Our clown obviously does not like the Sweden/Swiss/UK data we linked. 80+ has no more protection. (-75% for infection..)
Overall 50% is seen for severe outcome what is =0 if we discount recovered...
But is see that the free mason clowns are disparate. How could the brightest of the dark lights so blatantly fail...
So now they enjoy comics, what is a typical evasion of overstrained children minds....
And...
A great fact-ful talk
On 9/24/21 I gave a talk at Virginia Tech on evaluating and aggregating emerging knowledge in the pandemic. It might be the most comprehensive summary I've given about the key points about the current state of the pandemic. Based on my work on this covid-datascience.com blog site, the main points are:
Here is a link to the talk, which is 1 hour long with 15-20 minutes of questions at the end.
For our clown once more real data from Sweden:: Effectiveness of Covid-19 vaccination against risk of symptomatic infection hospitalization and death a swedish total population cohort study .pdf
No more vaccine protection at all if we discount natural immunity and recovered it is highly negative.
My comment. I agree here that all results must be taken in context and the UK and Canadian figures (not outliers as this) are more reliable.
But I'd also point out that overall efficacy (against death) is not the most significant figure from either a personal or a public health standpoint.
What we actually want is efficacy weighted by risk of mortality, which will correspond to the reduction in population-wide mortality. We know vaccines will work less well for older people, and also that they are at higher unvaccinated risk.
Conclusions
Overall, this is a solid study with a remarkably data source provided by the well-coordinated Israeli electronic medical record system enabling the study to encompass >25% of Israeli residents and using rigorous modeling approaches to adjust for the key confounders including time, age, SES, and pre-existing conditions. The study provides reasonable evidence that immune protection might wane over time, but there are enough questions about unadjusted confounders, especially differential exposure and testing rates among those vaccinated early vs. late, that might remain and be strong drivers of the outcome. My own opinion is that the data are strong enough to suggest some waning of protection, but the magnitude might be less than what is observed in this study because of these confounding factors. Also, it might be that the loss of protection is limited to asymptomatic infection and not noticeable in the more clinically important symptomatic infection, hospitalization and death rates.
Even if the results suggested by this study hold, they do not indicate the vaccines no longer work, but simply that their efficacy is somewhat attenuated. A more careful characterization of the breakthrough infection risks relative to unvaccinated infection rates is needed to assess to what degree protection vs. infection wanes, and also to look at the analogous measures for symptomatic disease, hospitalization, and death. If the breakthrough infections are largely asymptomatic infections that rarely lead to severe disease and possibly transmit to others substantially less, then it might not make sense to change the distribution policies on the basis of these results. There are numerous studies measuring immune markers over time suggesting that the vaccine-induced immune protection is quite durable. For example, this study published in New England Journal of Medicine in April measured levels of spike-binding antibodies, neutralizing antibodies, and live virus neutralization in healthy adults for many months after vaccination and found these levels to be strongly retained at 6 months past vaccination, with levels still 500-5000x higher than pre-vaccination. Another paper being written by researchers at University of Pennsylvania and soon to be submitted shows strong and durable targeted memory B-cells, helper T-cells, and killer T-cells, markers more indicative of long term immune protection than antibody levels, through at least 6 months vaccination. There are numerous others, and they have consistently found durable immune markers post-vaccination. Many of these studies were pre-Delta, so we need to see to what degree these results hold for Delta variant infections, but it is hard to imagine immune protection waning so much in this time frame to render the vaccines anywhere near non-protective.
There are other considerations in assessing whether boosters should be used or not. The pandemic is an international problem and given many countries in the world are having trouble securing enough vaccine for substantial vaccination of their populations, the benefit that a third shot might provide to boost immune protection somewhat in a country that already has high levels of vaccination needs to be weighted against the benefit of helping other countries obtain primary vaccination, that could reduce international spread and development of new variants that could eventually affect Israel.
It is clear we still have a lot to learn, and need continuing analyses and assessment using rich data like these to further characterize the durability and strength of immune protection provided by vaccines and previous infection, especially for emerging variants like Delta, to intelligently inform the policymaking.
There a paper published in Toxicology Reports that included an analysis purporting to estimate causal vaccine deaths in the US claiming between 227,792 and 1,381,429 have died "from" the vaccine in the USA within 31 days of inoculation, suggesting the vaccines killed 5 for every 1 saved, and that this was just the tip of the iceberg.
Here is the paper. Note that the senior author of the paper is the editor-in-chief of the journal, and listed as the editor who handled the peer review of this paper. This is unusual. Later they said he was mistakenly listed as the handling editor and it wasn't really him. Oops.
Like Kirsch's VAERs analysis critiqued in a previous blog post, their conclusions are completely driven by the assumptions they make on the background death rates and underreporting rate. However, their assumptions as detailed in his appendix are even more extreme than Kirsch's.
Implicitly assuming reporting rates to VAERs are constant as a function of the number of days since inoculation, the authors posit that the background rate of reported VAERs deaths not caused by vaccine can be estimated from the typical daily VAERs death reports >31 days after inoculation, and then assume that any reported deaths in the first 31 days above this number must have been caused by vaccine.
They subsequently double down on this assumption by using it to justify very high underreporting rates between ~125x and ~500x from which they extrapolate these numbers up to his enormous projected numbers. If events are more likely to be reported closer to vaccination, e.g. a death occurring the day after vaccination much more likely to be reported to VAERs than one occurring 2 months later, then this methodology will produce extremely biased estimates of purported vaccine-caused deaths.
It is especially strange they make this assumption given that elsewhere in the paper they acknowledge that deaths right after inoculation are far more likely to be reported than those much later in making a different point (see page 1675:)
Furthermore, they emphasize that these 225k to 1.4m deaths they concluded were caused by vaccines within 31 days of inoculation are only the tip of the iceberg, claiming many more deaths will happen months and years after inoculation. In fact, most of the paper focuses on these deaths they speculate will happen much later, laying out their concerns, but not providing any evidence that these things are actually occurring.
Also, like Kirsch, they never assess the plausibility of their assertions. If 225k-1.4m deaths were caused by vaccines within 31 days of inoculation, were is the evidence of this and how would it go unnoticed? Here are the excess deaths in the USA from ourworldindata
The majority of USA vaccinated residents were vaccinated between March 1 and July 31, a time during which excess death counts lower than any time since the beginning of the pandemic. How could this be if their claims were true? Tracking the excess deaths over time, we see they have spiked precisely at the times of high levels of confirmed COVID-19 cases and COVID-attributed deaths, including the April 2020 spikes and summer 2020 pre-vaccination spikes, and the winter 2020 spike that started pre-vaccination but was ongoing when the public vaccination commenced.
Could the winter 2020 spike be caused by misattributed vaccine deaths as they might claim? Well, this spike in excess deaths started increasing precipitously in November 2020 and reached its peak in early January, when vaccinations had just started, and then sharply declined in January and February as vaccinations of seniors and other vulnerable members of society were ramping up. And then this lull of the lowest weekly excess death numbers of the pandemic kicked in from March through July, the time period during which most vaccinated USA residents received their inoculations, before increasing again in late July and early August as the Delta surge kicked in (also a time with very low daily inoculation rates).
Where would all these hundreds of thousands or millions of purported vaccine-induced deaths be hiding?
To further illuminate this point consider that @hmatejx plotted excess deaths vs. vaccinations and covid cases over time for 100 countries in the world. Here is the USA.
The black line is all cause excess deaths, the blue line vaccinations, and red lines confirmed cases, rescaled to fit on the same plot.
It is clear that that the excess deaths have tracked closely with confirmed case counts, so in spite of imperfections in SARS-CoV-2 testing and reporting, and in COVID-19 death attribution, the order of magnitude seems right.
It is also clear that it is not possible that the vaccines have caused a substantial number of deaths, and highlights the cartoonish nature of Kirsch and Kostoff, et al.'s projections, and their clear implausibility.
This analysis of recent US research looks to me to be useful: it includes a lot of the dificult confounding effects that make single numbers unhelpful: and usefully analyses in detail the effect of different variants.
There is some concern of confounding with variant type since Delta emerged more recently the longest after vaccination.
But looked at waning VE separately by variant, and found that the waning was not an artifact of Delta, and that the waning effect is seen across all variants.
They also analyzed Pfizer vaccine effectiveness vs. hospitalization, with cases defined as hospitalizations with positive PCR test between 14 days before admission to 3 days after admission, using a similar model.
There is no sign of any waning VE vs. hospitalized infections in any age group (see plot above for legend for which color line corresponds to which age group), remaining near 90% through 5m post vaccination. Taken together, this paper validates other data showing:
(1) VE vs. infection wanes down to ~50% after 6m
(2) VE vs. serious disease remains >90% after 6m.
These results match what was found by a study of waning VE done in Israel last month that also rigorously modeled various key confounding factors .
Note: It is disclosed that Pfizer sponsored this study and was involved in the interpretation. Thus, I encourage critical assessment of the design, analysis, and interpretation.
But from my initial reading, the study was well designed, rigorously analyzed using appropriate statistical analysis methods that account for known confounders as best as possible, and the conclusions they draw are appropriately supported by the data, with appropriate accounting for uncertainty. Thus, it appears to be a well-done study that adds to our accruing knowledge of waning vaccine effectiveness for Pfizer vaccines.
Appendix 10/7/21 -- NEJM Study on Waning Immunity from Qatar:
Another paper just came out in NEJM with further corroborating evidence for the waning of vaccine effectiveness vs. infection from a large matched case/control (vaccinated/not) test negative design study out of Qatar.
The study similarly found a sharp reduction in VE vs. infection at 5-6m after vaccination. The magnitude was greater than the USA or Israeli studies showed. This might be related to the fact that Qatar does extensive asymptomatic testing, testing every person in the country every 2 weeks regardless of symptoms, so the vast majority of detected breakthrough cases are symptomatic. We know the vaccines protect less strongly against asymptomatic than symptomatic disease, especially over time as the waning effect is much stronger in asymptomatic disease.
Also, the Qatari population demographics is very different than most other countries -- nearly all younger people and from all over the world -- with only 1-2% over age 65. These dynamics can strongly affect the risk of exposure, especially with certain travel and other privileges only available to vaccinated individuals. The Qatari study looks very well designed, and provides an important complementary perspective on vaccine effectiveness over time in a different population demographic and in a setting with extensive asymptomatic testing.
On the positive side, as we have seen in other studies, even with this sharp decline in VE vs. infection at 5-6m, the VE vs. serious/hospitalized/fatal disease remains much more durable over time, remaining near 90% even at these time points.
CDC study: Vaccination offers better protection than previous COVID-19 infection Laboratory-confirmed SARS-CoV-2 infection was identified among 324 (5.1%) of 6,328 fully vaccinated persons and among 89 of 1,020 (8.7%) unvaccinated, previously infected persons.
Nice try, but the comparison should have been between those 324 fully vaccinated with COVID and 89, unvaccinated. They keep comparing the 6328 with the 1020, which doesn't make sense and the headline is misleading, because they base their results on COVID like illness (?), not the actual COVID positive patients. It means people with symptoms like COVID-19. Many viral diseases have similar symptoms. So basically they use that term for all patients that arrive with symptoms, even though some of them will actually end up negative if tested.
The study should have included data of ages and the time of vaccination versus infection for the actual COVID positive cases. From the data they have compiled, you can't deduce anything regarding those groups other than the numbers of 324 fully vaccinated and 89 unvaccinated. They're using "hospitalized with COVID-like symptoms" as the overall criteria for the two groups, and even though the two groups differ wildly in age, they're treating them as though they're matched. Shouldn't a study like this be based on people who actually test positive for COVID? If it did, it wouldn't have numbers that favor Pfizers bottom line. Look at the conflict of interest statement.
THE IMPORTANT PLAYERS IN MEDICINE ARE NOT HOLDING FEDERAL HEALTHCARE AGENCIES ACCOUNTABLE FOR THEIR ACTIONS
Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.
There are four major trials of ivermectin for early COVID, one completed and three (3) in progress. Patients received about 20% of the ivermectin dosage they should have in the completed Together Trial in which it showed possible mild benefit. Principal investigator, Dr. Edward Mills, announced that ivermectin showed “absolutely no benefit” but the actual data showed otherwise. Was Dr. Mills biased? ACTIV-6, COVID-OUT, and PRINCIPLE are using even lower doses of ivermectin than the Together trial, clearly absurd and suspicious for corruption.
Who will Share the Truth?
Many physicians are anxiously awaiting the results of these trials. They deserve to know what is going on but will major medical journals report the underdosing in all the trials? The editors in chief of NEJM, JAMA, the Annals of Internal Medicine, CHEST, British Medical Journal, and the Lancet have been informed. The president elect, treasurer and head of ethics for the ACP have been told. The president, president elect, and CEO of the Infectious Disease Society of America have been told. 15 board members of the American Medical Association have been told. So has the principal investigator of ACTIV-6 and WCG IRB. The principal investigator of COVID-OUT at the University of Minnesota has been told. So has the the PRINCIPLE group in London. Moreover, the president of NIH and deputy chairman of NIAID have been told.
The Response
After numerous email communications with associated letters articulating the situation this was the response obtained: “At this time, the issues you have raised regarding dosing are under active consideration by those involved in oversight of the study. There is not much more we can say at present but anticipate the study team may have something to say in the future.”
It’s been 11 weeks since Together was reported and patients are still being randomized to placebo or a dose of ivermectin they know doesn’t work.
Goodbye Practice of Medicine
The pandemic has seen a lot of controversial decisions by our federal healthcare agencies. By and large physician healthcare organizations have rubber-stamped everything the government does. The AMA went public that ivermectin should only be used in trials. All fear their members will never see grant money from NIH or drug companies again if they misspeak.
Medical journals rarely say anything controversial. JAMA printed the infamous Lopez Medina study sponsored by 5 drug company competitors of ivermectin which 100 experts demanded be retracted but wasn’t. Many individual physicians speak their minds often to consequences. No one with clout will stand up to Dr. Anthony Fauci et al. even when their decisions are absurd. On that topic, numerous researchers have informed us off-record that to go up against Fauci is to lose any hope of NIH funding.
Dosed for Failure
In Together, ivermectin was dosed initially at one day of 0.4 mg/kg on an empty stomach. When challenged that it was ridiculous, principal investigator, Dr. Edward Mills increased it to 3 days which is still ridiculous. Fluvoxamine was given for 10 days. Ivermectin is 2.6 times better absorbed with a meal. For the delta variant, patients should receive 0.6 mg/kg with food for 5 days or until cured per the FLCCC Alliance. There is much evidence of the safety of this dosing on the FLCCC Alliance website. One might think that Dr. Mills’ mentor, Bill Gates, Dr. Fauci’s friend, might have had something to do with it. Yes, that sounds conspiratorial, and, no, we are not conspiracy theorists here.
Here is a review of the ivermectin portion of Together. By COVID Analysis. Analysis of Ivermectin in Together
Hiltzik the Hack
The newspapers, who would have no idea how to review a study, gleefully leaped to ring the death knell of ivermectin. Michael Hiltzik, the business reporter for the LA Times, had written an article very critical of ivermectin after Together was reported. When I told him of the problems in the trial and that ivermectin was being underdosed in all 4 major trials his response was:
“Thanks for writing. It’s crystal clear that no evidence exists for the efficacy of ivermectin against COVID. My feeling is that any physician who prescribes it for that purpose should have his license scrutinized.”
For a TrialSite review of Mr. Hiltzik’s writing, follow the link.
Media Blackout
Together was presented to NIH 8/6/21. NIH did not comment on the obviously absurd way they treated Ivermectin patients. There has been little to nothing in the press or in medical journals about the problems with the study. It has not been officially peer-reviewed. Dr. Mills attacked ivermectin proponents and showed a high level of bias. One hopes when the ivermectin portion of Together is peer-reviewed, Dr. Mills will be cited for investigator misconduct.
The Test: And We Are Watching
The important people in medicine have had this information only a few days. We will find out who is willing to stand up for honor and integrity, who will stand up for right and wrong and who will stand up for physicians and patients.
The power of medical journals and physician organizations is limited by how much they can induce physicians to respond. I don’t have a lot of faith in physicians right now. They wouldn’t use repurposed drugs that might have worked on sick COVID patients. Our totalitarian medical system has them afraid of being called before a medical board if big brother doesn’t like what they do.
I hope someone in medicine will stand up but I’m not holding my breath until someone does. You are better off going to your congressmen and senators about the obvious corruption. NIH is spending millions of taxpayer dollars to intentionally make ivermectin fail. Maybe they will pay attention
NYC: Is Safety Being Sacrificed?
In the Spring of 2020, every evening at 7pm Manhattanites would lean out their windows or stand on their balconies banging pots and pans, blowing horns, applauding, and making any cheering noise they could acknowledging New York City’s first responders just for doing their job. At that time, an ambulance siren would sound every ten minutes for a victim of Covid 19. The ambulance drivers and EMT’s of New York City worked continuously during the peak of the pandemic. Now, those first responders, firemen, police officers, and sanitation workers are just some of the New York City employees protesting a vaccine mandate put into place by New York City’s Mayor Bill de Blasio. The mandate takes effect at 5pm on Friday, October 29. If any of the 160 thousand employees of the city of New York do not comply with the vaccination requirement they won’t be getting a paycheck. According to The New York Times, the head of New York’s Emergency Medical Service’s worker’s union, Oren Barzilay said: “The mayor seems to have forgotten the sacrifices we made during the pandemic.” Mayor de Blasio insists if there is a shortfall of workers, vacations will be canceled, and workers who have complied with the mandate will be forced to work overtime.
Up until October 20, it was acceptable for city workers to get tested weekly as opposed to getting vaccinated. This past Thursday, NYC Municipal workers protested outside Gracie Mansion, de Blasio’s official residence. The protesters insisted they’re not anti-vaccine, just anti-mandate. The mayor is enforcing the mandate saying that as of Monday, November 1, if any unvaccinated municipal worker shows up for work, they will be put on unpaid leave. Mayor de Blasio is offering a $500 bonus for any worker who gets vaccinated before the deadline.
As of Friday, October 29, 2021, 80% of the New York City Police Force has been vaccinated and 72% of New York City Firemen have complied with the mandate. New York City has the largest fire department in the United States. Both the Uniformed Fireman’s Association, the firefighter’s union, and the Patrolmen’s Benevolent Association, the NYPD union, filed lawsuits trying to prevent the mandate. Their lawsuits were rejected by a state judge. The main complaint was that the city gave municipal workers only 9 days to get vaccinated. Now, the unions are in negotiations for an extension.
But New York City is already starting to see the effects of a slowdown by municipal workers. Parts of the city are lacking timely garbage pick-up and the head of the New York City Detectives union (The Detective’s Endowment Association) Paul DiGiacomo, has predicted a possible mass retirement. “It won’t be easy to obtain and replace those people,” he said in an interview on NY’s 1010 WINS news radio. DiGiacomo also said de Blasio is enforcing the mandate for his own “political purpose.”
TrialSiteNews has reported on Chicago’s vaccine mandate for their police department and the questions about safety in Chicago where the murder rate has climbed 56%. The Chicago mandate has already resulted in about two dozen firefighters and EMT’s being placed on a “no pay” status. In the meantime, the Chicago Police Union is still challenging the mandate in court.
Like Chicago, New York City is now facing a potential safety problem. Now that a vaccine is mandated in New York, the same questions asked about Chicago are now applicable to New York. What’s more important, vaccine mandates or protecting the public?
Never Again: $1.9m in Grant to Study How to Protect Nursing Home Residents from Pandemic
TrialSite chronicled horrific outcomes associated with long-term care facilities (nursing homes) during the pandemic. That respiratory infections can spread rapidly in nursing homes is not new. But the scope and severity of what unfolded was frankly, unacceptable. To study how to improve respiratory infection outbreaks in nursing homes recently research faculty at the University of Missouri received a $1.9 million 4-year grant from the Agency for Healthcare Research and Quality. The research team led by Lori Popejoy and Amy Vogelsmeier were working as registered nurses early in their careers, they saw firsthand how quickly respiratory infections, such as the common flu, could spread in nursing homes.
The Data
According to research from Kaiser Family Foundation (KFF) nursing homes deaths represented an absolute national tragedy as 31% of all COVID-19 deaths in the U.S. as of June 30, 2021, involved nursing home residents.
While the pandemic waned after the initial surge and with the onset of the Delta variant health authorities and health providers focused on younger populations. However, older Americans continued to suffer via high risk of death due to SARS-CoV-2.
The Study
To help assess how more than 500 Missouri nursing homes have responded to the COVID-19 pandemic, Popejoy and Vogelsmeier, will identify strategies nursing homes used to overcome challenges related to the pandemic, the research team hopes to develop recommendations nursing homes across the country can use to improve quality of care and, ultimately, patient health outcomes.
PI Point of View
“Outbreaks of respiratory infections are notoriously hard to control in places like nursing homes because you typically have enclosed spaces where many elderly people are close together,” said Popejoy, an associate professor in the MU Sinclair School of Nursing. “While a global pandemic of this magnitude with COVID-19 has been rare, infectious outbreaks in nursing homes do occur from time to time. So, it is important to help guide these facilities in managing infectious diseases so they are better prepared for the next outbreak.”
What Worked…What Didn’t
“We will be taking a comprehensive view by comparing facilities in both urban and rural areas, as well as facilities with both high COVID-19 infection rates and facilities with low infection rates, which allows us to potentially identify patterns for what went well or what can be improved,” said Vogelsmeier, an associate professor in the MU Sinclair School of Nursing. “By talking to various stakeholders, including residents and their families, nursing home staff and administrators, public health experts and the Department of Health and Senior Services, we can find helpful strategies to assist nursing homes to better prepare and respond to infectious outbreaks.”
Labor Shortages
Since the pandemic began, nursing shortages that already existed have gotten worse due to burnout and exhaustion. A recent MU study found 31% of all Missouri nurses are older than age 54, and some rural Missouri counties have more than half of their nursing workforce aged 54 or older.
“The workforce was already at a breaking point, and now the pandemic has pushed many of these older nurses into retirement,” Popejoy said. “These kind of studies can help inform public policy and hopefully implement best practices that nursing homes dealing with similar challenges can implement nationwide.”
Vogelsmeier added how powerful empathy can be when talking with nursing home administrators and staff, given she and Popejoy know firsthand the obstacles nursing homes are trying to overcome.
“When we were in practice, we could influence things at a very local level, but now as researchers, we have the chance to influence things at the state and national level,” Vogelsmeier said. “It is very rewarding to make a difference that positively impacts nursing home care and quality, which ultimately improves patient health outcomes.”
Funding
Funding for the study was provided by the Agency for Healthcare Research and Quality.
Lead Research/Investigator
Lori Popejoy PhD, RN, FAAN, Associate Professor
Amy Vogelsmeier, PhD, RN, FAAN, Associate Professor
https://feeds.resonaterecordings.com/the-covax-files
https://podcasts.apple.com/.../the-covax.../id1546280287...
Other expert guests also appearing on this podcast include: Dr Maria Elena Bottazzi: Associate Dean of Tropical Medicine, Baylor College of Medicine Dr Nikolai Petrovsky: Prof of Medicine and vaccine developer, Flinders University Dr Andrew Read: evolutionary biologist & Prof of Biology, Penn State University
The discussion I was involved in covers the following topics:
"When people cherry pick simplified summaries of data that have not been properly stratified for normalized they can significantly distort the truth (and cause confusion), and this has been happening a lot during the pandemic with uninformed members of the public trying to interpret complex and multi-layered scientific data"
She is incredibly skilled as an investigative journalist and scientific communicator, with very accessible, well-organized podcasts.
For our clown once more real data from Sweden:: Effectiveness of Covid-19 vaccination against risk of symptomatic infection hospitalization and death a swedish total population cohort study .pdf
No more vaccine protection at all if we discount natural immunity and recovered it is highly negative.
Can you show me your assumptions and maths here? It does not seem like that to me.
There is no sign of any waning VE vs. hospitalized infections in any age group (see plot above for legend for which color line corresponds to which age group), remaining near 90% through 5m post vaccination.
This is obvious fake data. In both countries CH/DE 33% (rate!) of hospital cases/deaths are double vaxx- So USA is a propaganda wonderland. But I refer to the actual data given in yesterdays TV news. So vaccine protection is 50% at best. What all serious reports confirm. Sweden is even at a lower rate. If we count in a 50% minimal protection from recovered then vaccine protection is 0=zero now for at least Pfizer/Oxford crap.
Moderna look much better. But the older and 100x more vulnerable have been vaccinated first ... with crap..(greed kills) .But reality is that most countries after the peek of the delta wave do have 70% recovered immunity. So vaccines do already produce a negative effect.
So looking at studies is difficult if these make no proper timeline. A good one can be seen in the excellent Swedish study.
These results match what was found by a study of waning VE done in Israel last month that also rigorously modeled various key confounding factors .
A very bad example is the above fake study from Israel. They write the following obvious missleading lie::
The study data describes 4,785,245 individuals. Of these individuals, 12,927 had a positive PCR test and
348 deteriorated to a severe condition.
But this figures only work because they look at a period with more or less no infections happening...So the lie is made intentional by using misleading data.
Everybody familiar with Israel data immediately sees that this is crap. During the worst day Israel had close to 20'000 cases. 80% according multiple hospital information have been double vaxx. So already the worst day did deliver more PCR+ that they claim for the whole period. Nobody will look at this crap.
The current vaccine terror (FM/R/J/B) meme is the following:
1) Claiming vaccination is better than natural immunity by using improper aligned data. Reality (Israel 2 mio base data): Natural infection protects at least 25x better than "vaccine" (Pfizer)!
2) High rates of long Covid. Now the folks start to count in Symptoms after 3 months past infection. These symptoms mostly are caused by lock down and social pressure (lost labor school problems etc..) and almost all studies are against all rules for psychological studies.
3) Claiming vaccines work. Since day one recovered have been included into the vaccination program what is now a highly elevated 50..70% cheating factor. So for most vaccines it is clear: These no longer work.
4) Natural immunity has been 75% for Alpha and now is 83% for delta. Using this figures vaccines never did work....Except short time (1..4 months) for people with no natural immunity.
Why do we damage the 83% that wont need a monoclonal cancer chemo (called vaccine what it is not)? It was always easy to find the vulnerable. 85% (UK,CH data) of all serious CoV-19 PCR+ cases had at least one comorbidity.
It even is much easier to treat all PCR+. Look at India. Ziverdo kit for 1-2$ depending on source and your country will be free of COV-19 within 4 weeks!
Be aware of the US vaccine terror propaganda and learn how to ignore fake studies that our clown regularly links.
Favipiravir Sales Up 1567% in Just 2 Quarters as UAE Venture Supplies Economical COVID-19 Antiviral
The Dubai Health Authority’s (DHA) National Guidelines for Clinical Management and Treatment of COVID-19 added Favipiravir (Avigan) to the list of approved therapeutics for COVID-19 over the summer. The drug is developed by Japan-based FUJIFILM Chemical Toyama Ltd (FUJIFILM), which licensed the rights to the Favipiravir (trade name Avigan) to Global Response Aid, a Dubai, United Arab Emirates (UAE)-based 50-50 joint venture owned by logistics venture Agility (KSE/DFM: AGLTY) and AiPharma, a pharmaceutical research and development company, that controls joint marketing and distribution rights to Avigan globally outside of Japan, China, and Russia. Sales of the repurposed antiviral targeting COVID-19 have skyrocketed from $9 million in Q1 to $150 million in Q3 2021. Over the past 12 months, governments stockpiled over 80 million tablets. Demand for early-onset COVID-19 care in the UAE has driven AiPharma to ink a deal with the Middle East generic drug producer Pharmax to spearhead Avigan regulations, sales, and distribution efforts. This past week alone, GRA (AiPhrma) and Pharmax delivered 1.2 million tablets to the Emirates for Abu Dhabi-based ADQ’s affiliate RAFED—a group purchasing company for healthcare. Apparently, RAFED has already procured more. Favipiravir competes with off-label use of therapies such as ivermectin and Molnupiravir—although the latter isn’t yet approved anywhere. However, countries are buying Molnupiravir from Merck in anticipation of imminent emergency use authorization in places like Europe and America. Meanwhile, the players behind Favipiravir’s distribution worldwide have a message. The CEO of AiPharma, Dr. Alessandro Gadotti, declared the demand in Avigan will skyrocket because governments “understand the need to have an arsenal of different therapeutics to treat different [COVID-19] patient populations.”
What follows is a breakdown of this recent news released by AiPharma, the pharmaceutical company and 50% owner of Global Response Aid, and an overview of the unfolding global Favipiravir market for early-onset SARS-CoV-2, the virus behind COVID-19.
Favipiravir Background
Back in March 2020, TrialSite first introduced readers to Favipiravir (Avigan). Developed by Japan’s FUJIFILM Toyama Chemical Co., Ltd., the product was approved by Japanese health authorities in 2014 as a stockpile antiviral for novel influenza, that is strains that cause more severe disease rather than the seasonal type.
Favipiravir is now authorized on an emergency basis for treating COVID-19 in many countries, including Russia, India, Serbia, Turkey, and others. Of note, many other countries allow some form of compassionate use of the drug. As the patent expired in 2019, some nations such as China have seized on the opportunity. TrialSite reported recently, the Chinese military successfully secured a patent for the drug targeting COVID-19.
What is Favipiravir?
A small molecule, this novel, broad-spectrum antiviral agent includes activity against all RNA virus families tested, including rabies, Ebola, Lassa, and coronaviruses. It has been in clinical trials for influenza, severe fever associated with thrombocytopenia, and Ebola. It has been used under compassionate release for Ebola, rabies, Lassa fever, norovirus, severe acute respiratory syndrome, and SARS-CoV-2, the novel coronavirus that causes the coronavirus disease of 2019 (COVID-19).
Does Favipiravir help treat COVID-19?
According to many countries’ health authorities—yes it does help treat Covid. However, hardly any Western press tracks these authorizations. The drug is now available on a compassionate use basis in the UK. Dozens of clinical trials have been completed with mixed results. A rapid meta-review in September 2020 (based on four studies) noted that the drug led to clinical and radiological improvement, but no reduction in mortality nor differences in oxygen-support requirement were found while more rigorous studies were sought.
In Russia, multiple products are now authorized—TrialSite reported the very first favipiravir product was authorized in June 2020, called avifavir. Multiple generic companies in India have emergency use authorization to produce, market, and distribute favipiravir-based drugs under different generic names. Glenmark Pharmaceuticals is one of those firms. By September 2020, sales grew, and in June 2021, the company reported positive clinical trial results.
Global Response Aid, along with partners Appili Therapeutics and Dr. Reddy’s Laboratories, another Indian generic pharmaceutical company, applied for market authorization with Health Canada during December 2020. The health regulator needed more clinical trials data, as did the Japanese authorities for FUJIFILM’s market authorization submission in that Asian country. The Japanese regulatory needed more clinical data.
Nations that have authorized use for emergency purposes include Mexico, Thailand, Indonesia, India, Russia, UAE, and Malaysia. Compassionate use programs for favipiravir include the UK, Greece, Hungary, and Saudi Arabia.
Is it true that Western countries with big Pharma lobby avoid use for COVID-19?
Yes. That certainly appears to be the case. The Global Response Aid consortium sought to secure approval in Canada with no luck of a break. Ditto for the effort in Japan, where “Big Pharma” has a powerful presence.
Are Pharma companies divvying up the world in territories?
Very Possibly. The industry has fought back the use of ivermectin, supporting a smear campaign fueling fear, uncertainty, and doubt for any off-label use.
Even though favipiravir is under study in the United States, the United Kingdom, and elsewhere (as is ivermectin), these markets will commit to Merck’s Molnupiravir should it be authorized under emergency use or approved, as well as other branded antivirals as they come available.
Why the skepticism about Western market interest in repurposed generics?
TrialSite advisors have suggested ivermectin is under-dosed in major clinical trials in America and the UK, for example. While favipiravir is also an understudy of the PRINCIPLE study, there seems to be no urgency as compared to vaccination or the level of buzz associated with Merck’s antiviral.
Did the USA spend $200+ million on favipiravir clinical trials?
By 2015, defense subcontracting biotech companies were testing favipiravir for an emergency pandemic or biowarfare scenarios. The results of those studies were never made available to the general public. Read TrialSite’s articles on the topic, such as “Favipiravir Follow-up: DoD Led the Way, but U.S. is Left Out?”
How many COVID-19 trials involve Favipiravir?
14 studies have been completed as of this writing, with a majority of them showing some benefit. For example, a recent study done in Saudi Arabia called Alotaibi et al., peer-reviewed in the International Journal of General Medicine in 2021, involves a retrospective study evaluating hospitalized patients in Saudi Arabia. The results demonstrate lower morality with favipiravir as compared to hydroxychloroquine for the management of COVID-19.
How many clinical trials targeting COVID-19 currently ongoing?
36 clinical trials are ongoing.
How many in North America?
TrialSite reported on a favipiravir study led by Stanford University’s Bonnie Maldonado. The Phase 2 randomized controlled trial was to evaluate the safety and effect on 149 COVID-19 patients.
The other major trial (NCT04358549) in the U.S. is also completed. Sponsored by FUJIFILM trial sites including HonorHealth (Arizona), Boston Medical Center, and others, this study targeted 50 participants to be randomized in a 1:1 ratio to receive either favipiravir and standard of care or standard of care alone. Results haven’t been published. TrialSite has requested information from both studies, including Stanford’s Dr. Maldonado.
In Canada, Global Response Aid’s AiPharma, in partnership with Appili Therapeutics, continues a Phase 3 U.S.-Canada study called PRESECO (PREventing Severe COVID-19).
How is commercial territory divided?
FUJIFILM will market the drug to Japan for COVID-19 should Japanese health regulators authorize the drug at some point for the novel coronavirus. In China, TrialSite reported by June 2020, HISUN, a Chinese licensee, stated the positive impact of the drug in China during the earlier part of the pandemic.
In Russia, generic producers have the rights, as is the case in India. In Canada, Appili Therapeutics partners with Global Aid Response (AiPharma). AiPharma has the rest of the world.
What are the most recent favipiravir sales numbers?
As reported by AiPharma, they declared sales this year have grown from $9 million in Q1 to $150 million in Q3.
Why did AiPharma partner with Pharmax in the Gulf Emirate region?
To help satisfy the growing demand for the product, according to AiPharma’s recent press release.
What’s Pharmax’s background?
Pharmax is a UAE-based generic pharmaceutical production company.
Who are the players touted recently?
In a press release meant to announce the progress of sales and momentum, Global Response Aid and AiPharma discussed rapidly growing sales as well as the significant demand in the UAE.
Dr. Madhukar Tanna, who leads Pharmax as CEO, shared the importance of making this drug available “…given the current and potential future surges of COVID-19.”
Dr. Alessandro Gadotti, CEO of AiPharma, declared they have been working “tirelessly to deliver solutions to meet the global health crisis.”
What is RAFED and why are they important in the Gulf region?
RAFED is a group purchase organization for healthcare, positioning itself as “The UAE’s leading healthcare supply chain
I'm sorry if this has been posted before but I just came across this:
https://onlinelibrary.wiley.com/doi/10.1111/eci.13554
Remember when they were telling us the IFR is 1%, 10X that of the flu (.1%) ? Our hospitals will be overrun !!
Turns out:
"the available evidence suggests average global IFR of ~0.15% and ~1.5-2.0 billion infections by February 2021 with substantial differences in IFR and in infection spread across continents, countries and locations."
I guess that means flu vaccine mandates are going to be around the corner because now they are almost the same ...
Display MoreI'm sorry if this has been posted before but I just came across this:
https://onlinelibrary.wiley.com/doi/10.1111/eci.13554
Remember when they were telling us the IFR is 1%, 10X that of the flu (.1%) ? Our hospitals will be overrun !!
Turns out:
"the available evidence suggests average global IFR of ~0.15% and ~1.5-2.0 billion infections by February 2021 with substantial differences in IFR and in infection spread across continents, countries and locations."
I guess that means flu vaccine mandates are going to be around the corner because now they are almost the same ...
Hi UncertainH,
That would be correct, if the countries that care about deaths - the developed ones with older populations and good health systems - had that 0.15%.
And, at least in the UK, our hospitals have been on the edge twice now, and this winter are on the edge again. We may be Ok this time because we cam sustain a much higher COVID rate than before due to high vaccination and therefore lower Uk IFR now. Of course vaccination reduces infections as well as deaths - but it reduces deaths a lot more than infections, hence vaccinated show lower IFR.
Three factors make that estimate wrong for US and UK (at least until we got most of our populations vaccinated).
(1) In some countries COVID deaths are dramatically undercounted (also possible is dramatic overcounting, but in terms of world population average, undercounting is more likely.
The infection fatality ratio (IFR) is the risk of death per infection and is one of the most important epidemiological parameters. Enormous efforts have been undertaken to estimate the IFR for COVID-19. This study examined the pros and cons of several approaches. It is found that the frequently used approaches using serological survey results as the denominator and the number of confirmed deaths as the numerator underestimated the true IFR. The most typical examples are South Africa and Peru (before official correction), where the confirmed deaths are one-third of the excess deaths. We argue that the RT-PCR-based case fatality ratio (CFR) is a reliable indicator of the lethality of COVID-19 in locations where testing is extensive. An accurate IFR is crucial for policymaking and public-risk perception.
(2) demographics
We find that age-specific IFRs follow an approximately log-linear pattern, with the risk of death doubling approximately every eight years of age. Using these age-specific estimates, we estimate the overall IFR in a typical low-income country, with a population structure skewed towards younger individuals, to be 0.23% (0.14-0.42 95% prediction interval range). In contrast, in a typical high income country, with a greater concentration of elderly individuals, we estimate the overall IFR to be 1.15% (0.78-1.79 95% prediction interval range). We show that accounting for seroreversion, the waning of antibodies leading to a negative serological result, can slightly reduce the IFR among serosurveys conducted several months after the first wave of the outbreak, such as Italy. In contrast, uncertainty in test false positive rates combined with low seroprevalence in some surveys can reconcile apparently low crude fatality ratios with the IFR in other countries. Unbiased estimates of the IFR continue to be critical to policymakers to inform key response decisions. It will be important to continue to monitor the IFR as new treatments are introduced.
(3)
Any counting after approx November 2020 will include lower IFR due to vaccination. Countries rollout vaccinations first to the most-at-risk so IFRs can drop quite quickly.
For example August 2021 in UK:
In addition
IFR is one of the most interesting and difficult figures to reason about.
You can measure UK IFR quite well from the ONS data on infection rate and deaths. Both are pretty well bulletproof: deaths measure everyone, infection data from ONS random samples households longitudinally over 3 months / household with very little bias (they bribe people to take part with £100 coupons per visit).
However even with that, infection rate in institutions will e different from that in the community.
One problem is that worldwide comparisons are no longer meaningful with some countries fully vaccinated and some not at all. More complication is that the not vaccinated countries may been hit hard by COVID in the past and have natural immunity reducing death rates now.
THH
I guess that means flu vaccine mandates are going to be around the corner because now they are almost the same ...
In the UK we have neither COVID nor Flu vaccine mandates (except for health and care home workers where for obvious reasons COVID spreaders are pretty disastrous).
But our doctors our doing everything they can to up both Flu and COVID vaccination rates, because our hospitals are under threat this Spring potentially from both Flu and COVID. We always have a difficult month of two from Flu, due to running hospitals at very high besd capacity in normal times. COVID on top of that is not good, unless we can get hospitalisation rates down.
Worth pointing out that here, the government does not much care. After 18 difficult months the doctors are terrified. Everyone is pretty well exhausted from previous waves.
