(CHILDREN’S HEALTH DEFENSE) – How accurately do the reviewers of VAERS reports distinguish “serious” from “non-serious” adverse events?
When it comes to Merck’s Gardasil HPV vaccine, the answer is “not very,” according to the authors of an article published in the peer-reviewed journal, Science, Public Health Policy, and The Law.
Based on an FDA/CDC post-licensure safety surveillance report for Gardasil, VAERS reviewers determined a 6.2% rate of serious adverse events. Because VAERS reports are publicly available, the authors randomly selected 2,000 reports from those referenced in the FDA/CDC study for independent review. They discovered an alarming pattern of mislabeling “serious” cases as “non-serious.”