Posts by Fm1

Is Biden Contradicting Federal Vaccine Policies On The International Stage? Yes.

Is Biden Contradicting Federal Vaccine Policies On The International Stage? Yes.

US President Joe Biden is set to deliver a call to arms at a virtual summit on the current state of the COVID-19 pandemic to members of the international

trialsitenews.com

US President Joe Biden is set to deliver a call to arms at a virtual summit on the current state of the COVID-19 pandemic to members of the international community, asking them to boost their efforts in delivering on their commitments to close the global vaccine inequity gap. According to multiple sources, President Biden wants to persuade other countries that produce vaccines internally to balance out their domestic needs for vaccination with the crisis of vaccine inequity across the developing world.

Set for Wednesday, Biden’s plea will be delivered during the annual meeting of the United Nations General Assembly in New York City. The primary governing body of the United Nations is expected to further discuss the global response to the pandemic and the worsening state of the global climate. To say the least, Biden’s strategy is exceptionally topical for the coming weeks of vaccine geopolitics. However, POTUS is positioning himself for further criticism for the apparent hypocrisy of the federal government’s Frankenstein monster of a vaccine policy. TrialSite had reported previously that Biden’s goal to implement booster vaccinations in America, tied with the controversial rollout of the national vaccine mandate expected to impact over 100 million Americans, is quickly evolving into a snowball of irony and contradiction expected to crash down on the country and the entire global community.

Please consider a few things. We don’t like being repetitive, but simple math shows a plethora of scenarios of what could go wrong if Biden and his administration don’t tighten up their approach to COVID-19 vaccines. First, the president and his public health team are expected to rebuke a recommendation given by the Food and Drug Administration advisory committee for vaccine approval that disapproved of Pfizer’s proposal to implement mass inoculations of their booster shot to a general population. Rather, the advisory committee overwhelmingly adopted a plan that targets booster doses for the elderly and other high-risk groups of immunocompromised individuals.

Since the White House is hell-bent on vaccinating the entire US population with a booster and a primary dose of the COVID-19 vaccination, the political force behind such an ambitious plan will direct the president and his advisers to dismiss the recommendations of the FDA committee at some point and in some format in the very near future.

Secondly, Biden is apparently pressuring India and Prime Minister Narendra Modi to resume vaccine exports to the global south, including to the wholly underserved countries in Africa and Central Asia. While a collective call from the outside looking in, the ebb and flow of this diplomatic discussion places America, again, in contradiction land. We reported recently that Modi suspended the exportation of AstraZeneca’s cheap-to-make COVID-19 vaccine earlier this year to deal with the spread of the novel coronavirus disease among India’s gargantuan population of 1.366 billion people.

A month ago, data indicated that at least two-thirds of the Indian population was exposed to the virus and that only a portion of the population, about 20% of the total adults in the country, have been jabbed with at least one dose of a COVID-19 vaccine. Of course, numbers are relative. But the optics of the US government pressuring another country that has the same, possibly greater, level of vaccine manufacturing capacity but a significantly larger population appears a bit selfish and dumbfounding.

By comparison, the total US population is over 54% fully vaccinated. Herd immunity is already in sight. Why can’t the U.S. spare some more vaccines and send them to the most vulnerable and neediest countries?

On a third note, the Biden administration emphasizes that they are already in the process of distributing vaccine doses to developing countries. But will it be enough? One of the biggest issues with the global vaccine drive has been the persistent failure of the COVAX consortium. The World Health Organization, a United Nations agency, announced early on in the pandemic the formation of the COVAX initiative consisting of national governments, non-governmental organizations, charities, and private companies working under one umbrella to coordinate and ensure the equitable distribution of vaccines across the world.

However, as the World Health Organization has declared for months, the majority of the vaccines administered throughout the world have been administered by only ten to fifteen of the largest and wealthiest countries. This, of course, includes the United States. Poorer countries, including India in the global south, are still struggling to implement vaccine drives at larger scales. Governments in countries such as South Sudan, Sudan, DR Congo, Zambia, Lesotho, and so many others, have been unable to deliver vaccines to their populations because, in part, the high concentration of doses already administered in highly developed countries in North America and Western Europe. That said, Biden’s attempt to play global citizen and friend to the developing world could fall short due to the chink in his armor: his domestic politics related to the COVID-19 vaccine.

It’s statecraft 101. In order to show force on the global stage, a national government must demonstrate that they have effectively or given the impression that they have balanced domestic politics. It’s cyclical. Domestic politics inform foreign policy. That said, how does Biden intend to show force through humanitarianism during his call for other governments to contribute to the efforts of countering global vaccine shortage when the discussion of vaccine policy isn’t even close to being settled on the United States domestic scene? Naturally, this is a rhetorical question. But a valid one that necessitates multiple answers from different perspectives on the subject matter.

Biden is setting himself up for an international embarrassment if he continues down this politically driven vaccine approach. We can sit and chat about mandatory vaccines for days and whether boosters are viable for the general public. But, for the case of addressing the problem globally, the issue of overcommitting resources to one policy and not enough to the other could have enumerable consequences, both politically, legally, and negatively with regards to the security of the domestic and international public health.

Quote from jox

"Tidewater Physicians Multispecialty Group Takes on the Molnupiravir ‘Household Contacts’ Phase 3 Clinical Trial"

......... Yes but does it kill worms in horses?.... for virtually nothing

It does in dogs don't know about horses and no it costs a boatload ! But I'm already paying for it, the us government already bought 1.7 million does in June . Your tax dollars at work!

U.S. signs $1.2 bln deal for 1.7 mln courses of Merck's experimental COVID-19 drug

U.S. signs $1.2 bln deal for 1.7 mln courses of Merck's experimental COVID-19 drug

Merck & Co Inc (MRK.N) said on Wednesday the U.S. government has agreed to pay about $1.2 billion for 1.7 million courses of its experimental COVID-19…

www.reuters.com

Tidewater Physicians Multispecialty Group Takes on the Molnupiravir ‘Household Contacts’ Phase 3 Clinical Trial

Tidewater Physicians Multispecialty Group Takes on the Molnupiravir ‘Household Contacts’ Phase 3 Clinical Trial

Based in Newport News, Virginia, Tidewater Physicians Multispecialty Group (TPMG) was formed in 1992 first as a primary care medical group. Today the

trialsitenews.com

Based in Newport News, Virginia, Tidewater Physicians Multispecialty Group (TPMG) was formed in 1992 first as a primary care medical group. Today the group includes 200 primary care, specialty physicians, and advanced practice clinicians in dozens of office locations across coastal Virginia. This multispecialty practice also serves as a trial site for research. Recently local press promoted a study at the TPMG Hampton Roads clinic emphasizing the introduction of an investigational antiviral that “may prevent unvaccinated people from getting COVID-19.” A strong claim, TrialSite investigated this trial site and the study drug.

It turns out that TPMG was recruited by Merck as part of the molnupiravir “MOVe-AHEAD study (NCT04939428) investigating the orally-administered, antiviral medication for COVID-19. Identified as site number 3495, TPMG’s participation is led by principal investigator Dr. Vijay Subramaniam. The recent local media entry explains the study drug as designed to “make genetic copying mistakes to prevent it from reproducing.”

What is the MOVEe-AHEAD study

Sponsored by Merck, this multicenter, randomized, double-blind, placebo-controlled study investigates the efficacy, as well as safety and tolerability of molnupiravir (MK-4482) in adults who reside with a person infected with COVID-19.

How many total Participants targeted?

1,332 total and 10 participants at the TPMG trial site location.

What is the study hypothesis?

Molnupiravir is superior to placebo in preventing laboratory-confirmed COVID-19 infection through Day 14 of the study in participants who do not have confirmed or suspected COVID-19 at time of screening and randomization.

Put another way this is a household “contacts” study meaning that individuals that reside with a household member that is infected with SARS-CoV-2 is a potential candidate for the study.

What is study duration?

August 2021 to April 3, 2022

What are the primary outcome measures or “endpoints”?

First, the sponsor seeks to measure the percentage of the participants on study drugs that actually were infected with SARS-CoV-2—meaning they test positive with the coronavirus in the first 14 days of the study. So, if study subjects start noticing symptoms such as cough or sore throat, they will have a nasopharyngeal (NP) swab test for SARS-CoV-2 using reverse-transcription polymerase chain reaction (RT-PCR).

Second, although a Phase 3 study, Merck is probing in this study for adverse events. The study team will monitor for adverse events up to 29 days from the start of the study. Finally, the study sponsor seeks to measure participants dropout due to adverse events within the first five days.

What are the inclusion criteria (Who can participate?)

First, the study participant must be 18 years of age and up and reside in a household with an individual with a documented COVID-19 infection, including 1) first positive SARS-CoV-2 test result from a sample collected within ≤5 days prior to randomization of the participant and 2) at least one symptom attributable to COVID-19. Second, the participant cannot have a SARS-CoV-2 infection themselves—again, this study was designed to determine if the Merck drug molnupiravir can prevent infection much like a prophylaxis 3) the participant must be willing to take an investigational oral medication 4) must be male and willing to be abstinent from heterosexual intercourse or use acceptable contraception during the study for ≥ 4 days post the last dose of study intervention and 5) if female—must not be pregnant/breastfeeding and at least one of the following applies during the study and for ≥ 4 days thereafter: A) is not a woman of childbearing potential B) is a woman of childbearing potential and uses highly effective contraception (low user dependency method or a user-dependent hormonal method in combination with a barrier method of C) a woman of childbearing age who is abstinent from heterosexual intercourse.

What are the exclusion criteria (Who cannot participate?)

This is a substantial list and includes a number of exclusions, including, of course, no prior history of laboratory-confirmed SARS-CoV-2 infection to a range of co-morbidities and other viruses to on existing therapies considered prohibited to any COVID-19 vaccination with the first dose ≥7 days prior to study randomization to a limit of 10 or more people in the household to a number of other exclusions.

How does the study work?

One-half of the study group receives the study drug, while the other half receives a placebo (looks like a study drug). Neither the patients nor the study team will know who has received the study drug or the placebo (masking).

What is the background of the PI at TPMG?

Vijay Subramaniam, MD, FCCP, is a board-certified Critical Care Medicine (2008), Pulmonary Medicine (2007), Internal Medicine (2004) and sleep Medicine (2016) and member of the American College of Chest Physician (Fellow), American Thoracic Society, Society of Critical Care Medicine, American Academy of Sleep Medicine, American Association of Cardiovascular and Pulmonary Rehabilitation, American Association of Chest Physician of Indian Origin and Association of Physician of India.

Dr. Subramaniam grew up in Logan, WV, and attended medical school at Mahadevappa Medical College, then joined Overlook Hospital in Summit, NJ, where he completed his internship in internal medicine. His residency was completed at Mercy Hospital of Pittsburgh; thereafter, he spent three years as a pulmonary and critical care fellow at Allegheny General Hospital.

What’s the PI’s POV of this Study

Dr. Subramaniam deems the investigational product’s prospects a “secondary prevention” measure declaring, of course, vaccination should be first. In an interview with the Pilot Online, the investigator stated, “The real goal is to give you a medicine that helps fight the virus off before it can get a hold of your body.”

Will Participants be Paid?

Yes. For travel, etc.

How many Trial Sites are involved?

According to the trial disclosed in the clinical trial registry, 43 trial sites are involved in 19 states across America as well as in the District of Columbia. The study also includes sites in France, Hungary, Spain, and Turkey.

Are there any safety data points in clinical trials?

In March 2021, Ridgeback Biotherapeutics and Merck reported preliminary results from a Phase 2a study evidencing positive data associated with secondary endpoint and no material safety issues. Four adverse events were deemed not associated with the study drug.

Has TPMG participated in other COVID-19 clinical trials?

Yes. Last year they served as a trial site for a study investigating a corticosteroid inhaler commonly used in asthma cases. The medical practice was able to recruit 70 participants with mild-to-moderate COVID-19 for that study. Note 60% of those participants were not patients of the practice.

Call to Action: Those that reside in or near South Hampton Roads or, more broadly, Northern Virginia can contact the group at [email protected]

https://www.businesswire.com/news/home/20210305005610/en/

Coronavirus mutated 30 times in South African woman: report

Coronavirus mutated 30 times in South African woman: report

The woman was HIV-positive and carried coronavirus for 216 days, bioinformatics professor Tulio de Oliveira says

www.geo.tv

The woman was HIV-positive.

She carried virus for 216 days.

Serval variants have originated in S Africa.

The coronavirus mutated at least 30 times as an HIV-positive South African woman carried the virus for 216 days, Bloomberg reported Monday.

The publication said Tulio de Oliveira, bioinformatics professor who runs gene-sequencing institutions at two South African universities, revealed the development at a conference.

“There is good evidence that prolonged infection in immunocompromised individuals is one mechanism for the emergence of COVID-19 variants", the bioinformatics professor said.

Africa, according to the publication, is the continent with the lowest vaccination numbers, and thus, several COVID-19 variants have originated here — beta mutation found in South Africa, eta from Nigeria, and most recently C.1.2, again from South Africa.

Meanwhile, President of the South African Medical Research Council Glenda Gray said people who are immunocompromised shed for much longer, and viral evolution happens when you are shedding.

“Speed and coverage are important to make sure that people who are HIV-positive are getting vaccinated," Gray added.

Ivermectin, two other drugs being tested in MUSC COVID-19 clinical trial

Ivermectin, two other drugs being tested in MUSC COVID-19 clinical trial

Ivermectin, a drug used to treat parasitic infections, has been getting a lot of attention recently about whether it should be used to treat COVID-19.

www.waff.com

CHARLESTON, S.C. (WCSC) - Ivermectin, a drug used to treat parasitic infections, has been getting a lot of attention recently about whether it should be used to treat COVID-19. Now that drug and two others are being tested as part of a COVID-19 clinical trial that MUSC is participating in.

According to MUSC, there are limited options for COVID-19 treatments that are FDA approved and that are for patients who are not sick enough to be in the hospital. Doctors with MUSC said they hope this trial will help answer some questions about various treatments and dispel any incorrect information that has been swirling.

“We have seen a lot of misinformation out there, and unfortunately, some patients have received non-FDA approved medications outside of a clinical trial,” Rami Zebian, M.D. said in a release. “That is not a safe practice, and we have seen many reports of toxicity – and we have many unanswered questions.”

In addition to Ivermectin, fluticasone—a corticosteroid used for asthma or other conditions—and fluvoxamine—an antidepressant—are also included in the study.

Officials with MUSC said this is a safe way to see if these drugs are actually effective in reducing symptoms of the virus.

According to MUSC, this study is completely remote, so you do not need to live near an MUSC campus to participate. You also can pick which drug you would like to be assigned and you will either be given a placebo or the drug.

MUSC officials said if you are accepted into the trial, you will take the drug as directed, fill out daily surveys and respond to call questionnaires. After 90 days, each participant will receive a $100 Amazon gift card.

In order to be eligible to participate in the study, you have to be at least 30 years old, have a positive covid test in the last 10 days and be experiencing at least two COVID symptoms.

https://web.musc.edu/about/news-center/2021/09/17/trial-of-outpatient-drugs-for-covid19-opens-to-all-south-carolinians

mRNA COVID-19 Vaccination and Development of CMR-confirmed Myopericarditis

ABSTRACT

Introduction Several case reports or small series have suggested a possible link between mRNA COVID vaccines and the subsequent development of myocarditis and pericarditis. This study is a prospective collection and review of all cases with a myocarditis/pericarditis diagnosis over a 2-month period at an academic medical center.

Methods Prospective case series from 1st June 2021 until 31st July 2021. Patients were identified by admission and discharge diagnoses which included myocarditis or pericarditis. Inclusion criteria: in receipt of mRNA vaccine within one month prior to presentation; The CMR protocol included cine imaging, native T1 and T2 mapping, late gadolinium enhancement and post contrast T1 mapping. All CMR studies were read in consensus by two experienced readers. Diagnosis was based on clinical presentation, ECG/echo findings and serial troponins and was confirmed in each case by CMR. Incidence was estimated from total doses of mRNA vaccine administered in the Ottawa region for the matching time-period. This data was obtained from the Public Health Agency of Ottawa.

Results 32 patients were identified over the period of interest. Eighteen patients were diagnosed with myocarditis; 12 with myopericarditis; and 2 with pericarditis alone. The median age was 33 years (18-65 years). The sex ratio was 2 females to 29 males. In 5 cases, symptoms developed after only a single dose of mRNA vaccine. In 27 patients, symptoms developed after their second dose of. Median time between vaccine dose and symptoms was 1.5 days (1-26 days). Chest pain was the commonest symptom, but many others were reported. Non-syncopal non-sustained ventricular tachycardia was seen in only a single case. Median LV ejection fraction (EF) was 57% (44-66%). Nine patients had an LVEF below the normal threshold of 55%. Incidence of myopericarditis overall was approximately 10 cases for every 10,000 inoculations.

Summary and Conclusions This is the largest series in the literature to clearly relate the temporal relationship between mRNA COVID vaccination, symptoms and CMR findings. In most patients, symptom onset began within the first few days after vaccination with corresponding abnormalities in biomarkers and on ECG. Cardiac MRI confirmed acute myocardial and pericardial changes with the presence of edema demonstrated with both tissue mapping and late gadolinium enhancement. Symptoms settled quickly with standard therapy and patients were discharged within a few days. No major adverse cardiac events and no significant arrythmias were noted during inpatient stay. Further follow up will be required to ascertain the longer-term outcomes of this patient group.

Study Spots People at High Risk for Severe Breakthrough COVID

https://www.newsmax.com/amp/health/health-news/covid-high-risk-breakthrough-vaccinated/2021/09/20/id/1037153/

A study of millions of people vaccinated against COVID-19 has identified those at greatest risk of hospitalization and death after breakthrough infection.

The most vulnerable are those who are immunosuppressed from chemotherapy, a recent bone marrow or solid organ transplant, or HIV/AIDS. Also at risk are people with neurological disorders (such as dementia and Parkinson's disease), nursing home residents, and those with chronic disorders (including Down syndrome).

For the report, British researchers updated a tool called QCovid, using datasets from general practice, national COVID-19 vaccination and testing, death registry and hospital data in the United Kingdom. In all, a sample of nearly 7 million vaccinated adults was included, of whom more than 5 million had received both vaccines doses.

The report was published Sept. 17 in the journal BMJ.

This enormous national study of over 5 million people vaccinated with two doses across the U.K. has found that a small minority of people remain at risk of COVID-19 hospitalization and death. Our risk calculator helps to identify those who remain most at risk post-vaccination," according to researcher Aziz Sheikh. He is a professor of primary care research and development at the University of Edinburgh.

Within the vaccinated group, there were more than 2,000 COVID-19 deaths and nearly 2,000 COVID-19-related hospital admissions, the investigators found. Eighty-one of the deaths and 71 admissions occurred 14 or more days after the second vaccine dose, when substantial immunity is expected.

The researchers also took into account factors such as age, sex, ethnicity and the rate of COVID-19 infections, they noted in a news release from the University of Oxford.

Relatively few COVID-19-related hospitalizations or deaths occurred among those who received a second dose of the vaccine. This means the study lacked the statistical power to determine if the at-risk groups are more, or less, vulnerable after a second vaccine dose, compared with post-first dose.

According to study co-author Julia Hippisley-Cox, a professor of clinical epidemiology and general practice at the University of Oxford, "Individual risk will always depend on individual choices as well as the current prevalence of the disease, however we hope that this new tool will help shared decision making and more personalized risk assessment."

Egypt’s Ministry of Health Moves To Merck’s Molnupiravir

Egypt’s Ministry of Health Moves To Merck’s Molnupiravir

Merck has been quietly making moves worldwide to position molnupiravir as the standard early-onset, orally-administered antiviral treatment for COVID-19.

trialsitenews.com

Merck has been quietly making moves worldwide to position molnupiravir as the standard early-onset, orally-administered antiviral treatment for COVID-19. TrialSite has reported that Merck’s teams are crisscrossing the globe, inking deals with governments and generic drug companies. In Vietnam, the drug is even being administered as part of a home care program in Ho Chi Minh City, similar to how ivermectin has been used in Uttar Pradesh, India, and other places. Controversially this is outside of a controlled trial. Now the Egypt Independent reports, “Egypt’s Ministry of Health and Population has started working to provide new drugs that will change coronavirus resistance by reducing the viral load.” In a statement on Friday, the ministry said that the “molnupiravir” drug reduces the viral load of the disease and that Egypt is participating in two studies by the company producing the drug.

Egypt’s existing national COVID-19 protocol includes Hydroxychloroquine, Budesonide, and several other treatments depending on the stage of infection. By last year, an Egyptian pharmaceutical company, Eva Pharma, was also producing both remdesivir and favipiravir.

The ministry noted that the new drugs it is providing include medicines to people in contact with infected cases, which means that Egypt is positioning the drug molnupiravir not only to those infected with SARS-CoV-2 but also potentially household contacts.

COVID-19 in Egypt

With about 105 million people, approximately 297,000 COVID-19 cases have been reported in the country over four waves of infections during the pandemic. Approximately 16,970 deaths associated with SARS-CoV-2 have been reported. Overall, the number of deaths and reported infections declined—the most deadly pandemic wave was the first surge in late May through July 2020.

A Delta variant-driven spike now unfolds as the cases have steadily risen since mid-August 2021.

Current Vaccination Rates

Egypt’s vaccination rate is considerably lower than much of the wealthy nations of Europe or North America, or for that matter, Israel. Presently, only about 4.2% of the population has received both COVID-19 vaccine doses, while about 7.7% have received one dose.

The ministry announced the vaccination of 2.4 million people working in the state’s administrative apparatus, and about one million others will be vaccinated within days, in addition to workers of the Education Ministry.

The ministry said it has provided two million doses to vaccinate university students and workers in the Ministry of Higher Education before October 9. In late August, the prime minister shared with the nation that the government planned to inoculate 40% of the population by the end of 2021. Based on the progress thus far, that target looks nearly out of reach.

The nation has received millions of COVID-19 vaccine doses from several suppliers, including AstraZeneca, Sinopharm, Sinovac, Sputnik, and Johnson & Johnson. Moreover, the country set up a localized production partnership with Sinovac—15 million doses of that Chinese vaccine can be produced locally. And in August, Reuters reported the country was scheduled to receive 5.2 million doses produced by Pfizer-BioNTech and Moderna.

Some of those shipments arrive soon, including 1.6 million doses of the Pfizer vaccine on September 24. More than 1,000 refrigerators will be contracted to store the vaccines as a gift from the United Nations Children’s Fund (UNICEF). Also, during the next week, Egypt will receive more than 3.5 million doses of the AstraZeneca vaccine.

Egypt changes rules for fighting COVID-19 - Egypt Independent

Egypt’s Ministry of Health and Population has started working to provide new drugs that will change coronavirus resistance by reducing the viral load. In a…

www.egyptindependent.com

FDA Grants EUA for Post-Exposure Prophylaxis to High-Risk COVID-19 Outpatient Care: Lilly’s Bamlanivimab & Junshi Bioscience’s Etesevimab

FDA Grants EUA for Post-Exposure Prophylaxis to High-Risk COVID-19 Outpatient Care: Lilly’s Bamlanivimab & Junshi Bioscience’s Etesevimab

Eli Lilly is back in business with their experimental monoclonal antibody (mAb) product as U.S. demand for monoclonal antibody treatments spike during the

trialsitenews.com

Eli Lilly is back in business with their experimental monoclonal antibody (mAb) product as U.S. demand for monoclonal antibody treatments spike during the Delta-variant has driven surge. In this case, a significant breakthrough as the combination experimental monoclonal antibody (mAb) therapy—including a licensed mAb from a Chinese biotech called Junshi Biosciences (HKEX: 1877; SSE: 688180) secures post-exposure prophylaxis status for certain high-risk people. This is a big deal. The U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) for the combined monoclonal antibody product (bamlanivimab (LY-CoV555) 700 mg and etesevimab (JSo16/LY-CoV016) 1400 mg) administered together to include post-exposure prophylaxis (PEP) in select individuals for the prevention of SARS-CoV-2 infection. Moving forward, select infusion centers will be able to use these neutralizing antibodies together to treat high-risk individuals 12 years of age and up who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at a high risk of exposure in an institutional setting, including a nursing home or prison. This authorization follows the national reopening of distribution earlier this month. Positive news indeed that a PEP therapy, albeit still investigational, is available now to treat patients that meet inclusion criteria.

Delta-Surge Required Action for Prophylactic Care

With an ongoing surge in COVID-19 cases, the U.S. political economy faces deep trouble if the contagion isn’t contained relatively soon. U.S. authorities and medical societies have grown increasingly aggressive in inhibiting the use of approved yet off-label treatments such as Ivermectin (monthly prescriptions have skyrocketed over 2,000%) while there are currently no approved early-stage treatments for COVID-19.

The government now makes a move to offer treatments for high-risk demographic cohorts, and in this case, now introduce the use of the Lilly and Junshi Bioscience combined mAb investigational product as a post-exposure prophylaxis, meaning a way to prevent the disease once someone has experienced contact with a SARS-CoV-2 infected person.

Eradication by Vaccination Won’t Work by Itself

The government increasingly acknowledges to American society that vaccination won’t be enough to transcend the public health crisis. Due to the early maturity of existing COVID-19 vaccines, for example, vaccine hesitancy is pervasive around the country, with over 80 million people not comfortable with the jab—at least not yet—despite POTUS recent move to force up to 100 million people to succumb to vaccination.

Myron Cohen, MD, director of University of North Carolina’s Global Health and Infectious Diseases, shared in the recent Lilly press release that “Recent reports suggest that fully vaccinated residents of nursing homes have contracted COVID-19, some of whom became quite ill.” Dr. Cohen continued, “This additional emergency use authorization of monoclonal antibodies for post-exposure prophylaxis in addition to the treatment of COVID-19 offers an achievement in the fight against the pandemic.”

Bring on the Care— TrialSite’s Founder on the Record

TrialSite’s Founder, Daniel O’Connor, suggested that the EUA was important—a positive move by the FDA to get care options out to the people declaring “front line doctors have lamented for nearly 1.5 years that early access treatments, including critically important pre-and post-exposure prophylaxis, are necessary for addition to safe and effective vaccines.”

O’Connor continued, “What is needed to manage and eventually overcome this crisis are a portfolio of options from safe and effective vaccines to a spectrum of affordable early-care treatments, specialized monoclonal antibody options like the Lilly and Junshi combination, in addition to the Regeneron and GSK/Vir products and importantly, data-driven, risk-based targeted public health initiatives that are not politicized.”

TrialSite provides a breakdown of this overall good news in a question and answer format.

Does this move indicate the government’s recognition that a vaccine-centric strategy is not sufficient to overcome SARS-CoV-2?

Yes. Despite widespread vaccination in nations such as Israel, Iceland, and many other places, breakthrough infections rage due to a confluence of factors, including the early maturity of the existing COVID-19 vaccines (first generation) and the overpowering SARS-CoV-2 mutant strains such as the Delta variant.

Hence Daniel Skovronsky, MD, Ph.D., Lilly’s chief scientific and medical office and president of Lilly Research Laboratories, went on the record that although COVID-19 vaccination is improving public health, unfortunately, “with the rise of the highly contagious Delta variant, the virus continues to have a devastating impact on the most vulnerable individuals, including nursing home residents and individuals with medical conditions that put them at high risk for the most severe conditions.”

What is the basis for the expanded EUA?

The FDA reviewed the data from the BLAZE-2 study conducted in partnership with the National Institutes of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN), that enrolled residents and staff at long-term care facilities, commonly referred to as nursing homes, across the U.S. In this placebo-controlled Phase 3 study, bamlanivimab 4200 mg reduced the risk of contracting symptomatic COVID-19 by up to 80 percent in nursing home residents and up to 57 percent among residents and staff of long-term care facilities.

What is Lilly’s Bamlanivimab?

Also known as LY-CoV555, this monoclonal antibody was actually developed by a partnership between AbCellera Biologics (a University of British Columbia spin-off) and some sharp scientists at Lilly as a treatment for COVID-19. The investigational therapy was first granted EUA by the FDA in November 2020, and 950,000 doses were acquired by the U.S. government as of December 2020. By April 2021, the EUA was revoked.

An IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2 the drug serves to block viral attachment and entry into human cells, thus neutralizing the pathogen. Of course, the combination with Junshi Biosciences etesevimab was granted a EUA by the FDA just recently. See that fact sheet.

Were shipments halted in June?

Yes. By June 25, 2021, the U.S. government (Office of the Assistant Secretary for Preparedness and Response or ASPR) issued a pause in the distribution of the combination mAbs as well as etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under the UEA) due to intensifying circulation of SARS-CoV-2 variants.

The government informed that other mAbs were available, including Regeneron’s REGEN-COV and GSK/Vir Biotech’s sotrovimab.

When were shipments allowed again?

On September 2, ASPR, alongside the FDA, resumed the shipment and distribution of bamlanivimab and etesevimab administered together.

Why were they given the greenlight?

Because pseudovirus and authentic virus studies demonstrate that bamlanivimab and etesevimab work together to retain neutralization activity against the Alpha and Delta variants.

Is the mAb combo of bamlanivimab and etesevimab the only way to access these products?

Yes.

What is the track record of bamlanivimab and etesevimab to date?

Bamlanivimab alone or in combination with etesevimab to date has been used in over 535,000 treatment courses, and the government suggests that the treatment could have prevented over 25,000 hospitalizations and 10,000 deaths.

Where can care providers & patients find more information about the use of the combination mAbs under expanded EUA?

The FDA EUA includes a Fact Sheet for Healthcare Providers as well as Fact Sheet for Patients, Parents, and Caregivers in both English and Spanish. Lilly also provides a 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Lilly’s media kit can be found here.

Where can patients find infusion centers?

Patients can check out the NICA Infusion Center Locator or the HHS Therapeutics Distribution Locator to find a potential therapy location.

What is the authority for EUA?

Bamlanivimab and etesevimab together are authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.

What’s the fine print on investigational products authorized under FDA EUA?

These are not approved drugs—rather, they are still experimental. Lilly must declare that it is not known if bamlanivimab and etesevimab together are safe and effective for the treatment of post-exposure prophylaxis of COVID-19.

What is the treatment patient demographic?

Bamlanivimab and etesevimab together are authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Are there other limitations of use?

Yes. For example, the mAb combo therapy can’t be used in states, territories, and U.S. jurisdictions in which the combined frequency of variants resistant to each mAb exceeds 5%. The FDA provides a list of such places here.

Also, the mAb combo cannot be administered to patients who are A) hospitalized due to COVID-19, B) require oxygen therapy due to COVID-19, or C) require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.

Note that this mAb combo hasn’t been studied in hospitalized patients, and use there may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

What are FDA’s instructions around Post-Exposure Prophylaxis use?

The mAb combo can be used for PEP of COVID-19 adults and pediatric individuals (12+ a weighing at least 40kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, including A) those who are not fully vaccinated or are not expected to

Bamlanivimab and etesevimab administered together are authorized for post-exposure prophylaxis of COVID-19 in adults and pediatric individuals (12 years of age or older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, and are to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications and A) have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC) or B) who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons).

What are Limitations of Authorized Use: Post-Exposure Prophylaxis

Bamlanivimab and etesevimab are not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%.

A list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available on the following FDA website.

Post-exposure prophylaxis with bamlanivimab and etesevimab is not a substitute for vaccination against COVID-19.

Bamlanivimab and etesevimab together are not authorized for pre-exposure prophylaxis for prevention of COVID-19.

What are safety risks?

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with the administration of bamlanivimab and etesevimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.

Infusion-related reactions, occurring during or up to 24 hours after infusion, have been observed with the administration of bamlanivimab and etesevimab together. These reactions may be severe or life-threatening. Signs and symptoms of infusion-related reactions may include:

fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. presyncope, syncope), dizziness, and diaphoresis.

Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.

Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of bamlanivimab and etesevimab under Emergency Use Authorization.

Clinical Worsening After Receiving Bamlanivimab and Etesevimab Administration

Clinical worsening of COVID-19 after administration of bamlanivimab and etesevimab together has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab and etesevimab use or were due to progression of COVID-19.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. See Limitations of Authorized Use.

Adverse Reactions

Adverse reactions observed in those who have received bamlanivimab and etesevimab are anaphylaxis (n=1, 0.07%) and infusion-related reactions (n=16, 1.1%). The most common treatment-emergent adverse events included nausea, dizziness, and pruritus. No treatment-emergent events occurred in more than 1% of participants, and rates were comparable to placebo.

Use in Specific Populations

Pregnancy

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bamlanivimab and etesevimab together should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Breastfeeding

There are no available data on the presence of bamlanivimab or etesevimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

Investigational mAb Combo Therapy Description

Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It was designed to block viral attachment and entry into human cells, thus neutralizing the virus. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Bamlanivimab was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Etesevimab (LY-CoV016, also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

Results from a Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) were published in the New England Journal of Medicine. Results from a Phase 3 study of bamlanivimab in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) were published in the Journal of American Medical Association (JAMA). A Phase 2 study assessing the efficacy and safety of bamlanivimab alone and bamlanivimab with other neutralizing antibodies versus placebo for the treatment of symptomatic low-risk COVID-19 in the outpatient setting (BLAZE-4. NCT04634409) has completed enrollment.

For more information, follow up and read Lilly’s press release.

Emergency Use Authorization for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19 | Eli Lilly and Company

The Investor Relations website contains information about Eli Lilly and Company's business for stockholders, potential investors, and financial analysts.

investor.lilly.com

Post Approval Real-World Study of Favipiravir in India: Antiviral Helping in India’s War Against COVID-19

Post Approval Real-World Study of Favipiravir in India: Antiviral Helping in India’s War Against COVID-19

Glenmark Pharmaceuticals (Glenmark), one of the Indian generic pharmaceutical companies commercializing Favipiravir as a treatment for early-onset

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Glenmark Pharmaceuticals (Glenmark), one of the Indian generic pharmaceutical companies commercializing Favipiravir as a treatment for early-onset mild-to-moderate COVID-19, reports positive results in a post-market surveillance involving 1,083 patients with mild-to-moderate COVID-19. In India, Favipiravir competes against Ivermectin in the world’s second-most populous nation as well as the indigenously developed 2-DG and possibly new entrants such as Merck’s Molnupiravir, presently in clinical trials. Glenmark reports positive results from its “Post-Marketing Surveillance” (PMS) activity over real-world outcomes for the antiviral drug developed originally in Japan by FUJIFILM Toyama Chemical. In use in dozens of countries to treat COVID-19, from Russia and Turkey to China and India, Favipiravir was also extensively studied by the U.S. Department of Defense just six years ago in 2015—over $200 million in taxpayer money went into Phase 3 clinical trials. The Mumbai-based generic pharmaceutical producer’s version of the drug, known as “Fabiflu®,” is at the center of attention in the first and largest PMS conducted in India in mild to moderate COVID-19 patients. This PMS study was part of a deal with Indian regulators: in exchange for a restricted emergency use approval for Favipiravir. The results indicate no new safety signals or concerns to date, while side effects are in line with the drug’s known safety profile.

American Media: Pathetic

While Favipiravir is now used in dozens of countries as a treatment for early-onset, mild-to-moderate COVID-19, the U.S. media market all but blacks out this topic—much like Ivermectin (unless, of course in the latter, they take pot-shots calling it the horse deworm medication), if the average American health consumer simply relies on CNN, MSNBC, Fox, and even PBS they actually are kept completely in the dark as to what’s going on in the world when it comes to various early care treatments for COVID-19.

More than likely, that’s because the U.S. economy and society have been usurped by special interests leading to regulatory capture and a particular brand of market political economy called “Crony Capitalism.” Now with COVID-19, a medical-industrial complex emerges through the use of regulators and other purportedly “independent” agencies, influencing what can, and what cannot be broadcast or shared on social media.

Consequently, at this stage in the United States, thought control is not needed due to “thought contraception.” Meaning a combination of mass media, social networking, and complicit government bodies support a joint narrative that essentially keeps competition out. Thankfully TrialSite is an independent media platform that delivers the latest news, information, and analysis about biomedical research around the world.

Indian Competition

Generally, TrialSite reports the Indian pharmaceutical market is a dynamic, robust, and competitive space—far more than America- and for this early stage, mild-to-moderate COVID-19 treatment, a number of generic producers possess Favipiravir licenses, including Sun Pharma, Hetero, Cipla, Dr. Reddy’s Laboratories and others.

The PMS Study

Starting back in July 2020, the company initiated the post-marketing surveillance (PMS) study to investigate the safety and efficacy of Favipiravir in mild-to-moderate COVID-19 patients. With 1,083 patients enrolled in the prospective, open-label, multicenter, single-arm study, 13 trial site organizations—both from the government and private sector—evaluated the drug across Mumbai, Bengaluru, Hyderabad, Nashik, Nagpur, and Thiruvananthapuram.

Glenmark reports in their press release that in this PMS study, the average age of patients was 40 years, with women comprising 40%, while men 60% of the study population. Hypertension (11%) and diabetes (8%) were the two most common comorbidities noted in these patients. Fever was present in all patients at baseline, followed by cough (81%), fatigue (46.2%), and new loss of taste (41%).

The Results

The sponsor, Glenmark, reports no new safety signals or concerns with the use of Favipiravir, although known side-effects were chronicled from weakness to gastritis and diarrhea, and vomiting. However, these effects were overwhelmingly mild in nature. Glenmark reports that the Favipiravir (FabiFlu) cohort experienced fever resolution in four (4) days, with an average clinical cure in seven (7) days.

Executive Comments

Alok Malik, Glenmark Vice President & Head (India Formulations), went on the record “This study was crucial as it examined the safety and efficacy of FabiFlu® in real-world settings, where multiple variables can impact the results. Despite these factors, the PMS study demonstrated FabiFlu’s consistent ability to provide symptomatic relief and improve clinical outcomes in patients with mild to moderate COVID19. It is a step forward both for Glenmark and the medical community, as it reinforces the multiple benefits in tackling the pandemic.”

Peer-Review Published Results

The study results come by way of a company press release. While informative, the company will need to write up the results, secure peer-review journal entry, and thus have the outcomes validated by the wider biomedical community.

Welcome to Glenmark | Glenmark

I like this Dr Cole

Our greatest weapon against the coronavirus is Vitamin D: Board-certified pathologist

‘We don't just have a viral pandemic, we have an international Vitamin D deficiency pandemic – 70 percent of the world is immune-suppressed,' Dr. Ryan Cole says

Our greatest weapon against the coronavirus is Vitamin D: Board-certified pathologist - LifeSite

‘We don't just have a viral pandemic, we have an international Vitamin D deficiency pandemic – 70 percent of the world is immune-suppressed,' Dr. Ryan Cole…

www.lifesitenews.com

March 29, 2021 (LifeSiteNews) –A founder of one of the largest independent laboratories in Idaho is declaring loud and clear that the greatest weapon against the coronavirus is Vitamin D.

(The) biggest lost message in this entire pandemic is Vitamin D. It is the master key to your immune system, the master key. So we don't just have a viral pandemic, we have an international Vitamin D deficiency pandemic – i.e., 70 percent of the world is immune-suppressed,” Dr. Ryan Cole, founder of Cole Diagnostics, said during a March Capitol Clarity talk hosted by the Idaho Freedom Foundation.

Dr. Cole introduced himself as a “Mayo clinic trained, board-certified pathologist, board certified anatomic and clinical pathology,” who had seen about 350,000 patients in his career, and had done about 100,000 COVID tests and read about 6,000 articles in the past year.

“It is right up my alley, and so I’m not just blowing smoke today,” he explained.

“Normal D levels decrease your COVID symptom severity risk for hospitalization by 90 percent. There have been a lot of placebo controlled trials that show this all around the world. It is scientific fact, not just a correlation,” said Dr. Cole.

Dr. Cole explained why Vitamin D deficiency is the biggest contributor to both Wuhan coronavirus hospitalizations and deaths: “Data shows what kills people. Cytokine storm. If you are in (Vitamin D) mid-level range, you will not die from COVID because you cannot get a cytokine storm.”

According to Dr. Cole, widespread Vitamin D deficiency makes this a big problem. “Seventy to 80 percent of all Americans are immune suppressed because they are D deficient.” He further noted that “96 percent of people in the ICU are Vitamin D deficient.”

Dr. Cole cited statistics showing lower levels of Vitamin D in darker skinned populations, which he says is due to biology, and not “social disparity.”

“Eighty-three percent of African Americans, 70 percent of Latinos, 72 percent of Native Americans, 47 percent of Caucasians are deficient,” Dr. Cole said. “The darker your skin, the further north you live, the harder it is to synthesize Vitamin D.”

Along with low Vitamin D levels, Dr. Cole discussed what he called the other “highest risk factors” for COVID-19: obesity and advanced age.

“Ninety percent of deaths in the state have been over 70 years of age. That’s the at-risk population. We have stopped our society for something that's taking people that are already at that death risk age anyway,” said Dr. Cole.

Dr. Cole explained that obesity contributes to higher risk of symptoms and death at least in part because it “drastically reduces your ability to get Vitamin D into your circulation.”

“D is a fat soluble vitamin. The heavier set you are, the more it goes into your fat and not into your circulation to stimulate your immune system,” Dr. Cole explained.

“If you don't have D in normal range, how do we get D? Sunshine,” he continued.

“There's only about a three-hour window a day, without your sunscreen. You need to be outside for 20 to 30 minutes during the spring and summer to get natural Vitamin D. In the fall, in the winter, you need to supplement to boost your immune system.”

To help guide the best use of time spent outdoors, Dr. Cole recommended an app called D Minder that “shows you when you can synthesize your vitamin D.”

Dr. Joseph Mercola stresses the importance of taking vitamin K2 while supplementing with vitamin D, to prevent any potential vitamin D toxicity symptoms. He recommends supplementing with vitamin D3, instead of vitamin D2, at 5,000 units per day for adults.

Dr. Cole noted that Dr. Fauci revealed in an interview in November that he takes 8,000 to 9,000 IU of vitamin D a day in the winter. “Yet inexplicably, that’s not a public health message,” Dr. Cole continued.

While Dr. Cole focused on the preventative power of vitamin D, he also emphasized the importance of early treatment of COVID-19, if and when the disease is contracted, through the use of Ivermectin.

“This medication won the Nobel prize for the discoverer. It is on the world’s safest and most essential drugs list,” Dr. Cole explained.

“Ivermectin, if that’s added to the mix, it decreases the death rate by 75 percent. If given early, by 86 percent. What does that mean? Of the half-million deaths we have in North America we would have 375,000 less deaths. There is blood on the hands of the bureaucrats in Washington who have suppressed this life-saving medication,” he continued.

“Wherever it has been given in the world, they’re back to normal life. 100 percent of the world trials have shown benefit. In Argentina, in a hospital trial it prevented 100% of acquisition in health care workers. In the placebo group, 57% got Covid that were not on Ivermectin. To a ‘T,’ every person that’s had Covid I’ve treated with this has been better in 12 to 48 hours. 42 people. I know it works.”

“The beauty of it: It can cover all the variants because of its mechanism,” he continued.

Dr. Cole didn’t stop at promoting prevention and treatment of Covid. During his talk, he warned about the potential dangers of the mRNA so-called “vaccines.”

He first pointed out, “If there’s a treatment for a disease, the federal government cannot approve a vaccine. By law. The NIH who is involved in approving medications, they co-hold the patent on the “vaccine” with Moderna. That is insanity, to have the government in bed with a private company vending a product that they want to give to everybody.”

He further explained that the mRNA injections don’t fall under the definition of vaccines, but are rather “experimental biological gene therapy.”

“Long-term safety data is not there. MRNA trials in mammals have led to odd cancers. mRNA trials on mammals have led to auto-immune diseases, not right away — six, nine, twelve months later,” said Dr. Cole.

“The companies did their own data. There were no independent observer groups looking at the data. They don't fall under the definition of creating peer immunity and preventing transmission. If you are immune after injection, why in the world would you have to mask and social distance. That is an admission that they don't know that it’s a vaccine. That’s an absurdity,” he continued.

“My biggest concern is antibody-dependent enhancement reaction. If you get a coronavirus shot, historically SARS, MERS, animal coronaviruses, when you are exposed to a wild type variant of the virus, six, nine, twelve months later the immune system can go haywire.”

“In the SARS vaccine trials, in the ferrets and the monkeys, 100 percent of the animals, when exposed to wild type virus, ended up with immune reaction.”

Dr. Cole also explained that COVID, like other coronaviruses, must be allowed to run its course, and slammed some of the measures being currently used to keep it in check.

“Coronaviruses are seasonal. They follow a 6-9 month life cycle – no matter what we do, they’re going to do what they do, and then they’re going to fade. What happened to SARS? What happened to MERS? What did we do to stop them? Nothing. They did their thing.”

He showed a graph of Idaho daily cases over the past year and explained that Idaho is no longer in a state of pandemic, but in an endemic. “Statistically, once we are below a certain percentage we are not in a pandemic. Is the disease present? Sure it is. Is it widespread? No. At most we are seeing 2% (positives) per day now and so the numbers are going way down.”

Dr. Cole also explained why wearing masks outside is “insanity.”

“The virus is fragile. It doesn’t live outside. UV light fractionates it, kills it, blows it apart. Ventilation and the wind blows it away. It is insanity to wear a mask outside. Absolute insanity. There is not one study that has shown any superspreader to have occurred outside. They have all happened indoors with poor ventilation.”

Idaho doctor reports a ‘20 times increase’ of cancer in vaccinated patients

Idaho doctor reports a ‘20 times increase’ of cancer in vaccinated patients  - LifeSite

'Post-vaccine, what we are seeing is a drop in your killer T-cells, in your CD8 cells,” said Dr. Ryan Cole.

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BOISE, Idaho (LifeSiteNews) — A doctor has found an increase in cancers since the COVID-19 inoculation rollout.

On March 18, Dr. Ryan Cole, a board-certified pathologist and owner and operator of a diagnostics lab, reported to the public in a video produced by Idaho state government’s “Capitol Clarity” project, that he is seeing a massive ‘uptick’ in various autoimmune diseases and cancers in patients who have been vaccinated.

Since January 1, in the laboratory, I’m seeing a 20 times increase of endometrial cancers over what I see on an annual basis,” reported Dr. Cole in the video clip shared on Twitter.

“I’m not exaggerating at all because I look at my numbers year over year, I’m like ‘Gosh, I’ve never seen this many endometrial cancers before’,” he continued.

Explaining his findings at the March 18 event, Cole told Idahoans that the vaccines seem to be causing serious autoimmune issues, in a way he described as a “reverse HIV” response.

Cole explained that two types of cells are required for adequate immune system function: “Helper T-cells,” also called “CD4 cells,” and “killer T-cells,” often known as “CD8 cells.”

According to Cole, in patients with HIV, there is a massive suppression of “helper T-cells” which cause immune system functions to plummet, and leave the patient susceptible to a variety of illnesses.

Similarly, Cole describes, “post-vaccine, what we are seeing is a drop in your killer T-cells, in your CD8 cells,”

“And what do CD8 cells do? They keep all other viruses in check,” he continued

Much like HIV causes immune system disruption by suppressing CD4 “helper” cells, the same thing happens when CD8 “killer” cells are suppressed. In Dr. Cole’s expert view, this is what seems to be the case with the COVID-19 jabs.

Cole goes on to state that as a result of this vaccine-induced “killer T-cell” suppression, he is seeing an “uptick” of not only endometrial cancer, but also melanomas, as well as herpes, shingles, mono, and a “huge uptick” in HPV when “looking at the cervical biopsies of women.”

This is not the first time the COVID-19 vaccines have been linked to serious issues regarding women’s health.

According to a German research study, polyethylene glycol, an ingredient found in the Pfizer and Moderna jabs, has been found to pose a “potential toxicity risk” to women’s ovaries.

Dr. Michael Yeadon, a former vice president at Pfizer, has cited the German study as a possible explanation for the large number of menstrual irregularities and miscarriages being reported by vaccinated women.

Yeadon warns young women to avoid the vaccine for, in his expert opinion as a toxicologist, the shots will likely impede a woman’s ability to get pregnant and carry a baby to term.

Dr. Cole states in his video that, not only are melanomas showing up more frequently, like endometrial cancers, the melanomas are also developing more rapidly, and are more severe in younger people, than he has ever previously witnessed.

“Most concerning of all, there is a pattern of these types of immune cells in the body keeping cancer in check,” stated the doctor.

“I’m seeing invasive melanomas in younger patients; normally we catch those early, and they are thin melanomas, [but] I’m seeing thick melanomas skyrocketing in the last month or two,” he added.

Cole came into prominence in January of 2021 when the Idaho government put in place an effort called “Capitol Clarity,” with the stated goal of keeping Idahoans informed about the facts surrounding COVID-19.

Capitol Clarity has since hosted Dr. Ryan Cole multiple times to provide information to the public about vaccine safety and COVID-19 measures more broadly.

The videos of Dr. Cole at these events, which were originally posted on YouTube, have since been deleted by the Google owned video platform in a continual effort of censorship by Big Tech.

“You’re not being told the truth,” said Yeadon “Thinking about this, I try to imagine that I was speaking to my own young adult daughters, for whom I would be very concerned if they got these vaccines.”

LifeSiteNews has produced an extensive COVID-19 vaccines resources page. View it here

Biden Could Dismiss FDA Committee’s Pfizer Decision: At Great Cost However

Biden Could Dismiss FDA Committee's Pfizer Decision: At Great Cost However

The Food and Drug Administration (FDA) recommended that biotech Pfizer’s COVID-19 booster doses shouldn’t be provided to the general public yet. However,

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The Food and Drug Administration (FDA) recommended that biotech Pfizer’s COVID-19 booster doses shouldn’t be provided to the general public yet. However, booster doses for people who are 65 years or older or those who fall under high-risk classifications should get a booster dose. This could boost efforts to send vaccine doses to the global south.

The FDA advisory committee overwhelmingly denied a proposal for booster shots of the Pfizer/BioNTech COVID-19 vaccine, which impacts President Joe Biden’s outspoken plans to vaccinate the entire US population with a booster dose once the initial full dosing is complete. The advisory committee voted 16 to 2 against booster vaccines for Americans aged 16 years and older before they unanimously endorsed a plan to give boosters to the high-risk groups that we already mentioned. The committee, known as the FDA Vaccines and Related Biological Products Advisory Committee, has reached a non-binding conclusion that the Pfizer application was a step too far at this current time.

But that is a part of the issue. The FDA’s vaccine advisory committee can issue as many recommendations as they want, but they aren’t binding by law nor federal regulations. Since the Biden administration wants to begin offering booster shots to the general public in the next week, the decision could come from other sources rather than the actual body that regulates and approves would-be therapeutics and medicines for COVID-19. Rest assured, the FDA has followed the advice of the committee. It often does. But there have been instances where the final FDA decision made by the commissioner, Janet Woodcock, neglected the input of the committee and opted to approve or deny certain policies.

“We are not bound at FDA by your vote, just so you understand that,” said Peter Marks, head of the FDA Center for Biologics Evaluation and Research. “We can tweak this as need be.”

National Institutes of Health director Francis Collins also said that he expects booster shots to be distributed and administered, despite the recommendations of the FDA committee. In fact, Collins hinted at this, snidely, during an interview with Fox News. Collins told “Fox News Sunday” that “we’re going to see what happens in the coming weeks.” “It would surprise me if it does not become clear over the next few weeks that the administration of boosters may need to be enlarged. Based upon the data that we’ve already seen both in the U.S. and in Israel, it’s clear that the waning of the effectiveness of those vaccines is a reality, and we need to respond to it,” Collins openly insinuated.

The US Centers for Disease Control and Prevention, reportedly. Is expected to hold a multi-day conference with stakeholders in the coming days to describe the requirements for a nationwide COVID-19 booster shot drive in the United States.

Trial Site News reported recently that some high-ranking FDA scientists, flanked by colleagues at the World Health Organization, have come out against boosters at the current time. The scientists conducted an evidence review that highlighted the effectiveness of current vaccines, though waning, is still sufficient as a baseline to reach greater population-level herd immunity from vaccinations among the majority of Americans. Unfortunately, the eagerness to distribute booster doses lacks the pragmatism required to effectively navigate the pandemic. From a policy standpoint, the White House needs to be smart and cautious. Smart with regard to ensuring vaccine doses are given to the neediest populations. Caution should be urged when it comes to enforcing vaccine policies that further complicate other responsibilities of the government to be unbiased as much as possible and to make sure that safeguards are in place for such a potential failure to be smart and cautious.

The geopolitical environment must, again, be noted. The White House should heed the calls of the World Health Organization and other world leaders as the global inequity in vaccination distribution persists thanks to the ten richest countries in the world. Biden should boost vaccine exports instead of asking other countries to pick up the slack. Plus, the White House needs to remain cognizant of the recommendations of their own advisory committees. If Biden proceeds with the distribution of vaccine booster doses, he’s betraying the consensus of scientists who have better grounds to issue informed medical opinions. Medical opinions and recommendations that are even counter and opposite of the political agenda of the president.

For a pro-science presidential administration, choosing to dismiss the collective insight of a FDA advisory committee on vaccines could possibly be the most anti-science thing to do.

Kentucky Circuit Judge: Norton Healthcare Doesn’t Need to Treat a Severely Ill COVID-19 Patient with Ivermectin

Kentucky Circuit Judge: Norton Healthcare Doesn’t Need to Treat a Severely Ill COVID-19 Patient with Ivermectin

In yet another case involving a dying COVID-19 patient, a judge has overruled a previous decision denying the patient’s wife’s request that he be treated

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In yet another case involving a dying COVID-19 patient, a judge has overruled a previous decision denying the patient’s wife’s request that he be treated with ivermectin while in the hospital. The latest case occurred in a Jefferson County, Kentucky Circuit Court where the patient’s wife, Angela Underwood, filed a lawsuit representing herself and her husband to compel a Norton Healthcare hospital to treat her ill husband with ivermectin. A registered nurse, she shared recently via social media that her husband is “…on the ventilator fighting for his life.” In what appears to be a recurring theme, the first judge in the case, Judith McDonald-Burkman, sided with the plaintiff, ordering the hospital to treat the husband, Lonnie Underwood, with ivermectin “If medically indicated and ordered by an appropriate physician.” This past Tuesday, the same judge also granted “an emergency junction to administer intravenous Vitamin C.

Reporting for the Courier Journal, Mary Ramsey shared that after Judge McDonald-Burkman initially ruled in Angela Underwood’s favor, a new judge was assigned purportedly because McDonald-Burkman had to retrial a double homicide case and hence, not available for the Underwood case.

But the first judge could be at the second hearing in a similar case to Ohio a week or so ago. Enter Circuit Judge Charles Cunningham who wrote mid-last week that the hospital confided that the doctor “Refused to come to see his patient,” and consequently, the court “cannot require a hospital to literally take orders from someone who does not routinely issue such orders.”

Much of the mass media now completely vilify the drug, referring it to deworming medication for horses. In fact, there are two versions of the drug, including one for humans and one veterinary version. Over 4 billion doses have been administered over the past four decades, and the drug is on the World Health Essential Medicines List.

TrialSite reports a more balanced, objective, and unbiased view of the drug. With 64 studies (the overwhelming majority with positive results), tremendous resistance to any affirmative interpretation from developed world medical establishments indicates some form of bias.

See the TrialSite Fact Sheet for about as objective a view as possible. The legal system initially was more favorable to patient preference, but that trend has gone through an abrupt turnaround. The nation’s health system wants people vaccinated with no dependence on generic, low-cost drugs, no matter the perceived benefit.

About Norton Healthcare

The patient was at one of Norton Healthcare’s numerous hospitals. In fact, the health system runs over 40 clinics and hospitals around Louisville, KY, representing the state’s third-largest employer.

The not-for-profit system includes five Louisville hospitals with 1,837 beds, seven outpatient centers, 12 Norton Immediate Care Centers with over 13,000 employees. Norton retains 653 employed medical providers and about 2,000 physicians on its medical staff.

Judge denies Louisville woman's request for Norton to treat her husband with ivermectin

Angela Underwood claimed in a Sept. 9 lawsuit she is a registered nurse and her husband, a COVID-19 patient at Norton Brownsboro, needs ivermectin.

www.courier-journal.com

Ivermectin Wars: Dr. Hector Carvallo Versus the Medical Establishment

Ivermectin Wars: Dr. Hector Carvallo Versus the Medical Establishment

A new profile of Dr. Hector Carvallo of Argentina is titled “A Lifeline from Buenos Aires,” and it focuses of his use of and advocacy for ivermectin as a

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A new profile of Dr. Hector Carvallo of Argentina is titled “A Lifeline from Buenos Aires,” and it focuses of his use of and advocacy for ivermectin as a treatment for COVID-19. The doctor is a professor of medicine and former director of a large hospital, retired from University of Buenos Aires. TrialSite has followed his ivermectin studies. By February 2020, our pandemic was already looking dangerous to the world. And later that month, Hector’s wife, Mirta Carvallo, MD, heard that “something’s going on with ivermectin in Australia,” and she informed her husband of this: scientists at Monash University in Australia had shown that ivermectin could fight SARS-CoV-2 in vitro. Hector was intrigued; the anti-parasite medicine had already saved millions of folks in the southern hemisphere from river blindness, known as onchocerciasis. The doctor and his wife had often prescribed the drug for scabies, rosacea, and other ailments, and he says it is “one of the safest medicines I’ve ever used. ”Considered one of the most important drugs of the 20th century, ivermectin’s creators won the Nobel Prize 2015 for their work on the drug.

Crying for Joy, Then Crying from Frustration

Mere weeks later, prior to any official reporting of the Australian findings, Hector and a colleague conducted the first human trials of ivermectin as a prophylactic preventative against COVID-19. “I am not ashamed to say I cried when we got the results,” Carvallo remembers. Yet months later, for a very different reason, Hector reports, “I cried again.” This time his emotions were due to the medical authorities in Argentina began an effort to suppress knowledge about ivermectin’s safety and efficacy, question Hector’s results, and even attack his reputation. The doctor is reportedly soft-spoken and gracious personally, and he speaks perfect English partially due to a childhood attachment to TV medical drama, the latter inspired him to be a doctor. Within days of his wife hearing rumors of ivermectin from down under, Dr. Carvallo met with a top Argentine infectious disease expert, Dr. Roberto Hirsch, to discuss ivermectin.

Not an Animal Drug Only

Little known in North America and Europe except for veterinary use—or perhaps for lice or scabies—ivermectin was reputed to inhibit RNA viruses such as dengue, Zika, and yellow fever in vitro. It is thought that the drug blocks virus’s capacity “to transport from a cell’s watery cytoplasm to its nucleus.” In early March 2020, Carvallo and his colleague penned a message to the Journal of the American Medical Association. Noting the drugs, “virucidal properties,” the letter offered that ivermectin might be “a safe, potent, widely available and cheap prophylaxis against Covid, urgently in need of swift investigation. ”They also posited that the drug might be effective against active COVID-19 cases, that it could be a treatment as well as a preventative. “But the editor of JAMA said he was not interested. He gave us no good reason,” Carvallo says. “I was surprised. I wrote to say, ‘At least take it as a possibility,’ but we never heard back. So, we decided to form our own trials. We would replicate what the Australians had done in vitro, but we would do it in vivo.”

Observational Studies Show Great Promise

The doctors then proposed an experiment to the ethics committee of Eurnekian Hospital: giving weekly ivermectin to about 100 hospital workers who were often exposed to COVID-19 patients. Another 100 who chose not to take ivermectin functioned as the control group. Carvallo and Hirsh both felt that lengthy RCT’s would be unethical: “If I had to post my hypothesis atop a pile of corpses, that’s criminal,” he said. Their approach was a “classic” type of research, an observational study. “Elated” by the proposed study, hospital officials, said yes to the idea, and the government health office quickly approved the protocols. The trial started in April, without funding or RCT formality, and utilizing donated medicine. 131 subjects used ivermectin, and 98 did not. The results were stunning: of the 98 who did not use ivermectin, 11 contracted the virus, of the 131 who had gotten the drug, zero cases of COVID-19 were found. “Word spread quickly through the hospital, and the union representing our health care workers demanded the prophylaxis be given to everyone [on staff] who wanted it. With this large “volunteer pool” available, the doctors started a second and expanded version of the trial. Due to running out of free medicine, this expanded study ended in August 2020. The findings: of 407 folks in the control group, 58.2 were infected with SARS-CoV-2, of 788 patients treated with ivermectin (and carrageenan), zero had contracted the virus.

“Not Allowed to Keep Investigating Ivermectin”

By this point, the doctors had begun a new study of folks already suffering with COVID-19. They signed up 135 outpatients with mild symptoms and 32 in patients with moderate to severe symptoms. All were given ivermectin on a weekly basis. The hospitalized also got steroids and a blood thinner if symptoms warranted. Four weeks later, none of the 135 required going to the hospital. One inpatient, an 82-year-old with “severe co-morbidities,” died. So, the doctors saw that there was a death rate of 3.2 percent of those using their protocol, far less than the 23.5 percent overall rate for hospitalized patients in Argentina. Days later, Carvallo got a call at home. The secretary for the health minister was on the line, and “he said I was not allowed to keep investigating ivermectin, or it would put my job in jeopardy. I was baffled. I said, ‘Why?’ and he would give me no answer—And that’s when I cried again, from frustration. I’m not ashamed to say I cried because it’s true.” Now, a year and a half later, “ivermectin still struggles for official recognition as an anti-Covid agent despite the large body of research in its favor.”

Three Phases of Truth

The May 2021 issue of Antibiotics Review, for example, put out a metanalysis of ivermectin which showed that 100% of 36 prophylaxis and early treatment studies showed positive results, and 26 of the studies showed “statistically significant improvements.” But in August 2021 FDA was “still pounding the same drum it first pounded in June 2020, when the Australian researchers published their findings.” FDA warned, “Taking a drug meant for horses and cattle to prevent or treat COVID-19 is dangerous and could be fatal.” To Carvallo, this mockery and bad information were “very frustrating.” Next, on September 2, the outlet BuzzFeed put out a lengthy and critical look at the doctor’s work. They reported that the studies “raised questions about how the study’s data was collected and analyzed.” Carvallo says the ivermectin backlash is “not a matter of ignorance.” He notes that NIH, CDC, and FDA have read the pertinent studies. The doctor feels that a double standard is in place: “The more expensive a compound is, the less quantity of evidence is required to get it approved. “But when a compound is cheap and available,” he opined, “that’s another matter.” He is confident that eventually, ivermectin will be widely used against COVID-19. “All truth passes through three phases,” he told BuzzFeed. “First it is ridiculed, then it is violently opposed, then it is accepted as self-evident. We are in phase two now.”

Menstrual changes after covid-19 vaccination

A link is plausible and should be investigated

Common side effects of covid-19 vaccination listed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) include a sore arm, fever, fatigue, and myalgia.1 Changes to periods and unexpected vaginal bleeding are not listed, but primary care clinicians and those working in reproductive health are increasingly approached by people who have experienced these events shortly after vaccination. More than 30 000 reports of these events had been made to MHRA’s yellow card surveillance scheme for adverse drug reactions by 2 September 2021, across all covid-19 vaccines currently offered.1

Most people who report a change to their period after vaccination find that it returns to normal the following cycle and, importantly, there is no evidence that covid-19 vaccination adversely affects fertility. In clinical trials, unintended pregnancies occurred at similar rates in vaccinated and unvaccinated groups.2 In assisted reproduction clinics, fertility measures and pregnancy rates are similar in vaccinated and unvaccinated patients.3456

MHRA states that evaluation of yellow card reports does not support a link between changes to menstrual periods and covid-19 vaccines since the number of reports is low relative to both the number of people vaccinated and the prevalence of menstrual disorders generally.7 However, the way in which yellow card data are collected makes firm conclusions difficult. Approaches better equipped to compare rates of menstrual variation in vaccinated versus unvaccinated populations are needed, and the US National Institutes of Health has made $1.67m (£1.2m; €1.4m) available to encourage this important research.8

Menstrual changes have been reported after both mRNA and adenovirus vectored covid-19 vaccines,1 suggesting that, if there is a connection, it is likely to be a result of the immune response to vaccination rather than a specific vaccine component. Vaccination against human papillomavirus (HPV) has also been associated with menstrual changes.9 Indeed, the menstrual cycle can be affected by immune activation in response to various stimuli, including viral infection: in one study of menstruating women, around a quarter of those infected with SARS-CoV-2 experienced menstrual disruption.10

Biologically plausible mechanisms linking immune stimulation with menstrual changes include immunological influences on the hormones driving the menstrual cycle11 or effects mediated by immune cells in the lining of the uterus, which are involved in the cyclical build-up and breakdown of this tissue.12 Research exploring a possible association between covid-19 vaccines and menstrual changes may also help understand the mechanism.

Although reported changes to the menstrual cycle after vaccination are short lived, robust research into this possible adverse reaction remains critical to the overall success of the vaccination programme. Vaccine hesitancy among young women is largely driven by false claims that covid-19 vaccines could harm their chances of future pregnancy.13 Failing to thoroughly investigate reports of menstrual changes after vaccination is likely to fuel these fears. If a link between vaccination and menstrual changes is confirmed, this information will allow people to plan for potentially altered cycles. Clear and trusted information is particularly important for those who rely on being able to predict their menstrual cycles to either achieve or avoid pregnancy.

We are still awaiting definitive evidence, but in the interim how should clinicians counsel those who have experienced these effects? Initially, they should be encouraged to report any changes to periods or unexpected vaginal bleeding to the MHRA’s yellow card scheme. This will provide more complete data to facilitate research into any link and signal to patients that their concerns about vaccine safety are taken seriously, building trust. In terms of management, the Royal College of Obstetricians and Gynaecologists and the MHRA recommend that anyone reporting a change in periods persisting over several cycles, or new vaginal bleeding after the menopause, should be managed according to the usual clinical guidelines for these conditions.714

One important lesson is that the effects of medical interventions on menstruation should not be an afterthought in future research. Clinical trials provide the ideal setting in which to differentiate between menstrual changes caused by interventions from those that occur anyway, but participants are unlikely to report changes to periods unless specifically asked. Information about menstrual cycles and other vaginal bleeding should be actively solicited in future clinical trials, including trials of covid-19 vaccines.

Footnotes

Competing interests: The BMJ has judged that there are no disqualifying financial ties to commercial companies. The author declares the following other interests: research funding from the Wellcome Trust and research charity Borne; payments to act as an external examiner for the University of Cambridge and the University of Leeds; and royalties received for my contribution to Immunology 9th edition (Elsevier). Further details of The BMJ policy on financial interests is here: https://www.bmj.com/sites/defa…mj-education-coi-form.pdf.

Global Takeover of Healthcare Comes to Switzerland As Pressures from Above Stop Doctors from Treating COVID-19 Patients with Ivermectin

Global Takeover of Healthcare Comes to Switzerland As Pressures from Above Stop Doctors from Treating COVID-19 Patients with Ivermectin

The ivermectin controversy continues to unfold worldwide as many doctors prescribing the drug, successfully they might add, face growing scrutiny and even

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The ivermectin controversy continues to unfold worldwide as many doctors prescribing the drug, successfully they might add, face growing scrutiny and even heavy-handed tactics leading to censorship and other repressive policies from governments and physician licensing boards. The latest news takes the TrialSite community to the shores of Lake Leman in French-speaking Switzerland. Apparently, doctors at Hospital Riviera-Chablais have been successfully treating patients here for COVID-19 since January 2021. According to physicians, 350 to 400 patients have been successfully treated, helping them to overcome COVID-19. But too much success broadcast on social media generates attention from elites in high places. As patients raved online of a great track record associated with ivermectin, the hospital’s Medical Committee undoubtedly was contacted by some powerful people—from within Switzerland and without. They summarily banned the use of ivermectin in this Swiss hospital, declaring that “only national and international recommendations concerning the treatment of COVID-19 should guide the management of COVID-19 cases,” reported Christophe Schull, Head of Communications.

As reported by local French-speaking L’Impertinent Media in Switzerland, a recent move by the hospital’s leadership, which includes all of its chief medical officers, evidences an outright purge of any early-onset COVID-19 care treatments not ordained by international and national standards.

An unprecedented almost international takeover of medicine itself, doctors are now subject to national and, even more disturbingly, international rules or standards promulgated by faceless bureaucrats—even politicians—all, of course, influenced by the deep pockets of industry.

While the executives that run this local hospital cite “current literature” that the drug “does not demonstrate any benefit” for the treatment of COVID-19, another point of view suggests these actions reflect a top-down, specialist-interest-driven, biased information war that now reaches from the highest international power structures down to the local practice of medicine.

TrialSite includes what is more of an objective, unbiased ivermectin fact sheet. In contrast, the Swiss HRC hospital leadership follows what bureaucrats at the World Health Organization or those at the national level in Switzerland declare. Doctors seemingly have little to no say anymore with their patients.

Use of ‘Experts’ to Trounce Doctor’s & Patient’s Rights

COVID-19 represents a convenient cover for what is, in fact, an unfolding geopolitical event, one that will permanently reset every facet of society. In this unprecedented takeover of the practice of medicine by a combination of supranational and subordinated national forces, a global reconfiguration of power, money and political influence usurp healthcare, the ultimate control over one’s very existence—the determination of life and death. Prominent academicians are employed to justify or validate what in some cases emerges as unconscionable moves, such as intervening between the care of a local doctor and consenting patient. Much like priests were used in medieval times to reinforce a draconian and, in reality, barbaric top-down order, esteemed medical professors and researchers now declare to the world what is safe to use versus what is taboo. Switzerland’s Professor Oriol Manuel, a CHUV professor, summarily decides on ivermectin’s fate for those doctors and patients at HRC—permanently interrupting the essential local physician and patient relationship.

Call to Action: For those in Switzerland who want to know who decided that they couldn’t receive ivermectin from their local doctor, the answer is Professor Oriol Manuel.

Média | L'Impertinent

Vous recherchez de l'information, du journalisme indépendant, des médias porteurs de nouveaux concepts? Découvrez L'Impertinent, le site qui remet…

www.limpertinentmedia.com

Quote from Shane D.

Anyone have a link to this MSN article? Been looking, and all I see are negative stories.

Sorry

Uttar Pradesh government says early use of Ivermectin helped to keep positivity, deaths low

University of Ottawa Heart Institute Retrospective Study Finds 1 in 1,000 mRNA Vaccinations Leads to Myopericarditis

University of Ottawa Heart Institute Retrospective Study Finds 1 in 1,000 mRNA Vaccinations Leads to Myopericarditis

A research team from the University of Ottawa Heart Institute in Canada recently concluded and uploaded study results investigating the relationship

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A research team from the University of Ottawa Heart Institute in Canada recently concluded and uploaded study results investigating the relationship between mRNA COVID-19 vaccinations (Pfizer-BioNTech and Moderna) and heart-related conditions of myocarditis/pericarditis diagnosis over a two-month period from June 1, 2021, to July 31, 2021. A prospective study, the Ottawa-based study team, studied the records of patients that received an mRNA vaccine within a month prior to symptom presentation. The study subjects were admitted into the hospital with heart and chest-related symptoms. With data obtained from the Public Health Agency of Ottawa, the study team was able to compare data sets, declaring that this study effort represented the largest case series relating temporal relationship between mRNA COVID vaccination, symptoms, and findings. Study subjects were patients at the Heart Institute. Summarizing the study results, the study authors found that among the subjects, typically, symptom onset commenced during the first few days post-vaccination. Study investigators identified 32 patients during the study period fitting the study inclusion criteria, with 18 patients diagnosed with myocarditis. They concluded that in this part of Ottawa, Canada, during the study term that approximately one out of every 1,000 inoculations led to myopericarditis. While the Ottawa team cannot provide causation, they most certainly declared a tight temporal association between jab and myocarditis-related hospitalization.

In this health catchment area, the investigators found that during the study period, 32 patients met the study inclusion criteria. Of that group, 18 were diagnosed with myocarditis, 12 with myopericarditis, and 2 with pericarditis alone. At a median age of 33, the majority of subjects were males (29 out of 32).

The study team found that in five cases, symptoms emerged after the first mRNA vaccine dose. While 27 of the subjects developed symptoms after the second dose. The investigators observed that the median time from vaccine dose and symptom onset equaled 1.5 days. As far as symptoms associated with the adverse events, chest pain was most common, but investigators identified numerous other conditions.

The authors, led by Andrew M. Crean with the University of Ottawa Heart Institute, found that the median LV ejection fraction (EF) equaled 57% (44-66%) while investigators observed nine patients with an LVEF under the normal baseline of 55%.

Again this still non-reviewed study represents the “largest series in the literature to clearly relate the temporal relationship between mRNA COVID vaccination, symptoms and CMR findings.”

Cases Settled

Luckily the investigators reported that for the study group, “symptoms settled quickly with standard therapy, and patients were discharged within a few days.” The Canada-based team reported “no major adverse cardiac events and no significant arrhythmias” during the patient’s time in the hospital.

Limitations

The investigators declare that these study results don’t necessarily indicate evidence of causation—yet what they refer to as “the tight temporal coupling between vaccination and symptom onset represents a strong causal signal,” which they note are replicated in other reports. Moreover, they benefited from a central referral process, yet they cannot be certain of complete case capture. The study team acknowledged that they didn’t routinely test for other causes of myocarditis.

With limited short-term outcome data, and acknowledge that the basis for the incidence numbers are based on imperfect public health data. They could not distinguish incidents associated with the first or second dose, so consequently report more generalized data.

Of course, the study has not been peer-reviewed, and consequently, these results shouldn’t be interpreted until the data is further scrutinized.

Risk Factors

According to one recent research paper, the incidence of myocarditis equals between 10 to 20 persons per 100,000 worldwide. The authors from the University of California, Riverside, suggest that a majority of these patients are young and healthy.

While no conclusions can be made from the present data, the Ottawa study indicates that incidence of myocarditis is more frequent post mRNA COVID-19 vaccination than the normal risk for an average young person. To better understand risks associated with vaccination and COVID-19, it would be important to understand what is the probability of a healthy young person to become infected with a severe case of SARS-CoV-2, leading to serious adverse events and hospitalization.

University of Ottawa Heart Institute

The University of Ottawa Heart Institute, located in Ottawa, Canada, originated as a department in The Ottawa Hospital and since then evolved into Canada’s only comprehensive cardiac center, encompassing prevention, diagnosis, treatment, rehabilitation, research, and education.

The center cares for over 100,000 patients annually and reports very high patient satisfaction. The center is affiliated with the Ottawa Hospital and the University of Ottawa, Faculty of Medicine. The center includes 60 principal investigators leading $65 million worth of research studies per year.

Lead Research/Investigator

Andrew M. Crean, BSc, BM, MRCP, FRCR, MPhil, MPH

Call to Action: Researchers declared additional follow-up is necessary to better understand long-term outcomes for the study group.