Gardasil Information
Centers for Disease Control Gardasil reporting, here
A Homeopathic Perspective, here
Gardasil Human Papillomavirus (HPV) Vaccine
On June 8, 2006, the FDA licensed Gardasil®, the first vaccine developed to prevent cervical cancer caused by certain kinds of human papillomavirus (HPV). Since then, more than 12 million doses of Gardasil vaccine have been distributed. In 2006, a total of 2,151,000 doses were distributed and in 2007, another 11,317,902. At this time, the U.S. does not have a national registry for immunization and vaccination and therefore cannot report the total number of people who have received Gardasil.
The FDA has licensed the vaccine as safe and effective. This vaccine has been tested in thousands of females (9 to 26 years of age) around the world. These studies have shown no serious side effects. The most common side effect is brief soreness at the injection site. CDC, working with the FDA, will continue to monitor the safety of the vaccine after it is in general use.
CBS News story, here
Age for HPV vaccination.
Harper DM, Paavonen J.
Dartmouth College, Department of Women’s and Gender Studies, Obstetrics and Gynecology, Community and Family Medicine, Hanover, NH, USA. Diane.M.Harper@Dartmouth.edu
HPV vaccination of pre-pubescent girls will be effective for many girls. Vaccinating girls and women older than 12 years of age may accelerate the reduction in cervical cancer rates. Currently HPV vaccines are effective for at least 5 years in the prevention of HPV 16 and 18 associated precancerous lesions however the duration of vaccine protection is unknown. The need for booster shots must therefore be addressed with patients as unknown. Continued cervical cancer screening is necessary regardless of vaccination. Vaccination alone will not eliminate cervical cancer.
Vaccine. 2008 Mar 14;26 Suppl 1:A7-11
EMEA Statement On The Safety Of Gardasil, Europe
Article Date: 25 Jan 2008
The European Medicines Agency (EMEA) has received reports of deaths in women who had previously received Gardasil, including two reports concerning the sudden and unexpected deaths of two young women in the European Union (EU). Gardasil is a vaccine approved in the EU for the prevention of cervical cancer and other diseases caused by human papillomavirus (HPV) types 6, 11, 16 and 18. It is estimated that about 1.5 million patients have been vaccinated with this HPV vaccine in Europe.
The two European cases were reported as part of the continuous monitoring of the safety of medicines. One of the cases occurred in Austria and the other in Germany. In both cases, the cause of death could not be identified. No causal relationship has been established between the deaths of the young women and the administration of Gardasil.
On the basis of the currently available evidence, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) is of the opinion that the benefits of Gardasil continue to outweigh its risks and that no changes to its product information are necessary.
The EMEA will continue to closely monitor the safety of Gardasil and take appropriate actions should new information emerge that has an impact on the benefit-risk profile of Gardasil.
Notes:
1. The approved indication in the EU for Gardasil is: “Gardasil is a vaccine for the prevention of high-grade cervical dysplasia (CIN 2/3), cervical carcinoma, high-grade vulvar dysplastic lesions (VIN 2/3), and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. The indication is based on the demonstration of efficacy of Gardasil in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males. The use of Gardasil should be in accordance with official recommendations.” For more information on Gardasil, please see here.
2. HPV types 6, 11, 16 and 18 vaccine is also marketed in the EU as Silgard. For more information on Silgard, please see here.
