez, at least they can develop vaccines for a virus so there is some hope. Prions, plumb out of luck, self replicating molecules, scared the s&%t out of us in our biotechnology company, heck they survived the autoclaves.

CWD is a transmissible spongiform encephalopathy affecting deer. TSEs are a family of diseases thought to be caused by misfolded proteins called prions and include similar diseases such as Mad Cow Disease / BSE / bovine spongiform encephalopathy in cattle, Creutzfeldt-Jakob disease in humans and scrapie in sheep. In the US, CWD affects mule deer, white-tailed deer, red deer, sika deer, elk, caribou, and moose. Natural infection causing CWD affects members of the deer family.

I have a lot of large mule deer visit and bed down in my yard, only the occasional mountain lion and coyotes and bears. No wolves in town yet but one hears their calls on the fringes. Haven't had a skunk wander into our home at night for a couple of years [we often leave the front and back door open at night when it is warm to allow a breeze to flow through since we don't have A/C in this climate, nor do we have screen doors since there are very few bugs, things come in and out from time to time, every once in a while a drunken neighbor who has lost their way home from the bars after closing hour. My wife caught the last skunk around 3 AM helping itself to some of our dog's kibble food that was in a forty pound bag in the pantry, cute little face peaking out from behind the bag. So glad the dog did not awaken to discover the skunk as that would have fast become a stinky affair. His tangling with the porcupine did not go well, a snoot full of quills that had to be pulled out with pliers, no joy performing that on our pet.

So one can just imagine having Zombie Dear AND Mad Cows. ARGHHH, pure nightmare material in Montana.

Definitely going to move out of the State if we end up with Zombie Grizzly Bears, nothing like a mad mother Griz, or if we end up with Wacko Wolves.

Stay safe, stay healthy.

And I recommend that you do NOT eat any Tide Pods.

[Lake-Effect]

Originally Posted by Thumbs Up

Here is info about all of the studies. https://ivmmeta.com/
Positive results across 50 studies so far.

That site is "noisy" and is pushing a conclusion. A sister page claims that HCQ is effective against COVID as well, which kind of dents its credibility.

The few positive papers that I spent any time with were from earlier in the pandemic, and the drugs were used in combination with others. Further, claims that most people on the drug got better in 5 days is kind of specious, since most people get over COVID-19 in 5 days, period.

But I'd be happy to look at more recent trials from the western world.

[Mike OReilly]

Originally Posted by CatNewBee

Yes, digital tracking, nothing to do with covid, electronic fancing and surveillance of the population to curb free movement without border controls.
electronic ankle cuffs

If this was the goal of the Grand International Cabal or Illuminati that you see behind Covid-19, then they sure as heck didn't need to go through such an elaborate, intricate and expensive "hoax". All that they needed to do is dangle more shinny digital things through Facebook, Google, or offer more "points cards" to the wealthy.

Most people already voluntarily agree to be surveilled nearly all the time in our societies. And that's even disregarding the near-ubiquitous cameras for "security" purposes.

You don't need to invoke silly conspiracy theories to see that most of us have already given up our right to privacy, and done it for something far less important than immunity to a deadly disease.