The Lancet, Volume 375, Issue 9719 , Pages 963 – 964, 20 March 2010 By: Peter S. Bach The 2006 approval of Merck’s human papillomavirus (HPV) vaccine (Gardasil) by the US Food and Drug Administration (FDA) exemplified the potential of bench-to-bedside research. This vaccine against the virus that causes cervical cancer received immediate recommendation […]
New FDA Records Obtained by Judicial Watch Indicate 28 Deaths Related to Gardasil in 2008
Washington, DC — June 22, 2009 Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced today that it has obtained records from the Food and Drug Administration (FDA) documenting 28 deaths in 2008 associated with Gardasil, the vaccination for human papillomavirus (HPV), up from 19 deaths in 2007. The total […]
A Judicial Watch Special Report: Examining the FDA’s HPV Vaccine Records
Detailing the Approval Process, Side-Effects, Safety Concerns and Marketing Practices of a Large-Scale Public Health Experiment June 30, 2008 This Judicial Watch Special Report is an analysis of records obtained from the Food and Drug Administration (FDA) concerning a recent vaccine called Gardasil. Gardasil helps protect against four types of human papillomavirus (HPV). The […]
Memo from: DHHS/FDA/CBER
Subject: Gardasil Pediatric Utilization and Safety Review for Pediatric Advisory Committee Meeting On June 8, 2006, the US Food and Drug Administration approved the first vaccine against the human papillomavirus (HPV). Gardasil was initially licensed for females aged 9–26 years for the prevention of cervical cancer and precancerous lesions, as well as genital warts […]
Gardasil Safety: Post-marketing Experience
CONTRAINDICATIONS Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. WARNINGS AND PRECAUTIONS Syncope Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination […]