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Daniel Horowitz Op-ed: The FDA is planning a therapeutic jihad on American children in June


Commentary by Daniel Horowitz | May 12, 2022

Read more at https://www.conservativereview.com/horowitz-fda-therapeutic-children-2657308197.html/

Typically, a lack of efficacy and a cataclysmic level of hundreds of different side effects would be reason to take a therapeutic off the market. But in the post-Nuremberg Code era we find ourselves in, such outcomes serve as a resume enhancer for the product. The FDA is planning a blitz of increased approvals of the shots on the youngest of Americans, yet not a single national Republican has stood up and said “No.” Only one governor, Ron DeSantis, has recommended against their use in children. Which will be the first state to block implementation of the FDA’s new therapeutic jihad on behalf of Big Pharma?

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has an ambitious schedule for this coming June. Here are its upcoming meetings.

June 7: Approval of Novavax first time for those over 18.

June 8: Approval of Moderna in teenagers.

June 21: Approval of Moderna in kids under 6.

June 22: Approval of Pfizer in kids under 5.

June 28: Exploring new shots for new variants.

Isn’t it interesting how they are meeting about the need for new shots for the current variants after already likely approving old shots on babies who don’t need the shots and for a variant that hasn’t existed for over a year?

Here we have many European countries banning the Moderna shot on those under 30 because of myocarditis, yet our government will likely expand its use to babies at a whopping dose of 25 micrograms! We now have over 1.2 million adverse events reported to VAERS, and CDC researchers admitted in a JAMA paper that the myocarditis numbers – just shy of 40,000 – are “likely” underreported. Also, we now know that Pfizer and the FDA knew about 1,223 deaths shortly after release. As for Moderna, we don’t have a single court-released document from the company yet, so who knows what they are hiding?

It would be one thing to approve something that worked amazingly for COVID despite terrible side effects. But the shot is a complete bust.

The expectation of negative efficacy from these shots has become so widely accepted that now the only question is who is the next famous politician or celebrity to get COVID multiple times after having gotten three or four shots. Take a look at this chart from the Walgreens COVID-19 index of all its testing this past week broken down by vaccination status:

Have you ever seen a vaccine of which the more doses you get, the more likely you are to test positive? Notice how the unvaccinated account for a lesser share of cases than either their share of the population or of Walgreens-administered COVID tests. The results are based on 81,818 tests administered nationwide in Walgreens stores from May 2 through May 8.

So now they want to take vaccines with such counterproductive outcomes and foist them upon children? Remember, the FDA has already demanded the manufacturers produce a study on subclinical myocarditis. In its Pharmacovigilance Plan Review Addendum for Comirnaty, the agency cited one study at the time of Pfizer’s approval noting that subclinical myocarditis might be 60 times as prevalent as clinical myocarditis. That would bring down the 1 in 1,000 rate among young males to as low as 1 in 17 for subclinical ticking time bombs!

Let’s not forget that in all the children’s trials, there were zero deaths and hospitalizations in the placebo groups. So, what exactly were we trying to protect against – even before we knew the shots weren’t effective and possibly negatively effective? Cold or flu-like symptoms? Well, here is the data of side effects from Moderna’s 5-11 trial:

“The most frequently reported adverse reactions were pain at the injection site (92%), fatigue (70%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23%), axillary swelling/tenderness (19.8%), fever (15.5%), injection site swelling (14.7%) and redness (10%).”

So even before we get to more serious side effects like heart inflammation, we have a massive percentage of children getting flu-like symptoms from the shots, which is what they would get anyway from the virus. How can this pass the threshold of any principle laid out in the Nuremberg Code or the Helsinki Declaration?

It’s gotten so bad that Pfizer and Moderna can no longer rely upon dubious trials showing a 90% reduction in COVID. Especially for young children, even for mild infection, they couldn’t even manipulate any data showing any degree of efficacy, so they had to rely on an arbitrary measure of antibody titers rather than clinical outcomes. In shocking statement before the House Select Subcommittee on the Coronavirus Crisis, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, conceded they would approve the shots on young children even if the manufacturer’s own dubious data shows less than 50% efficacy (and even that is only for minor illness).

“If these vaccines seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize” because they nonetheless reduce the risk of severe disease in the mildest COVID variant, Marks revealed during the May 9 briefing.

Just keep in mind that, according to the CDC, 74.2% of kids 0-11 already got natural immunity from prior infection. So not only will they fail to test kids for antibodies before injecting them, but even the remaining quarter who might be COVID-naive, they are trading risk of death and severe side effects (and pervasive mild side effects) for a possible tiny degree of very short-term efficacy against sniffles, but a long-term negative efficacy against those sniffles. A preprint study by the NY State Department of Health in February showed that the Pfizer shot was just 12% effective against the first Omicron variant for 5- to 11-year-olds, but drops to -41% after just 42 days!

How can any of these shots be administered until we understand why so many data points seem to show intensifying negative efficacy with time? It’s like investing in a stock that first goes up for a few weeks, but then you erase all the gains within a few days and then gradually lose all your principal investment. Every Republican claims to be pro-life, but distributing these shots to young children is not pro-life, even if they are not quite mandated. Would they sit idly by if the federal government distributed abortifacients throughout their states?

Daniel Horowitz Op-ed: FDA’s own Pfizer approval document suggests myocarditis from shot might be bigger threat than COVID


Commentary by DANIEL HOROWITZ | November 09, 2021

Read more at https://www.theblaze.com/op-ed/horowitz-fdas-own-pfizer-approval-document-suggests-myocarditis-from-shot-might-be-bigger-threat-than-covid/

They are not even trying to convince us any more. They are now using brute force to coerce us into COVID fascism, including forced injections, so they have no need to even hide their false information.

In Pfizer’s FDA briefing document prepared for the Oct. 25 meeting was an admission that even according to the company’s own unverified and misleading math, there is a scenario where there would be more hospitalizations among children for myocarditis — just one side effect — than from COVID. “Under Scenario 3 (lowest incidence), the model predicts more excess hospitalizations due to vaccine-related myocarditis/pericarditis compared to prevented hospitalizations due to COVID-19 in males and in both sexes combined,” states Pfizer in page 33 of the document.

How in the world could there be any universe where we would approve a shot, much less promote and force it in many settings, when there is a possibility of greater harm than benefit, when the harm is man-made and the virus is left to chance? They know quite well that this approval will eventually lead to soft and hard mandates, which have already begun in California schools.

The document concludes by expressing the same callous attitude toward those raising concerns as toward all their interventions from day one. “However, in consideration of the different clinical implications of hospitalization for COVID-19 versus hospitalization for vaccine-associated myocarditis/pericarditis, and benefits related to prevention of non-hospitalized cases of COVID-19 with significant morbidity, the overall benefits of the vaccine may still outweigh the risks under this lowest incidence scenario.” In other words, sure, we have no clue what’s going to happen, but it’s always better to err on the side of shoving this on children who have a 99.9% recovery rate.

Moreover, there are a couple of obvious factors that demonstrate clearly, by their own admission, the shots pose more risk than benefit:

  • Already in March, 42% of children 5-17 have had the virus, according to the CDC, and that number is likely much higher following the prolific spread of the Delta variant. So the benefit in terms of lives saved is much less than they predict, because the majority of children likely already have protection even from mild illness. We are not beginning with a clean slate with 100% of children vulnerable to getting the virus. Plus, studies have shown among adults that those who already had the virus not only don’t need a vaccine, but these shots pose a greater risk to them than to those without prior infection.
  • Even the infinitesimal risk of serious illness among young children is clearly limited to a very defined pool of very sick and severely obese children. It would be one thing to just make it available for those children. But if you isolate healthy children, it’s quite evident that so many more lives would be lost than saved because healthy children essentially do not get seriously ill from this virus.
  • COVID hospitalizations among children are grossly exaggerated in the data and conflated with those admitted for other ailments who just had COVID incidentally. A study published in the Journal of American Academy of Pediatrics found, “Nearly one-half of the infected children had coinfection with other common respiratory pathogens.” Scientists from University College London and the Universities of York, Bristol, and Liverpool studied the data from all pediatric COVID-19 infections in the U.K. and found that 61% of the reported pediatric COVID deaths were overstated.
  • This analysis still assumes that the vaccines are over 90% effective. In reality, Sweden’s extremely large study has shown that the efficacy wears off to zero after seven months, and the U.K data demonstrate that thereafter the vaccinated are more likely to get COVID than unvaccinated people. Thus, if the entire benefit of injecting children, as suggested by Pfizer, is to prevent mild non-hospitalized cases, the vaccines actually contribute to the risk incurred, not the benefits reaped from the shots.
  • This analysis ignores the fact that there are numerous other treatment options for children and adults alike that will reduce chances of death without causing side effects like myocarditis. We need not be faced with the false dichotomy between poisonous shots and not treating the virus. Why are these shots getting approval for children’s use before the monoclonal antibodies, which are much safer and have been shown to work even pre-emptively up to eight months later?
  • Are we really going to trust Pfizer’s numbers? In reality, independent studies have found the risk of myocarditis to be much worse. A preprint from University of California Davis found that “for boys 12-15 without medical comorbidities receiving their second mRNA vaccination dose, the rate of CAE [cardiac adverse event ] is 3.7 to 6.1 times higher than their 120-day COVID-19 hospitalization risk as of August 21, 2021.” A recent study of the Danish population published in the Pediatric Infectious Disease Journal found that “the incidence of myopericarditis after COVID-19 vaccination among males appears higher than reports from the United States.” Have you ever wondered why it always seems that the negative information on the vaccines is downplayed and the supposed positive benefits are exaggerated in the U.S. more than elsewhere? Clearly, the signals regarding cardiovascular side effects are greater than U.S. authorities are willing to admit. In September, the U.K. Telegraph reported, “Data from Public Health England (PHE) shows that during that period there were 2,103 extra death registrations with ischemic heart disease, 1,552 with heart failure, as well as an extra 760 deaths with cerebrovascular diseases such as stroke and aneurysm and 3,915 with other circulatory diseases.”

The question everyone should be asking is, “What is the Number Needed to Vaccinate (NNTV) to prevent a single COVID-19 fatality in this age group, and how many people will we kill, maim, and weaken their immune systems on the way to achieving that number?” Dr. Toby Rogers, an economist and statistician, laid out the numbers in simple arithmetic last week. He concludes that if you give Pfizer 80% effectiveness against the 57 reported fatalities over this six-month period, it would work out to saving 45 lives after vaccinating 28 million children. So, the NNTV to prevent a single COVID death would be 630,775 (28,384,878 / 45), but because it’s a two-dose regimen, you would need 1,261,550 total injections.

Now what about the risk? If you take the 128 reported vaccine deaths among those ages 12-24 as a baseline, then utilize Kirsch, Rose, and Crawford’s estimate that VAERS undercounts fatal reactions by a factor of 41, that would amount to 5,248 fatal side effects during the same period of time. Thus, in order to save 45 children, we’d kill 5,248 — for a ratio of one kid saved for 117 killed. And again, this analysis doesn’t account for the fact that for healthy children, there are essentially zero COVID deaths, more than half the children likely already had COVID, there are other treatments available, and on the risk side, we don’t know if there are long-term side effects that will create excess deaths well beyond the shot’s six-month window of efficacy.

Additionally, we don’t even know if those getting the shot now will enjoy anywhere near this degree of efficacy given that the virus is rapidly changing. What we do know, however, from the adult vaccinations, is that adults are more vulnerable to the virus for the first month, then again as the vaccine wanes after six months. Plus, Pfizer’s trial shows that more than half the children experienced cold or flu-like symptoms from the shots. So they admit that there were no cases of serious illness in the control group and are thus using the shot to merely prevent a flu, yet it will likely give them flu-like symptoms up front and make it more likely they will get the virus after six months.

Indeed, there has never been such a lopsided risk-benefit ratio to any medical device approved by our government, even on a limited basis, much less used to bribe and shame children into injecting. As Dr. Eric Rubin, member of the FDA’s advisory committee on vaccines and editor of the New England Journal of Medicine, said during the Oct. 26 meeting: “We’re never going to learn about how safe the vaccine is unless we start giving it, and that’s just the way it goes.”

Editor’s note: This article has been corrected to note that Dr. Rubin is a member of the FDA’s advisory committee on vaccines, rather than the CDC’s Advisory Committee on Immunization Practices (ACIP).

Report: Fetal tissue supplier hired by federal health agencies


waving flagPublished August 06, 2015; FoxNews.com

PP MonsterA company mentioned as a fetal tissue supplier in recent Planned Parenthood sting videos reportedly does business with two federal health agenciesAccording to a report in Politico, Advanced Bioscience Resources, a contracting research company, has made over $300,000 in transactions with the National Institutes of Health and Food and Drug Administration. Both agencies reportedly had contracts with the firm since 2009, and have paid money for materials in order to conduct various types of research, including HIV and eye disease studies.

Politico reports it’s unclear if the firm got any tissue from abortions at Planned Parenthood, though the company was mentioned in one of the recent videos released by an anti-abortion group. Those videos show Planned Parenthood officials discussing fetal tissue harvesting.

Officials reportedly said NIH has paid the ABR firm $257,000 since 2009 and $53,000 last year alone. The officials, however, didn’t explain how much of the money went toward fetal tissue and how much went to other supplies. The report added that some tissue came from 17- to 22-week-old fetuses. Multiple anti-abortion organizations want to prohibit most abortions after 20 weeks.Abortion monster

The FDA also paid the firm $73,000 in the same amount of time. Officials told Politico that much of that money was for certain liver and thymus tissue in order to test drug therapies.

The firm did not return Politico’s requests for comments.

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