If Natural Immunity Is More Effective Immunity - Why Would Any Previously Infected Need A Vaccine ID?

medrxiv  |  CONCLUSIONS: “This study demonstrated that natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity.

Background: Reports of waning vaccine-induced immunity against COVID-19 have begun to surface. With that, the comparable long-term protection conferred by previous infection with SARS-CoV-2 remains unclear. Methods: We conducted a retrospective observational study comparing three groups: (1)SARS-CoV-2-naive individuals who received a two-dose regimen of the BioNTech/Pfizer mRNA BNT162b2 vaccine, (2)previously infected individuals who have not been vaccinated, and (3)previously infected and single dose vaccinated individuals. Three multivariate logistic regression models were applied. 

In all models we evaluated four outcomes: SARS-CoV-2 infection, symptomatic disease, COVID-19-related hospitalization and death. The follow-up period of June 1 to August 14, 2021, when the Delta variant was dominant in Israel. Results: SARS-CoV-2-naive vaccinees had a 13.06-fold (95% CI, 8.08 to 21.11) increased risk for breakthrough infection with the Delta variant compared to those previously infected, when the first event (infection or vaccination) occurred during January and February of 2021. The increased risk was significant (P<0.001) for symptomatic disease as well. 

When allowing the infection to occur at any time before vaccination (from March 2020 to February 2021), evidence of waning natural immunity was demonstrated, though SARS-CoV-2 naive vaccinees had a 5.96-fold (95% CI, 4.85 to 7.33) increased risk for breakthrough infection and a 7.13-fold (95% CI, 5.51 to 9.21) increased risk for symptomatic disease. 

SARS-CoV-2-naive vaccinees were also at a greater risk for COVID-19-related-hospitalizations compared to those that were previously infected. 

Conclusions: This study demonstrated that natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity. Individuals who were both previously infected with SARS-CoV-2 and given a single dose of the vaccine gained additional protection against the Delta variant. 

Breakthrough Prevalence Among Israel's Pfizer Ultra-vaxxed A Dire Warning For America

thedailybeast |  The massive surge of COVID-19 infections in Israel, one of the most vaccinated countries on earth, is pointing to a complicated path ahead for America.

In June, there were several days with zero new COVID infections in Israel. The country launched its national vaccination campaign in December last year and has one of the highest vaccination rates in the world, with 80 percent of citizens above the age of 12 fully inoculated. COVID, most Israelis thought, had been defeated. All restrictions were lifted and Israelis went back to crowded partying and praying in mask-free venues.

 Fast forward two months later: Israel reported 9,831 new diagnosed cases on Tuesday, a hairbreadth away from the worst daily figure ever recorded in the country—10,000—at the peak of the third wave. More than 350 people have died of the disease in the first three weeks of August. In a Sunday press conference, the directors of seven public hospitals announced that they could no longer admit any coronavirus patients. With 670 COVID-19 patients requiring critical care, their wards are overflowing and staff are at breaking point.

“I don’t want to frighten you,” coronavirus czar Dr. Salman Zarka told the Israeli parliament this week. “But this is the data. Unfortunately, the numbers don’t lie.”

Israel vaccinated its population almost exclusively with the Pfizer/BioNTech vaccine, which received full FDA approval on Monday and remains the gold standard for the prevention of severe illness due to the coronavirus.

But in early July, with citizens over the age of 60 almost completely vaccinated, Israeli scientists began observing a worrisome rise in infections—if not in severe illness and death—among the double-vaccinated.

Fully vaccinated people with weakened immune systems appeared particularly vulnerable to the aggressive Delta variant.

By mid-July, Sheba Hospital Professor Galia Rahav began to experiment with booster shots for oncology patients, transplant patients, and the hospital’s own staff. A group of 70 elderly vaccinated Israelis with transplanted kidneys were the first to receive a third dose.

The success of Rahav’s trials in boosting immunity at about the sixth-month mark contributed to the Centers for Disease Control decision, announced last week, to begin offering booster shots to Americans in September.

In order to keep severe illness and the number of COVID deaths down, and avoiding a fourth national lockdown, Israel has embarked on an aggressive effort to provide all adults with boosters in a matter of weeks.

 

It Is Irresponsible To Push For mRNA Boosters For Healthy People Prior To A Safety Review

MedPageToday |  Over the last week, the topic of COVID-19 booster shots -- a third dose of mRNA vaccine for healthy Americans -- has been thrust into the spotlight. The surgeon general, CDC director, Anthony Fauci, MD, and President Biden have announced that they wish for boosters to be available by late September for healthy adults who are 8 months out from their original two-dose series. While this will be contingent on an FDA evaluation to determine the "safety and effectiveness of the third dose," a clear path forward has already been set. And just like everything else throughout the course of the pandemic, the choice has been made with a dearth of data and an abundance of political pressure.

Diminishing vaccine effectiveness supposedly makes the case for boosters. But there are two big questions here: First, what is current vaccine effectiveness? And second, what justifies boosters? Let's consider these in turn.

What Is Vaccine Effectiveness Now?

We have to be honest, many vaccine effectiveness studies are poorly done. All studies compare the rate of getting a breakthrough infection among vaccinated people against the rate of infection in unvaccinated people. But there are some issues with this approach. First, as time goes on, more unvaccinated people have had and recovered from COVID-19 (and these individuals may be less likely to go on to get a shot). This means that their risk of getting COVID-19 a second time is far less than the typical unvaccinated person who has never been sick. Even if vaccines "work" as well as before, this factor alone will result in the appearance of diminishing vaccine effectiveness.

Decisions about boosters have to be based in science and made by vaccine regulators. They should not be subject to the pressure of manufacturers, politicians, or political appointees. They should not be rushed. On Sunday television, Surgeon General Vivek Murthy, MD, was specifically asked if the third shot was safe. His response: "the plan is contingent on that..."

Excuse me? We don't know that to be true, and yet, our top medical and public health experts are pushing for boosters? Drug safety expert Walid Gellad, MD, MPH, tweeted: "It was irresponsible to push for boosters in healthy people before safety review."

Two days after the White House's announcement, two people with knowledge of the FDA's deliberation told The Washington Post that the agency was investigating myocarditis signal with the Moderna vaccination. Canadian data suggest the risk may be 2.5 times that of Pfizer's vaccine. The timing of this internal information leaking to reporters naturally leads me to wonder if reviewers in the agency are attempting to counteract political pressure, and create space to conduct a thorough review of booster data.

 

We’re Lacking Crucial Data On Breakthrough Infections Because CDC Actively Refused To Collect It

politico  |   The Centers for Disease Control and Prevention is using outdated and unreliable data on coronavirus breakthrough infections to help make major decisions, such as who gets booster shots, according to three officials with direct knowledge of the situation.

The agency originally tried to track all infections in vaccinated people, from mild to severe. But in May it decided to focus on the most severe cases, saying that would allow it to better monitor overall conditions and make more informed, targeted policy decisions.

Forty-nine states are now regularly sending CDC information on hospitalized breakthrough patients. But more than a dozen told POLITICO that they do not have the capacity to match patients’ hospital admission data with their immunization records. Instead, those states rely on hospital administrators to report breakthrough infections. The resulting data is often aggregated, inaccurate and omits critical details for teasing out trends, such as which vaccine a person received and whether they have been fully vaccinated, a dozen state officials said.

The gaps in this crucial data stream raise questions about the Biden administration’s ability to spot and respond to changes in the virus’s behavior — such as the rapid spread of the Delta variant, which crowded out other strains — or vaccines’ performance. It also underscores the extent to which the CDC and public health departments across the country are still struggling to collect and study critical Covid-19 information 18 months after the pandemic began.

“I think it would be really challenging [for the CDC] to interpret the results or to interpret the data when you have only some jurisdictions reporting [breakthrough infections],” said Theresa Sokol, lead epidemiologist for Louisiana’s state public health department, which is working closely with the CDC on studies of breakthrough infections. “I know that there are some jurisdictions that don't even have access to their vaccination data. They don't have the authority or their permission.”

Many of the hurdles facing CDC and state officials trying to gather data during the age of the Delta variant are the result of the patchwork of public-health agency data systems, many of which cannot communicate with each other. For more than a decade, states have pleaded with the federal government for money to make it easier to gather and study disease trends electronically. The pandemic has overloaded those arcane systems, revealing the disorganized nature of public health reporting and case investigation.

Now Is The Time To Use Ivermectin

yomiuri shimbun  |  During the Tokyo Olympics, Delta strains originating in India raged and the number of infected people continues to increase. Why is Japan not trying to use ivermectin, which has few reports of side effects and has been reported to be effective in clinical trials in other countries? On August 5, we had an urgent interview with Mr. Ozaki, chairman of the Tokyo Metropolitan Medical Association, who had been proposing effective uses of ivermectin from early on.

The peak of infection spread that is not yet visible

――It seems that the explosive spread of infection, which is also called the 5th wave, is still rising. The number of people waiting at home and receiving medical treatment is increasing rapidly. How is the Tokyo Metropolitan Medical Association responding?

　"When the number of people waiting at home and receiving medical treatment increased sharply in the third wave of January, this was no good, and the Tokyo Metropolitan Medical Association and the Tokyo Metropolitan Medical Association worked together to build a system with the goal of 24-hour support. We have been able to handle up to 37 of the 47 district medical associations. However, the current situation where more than 1000 home caregivers are piled up every day is beyond the limit. , Vaccination, medical examination, home visit, etc. are not available. Now, the health center is coordinating hospitalization. There is also a hospitalization coordinating center in Tokyo, but there is a system that can quickly accept and treat suddenly changed corona patients. I haven't gotten to the point of being established. "

Many clinical trial results are "effective for prevention and treatment"

--If you read the papers on clinical trials of ivermectin that have been published around the world, there are many examples that are effective for both prevention and treatment.

　"I am aware that there are many papers that ivermectin is effective in the prevention and treatment of corona, mainly in Central and South America and Asia. There is no effective therapeutic drug, although it is necessary to deal with patients who develop it one after another. The vaccine is not in time. At such an imminent time, there is a paper that ivermectin is effective for corona, so it is a natural response for clinicians to try using it. Doctor-led clinical practice That's why many test papers came out. "

--Usually, pharmaceutical companies conduct large-scale clinical trials to see the effects, but ivermectin has been selected by the World Health Organization (WHO) as a silver bullet for tropical diseases such as onchocerciasis (river blindness) and lymphatic filariasis. It is a drug approved by countries around the world more than 20 years ago. If it is effective for the new corona, it is not applicable, but it is unavoidable that we decided to use it in a pandemic.

　"That's right. The medical field of a pandemic is a battlefield. It's the same as a field hospital. Patients are brought in and their condition deteriorates one after another and they die. So I can understand the feelings of the doctor who clings to this and administers it. "

　"The other day, a research group at the All India Institute of Medical Sciences / AIIMS, which sets guidelines for the treatment of corona infections in India, has published a paper investigating the preventive effects of ivermectin. According to the report, about 3,900 medical workers (staff and students) were given 0.3 mg / kg of ivermectin twice at 3-day intervals, only once, and then. As a result of conducting clinical trials divided into three groups of those who did not, it is said that those who received ivermectin twice reduced the new corona infection by 83%. It was the first time in the world to publish a paper. It's a class research group, so it's very reliable. "

 

How Did India Abruptly Stop Being Ground Zero Of The Coronapocalypse?

Why is no one interested in India anymore with respect to the Coronapocalypse? Can a couple of weeks really make such an incredible difference? The contrast from July to August is really stark. When the news was bad you couldn't turn to a news outlet that wasn’t reporting about the continuous megadeath in India. Now, not nary a peep...,

Speaks volumes how reporting is being used to gin up fear beyond what is suggested by the "science". Since the Indian coronapocalypse has fallen off the official narrative radar, I went over to the Times of India to have a look. They have a “Covid Tracker” that says that there were 382 deaths on Aug 22 related to Covid-21. New Cases are down 30%, to 25,320.

Now if you do the math, India has ~1.4 billion people. These Covid-21 figures don't even amount to rounding errors. Given that Ivermectin is in the Indian Covid-21 treatment protocol - AS ACROSS PARTS OF THE AFRICAN CONTINENT - maybe the 1.4 billion horse-paste eating Indian animals are getting some type of prophylactic and curative benefit from their veterinary medicine?

This site is another good place to watch and keep track of the numbers. I follow Uttar Pradesh. Their deaths from Covid today (with a population above 500 million) were …. zero, niente, rien, zed. aka none. 

Of course there were likely a few, but I challenge anyone to prove that India’s numbers are as through the roof as the U.S. There are no funeral pyres burning, floating bodies in the Ganges, hospitals overflowing, shortages of O2 canisters, etc.

Ivermectin use? High.

Vaccination rate? Still in the single digits.

Florida? Under reporting did you say? 

Texas? Pediatric wards packed. 

Oregon? Sending children to hospital in Seattle due to lack of beds?

India? Passez moi l’ ivermectin stp dégolas!

Covid-19 The Ivermectin African Enigma

onafhanklik |  The low frequency of cases and deaths from the SARS-CoV-2 COVID-19 virus in some countries of Africa has called our attention to the unusual behavior of this disease. Data from 19 countries that participated in the WHO sponsored African Programme for Onchocerciasis Control (APOC), from 1995 until 2015, intended to treat over 90 million people annually and protect an at-risk population of 115 million, were compared with thirty-five (Non-APOC), countries that were not included. The statistics show a significant 28% lower mortality (0.72 IC 95% 0,67-0,78) and 8% lower rate of infection (0.92 IC95% 0,91-0,93) due to COVID-19.  It was concluded that the incidence in mortality rates and number of cases is significantly lower among the APOC countries compared to non-APOC countries. Additional studies are needed to confirm it.

Ivermectin has been banned in South Africa to used for Covid19 – there is no vaccine and those “promised vaccines” all over, are also not of any guarantee to anybody. For how long is those vaccines, for a year perhaps? And people still need to wear masks and closed down businesses to harm all economies. No income, no food and no employment. Mass control and manipulation.

What are the benefits of Ivermectin? There were already various trials in different countries.

Ivermectin – Prof Paul Marik

FLCCC Alliance – Ivermectin …

Ivermectin – Covid-19 – Prof Thomas Borody

Zinc – Ivermectin – Doxycycline – virus

Regarding the Covid-19 virus, it was earlier stated on 2 November 2020, that when Covid-19 arrived in Tanzania, their President Magufuli didn’t believe in his people to stay at home. He wanted his people to get into the churches and mosques to pray.  

Tanzania Africa
 

Speaking during a political rally in Chato Geita, Magufuli said his government did not bow to pressure to lockdowns.    He stated that many threatened us with dire consequences, they wanted us to shut down the economy so that we run away from the problem but in reality, leadership is about carrying the problems on those you lead on your shoulders that is why today we are here.   He is not the only country that decided not to close down the businesses and economy.

Tanzania – September 2020

Tanzania’s economy must go ahead as it is more important than coronavirus, which has killed 21 people in the East African country, according to the president.

Corona tests – Tanzania

The Mechanisms Of Action Of Ivermectin Against SARS-CoV-2: An Evidence-based Clinical Review

nature | Considering the urgency of the ongoing COVID-19 pandemic, detection of various new mutant strains and future potential re-emergence of novel coronaviruses, repurposing of approved drugs such as Ivermectin could be worthy of attention. This evidence-based review article aims to discuss the mechanism of action of ivermectin against SARS-CoV-2 and summarizing the available literature over the years. A schematic of the key cellular and biomolecular interactions between Ivermectin, host cell, and SARS-CoV-2 in COVID-19 pathogenesis and prevention of complications have been proposed.

Introduction

A relatively recent surge in zoonotic diseases has been noted over the past few decades. Several reasons could be responsible for this “spill-over” of disease-causing agents from animals to humans. These include an exponential rise in the global population causing man to encroach new ecological habitats in search of space, food, and resources as well as improved opportunities for rampant wildlife trade causing inter-species pathogen jumps. The 1980s was known for HIV/AIDS crisis that originated from the great apes, while the Avian flu pandemic in 2004-07 came from the birds. The pigs lead to the Swine flu pandemic in 2009 and bats were the original hosts of Ebola, Severe Acute Respiratory Syndrome (SARS), Middle Eastern respiratory syndrome (MERS), and probably Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) outbreak as well.

COVID-19 has already caused millions of deaths worldwide and has paralyzed not only the world’s healthcare system but also the political and economic relations between countries [1]. The fact that the SARS-CoV-2 virus has been thought to have originated from wildlife and may have “jumped” into humans, not only highlights future risks from animal-borne diseases but also provides an important clue to its resolution.

You are not a horse. You are not a cow. Seriously, y'all. Stop it. https://t.co/TWb75xYEY4

— U.S. FDA (@US_FDA) August 21, 2021

In such a scenario, where this “jump” has been made from animal to human, it seems only logical to review a drug that has worked efficiently against a disease-causing agent and is available in a form that is safe for human consumption since the early 1980 s.

Ivermectin belongs to a group of avermectins (AVM), which is a group of 16 membered macrocyclic lactone compounds discovered at the Japanese Kitasato institute in 1967 during actinomycetes cultures with the fungus Streptomyces avermitilis [2]. This drug radically lowered the incidence of river blindness and lymphatic filariasis and was discovered and developed by William C. Campbell and Satoshi Ōmura for which they received the Nobel Prize in Physiology or Medicine in 2015 [3, 4]. Ivermectin is enlisted in the World Health Organization’s Model List of Essential Medicines [5].

Drug repurposing, drug redirecting, or drug reprofiling is defined as the identification of novel usages for existing drugs. The development risks, costs as well as safety-related failure, are reduced with this approach since these drugs have a well-established formulation development, in vitro and in vivo screening, as well as pharmacokinetic and pharmacodynamic profiles. Moreover, the first clinical trial phases of many such drugs have been completed and can be bypassed to reduce several years of development. Therefore, drug repurposing has the potential to reduce the time frame for the whole process by up to 3–12 years and carries great potential [6].

Although several drugs received Emergency Use Authorization for COVID-19 treatment with unsatisfactory supportive data, Ivermectin, on the other hand, has been sidelined irrespective of sufficient convincing data supporting its use. Nevertheless, many countries adopted ivermectin as one of the first-line treatment options for COVID-19.

With the ongoing vaccine roll-out programs in full swing across the globe, the longevity of the immunity offered by these vaccines or their role in offering protection against new mutant strains is still a matter of debate. The adoption of Ivermectin as a “safety bridge” by some sections of the population that are still waiting for their turn for vaccination could be considered as a “logical” option.

Several doctor-initiated clinical trial protocols that aimed to evaluate outcomes, such as reduction in mortality figures, shortened length of intensive care unit stay and/or hospital stay and elimination of the virus with ivermectin use have been registered at the US ClinicalTrials.gov [7]. Real-time data is also available with a meta-analysis of 55 studies to date. As per data available on 16 May 2021, 100% of 36 early treatment and prophylaxis studies report positive effects (96% of all 55 studies). Of these, 26 studies show statistically significant improvements in isolation. Random effects meta-analysis with pooled effects using the most serious outcome reported 79% and 85% improvement for early treatment and prophylaxis respectively (RR 0.21 [0.11–0.37] and 0.15 [0.09–0.25]). The results were similar after exclusion based sensitivity analysis: 81% and 87% (RR 0.19 [0.14–0.26] and 0.13 [0.07–0.25]), and after restriction to 29 peer-reviewed studies: 82% and 88% (RR 0.18 [0.11–0.31] and 0.12 [0.05–0.30]). Statistically significant improvements were seen for mortality, ventilation, hospitalization, cases, and viral clearance. 100% of the 17 Randomized Controlled Trials (RCTs) for early treatment and prophylaxis report positive effects, with an estimated improvement of 73% and 83% respectively (RR 0.27 [0.18–0.41] and 0.17 [0.05–0.61]), and 93% of all 28 RCTs. These studies are tabulated in Table 1. The probability that an ineffective treatment generated results as positive for the 55 studies to date is estimated to be 1 in 23 trillion (p = 0.000000000000043). The consistency of positive results across a wide variety of cases has been remarkable. It is extremely unlikely that the observed results could have occurred by chance [8].

The Human Use Of Ivermectin

nih.gov |  Ivermectin has continually proved to be astonishingly safe for human use. Indeed, it is such a safe drug, with minimal side effects, that it can be administered by non-medical staff and even illiterate individuals in remote rural communities, provided that they have had some very basic, appropriate training. This fact has helped contribute to the unsurpassed beneficial impact that the drug has had on human health and welfare around the globe, especially with regard to the campaign to fight Onchocerciasis.⁵⁷⁾

Today, ivermectin is being increasingly used worldwide to combat other diseases in humans, such as Strongyloidiasis (which infects some 35 million each year), scabies (which causes 300 million cases annually), Pediculosis, Gnathostomiasis and Myiasis—and new and promising properties and uses for ivermectin and other avermectin derivatives are continuing to be found.⁵⁸⁾ These include activity against another neglected tropical disease, Leishmaniasis.^59,60) Of perhaps even greater significance is the evidence that the use of ivermectin has both direct and indirect beneficial impact on improving community health. Studies of long-term treatment with ivermectin to control Onchocerciasis have shown that use of the drug is additionally associated with significant reduction in the prevalence of infection with any soil-transmitted helminth parasites (including Ascaris, Trichuris and hookworm), most or all of which are deemed to be major causes of the morbidity arising from poor childhood nutrition and growth.⁶¹⁾ It is also known that the prevalence of head lice is markedly reduced in children taking ivermectin tablets⁶²⁾ and that scabies is markedly reduced in populations taking the drug regularly.⁶³⁾ Above all, ivermectin has proved to be a medicine of choice for the world’s rural poor. In many underprivileged communities throughout the tropics, intestinal worms and parasitic skin diseases are extremely common and associated with significant morbidity. They usually co-exist, with many individuals infected with both ecto- and endoparasites.^64,65) Mass treatment of poly-parasitized populations is deemed to be the best means of control and ivermectin is the ideal drug for such interventions. A recent study in Brazil, using locally produced ivermectin, looked at the impact on internal helminthes and parasitic skin diseases. The researchers concluded that “mass treatment with ivermectin was an effective and safe means of reducing the prevalence of most of the parasitic diseases prevalent in a poor community in North-East Brazil. The effects of treatment lasted for a prolonged period of time”. This study also represented the first published report of human medical intervention using ivermectin that had not been produced by the hitherto traditional manufacturer, Merck & Co. Inc., the patent on the drug expiring in 1997.⁶⁶⁾

In reality, the renewed interest in fighting tropical diseases, including the involvement of the pharmaceutical industry, which has become increasingly evident over the past three decades, and which has saved lives and improved the welfare of billions of people, notably the poor and disadvantaged in the topics, can be traced back to the 1987 introduction of ivermectin for use in humans. According to a recent report, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) data show that the global pharmaceutical industry provided over $9.2 billion in health interventions (medicines and equipment) between 2000–2007 alone, benefitting 1.75 billion people worldwide.⁶⁷⁾ The hitherto unprecedented donation of ivermectin in 1987 can rightly be seen to be the origin of this philanthropic outpouring.

Since the inception of the Mectizan Donation Programme, Merck has donated well over 2.5 billion Mectizan^® tablets for Onchocerciasis treatment, with in excess of 700 million treatments authorised. Currently, some 80–90 million people are taking the drug annually through MDA in Africa, Latin America and Yemen. A further 300 million total treatments have been approved for lymphatic filariasis, with around 90 million treatments being administered annually (Fig. ​(Fig.8 ).8 ). At present 33 countries are receiving ivermectin for Onchocerciasis and 15 for Lymphatic filariasis. Consequently, around US$4 billion worth of ivermectin tablets have been donated to date. In 2010, Ecuador became the second country in the Americas to halt River Blindness transmission. It is hoped that transmission of the disease in the Western hemisphere will be stopped by 2012—a goal that will have been achieved thanks to twice-yearly MDA with ivermectin. Lymphatic filariasis is targeted for global elimination by 2020, and, if all goes well, Onchocerciasis may well be eliminated from Africa soon thereafter.

The Story Of Ivermectin

isglobal  |   What do penicillin, aspirin and ivermectin have in common? Apart from the fact that they rhyme, all three belong to a very select group of drugs that can claim to have had the “greatest beneficial impact on the health and well-being of humanity”.

They have at least two other things in common: all three were found in nature and all three led to a Nobel prize. Aspirin is derived from salicin, a compound found in a variety of plants such as willow trees. Its use was first mentioned by Hippocrates in 400 BC, but was isolated only in 1829 as salicylic acid and synthesised some years later as acetylsalicylic acid. The discovery of the mechanisms underlying aspirin’s effects gave Sir John Vane the Nobel prize in 1982. Penicillin was isolated from mold that grew by accident on a Petri dish in Alexander Fleming’s laboratory. Its discovery changed the course of medicine, and earned Fleming the Nobel prize in 1945, which he shared with Howard Florey and Ernst Chain.

And this brings us to ivermectin- not likely a drug you will have in your first-aid kit, like aspirin or penicillin, but definitely a drug that has improved the lives of millions of people since its discovery in 1975.

The story of how ivermectin was discovered is quite incredible. In the late 1960s, Satoshi Ōmura, a microbiologist at Tokyo’s Kitasako Institute, was hunting for new antibacterial compounds and started to collect thousands of soil samples from around Japan. He cultured bacteria from the samples, screened the cultures for medicinal potential, and sent them 10,000 km away to Merck Research Labs in New Jersey, where his collaborator, William Campbell, tested their effect against parasitic worms affecting livestock and other animals. One culture, derived from a soil sample collected near a golf course southwest of Tokyo, was remarkably effective against worms. The bacterium in the culture was a new species, and was baptised Streptomyces avermictilis. The active component, named avermectin, was chemically modified to increase its activity and its safety. The new compound, called ivermectin, was commercialised as a product for animal health in 1981 and soon became a top-selling veterinary drug in the world. Remarkably, despite decades of searching, S. avermictilis remains the only source of avermectin ever found.

Questions For The FDA

BritishMedicalJournal |   With the US awash in news about rising cases of the Delta variant, including among the “fully vaccinated,” the vaccine’s efficacy profile is in question. But some medical commentators are delivering an upbeat message. Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board, said: “Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”

Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe covid-19” endpoint results as “preliminary evidence.” Hospital admission numbers were not reported, and zero covid-19 deaths occurred.

In the preprint, high efficacy against “severe covid-19” is reported based on all follow-up time (one event in the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data last year showed that 21 of 30 “severe covid-19” cases were not admitted to hospital; Table S14).

And on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).

The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease. Unfortunately, Pfizer’s new preprint does not report the results in a way that allows for evaluating this question.

Approval imminent without data transparency, or even an advisory committee meeting?

Last December, with limited data, the FDA granted Pfizer’s vaccine an EUA, enabling access to all Americans who wanted one. It sent a clear message that the FDA could both address the enormous demand for vaccines without compromising on the science. A “full approval” could remain a high bar.

But here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data. (The preprint reports “decreased appetite, lethargy, asthenia, malaise, night sweats, and hyperhidrosis were new adverse events attributable to BNT162b2 not previously identified in earlier reports,” but provides no data tables showing the frequency of these, or other, adverse events.)

It’s not helping matters that FDA now says it won’t convene its advisory committee to discuss the data ahead of approving Pfizer’s vaccine. (Last August, to address vaccine hesitancy, the agency had “committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.”)

Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.

I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”

FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.

Peter Doshi, senior editor, The BMJ.

Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.

Has This Safety Monitoring Been Done? If So, What Were The Results?

FDA  | From Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum  - Page 44

5.2. Pharmacovigilance Activities
Pfizer submitted a Pharmacovigilance Plan (PVP) to monitor safety concerns that could be associated with Pfizer-BioNTech COVID-19 Vaccine. The Sponsor identified vaccine-associated enhanced disease including vaccine-associated enhanced respiratory disease as an important potential risk.

Move Along Now, No Influence, No Conflict Of Interest To See Over Here....,

divergemedia  |  Jim Smith, the Former President and CEO of Thomson Reuters and now the current Chairman of the Thomson Reuters Foundation, the corporate arm of the company, also sits as a board member at Pfizer – except under the name James Smith. Robert Malone, the self proclaimed creator of mRNA vaccines was the first to post Mr. Smith’s LinkedIn profile that showed the connections. The LinkedIn profile that Mr. Malone posted reads that “Jim is a non-executive director of Pfizer Inc.”

regarding the "Trusted News Initiative" and censorship of information regarding COVID vaccine safety, please be aware of the link between Pfizer and Reuters. I would call that a journalistic conflict of interest. What do you think? pic.twitter.com/qQCysxnPX6

— Robert W Malone, MD (@RWMaloneMD) June 28, 2021

Since that tweet, it appears that Mr. Smith has removed his picture off of his LinkedIn profile in an attempt to make the connection harder to make. However, the pictures are the same person and the “James Smith” that sits on the board at Pfizer admits to being the Chairman of Thomson Reuters foundation and the former president – verifying it is in fact the same Mr. Smith. Mr. Smith is also a “member of the International Business Council of the World Economic Forum.”

People all over the world are hungry for unbiased information that they can trust. When the chairman of a media company like Reuters also sits on the board at Pfizer how can we believe that there isn’t any form of bias occurring in their coverage of the vaccine rollout? Are we to really believe that there is no conflict here? Do people really believe someone can sit on the board of a major vaccine manufacturer and still provide unbiased coverage of that same vaccine? I don’t think you can remain unbiased – but that’s just my take.

*We have reached out to the Thomson Reuters Foundation about the connection but did not receive a message back before the release of this article.*

 

It's The Smell..., That 80 Year Old Pelosi Smell....,

thesun  |  The event was hosted in Napa Valley over the weekend and the clip of the dozens of guests sitting side-by-side was shared online by Dem donor and winemaker Kathryn Walt Hall.

Critics were quick to slam Pelosi for attending the event in an area where Covid-19 cases are once again spiking.

"Speaker Pelosi wants to lock you down again while she wines and dines with her political donors," House Minority Leader Kevin McCarthy said.

"It's utter hypocrisy."

Controversial QAnon Congresswomen Marjorie Taylor Greene also took shots at Pelosi's fundraiser, alleging that Democrats only care about "controlling you."

"[Speaker Pelosi] does not care about Covid," she wrote on Twitter. 

"Democrats don’t care about covid. They only care about controlling you.

"Magical covid science: The virus stops spreading the minute you sit down to eat or when you speak in a microphone or if you are one of the elites. Liars."

This is not the first time Speaker Pelosi has been slammed for flouting Covid-19 restrictions while California was dealing with outbreaks.

Last year, she was caught on video inside a hair salon with no mask on while such establishments were supposed to be closed due to the virus.

Pelosi was widely slammed online for ignoring rules that she adamantly supported when speaking publicly.

She later alleged that the owner of the hair salon set her up.

 

Biden Is Under Nearly Unprecented Military-Media Assault For Asserting Civilian Control

NYTimes  |   President Biden used his daily national security briefing on the morning of April 6 to deliver the news that his senior military leaders suspected was coming. He wanted all American troops out of Afghanistan by Sept. 11, the 20th anniversary of the attacks on New York and the Pentagon.

In the Oval Office, Defense Secretary Lloyd J. Austin III and Gen. Mark A. Milley, the chairman of the Joint Chiefs of Staff, wanted to make certain. “I take what you said as a decision, sir,” General Milley said, according to officials with knowledge of the meeting. “Is that correct, Mr. President?”

It was.

I’ve never seen such a coordinated media-military attack on a President for asserting civilian control of the military. https://t.co/BVPXHUTxed

— Matt Stoller (@matthewstoller) August 21, 2021

Over two decades of war that spanned four presidents, the Pentagon had always managed to fend off the political instincts of elected leaders frustrated with the grind of Afghanistan, as commanders repeatedly requested more time and more troops. Even as the number of American forces in Afghanistan steadily decreased to the 2,500 who still remained, Defense Department leaders still cobbled together a military effort that managed to protect the United States from terrorist attacks even as it failed, spectacularly, to defeat the Taliban in a place that has crushed foreign occupiers for 2,000 years.

The current military leadership hoped it, too, could convince a new president to maintain at least a modest troop presence, trying to talk Mr. Biden into keeping a residual force and setting conditions on any withdrawal. But Mr. Biden refused to be persuaded.

The two Pentagon leaders stood before Mr. Biden near the same Resolute Desk where President George W. Bush reviewed plans in 2001 to send in elite Special Operations troops to hunt for Osama bin Laden only to see him melt over the border into Pakistan. It was the same desk where President Barack Obama decided on a surge of forces in 2009, followed by a rapid drawdown, only to discover that the Afghan military was not able to defend itself despite billions of dollars in training. It was there that President Donald J. Trump declared that all American troops were coming home — but never carried through a plan to do so.

The Root Cause of the Afghanistan Crisis? U.S. Corporate Profit-Seeking...,

diplomaticourier |  With twenty years to prepare for it, there should be plenty of clarity in the post-mortem on “what went wrong in Afghanistan” for American policy. History warned us with everything but flashing red lights that all was not well as the twenty years progressed. History should also tell us that there will be as little clarity as to how America and allies failed in Afghanistan as the lack of clarity that doomed the enterprise.

The comparisons to Vietnam were already numerous. These will only proliferate as photojournalists -- instinctually sensing a fall of Saigon moment -- capture images of the chaotic and poorly planned evacuation of Kabul. Like America’s involvement in Vietnam, this failure did not happen in a vacuum; it happened in a sequence. Policy failures, lacking political will, military issues, and cultural upheaval all contributed to the images of the helicopter leaving the American embassies in both Saigon, with a long line queued up for an escape that was never to come.

That sequence continued after the Vietnam War. In the decades since, that failure has been studied and debated militarily, politically, and policy-wise. The United States military took the lessons of failure and revolutionized itself, moving to an all-volunteer force, integrating National Guard and Reserve components, and focusing on technological superiority and precision. The result was a much smaller overall force that is more capable, lethal, and diverse, while constituting only 1% of the American population.

The government which that military serves, however, failed to carry out a similar soul searching and rebuilding process. Lip service was given, policy papers were written, debates were had, but the power structure largely remained unchanged. The decades of distance meant the personal lessons of Vietnam were operationally lost to the very impersonal machine of American governance. Accountability for decision-making is lacking. The politics of the day has become more about overseeing the system for what could be gained individually and for one’s party than about operating it effectively for the gain of all. The watchdogs of the free press became increasingly reliant on access journalism to the superstars of the political world, and by omission or commission had their investigatory mandate dulled. A vast majority of the American citizenry, most of them lulled into complacency by a level of prosperity unheard of in all of recorded human history, had little interest in changing the systems that weren’t bothering them, even as the number of individuals suffering from it steadily grew.

The answers to "what went wrong in Afghanistan" begin in that grey area of unlearned history lessons from the last failure of American foreign policy leading to desperate evacuations of an embassy in Saigon to the embassy in Kabul. Afghanistan is a political failure, it is a policy failure, it is a military failure, and it is a human failure. Most of all, it is, was, and will forever be known as an avoidable failure as too many of us watched idly while it slowly metastasized into today’s crisis -- a crisis which history and common sense were warning us about.

Any post-mortem on "what went wrong in Afghanistan" that does not include a root cause of dysfunction within the United States government to operate as a competent and accountable governing mechanism is missing the root domestic cause of the foreign policy disaster that the Global War on Terror has become. The failures of the United States government to learn from past mistakes incubated the current dysfunction that inevitably bled through to foreign policy failures like America’s 20 years in Afghanistan. A United States that cannot conduct conflict resolution within its own government can neither project nor maintain a coherent foreign policy to the rest of the world.

Vaccine Resistance In The Military Remains Very Strong

WaPo  | The Pentagon’s effort to mandate coronavirus vaccination for all 1.3 million active-duty service members will continue to face resistance from a segment of the force, troops and observers say, until military leaders devise an effective strategy for countering pervasive doubt about the pandemic’s seriousness and widespread misinformation about the shots designed to bring it under control.

When Defense Secretary Lloyd Austin announced earlier this month that he would seek to require inoculation no later than mid-September, Pentagon data showed that thousands of personnel — about one-third of the force — remained unvaccinated. President Biden quickly endorsed the move.

The looming mandate comes as the virus’s highly transmissible delta variant fuels a new wave of infections globally, and after Biden, in what was widely seen as a signal to state and local governments and the private sector that they should follow suit, directed agencies throughout the federal government to implement proof-of-vaccination requirements or impose restrictions on employees who refuse. For military personnel, administration officials have said, the need is particularly urgent.

“Right now it’s being framed as a readiness issue,” said Katherine Kuzminski, a senior fellow at the Center for a New American Security, pointing to the current security crisis that has unfolded in Afghanistan’s capital, where thousands of U.S. troops were sent with little notice to help evacuate American citizens and U.S. allies following the Taliban’s takeover of the country. “As we see in Afghanistan, there is certainly a need to rapidly deploy people, and they may or may not be going to places that have relatively high rates of vaccinations.”

But, Kuzminski added, “I don’t think we’ve seen a vaccine that was [so] politicized.”

The Defense Department did not respond to a request for comment about its efforts to address vaccine hesitancy within the ranks.

 

Authority Crumbles When The Truth Is Shared

aeromagazine  |  The First Amendment of the US Constitution specifies that Congress “shall make no law … abridging the freedom of speech.” In fairness, Congress has made no such law. The executive branch is simply stating that it will invoke its power to censor by fiat in collaboration with social media companies, on the pretext of a national emergency.

Given that the federal government enjoys the cooperation of the vast majority of media outlets, the fact that competing social media narratives are sufficient to prevent them from being able to convince the nation that their message is correct represents a significant problem with the message itself, the effectiveness of its communication or the credibility of their sources.

Of these three factors, credibility seems especially weak. Since the start of the pandemic, health leaders have made definitive statements that have subsequently needed to be reversed. First, early in 2020, they insisted the wearing of masks by the public was unnecessary, as it was not believed that the virus spread via airborne transmission. That was incorrect. The hypothesis that the origin of the virus was a lab leak from the Wuhan Institute of Virology was labelled a conspiracy theory, but has now been deemed as likely as a natural origin. In late March, the current CDC cirector, Rochelle Walensky, announced that vaccinated individuals were unable to carry the virus, even though existing studies confirmed that they could both carry and spread it. The CDC later awkwardly walked these comments back. In May it was announced that vaccinated individuals were free to roam unmasked in most settings because they would not spread or contract the virus except in the rarest of circumstances. This directive has now been reversed again due to the rise of the Delta variant, as data have shown that vaccinated individuals may have the same viral load as the unvaccinated, and may indeed be able to spread it to others. The CDC says that vaccinated individuals should return to masking indoors. Even though some of these reversals were due to changing circumstances, the ongoing back-and-forth leads many to question the credibility of the messengers.

It has also become clear that leaders are disseminating misinformation—or, in some cases, disinformation—on behalf of those who know the truth but are making statements to the contrary.

In a 21 July 2021 CNN Town Hall, President Biden insisted: “You’re not gonna get Covid if you have these vaccinations.” This was a completely inaccurate statement. Vaccinated people have contracted Covid since the vaccinations began, and this trend is increasing now that the Delta variant is the dominant viral strain. Data from the Israeli Ministry of Health reveal that, at five months and six months after the second vaccine dose, individuals are only protected from symptomatic Covid at levels of 44% and 16% respectively. Meanwhile, a new study from Israel indicates that protection from serious disease has fallen to 80%.

It may be that this misinformation was conveyed accidentally as a result of inelegant delivery by the president. But this was a very dangerous statement, as it promoted a false impression that the vaccines are completely protective, and was likely to make many question and potentially resist the new announcement from the CDC that vaccinated people should wear masks indoors.

The CDC director declared that this was a pandemic of the unvaccinated—and was soon echoed by President Biden. A large number of health leaders and media contributors have continued to parrot this phrase. But case data from Israel, the UK and many other countries prove that vaccinated individuals are being significantly impacted. Israel recently announced that 60% of its hospitalised Covid patients were fully vaccinated. The newest Public Health England technical report reveals that 25% of Delta hospitalisations and 54% of Delta deaths have occurred in the fully vaccinated. Iceland has achieved a vaccination rate of almost 90% among adults, but still needed to reinstate public health measures due to a surge in Delta infections. Now that the Delta variant has taken hold in the US, there have been numerous instances of vaccinated individuals being infected, including the notable breakthrough infections in Provincetown, Massachusetts that were a central factor prompting new CDC guidance on indoor masking. It is clear that the Delta variant has produced a much more complicated landscape, in which merely the amount of vaccine that has been administered is a less significant data point. In short, it is false to claim that the pandemic affects only the unvaccinated.

In addition to being inaccurate, the narrative that the pandemic now only affects the unvaccinated has created division and hostility between different groups, which is extremely unhelpful given the many cases of shootings in the US, as well as violent outbursts in public spaces including airlines. I have seen vitriolic statements on social media by vaccinated individuals who are blaming the unvaccinated for the Delta variant, even though it was discovered in autumn of last year, before vaccinations were available to the general public. Even some in the media have engaged in blaming the unvaccinated. CNN host John Berman insisted: “If the unvaccinated aren’t to blame, who is?” We urgently need to promote a climate in which people work together rather than being turned against one another.

Some leaders have suggested that increased vaccination levels will arrest the surge in the Delta variant. After the second dose, it takes 35 days with Pfizer or 42 days with Moderna to achieve fully vaccinated status. It is obvious that new vaccinations, which take more than a month to provide full protection, cannot prevent a viral surge that is presently underway. Additional vaccines may indeed help more people to have better health outcomes if they were to become infected—but that is an entirely different claim.

 

We Don't Need No Stinking Public Discussion Of Our Political Decisions...,

britishmedicaljournal |  Transparency advocates have criticised the US Food and Drug Administration’s (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine.

Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.

“The FDA has held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to covid-19 vaccines, including a 22 October 20202 meeting to discuss, in general, the development, authorisation, and licensure of covid-19 vaccines,” an FDA spokesperson said.

“The FDA also has held meetings of the VRBPAC on all three covid-19 vaccines authorised for emergency use and does not believe a meeting is needed related to this biologics license application.”

The spokesperson added, “The Pfizer BioNTech covid-19 vaccine was discussed at the VRBPAC meeting on 10 December 2020.3 If the agency had any questions or concerns that required input from the advisory committee members we would have scheduled a meeting to discuss.”

The vaccine has already been rolled out to millions of Americans through an emergency use authorisation. Companies typically apply for full approval after a longer period has elapsed so that more data are available for review.

But with the US government indicating this week that it plans to start making booster shots widely available next month, experts said the decision not to meet to discuss the data was politically driven.

Data scrutiny

Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee,4 said the decision removed an important mechanism for scrutinising the data.

“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,” she said. “The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval.”

Petition To The FDA To Refrain From Premature Final Approval Of mRNA Neo-Vaccinoids

britishmedicaljournal |  We are part of a group of clinicians, scientists, and patient advocates who have lodged a formal “Citizen Petition” with the United States Food and Drug Administration (FDA), asking the agency to delay any consideration of a “full approval” of a covid-19 vaccine. The message of our petition is “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.” We believe the existing evidence base—both pre- and post-authorization—is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.

The covid-19 vaccines in widespread use have emergency authorizations (EUA), not actual approvals, a crucial regulatory distinction that reflects major differences in the level of regulatory scrutiny and certainty about the risk-benefit balance.

Our petition doesn’t argue that risks outweigh benefits—or that benefits outweigh risks. Rather, we focus on methods and processes, outlining the many remaining unknowns about safety and effectiveness—and suggest the kinds of studies needed to address the open questions.

If the FDA listens to us, they won’t give serious consideration to approving a covid-19 vaccine until 2022. Our first request is that the FDA require manufacturers to submit data from completed Phase III trials—not interim results. Trials by vaccine manufacturers were designed to follow participants for two years, and should be completed before they are evaluated for full approval, even if they are now unblinded and lack placebo groups. These Phase III trials are not simply efficacy studies; they also are necessary and important safety studies (as the study titles say), and all collected data remain invaluable.

We also call on FDA to require a more thorough assessment of spike proteins produced in-situ by the body following vaccination—including studies on their full biodistribution, pharmacokinetics, and tissue-specific toxicities. We ask the FDA to demand manufacturers complete proper biodistribution studies that would be expected of any new drug and request additional studies to better understand the implications of mRNA translation in distant tissues. We call on data demonstrating a thorough investigation of all serious adverse events reported to pharmacovigilance systems, carried out by independent, impartial individuals, and for safety data from individuals receiving more than two vaccine doses, in consideration of plans for future booster shots. We ask the FDA to request necessary studies in specific populations, including those previously infected with SARS-CoV-2, pediatric subjects, and those with immunological or other underlying medical complexities. Given the nature of the novel vaccine platforms, our petition asks for experts in gene therapy to be included among the external committee advising the FDA.

These are several of our major requests. The petition has been signed by a group of 27 clinicians, researchers, and consumer advocates with diverse experiences and thoughts about the pandemic. We all agree that there remain many open, unanswered questions surrounding the efficacy and safety of covid-19 vaccines that must be answered before the FDA gives serious consideration to granting full approval.