Whistleblower says FDA minimized safety risks at Merck vaccine plant

https://www.politico.com/amp/n…erck-vaccine-plant-478757

Food and Drug Administration inspection officials downplayed critical safety and hygiene concerns at a Merck factory that is being retrofitted to help produce Johnson & Johnson's coronavirus vaccine, according to a complaint filed by the Office of Special Counsel.

Former FDA safety officer Arie Menachem alleges in the complaint that inspectors downgraded the Merck facility in Durham, N.C., from a category requiring immediate corrective action to a less-urgent category after a 2017 inspection — without following established procedure and despite serious hygiene and public health concerns the safety officer later discovered

Big pharma wins again

Recommend Not To Use Ivermectin In Patients With Covid-19": WHO

In response to the swirl of claims around the cheap anti-parasite drug, the WHO issued guidelines saying ivermectin should only be used on Covid-19 patients in clinical trial settings

.https://www.ndtv.com/world-news/world-health-organization-ivermectin-should-not-be-used-to-treat-coronavirus-patients-2403299?amp=1&akamai-rum=off

Geneva : The World Health Organization said Wednesday that ivermectin -- touted by some on social media as a Covid-19 "miracle cure" -- should not be used to treat coronavirus patients.

In response to the swirl of claims around the cheap anti-parasite drug, the WHO issued guidelines saying ivermectin should only be used on Covid-19 patients in clinical trial settings.

The UN health agency said there was a "very low certainty of evidence" on ivermectin's effects on mortality, hospital admission and getting rid of the virus from the body.

Anti-inflammatory Therapy May Protect Against COVID-19 Inflammation

https://www.contagionlive.com/…nst-covid-19-inflammation

A recent study conducted by investigators from the Mount Sinai hospital and the Mount Sinai School of Medicine has discovered that a widely available and inexpensive therapy which targets inflammatory genes reduces morbidity and mortality in mice infected with the SARS-CoV-2 virus. Results from the study were published in the journal Cell.

The therapy, called Topotecan (TPT), inhibited the expression of inflammatory genes in the lungs of the mice as late as four days after infection.

"So far, in pre-clinical models of SARS-CoV-2, there are no therapies--either antiviral, antibody, or plasma--shown to reduce the SARS-CoV-2 disease burden when administered after more than one day post-infection" Ivan Marazzi, senior author on the study said. "This is a huge problem because people who have severe COVID19 and get hospitalized, often do not present symptoms until many days after infection.”

For the study, the investigators expanded on previous work they have done that found inhibiting the activation of inflammatory genes could help prevent animal deaths from viral and bacterial infections.

The team discovered that many anti-inflammatory therapies were not as effective as TPT because they only target a single inflammatory mediator such as IL6 or IL1.

"The fact is, a multitude of inflammatory genes and signaling pathways are dysregulated during a SARS-CoV-2 infection," Jessica Sook Yuin Ho, lead author on the study said.. "We demonstrated that TOP1 inhibitors were able to broadly or systemically dampen inflammatory gene expression in animal models, regardless of the gene or activation pathway."

The team plans for future research to evaluate the safety and efficacy of treating humans with TPT for COVID-19 at various site around the globe, including India and Singapore.

"Findings from our work suggest that repurposing the TOP1 inhibitor could be a valuable global strategy for treating severe cases of COVID-19," Marazzi said. "Particularly attractive is the fact that TPT is already FDA-approved and that its derivatives are inexpensive, with generic formulations existing throughout the world. This makes these drugs readily accessible and available for immediate use in both developing and developed countries across the world."

Experts have been 'woefully wrong or pathetically late' with COVID recommendations

https://www.foxnews.com/media/…covid-pandemic-wrong-late

The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) "have been either woefully wrong or pathetically late in their recommendations," during the coronavirus pandemic, Fox News host Laura Ingraham said Wednesday.

"To make matters worse," said "The Ingraham Angle" host, "various made-for-TV doctors and analysts mindlessly repeat their drivel. Few have actually treated COVID patients or even remember their 11th grade biology. To this day, few have been held accountable for their mistakes."

Ingraham spotlighted the example of the Amish and Mennonite communities in Lancaster County, Pennsylvania who initially complied with stay-at-home orders before resuming traditional worship services in the spring of 2020

Allen Hoover, an administrator at Parochial Medical Center in New Holland -- one of the larger boroughs in the Amish part of Lancaster -- told the New York Post that while COVID initially ripped through the area "like a tsunami", the facility has not seen a single COVID patient in the past six weeks.

AMISH COMMUNITY MAY HAVE REACHED CORONAVIRUS 'HERD IMMUNITY', HEALTH OFFICIAL SAYS

Hoover added that it is impossible to know the full extent of the virus outbreak in the community since, in his estimation, fewer than 10% of symptomatic patients agreed to be tested for the virus.

"The Amish have been living the 'really old' normal since last April," Ingraham pointed out. "No masks, no social distancing, no lockdown. The end result: Herd immunity ... horse-and-buggies beat the rest of America still wearing masks in their cars."

Turning to "the dangers of lockdowns," the host recalled that "we tried to warn red and blue states if they went the way of Europe and slow-rolled their reopening, the free states would ultimately leave them all behind. Governors of places like Texas and Florida tried this more nuanced approach."

Meanwhile, Ingraham added, people like Dr. Anthony Fauci were given an "outsized public platform" and reciprocated by blaming former President Donald Trump for "their own failures."

A COVID-19 prophylaxis? Lower incidence associated with prophylactic administration of ivermectin

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7698683/

As COVID-19 is such a new disease, none of the existing MDA campaigns are targeted at controlling its spread. Nor is there any documented prophylactic use of the deployed drugs against SARS-CoV-2 infection. However, there is a very strong negative correlation between the use of PCT—especially involving ivermectin—and COVID-19 proliferation. This, paired with ivermectin's proven inhibitory effect on SARS-CoV-2 replication in vitro, leads us to the hypothesis that the drug may have a—likely indirect—prophylactic effect and thereby reduce the spread of the disease.

It might be interesting to note that the percentage of the overall population that received PCT using ivermectin mostly ranged from 30–90%, yet there was no significant difference in the resulting incidence of COVID-19. Even the lower treatment coverages achieved the same reductions resulting from MDA reaching nearly the entire population. The reasons for this fact are so far unexplained. There was also no detectable advantage to any one administration timeframe or interval. While individual dosages generally varied between 150 μg and 200 μg per kilogram of body weight, there seemed to be no notable difference in COVID-19 incidence among recipients of different dosages either. It must therefore be assumed that any pathway connecting ivermectin administration and lower COVID-19 incidence is achieved by administration of the drug in relatively low doses far below potentially dangerous levels considered elsewhere as potentially effective for COVID-19 treatment [19]. This becomes less surprising once we consider the relatively short half-life of ivermectin [20], meaning that the added effect of any higher dose would not be prolonged. Instead, we hypothesise that there is an as of yet unknown pathway that can be triggered with lower, proven safe doses.

The fact that PCT without ivermectin also showed a strong negative—albeit not statistically significant—correlation with COVID-19 incidence suggests that other drugs used in MDA campaigns might include additional candidates for the treatment and/or prevention of COVID-19. It is, however, important to note that many of the analysed countries that only administered these other drugs in 2018 actually have used ivermectin in previous or following years. Hence, a residual effect of an ivermectin-induced pathway cannot be ruled out, although the exact nature of such a pathway would still need to be discovered. This speculation would gain further strength if experimental analysis could prove that SARS-CoV-2 replication remains inhibited after serum levels of ivermectin decline.

It is important to note that the hypothesis that ivermectin might have a prophylactic effect against SARS-CoV-2 is merely based on a rather strong correlation. On the other hand, this correlation has grown increasingly stronger in the worldwide data set earlier this year and then been independently replicated within the African data set later in the summer. Both remain highly significant, suggesting that there may be a causal connection, which is also suggested by other recent findings reported in literature. We therefore hope that this communication may serve as an invitation to further investigate and consider ivermectin as a potential prophylactic against COVID-19. In addition to the obvious advantages of a potential prophylactic, more refined results could hopefully also deter the public from further dangerous self-medication with ivermectin that has sometimes included veterinary-grade products that contain additional ingredients [21]. In this sense, even negative results might be very valuable to the health community and to society at large.

15 million doses of the J&J vaccine were ruined accidentally. What a shame! There are bound to be setbacks in this kind of crash project . . .

https://www.nytimes.com/2021/0…-coronavirus-vaccine.html

Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson

A manufacturing subcontractor in Baltimore mixed ingredients from the coronavirus vaccines of Johnson & Johnson and AstraZeneca, delaying U.S. shipments of the “one-and-done” shot.

WASHINGTON — Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago, contaminating up to 15 million doses of Johnson & Johnson’s vaccine and forcing regulators to delay authorization of the plant’s production lines.

The plant is run by Emergent BioSolutions, a manufacturing partner to both Johnson & Johnson and AstraZeneca, the British-Swedish company whose vaccine has yet to be authorized for use in the United States. Federal officials attributed the mistake to human error. . . .

Quote from Fm1

Still, the report offers compelling reasons why it's extremely unlikely the virus escaped from a lab.

You have to know how politics works. These people want to go back to China. You also have to know how intense care in all far east trades work...

The fact is: It is absolutely unlikely that the CoV-19 virus is of natural origin. The best fit so far is from a miners event , where a known bat virus killed some 10 people. The match is about 96% or it is > 1200 mutations off. Further no natural mutation pathway does exist that can add the 4 AIDS extensions to the spike genom.

The whole story is ridiculous: But this is today's level of news that people (the cattle of animal farm) are feed with.

t would be interesting to see the complete WHO report..

Tess Lawrie preliminary review of the latest WHO metaanalysis..

Significant death reduction with IVM cannot be denied..

but WHO has removed significant data from their meta-analysis. reducing the confidence..

compared to previous metaanalyses by /Hill BIRD (LAwire)

Justification? WHO WHY?

Still haven't seen the complete WHO report..

look forward to .microscrutiny of their vocabulary/spin and data set

by a panel of nonWHO experts..

TM 25.29

In mutant variants, has the coronavirus already revealed its hand?

https://www.japantimes.co.jp/n…oronavirus-mutant-future/

Evolution in real-time

The process of different species independently evolving the same traits that improve survival odds is central to evolutionary biology. And the vast scope of the COVID-19 pandemic — with 127.3 million infections globally — allows scientists to observe it in real time.

“If you wanted to sort of write a little textbook about viral evolution, it’s happening right now,” Dr. Francis Collins, a geneticist and director of the U.S. National Institutes of Health, said in an interview.

Scientists saw the process on a smaller scale in 2018 as a dangerous H7N9 bird flu virus in China appeared to begin adapting to human hosts. But no pathogen has evolved under such global scrutiny as SARS-CoV-2.

Wendy Barclay, a virologist and professor at Imperial College London and a member of a scientific advisory panel to the U.K. government, said she is struck by the “amazing amount of convergent evolution we’re seeing” with SARS-CoV-2.

“There are these infamous mutations — E484K, N501Y and K417N — which all three variants of concern are accumulating. That, added together, is very strong biology that this is the best version of this virus in the given moment,” Barclay said.

It’s not that this virus is especially clever, scientists said. Each time it infects people it makes copies of itself, and with each copy it can make mistakes. While some mistakes are insignificant one-offs, the ones that give the virus a survival advantage tend to persist.

“If it keeps happening over and over again, it must be providing some real growth advantage to this virus,” Collins said.

Some specialists believe there may be a limited number of mutations it can sustain before compromising its fitness — or changing so much it is no longer the same virus.

“I don’t think it’s going to reinvent itself with extra teeth,” said Ian Jones, a professor of virology at the U.K.’s University of Reading.

“If it had an unlimited number of tricks … we would see an unlimited number of mutants, but we don’t,” said Michel Nussenzweig, an immunologist at Rockefeller University in New York.

Quote from Wyttenbach

You have to know how politics works. These people want to go back to China. You also have to know how intense care in all far east trades work...

The fact is: It is absolutely unlikely that the CoV-19 virus is of natural origin. The best fit so far is from a miners event , where a known bat virus killed some 10 people. The match is about 96% or it is > 1200 mutations off. Further no natural mutation pathway does exist that can add the 4 AIDS extensions to the spike genom.

The whole story is ridiculous: But this is today's level of news that people (the cattle of animal farm) are feed with.

You missed the point, china must have pissed Tedros Adhanom Ghebreyesus off for hm to question its own report

Dr Jcckie Stone.. Zimbabwe warrior ... clever ,articulate , motivated...clinical EXPERT

ignored by the WHO... etc.

"TM 10.56

"background is aviation medicine and you have to know

the oxygen dissociation curve when people are going

above 10 000 feet when a patient goes below 90 oxygen

do you think there's much of a difference between 89 and 83?

and the answer is no

because hemoglobin will not release oxygen

so you've got a bus going round and round

in the circulation which is thrombosing off ,by the way

and in that circulation hemoglobin's holding on to its oxygen

so you've got tissue hypoxia everywhere"

RDT testing? "TM 24.20

it's as useful as breasts on a fish actually

Nebulised silver.. Jackie stone

Trump-Touted Drug Lives On as Covid Therapy Despite Trial Flops

https://www.bloomberg.com/news…erapy-despite-trial-flops

Concern is growing that patients are at risk of harm because physicians continue to prescribe hydroxychloroquine over other potentially life-saving Covid treatments. In June, the Food and Drug Administration revoked the emergency use authorization for hydroxychloroquine “in light of ongoing serious cardiac adverse events and other serious side effects.” The potential benefits of the drug no longer outweigh the known and potential risks for the authorized use, the agency said in a statement.

“I would say if it’s not malpractice then it’s certainly close,” said William Haseltine, a former Harvard Medical School professor and a pioneering HIV researcher who now chairs Access Health International, a health equity think tank. “It’s unfortunate. The patients that are receiving [hydroxychloroquine] are not receiving benefit. It’s not particularly toxic, although it is toxic in some cases for people with heart problems -- so it could harm those people.”

George Smith, a family doctor who runs a solo practice in Covington, Georgia, said he has prescribed hydroxychloroquine to about 160 Covid-19 patients since the virus hit his community in March 2020. Many came to him because their own physicians wouldn’t treat them with the drug.

He resigned from a job as a nursing home physician after the medical director refused to allow him to treat patients with hydroxychloroquine.

“There have been so many people who have died from Covid needlessly because of government obstruction -- it’s a crime, it’s such a shame,” Smith said in a phone interview. “I look at it this way: I swore the Hippocratic oath when I finished medical school to treat my patients the best way I know how -- and so that’s what I’ve done. If they come and take my license, then they come and take my license. But I’m not going to let somebody die over some stupid government regulation.”

The FDA authorized the emergency use of hydroxychloroquine in March 2020. A week later Trump endorsed the drug as a potential Covid-19 treatment and the government stockpiled millions of doses. After Trump promoted the drug in March, monthly prescriptions jumped 93% to 890,000.

While demand for the drug has tailed off since then, it is still significantly higher than at the start of the pandemic -- in February 2021, there were 560,000 hydroxychloroquine prescriptions written, 22% higher than a year earlier. It’s difficult to predict how many of these were off-label, though researchers estimate that off-label versions make up between 12% and 38% of all prescriptions in the U.S, according to a recent report by the Congressional Research Service.

vaccine data hack

N-terminal domain antigenic mapping reveals a site of vulnerability for SARS-CoV-2

https://www.cell.com/cell/fulltext/S0092-8674(21)00356-1

Highlights

•

NTD-targeting antibodies are a key part of immunity to SARS-CoV-2

•

NTD neutralizing antibodies target a single antigenic site of vulnerability

•

Neutralizing NTD antibodies protect hamsters from SARS-CoV-2 challenge

•

Variants of concern have mutations in the NTD that escape neutralization

Summary

The SARS-CoV-2 spike (S) glycoprotein contains an immunodominant receptor-binding domain (RBD) targeted by most neutralizing antibodies (Abs) in COVID-19 patient plasma. Little is known about neutralizing Abs binding to epitopes outside the RBD and their contribution to protection. Here, we describe 41 human monoclonal Abs (mAbs) derived from memory B cells, which recognize the SARS-CoV-2 S N-terminal domain (NTD) and show that a subset of them neutralize SARS-CoV-2 ultrapotently. We define an antigenic map of the SARS-CoV-2 NTD and identify a supersite (designated site i) recognized by all known NTD-specific neutralizing mAbs. These mAbs inhibit cell-to-cell fusion, activate effector functions, and protect Syrian hamsters from SARS-CoV-2 challenge, albeit selecting escape mutants in some animals. Indeed, several SARS-CoV-2 variants, including the B.1.1.7, B.1.351, and P.1 lineages, harbor frequent mutations within the NTD supersite, suggesting ongoing selective pressure and the importance of NTD-specific neutralizing mAbs for protective immunity and vaccine design.

Can Canada escape the third wave?

https://apple.news/AfydjjYukR8GEBl0cHMdq0Q

FLCCC update

Here is some good advice about the vaccine:

https://www.nytimes.com/2021/0…ine-side-effects-faq.html

Is the Second Dose Bad? If I Feel OK, Is It Working? Can I Take Tylenol?

The most common questions about vaccination side effects, answered. . . .

Q: I’ve heard the Covid vaccine side effects, especially after the second dose, can be really bad. Should I be worried?

Short-lived side effects like fatigue, headache, muscle aches and fever are more common after the second dose of both the Pfizer-BioNTech and the Moderna vaccines, which each require two shots. (The Johnson & Johnson vaccine requires only a single shot.) Patients who experience unpleasant side effects after the second dose often describe feeling as if they have a bad flu and use phrases like “it flattened me” or “I was useless for two days.” . . .

Q: I didn’t have any side effects. Does that mean my immune system didn’t respond and the vaccine isn’t working?

Side effects get all the attention, but if you look at the data from vaccine clinical trials and the real world, you’ll see that many people don’t experience any side effects beyond a sore arm. . . .

Q: Will the vaccines work against the new variants that have emerged around the world?

The vaccines appear to be effective against a new variant that originated in Britain and is quickly becoming dominant in the United States. But some variants of the coronavirus, particularly one first identified in South Africa and one in Brazil, appear to be more adept at dodging antibodies in vaccinated people.

While that sounds worrisome, there’s reason to be hopeful. Vaccinated people exposed to a more resistant variant still appear to be protected against serious illness. . . .

. . . People who are vaccinated should still wear masks in public and comply with public health guidelines, but you shouldn’t live in fear of variants, said Dr. Peter J. Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. “If you’re vaccinated, you should feel pretty confident about how protected you are,” said Dr. Hotez. “It’s unlikely you’ll ever go to a hospital or an I.C.U. with Covid-19. In time you’re going to see a recommendation for a booster.” . . .

Quote from Toffoli

3,964 Dead 162,610 Injuries: European Database of Adverse Drug Reactions for COVID-19 “Vaccines”

This 100% pure, unadulterated bullshit. It is an outrageous lie, apparently intended to frighten people. I suppose in order to enhance the political power of this website, even at the cost of killing people. In short, this is evil. The correct number of people killed and seriously injured worldwide by the COVID-19 vaccines is: 0 (zero). That is what you expect from a modern vaccine.

Anyone who believes this garbage is an idiot. Anyone who posts it, spreading the lie, contributes to the destruction and misery these people want to spread. You are part of the anti-science death cult.

If even 100 people had been killed, or even 10, that would be headline news worldwide in every mainstream news source. There is no chance it would be covered up. Right-wing news sources in particular such as Fox News would jump on it, because they have been fighting against the vaccine and other public health measures from the start. Some of their top talent such as Tucker Carlson are starring members of the death cult. Carlson has promoted the lie that the vaccine caused deaths, but the rest of Fox has not gone along. Even Trump recommended that people get the vaccine.

See:

https://www.vanityfair.com/new…id-vaccine-story-straight