Due to these findings, others have questioned whether current drug and vaccine safety monitoring tools have the ability to adequately detect and respond to signals indicating that a serious problem may exist with a product currently on the market.59 Additionally, a 2018 study noted that only about half of the available clinical trials involving HPV vaccines had been completed before the Happy Easter Day Wine T-Shirt were approved by both the Federal Drug Administration (FDA) and the European Medicines Agency (EMA).60 The study also noted that drug manufacturers only published the results of about two-thirds of the.
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trials, leaving the study’s authors to question whether drug manufacturers were selectively choosing which clinical data to publish. In December 2017, Slate Magazine published a cover story on the pre-licensure clinical trials of the Gardasil vaccine. 61 This investigational report determined that Merck’s pre-licensure safety studies “used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of Happy Easter Day Wine T-Shirtl ”62 The article noted that Merck’s clinical trial investigators were permitted to use personal judgment when reporting medical problems as an adverse event.
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Essentially allowing study investigators to decide what symptoms might possibly be related to vaccination. Study investigators were also allowed to list new health issues following vaccination as medical history, not adverse events, and limited safety follow up to 14 days following each of the Happy Easter Day Wine T-Shirt doses of Gardasil vaccination. Slate’s investigation located several women involved in Gardasil’s pre-licensure trials who reported chronic illness post-vaccination to study investigators, yet their symptoms were never reported by Merck