Saturday, January 21, 2023

My recipe blog

I have just put up another recipe on my Recipe Blog. It is for an unusual but very tasty meal

Friday, January 20, 2023

The Ongoing Mutation of SARS-CoV-2 & Attempts at Vaccination-based Control


Top scientists investigating the crossroads of genomics, immunology, microbiology, and infectious disease concluded the extreme difficulty of RNA virus immunization in a 2018 research paper titled “Immune Responses to RNA Viruses,” all but cautioning public health agencies’ responses to most RNA viruses and their respective threats to public safety. They wrote that in the aggregate, RNA pathogens, including human immunodeficiency virus (HIV), hepatitis C virus (HCV), Ebola virus, Zika virus, respiratory syncytial virus (RSV), influenza viruses, yellow fever virus, dengue virus, rhinoviruses (common cold), human T-lymphotropic virus type 1 (HTLV-I), poliovirus, and measles virus take hundreds of millions of lives daily worldwide. Published just a year-and-a-half before the outbreak of SARS-CoV-2, the authors acknowledged the current state of science: “that at the present time, no vaccine or specific treatment is available for many of these viruses, and some of the available vaccines and treatments are not highly effective.” So, this is for viruses known to human science for decades in some cases. What about a brand-new pathogen with certain heretofore not seen qualities making the RNA virus far more transmissible? How could government research entities and industry be so confident as to a blockbuster vaccine response that would control the pathogen, leading to herd immunity? After all, this was the initial impetus behind the mass vaccine development as evidenced by underlying drivers to control the virus by achieving a 70% vaccination rate. Well-intentioned to rapidly respond to a deadly pathogen, time is now to critically evaluate options with a willingness to let go of any faulty assumptions.

In Detail:

The human innate immune system represents a key force in sensing RNA viruses and, thus, a considerable influence on the antiviral responses and the pathogenesis of diseases caused by such RNA viruses. Yes, special attention needs to be directed toward the immune response to RNA viruses and SARS-CoV-2. In that 2018 piece, the authors Said et al. introduce an RNA virus, HIF, as an example of the interaction between an RNA virus and the immune system and how such interactions control the pathophysiology of the disease caused by the virus.

While in the COVID-19 response to the novel RNA virus called SARS-CoV-2, health authorities across public agencies and their apex research institutes sought to use an mRNA vaccine developed across the finish line in just about 10 months as a means of mass controlling the pathogen as evidenced by repeated targeting of 70% of vaccination rates by the World Health Organization initially to achieve herd immunity to stop the spread of the pathogen, not just to protect the highest risk populations viral surges with bolstered human antibody responses.

No, early on it was clear that from health authorities to governments and elected officials to the vaccine developers (pharma) that the vaccine was a means of eradicating the viral pathogen from existence. Even with clear evidence by the spring of 2021 that the novel vaccines would not stop viral transmission, intense public campaigns commenced, including announced mandates by POTUS precisely to stop viral spread.

Despite these intensive public health initiatives seeking to control the COVID-19 pandemic, wave after wave of viral mutation, starting first with the Delta variant of concern, followed by a series of Omicron subvariant mutants, the recent entry of the highly infectious, considerably resistant, and intensely immune system-evading XBB.1.5 SARS-CoV-2 subvariant merely represents the latest such pathogen, not something that should be surprising the scientific community at this point, yet the popular press treats it as a novelty.

The latest RNA-based viral mutation comes out of the XBB lineage, which emerged after a natural co-infection of a human host with two key Omicron subvariants, including BA.2.10.1 and BA.2.7 first identified in India several months ago (summer 2022). The “fifth grandchild” of the first XBB variant, it could be the most genetically sophisticated and contagious of the Omicron subvariants to date since the initial advent of this version of SARS-CoV-2 in November 2021.

In circulation in nearly 40 nations, as reported by the World Health Organization (WHO), it’s now dominating in the United States. Importantly, the current vaccine booster (Omicron bivalent BA.4/BA.5) was developed for a version that is on its way toward extinction while this untargeted mutant surges, especially on the east coast. XBB.1.5 will more than likely become the predominant SARS-CoV-2 pathogen, that RNA class of virus that scientists all along have suggested is extremely difficult to stop.

Current SARS-CoV-2 Viral Variants Across the USA
The Centers for Disease Control and Prevention (CDC) report on variant representation and distribution across America.

XBB.1.5 now represents 43% of all SARS-CoV-2 variants in circulation as of January 14, 2023, reports the CDC.

There is limited data about the ability of XBB.1.5 to cause serious illness. According to the World Health Organization, XBB.1.5 does not have any specific mutations that make it any more dangerous than its ancestral subvariants.

Nonetheless, XBB.1.5 is perceived as being equally capable of causing serious illness in elderly and immunocompromised persons compared to previous Omicron subvariants of concern.

It’s not clear how dangerous this particular variant will be as measured by contribution to morbidity and mortality rates, but evidence suggests higher transmission rates yet likely, lower mortality rates.

But while public health messaging continues to declare repeatedly that vaccination is the best means of stopping serious SARS-CoV-2 illness, XBB.1.5 and other variants such as XBB.1 under the Omicron umbrella, represent the pathogens with the most immune-evasive properties as discussed by WHO directly.

Initial laboratory study results didn’t bode well for the prospects of the Omicron bivalent BA.4/BA/5 booster vaccine targeting this latest mutation (XBB.1.5). TrialSite reported that a notable team at University of Texas Medical Branch reported that a group of scientists at the University of Texas Medical Branch (UTMB) in Galveston, Texas reports the mutating Omicron subvariants such as BA.2.75.2, BQ.1.1., and XBB.1 feature additional spike mutations, further inhibiting COVID-19 vaccine booster effectiveness. Led by Pei-Yong Shi, Ph.D., UTMB’s Vice President for Research, co-corresponding authors Ping Re, Ph.D., an epidemiologist, and Xuping Xie, Ph.D., an assistant a professor of biochemistry and molecular biology, the UTMB investigators reported that this particular vaccine now aggressively promoted by the U.S. government failed to generate robust neutralization against the newly emerged BA.2.75.2, BQ.1.1, or XBB.1. At the time (Dec 7), TrialSite reported that unfortunately, BQ.1 and BQ.1.1 represent the fastest growing Omicron subvariants across America.

This media also reported on a study with disturbing results from a large retrospective cohort study sponsored by the Cleveland Clinic, tapping into robust data associated with the hospital’s electronic health records. The data suggests a growing number of SARS-CoV-2 infections associated with number of vaccination boosters. But several confounding factors could influence that outcome.

TrialSite reported on the lab results from Columbia University’s David Ho, revealing declining bivalent BA.4/BA.5 booster performance against XBB.1.5, 155-fold lower than against the wild-type virus after a boost targeting the monovalent strain. See TrialSite’s “Bivalent Bombshell? BA.4/BA.5 mRNA Booster Dose Fails Comparative Antibody Titer Test: Could it be Antigenic Sin?”

Even renowned vaccine expert and FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) member, Dr. Paul Offit, has gone to the press announcing the current COVID-19 vaccine trajectory has all but failed at this point.

One other recent study result shows concerns such as “T-cell exhaustion” that implies with multiple boosters comes the prospect of externalities with unknown implications, although the study may be underpowered.

So, what degree of protection does the current booster doses offer people against XBB.1.5?
Regardless of point of view, the unfolding science appears clear now that both monovalent and bivalent booster jabs cannot be counted on for sufficient protection against XBB.1.5, yet government scientific agencies’ stance continues to remain to the contrary.

Some state level health officials have moved in the direction of the unfolding science such as in Florida, subjecting all involved to intense public scrutiny and pressure. There in the Sunshine State, given the large percentages of the American population have either been previously vaccinated and/or infected, even the State of Florida’s Surgeon General Joseph Ladapo now recommends against healthy young people getting the COVID-19 vaccine booster. This recommendation, however, goes against CDC, and other major medical associations and societies that remain steadfast that boosting with the latest dose, even if BA.5 is not much in circulation, offers some degree of protection for at least, the handful of cold winter months where populations will be more vulnerable.

Back to the scientific challenges posed with RNA viruses at the onset of this article, any attempt to use vaccination thus far as means of actually controlling the SARS-CoV-2 based pandemic hasn't worked out well. More people have died during the first year of mass vaccination versus the first year of the pandemic, although vaccination does provide a surge of antibodies that does protect people from more serious hospitalization, at least temporarily. But how long remains an open question—part of an unfolding science. As of August 2022, the Washington Post itself reported that the pandemic was no longer one of the “unvaccinated,’ as more deaths involved the vaccinated than the unvaccinated.

Of course, this is explained in part by the fact that about 70% of the American population is fully vaccinated. But this also demonstrates how mutating variants such as XBB.1.5 more easily evade neutralizing antibodies. Assessments of the U.S. [and world] pandemic response are in order. See TrialSite’s founder Daniel O’Connor’s “Pandemic Response 2.0---How Could it be Better: A Review of What We Know.”

We do now that commonsensical measure for protection range from good hygiene practices—such as handwashing, respect of people’s space [distancing], masking--although controversial [at least indoors in public spaces], and if one has an upper respiratory infection, remaining at home and resting and not increasing the probability of spreading the virus to others is a good start.

Existing monoclonal antibodies don’t work well, if at all, against the mutating variants such as XBB.1.5, meaning the ongoing intense evolution of this RNA virus makes it difficult for pharmaceutical products designed against a specific variant of concern. The antiviral Paxlovid offers some protection for some cohorts fitting in the inclusion criteria for the drug although rebound cases are reported.

David Boulware recently reported to TrialSite that metformin appears to have supportive effect against SARS-CoV-2—more so than even fluvoxamine. While TrialSite reported this on the day after Christmas the mass media was strangely silent on this good news. See TrialSite’s “Bramante & Boulware Deliver an Early Christmas Gift: Metformin Lowers Risk of Long COVID.”

Front line physicians independent of health systems have taken matters into their own hands. For example, the controversial but much loved Front Line Covid-19 Critical Care (FLCCC) Alliance, or Dr. Peter McCullough, treats patients with various protocols involving repurposed medicines.

In typical times, licensed physicians and consenting patients can without controversy use off label drugs to treat conditions so long as this is done responsibly with full patient consent, and the like. But during the pandemic, with an unprecedented centralizing of medicinal response, discussing off label regimen such as ivermectin is classified as “misinformation,” and in states like California with its new law in effect, can lead to the loss of licensure for physicians that dare to utter alternative approaches.

Meanwhile, no medicinal products are perfect. Some vaccines may have rare side effects. In the case of the SARS-CoV-2 vaccines, given the magnitude and scale of the pandemic response with 225 million plus fully vaccinated, even a 0.2% serious side effect rate equals nearly half-a-million vaccine-injured persons. Due to intense social pressures doctors and health systems are not recognizing this problem, leading to stigmatization and a lack of care. Groups such as React19 have been formed to represent vaccine injured. They should be properly funded, advocating for the injured as the vaccines were mandated on the population. A much larger long COVID group needs attention and care as well as nations attempt now to transition to an endemic reality.




Thursday, January 19, 2023

Moderna and Regulatory Agencies Caught Leaving Out Bivalent Vaccine Data, Physicians Skeptical of Timing

Moderna and regulatory agencies did not present clinical data on bivalent shots at the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) committee meetings in June and September 2022, respectively.

Presentations to the FDA and CDC advisory committee excluded data from Moderna’s own clinical study that showed bivalent boosters may be no better at preventing infections than previous booster shots.

The data showed that among people who were never infected, 3.2 percent who took the bivalent booster got infected afterward, while 1.9 percent who took the monovalent booster were later infected.

Advisors to the FDA and CDC expressed concerns of lack of transparency.

Dr. William Schaffner from Vanderbilt University, a nonvoting member of the CDC advisory committee, said that he was disappointed that the data were not presented.

“I think in the interests of transparency, those data should have been presented,” Schaffner said, “though they were very limited, and early data.”

FDA advisor and a professor of clinical pediatrics at the University of California San Diego, Dr. Mark Sawyer, said that he understands people’s concern with the data being excluded, but not all information can be presented.

The committee has limited time, so the information presented must be relevant to the big picture.

“Seeing that data would not have changed my opinion about the outcome,” said Sawyer, “and it would certainly have distracted from the discussion.”

The four advisors for the FDA and CDC who were contacted by The Epoch Times agreed that if the data were presented, it may have prolonged the discussion, but would not have changed the voting outcomes.

Both the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting and the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting approved Moderna bivalent boosters.

The excluded data come out of a Moderna study with 772 participants. The study compared bivalent boosters containing mRNA components of the original and the BA.1 Omicron strain against the original Wuhan-strain booster.

The study primarily investigated the safety and immunogenicity of boosters, but also looked into the infection and reactogenicity of the subjects.

Immunogenicity, the focus of the study, is defined as the ability of the vaccine to trigger an immune response. Though the study authors reiterated that the trial does not examine vaccine efficacy, the authors acknowledged that immunogenicity has been used to infer efficacy.

Three days before the FDA VRBPAC meeting on June 28, 2022, Moderna published the study as a preprint, and in September, published the study in the New England Journal of Medicine (NEJM).

Both the preprint and peer-reviewed study included data on immunogenicity, safety, reactogenicity, as well as infection.

Moderna’s spokesman Christopher Ridley also told CNN that the company shared the infection data with the FDA and published the study before the FDA panel meeting.

At the VRBPAC meeting, Moderna president Stephen Hoge made several references to the study’s immunogenicity data, which showed that people who took the bivalent shots had a higher antibody level than those who took the monovalent booster, as an argument for the bivalent booster’s superiority.

Hoge also made references to the same study’s data on safety and reactogenicity, but infection rates were excluded.

The FDA’s documents provided to the committee panel on the same day, also referenced the study’s data on immunogenicity, safety, and reactogenicity, yet the infection data were similarly excluded.

According to CNN, the FDA spokesman explained in an email that the data on infection were not included, as “the FDA received the preprint less than a day prior to the advisory committee meeting,” and “generally the FDA only discusses data at advisory committee meetings that the agency has had the opportunity to substantively review.”

This means that the FDA could review the study’s data on immunogenicity, safety, and reactogenicity, but had no opportunity to examine infection data.

VRBPAC member and professor of microbiology and immunology from the University of Iowa, Dr. Stanley Perlman, said that with the absence of these data, there is always the concern that the public will lose trust in the health care system.

At the end of the meeting, the VRBPAC committee ruled in favor of using the Omicron variant’s mRNA in boosters to produce the bivalent COVID-19 vaccines in a 19-2 motion.

It is worth noting that by the time of the FDA committee meeting, the BA.1 strain of the Omicron variant was no longer dominant.

Though the presentations referenced data on bivalent boosters composed of the BA.1 and Wuhan mRNA components, the boosters that were later FDA-emergency authorized contained BA.4 and BA.5 components rather than BA.1.

None of the presentations on Moderna boosters contained clinical data on participants who were inoculated with BA.4/BA.5 bivalent boosters.

The CDC’s meeting with members of the Advisory Committee on Immunization Practices (ACIP) on Sep. 1, 2022, presented by Moderna staff Dr. Jacqueline Miller, also excluded data on infection rates in the presentation (pdf).

Hours into the CDC meeting, voting member of the ACIP Dr. Sybil Cineas asked whether there were any data on breakthrough infections between two experimental groups.

Miller said that between the overall cohort of people who received the bivalent vaccine, the infection rate was 2.5 percent, and for the monovalent group, the rate of 2.4 percent.

However, she failed to mention that for people who never had a previous infection, 3.2 percent of those who took the bivalent vaccine became infected, while 1.9 percent of subjects who took the monovalent developed an infection.

The ACIP members approved Moderna bivalent boosters being made available to people aged 18 and over in a 13-1 vote.

Limitations of Study

Dr. Cody Meissner, a VRBPAC member and a professor in the division of infectious diseases and international health from Dartmouth Health Children’s, also pointed out that the infection data came out of a non-randomized and non-blinded study.

This introduces the risk of bias into the study, as those assigned to bivalent or monovalent boosters were not based on random chance, and trial administrators would know what booster participants received.

While this possibly discounts the significance of the data on infection rates, it can also affect the validity of the findings on immunogenicity, safety, and reactogenicity.

Biochemist and mRNA platform inventor Dr. Robert Malone raised the point that immunogenicity data that only look at antibody levels are not good surrogate measures for vaccine efficacy.

Antibody levels are also not a good measure of immunity, as antibodies will and should wane with time. The long-term immunity they provide is therefore unknown.

It is also unconfirmed if the antibodies produced are neutralizing antibodies that can block the virus and spike proteins, or if they may actually prevent the immune system from killing and controlling the virus, a scenario known as antibody-dependent enhancement.

Increasing Scrutiny of Bivalent Boosters

Bivalent boosters have come under increasing scrutiny for their rapidly declining effectiveness.

A December 2022 preprint study on bivalent vaccines, authored by the Cleveland Clinic, found that the higher the number of previous vaccinations, the greater the risk of contracting COVID-19.

In a letter to the editor (pdf) published in the NEJM, researchers from Columbia University compared antibody serum responses among people who received bivalent boosters, monovalent boosters, and those who were infected.

The authors found that there was no significant difference in neutralizing abilities among these groups when tested against Omicron and other variants.

Dr. Paul Offit, an advisor on the VRBPAC committee who voted against bivalent boosters at the meeting, also published a commentary, saying that young and healthy people shouldn’t get the latest boosters.

“I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later,” wrote Offit, also an FDA vaccine panel adviser and professor of pediatrics at the Children’s Hospital of Philadelphia, in the NEJM on Jan. 11, 2023.

In his article, Offit cited two studies suggesting that bivalent boosters, which target the original COVID-19 strain and two Omicron subvariants BA.4 and BA. 5, do not “elicit superior immune responses.”

“Why did the strategy for significantly increasing BA.4 and BA.5 neutralizing antibodies using a bivalent vaccine fail?” he asked.

“The most likely explanation is imprinting. The immune systems of people immunized with the bivalent vaccine, all of whom had previously been vaccinated, were primed to respond to the ancestral strain of SARS-CoV-2. They therefore probably responded to epitopes shared by BA.4 and BA.5 and the ancestral strain, rather than to new epitopes on BA.4 and BA.5.”

Meissner, likewise, expressed that healthy people younger than 65 years of age may not need bivalent boosters.

“We don’t know … how many or how often boosters are necessary. And could there be consequences from giving multiple vaccine doses that we don’t fully understand at this time?”

A peer-reviewed study published on Jan. 12 in Germany also showed that people who received higher numbers of mRNA vaccines had a higher IgG4 antibody response. The authors did not further discuss what these antibody levels may indicate, but studies have associated IgG4 antibodies with immune tolerance, which is when the body reduces its immune response to fight off an infection.

People who had a previous infection or vaccination with the adenovirus COVID-19 vaccine had zero or low IgG4 antibody responses, respectively.

The Timing of Discovery of Excluded Data Is Dubious: Physicians

Retired clinical trialist and epidemiologist Dr. Andrew Bostom was skeptical of the timing of the discovery of the withheld data.

“Why did it take so long to follow up on these findings?” Bostom asked.

Bostom himself noticed the infection data signals when the study was published in the NEJM on Sep. 16, 2022, and posted his findings on his now-reactivated Twitter account.

Even before the FDA’s announcement of emergency-use authorizations of the bivalent vaccines on Aug. 31, 2022, pharmacies and health centers were already being encouraged to take preorders for the bivalent boosters.

“In many ways, the U.S. government was already committed. They already bought these before they knew the results,” board-certified internist and cardiologist Dr. Peter McCullough said.

McCullough argued that it is far too late to discuss the nuances of withheld data and immunogenicity, with increasing reports of vaccine injury and adverse events.

Meissner and Sawyer said that the VRBPAC committee is following the rapidly emerging research on the boosters and that there would be further discussion of all available data at the meeting on Jan. 26.

The FDA, CDC, and Moderna did not respond to requests for comment.




Wednesday, January 18, 2023

DOJ Still Fighting in Court for Forced Masking on Transportation

On April 18, 2022 U.S. District Judge Kathryn Kimball Mizelle struck down President Joe Biden's mask mandate for air and rail transportation. The Department of Justice quickly appealed the decision after a request from the Centers for Disease Control.

"To protect CDC’s public health authority beyond the ongoing assessment announced last week, CDC has asked DOJ to proceed with an appeal in Health Freedom Defense Fund, Inc., et al., v. Biden, et al. It is CDC’s continuing assessment that at this time an order requiring masking in the indoor transportation corridor remains necessary for the public health. CDC will continue to monitor public health conditions to determine whether such an order remains necessary. CDC believes this is a lawful order, well within CDC’s legal authority to protect public health," the CDC released in a statement.

At the time, the White House admitted the appeal was to preserve the power of the federal government.

When the mandate was lifted, flights erupted with cheers.

Nearly a year later, federal attorneys are still working to force masking on transportation.

The Eleventh Circuit of Appeals will hear arguments over a federal mask mandate on Tuesday, Jan. 17.

Beginning at 9 a.m., attorneys will present arguments over the transportation mask mandate.

The appeal drew criticism from the U.S. Travel Association, which along with other industry groups had been pressuring the Biden administration for months to end the mask mandate for travel.

The Health Freedom Defense Fund outlined arguments in court documents, stating they believe the CDC has no legal authority to adopt a mask mandate.

Following today's hearing, the court will decide whether to affirm the decision to strike down the mask mandate. A judge will draft a written decision which may go through several rounds before a majority of the court agrees and the written decision is published.

DOJ continues this fight despite President Joe Biden declaring the pandemic is over and after a recent admission from White House COVID Response Coordinator Dr. Ashish Jha that masks don't work to mitigate the spread of COVID-19.


Omicron Subvariant XBB.1.5 Could Be More Likely to Infect Vaccinated: NYC Health Officials

The Omicron XBB.1.5 variant of COVID-19 is more likely to infect individuals who have been vaccinated, according to New York City health officials.

“Omicron subvariant XBB.1.5 now accounts for 73 percent of all sequenced COVID-19 cases in NYC. XBB.1.5 is the most transmissible form of COVID-19 that we know of to date and may be more likely to infect people who have been vaccinated or already had COVID-19,” the NYC Department of Health and Mental Hygiene wrote on Twitter on Jan. 13.

Despite this, the department urged New Yorkers to get vaccinated and receive the updated COVID-19 booster shot, stating that doing so “is still the best way to protect yourself from hospitalization and death from COVID-19, including from these new variants.”

The XBB.1.5 variant is quickly becoming the dominant subvariant in the United States. Data from the Centers for Disease Control and Prevention (CDC) show that XBB.1.5 accounted for an estimated 43 percent of COVID-19 cases in the country for the week ending Jan. 14.

World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said earlier this month that the subvariant is on the rise in the United States and Europe and has now been identified in more than 25 countries.

The subvariant has now overtaken the BQ.1.1 subvariant, which was first identified in September, and which now accounts for an estimated 28.8 percent of cases in the country, according to CDC data.

XBB.1.5 Unlikely to Increase Severity

Although there has been a surge in XBB.1.5 cases, the WHO has stated that the variant does not have any mutations known to increase the severity of the virus in individuals.

In a risk assessment (pdf) published on Jan. 11, the health body said that XBB.1.5, based on its genetic characteristics and early growth rate estimates, may contribute to a surge in cases around the world but it “does not carry any mutation known to be associated with potential change in severity.”

Barbara Mahon, head of the CDC’s proposed Coronavirus and Other Respiratory Viruses Division, also told CBS News on Jan. 6 that there is no suggestion that XBB.1.5 is more severe than previous strains of Omicron.

The WHO in its risk assessment did, however, note that “the overall confidence in the assessment is low” owing to a lack of data on the subvariant, most of which come from the United States, and said that more data and laboratory testing is needed to know for sure how severe the subvariant is.

The health body also noted that XBB.1.5 is one of the COVID-19 subvariants that is most resistant to antibodies acquired from vaccination or previous infection.

According to the CDC, approximately 666,511,603 vaccine doses have been administered in the United States, of which 268,556,888 people have received at least one dose of the vaccine and 229,359,062 have completed the primary series of vaccinations.

Vaccine Effectiveness Only Lasts 3 Months

Additionally, 15.9 percent of the U.S. population aged 5 and over have received the updated bivalent booster shot.

In an interview with Science News on Jan. 13, infectious diseases specialist Peter Chin-Hong of the University of California, San Francisco, stated that vaccinations are likely to provide just three months of protection against the XBB.1.5 variant of COVID-19.

“The new updated boosters generally work a little better than the old vaccines in terms of overall efficacy and preventing infection. But with these new slippery variants like XBB.1.5 … if you’re looking to prevent infections, even a mild infection, the vaccines are probably going to last maybe three months,” Chin-Hong said.

“But if you’re talking about preventing me from dying or going to the hospital, those vaccines are going to give me a boost of protection for many, many months, probably until next winter for most people. For older people, older than 65, if they’re not boosted today, then it’s a problem,” the infectious diseases specialist added.


Here's Why the CDC Just Launched 'Additional Investigation' of COVID Vaccine Safety

The Centers for Disease Control and Prevention (CDC) announced on Friday afternoon — in something of a pre-weekend news dump — that the agency's Vaccine Safety Datalink (VSD) has "met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent."

It's worth noting that the CDC's VSD is different from its Vaccine Adverse Event Reporting System (VAERS).

The CDC's Friday updated emphasized that "[t]o date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal" and that "[n]o change is recommended in COVID-19 vaccination practice" at this time while an additional investigation is conducted.

The CDC explains more about the signal that met its threshold for additional investigation:

Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation.

Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:

A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke

A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine

The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine

Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine
Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines

Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal. CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

So while the CDC is firm in its belief that a "true clinical risk" does not exist in terms of ischemic stroke in the three weeks after a person over 65 received the Pfizer COVID vaccine, there have been enough reports for a signal to trigger further investigation which has not yet allowed the potential risk to be ruled out.

Dr. Marty Makary shared the CDC's update on vaccine safety and issued a call for the raw data that prompted the additional level of review to be made public, allowing Americans and their doctors to have all the information that exists to use in their decisions about vaccination.




Tuesday, January 17, 2023

Evidence of Serious Adverse Events in What Is Believed to Be One of the Most Effective Vaccines

The decline of public trust in COVID-19 vaccines significantly impacts vaccination rates against routine childhood diseases. This multiple-part series explores the international research done over the past two decades on the human papillomavirus (HPV) vaccine—believed to be one of the most effective vaccines developed to date.

Summary of Key Facts

This multiple-part series offers a thorough analysis of concerns raised about HPV vaccination following the global HPV campaign, which commenced in 2006.

In the United States, the HPV vaccine was reported to have a disproportionately higher percentage of adverse events of fainting and blood clots in the veins. The U.S. Food and Drug Administration (FDA) acknowledges that fainting can happen following the HPV vaccine, and recommends sitting or lying down to get the shot, then waiting for 15 minutes afterward.

International scientists found that the U.S. Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Events Reporting System (VAERS) logged a substantial increase in reports of premature ovarian failure (POF) from 1.4 per year before 2006 to 22.2 per year after the HPV vaccine approval, yielding a Proportional Reporting Ratio of 46.1.

The HPV vaccine is widely regarded as one of the most effective vaccines developed to date. Nevertheless, safety issues have been raised following its approval, and in response, additional research has been published and litigation has been brought on behalf of those with a vaccine injury.

In this HPV vaccine series, Parts I and II explain how the vaccine works and the evidence suggesting there may be legitimate safety concerns. The remaining parts present questions about real-world vaccine effectiveness and identify specific ingredients which may pose harm.

The information presented here is drawn from peer-reviewed scientific literature from the United States, Australia, Denmark, Sweden, France, and Japan, as well as statistics published by public health agencies in each of these countries. More than 100 hours of research and internal peer review among scientists with experience in infectious diseases, virology, clinical trials, and vaccine epidemiology have been invested in presenting this summary of the evidence.

Large registry-based studies have identified plausible associations between HPV vaccination and autoimmune conditions, including premature ovarian insufficiency or failure (POI/POF), Guillain-Barré syndrome (GBS), postural orthostatic tachycardia syndrome (POTS), and chronic regional pain syndrome (CRPS).

While it is easy to be enthusiastic about recent advances in human vaccine technology, we should keep in mind that achieving real and lasting good health is much more than just the absence of a certain virus.

What Is Human Papillomavirus (HPV)?

According to the CDC, HPV is the most common sexually transmitted infection (STI) in the United States.

HPV is a small DNA virus infecting human cutaneous epithelial cells in the mucosa and skin. More than 150 strains of the HPV virus have been identified.

HPV infection is so common that the majority of sexually active people will get it at some point in their lives, even if they have only one or very few sexual partners. It can spread through sexual intercourse and oral sex. It can also pass between people through skin-to-skin contact, even by people who have no symptoms.

HPV infection causes genital warts, some of which can turn into cancer. For the most part, however, HPV infection is benign. More than 90 percent of HPV infections cause no clinical symptoms and are self-limited, meaning the virus is cleared by the body via natural immunological defenses.


Pentagon Appears to Have No Plan to Reinstate Troops Discharged for Refusing Vaccine Mandate

The Department of Defense has rescinded the COVID-19 vaccine mandate for service members. But the Pentagon doesn’t appear to have a plan to reinstate military personnel who lost their jobs for refusing the vaccine.

The Daily Signal asked the Defense Department whether there would be an effort to bring military personnel who had been discharged for refusing the vaccine back into the military.

“Regarding your final question, former service members may petition their Military Department’s Discharge Review Boards and Boards for Correction of Military or Naval Records to individually review and correct personnel records, including records regarding the characterization of their discharge,” Pentagon spokesperson Lisa Lawrence told The Daily Signal in an email Wednesday.

The Defense Department issued a memo Tuesday explaining that military members dismissed for refusing the COVID-19 vaccine may be eligible to receive an honorable discharge, but the memo did not acknowledge any plan to reinstate those men and women.

The Pentagon confirmed to The Daily Signal in December that a total of 8,424 military members have been discharged for refusing the vaccine.

“[Defense] Secretary Lloyd Austin’s rescinding of the military vaccine mandate is long overdue,” the newly-elected head of the House Homeland Security Committee, Rep. Mark Green, R-Tenn., told The Daily Signal in an email Wednesday.

“Service members punished for refusing the mandate should be reinstated,” said Green, a three-tour combat veteran. “Those who do not wish to return should receive full veteran benefits where appropriate for their service to our country, and service members who were ineligible for these veteran benefits should also retroactively receive them in full.”

The military vaccine mandate came to an end Dec. 23, with the signing of the National Defense Authorization Act for fiscal year 2023.

More than two weeks after the vaccine mandate expired, but within the allotted 30-day period to release the new guidance, the Pentagon issued a memo announcing the official end of the mandate.

“Section 525 of the NDAA for [fiscal year] 2023 requires me to rescind the mandate that members of the armed forces be vaccinated against COVID-19 …. I hereby rescind that memorandum,” Austin wrote in the memo.

The memo explains that “individuals currently serving in the armed forces” will not be dismissed “solely on the basis of their refusal to receive the COVID-19 vaccination if they sought an accommodation on religious, administrative, or medical grounds.”

Lawrence, the Pentagon spokesperson, told The Daily Signal that “Secretary Austin is directing the secretaries of the military departments to cease any ongoing reviews of current service members’ religious, administrative, or medical accommodation requests solely for exemption from the COVID-19 vaccine or appeals of denials of such requests.”

Ahead of Congress’ vote on the NDAA in December, Republican Sens. Ted Cruz of Texas and Ron Johnson of Wisconsin introduced an amendment that would have allowed those who refused the vaccine to be reinstated and provided with back pay. The amendment failed.

“This vaccine mandate never should have been put in place,” Rep. Kevin Hern, R-Okla., told The Daily Signal. “It has negatively impacted recruitment and the ability to maintain the amount of military men and women needed to keep our country safe.”

Rep. Ralph Norman, R-S.C., said that forcing military members to choose between getting vaccinated and having a livelihood “was completely inappropriate and contrary to the very freedoms those service members defend.”

“Just as troubling is this apparent delay for the [Pentagon] to formally issue its memo on the rescission of the mandate, more than two weeks after this was directed through the NDAA,” he added.

Mike Berry, director of military affairs for First Liberty Institute, said in a statement Wednesday that while the “secretary of defense did as Congress directed,” it was “the bare minimum owed to our brave service members.”

“In fact, the secretary’s memo still permits military commanders to require the vaccine in making decisions regarding unvaccinated service members,” Berry said. “There are still far too many in our military who were forced out or are still facing career-ending actions because of the COVID vaccine mandate. America owes it to those who defend our Constitution and our freedoms to ensure they do not lose theirs.”


FDA Adviser Says Young and Healthy People Shouldn’t Get Latest COVID Boosters

A vaccine adviser to the Food and Drug Administration is questioning whether young, healthy people should get new COVID-19 boosters, arguing those shots should be used for older individuals.

“I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later,” wrote Dr. Paul A. Offit, an FDA vaccine panel adviser and professor of pediatrics at the Children’s Hospital of Philadelphia, in New England Journal of Medicine on Jan. 11.

In his article, Offit cited two studies suggesting that bivalent boosters, which target the original COVID-19 strain and two Omicron subvariants BA.4 and BA. 5, do not “elicit superior immune responses.”

“Why did the strategy for significantly increasing BA.4 and BA.5 neutralizing antibodies using a bivalent vaccine fail?” he asked. “The most likely explanation is imprinting. The immune systems of people immunized with the bivalent vaccine, all of whom had previously been vaccinated, were primed to respond to the ancestral strain of SARS-CoV-2. They therefore probably responded to epitopes shared by BA.4 and BA.5 and the ancestral strain, rather than to new epitopes on BA.4 and BA.5.”

Offit noted that based on those studies, “boosting with a bivalent vaccine is likely to have a similar effect as boosting with a monovalent vaccine” but stressed that “booster dosing is probably best reserved for the people most likely to need protection against severe disease.”

Another doctor appeared to agree with Offit’s conclusions regarding “imprinting.” Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security, told U.S. News that “it may be that people’s immune systems are so primed to respond to the ancestral strain spike protein that a reformulated booster is unable to fully stimulate the immune system because it has been ‘imprinted’ by the original version of the virus.”

Data and studies have shown that older adults and people who have compromised immune systems are most at risk of developing severe COVID-19 symptoms, hospitalization, and death. Children, meanwhile, have long been shown to have the lowest chance of death, hospitalization, or developing severe symptoms since the pandemic started.

Both the Centers for Disease Control and Prevention (CDC) and FDA said that everyone over the age of 6 months get updated boosters at least two months after their last doses of the vaccine. The bivalent boosters were authorized under emergency use for children aged 6 months to 4 years on Dec. 9.

Meanwhile, a small number of Americans have received the updated boosters, according to the CDC. As of Jan. 4, some 15 percent of individuals aged 5 and older received the bivalent shots, while about 38 percent of adults aged 65 and older have gotten them.

That same CDC data also shows that about 80.9 percent of all Americans received at least one dose of a COVID-19 vaccine since they were rolled out two years ago, while 69 percent have completed their initial, “primary series.”

An FDA spokesperson Abigail Capobianco responded to Offit’s article this week, telling NBC News that Offit allegedly used “selective” data to reach his conclusions and that “we strongly believe that the totality of the available evidence continues to support the use of these vaccines in all age groups.”

“Dr. Offit is entitled to his opinion about the effectiveness of the COVID-19 bivalent vaccines used as boosters,” Capobianco also said.

Earlier this week, Offit told CNN that the CDC and FDA said they were not provided with real-world data on how well the bivalent booster performs at blocking transmission of the virus before those boosters were approved by the federal agencies. Data showed that about 1.9 percent of people who got the first booster were infected, compared with 3.2 percent who got the bivalent shot, CNN reported.

“I was angry to find out that there was data that was relevant to our decision that we didn’t get to see,” Offit told CNN. “Decisions that are made for the public have to be made based on all available information—not just some information, but all information.”

The FDA’s vaccine panel is scheduled to meet on Jan. 26 to determine future vaccination regimens to address COVID-19.




Monday, January 16, 2023

Medical researcher Calls for Withdrawal of Pfizer, Moderna COVID-19 Vaccines Following New Research

An American doctor is joining the calls for the withdrawal of the messenger RNA COVID-19 vaccines, pointing to new research that highlights a connection between the shots and adverse events.

Dr. Joseph Fraiman, a doctor based in Louisiana who also conducts research on COVID-19 and other health issues, says it’s time to halt the administration of the Pfizer and Moderna COVID-19 vaccines until new clinical trials prove the benefits from the vaccines outweigh the harms.

The new research, including a reanalysis of the trials for the vaccines, raise concerns about whether the benefits from the vaccines outweigh the harms, according to the doctor.

“I don’t see how anyone couldn’t be certain that the benefits are outweighing the harms on a population level, or even in the high-risk groups. I don’t see the evidence to support that claim,” Fraiman told The Epoch Times. “But I also can’t say that there’s evidence to support that it’s potentially more harmful, but there’s also uncertainty here. … Given that scenario, I believe that people should not be given the [vaccines] outside of a clinical trial, because we need to figure out … if their benefits outweigh harm or if harm outweighs benefits.”

“The only thing that can answer that question is going to be a randomized trial,” he added.

Pfizer and Moderna did not respond to requests for comment.

The U.S. Food and Drug Administration (FDA), which cleared the shots and has never stopped promoting them, did not return an inquiry.

The Data

Fraiman led a study that reanalyzed the original Pfizer and Moderna trials. He and his colleagues concluded in a study published following peer review that the vaccinated were at higher risk of serious adverse events.

That’s one data point. Another is the identification of safety signals, or adverse events, that are potentially caused by the vaccines but require further study. The FDA revealed in December 2022 that the Pfizer vaccine was linked to blood clotting in elderly individuals. The U.S. Centers for Disease Control and Prevention (CDC), which recommends the vaccines for virtually all Americans, found hundreds of other signals in its research, according to records obtained by The Epoch Times.

Several serious problems that can lead to death have been causally linked, or proven to be caused by the vaccines. They include myocarditis, or heart inflammation.

While U.S. health officials have repeatedly downplayed the severity of myocarditis and a related condition, pericarditis, German researchers who dug into the deaths of 25 people who died suddenly at home after vaccination ruled out every potential cause except for vaccination for five of the people. They reported their results in a study that was published after peer review in late 2022.

“Given alternative causes are unlikely to cause myocarditis within one week of vaccination, this is essentially conclusive evidence that we’re seeing sudden cardiac deaths from the vaccines,” Fraiman said.

Fraiman also noted that excess mortality, or deaths from all causes, have risen during the pandemic—with spikes correlating with the introduction of the vaccines. Vaccines may not have caused the additional deaths, he says, but some researchers, including British professors Norman Fenton and Martin Neil, have examined the data and found a signal that the vaccines were linked to at least some of the excess deaths. U.S. officials say some of the deaths may be from COVID-19.

Initial Thoughts

When the vaccines were first introduced, Fraiman backed giving them to the elderly and others at high risk from COVID-19, or people of all ages with serious underlying health conditions. He says he also did not recommend against vaccination for any ages, though he told younger family members he was not sure if it was a good idea to get a jab.

Fraiman also says the vaccines likely reduced hospitalizations in the first two quarters of 2021, recalling how he did not see a single vaccinated person in his hospital until June of that year.

When he and the other scientists discovered the vaccinated were at higher risk of serious problems, he shifted to a stance of the harms likely outweighing the benefits among healthy people.

With the new evidence of harm, along with Omicron being less dangerous and more likely to evade vaccine immunity, Fraiman questions whether the benefits outweigh the serious harms even among the elderly and otherwise infirm.

“I see the likelihood that the harm could outweigh the benefit in the group who stood to benefit the most from the vaccine,” he said.

Standards Fall

Clinical trial data on the vaccines have been hard to come by, especially trials not run by the vaccine makers themselves, and the standards for the trials have been lowered over time.

The FDA authorized shots for children based on immunobridging, or trial data that found the vaccines triggered a similar antibody response in kids than that in adults. For the new bivalent boosters, created because the original vaccines have been providing much lower levels of protection against Omicron and its subvariants, no clinical data, not even antibody measurements, was provided at all. Months later, that data is still not available to the public.

Some observational studies have estimated the boosters provide subpar protection against infection and solid protection, at least initially, against hospitalization. Randomized, controlled trials are typically considered superior.

Fraiman recommends withdrawing the vaccines and U.S. officials going to the vaccine makers and asking them to demonstrate the benefits outweigh the harms in light of the changed dynamics of the pandemic. The trials should feature investigators looking closely at each COVID-19 hospitalization to distinguish whether they were caused by COVID-19, or the COVID-19 diagnosis was incidental. That distinction is known widely as being hospitalized, or dying, with COVID-19 versus from COVID-19.

The trial would take five or six months, similar to the original ones, Fraiman says.

Other Calls

Some countries, such as Denmark, meanwhile, have stopped offering booster shots to certain segments of the population. A growing number of experts, meanwhile, are calling for the administration of the Moderna and Pfizer shots, which are by far the most administered in the United States, to be halted.

The group includes Dr. Aseem Malhotra, a British doctor who turned against the vaccines in 2022 due to the growing evidence of side effects. Malhotra’s citations included the Moderna and Pfizer trials, which showed no reduction in mortality or severe disease, and the research led by Fraiman.

Linda Wastila, director of policy and research of the Peter Lamy Center for Drug Therapy and Aging at the University of Maryland, said she agrees with Fraiman, pointing to the research as well as data from the Vaccine Adverse Event Reporting System. Reports of thousands of post-vaccination deaths have been lodged with the system, in addition to hundreds of thousands of injuries.

“I’m a data scientist, and I’m overwhelmed by the congruence of all these data coming together so rapidly, all painting a horrific picture of vaccine harms that really cannot be ignored,” Wastila told The Epoch Times via email.

Wastila called for the removal of the vaccines from the market immediately, at least until safety signals identified by the CDC and FDA are closely studied.

“In not doing so, FDA and the rest of government agencies pushing these products are not only placing millions at risk for injury or death, they also are successfully encouraging rapid distrust of the institutions that are supposed to protect us,” she said.

There are other experts, such as Florida Surgeon General Dr. Joseph Ladapo, who have recommended against certain populations getting vaccinated, such as healthy young men, because they’re at higher risk of one or more side effects and stand to gain little benefit against a disease that already poses minimal risk to them. Still, other experts continue to back the vaccination of virtually all people, including Dr. Ashish Jha, coordinator of the White House COVID-19 response.


Oh, So That’s What Moderna Forgot to Tell Us About Their COVID Vaccine

The more we learn about these COVID vaccines, the more I sort of regret getting the vaccine. I already survived the virus pre-vaccine, but still got vaccinated and boosted. I’m shocked that I haven’t had a cardiac event, given how scores of young people are “dying suddenly.” I’ll have more about that later, but the death rates for young Americans have spiked, and there may be some inquiries into how these vaccines might be a factor.

Today, we’re going to piggyback off something our friends at RedState touched upon concerning Moderna not being forthcoming about some data about the vaccine. Information about the reinfection rate was buried, and an FDA panel member is not too pleased about that development. What’s even more surprising is that CNN is the outlet who reported on the incomplete disclosure of Moderna’s vaccine:

“I was angry to find out that there was data that was relevant to our decision that we didn’t get to see,” said Dr. Paul Offit, a member of the Vaccines and Related Biological Products Advisory Committee, a group of external advisers that helps the FDA make vaccine decisions. “Decisions that are made for the public have to be made based on all available information – not just some information, but all information.”

At a meeting of this FDA advisory group in June and a meeting in September of a panel that advises the US Centers for Disease Control and Prevention, the experts were presented with reams of information indicating that the new vaccine worked better than the one already on shelves, according to a review of videos and transcripts of those meetings and slide presentations made by Moderna, CDC and FDA officials.

That data – called immunogenicity data – was based on blood work done on study participants to assess how well each vaccine elicited antibodies that fight off the Omicron strain of the virus that causes Covid-19.

The data that was not presented to the experts looked at actual infections: who caught Covid-19 and who did not.

Streiff adds:

There are a few observations that can be made here. First, omitting critical data to the FDA advisory committee isn’t an oversight. Moderna’s team either knew the proposed vaccine had nearly double the current vaccine and deliberately didn’t flag that data, or they are idiots. It isn’t easy to come up with other alternatives.

The reason they did it is pretty simple. Money.

And let’s not forget that these pharmaceutical companies have full immunity from legal action. These companies can get a legal shield, but there shouldn’t be the same protections for the gun industry which has enemies at the gates looking to litigate them into extinction. They didn’t disclose all the data over money and for the sheer fact that no legal fallout could ever occur. I’m sadly not shocked there was a failure to disclose all the data before the political class, Fauci, and the Democrats forced this down our throats by threatening our employment.




Sunday, January 15, 2023

The official response to Covid was modern-deay Lysenkoism

Comment from Australia

‘Truth, like all other good things, may be loved unwisely – may be pursued too keenly – may cost too much.’ (Spigelman, 2004).

Has this statement by Vice-Chancellor Knight Bruce in 1846 become the principle to which governments, health regulators, and the pharmaceutical industry proclaim?

Well, perhaps Dr Kerryn Phelps and her wife, in their disclosure just before Christmas 2022 admitting that they had suffered severe side effects from their Covid vaccines, would agree. But why are we no longer seeing the daily media parade at 11 am from Health Ministers, regulators, and fringe-dwelling health bureaucrats with little to no clinical experience with Covid addressing the serious adverse effects and deaths from vaccines?

If we recall, government Ministers and bureaucrats across the country all marched to the beat of the same drum – get vaccinated as the alternative of being ostracised. Losing your livelihood and being publicly ridiculed was too much for the majority. We could not move outside a 5km radius, work, or visit loved ones for fear of transmitting the virus unless we were injected. Strangely the Supreme Court held that this was not coercion, because apparently you had a choice as to whether you wanted to work or travel outside the ‘5km bubble’, but of course, this was predicated on whether you had the jab.

Daily briefings similar to a kindergarten roll call for Australians became a generic message about the importance of addressing Covid in the community with no response to genuine concerns from those seeking relevant, accurate, and scientifically proven data.

It is ironic that given we are entering the third year of the Covid era, Public Health Officials continue to use the only two weapons in the fight against the continual increase in Covid Infections: facemasks and further boosters for prior injections that did not stop transmission, hospitalisations, or deaths.

Meanwhile, antivirals with decades of safety data are now being prescribed despite being made previously illegal and/or banned by regulators, all in an effort to socially construct a perception that the only thing that could save humanity was an untested mRNA injection. Or was this to ensure the Bio Security Act 2015 (Commonwealth) was complied with, ensuring that ‘no other medications were available’, thereby perceivably justifying a national campaign of social and medical coercion? I will leave this logical conundrum for you to grapple with, as many still need help understanding this line of reasoning.

Could the flood of experimental vaccines mandated upon the Australian population have, in effect, put ordinary Australians on trial? Greg Hunt, the former Federal Health Minister, said of the Pfizer and other Covid injections, ‘The world is engaged in the largest clinical vaccination trial.’ (Roberts, 2022) I would go further and say, in history…

The phrase ‘on trial’ does not solely relate to being tried in a court of law. It can apply when a government observes people to see whether they succeed or fail. It seems that government priorities now depend on getting people to act differently through enforced compliance whilst reducing transparency and accountability measures. (Shergold, 2007; Boughey, 2021)

One could assume that following the rollout of the injections, there are now two groups of people:

Those who complied with the government’s policy to get injected; and

Those that have now been put on Santa’s naughty list.

In return, they cannot work or engage in what was normal life free from government intervention, harassment and, in some cases, State-sponsored police brutality, similar to that of paramilitary organisation exacting extra curial punishment for not complying with the edicts of their grand masters.

Reminiscent of Trofim Lysenko (Lysenkoism), whose maligned ideological influence dominated biology in the Soviet Union, Lysenko, like the health bureaucrats of today, owe their ascendancy to the repeated promises of fear, doom, and insecurity, topics that worked well in Marxist-driven society.

As Lysenko’s power grew, he smothered scientific debate despite the fact that his strategy was and remains an epic failure. He crushed all opposition by deploying the State’s apparatuses to censor, intimidate, arrest, and execute scientists until the only scientists left standing were those who sold their souls to the Lysenkoism doctrine.

The result was the development of an ideology-based pseudo-science (a mere semblance of science wrapped in politics, State-run media marketing, and ideology) that did not base itself on evidence. Instead, ideology was enforced through coercion and paramilitary doctrines. State apparatuses such as Courts (if one made it to the court) were not there to hear the evidence; rather, they were used to sanitise the public record and act as gatekeepers of truth, holding back knowledge. They held back knowledge using State-sponsored experts rewarded through promotions for their loyal adherence to the cause.

The Lysenko phenomenon is the most extreme but by no means the only example of the perversion of science by ideology (as seen in Germany during the second world war and later prosecuted through Nuremberg), often with the acquiescence of the scientific community. Over the past three years, legislation has been introduced to silence medical practitioners/scientists in California (USA) and Queensland (Australia), which does not give us confidence that nothing of the kind could happen today in what used to be legally obliged participatory democracies. Perhaps the parliamentary Ministers and health bureaucrats during Covid have aligned themselves with this doctrine…?

It is apparent that politicians and so-called experts had not seen any scientific data to support their claim that the vaccines were safe and effective because we know now that the manufacturer did not have this data. So, what evidence did ATAGI, State-sponsored experts, and the TGA rely on to approve these vaccines if the manufacturer did not have that data available? The TGA states on its website:

Before any Covid-19 vaccine is approved for use in Australia, it will be subject to the well-established and rigorous assessment and approval processes of the Therapeutic Goods Administration (TGA).

One of the most poignant examples relates to the experts and high-level politicians all over Australia and the world stating that the science supported their claims when in fact, no such science existed.

We heard many notable prominent people go on the public record and state (words to the effect), ‘if you get vaccinated you will not get the virus’ or ‘get vaccinated to save your grandmother and family’.

Well, all you have to do is refer to the statement of Greg Hunt above relating to the World’s biggest ‘clinical trial’. So who is telling fibs? The manufacturer, doctors, health bureaucrats, and/or politicians? Or, is this a well-coordinated program where it is the consumer who must work out the dangers as to who is responsible (similar to the Abbott and Costello movie): ‘Who’s on first? No… Who is on second!’ Or will the doctors and injectors be thrown under the bus and held to account under the learned intermediary doctrine (LID)?

The Lysenko affair stands as a classic example of how politics can corrupt and undermine the rational, proven approach of the evidence-based scientific method. Subtle subversion of the scientific method occurs at many levels, but as with Lysenko, there must be a root and branch adoption by the highest institutions of power to ensure that the burden of proof for the ‘commoner’ is perceivably futile. And those who question the ideology are publicly ridiculed by the Fourth Estate (media) and reprimanded for daring to challenge ‘their’ agenda with evidence.

The traditional common law method of induction in our legal system is the principle of a fair trial (Spigelman, 2004) yet, according to Phelps in her recent submission to Parliament:

‘The burden of proof seems to have been placed on the vaccine injured.’ (Phelps, 2022)

I too have written previously about the burden of proof being shifted so far that the consumer must prove a product or medical device is dangerous rather than well-resourced multi-national pharmaceutical companies to prove they are safe. In simple legal terms, the bar is so high, it is difficult for anyone to suggest that any future plaintiffs may have a fair hearing.

The High Court has provided an opinion relating to the burden of proof and how it can be managed in Kuczborski v Queensland (2014) inter alia, in which it was noted that the Parliament may reverse the onus of proof, but will this be enough if its interpretation is misguided?

For people to have confidence in any system, it needs to be perceived as open, balanced, transparent, and operate without fear or favour; this is something that has yet to occur because all we have seen is censorship, exclusion, ridicule, and propaganda which is creating the impression of an alternate reality, one where truth has been manipulated to become misinformation, and misinformation has become truth.

Many may not be aware from the Kassam Judgement that 6,000 individual patient medical records, 50 per cent vaccinated and 50 per cent not vaccinated were before the court. Of the 6,000, only four people passed away due to advanced Covid (that is, they arrived at the hospital too late). More telling is that Dr Bryan Tyson provided the (anti-viral) treatment protocol to the Supreme Court of NSW that assisted the remaining patients (5,996) in recovering. Yet the State expert Prof Kristine Macartney was declared an impressive witness even though Prof Macartney conceded that she had never treated a Covid patient. Still, we know that this was a golden opportunity for the administrative bodies to take notice for the sake of community safety, but did they? Indeed, the mystery of Lysenko’s Australian-adopted science continues to evade logic.

Evidence is now emerging from NSW Health data indicating that it is the jabbed presenting high levels of hospital admissions. The media have not hyped the message that the unjabbed may not be at significant risk, but the data is telling if anyone decides to examine it closely without bias

Almost 18 months later from the plaintiffs in Kassam adducing evidence and placing their stake in the sand, documents emerged from Pfizer revealing this untold truth to all that there was never any research to support the experts making representations that the injections reduced or stopped transmission; a topic very quickly deflected or ignored in the legacy media networks. Indeed, Australia’s chief health officers conceded they had never read the Pfizer nonclinical report, so where on earth did experts and politicians get their information from if it was not the manufacturer?

Perhaps government experts should have called upon the Kassam plaintiffs’ experts, who had demonstrated extraordinary insight when they made submissions in the NSW Supreme Court to Chief Justice Beech-Jones at CL that lockdowns do not stop transmission, nor does the Covid injection provide lasting immunity or stop transmission rates, thereby rendering any lockdowns and fines nugatory and legally unreasonable. However, anyone questioning such anomalies were labelled ‘anti-vaxxer’, a bullying term that strangely also attaches to those who have been vaccine injured.

But who benefits from this forced clinical trial – Big Pharma! Perhaps this is why the burden of proof has shifted from the manufacturer to the consumer. Or could this be a military operation whereby the military, acting as prime movers, deployed vaccines as militaristic countermeasures against a perceived biological attack? (Altman et al, 2022). In either case, both do not accord with transparent democratic processes and appear to contravene the Nuremberg code. The court created this code (U.S.A. v. Karl Brandt et al.: The Doctors’ Trial) to combat gross institutionalised overreach and mass experimentation on populations. It has become clear that there are apparent complexities associated with institutions providing a balanced approach to accessing information to allow consumers to meet the burden of proof.

Presently the consumer has an insurmountable task to establish any causal link between injury or death. Rather than engaging in an adversarial struggle with the opponent, they find themselves battling a government-sponsored ideology promulgated by the legacy media that places pressure on institutions to toe the line, thereby unreasonably shifting the burden of proof on the consumer. Perhaps next, we will see the vehicle manufacturers rely on consumers to do their own car crash tests, too; only time will tell.

By virtue of the preponderance of the evidence, the burden of proof has been switched so much that it has legally muzzled the consumer/patient/doctors, and scientists in what should be a balanced system governed by the Rule of Law. Even where a consumer may seek information, it is often an unreasonably tedious and costly threshold because it is difficult for a consumer to gain access to the data under Freedom of Information laws. A sentiment shared by Sir Anthony Mason (2007), who stated: ‘The Freedom of Information Act 1982 had proven to be a “substantial disappointment.’

This has placed a disproportionate disadvantage on individuals who cannot have confidence in a system perceived to be broken by the significant erosion of certain key administrative institutions and values. Some of these issues involve the institutions of government withholding key documents such as vaccine procurement contracts from the public or the documents relating to the discussions of the National Cabinet meetings about the federal and state government rollout of jabs.

Unfortunately, the pharmaceutical industry has been able to establish with governments a special type of privilege within the legal system, which has made it very difficult for consumers to demonstrate that vaccines (along with many other pharmaceuticals) can ever be at fault for anything.

This privilege often carried through lobbying and grants, has been aided to a great extent by medical regulatory bodies such as the TGA and APHRA, silencing those that seek to question or challenge the increasing concerns surrounding the safety and efficacy of these drugs. (Burger, 2020)

These facts raise a very relevant question as to whether the onus of proof has shifted to such an extent that pharmaceutical companies are just ‘too big to fail’ or is it just part of a counterfeit business plan where million-dollar settlements are factored into the business plan – yes! Preempted.

Without engaging in litigation and risking costs orders, consumers are held hostage by an almost prohibitive costs regime restricting access in matters of significant public interest. Perhaps this is the goal of Lysenkoism, or perhaps not? The same cannot be said for multi-national companies who are prepared to defend their special privileges at any cost!

Australians like Phelps and many others before her, who fell into line to take their shots, are suffering. Many only took their shots to save their jobs, but now they are still waiting for compensation. All over the world, millions of people have died, and hundreds of millions are living with severe adverse reactions, including the suspected deaths of ‘children’. These people are not just statistics in some database – no, they are human beings, family members, and loved ones that deserve to be heard, but is it an uncanny coincidence that cases coming before Courts ‘globally’ appear to be dismissed often with adverse costs orders, despite the laser-focused temporal correlations being evident?

Individuals now face difficulties after suffering a vaccine-related injury. Many Australians are still awaiting compensation after more than one year of lodging their report to the TGA. Indeed, a forensic pathologist report of patient (X) (also tendered in the Kassam case) directly linked a vaccine to the death of a 51-year-old father. This family is still waiting for compensation and still waiting for the TGA to list the death on their public website. Perhaps these delays are not intentional due to a large number of reports that have clogged the system. But suppose the daily media parades announcing the deaths of the elderly with comorbidities on the hour were sufficient, then why are we not seeing the same treatment for those injured by the so-called vaccine or gene therapy now?

Has the ‘pat on the back’ given to many Australians from the government for complying with their policy to get vaccinated become a ‘slap in the face’?

As suggested in the journal articles reviewed, what is becoming increasingly clearer is that the experts claiming boosters improve protection against the XBB variant may be the ones engaging in disinformation, and this squarely places them at potential risk of breaching the California and Queensland legislation relating to disinformation.

Why were government officials left in the dark if the Kassam plaintiffs knew this truth from publicly available scientific data 18 months ago? This is clear, the state of scientific knowledge was available in 2020, and by the time Kassam went to the hearing, that knowledge had progressed sufficiently to provide protections for Australian citizens. But, this was not to be. Since our letter dated July 7, 2021, to Brad Hazzard and Co in response to community concerns about the safety and efficacy of the various Covid vaccines, we have unfortunately seen these numbers increase considerably. We raised questions relating to the conduct of some of Australia’s highest institutions, such as the TGA and AHPRA, aligned universities, and health bureaucrats all vying for research grants and recognition.

Our letter, written before vaccine-related injuries and deaths were as bad as they are now, clearly articulated these risks and essentially puts politicians and courts on notice. We are still waiting for a response from the government addressing these concerns.

Sadly, many Australian citizens have paid the ultimate price as a result, and many families were unaware of the true state of scientific knowledge because it was censored, ridiculed, and shunned. Although a clear vindication of the Kassam plaintiff’s position is on the cards, it is too late for many families who have lost loved ones, something we warned would occur. However, there are many courageous and ethically minded senators and politicians from all over the world, such as Senators Gerard Rennick, Alex Antic, Malcolm Roberts, Matt Canavan, Ralph Babet, Pauline Hanson, Craig Kelly (former MP), Senator Rand Paul, Rob Johnson (USA), and European parliamentarians who have continually voiced concerns over the manner in which the injections were rolled out across their respective continents.

Lawyers from around the world have united, strongly driven by perceived injustices against humanity, such as Aaron Siri, Thomas Renz, and Reiner Fuellmich et al., and have launched actions and continue to do their duty to ensure the Rule of Law is followed internationally.

Lessons learnt over the past few years have taught us that the idea of informed and valid consent has become a thing of the past with relentless labelling of people as ‘anti-vaxxers’ that chose to seek information about the safety and efficacy of these vaccines. In fact, what Dr Kerryn Phelps and others injured by the vaccine have come to know is that in exchange for speaking out about their vaccine injury, they are rubber-stamped as anti-vaxxers, the go-to attack line by the captured legacy media.

We have been directly involved with matters concerning long-serving police members (without disciplinary records) who have been dismissed from employment for electing, under their ‘informed consent rights’, not to comply with the Commissioner’s Direction to be vaccinated. These hardworking Police Officers, who only 12 months earlier were labelled heroes, cannot find employment in other industries, such as the security industry, because the Commissioner has sacked them for misconduct and classified them as not having sufficient ‘integrity’. Minister Paul Whelan MP, in his second reading speech to Parliament, on November 13, 1996, said:

‘The vast majority of police are, of course, hardworking and honest. They are constantly let down by the corrupt and incompetent. It is essential that these undesirable elements are removed to allow talent to blossom and performance to improve.’

He further stated:

‘The government recognises that the authority to terminate employment under the Commissioner’s confidence provisions vests considerable power in the Commissioner … checks, and balances are required to ensure that it is only used as it is meant to be, and is neither exceeded nor abused.’

Whilst we deeply respect our Police forces, I merely point out that Lysenkoism appears to be thriving in Australia in 2023.

Similar to Maoist China we have also seen Fair Work Commission members sent into reeducation for towing the party line. One stark example is Jennifer Kimber v Sapphire Coast Community Aged Care Ltd[2021] FWCFB 6015 Deputy President Lyndell Dean stated that mandatory immunisation could not be justified in ‘almost every workplace in Australia’.

‘All Australians should vigorously oppose the introduction of a system of medical apartheid and segregation in Australia,’ she said. ‘It is an abhorrent concept and is morally and ethically wrong, and the antithesis of our democratic way of life and everything we value.’

In a move from Maoist China, Deputy President Dean was removed from hearing any further vaccine-related cases and was required to undertake ‘re-education’. Anyone who understands history will tell you that similar conduct occurred in China if one did not adhere to the Communist party line.

Many brave professionals worldwide risked their livelihoods to fulfil their duty to raise the alarm about the damaging physical and mental health impacts of the prevailing Covid policies. These ethically minded doctors, scientists, and social advocates, such as Prof Jay Bhattacharya, Prof Gupta, Prof Martin Kulldorff, Dr Peter McCullough, Prof Clancy, Dr Malhotra, Dr Phillip Altman, Dr Hobart, Dr Sabine Hazan, Dr Maryanne Demasi, Dr Chris Neill, Dr Cosford, Prof Brighthope, Dr Ryan Cole, Dr Bryan Tyson, Dr Michael Palmer, the late Dr Zelenko, Prof Robert Clancy, Dr Geert Vanden Bossche, Ivor Cummings, Dr Ah Khan Syed, Arkmedic, Nicki Evans, and JikkyLeaks (to name a few); along with tens of thousands of others, signed the Great Barrington Declaration. Many social media personalities also spoke out about the experimental vaccines’ effects on ordinary Australians’ daily lives, such as Graham Hood, John Larter, and prominent journalists Alan Jones, Rowan Dean et al. I dread to think how worse our society would be if it were not for these individuals.