Editor of the British Medical Journal tells the FDA about Serious Concerns over Pfizer Trial Data Integrity

And the lack of FDA oversight

Dr Doshi in an associate professor of pharmaceutical health at the University of Maryland School of Pharmacy, as well as a senior editor at the British Medical Journal. “His research focuses on the drug approval process, how the risks and benefits of medical products are communicated, and improving the credibility and accuracy of evidence synthesis and biomedical publications.”

In the most recent Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee meeting in the US (6 April 2022), Peter dialled in to the Open Public Hearing Session. This is where members of the public can present their own information to the FDA. The committee was meeting to discuss considerations for the use of COVID-19 vaccine boosters and the process for COVID-19 vaccine strain selection to address current and emerging variants.

Peter told the FDA about Brook Jackson, a whistle-blower from Ventavia, which ran Pfizer’s vaccine trials. He discussed how unblinding of trial participants seems to have occurred and how this creates serious concerns about data integrity.

Last November, The BMJ reported the disclosures of a whistle-blower named Brook Jackson, who worked for Ventavia, a contract research company that ran three of the clinical trial sites for Pfizer’s vaccine. Jackson alleged the company had falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events. She provided The BMJ with company emails, internal documents, text messages, photos and recordings of her conversations with company employees.

This photo, for example, shows vaccine packaging materials that are only supposed to be seen by unblinded staff, just left out in the open.

And unblinding may have occurred on a far wider scale. Here you can see the document containing the instructions Ventavia staff were given to file each trial participant’s randomization and drug assignment confirmation sheet into each participant’s chart. This contained unblinded information.

Unblinding, as I think everybody knows, creates serious concerns about data integrity. Once this massive error was discovered, Ventavia asked staff to go through each and every chart to take out the randomization and drug assignment confirmations. You can see here an email from Ventavia’s COO reacting after discovery of the problem: they had not even realized that the drug assignment confirmation contained unblinding information.

In the heat of a pandemic, it’s not hard to imagine that corners were cut and mistakes were made. Some mistakes are benign, but others carry serious consequences to data integrity. One hopes Ventavia is an extreme outlier, but we need more than just hope. We need evidence that the data were dealt with properly. We need regulatory oversight. But despite whistleblower Brook Jackson’s direct complaint to the FDA, FDA never inspected Ventavia. In fact, FDA only inspected 9 of the trial’s 150-plus sites before approving the vaccine. Just 9 sites. And Pfizer continues to use Ventavia for trials.

What about Moderna? FDA had over a year and inspected just one – ONE – of the trial’s 99 sites. How can FDA feel confident in the Moderna data based on a 1% sample?

Data integrity requires adequate regulatory oversight. Trustworthy science requires data transparency. It’s been over a year, but anonymised participant level data remain inaccessible to doctors, researchers, and the public. The public paid for these products, and the public takes on the balance of benefits and harms post vaccination. The public has a right to data transparency, and FDA has an obligation to act. Thank you.

The video for the meeting is below. Peter Doshi’s statement starts at 5:34:44 but all of the public presentations are interesting and these begin at around 5:15.

Pfizer-BioNTech Vaccine Much Weaker in Kids Against Omicron and More

Authors: Mark Terry Published: Mar 01, 2022  BIOSPACE

Pfizer-BioNTech Vaccine Only 12% Effective Against Omicron in 5-11-Year-Olds 

In a new study that is yet to be peer-reviewed, the New York State Department of Health found that the PfizerBioNTech vaccine was only about 12% effective for children ages 5 to 11 years against the Omicron variant. In that age group, it was about 68% effective against Delta, but the effectiveness dropped significantly during the Omicron surge from Dec. 13, 2021, to Jan. 24, 2022. Protection against hospitalization also plummeted from 100% to 48% in the same period. 

The authors of the report think this drop may be the result of the lower dosage the children received. They were dosed with two 10-microgram shots, compared to 30-microgram doses for children 12 to 17 years of age.  

“Given rapid loss of protection against infections, these results highlight the continued importance of layered protections, including mask-wearing, for children to prevent infection and transmission,” the authors wrote. 

Pfizer-BioNTech Vaccine Integrates into Liver Cells in Cell Cultures 

Researchers at Lund University in Sweden conducted research into the Pfizer-BioNTech COVID-19 vaccine and human liver cell lines to determine what kind of effect the vaccine might have on liver cells. The research was published in Current Issues in Molecular Biology. The authors, noting the safety and efficacy of the vaccine against COVID-19, also point out that long-term studies have not been conducted. They note pharmacokinetics data provided by Pfizer to the European Medicines Agency (EMA) showed that the “injection site and the liver were the major sites of distribution, with maximum concentrations observed at 8-48 hours post-dose.

Furthermore, in animals that received the BNT162b2 injection, reversible hepatic effects were observed, including an enlarged liver, vacuolation, increased gamma-glutamyl transferase levels, and increased levels of aspartate transaminase (AST) and alkaline phosphatase (ALP).” They add that transient liver effects caused by the lipid nanoparticle (LNP) delivery systems used with mRNA vaccines have been previously reported, although LNP with no mRNA in it doesn’t cause any significant liver injury. 

Working with the specific human liver cell line Huh7 and the Pfizer-BioNTech vaccine, they found that the vaccine was able to enter the cell line as quickly as six hours after exposure. They cite a report saying some people who received the vaccine developed autoimmune hepatitis, and they question if the human liver cells, integrating the vaccine mRNA, produce SARS-CoV-2 spike protein that then catches the attention of the body’s immune system, inadvertently attacking the liver.

However, there does not appear to have been many other cases of this happening, which would make it extremely rare, assuming it was actually caused by the vaccine and not something else. 

The researchers note, “At this stage, we do not know if DNA reverse transcribed from BNT162b2 is integrated into the cell genome. Further studies are needed to demonstrate the effect of BNT162b2 on genomic integrity, including whole genome sequencing of cells exposed to BNT162b2, as well as tissues from human subjects who received BNT162b2 vaccination.” 

Adamis’ COVID-19 Trial Surpasses Enrollment Expectations 

San Diego-based Adamis Pharmaceuticals reported that due to the acceleration of enrollment in its Phase II/III study for Tempol for COVID-19, its Data Safety Monitoring Board (DSMB) decided the study could continue. No safety or clinical problems were observed. The data from the first 50 participants will be reviewed again in March as part of the first planned interim analysis. 

Tempol has strong, broad in vitro anti-cytokine activity, and in animal studies, appeared to have anti-inflammatory effects in the lungs. 

“We are pleased with the progress of the trial, which has already exceeded the required number of subjects (124) for the second planned interim DSMB analysis,” said Dr. Dennis J. Carlo, president and CEO of Adamis. “We appreciate the feedback from the DSMB. Following the first planned interim analysis, if the DSMB advises for the study to continue, we will also report on the second planned DSMB review following its completion, which may provide additional insight into the safety and clinical results at that time.” 

Study into mRNA vaccine death rates sends ‘danger signals’

A new Danish study reveals disparities in all-cause mortality between mRNA and adenovirus vaccines

Do the covid vaccines save lives? That is the question on many people’s minds, that has led to heated discussions across the world.

A bombshell new study by a distinguished team of Danish researchers led by Prof. Christine Stabell-Benn suggests a surprisingly nuanced answer. In the randomized trials of the covid vaccines, the adenovector-based vaccines, including the AstraZeneca and Johnson & Johnson vaccines, reduced all-cause mortality of study participants relative to people randomly assigned a placebo. Indeed, the reduction in mortality is larger than expected from the Covid effect and may suggest additional beneficial “non-specific effects” from those vaccines against other health threats.

On the other hand, Stabell-Benn and her colleagues found no statistically meaningful evidence in the trial data that the mRNA vaccines reduced all-cause mortality. The numbers of deaths from other causes including cardiovascular deaths appear to be increased in this group, compensating for the beneficial effect of the vaccines on Covid. Stabell-Benn is keen to stress that the sample is relatively small and is calling for further investigation, and also that the study took place during very low levels of Covid, so the relative advantage of protection against Covid would have been smaller at that time compared to at other points in the pandemic.

However, these preliminary results stand in sharp contrast to the unambiguous message from public health agencies and governments worldwide, which granted emergency authorization to the vaccines based on evidence from the trials that the vaccines reduce the likelihood of getting symptomatic covid. From a purely scientific perspective, preventing symptomatic covid is an interesting outcome to study. From a public health perspective, prevention of covid symptoms is not as important as prevention of death or disease transmission, which the randomized trials did not study. Dr. Stabell Benn and her colleagues have now looked at overall mortality for the first time.

At the very least, the plain implication (since both sets of vaccines are available) is that public health authorities should have recommended the cheaper adenovector vaccines over the mRNA vaccines all along for most patients.

In other words, the international move to de-authorise the AstraZeneca vaccine across Europe and elsewhere looks like it may have been a mistake, and that AZ was actually a better option than the Pfizer or Moderna vaccines.

It offers a potential contributory explanation for the better overall mortality outcomes in the UK (which overwhelmingly used the AZ vaccine) than much of continental Europe (which phased out the AZ vaccine) after the vaccine programme in the second half of 2021. 

Since its publication in pre-print, the Stabell-Benn study has received very little coverage in the media. As Dr Stabell-Benn told Freddie Sayers in her UnHerd interview, she has become used to this reticence: I have been in this game for now almost thirty years, studying vaccines and finding these non-specific effects which have been very controversial. There are strong powers out there that don’t really want to hear about them. But to me this is good news: it means that we can optimize the use of vaccines to not only be strong protective effects against vaccine disease, but we can also optimize their use in terms of overall health. – PROFESSOR CHRISTINE STABELL-BENN, UNHERD

The reaction 

For a study with such a consequential conclusion, review from independent experts is crucial. In the past, such peer-review took place in anonymity, behind the closed doors of a scientific journal, with a single editor or associate editor serving as an umpire. Because of the small number of people involved in the review, the peer-review process is subject to well-known biases and long delays (months or longer). Worse, the public never had access to these deliberations and was asked to take it as an article of faith that a published peer-reviewed paper presented accurate conclusions.

A better process for the scientific review of some important papers has emerged during the pandemic – open peer review whereby the public can see the conversation among scientific experts. Though the Danish team released their paper in early April, it was an online review by vaccine safety expert and world-renowned epidemiologist Martin Kulldorff that catalyzed a discussion by scientists about it.

In his review, Kulldorff pointed to the clear implication of the results of the Danish paper. When both mRNA and adenovector vaccines are available, it’s better to take the vaccine with good randomized evidence of reductions in all-cause mortality rather than taking a vaccine where we cannot tell from the best evidence whether it reduces mortality. Kulldorff called for a new randomized controlled trial of the mRNA vaccine to find out if they can compete with the adenovirus-vector vaccines – as should occur in medicine whenever an effective intervention exists and another intervention seeks to show that it is as good or better. He also suggested that it is inappropriate to mandate vaccines for which the randomized clinical trials show a null result for mortality. 

Kulldorff’s open peer-review stoked some discussion among scientists about the feasibility of running a randomized trial comparing the vaccines. Mortality rates from covid infection – due partly to high levels of population immunity from covid recovery – are low, so a large sample size would be necessary to detect a difference. Whether such a study is even feasible is an open question, as is the importance of such a study. This kind of constructive discussion happens all the time in science.

However, some scientists – including zero-covid advocate Deepti Guradsani – reacted to Kulldorff’s article with public smears, false accusations of spreading vaccine misinformation, and the usual claims about right-wing connections. Even Jeremy Farrar, the head of the Wellcome Trust and a prominent architect of the pandemic policy in the UK, joined the fray by promoting such smears on his Twitter feed. 

Kulldorff is a prominent vaccine scientist who has presented his honest views on the covid vaccines, even when they go against the established narrative. In March 2021, he lost his position as an advisor to the US CDC for recommending against pausing the Johnson & Johnson vaccine for older Americans – an action that effectively killed the demand for the adenovirus vector vaccines in the US. He is the only person I know who the CDC has fired for being too pro-vaccine.  

When scientists slander prominent vaccine scientists, that damages vaccine confidence. Scientists should be encouraged to evaluate, compare and discuss the strengths and weaknesses of different vaccines, and to be free to advocate for one vaccine over another. Farrar’s promotion of the lies is particularly insidious because it sends a signal to scientists who might be interested in funding from the Wellcome Trust to shy away from voicing their honest thoughts about the Danish study or vaccines in general.

The stakes in the discussion about this paper are tremendously high. Of course, for the public at large, what covid vaccine is best for them is literally a life-and-death question. For scientists, at stake is the ability to participate honestly in open scientific reviews of hot button topics without having to face smears and reputational damage based on lies by other prominent scientists. If scientists lose their ability to reason publicly about studies like the ground-breaking Danish study, physicians will have no solid basis for their advice to patients on this topic or much else, and the public will have no reason to trust physicians and scientists.

Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021

Authors: Matthew E. Oster, MD, MPH; David K. Shay, MD, MPH; John R. Su, MD, PhD, MPH; Julianne Gee, MPH; C. Buddy Creech, MD, MPH; Karen R. Broder, MD; Kathryn Edwards, MD; Jonathan H. Soslow, MD, MSCI; Jeffrey M. Dendy, MD; Elizabeth Schlaudecker, MD, MPH; Sean M. Lang, MD; Elizabeth D. Barnett, MD; Frederick L. Ruberg, MD; Michael J. Smith, MD, MSCE; M. Jay Campbell, MD, MHA; Renato D. Lopes, MD, PhD, MHS; Laurence S. Sperling, MD; Jane A. Baumblatt, MD; Deborah L. Thompson, MD, MSPH; Paige L. Marquez, MSPH; Penelope Strid, MPH; Jared Woo, MPH; River Pugsley, PhD, MPH; Sarah Reagan-Steiner, MD, MPH; Frank DeStefano, MD, MPH; Tom T. Shimabukuro, MD, MPH, MBA
IMPORTANCE Vaccination against COVID-19 provides clear public health benefits, but
vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19
vaccination are unclear.

OBJECTIVE

To describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US.

DESIGN, SETTING, AND PARTICIPANTS

Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021.

EXPOSURES

Vaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna).

MAIN OUTCOMES AND MEASURES

Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes.

RESULTS

Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%).

CONCLUSIONS AND RELEVANCE

Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination. JAMA. 2022;327(4):331-340.

doi:10.1001/jama.2021.24110
Supplemental content
Author Affiliations: US Centers for Disease Control and Prevention,
Atlanta, Georgia (Oster, Shay, Su, Gee, Broder, Sperling, Marquez, Strid, Woo, Pugsley, Reagan-Steiner, DeStefano, Shimabukuro); School of Medicine, Emory University, Atlanta, Georgia (Oster, Sperling); Children’s Healthcare of Atlanta, Atlanta, Georgia (Oster); Vanderbilt University
Medical Center, Nashville, Tennessee (Creech, Edwards, Soslow, Dendy); Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio (Schlaudecker, Lang); Boston Medical Center, Boston, Massachusetts (Barnett, Ruberg); Duke University, Durham, North Carolina (Smith, Campbell, Lopes); US Food and Drug Administration, Silver Spring, Maryland (Baumblatt, Thompson).
Corresponding Author: Matthew E. Oster, MD, MPH, US Centers for Disease Control and Prevention,
1600 Clifton Rd, Atlanta, GA 30333 (eocevent416@cdc.gov). Research J

To Read The Full Journal Publication in JAMA Click Below:

https://jamanetwork.com/ on 01/25/2022

American Scientists Confirm Toxic Graphene Oxide, and More, in Covid Injections

Authors: RHODA WILSON   

It is a human right, and global law governed under the Nuremberg Code, that vaccine specific ingredient information is disclosed.  It is critical, required and necessary information so anyone, from any country in the world, can make an informed decision whether or not to consent to medical intervention.  Because the full list of ingredients of the Covid “vaccines” have not been made available, Dr. Robert Young and his team conducted research to identify the specific ingredients in the Pfizer, Moderna, AstraZeneca and Johnson & Johnson Covid injections.  On 20 August, they published their findings.

Dr. Young is a biochemist, microbiologist, and clinical nutritionist.  He and his team of scientists have confirmed what the La Quinta Columna researchers found – toxic nanometallic content which are magneticotoxic, cytotoxic and genotoxic to plants, insects, birds, animals and humans – all life on the planet.  One of the “vaccines” even contained life-threatening parasites. Taken together, the “vaccine” components – which include graphene oxide among many others and which may be influenced by radiation sources external to us – create a toxic chemical and radiative soup inside our bodies.  Anyone who has a Covid injection is seriously putting their lives at risk.

We previously covered some of La Quinta Columna’s research in two articles: Spanish Researchers Find Covid-19 Vaccines Contain TOXIC Levels of Graphene Oxide; and, The real pandemic – Covid-19 or Graphene Oxide? Poisonous Nano-Material found in Covid Vaccines and Face Masks. For additional resources visit Orwell City, a website that translates, transcribes and adds English subtitles to a good portion of La Quinta Columna’s materials.

“Vaccines” from the four major pharmaceutical companies were analysed by Dr. Young: Pfizer/BioNTech (“Pfizer”); Moderna/Lonza mRNA-1273 (“Moderna”); Vaxzevria by AstraZeneca (“AstraZeneca”); and, Janssen by Johnson & Johnson (“Janssen”).

Liposome capsids are fatty lipid capsules. We are told their purpose is to envelope the mRNA to protect the genetic material from breaking down before it has reached its target – our body’s cells.  All four Covid “vaccines” contain relatively high levels of graphene oxide but both the Pfizer and Moderna liposome capsids are 100% graphene oxide (after extracting the mRNA). 

Graphene oxide is cytotoxic, genotoxic, and magneticotoxic.  The image below shows the liposome capsid containing graphene oxide in the Pfizer “vaccine.” The liposome delivers the graphene oxide to specific organs, glands and tissues, namely: the ovaries and testes; bone marrow; heart; and, brain.

Liposome Capsid from the Pfizer Covid injection

Also found in the Pfizer injection was Trypanosoma cruzi – a parasite of which several variants are lethal and is one of many causes of acquired immune deficiency syndrome or AIDS.  It’s not known if this was just a random ingredient or was purposefully placed and will be found in all Pfizer “vaccines.”

Trypanosoma parasite found in the so-called Pfizer “vaccine”

In the AstraZeneca “vaccines,” Dr. Young and his team identified histidine, sucrose, poly-ethylene glycol (“PEG”) and ethylene alcohol, which were also contained in the Pfizer, Moderna and Janssen Covid injections. PEG was the only adjuvant declared on the data sheet listing the ingredients of the AstraZeneca injection.

The injection of PEG and ethylene alcohol are both known to be carcinogenic and genotoxic.

Janssen also contains particles which are composed of stainless steel which are glued together with a “Carbon-based glue” of reduced graphene oxide.

This aggregate is highly magnetic and can trigger pathological blood coagulation and the “Corona Effect” or the “Spike Protein Effect”

Cells on the left are healthy, concave. Cells on the right are hollow, not concave, they have lost their haemoglobin which is the “Spike Protein Effect” or “Corona effect”
Coagulation of the blood. On the left, white blood cells with lactic and citric acid crystals and pathological blood coagulation. On the right, blood analysis showing disseminated intravascular coagulation, thrombosis, immature neutrophils, the ‘Corona Effect’ and Acanthocytosis

The Moderna “vaccine” also contains many spherical foreign bodies with some bubble-shaped cavities. These highly toxic nano particulate composition are quantum dots of cadmium selenide which are cytotoxic and genotoxic. Quantum dots are semiconductor nanoparticles that glow a particular colour after being illuminated by light. The colour they glow depends on the size of the nanoparticle.  The black spots on the image below are graphene oxide.

Nano dots and graphene oxide found in the Moderna so-called “vaccine”

Dr. Young’s paper concludes, these Covid injections “are NOT vaccines but nanotechnological drugs working as a genetic therapy … All these so-called “vaccines” are patented and therefore their actual content is kept secret even to the buyers, who, of course, are using taxpayers’ money. So, consumers (taxpayers) have no information about what they are receiving in their bodies by inoculation.”

Summary of undisclosed ingredients extracted from Dr. Young’s published scientific paper

According to Dr. Young an estimated 500 million people worldwide have already been injured, with potentially 35 million deaths, due to Covid injections. This is likely to increase in the coming months with people who have had two injections being 13 times more likely to be injured, hospitalized or killed by the “Delta variant” compared to those with natural immunity. But what is actually causing the Covid “variants” and future “waves”?

The genetic code for the Spike Protein in the “vaccines” is computer generated, it is “man-made”, and can be easily altered.  And, the graphene oxide in the body’s tissues – brain, connective tissue, potentially in the muscles – will interact with pulsating frequencies within the 5G range, said Dr. Young, this will be what causes the next “wave” predicted in October.

Stop putting poison into your body, Dr. Young said, “these [Covid] inoculates are dangerous because the nano particulates can pass right through the blood-brain barrier, they can pass right through the air-blood barrier.  That’s why these inoculations are so dangerous.  It’s because the particulates break through: the blood-brain barrier, which is protected; the air-blood barrier; and, the testicular or ovarian-blood barrier.  The particulates go right in.” To poison the body in order to heal the body makes no sense – it is a failed narrative.

Dr. Young’s published scientific paper, Scanning & Transmission Electron Microscopy Reveals Graphene Oxide in CoV-19 Vaccines, can be read by following this LINK or in the pdf document as attached:Robert-Young-GrapheneOxideVaccinePaperUpdatedDownload

The paper is technical and those of us who have not made a career in science or medicine may struggle to understand its full implications.  Dr. Young discussed his findings in depth during an interview which you can watch HERE.  Beginning at the one hour mark he works methodically through the paper’s highlights.  What he has to say is of enormous importance to us all. Whether we have had, are considering having or decline to have a Covid injection it’s worth taking the time to hear what he has to say.

Further reading:

Why would they put graphene oxide in the Covid injections?  At the end of July a Pfizer whistle-blower, Karen Kingston, confirmed there is undisclosed graphene oxide in the Covid injections.  She gives some insight as to the reason why which aligns with that given by Dr. Young.  You can watch Kingston’s interview HERE.

On 26 August, Japan announced it was suspending the use of the Moderna “vaccines” due to reports of contamination with “a substance that reacts to magnets … it could be metal.”

Previously all Covid injections had emergency use authorization only but on 23 August, for America, the FDA approved the Pfizer “vaccine”.  Last Wednesday in a second interview Kingston discussed the impact this approval had on disclosure of ALL ingredients, including those not previously disclosed: https://rumble.com/embed/vj26z2/?pub=4#?secret=puKEYSNBOa


Changing recommendations for boosters lead to confusion for the vaccinated and their doctors

Author: Carissa Wolf, Frances Stead Sellers, Ashley Cusick, Kim Mueller  1 day ago

Even in Idaho, which has one of the lowest coronavirus vaccination rates in the country, clinics have been gearing up for an onslaught of calls and emails requesting booster shots.

Administrators at the Primary Health Medical Group updated their website Thursday and then set about revising it Friday when government eligibility recommendations for boosters suddenly changed to include workers in high-risk jobs. Even then, the clinic’s chief executive had to figure out which occupations that meant.

“Who’s at high risk? I had to look it up. Is it firemen? I don’t know,” said David Peterman. “This is so confusing to the public and creates mistrust. And we can’t have that right now. Right now, we need the public to say, ‘Let’s get vaccinated.’ And for those that need boosters, we need to say that ‘This is safe, and this is what we need to do.’”

Confusion over boosters, which has been brewing for months, heightened over the past week as government regulators and advisers met to hash out the pros and cons of administering third doses.

Hours of meetings were followed by a dramatic decision Thursday: The Centers for Disease Control and Prevention’s advisory group narrowed the Food and Drug Administration’s recommendation for who should get a third Pfizer shot, only to be overruled in a late-night announcement by the CDC director: Along with Americans 65 and older, nursing home residents and people ages 50 to 64 with underlying medical conditions, who the advisory panel had suggested should get shots, Rochelle Walensky added the people in high-risk jobs.

“It’s a communications crisis,” said Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, who said he received worried calls Thursday evening from health-care workers who thought they would not be eligible for the shots, followed by messages Friday from colleagues wondering when and where to go.The deluge of phone calls about booster shots to Primary Health clinics in Southwestern Idaho began weeks ago. On Friday morning, the group’s Garden City clinic, where Maddie Morris fields inquiries, saw an increase in calls, mostly from senior citizens.

“The calls seem pretty nonstop,” the customer service representative said. “It seems like a lot of people are anxious to get a booster.”

Doctors say confusion clouds patients’ willingness to receive boosters. In Idaho, the problem coincides with the primary health-care system’s struggle to meet the demands of the latest covid-19 crush, which earlier this month plunged the state into crisis standards of care — essentially the rationing of health care as demand overwhelms resources.Four patients, two dialysis machines: Rationing medical care becomes a reality in hospitals overwhelmed with covid patients

Peterman expects the new booster guidelines to prompt an increase in inquiries just as the number of providers out sick is at an all-time high.

“We went from 40,000 phone calls daily at 21 clinics to 80,000. Eighty thousand! On top of that, we went from maybe 20 of our employees being out a day to 30 to 40,” Peterman said.

“In the next 72 hours, I want [the CDC] to answer our phones,” he said.

Many newly eligible patients are over 65 and not comfortable using the Internet to find information. So the phones keep ringing at Morris’s desk.

“You really can’t take a breather. You just have to jump to the next call,” she said. And Peterman says he has had to ask staffers to take extra shifts and work long into the night to help close the staffing gap.

Much of the muddle stems from legacy systems at the FDA and CDC that were set up to handle routine drug approvals and childhood vaccinations, not a fast-moving public health crisis involving the entire population, said Jay A. Winsten, the founding director of the Center for Health Communications at the Harvard T.H. Chan School of Public Health.

The CDC’s Advisory Committee on Immunization Practices includes infectious-disease specialists, obstetricians and pediatricians who grappled Thursday with questions in which they have no expertise, such as whether offering boosters might undermine public confidence in the vaccines’ efficacy.

“What’s missing from the equation are communication experts,” said Winsten, including specialists in public-opinion polling and behavior change. “They need a seat at the table.”

Health-care providers across the nation have been helping patients for weeks to filter through not just misinformation and disinformation about boosters but also a surfeit of real-time information.

“That’s the biggest problem,” said Clay Marsh, a pulmonary critical care doctor and executive dean for health sciences at West Virginia University. “The amount of information is dizzying,” Marsh said, “It creates chaos.”

Across the New Orleans metropolitan area, new CDC guidelines had failed to trickle down to many administration sites by Friday morning.

The Louisiana National Guard, which helps to run testing and vaccination sites, was still awaiting clarity.

“We are just administering the first and second doses,” said Sgt. Gaynell Leal, a guard spokeswoman. “As far as the booster part of it, that hasn’t come our way yet.”

“The biggest thing is gaining people’s confidence in science,” Leal said. “My civilian job is I’m a funeral director. So I’ve seen this on both sides.”

On the ground, some National Guard-run sites did offer booster shots Friday, but the eligibility benchmarks they used had not yet caught up with the CDC’s latest guidelines.Tracking the coronavirus vaccine

At a drive-through testing and vaccine site in Meraux, La., just east of New Orleans, medics offered booster shots to those who met the requirements laid out on a “self-risk attestation form” issued in mid-August by the Louisiana Department of Health. That form offered a checklist of reasons one might qualify for a third dose, including active cancer treatment, HIV infection, immunodeficiency issues or the use of immunosuppressants. The form did not account for the age or job-related eligibility factors the CDC announced late this week.

In the French Quarter, Tara Thompson, 53, enjoyed a drink in Pirate’s Alley with her husband.

Thompson said that although she took the vaccine to spend time with her elderly parents, she hoped this week’s guidelines would not lead to booster shots soon being pushed on the public.

“I personally don’t want it if I don’t have to have it,” she said. “It’s a matter of trusting the science that seems to be skewed toward the benefit of certain political mind-sets.”

Thompson said she could change her mind if the shots help with travel.

“Or, if the booster shots help Mardi Gras to happen,” she said. “I might consider it then.”

In Chalmette, La., Kerissa Fernandez, 37, wanted more clarity on how the new booster shot guidelines applied to her.

Fernandez, a family nurse practitioner, said she and the staff at the small urgent care clinic she runs with her husband all meet the front-line worker requirement for booster shots. But none of the staffers at the Bayou Urgent Care Clinic had received the Pfizer vaccine, she said.

“I had Moderna. We all got Moderna,” she said. But when the delta variant reached record numbers in Louisiana, she and her husband both ended up with breakthrough infections.

Knowing firsthand the virus’s ability to shape-shift, Fernandez said she and her staff are all eager to get booster shots.

Many newly eligible people say they aren’t waiting for the rules and recommendations to change again. Ann Mackey, 66, qualifies for a booster shot.

“I have a doctor’s appointment next week, so I might see if they can jab me then,” she said from her high-rise apartment in downtown Kansas City, Mo.

The former FDA employee said the government’s conflicting messages have been confusing. She doesn’t understand why she can receive a Pfizer booster, but her friends and family can’t get their third Moderna shot. She is confused about how the government defines “high risk” and who will enforce the newest set of recommendations. And she worries that public confusion will provide another excuse for people to avoid getting their first dose.

“There already is a lot of vaccine hesitancy, and they are just looking for reasons not to get vaccinated,” Mackey said.Americans are sneaking extra coronavirus shots as officials weigh who should get them

Others are considering creative ways to get boosters.

Derek Hoetmer has been following the news closely, hoping he and his wife, a nurse who worked on a covid response team, could get a booster before the Missouri winter.

The problem is that the rules keep changing — and not in the Hoetmers’ favor. They were pleased to wake Friday morning to find the vaccination door had been opened to people in high-risk jobs.

But not wide enough for the Hoetmers, who won’t qualify because their first two doses were Moderna jabs.

With the Missouri winter only two months away, Hoetmer is considering his options. He has heard that other Americans who do not qualify are secretly getting boosters, anyway.

n situation in letter to opposition

Even in Idaho, which has one of the lowest coronavirus vaccination rates in the country, clinics have been gearing up for an onslaught of calls and emails requesting booster shots.© Scott Olson/Getty Images HINES, ILL. – SEPTEMBER 24: Lalain Reyeg administers a coronavirus booster vaccine and an influenza vaccine to Army veteran William Craig at the Edward Hines Jr. VA Hospital on September 24, 2021 in Hines, Ill. (Photo by Scott Olson/Getty Images)

Administrators at the Primary Health Medical Group updated their website Thursday and then set about revising it Friday when government eligibility recommendations for boosters suddenly changed to include workers in high-risk jobs. Even then, the clinic’s chief executive had to figure out which occupations that meant.

“Who’s at high risk? I had to look it up. Is it firemen? I don’t know,” said David Peterman. “This is so confusing to the public and creates mistrust. And we can’t have that right now. Right now, we need the public to say, ‘Let’s get vaccinated.’ And for those that need boosters, we need to say that ‘This is safe, and this is what we need to do.’”

Confusion over boosters, which has been brewing for months, heightened over the past week as government regulators and advisers met to hash out the pros and cons of administering third doses.

Hours of meetings were followed by a dramatic decision Thursday: The Centers for Disease Control and Prevention’s advisory group narrowed the Food and Drug Administration’s recommendation for who should get a third Pfizer shot, only to be overruled in a late-night announcement by the CDC director: Along with Americans 65 and older, nursing home residents and people ages 50 to 64 with underlying medical conditions, who the advisory panel had suggested should get shots, Rochelle Walensky added the people in high-risk jobs.

“It’s a communications crisis,” said Robert Murphy, executive director of the Institute for Global Health at Northwestern University Feinberg School of Medicine, who said he received worried calls Thursday evening from health-care workers who thought they would not be eligible for the shots, followed by messages Friday from colleagues wondering when and where to get them.

“Everyone is kind of confused,” he said. The current discontent has deep roots. In April, Pfizer chief executive Albert Bourla said a third coronavirus dose was “likely” to be needed. In late July, Pfizer-BioNTech announced that their vaccine’s efficacy waned over time. Data from Israel confirmed a drop. Then, last month, as the delta variant of the coronavirus surged and the World Health Organization decried the distribution of third shots in wealthy countries while poor countries were lacking first doses, President Biden announced that most Americans could begin getting boosters of the Pfizer and Moderna vaccines Sept. 20 — subject to the government’s regulatory processes, which unfolded in recent days and focused only on Pfizer. R22egulators already allowed third shots for the immunocompromised who have received Pfizer or Moderna shots but have not yet made recommendations for all recipients of the Moderna and Johnson & Johnson vaccines.People who got Johnson & Johnson’s coronavirus shot feel left behind in push for boosters

The deluge of phone calls about booster shots to Primary Health clinics in Southwestern Idaho began weeks ago. On Friday morning, the group’s Garden City clinic, where Maddie Morris fields inquiries, saw an increase in calls, mostly from senior citizens.

“The calls seem pretty nonstop,” the customer service representative said. “It seems like a lot of people are anxious to get a booster.”

Doctors say confusion clouds patients’ willingness to receive boosters. In Idaho, the problem coincides with the primary health-care system’s struggle to meet the demands of the latest covid-19 crush, which earlier this month plunged the state into crisis standards of care — essentially the rationing of health care as demand overwhelms resources.Four patients, two dialysis machines: Rationing medical care becomes a reality in hospitals overwhelmed with covid patients

Peterman expects the new booster guidelines to prompt an increase in inquiries just as the number of providers out sick is at an all-time high.

“We went from 40,000 phone calls daily at 21 clinics to 80,000. Eighty thousand! On top of that, we went from maybe 20 of our employees being out a day to 30 to 40,” Peterman said.

“In the next 72 hours, I want [the CDC] to answer our phones,” he said.

Many newly eligible patients are over 65 and not comfortable using the Internet to find information. So the phones keep ringing at Morris’s desk.

“You really can’t take a breather. You just have to jump to the next call,” she said. And Peterman says he has had to ask staffers to take extra shifts and work long into the night to help close the staffing gap.

Much of the muddle stems from legacy systems at the FDA and CDC that were set up to handle routine drug approvals and childhood vaccinations, not a fast-moving public health crisis involving the entire population, said Jay A. Winsten, the founding director of the Center for Health Communications at the Harvard T.H. Chan School of Public Health.

The CDC’s Advisory Committee on Immunization Practices includes infectious-disease specialists, obstetricians and pediatricians who grappled Thursday with questions in which they have no expertise, such as whether offering boosters might undermine public confidence in the vaccines’ efficacy.

“What’s missing from the equation are communication experts,” said Winsten, including specialists in public-opinion polling and behavior change. “They need a seat at the table.”

Health-care providers across the nation have been helping patients for weeks to filter through not just misinformation and disinformation about boosters but also a surfeit of real-time information.

“That’s the biggest problem,” said Clay Marsh, a pulmonary critical care doctor and executive dean for health sciences at West Virginia University. “The amount of information is dizzying,” Marsh said, “It creates chaos.”

Across the New Orleans metropolitan area, new CDC guidelines had failed to trickle down to many administration sites by Friday morning.

The Louisiana National Guard, which helps to run testing and vaccination sites, was still awaiting clarity.

“We are just administering the first and second doses,” said Sgt. Gaynell Leal, a guard spokeswoman. “As far as the booster part of it, that hasn’t come our way yet.”

“The biggest thing is gaining people’s confidence in science,” Leal said. “My civilian job is I’m a funeral director. So I’ve seen this on both sides.”

On the ground, some National Guard-run sites did offer booster shots Friday, but the eligibility benchmarks they used had not yet caught up with the CDC’s latest guidelines.Tracking the coronavirus vaccine

At a drive-through testing and vaccine site in Meraux, La., just east of New Orleans, medics offered booster shots to those who met the requirements laid out on a “self-risk attestation form” issued in mid-August by the Louisiana Department of Health. That form offered a checklist of reasons one might qualify for a third dose, including active cancer treatment, HIV infection, immunodeficiency issues or the use of immunosuppressants. The form did not account for the age or job-related eligibility factors the CDC announced late this week.

In the French Quarter, Tara Thompson, 53, enjoyed a drink in Pirate’s Alley with her husband.

Thompson said that although she took the vaccine to spend time with her elderly parents, she hoped this week’s guidelines would not lead to booster shots soon being pushed on the public.

“I personally don’t want it if I don’t have to have it,” she said. “It’s a matter of trusting the science that seems to be skewed toward the benefit of certain political mind-sets.”

Thompson said she could change her mind if the shots help with travel.

“Or, if the booster shots help Mardi Gras to happen,” she said. “I might consider it then.”

In Chalmette, La., Kerissa Fernandez, 37, wanted more clarity on how the new booster shot guidelines applied to her.

Fernandez, a family nurse practitioner, said she and the staff at the small urgent care clinic she runs with her husband all meet the front-line worker requirement for booster shots. But none of the staffers at the Bayou Urgent Care Clinic had received the Pfizer vaccine, she said.

“I had Moderna. We all got Moderna,” she said. But when the delta variant reached record numbers in Louisiana, she and her husband both ended up with breakthrough infections.

Knowing firsthand the virus’s ability to shape-shift, Fernandez said she and her staff are all eager to get booster shots.

Many newly eligible people say they aren’t waiting for the rules and recommendations to change again. Ann Mackey, 66, qualifies for a booster shot.

“I have a doctor’s appointment next week, so I might see if they can jab me then,” she said from her high-rise apartment in downtown Kansas City, Mo.

The former FDA employee said the government’s conflicting messages have been confusing. She doesn’t understand why she can receive a Pfizer booster, but her friends and family can’t get their third Moderna shot. She is confused about how the government defines “high risk” and who will enforce the newest set of recommendations. And she worries that public confusion will provide another excuse for people to avoid getting their first dose.

“There already is a lot of vaccine hesitancy, and they are just looking for reasons not to get vaccinated,” Mackey said.Americans are sneaking extra coronavirus shots as officials weigh who should get them

Others are considering creative ways to get boosters.

Derek Hoetmer has been following the news closely, hoping he and his wife, a nurse who worked on a covid response team, could get a booster before the Missouri winter.

The problem is that the rules keep changing — and not in the Hoetmers’ favor. They were pleased to wake Friday morning to find the vaccination door had been opened to people in high-risk jobs.

But not wide enough for the Hoetmers, who won’t qualify because their first two doses were Moderna jabs.

With the Missouri winter only two months away, Hoetmer is considering his options. He has heard that other Americans who do not qualify are secretly getting boosters, anyway.

“I won’t lie. I’ve thought about that option,” Hoetmer said. “I would rather go about it the right way and not take away someone’s booster shot.”

FDA Issues Warning About Increased Risk Of Heart Inflammation Caused By Moderna Jab

Authors: BY TYLER DURDENMONDAY, AUG 30, 2021 – 02:14 P

Earlier this month, we reported on leaked data from a Canadian study which arrived at a disturbing conclusion: the risk of rare side effects like myocarditis and pericarditis – types of heart inflammation that are potentially deadly in some patients – was at least 2.5x higher in the Moderna jab than in its main competitor, produced by Pfizer-BioNTech.

The leaking of the data to the press was an embarrassment for the FDA and CDC, and so they pledged to investigate. Now, less than two weeks later, the FDA has just announced that it has updated its “fact sheet” to reflect the higher risk of heart inflammation in male patients under the age of 40.

For all patients, the “post-marketing” data examined by the FDA show that the risk of experiencing these side effects is highest within 7 days of receiving the second dose.

Only Pfizer has received full approval from the FDA; the Moderna jab is still technically under the emergency authorization. Whether this will delay or in any way impact the FDA’s approval of the Moderna jab remains unclear.

Here’s the full updated text:

Myocarditis and Pericarditis Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis

Questions about the link between the mRNA jabs and heart inflammation have been circulating since these side effects were first uncovered in a group of American soldiers reporting acute chest pain after their vaccinations.

The news is weighing on Moderna’s share price, which has fallen substantially since its Aug. 9 peak. It was down more than 3% on Monday afternoon.

Japan probes two deaths after jabs from tainted Moderna batch

Sat, August 28, 2021, 6:10 AM

Japan is investigating the death of two men who received jabs from batches of Moderna’s Covid-19 vaccine suspended from use due to contamination, the health ministry said Saturday.

The men aged 30 and 38 died earlier this month after getting their second Moderna doses from one of three manufacturing lots suspended by the government on Thursday after several vials were found to be contaminated, the ministry said in a statement.

The ministry said the cause of death was still being investigated and “currently, causal relations with the vaccinations are unknown”.- ADVERTISEMENT –

Both men contracted fever after receiving their vaccinations and neither had underlying health conditions or allergic history, the ministry said.

The suspension affects 1.63 million doses of Moderna Covid vaccines, which have been reportedly shipped to over 800 vaccination centres across Japan.

Takeda, which is in charge of sales and distribution of the Moderna shot in Japan, said it received reports from several vaccination centres that “foreign substances” have been found inside unopened vials.

Around 44 percent of Japan’s population has been fully vaccinated, as the country battles a record surge of virus cases driven by the more contagious Delta variant.

Over 15,700 people have died from Covid-19 in the country, and large parts of Japan are under strict virus restrictions.

COVID-19 also attacks the pancreas; one vaccine dose may be enough for those previously infected

Authors: Nancy Lapid February 3, 2021

COVID-19 attacks the pancreas

The new coronavirus directly targets the pancreas, infecting and damaging its insulin producing cells, according to a new study. The findings may help explain why blood sugar problems develop in many COVID-19 patients, and why there have been reports of diabetes developing as a result of the virus. The pancreas has two jobs: production of enzymes important to digestion, and creation and release of the hormones insulin and glucagon that regulate blood sugar levels. In a paper published on Wednesday in Nature Metabolism, researchers report that lab and autopsy studies show the new coronavirus infects pancreas cells involved in these processes and changes their shape, disturbs their genes, and impairs their function. The new data “identify the human pancreas as a target of SARS-CoV-2 infection and suggest that beta-cell infection could contribute to the metabolic dysregulation observed in patients with COVID-19,” the authors conclude. (https://go.nature.com/36Cmtfy)

One vaccine dose might be enough for COVID-19 survivors

COVID-19 survivors might only need one shot of the new vaccines from Moderna Inc and Pfizer/BioNTech, instead of the usual two doses, because their immune systems have gotten a head start on learning to recognize the virus, according to two separate reports posted this week on medRxiv ahead of peer review. In one study of 59 healthcare workers who recovered from COVID-19 and received one of the vaccines, antibody levels after the first shot were higher than levels usually seen after two doses in people without a history of COVID-19. In a separate study, researchers found that 41 COVID-19 survivors developed “high antibody titers within days of vaccination,” and those levels were 10 to 20 times higher than in uninfected, unvaccinated volunteers after just one vaccine dose. “The antibody response to the first vaccine dose in individuals with pre-existing immunity is equal to or even exceeds” levels found in uninfected individuals after the second vaccine dose, the authors of that paper said. “Changing the policy to give these individuals only one dose of vaccine would not negatively impact on their antibody titers, spare them from unnecessary pain and free up many urgently needed vaccine doses,” they said. (https://bit.ly/3je4Zv4; https://bit.ly/2YG0EYf)

Gout drug shows promise for mildly ill COVID-19 patients

Colchicine, an anti-inflammatory drug used to treat gout and other rheumatic diseases, reduced hospitalizations and deaths by more than 20% in COVID-19 patients in a large international trial. COVID-19 patients with mild illness and at least one condition that put them at high risk for complications, such as diabetes or heart disease, received either colchicine or a placebo for 30 days. Overall, the risk of hospitalization or death was statistically similar in the two groups. But among the 4,159 patients whose coronavirus infections had been diagnosed with a gold-standard PCR test, death or hospital admission occurred in 4.6% of those on colchicine versus 60% of those who got a placebo. After taking patients’ other risk factors into account, colchicine was associated with a statistically significant 25% risk reduction, the researchers reported on medRxiv ahead of peer review. Patients taking colchicine also had fewer cases of pneumonia. “Given that colchicine is inexpensive, taken by mouth, was generally safe in this study, and does not generally need lab monitoring during use, it shows potential as the first oral drug to treat COVID-19 in the outpatient setting,” the researchers said. (https://bit.ly/3oDSDgY)

Oxford/AstraZeneca vaccine might work better with doses months apart

Among recipients of the COVID-19 vaccine from Oxford University and AstraZeneca, prolonging the interval between the first and second doses led to better results, researchers said in a paper posted on Monday ahead of peer-review by The Lancet on its preprint site. For volunteers aged 18 to 55, vaccine efficacy was 82.4% with 12 or more weeks between doses, compared to 54.9% when the booster was given within 6 weeks after the first dose. The longest interval between doses given to older volunteers was 8 weeks, so there were no data for the efficacy of a 12-week dosing gap in that group. Europe’s medicine regulator has said there is not enough data to determine how well the vaccine will work in people over 55. Given their findings, the authors say “a second dose given after a three-month period is an effective strategy … and may be the optimal for rollout of a pandemic vaccine when supplies are limited in the short term.”

U.S. probing Moderna vaccine for higher heart inflammation risk – Washington Post

Authors: Reporting by Shubham Kalia in Bengaluru; Editing by Krishna Chandra Eluri and Ramakrishnan M.

Aug 19 (Reuters) – U.S. health officials are investigating reports that Moderna Inc’s (MRNA.O) COVID-19 vaccine may be linked to a higher risk of a rare heart condition in younger adults than previously thought, the Washington Post reported late on Thursday, citing people familiar with the review.

The report quoted a source saying it was too early for the regulators to reach a conclusion, and that additional work was needed before any recommendation was made.

Health regulators in June had added a warning to the literature that accompanies the mRNA vaccines produced by Moderna and Pfizer to flag the rare risk of heart inflammation seen primarily in young males. However, they said the benefit of the shots in preventing COVID-19 continued to outweigh the risks. read more

There might be a 2.5 times higher incidence of myocarditis in those who get the Moderna vaccine compared with Pfizer’s vaccine, the Post quoted a source as saying.

The investigation that is focused on Canadian data suggests that risks of myocarditis might especially be higher for males below the age of 30 or so, according to the report.

Moderna and the U.S. Food and Drug Administration (FDA) did not immediately respond to Reuters’ requests for comment.