In April 2021, Adele Fox received a single shot of the Johnson & Johnson COVID-19 vaccine. Within a few hours, the 60-year-old resident of Portsmouth, New Hampshire, started feeling shooting pains in her legs, arms, and neck. The pain didn’t abate over the next few days. Instead, it got worse and was accompanied by nausea and debilitating fatigue.
Within a few weeks, neurologists affiliated with Massachusetts General Hospital diagnosed her with several serious conditions they say were a result of her COVID-19 vaccine, including small-fiber neuropathy (which causes a painful tingling in the extremities) and Sjögren’s Syndrome (which leaves patients pained and fatigued, and in extreme cases, can damage internal organs).
This shot, which was supposed to get Fox back to normal, instead left her with diminished ability to work and enjoy life. Persistent physical therapy and experimental treatments she’s taken since have done little to alleviate her symptoms.
“I used to do so much, and now it’s a struggle,” she says. “Sometimes you just get down.”
With her medical bills mounting and her condition not improving, Fox sought compensation for her damaged health. Federal liability protections prevent the vaccine-injured from directly suing vaccine manufacturers like Johnson & Johnson. Instead, claimants have to go to the federal government for compensation.
But as Fox would soon learn, the government has two starkly different injury programs for vaccines. One operates like a civil court with a neutral judge, lawyers on both sides, and a guaranteed right of appeal. In recent decades, it has approved about 75% of claims and pays out hundreds of millions of dollars per year.
The other, which handles COVID-19 vaccines, has rejected almost every claim brought to it, awarding less than $10,000 since the pandemic. And in a nation nearly numb to the pandemic's toll and its scandals, the program is adding seething frustration atop lasting injury to Fox and people like her in a little reported aftermath to the government’s much criticized performance on vaccines – ranging from erratic booster advice to broad-brush vaccine mandates that cost people their jobs.
Fox filed her claim two years ago, submitting hundreds of pages of medical documents about her condition and diagnoses. She’s nevertheless one of the 10,887 people still waiting on a decision. “You’re not even hearing anything from the organization that’s supposed be helping you,” she says. “The phone keeps ringing, no one is emailing, nobody is doing anything.” --->READ MORE HERE
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The U.S. government’s safety surveillance system monitoring COVID-19 vaccine adverse events is “woefully inadequate” and may be missing safety signals, according to researchers who say the U.S. Food and Drug Administration (FDA) made multiple decisions to ensure its first published analysis only identified known safety signals.
In a peer-reviewed letter published June 16 in the journal Vaccine, a team of experts revealed “major shortcomings” with the FDA’s near real-time surveillance study assessing outcomes in U.S. COVID-19 vaccine recipients.
Dr. Joseph Fraiman, an emergency room physician associated with the Baromedical Research Institute in New Orleans, and his co-authors raise serious concerns about whether the surveillance system is fit for its purpose and how the FDA performed its analysis.
“The FDA has repeatedly stated that it is conducting intensive, historically unprecedented monitoring of COVID-19 vaccine safety and that the only serious harms associated with mRNA COVID-19 vaccines are anaphylaxis, myocarditis, and pericarditis,” the researchers said in an email to The Epoch Times. “However, in our letter, we detail why the U.S. government’s safety surveillance system is woefully inadequate and, as a result, potentially missing safety signals.”
In its first-ever surveillance analysis published Oct. 26, 2022, in Vaccine, the FDA assessed 17 adverse outcomes following COVID-19 vaccination with Pfizer, Moderna, and Johnson & Johnson’s vaccines and concluded 15 outcomes did not meet the threshold for a statistical signal.
The FDA based its analysis on medical and pharmacy claims data of 16 million vaccinated individuals aged 12 to 64 from Optum, HealthCore, and CVS Health using their Biologics Effectiveness and Safety (BEST) System—an active post-marketing surveillance program to ensure the safety and effectiveness of biologic products, including vaccines.
The FDA concluded myocarditis and pericarditis met the requirements to trigger an early detection safety signal for Pfizer’s COVID-19 vaccine in two of three large commercial insurance databases assessed, while anaphylaxis met the statistical threshold for Pfizer and Moderna vaccines in all three databases.
The agency did not detect any other adverse outcomes, including those previously acknowledged. Their results, the FDA said, were “consistent with published literature.” --->READ MORE HEREFollow links below to relevant/related stories and resources:
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