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Vaccine-related serious adverse events might have been under-recognized in the pivotal HPV vaccine randomized trial


The largest pre-licensure trial of the Gardasil-9 vaccine—which compared Gardasil-9 against Gardasil rather than against an inert placebo—showed that Gardasil-9 had significantly more serious adverse events than Gardasil (3.3% versus 2.6%, p=0.01). However, the trial investigators judged that 0% of the serious adverse events in both groups were vaccine-related. Gardasil-9 has “more than double [the] HPV virus-like particles and aluminum adjuvant” as Gardasil. The under-recognition of serious adverse events associated with Gardasil-9 “casts further doubt on HPV vaccine safety.”

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