New results from an extended follow up study further support the evidence that protection provided by the four-type (6,11,16,18) human papillomavirus (HPV) vaccine GardasilÂ® should be long-lasting.
The study looked at the one-type (16) HPV “Proof of Principle” (phase II) vaccine for GardasilÂ® and found that on average 8 years and up to 9.5 years after vaccination there was no HPV-16-related clinical disease (cervical lesions or pre-cancer ) in the vaccine group. All observed disease occurred in the placebo group. For some women follow up has already reached 9.5 years of follow-up.
This is the longest protection documented for any HPV vaccine. The results will be presented at the 25th International Papillomavirus Conference (IPV) in MalmÃ¶, Sweden.
GardasilÂ® has demonstrated sustained protection in phase II and phase III clinical studies for up to five and four years respectively , before independent experts recommended ending the follow-up and vaccinating the women in the placebo group in order not to leave them unprotected any longer , . In addition, the vaccine has demonstrated immune memory which experts consider a hallmark of long-term protection.
“Health authorities around the world have implemented HPV vaccination with GardasilÂ® based on robust evidence for high and sustained protection. The new results bring a new piece of evidence. In addition, the follow-up of a large cohort of women vaccinated with GardasilÂ® in the phase III clinical programme continues. These data suggest that we can be very confident today in the sustainability of the protection provided by GardasilÂ®”, says Professor Margaret Stanley, from the University of Cambridge in the United Kingdom.”
GardasilÂ® is the only four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, GardasilÂ® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases. , ,
GardasilÂ® is now approved in 109 countries and 44 million doses have been distributed worldwide since launch in June 2006 and until the end of March 2009.