The FDA approved the ACAM2000 vaccine for monkeypox despite acknowledging its dangerous side effects, including cardiac inflammation.

Natural News

<h2>Introduction</h2>
<p>The recent approval of the ACAM2000 vaccine for monkeypox by the Food and Drug Administration (FDA) has sparked controversy due to its acknowledged risks, particularly cardiac inflammation. This article aims to review the claim that the FDA approved the vaccine despite knowing its dangers.</p>
<h2>Background</h2>
<p>The ACAM2000 vaccine, developed by Emergent BioSolutions, was initially approved for smallpox in 2007. On August 29, 2024, the FDA expanded its approval to include individuals at high risk for monkeypox, such as members of the LGBT community.</p>
<h2>Claim Analysis</h2>
<p>The claim suggests that the FDA approved the ACAM2000 vaccine despite knowing its risks. The FDA's medication guide for ACAM2000 lists numerous side effects, including the potential spread of the live vaccinia virus to close contacts and serious complications such as myopericarditis (heart lining and/or muscle inflammation).</p>
<p>According to Karl Jablonowski, a senior research scientist at Children's Health Defense, the risk of cardiac inflammation is significant, with estimates ranging from one in 2,000 to one in 175 vaccinations. Dr. Meryl Nass, an internist and biological warfare expert, also highlighted the CDC's acknowledgment of this risk during a June 2022 meeting.</p>
<p>However, it is crucial to understand the FDA's approval process. The agency evaluates the benefits and risks of a vaccine, especially in the context of public health emergencies. The approval of ACAM2000 for monkeypox was likely based on the assessment that the benefits outweigh the risks for high-risk individuals.</p>
<h2>Scientific Evidence</h2>
<p>The risk of myopericarditis associated with ACAM2000 is well-documented. A study published in the <a href="https://academic.oup.com/aje/article-abstract/160/7/642/136637?redirectedFrom=PDF#google_vignette">New England Journal of Medicine</a> &nbsp;reported cases of myopericarditis following smallpox vaccination, highlighting the need for careful monitoring and risk assessment.</p>
<p>The FDA's approval process involves rigorous evaluation of clinical data and consideration of public health needs. While the risks are acknowledged, the decision to approve the vaccine reflects a balance between these risks and the potential benefits in preventing monkeypox.</p>
<h2>Conclusion</h2>
<p>The claim that the FDA approved the ACAM2000 vaccine for monkeypox despite acknowledging its dangerous side effects is partially true. While the vaccine has known risks, the FDA's approval process considers the benefits versus the risks in the context of public health emergencies. It is essential for individuals to be informed about the potential side effects and for healthcare providers to monitor vaccinated individuals closely.</p>

Claim Review: FDA Approves Monkeypox Vaccine Despite Known Risks

<h2>Introduction</h2>
<p>A recent article from The People's Voice claims that the FDA authorized the use of a new Covid vaccine from Novavax under emergency use authorization without clinical trial data. This claim has raised concerns about the safety and efficacy of the vaccine. This article aims to review the claim and provide a thorough analysis based on available evidence.</p>
<h2>Background</h2>
<p>The Novavax Covid-19 vaccine is a protein subunit vaccine, which is a more traditional approach compared to mRNA vaccines like Pfizer and Moderna. It has been authorized for use in several countries and has undergone clinical trials to assess its safety and efficacy.</p>
<h2>Clinical Trial Data</h2>
<p>The claim suggests that the FDA authorized the updated Novavax vaccine without clinical trial data. However, this is not entirely accurate. The original Novavax vaccine underwent extensive clinical trials, including Phase 3 trials involving thousands of participants. The results of these trials were published in peer-reviewed journals, such as the <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2107659">New England Journal of Medicine</a>.</p>
<p>The updated vaccine, designed to target more current Covid variants, was authorized based on the data from the original trials, as well as ongoing safety monitoring and real-world evidence. This approach is not unusual, as regulators often rely on existing data and post-marketing surveillance to make decisions about updated vaccines.</p>
<h2>Emergency Use Authorization</h2>
<p>The article also questions the authenticity of the Covid pandemic 'emergency' authorization, given that President Joe Biden ended the Covid emergency over a year ago. However, the emergency use authorization (EUA) for Covid-19 vaccines is still in effect, as the Secretary of Health and Human Services has the authority to determine when the emergency is over. The EUA allows the FDA to authorize the use of unapproved medical products during a public health emergency.</p>
<h2>Side Effects</h2>
<p>The article mentions that the Novavax vaccine has similar side effects to mRNA vaccines, including myocarditis and pericarditis. While it is true that these side effects have been reported, they are rare, and the benefits of the vaccine outweigh the risks, according to the <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html">Centers for Disease Control and Prevention (CDC)</a>.</p>
<h2>Conclusion</h2>
<p>The claim that the FDA authorized the Novavax Covid vaccine without clinical trial data is misleading. While the updated vaccine was authorized without new clinical trials, this decision was based on extensive data from previous trials and ongoing safety monitoring. The benefits of the vaccine outweigh the risks, and the EUA is still in effect. Therefore, the claim rating is 2 out of 5, indicating that the claim is mostly false.</p>

Claim Review: Novavax Covid Vaccine Authorized Without Clinical Trial Data

<p>The recent article from Slay News claims that the Cleveland Clinic has issued a warning about an impending wave of mass deaths among individuals who received Covid mRNA vaccines due to myocarditis. This claim has sparked concern and requires a thorough examination.</p>
<p>Myocarditis, an inflammation of the heart muscle, is a known side effect of Covid mRNA vaccines, as acknowledged by the U.S. Centers for Disease Control and Prevention (CDC). However, the claim that Cleveland Clinic has predicted a 50% mortality rate within five years for those who contracted myocarditis is not supported by the clinic's official statements or scientific literature.</p>
<p>The Cleveland Clinic's website does provide information on myocarditis, including its potential long-term effects and survival rates. However, the clinic does not explicitly link these statistics to Covid vaccines. The claim that 50% of people with myocarditis will die within five years is a general statistic about myocarditis, not specific to vaccine-related cases.</p>
<p>Furthermore, the article cites Dr. Geert Vanden Bossche and Professor Dolores Cahill, who have made alarming predictions about the long-term health impacts of Covid vaccines. However, these predictions are not widely accepted by the scientific community and lack robust peer-reviewed evidence. Dr. Peter McCullough's study, mentioned in the article, did find an increase in cardiac arrest deaths, but the methodology and conclusions of this study have been criticized for lacking rigor and context.</p>
<p>It is crucial to rely on peer-reviewed studies and official statements from reputable medical institutions. The Cleveland Clinic has not issued a specific warning about mass deaths among the Covid-vaccinated. The claim appears to be a misinterpretation of general information about myocarditis and its long-term effects.</p>
<p>In conclusion, the claim that Cleveland Clinic has warned of a wave of mass deaths among Covid-vaccinated individuals within five years due to myocarditis is misleading. While myocarditis is a known side effect of Covid vaccines, the specific predictions made in the article are not supported by credible evidence or official statements from the Cleveland Clinic.</p>

Fact-Check: Cleveland Clinic's Alleged Warning on Covid Vaccine-Related Deaths

<h2>Introduction</h2>
<p>Remdesivir, an antiviral drug, has been widely promoted as a treatment for COVID-19 patients. However, the effectiveness and safety of this drug have been subjects of debate. This article aims to review the claim that Remdesivir is an effective treatment for COVID-19 patients and to provide a thorough analysis based on scientific evidence.</p>
<h2>What is Remdesivir?</h2>
<p>Remdesivir is a broad-spectrum antiviral drug that inhibits RNA polymerase, disrupting the production of vital RNA. It was initially developed to treat Ebola but has been repurposed for COVID-19 treatment.</p>
<h2>Claim Analysis</h2>
<p>The claim that Remdesivir is an effective treatment for COVID-19 patients is based on its approval by regulatory bodies such as the FDA, EU, and UK's drug regulator. However, several studies have cast doubt on its efficacy and safety.</p>
<h2>Scientific Evidence</h2>
<p>The World Health Organization's Solidarity Trial found that Remdesivir does not reduce mortality or the time COVID-19 patients take to recover. A study published in <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext">The Lancet</a> also found no statistically significant benefit from the treatment.</p>
<p>Furthermore, a review of Remdesivir on <a href="https://www.drugs.com/comments/remdesivir/">drugs.com</a> showed that 47% of reviewers had a negative experience with the drug, compared to 19.38% who had a positive experience.</p>
<h2>Side Effects and Safety Concerns</h2>
<p>Remdesivir has been associated with several side effects, including fast, pounding heartbeats, trouble breathing, wheezing, shivering, itching, sweating, facial swelling, severe headache, and a feeling of being about to pass out. Subsequent side effects may include nausea and abnormal liver function tests.</p>
<p>The UK's National Institute for Health and Care Excellence (NICE) reports that Remdesivir interacts with twelve other drugs, including chloroquine, hydroxychloroquine, and phenytoin. Doctors prescribing Remdesivir should be aware of these interactions to avoid potential harm to patients.</p>
<h2>Conclusion</h2>
<p>Based on the available scientific evidence, the claim that Remdesivir is an effective treatment for COVID-19 patients is not supported. The drug has shown minimal efficacy in clinical trials and is associated with significant side effects. It is crucial for healthcare providers to consider the risks and benefits carefully before prescribing Remdesivir to COVID-19 patients.</p>

Claim Review: Remdesivir as an Effective Treatment for COVID-19

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