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Pfizer and Moderna will begin clinical trials to determine adverse heart risks from COVID-19 vaccines, such as myocarditis


By: PAUL SACCA | November 13, 2022

Read more at https://www.conservativereview.com/pfizer-and-moderna-will-begin-clinical-trials-to-determine-adverse-heart-risks-from-covid-19-vaccines-such-as-myocarditis-2658641780.html/

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The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on Dec. 11, 2020. A week later, the FDA issued an EUA for Moderna’s COVID-19 vaccine. Now, nearly two years later, Pfizer and Moderna will launch clinical trials to track adverse health issues stemming from the COVID-19 vaccines, such as myocarditis – inflammation of the heart muscle.

Pfizer is in the infancy of beginning clinical trials to determine if there are any health risks associated with their own vaccine. In a partnership with the Pediatric Heart Network, the trial will focus on vaccine recipients who have suffered heart issues following being jabbed with the COVID-19 vaccine. The clinical trials will monitor patients for five years.

Enrollment for the study in the U.S. and Canada has not started yet. However, the research team has already identified more than 250 patients with myocarditis, according to Dr. Dongngan Truong – a pediatrician at the University of Utah Health and a co-lead on the Pfizer study.

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NBC News reported on Friday, “The team will also compare the patients to a subset of patients with multisystem inflammatory syndrome in children, also known as MIS-C, which is associated with a COVID infection.”

The first findings are not expected to be released until sometime next year.

Moderna will be conducting their own studies about possible side effects of the COVID vaccines in five countries with the assistance of the European Medicines Agency. The data from those studies are not expected to be released to the public until next summer. Dr. Paul Burton – Moderna’s chief medical officer – admitted that scientists are not certain as to what causes the possible heart issues from the COVID-19 vaccine.

“We don’t understand yet and there’s no good mechanism to explain it,” Burton conceded to NBC News.

Burton theorized that the spike protein in the vaccine may stimulate a negative reaction in the body that could cause inflammation in the heart.

NBC News highlighted the alarming struggles of one Michigan man who suffered major health issues after receiving a COVID vaccine.

In October 2021, Detroit native Da’Vion Miller was found unconscious in the bathroom of his home one week after receiving his first dose of Pfizer’s COVID-19 vaccine. Miller, who was only 22 years old at the time, experienced chest pain two days after getting vaccinated. He also suffered from fatigue, dizziness, and shortness of breath. Miller was rushed to the Henry Ford West Bloomfield Hospital, where he was diagnosed with myocarditis and pericarditis – inflammation of the outer lining of the heart. Miller’s doctor advised him not to receive his second dose of the COVID vaccine.

In the year since being diagnosed with myocarditis, Miller is still experiencing chest pain and has been in and out of the hospital.

In July 2021, the Centers for Disease Control and Prevention (CDC) released a report that stated: “An elevated risk for myocarditis among mRNA COVID-19 vaccinees has been observed, particularly in males aged 12–29 years.”

The report found, “Myocarditis reporting rates were 40.6 cases per million second doses of mRNA COVID-19 vaccines administered to males aged 12−29 years.”

The CDC added, “Myocarditis and pericarditis have rarely been reported. When reported, the cases have especially been in adolescents and young adult males within several days after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna).”

In April, an Israeli large-population study of 196,992 unvaccinated adults who were post-COVID-19 infection were “not associated with either myocarditis or pericarditis.”

“We did not observe an increased incidence of neither pericarditis nor myocarditis in adult patients recovering from COVID-19 infection,” the authors wrote.

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).

20 million Americans could receive Covid-19 vaccine in December


Reported by SARAH OWERMOHLE | Politico | November 16, 2020

Roughly 20 million people could be vaccinated against the coronavirus in December, the head of the Trump administration’s vaccine and drug accelerator said Friday. Americans can expect that about 25 to 30 million people could be vaccinated each month afterward, said Moncef Slaoui, co-lead of Operation Warp Speed, during a Rose Garden event with President Donald Trump and other top health officials.

That timeline depends on the Food and Drug Administration authorizing the emergency use of one or more vaccines — which could happen in a matter of weeks, Slaoui noted.

Pfizer announced promising data this week suggesting its vaccine is more than 90 percent effective, and has said it will apply to FDA later this month. Moderna, which is working closely with the National Institutes of Health, is preparing to announce its own efficacy data in a matter of days. An emergency-use application could soon follow, Slaoui said.

Gen. Gustave Perna, Operation Warp Speed’s chief operating officer, said that the government would begin vaccination within 24 hours after a shot secures emergency authorization.

But while manufacturers have developed coronavirus vaccines in record speed, and dozens more are still in the pipeline, Slaoui’s projections mean it will likely take months just for first-priority groups such as health care workers and the elderly to get a shot.

Both the Pfizer and Moderna vaccines are given as two doses, effectively cutting in half the government’s initial order of 100 million doses from each of the those manufacturers.

But Slaoui added that there could be more authorized vaccines in the spring, boosting chances for more people to get vaccinated. Four vaccines, including the Pfizer and Moderna shots, are now in late-stage U.S. trials, and at least one other company plans to start such a study this month.

“We may be able to immunize a larger number of Americans on an ongoing basis, per month,” Slaoui said after name-checking other promising candidates from AstraZeneca and Johnson & Johnson.

The government has not yet released a comprehensive plan to distribute any coronavirus vaccines, including how it will handle logistics for shots that need to be shipped in below-freezing temperatures and outreach to skeptical communities.

Because of the real-world challenges of vaccine distribution and supply, federal health officials including CDC Director Robert Redfield project that broad access will not be a possibility until summer 2021.

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