By: Emily P. Walker 15 November 2010 WASHINGTON — Merck’s quadrivalent human papillomavirus recombinant vaccine, Gardasil, appears safe and effective at preventing anal cancer in males and females ages 9 to 26, FDA reviewers said. The vaccine was approved in 2006 to treat genital warts and cervical, vulvar, and vaginal cancer in females ages 9 […]
Gardasil Anal Cancer Indication to Face FDA Advisory Committee Scrutiny
By: S. Sutter 27 September 2010 Merck’s bid to further expand the label for its human papillomavirus vaccine Gardasil – this time for the prevention of anal cancer and anal dysplasia – will face FDA advisory committee scrutiny in November. The Vaccines and Related Biological Products Advisory Committee will meet on Nov. 17 to discuss […]
Gardasil and seizures: Is VAERS now taking a connection seriously?
Posted by: Kristin Johns 13 September 2010 Theresa E was floored when she got a phone call from VAERS, the FDA’s vaccine adverse event reporting system. Yes, the caller said, investigators did indeed feel that Theresa’s daughter’s seizures could be a serious reaction to Merck’s anti-HPV vaccine, Gardasil. Although Theresa had had a hunch that […]
Cervarix Warnings and Precautions
CONTRAINDICATIONS Severe allergic reactions (e.g., anaphylaxis) to any component of CERVARIX. WARNINGS AND PRECAUTIONS Syncope Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with CERVARIX. When syncope is associated […]
Cervarix: Food and Drug Administration
Proper Name: Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant Tradename: Cervarix Manufacturer: GlaxoSmithKline Biologicals 16 October 2009, Cervarix® was approved for use in the United States, by the FDA. To examine all available FDA documents pertaining to the approval of this HPV vaccine visit the two FDA links below. Proper Name: Human Papillomavirus […]