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FDA is still using emergency use authorization to release COVID-19 shots without meeting safety standards
By isabelle // 2024-09-17
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When the FDA announced that new COVID-19 vaccines addressing more recent variants of the virus were available last month, they left out one very important detail: like their predecessors, they were never officially established as being safe or even effective. How did they get away with it this time around? Much like the first COVID-19 vaccines, they took advantage of the “emergency use authorization” power that enables them to use a lower level of evidence than the traditional threshold for proving effectiveness in FDA product approvals. It essentially means that proving that they “may be effective” is justification enough to flood the market with these untested jabs. Although the reasoning for granting emergency use authorization might have made some sense when we were in the early days of the pandemic, a lot of people are wondering why this authority is still intact four years after the fact. After all, even the CDC and the World Health Organization have conceded that the virus is no longer a public health emergency -- more than a year ago. The latest statistics on the virus from health authorities back up the assertion that the virus is nowhere near the threat it once may have been. At the end of August, just 2.3% of visits to emergency rooms in the U.S. stemmed from COVID-19, while the hospitalization rate is on a downward trend and currently stands at just 0.005%. The death rate, meanwhile, has dropped from the 26,028 weekly deaths recorded at its peak in 2021 to just 663 – and that number refers to deaths “involving” COVID-19 but not necessarily caused by it. In an article published by The Federalist, Kentucky Senator Dr. Rand Paul asked why the FDA is so reluctant to call off the emergency designation. “Until the FDA stops approving new Covid vaccines under the EUA, and analyzes and reports the safety and efficacy of Covid mRNA vaccines based on established standards, there will remain a cloud of uncertainty about taking these medicines,” he wrote.

FDA is encouraging all Americans to get the latest shots despite declining hospitalizations and deaths

In August, it was announced that Pfizer and Moderna would be shipping millions of doses of the updated vaccines, with Novavax releasing a modified version of its own vaccine shortly thereafter. The CDC wasted no time in recommending the shot for all Americans aged six months or older, despite the numerous health risks being linked to previous iterations of the vaccines. The new fall vaccines target Omicron descendants, a subtype known as KP.2, even though the KP.3.1.1 variant is spreading at the moment, accounting for 37% of cases in mid-August. Pfizer maintains that its data shows the current batch provides better protection against multiple subtypes of the virus – but we should take that with a grain of salt considering how deceptive their data has turned out to be in the past. As part of the vaccine push, it is being noted that the versions released last fall target a different strain that is no longer in circulation. Moreover, uptake was low, with just over 22% of adults and 14% of children rolling up their sleeves last year. By now, many people already enjoy immunity from previous infections, and the virus itself has evolved to become more transmissible but less dangerous. When the latest vaccines were announced, the director of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, claimed in a statement: “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.” He conveniently forgot to mention that the standards remain way lower than usual thanks to their ongoing manipulation of emergency use authorization powers. Sources for this article include: TheFederalist.com APNews.com
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