Friday, November 18, 2022

Drug offers hope in fight against Covid

At last: Immunotherapy for Covid. Immunotherapy saved me from stomach cancer: Completely wiped it out

Australian scientists have taken a critical step towards developing a one-stop Covid-19 therapy to combat existing and future strains of the virus.

In what it described as a “very significant” development, a team at Brisbane’s Translational ­Research Institute repurposed an existing oral drug that acts on cholesterol receptors, activating the body’s immune response ­rather than attacking the virus. The drug reduces inflammation in the lungs and associated coughing and breathing difficulties.

A study involving mice, published in the European Respiratory Journal, found the virus that causes Covid-19, SARS-CoV-2, triggered the production of ­oxidised cholesterols.

In response, the body creates immune cells to fight the infection, which have a cholesterol-sensing receptor named GPR183. While white blood cells are ­important to fight the infection, having an excess of a particular type called macrophages is a hallmark of severe Covid-19.

Recent tests on infected mice found the drug was effective in blocking the cholesterol receptors and reduced the number of macrophages cells within the lungs. It also reduced the mice’s viral load. Associate professor Katharina Ronacher realised the significance of oxidised cholesterols in respiratory illnesses while ­researching tuberculosis six years ago while in South Africa. When she realised the two viruses worked in similar ways, she tested her findings on Covid-19.

“It was actually initially very intuitive,” Professor Ronacher said. “Once we understood the mechanism and studied this in mice infected with tuberculosis first, I knew it would actually work well in Covid-19.”

She said the reason the ­discovery was so exciting was ­because the cholesterol receptor had never before been targeted with a drug. “It’s a completely new therapy and this really opens up the research in other areas,” she said.

The study took two groups of mice infected with Covid-19 and gave one group the drug and the other a placebo. Mice given the treatment lost less weight, ­appeared happier and had less ­inflammation in the lungs. ­Researchers were also surprised to find the medication also caused them to carry less of the virus.

The treatments would not need to target a specific Covid-19 variant as it worked to trigger the immune response of the body rather than target the virus itself like typical antivirals.

With the fourth wave of Covid-19 expected to hit over the Christmas period, Professor ­Ronacher said it is important to have alternative treatments.

“At any time, a new variant can emerge that can be so different that our current immunity does not really help us much, and vaccines don’t really help much, then we definitely need other drugs,” she said.

“We also need drugs that are not necessarily antiviral, because viruses produce resistance to those back very quickly. We really need host-directed therapies … like a type of immune therapy.”

Patients with other severe respiratory illnesses and transplant recipients could also find relief with the drug, although this has not been tested.

“It has really far-reaching ­implications,” Professor Ron­acher said.

The study was a collaboration between Mater Research, the University of Queensland and the University of Copenhagen, and was funded by the Mater Foundation, the Australian Infectious Disease Research Centre and Diabetes Australia.

Human clinical trials have yet to be locked it, with more funding needed.


Novak’s mandate: How dangerous are the vaccines?

This week, Labor immigration minister Andrew Giles quietly confirmed on Tuesday 15 November that the ban on Novak (No Vax) Djokovic would be dropped but refused to comment ‘on privacy grounds’. Whose privacy? Presumably that of the minister, frightened of a backlash from zero-Covidian zealots. So far, it hasn’t materialised.

The tide is slowly turning in Australia. The latest True North Strategy Compass polling of Australians, released on 16 November, showed that despite the fact that 95 per cent of Australians over the age 18 had been vaccinated, almost half of all Australians surveyed, 46 per cent, said governments should not have the power to mandate vaccines and 8 per cent of those who were vaccinated regret it. On a national scale, that would equate to around 1.5 million Australians over the age of 18. Of those who got vaccinated most (48 per cent) said they were glad they did it because it allowed them to escape lockdown sooner. Only 44 per cent were glad because they didn’t get Covid.

The polling comes as the Australian Technical Advisory Group on Immunisation (ATAGI) quietly confirmed for the first time on 12 November that it was unlikely to approve another booster for people under 30 due to the increased risk of myocarditis and the fact that there would only be a ‘minimal’ reduction in transmission from a fifth jab. ATAGI member Professor Allan Cheng said ‘the more doses you get, the less benefit you derive from them and then we start to worry about causing side effects’. That’s a rare confession.

Woolworths, Australia’s largest retailer, which employs 180,000 people, announced on 15 November that it would end its vaccine mandates for staff effective 22 November.

But Australian Football League star and nurse Deni Varnhagen and fellow nurse Courtney Millington have lost their second legal challenge to the South Australian vaccine mandate for healthcare workers and their application to appeal the decision was dismissed.

Refusing to hire unvaccinated nurses is testimony to idiocy of the Australian health establishment which has belatedly admitted that vaccination doesn’t stop transmission and infection provides protection. So why persist with a mandate when the Australian Nursing and Midwifery Federation says there is a nationwide shortage of at least 8,000 nurses?

Varnhagen who was working in intensive care and has just given birth to a baby girl was particularly concerned about the impact of the vaccine on her fertility. She is not alone.

In the US, on 10 November Dr James Thorp, an obstetrician gynaecologist with over 40 years of experience including on the board of the Society of Maternal Foetal Medicine and the American Board of Obstetrics and Gynaecology, author of over 200 publications and a reviewer for major medical journals, wrote that Covid vaccinations are ‘the greatest disaster in the history of obstetrics and all of medicine’, should never have been used in pregnancy and were promoted unlawfully, with ‘falsified data’. He notes that it was known as early as 2012 that lipid nanoparticles concentrate in the ovaries of rats, that in the Pfizer trial on rats, vaccine concentrated in the ovaries 118-fold in 48 hours and may permanently damage the human genome for multiple generations. Thorp writes that he has witnessed a dramatic rise in foetal morbidity, malformations and mortality since vaccination commenced, a 75-fold increase in miscarriages and a 12,000-fold increase in menstrual abnormalities.

In France, Mélodie Feron has formed a group of 10,000 women called ‘Where’s my cycle’. She organised a rally in Paris attended by Dr. Laurence Kayser, a Belgian gynaecologist who told investigative journalist Mary Beth Pfeiffer that, ‘The injections didn’t create a new disease, they revealed… dormant pathologies, and allowed them to explode…’. In October, a committee of the European Medicines Agency recommended that heavy menstrual bleeding in menstruation be acknowledged as a possible side effect of mRNA vaccines.

Dr Kimberly Biss, an obstetrician gynaecologist in Florida, said in October that since the vaccine rollout she has seen a 50 per cent rise in infertility and miscarriages and a 25 per cent increase in abnormal Pap smears and irregular cervical malignancies.

Michelle Gershman, a whistleblower nurse in Fresno California reported an increase at her hospital in stillbirths after 20 weeks (foetal demise) from one to two every two or three months to 22 in July and 22 in August. Gershman released an email she received from the hospital which said stillbirths were projected to increase stipulating babies must be put in a white bucket and adding callously, ‘I know that it feels disrespectful to many of you to pour a bottle of saline over the baby, so you can wrap the baby in a saline soaked Chux if it feels better to you.’

Is it happening in Australia? The Australian Bureau of Statistics won’t release data on births for 2022 until December. So far, the Therapeutic Goods Administration has received more than 5,390 reports of menstrual disorders, 891 incomplete abortions, 844 spontaneous abortions, 235 reports of premature babies of whom 11 died, 176 foetal deaths, 88 cases of foetal distress, four of whom died, 90 stillbirths, 88 cases of multiple congenital abnormalities of whom 11 died, 62 cases of congenital heart disease of whom 10 died. The TGA says none are related to the Covid vaccines although it does admit that at least 14 Australians are likely to have been killed by the vaccines and at least 700 hundred injured by myocarditis.

Vaccine injuries are still a taboo topic in Australia. The federal government has only offered a maximum of $20,000 compensation for vaccine injuries but it will cover funeral costs. The October budget revealed the scheme has paid out less than $1 million but that is projected to increase to $76.9 million next year, the equivalent of 3,845 claims at the maximum rate. That is not going to be the end of it. So far there have been 136,529 reports of adverse events including 946 deaths, more than any other vaccine in history. In the absence of any longterm safety data, or evidence of efficacy, that should be reason enough to end the vaccine mandates.

Don’t hold your breath.




Thursday, November 17, 2022

Another unhelpful study of Ivermectin

Once again we have a study that fails to heed the stricture that Ivermectim has to be administered immediately symptoms emerge. Giving it up to 7 days later is pointless and proves nothng. Journal article below

Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate COVID-19 and Comorbidities (The I-TECH Study)

Question: Does adding ivermectin, an inexpensive and widely available antiparasitic drug, to the standard of care reduce the risk of severe disease in patients with COVID-19 and comorbidities?

Findings: In this open-label randomized clinical trial of high-risk patients with COVID-19 in Malaysia, a 5-day course of oral ivermectin administered during the first week of illness did not reduce the risk of developing severe disease compared with standard of care alone.

Meaning: The study findings do not support the use of ivermectin for patients with COVID-19.


Importance: Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19. Evidence-based data to recommend either for or against the use of ivermectin are needed.

Objective: To determine the efficacy of ivermectin in preventing progression to severe disease among high-risk patients with COVID-19.

Design, Setting, and Participants: The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was an open-label randomized clinical trial conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021. Within the first week of patients’ symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease.

Interventions: Patients were randomized in a 1:1 ratio to receive either oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n = 241) or standard of care alone (n = 249). The standard of care consisted of symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging.

Main Outcomes and Measures: The primary outcome was the proportion of patients who progressed to severe disease, defined as the hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation of 95% or higher. Secondary outcomes of the trial included the rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events.

Results: Among 490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80; P = .25). For all prespecified secondary outcomes, there were no significant differences between groups. Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09). The most common adverse event reported was diarrhea (14 [5.8%] in the ivermectin group and 4 [1.6%] in the control group).

Conclusions and Relevance: In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19.


Unjustifiable vaccine mandates did a lot of harm in Australia

In the 1980s movie Rain Man, the autistic Dustin Hoffman reliably informed Tom Cruise that Qantas was the safest airline in the world. Indeed, our national carrier has safely transported generations of Aussies around the world. The ‘flying kangaroo’ is our de facto international mascot and one of our most respected enterprises. Yet the ‘spirit of Australia’ now resides in a man who likes to tell members of the Australian public to ‘eff off’.

This occurred the other day when a disgruntled former employee attempted to ask Qantas CEO Alan Joyce about the vaccine mandates still in place for the airline’s employees.

During the same-sex marriage debate, Mr Joyce developed a taste for political campaigning and even encouraged people travelling on Qantas to wear a black ring on their finger to show their support for same-sex marriage – presumably so cabin crew could easily distinguish between those who were morally superior on supporting LGBT issues and those who were not. One Anglican archbishop complained that this sort of campaign was nothing short of corporate bullying of everyday Australians.

At the time Peter Dutton also maintained that it was completely unacceptable for Mr Joyce to use the Qantas brand in this way, saying, ‘Don’t use an iconic brand and the might of a multi-billion-dollar business on issues best left to the judgements of individuals….’

And that is the point. Whether it is political or cultural issues or medical interventions, the same principle should be true in a democracy: corporations and businesses should wherever possible leave judgment on non-corporate matters to the individual. But instead, Covid provided many corporations the opportunity to behave like the worst schoolyard bullies – imposing mandates and restrictions on loyal staff and customers despite then prime minister Scott Morrison insisting that there were no vaccine mandates in this country and that companies could only apply mandates that were ‘reasonable’.

Coerced vaccination is offensive and wrong under any circumstances. And the sort of draconian mass mandates imposed by Qantas, Woolworths and many other corporations were certainly not ‘reasonable’.

As we now know, and many writers in this magazine anticipated, the vaccines do not and never did protect other people from catching the coronavirus. By definition, all compulsory vaccine mandates and restrictions – which potentially damaged people’s mental health or income yet did not stop transmission – were futile and therefore unreasonable.

Many loyal long-serving employees of these companies had their lives, careers and livelihoods completely turned upside down. Ex-Qantas pilot Graham Hood who was forced to lose his career thanks to Mr Joyce’s unreasonable mandate was one, Alan Dana at Jetstar another. There were many, many others.

Woolworths appointed its own chief medical officer in August 2020 to ‘provide expert medical advice to help shape policies’ around Covid. In October last year, Woolies implemented a mandatory vaccination policy similar to that of Qantas and other large firms. At the time their chief medical officer stated that, ‘A vaccinated team member is far less likely to get Covid, much less likely to pass it on [our italics] and also significantly less likely to become seriously ill.’

But that was simply untrue. As was revealed in a recent article by the left-leaning Washington Post, the Biden administration knew in the early northern summer of 2021 – several months prior to that statement – that ‘the vaccines did a far worse job of blocking infection than originally expected.’ Similarly, Pfizer have also admitted that they never tested the vaccines for immunistation.

So Woolworths need to explain who specifically informed or advised them that the vaccines did stop transmission? As with so many other companies, where did this advice come from and what was it based on?

Furthermore, what steps were taken by each individual CEO, health officer or HR officer to verify that that information was factually correct before forcing people to lose their jobs because of an unnecessary mandate? Wasn’t there a duty of care to the mental health and wellbeing of all those individuals who lost their jobs because of reluctance to take the jab? A reluctance that with each passing day looks more and more understandable.

Indeed, read Rebecca Weisser in this week’s magazine on some of the disturbing questions that are now surfacing around issues of women’s reproductive health and potential vaccine injuries.

All of which is why we need a royal commission into the abuse of political and corporate power during Covid


Bivalent Vaccines probably useless

The US government vaccine program led by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) selected most recently mRNA booster vaccines that contained genetic code for the original (long extinct) Wuhan wild-type strain (50%) and Omicron BA4/BA5 subvariant (50%) produced by both Pfizer and Moderna.

These products were not only purchased but also authorized on an emergency basis and distributed on the market, with only preclinical animal study data as well as immune-bridging data. The FDA who is conflicted as a sponsor of the vaccine program authorized the products based upon a surrogate antibody elevation against BA4/BA5. Within a few short months, as depicted by the CDC Nowcast system, BA4/BA5 are on their way out giving way to BQ.1 and BQ1.1.[i]

This has been an accurate and helpful part of the CDC’s effort to inform the public and scientists on the outbreak: “To identify and track SARS-CoV-2 variants, CDC uses genomic surveillance. CDC's national genomic surveillance system collects SARS-CoV-2 specimens for sequencing through the National SARS-CoV-2 Strain Surveillance (NS3) program, as well as SARS-CoV-2 sequences generated by commercial or academic laboratories contracted by CDC and state or local public health laboratories.

Virus genetic sequences are analyzed and classified as a particular variant. The proportion of variants in a population are calculated nationally, by HHS region, and by jurisdiction. The thousands of sequences analyzed every week through CDC’s national genomic sequencing and bioinformatics efforts fuel the comprehensive and population-based U.S. surveillance system established to identify and monitor the spread of variants.”

So Nowcast is telling us the emerging dominant strains are BQ.1 and BQ.1.1 subvariants, known to have enhanced ability to fuse with the human ACE-2 receptor, dictated by the N460K mutation which is the principle site for antibody neutralization.[ii]

Qu et al. have recently demonstrated that sera from patients with BA4/BA5 had very poor antibody defenses against BQ.1 and BQ.1.1. The authors concluded: “The perpetual emergence of SARS-CoV-2 variants with enhanced immune escape continues to threaten public health. Monitoring the immune escape of emerging variants will be critical to improving mRNA vaccine reformulation, assessing new broader coronavirus vaccine candidates, as well as directing ongoing public health measures.”

Moderna conveniently just came out with a press release reported in this media that the novel booster in “exploratory analysis of approximately 40 participants using research assay, both bivalent vaccines demonstrates robust neutralizing activity against BQ.1.1…” However, Moderna's press release is in conflict with the findings of Qu et al., indicating that urgent research is needed with clinical outcomes to see of mRNA vaccines have any impact at all in patients with acute COVID-19.

But the release of these potent, gene therapy-based vaccines cannot be done through press release as a form of public health communique for vaccines that are already in circulation and promoted by regulators, public health agencies and health systems. This just isn’t the way drug and vaccine development are ethically done, at least not up until COVID-19. Declaring that the novel boosters elicit responses against the new variant in a 40-participant research assay tells us next to nothing.

All of this is a politically correct way of saying the new vaccines are essentially obsolete just a few months after their debut




Wednesday, November 16, 2022

Endocrinologist Forecasts More Hormone-Related Diseases as Spike Proteins Found to Deplete Endocrine ‘Reserves’

Dr. Flavio Cadegiani, a Brazilian endocrinologist, suspects that the worst has yet to come for spike protein-induced diseases in the endocrine system.

The endocrine system, colloquially known as the hormone system, is critical for our health. It regulates growth and development, mood, metabolism, reproduction, immunity, and functions of other organs through the secretion of hormones.

Hormones are one of the three biggest messengers in the body. Compared to the two other messengers—neurotransmitters and cytokines—hormones are slower in responding, and have systemic functions across the body rather than localized actions.

While cells can usually respond to neurotransmitters in milliseconds and cytokines in minutes to hours, cells that respond to hormones can take hours or even weeks.

Since hormones can have slow and systemic actions, a dysfunctional or damaged endocrine system will generally be slow in its symptom onset and recovery.

Studies have shown that spike proteins from COVID-19 infection and the vaccines can damage endocrine glands, including pituitary, thyroid, and adrenal glands, as well as reproductive organs, and many more.

Cadegiani raised a concern that the slower onset of endocrine pathologies may pose difficulties in diagnosis and treatment.

Depletion of Hormonal Reserves

Endocrine pathologies can take longer to become apparent because endocrine glands have “reserves,” according to Cadegiani.

“What we’re going to see in the future [for endocrine diseases] is a little bit different from the other fields, because glands have reserves and the decrease of the reserve will not be clinically seen right now, but it may be in the future,” said Cadegiani at a Front Line COVID-19 Critical Care Alliance (FLCCC) conference in Kissimmee, Florida.

Therefore, affected individuals may show no symptoms until their reserves have been depleted.

Cadegiani said that most of his concerns for the future are speculative and based his own clinical observations. But since the pandemic and the administration of COVID-19 vaccines began, there have been increasing reports that implicate endocrine pathologies.

Hormones regulate the entire body, so once the reserved are depleted and underlying endocrine pathologies are unmasked, there may be cases of systemic dysregulations.

Endocrine glands control the function of many organs across the body, and each endocrine organ is also connected through a feedback loop, also known as a hormonal axis.

At the top of this chain is the hypothalamus, which is a diamond structure in the brain and acts as a master switchboard. It sends messages to the pituitary glands, a small, oval structure tucked behind the nose.

The pituitary gland is colloquially known as the master gland; it regulates other endocrine organs, together with the hypothalamus forming hormonal axes.

The pituitary gland is part of the hypothalamic-pituitary-gonadal (HPG) axis which regulates the reproductive organs including the ovaries and the testes. In females, it is responsible for regulating the release of ovarian hormones as part of the menstrual cycle, and in males the axis regulates spermatogenesis.

The hypothalamic-pituitary-adrenal (HPA) axis is a neuroendocrine axis that mediates the adrenal glands, an organ that produce hormones that trigger the fight or flight response. The fight or flight process is a stress response that occurs in response to harmful threats, and can reduce metabolism, suppress immune, as well as activate the sympathetic nervous system.

Another major axis is the hypothalamic-pituitary-thyroid (HPT) axis. This regulates the thyroids and the hormones it secretes. Thyroid hormones are essential for biological functions of growth, regulation of the cardiovascular system, bone replacement, liver function, and metabolism.

How Spike Proteins Target the Endocrine System

The spike protein is the most toxic part of the SARS-CoV-2 virus. Studies on people with long COVID and post-vaccine symptoms often detected spike protein presence months or even a year after the exposure.

Spike protein particularly favors tissues and organs that express ACE2 and CD147 receptors. Many endocrine glands display ACE2 receptors, including the pancreas, thyroid, testes, ovaries, adrenal glands, and the pituitary gland, making the endocrine system particularly vulnerable to SARS-CoV-2.

The key driver behind spike protein-induced disease is inflammation.

Upon entering cells, spike protein can activate pro-inflammatory pathways by inducing DNA damage, inhibiting DNA repair, causing stress to the cell’s mitochondria, which is critical for cell energy production, and many more. All of this lead to cellular stress, injury, and possible cell death.

When many cells are affected, it can cause problems in tissues and organs, affecting individual endocrine glands and the system.

Spike proteins also inhibit autophagy, the cellular “recycling system,” thereby preventing the cells from clearing the toxic protein out, leading to prolonged damage.

Spike proteins may also contribute to autoimmunity. Since it shares many similarities with common human tissues and proteins—known as “molecular mimicry”—it has the potential to cause immune cells to mount an attack against the body’s own cells and organs, leading to endocrine damage.

Several studies have reported on endocrine pathologies following COVID-19, though data on the exact damage is still emerging.


Are Behavioral Changes Due to Mass Vaccination Behind Fertility Drop in Germany & Sweden? Study Suggests So

Reports of wide-scale fertility declines over the past couple of years have raised concerns about possible causes, including mass COVID-19 vaccination. This media reported on a specific example in Zurich, Switzerland, and broader trends in both Germany and Sweden, while journalist Mary Beth Pfeiffer just investigated the topic.

The research institute of the German federal government, managed under the Federal Ministry of the Interior and tasked with providing scientific advice to the federal government on issues relating to demography and demographic trends in fertility, nuptiality, morality, aging, migration, and other global issues, recently released its disturbing report suggesting dramatic declines which this media reviews in more detail.

The Federal Institute of Population Research led by Dr. Martin Bujard, Deputy Director at the Federal Institute for Population Research and supported by Gunnar Andersson, a Swedish fertility research expert from Stockholm University, found a fertility decline markedly different than an initial fertility trend in Southern Europe during the first stages of the pandemic. Seasonally adjusted monthly Total Fertility Rates (TFR) dropped 14% in Germany and 10% in Sweden in 2022.

After analyzing the trend against various categories from unemployment, infection rates or COVID-19 deaths, the authors report that for the two nations there appears a “strong association between the onset of vaccination programs and the fertility decline nine months after this onset.” Calling out the fertility declines in the first months of 2022 in both Germany and Sweden as “remarkable,” they argue that “common explanations of fertility during the pandemic do not apply in its aftermath.”

Assuming that vaccination is correlated, what's the cause—behavioral change or worse, a real-world impact of the vaccines themselves? The authors of this recent study titled “Fertility declines near the end of the COVID-19 pandemic: Evidence of the 2022 birth declines in Germany and Sweden” suggest the former—behavioral changes.

Referred to some by the ‘baby bust,” the report out of Germany most definitely offers novel information as described by the authors. A behavioral change in the populations of Germany and Sweden could have very well led to the disturbing decline in TRF in both nations. The mass vaccination program became a center topic and discussion, and it’s likely that although continuously promoted by health authorities as safe and effective for all (including pregnant persons), people in both Germany and Sweden may have changed behavior during 2021 and into 2022.

That could be the explanation---and it would be one that would have far less ominous implications than another explanation—that the vaccines were directly causing the decline in TRF (instead of behavior associated with the vaccines).

With no birth declines in the first months of 2021, Germany experienced a small increase of about 2.9% in the total number of births in 2021 when compared to 2020. But new births plummeted by February and March 2022, representing a 14.3% and 13.7% drop respectively when comparing them to the previous months last year. When looking at a five-year average in Germany (2016-2020), they still found a notable 8.2% and 11.1 % decline in those first months of 2022.

The trends are comparable in Sweden and in the report, the data can be found in tables 1 and 2.


The authors note that the data is “preliminary” and subject to change. But they do emphasize that any change wouldn’t be substantial when considering the overall trend observed. Certain assumptions underlying seasonal adjustments could be challenged. The authors disclose that their summaries are in part, based on “descriptive associations” not accounting for individual-level characteristics as well as additional contextual elements that could have an impact on the data. Research factoring in individual-level data would offer better insight into the outcomes observed—the fertility declines. For example, a look at parent and non-parent households; socio-demographic elements, etc.




Tuesday, November 15, 2022

Deep In The Wombs of Women: The Hidden Harm of Covid Vaccines

Mary Beth Pfeiffer

On a bright October day in Paris, I attended an unusual event in a long reporting career: A rally, just a stone’s throw from Napoleon’s Tomb, at which women spoke about their periods.

Organized by a group called “Where’s my cycle,” the rally focused on intimate revelations: heavy bleeding, unprecedented pain, humiliation, and elemental physical changes. These symptoms began, not coincidentally, at the start of 2021, when women put out their arms and took, or were coerced by employers to take, covid-19 vaccinations.

The 300 women, and men, at this rally—and the 10,000 that Oú est mon cycle represents—are fighting for basic expectations of life: a pain-free existence, a medical system they can trust, and the ability to bear children.

This was not just about inconvenience or embarrassment. It was about fertility.

Among the testimonials:

“I had a miscarriage in July 2021 [a month after the first vaccination]…I didn’t even know I was pregnant when I took my first dose.”

“My second dose was done at the same time that I became pregnant…this pregnancy [after bearing two healthy babies] was dramatic with a chromosomal abnormality of the fetus, heart also. It ended with an IMG [Interruption Médicale de Grossesse, or medical termination of pregnancy].” A year later, “I took a smear and it turned out to be abnormal with the presence of pre-cancerous lesions.”

“My menstrual cycle is completely out of order. I have them randomly, once bleeding and the next time almost nothing, not to mention that I can no longer get pregnant.”

So far, the collective has received about 1,000 reports of concerning and bizarre abnormalities, like 20-year-olds in pre-menopause and 70-year-olds suddenly menstruating. The list of complaints is a veritable gynecological glossary of woe: amenorrhoea, menorrhagia, adenomyosis, endometriosis, polycystic ovary syndrome, miscarriage, and hysterectomy.

European Union overseers concluded in June that the complaints of these women had “no link” to the vaccines. It’s difficult to know how such conclusions are drawn, since data is scant on fertility issues and vaccines. The only completed pregnancy study, in a September vaccine risk plan posted by the EU, was performed on rats, while research on human beings is incomplete. That lack of evidence—for or against vaccination—was one of many reasons Oú est mon cycle demanded, in a fifteen-page letter in September, that the EU reconsider the risk of covid vaccines to women.

Nonetheless, the EU is recommending fourth boosters to women of all ages. To that, the three hundred people at the rally had one word: “No.”

Dormant pathologies explode

Dr. Laurence Kayser, a gynecologist from Belgium, attended the rally as one of few doctors speaking out about the denial faced by women who report gynecological problems. Indeed, women said doctors routinely told them, when they questioned the inoculations, that they needed mental health care or were anxious. Rejected was any suggestion that vaccination was to blame.

Since the vaccine was rolled out, Kayser says she’s seen more miscarriages, babies too small for birth age, and rapidly growing fibroids that she said were unusual in shape and composition, “partially watery, necrotic.” She treated a 17-year-old whose period stopped for eleven months after vaccinations and may be infertile.

“The injections didn’t create a new disease, no,” she told me. “They revealed the frailties of people, the dormant pathologies, and allowed them to explode in broad daylight. You see more diseases, more often and more quickly than before.”

People like Kayser, whose Twitter profile describes her as a “rebellious…independent thinker,” have paid dearly for bucking covid directives. At a demonstration last January 30, she criticized doctors who failed to treat covid early, said masks do not work, and said that vaccines have side effects. For that, she faces professional charges and may lose her medical license. Nonetheless, she told me, “I’m in a good way. I’m not afraid about losing my job.”

Typhaine Pinsolle, a PhD microbiologist, lost her job in a hospital laboratory for refusing to be vaccinated. First, she saw injuries around her: four senior doctors hospitalized in ICU a week after their first shots; a 23-year-old colleague “blue from feet to head” after injection, and many women with “hemorrhagic periods.” Then, in May, her mother, 78 and otherwise healthy, died weeks after receiving the vaccine from a blood clot in the brain.

“It killed my mother,” she told me. But she had long before decided to refuse vaccines that were, to her, “scientific nonsense.” Her rationales? Her laboratory work showed robust antibodies after infection, but natural immunity was discounted. The spike protein as the foundation of vaccines was toxic. She worked closely with patients and took hydroxychloroquine; she had not gotten covid. And a hematologist advised against vaccination for health reasons, which her employer would not honor.

At the Oú mon cycle rally, Pinsolle read the emotional testimony of a friend whose covid vaccination caused a river of bleeding, a sudden fibroid that her doctor insisted was normal, thickening of the uterus and, finally, a recommended hysterectomy. “I blame the people who injected me with the anti-covid products,” the friend, Annelise Bocquet, wrote after I contacted her via email. “I believe that every caregiver, doctor or nurse (and even pharmacist), is responsible for the medical acts they perform.”

Bocquet holds a PhD in biology and, should surgery take place, said she will analyze “my damaged tissue” to look for key markers of inflammation in order to establish, or rule out, a link to vaccination. “I can’t understand why no team of scientists, nor high-ranking doctor, tries to determine the pathophysiological mechanisms induced by the injections,” she wrote.

Alexandra Henrion-Caude, a PhD geneticist for seventeen years who spoke at the rally, said she warned of infertility from the start, knowing from SARS-CoV-1 that “the spike went to the testes, placenta, and some to the ovary.”

“I believe in the therapeutic potential of RNA, relevant to people who are at risk,” she told me. “It was mad to give it to people when we knew so little about them.” Despite an Eisenhower fellowship and twelve years of research in mRNA, she has been censored by Facebook and LinkedIn, along with others who disagree.

The abnormal normalized

Changes in the cycle that governs human reproduction have been documented in recent months in several post-covid-vaccination studies. A July study in Science Advances reported “breakthrough bleeding” in 42 percent of women with regular periods, 71 percent on birth control, and 66 percent who were post-menopausal. Nonetheless, it concluded the changes were “not uncommon or dangerous.”

Another study, in Obstetrics & Gynecology found what the National Institutes of Health called a “small, temporary” increase—less than one day in the overall cycle length—in 6.2 percent of vaccinated women. A third study, in British Medical Journal, also found a one-day extension in women’s cycles, which it called “small and likely temporary.” A carefully worded NIH post assures women that the “normal” changes they may experience should not feed “vaccine hesitancy.”

Mélodie Feron, the rally organizer, argues that such conclusions are flawed because they excluded many women—on hormonal therapy, in menopause, or suffering other common problems. “What about endometriosis?” she asked.

Like Dr. Henrion-Caude, she sees pervasive censorship. “As long as you are talking about the vaccination, you are shadow banned,” she said, referring to suppression of information that does not support established covid doctrine. “It’s a very bad moment for women.”

A French Parliament report from June concluded that dismissing such reported menstrual irregularities as “frequent, self-limiting and…due to stress is not acceptable.”

“Given their volume and therefore the unlikely nature of a temporal coincidence,” the report stated, “…it is very surprising that they are not already considered as a proven adverse effect of the vaccine.”

That may be changing. In late October, a committee of the European Medicines Agency recommended that heavy bleeding in menstruation be added as a potential side effect of Moderna and Pfizer covid vaccines.

Quiet nurseries, empty wombs

The experiences of these French women may explain, at least in part, a concerning trend in countries around the world: Fewer babies are being born or born alive.

In Scotland, a “significant” increase in stillbirths in September of 2021 and March of 2022 led to a government investigation. Inexplicably, the probe ruled out any the role of covid vaccines, without even checking whether mothers were vaccinated.

In Zurich, Switzerland, births declined 21 percent in the first five months of 2022 compared to a year earlier, according to the newspaper Inside Paradeplatz. When the newspaper studied five years of pre-pandemic data, a second article found a decline of 31 percent in June 2022. Nearly 600 fewer babies were born in the first half of 2022 compared to the average for 2015 to 2019.

“This is a magnitude 10 earthquake,” the article stated. The headline: “Baby crash in the city of Zurich is accelerating massively.”

Unlike the Swiss newspaper report, a new research report from Europe points to Covid vaccinations as a factor in declining birthrates in Germany and Sweden. In early 2022, the fertility rate dropped 14 percent and 10 percent, respectively, in those countries.

Performed by the (German) Federal Institute for Population Research and Stockholm University, the analysis, using birth data since 2000, found a “strong association between the onset of vaccination programmes and the fertility decline nine months after of this onset.” It ruled out at three other possible factors: covid infections, covid deaths and unemployment.

“The fertility decline in the first months of 2022 in Germany and Sweden is remarkable,” the study said.

The media: silence

Similar to reports worldwide of excess deaths, which I wrote about in September, little media attention is being paid to fertility developments. Instead, they are informed often by anecdotal reports.

In Florida, Dr. Kimberly Biss, an obstetrician, states in a widely shared video: “I can definitely say since the vaccine rollout started, we have seen in our practice a decrease in new OB numbers, which would be infertility by about 50 percent. We’ve also seen an increase in miscarriage rates by about 50 percent. And I would say there’s probably about a 25 percent increase in abnormal pap smears as well as cervical malignancies in our area.” (I reached out to Dr. Biss but did not hear back.)

In California, a post-partum nurse from a major hospital center, Michelle Gershman, shared a September 8 email to maternity staff describing record numbers of fetal deaths.

“Well, it seems like the increase of demise patients that we are seeing is going to continue,” the email began. “There were 22 demises in August, which ties the record number of demises in July 2021 and so far in September there have been 7 and it’s only the 8th day of the month.”

“I’m blown away because this is not natural, this should not be happening,” Gershman said in an interview with Del Bigtree on The Highwire. Gershman said many women had been vaccinated shortly before giving birth, often early.

The timing of these deaths indisputably coincides with vaccine rollout, which began in December 2020. But there may be other factors driving these trends, such as covid itself, socioeconomics, or lockdown effects. Not all studies agree on declines in birthrates. An Australian study showed fewer stillbirths among vaccinated women, who tended to be more well-to-do, less apt to smoke, and were more often English-speaking and older first-time mothers.

The issue, amid denial and censorship, is whether the right questions are even being asked. Will women who question vaccines be heard?

“They are in the refusal mode to debate,” said Henrion-Caude, the geneticist at the Paris rally. “It’s never good, especially in science. It’s the path to any extreme.”

“The most awful thing is people have been suffering and dying unnecessarily,” she continued. “I have a strong sadness about this.”




Monday, November 14, 2022

Pfizer-BioNTech COVID-19 Vaccine Led to Multiple Cranial Nerve Palsies: Case Report in Romania

Late last year, physician-scientists associated with the Carol Davila University of Medicine and Pharmacy and the National Institute of Neurology and Neurovascular Diseases in Bucharest Romania reported on a post-COVID-19 vaccine injury via a case report involving a 29-year-old white male who had no known history presenting Bell’s palsy and diplopia.

Represented by corresponding author Maria Mirabela Manea, the Romanian medical research group reported that his symptoms commenced just 6 days after receiving the first dose of the Pfizer-BioNTech mRNA-based COVID-19 vaccine. With no disclosed allergic history, the doctors secured a signed patient consent to publish the case report using CARE reporting guidelines.

The Case Report

The doctors conducted a gadolinium-enhanced MRI which presented enhancement in the left facial, trigeminal and oculomotor nerves—this observation only persisted upon repeated examination. While cerebrospinal fluid analysis was done initially and one month after the start of the patient’s symptoms, the study authors found no signs of inflammation.

Reviewing a list of possible causes, the team eliminated one after the other while treating the patient with high doses of corticosteroids with an improvement in symptoms.


The BNT162b2 Pfizer-BioNTech vaccine the researchers determined was the cause of the enhancement observed in the left facial, trigeminal, and oculomotor nerves.


Part of the nervous system responsible for sending pain, touch and temperature sensations from one’s face to the brain, this large three-part nerve in the head powers significant neurological function. The mandibular nerve, a section, helps motor function to help chew and swallow.

The third cranial nerve (CN III), the oculomotor nerve supports the movement of the eye muscles, constriction of the pupil, eye focus as well as positioning of the upper eyelid. This nerve works with others to control eye movements while supporting sensory functioning.

Importantly when this case report was published in the journal Activa Neurological Scandinavica, the Romania authors cited four cases of Bell’s palsy occurring 3, 9, 37 and 48 days post the vaccine as reported by the FDA Vaccines and Related Biological Products Advisory Committee, December 10, 2020 Meeting Briefing Document—FDA 2020.

Additionally, the authors pointed out:

“Several cases are reported of peripheral facial palsy after immunization with PBV [Pfizer-BioNTech vaccine]: a patient with two episodes of contralateral Bell's palsies arising shortly after inoculation with the first and second dose of the PBV and other cases of unilateral facial palsy occurring 36 h after the second dose. Another published case involved abducens nerve palsy 2 day after PBV.”

The study authors reported on “the strength of this study” based on the “thorough work-up performed which enabled the exclusion of other potential causes.” They do acknowledge how this was a first of its kind involving multiple cranial neuropathies after SARS-CoV-2 infection.


The doctors overseeing this case report acknowledge the “efficacy and safety of these novel vaccines…” but emphasize the importance of “the monitoring period for the appearance of post-vaccine complications” currently limited to just “a few months.” Their point: “neurological side effects require close observation.”

About Carol Davila University of Medicine and Pharmacy
Based in Bucharest, Romania: Carol Davila University of Medicine and Pharmacy is known as UMFCD and serves as a vital public health sciences university in this major city of Romania. UMFCD represents one of the largest and oldest institutions in Romania.


Vaccine Expert Skeptical About Bivalent Booster

Paul Offit is a well-known pediatrician and researcher often seen on network television for his expertise on vaccines. TrialSite News has cited Offit for his known expertise specifically on vaccines, as he started to question the push for the bivalent Omicron BA.4/BA.5 COVID-19 vaccine booster.

Increasingly outspoken, it’s not too surprising that mainstream media such as The Philadelphia Inquirer features his growing restless point of view on the COVID-19 vaccination program, not to mention his skepticism of the new bivalent Covid vaccine and the government’s questionable response. Offit understands that the government’s obsession with vaccine hesitancy, and avoiding it, may lead to even more resistance.


According to Offit, who is on the independent Food and Drug Administration’s (FDA) advisory board regarding which vaccines the public should receive, the bivalent shot is unnecessary. “This product was grossly oversold,” says Offit, who was in the minority when the FDA Vaccine and Related Biologics Committee (VBRAC) recommended the booster in June with a 19-2 vote.

Recently, on the record, Offit declared :

“We have to be careful when we get in front of the American public and try to sell this vaccine as something that’s significantly better when all the evidence we have so far doesn’t support that.”

The Philadelphia-based physician-scientist grows more and more frustrated with the government's handling of the pandemic. Offit believes a person who has been fully vaccinated and boosted gets little benefit from additional Covid jabs. And Offit isn’t only a vaccine advocate, he’s also developed them. He was part of a team that developed a vaccine for rotavirus which is now given to every infant in the United States and has been accepted worldwide.

He’s also a founder and co-director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. Keeping this in mind, Offit isn’t completely against the bivalent jab, he thinks it should be given to vaccinated people 75 and older and those who are immunocompromised, but not to children ages 5 and above.

Really, he seems to be moving away from the pandemic one-size-fits-all approach that the government, academia, health systems, and industry are all aligned to promote. For example, Offit emphasizes now a risk-based approach focusing on higher-risk individuals:

“The take-home lesson is the people who were in high-risk groups and benefit from booster doses as we enter this late fall and early winter – those who are immunocompromised, who have high-risk medical conditions, who are elderly — they should get this booster dose,” says Offit.

Concerned Decision Not Backed by Science

As reported by TrialSite, there were no clinical trials of the bivalent booster [at the time of release to the public], a fact not missed by Offit. He’s also concerned about the federal government making a decision about the vaccine when it’s not backed by what Offit calls “robust science”.

Why would the government authorize the booster without input from the FDA advisory committee—asks Offit. Comparing the approval of the bivalent vaccine with the Trump administration’s pressure on health agencies to approve the use of hydroxychloroquine as a treatment for Covid—essentially stating the Biden administration is politicizing the pandemic as much as the previous Trump administration, Offit declares, “It isn’t different.”

Importantly, Offit is concerned about losing the trust of the majority of the American public. After all, he is aware that even up until now, less than 9% of all persons across America eligible for the bivalent booster have stepped forward to get it.

Offit says…

“If you’re advocating for a position where the science doesn’t really support that position, then what happens is you lose trust.”

In an April 2022 article in the New England Journal of Medicine, Offit points to the Centers for Disease Control (CDC) as the main government body which must educate the public about the Covid vaccines and boosters. In the article, Offit says people are now confused about what it means to be “fully vaccinated” and also asserts boosters are not “risk-free.”


Australian actress reveals why she refused to get a Covid jab and how she knew she 'wouldn't get another TV job' because she dared to lash out at lockdown lunacy

Australian actress Isabel Lucas sparked widespread backlash in 2020 after coming out against vaccine mandates and lockdowns amid the Covid pandemic.

And now the former Home and Away star has opened up about her decision to jib the jab, admitting that she knew it was 'highly likely I won’t work for years if I share this'.

Speaking to Stellar magazine, the 37-year-old said that she had 'several' vaccines when she was growing up, but chose not to get vaccinated against Covid.

'For me, I appreciate, what might be right for you may not be right for me, but it’s not right that either of us are being stripped of the freedom to choose,' she explained.

'Our relationship with our body is very personal and it’s deeply complex and so are our choices, and we’re claiming to engage in conversations about inclusion and diversity – you know, gender, religion, sexuality, race – without allowing our beliefs or observations to be acknowledged,' she continued.

'The diversity of choice is yet to be included, in my experience.'

Last November, Isabel said that she was 'pro-choice' when it came to the Covid vaccine. She later clarified her remarks on Instagram, saying she has 'concerns around "mandatory" vaccination, not vaccination itself'.

At the time, the star joined hundreds of people at a rally to protest Australia's Covid-19 vaccine mandates at the New South Wales-Queensland border.

In 2020, Isabel hit headlines when she shared anti-vaccination views on Instagram while commenting on a post by controversial chef Pete Evans.

Throwing her support behind the former MKR judge, she wrote: 'Freedom of choice is every human's right. I don't trust the path of vaccination.'

She received widespread backlash for her stance, and as a result was dropped as an ambassador for the charity Plan International Australia, which ironically champions equal rights for young girls.

Isabel has a long history of activism dating back to 2007, when she and fellow actress Hayden Panettiere joined activists on surfboards to try and stop a pod of dolphins being slaughtered in Japan.

In 2020, Isabel also attended a 'peaceful' anti-5G protest in Byron Bay, marching from the Jing Organics health food store to the proposed location of a 5G tower.

The Sydney-born beauty got her big break in acting playing Tasha Andrews on Home and Away from 2003 to 2006.

From there, she found stardom in Hollywood in films like Transformers: Revenge of the Fallen, Daybreakers, and Red Dawn.

More recently, she played Samantha Cage in season two of the MacGyver TV reboot.

Isabel has since left Los Angeles and moved back to Australia to start a new life in Byron Bay




Sunday, November 13, 2022

‘Masks reduce racism’ study is latest sign US medical establishment is insanely, perilously woke

A new study in the New England Journal of Medicine purports to show that mask policies in schools work to contain COVID. But that’s not all: The authors conclude, “We believe that universal masking may be especially useful for mitigating effects of structural racism in schools, including potential deepening of educational inequities.”

Sure, masks help fix structural racism. Why not? And the next study will show masking fights climate change.

No, what this study shows is that much of the medical establishment continues to be intensely woke — and deeply dishonest because of it. Just as the “experts” told us gathering in crowds wasn’t OK in spring of 2020, but just weeks later protesting for Black Lives Matter somehow was.

This dishonesty is going to hurt us all for a long time.

As for this study specifically: It does not prove what the authors intended to. It’s just the latest in a push by agenda-driven scientists, and the media who love them, to get people back in masks.

The study centers on two Massachusetts school districts that didn’t remove their mask mandates as soon as the state allowed, in March 2022, but kept them until June. A few months later, they saw slightly lower COVID rates than the other districts.

It’s amazing that COVID could lay in wait like that, ready to punish those who behaved badly months earlier. What’s even more startling: COVID rates in all the schools were higher before anyone took off their mask — but that uncomfortable fact goes unmentioned in the write-up.

Plus, the study doesn’t look at actual mask use, just the mandates. Nor does it account for any differences in behavior, income level, lifestyles and so on. (Which also means it can’t show a thing about masks and “structural racism,” whatever that is anyway.)

Oh, and: It’s an “observational” study — the kind the left dismissed as irrelevant when we’d point out that New Mexico and next-door Utah had very similar COVID trajectories despite very different masking policies. Or that Europe largely didn’t mask kids in school at all but had similar or lower rates than we did. None of that counted.

Which didn’t stop The New York Times’ Roni Caryn Rabin from promoting the new study as “a so-called natural experiment” and breathlessly concluding, “The bottom line: Masking mandates were linked with significantly reduced numbers of Covid cases in schools.”

This is full-on nonsense. The mask mandates did no such thing. New Mexico-Utah and Europe are just part of the avalanche of “natural experiments” that prove it.

It’s pathetic that in November 2022, we have to keep pointing out the obvious — and that garbage science like this destroys everyone’s confidence in the medical field.

Pre-COVID, trusting the medical establishment was the default for all of us, most conservatives included. I’m firmly on the right, but when the health agencies told me in the early days of the pandemic that masking worked, I believed them.

Yet things quickly stopped making sense. Masking outside seemed ludicrous right off the bat, yet it would be a long time before these same health agencies admitted it.

Not until April 25, 2021, did Dr. Anthony Fauci say, “It’s common sense to know that the risk when you are outdoors, which we have been saying all along, is extremely low, and if you are vaccinated it’s even lower.”

He had not, actually, been saying that all along — and those of us who had that “common sense” got targeted and ridiculed for being “anti-science.”

It wasn’t that we stopped “believing” in masking. It’s that we were lied to and then realized it.

And “common sense” did not prevail at all in blue areas. My family moved to Florida in January 2022 because our kids were still forced to mask at their New York City public schools, outdoors.

These bonkers policies destroyed the trust of so many people, and it will be far more difficult than it seems to restore it.

Again, the problem isn’t just with masking. It’s that the medical establishment has gone fully woke. Wokeness goes hand-in-hand with forced conformity.

No one is allowed to step out of the woke lines — though those lines are free to shift at any time. It’s very Soviet.

Under those rules, you can’t be critical of even this cockamamie study; you’re supposed to see that someone squiggled some lines on a graph and pretends it “proves” something it clearly doesn’t because you need to support your “side.”

Inside the woke echo chamber, you even have to embrace insane ideas like “masking fights racism.”


CDC boss tests positive for Covid AGAIN: Rochelle Walensky is diagnosed with virus just days after being given the all-clear

The head of the US Center for Disease Control and Prevention (CDC) has tested positive for Covid again - after a course of Paxlovid saw her recover from the virus.

Dr Rochelle Walensky initially tested positive on October 21 and tested negative sometime in recent days after taking Pfizer's antiviral pill.

But the CDC said today her symptoms had returned and she was positive for the virus again on Sunday, October 30.

Paxlovid has proven effective at preventing serious disease and death among those at highest risk, including older people and those who are immune compromised.

Some who take the drug have experienced a return of symptoms after completing Paxlovid’s five-day regimen of pills.

These include President Joe Biden and Dr Anthony Fauci, who both also had their symptoms rebound after recovering using the drug.

Dr Walensky, 53, has received four doses of the COVID-19 vaccines, including a bivalent booster received on September 22.

The agency reports that she is suffering mild symptoms and will take part in her planned meeting virtually.

Walensky has received four shots of a COVID-19 vaccine up to this point.

Her agency has warned repeatedly for Americans to get the bivalent booster in an effort to stave off a winter surge of the virus.

Uptick has been low so far, though, with only 22.8million having received the shot in the two months it has been available.

Up to 5.3 per cent of people that use Paxlovid will experience a rebound of symptoms. These include President Biden, who first tested positive for the virus on July 21 of this year.

He would then leave isolation after two consecutive negative tests, but then test positive for the virus once again on July 30.

Dr Fauci experienced a similar phenomenon when he caught Covid in June. He said that he beat the virus after a five day course of the drug. After testing negative for three days, his symptoms then returned.

Both President Biden and Dr Fauci fully recovered from the virus in the following weeks.

Scientists have not been able to determine why this rebound occurs, but believe it could be tied to the way the drug functions.

Paxlovid fights Covid by preventing its replication. After a course of a drug is finished, their could still be some infected cells lingering in a person's body.

Once the Paxlovid is no longer around to stop replication, the virus is able to begin infected the body once more.


FDA Regulators: Peter Doshi has a Message for You

Peter Doshi, Ph.D., is most certainly an accomplished, influential figure in American biomedical research. A senior editor of the respected medical journal, The BMJ, as well as an associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, Dr. Doshi could be classified as a clinical investigator heavyweight in any biomedical scientist match. An expert in not only the drug approval process but also how risks and benefits associated with medicinal products are evaluated, communicated, and ultimately approved, the Baltimore-based academic researcher and scientist has dedicated his career to improving the process of generating medical evidence.

TrialSite has showcased his and colleagues’ recent investigations raising concerning questions about COVID-19 vaccine safety, particularly in low-risk cohorts.

Although the indisputable pedigree, intellectual firepower, and an extensive network of connections are all in place, Doshi’s critique of the COVID-19 vaccines is completely evaded by mainstream academia, regulators, and industry.

Why? Because there has been so much pressure built up from the highest circles of power in Washington to drive a mass vaccination program during the pandemic that a certain top-down, politically-inspired rigidity has compromised objectivity, veracity, and frankly, morals and ethics.

Those regulatory and compliance professionals charged with doing their job are, unfortunately, missing in action. Doshi, a moral operator who isn’t worried about McMansion payments or keeping up with the academic ‘Joneses,’ takes an ever more proactive stand, calling out the Food and Drug Administration (FDA) to start handling their business, properly.

Disturbing Safety Signals Need Investigation

For example, the Baltimore-based academic and clinical research expert shared his findings, conveying his growing concern as to what happened to the Gold Standard regulatory agency. Why is the FDA MIA?

Doshi, who has communicated with TrialSite from time to time, shares that the safety signal he and colleagues have uncovered is troubling, to say the least.

Both Pfizer and Moderna’s Phase 3 clinical trials data suggest an investigation is needed, and now! Serious adverse events—those events that the companies themselves have classified as being the most concerning, are too high not to notice. This is no trivial matter, to be minimized and marginalized by the FDA, CDC, NIH, and others, not to mention political representatives. Clearly, the companies can’t get themselves to do the right thing as they and their shareholders are blinded by avarice and an insatiable urge for ever more capital accumulation. True, the shareholders demand such behavior but there’s ultimately a bigger, more sustained corporate brand health imperative that the CEOs must understand and ultimately embrace.

Doshi is one but a few lonely voices in academia calling for regulators to get off their tails and back into an independent regulatory groove. While political agendas and pharmaceutical sirens have lured the FDA’s independent regulatory ship into precarious, dangerous straits, the vaccine safety data calls for getting back on course—immediately.

What’s the trial data show?

Doshi shares that the trial data are indicating that serious adverse events occur at around 1 in 800 people vaccinated—“so 1 additional serious adverse event for every 800 people vaccinated.” This is a disturbingly high safety signal. For comparison, previous vaccines typically produce about 1 or 2 serious adverse events per million vaccinated persons.

Doshi reminds today’s regulators that at any other point in time there would be a serious investigation. For example, he recalls back in 1976: a small boost in the risk of a serious neurological disorder known as Guillain-Barre Syndrome (GBS) associated with the swine flu vaccine necessitated stopping the immunization to investigate. At that time, the rate of incidence was approximately 1 additional case of GBS for every 100,000 people who got the swine flu.

This is all very troubling—especially with the impact of the safety signal on low-risk groups—centering on young people. Doshi’s calls for a review should have long ago been heard.

Regulators—Are you Listening?

Dr. Doshi understands his obligation, regardless of political or career fallout, to intensify the call to the leadership at the FDA to wake up and start an investigation.

First reminding the FDA of their responsibilities and duties as the agency entrusted to protect public health, Doshi prompts the regulators that they need to be able to conduct an independent replication of the trial data using the individual participant data from the trials.

Second, he instructs the FDA leadership to ensure immediate receipt of all the necessary trial data—not summaries of the data. Finally, the Maryland-based professor directs the FDA to review this data with as much scrutiny as possible. He reminds all: “That’s the responsibility that I think a regulator has.”