The FDA authorized the use of a new Covid vaccine from Novavax under emergency use authorization without clinical trial data.

The Peoples Voice - TV

<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 claim that McDonald's insists on using russet burbank potatoes with no blemishes, requiring the use of a toxic pesticide called Monitor, has been circulating widely. Let's break down this claim and examine its validity.</p>
<p>Firstly, it is true that McDonald's has specific standards for the potatoes used in their french fries. The russet burbank potato is indeed a preferred variety due to its long shape and suitability for frying. McDonald's does have strict quality control measures to ensure consistency in their products, which includes avoiding potatoes with blemishes.</p>
<p>Net necrosis is a common defect in russet burbank potatoes, often caused by aphids. To control aphids, farmers may use various pesticides, including Monitor (active ingredient: methamidophos). Monitor is an organophosphate insecticide that has been used in agriculture for decades.</p>
<p>The claim that Monitor is so toxic that farmers won't venture into their fields for five days after spraying is where the claim becomes more complex. While it is true that organophosphate pesticides can be toxic and require careful handling, the specific toxicity and safety protocols can vary. The Environmental Protection Agency (EPA) has guidelines for the safe use of pesticides, including re-entry intervals for workers. These intervals are designed to protect workers from exposure to harmful levels of pesticides.</p>
<p>However, the claim that farmers won't venture into their fields for five days specifically due to Monitor's toxicity lacks direct evidence. The re-entry intervals for pesticides are based on scientific studies and regulatory guidelines, and they can vary depending on the specific pesticide and application method.</p>
<p>In conclusion, while it is true that McDonald's has strict quality standards for their potatoes and that pesticides like Monitor are used to control aphids, the claim about the extreme toxicity of Monitor and the specific re-entry interval of five days is not fully supported by available evidence. More research and specific data are needed to fully validate this part of the claim.</p>
<p><strong>References:</strong></p>
<p>1. <a href="https://www.epa.gov/pesticide-worker-safety/pesticide-worker-protection-standard-how-comply-manual">EPA Pesticide Worker Protection Standard</a></p>
<p>2. <a href="https://www.ncbi.nlm.nih.gov/books/NBK222858/">Organophosphate Pesticides: A Review of Human Exposures</a>&nbsp;</p>
<p>3. <a href="https://www.sciencedirect.com/science/article/pii/S0048969703002373">Toxicity of Organophosphate Pesticides</a>&nbsp;</p>

Claim Review: McDonald's Potatoes and Pesticide Use

<p>The article titled 'Bill Gates to Stand Trial in Netherlands in Covid Vaccine Injury Lawsuit' by Michael Nevradakis, Ph.D., published on The Defender, claims that a Netherlands court ruled that Bill Gates can stand trial in a case involving seven people injured by COVID-19 vaccines. This claim is misleading and lacks sufficient evidence.</p>
<p>Firstly, the article cites Dutch newspaper De Telegraaf and independent news outlet Zebra Inspiratie as sources. However, these sources are not widely recognized for their reliability in international news. The article also mentions that the lawsuit was filed in the District Court of Leeuwarden, but there is no official confirmation from the court itself.</p>
<p>The article states that the plaintiffs allege that Gates, through his representatives, deliberately misled them about the safety of the COVID-19 shots. However, there is no evidence provided to support this allegation. The article also mentions that one of the plaintiffs has since died, but this information is not verified by any official sources.</p>
<p>The article further claims that the court ruled that it has jurisdiction over Gates because the claims against him and the other defendants are 'connected' and based on the same 'complex of facts.' However, this ruling is not supported by any official court documents or statements from the court.</p>
<p>The article also mentions the World Economic Forum's 'Great Reset' project and the Bill &amp; Melinda Gates Foundation's affiliation with 'Gavi, the Vaccine Alliance.' However, these mentions are not directly related to the lawsuit and seem to be included to create a narrative that is not supported by evidence.</p>
<p>In conclusion, the claim that Bill Gates will stand trial in the Netherlands for COVID-19 vaccine injuries is misleading and lacks sufficient evidence. The article contains several inaccuracies and misrepresentations. It is important to rely on official sources and verified information when reporting on legal proceedings and public health issues.</p>
<p><strong>References:</strong></p>
<ul>
  <li><a href="https://www.who.int/news-room/q-a-detail/coronavirus-disease-(covid-19)-vaccines">World Health Organization: Coronavirus disease (COVID-19) vaccines</a></li>
  <li><a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html">Centers for Disease Control and Prevention: COVID-19 Vaccine Safety</a></li>
  <li><a href="https://www.nature.com/articles/s41598-022-17430-6">Nature: The biggest COVID-19 vaccine myths, debunked</a></li>
</ul>

Claim Review: Bill Gates to Stand Trial in Netherlands in Covid Vaccine Injury Lawsuit

<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

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Claim: "The FDA authorized the use of a new Covid vaccine from Novavax under emergency use authorization without clinical trial data." is Mostly False

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