European committee gives positive review to GARDASIL 9 HPV vaccine
The new nine-valent HPV vaccine, developed by Sanofi Pasteur MSD, now has the EMA’s recommendation to be authorized for administration to males and females as young as 9 years old. The vaccine is meant to protect people from cervix, vaginal, vulva and anus cancers, in addition to premalignant lesions, genital warts and other HPV symptoms.
GARDASIL 9 was also recently approved by the U.S. Food and Drug Administration (FDA).
GARDASIL 9 contains the seven high-risk HPV types: 16, 18, 31, 33, 45, 52 and 58. As of today, this is the largest quantity of HPV types contained in any single HPV vaccine. Experts attribute 90 percent of cervical cancers and 80 percent of high-grade cervical lesions to these seven HPV types.
GARDASIL 9 also contains two other HPV types, 6 and 11. Health professionals attribute 90 percent of patients with genital warts to these two types.
"We anticipate that, if approved, GARDASIL 9 will represent a major step forward in HPV prevention,” Dr. Jean-Paul Kress, president of Sanofi Pasteur MSD, said. “GARDASIL 9 has the potential to help prevent over 80 percent of genital cancers caused by HPV and to reduce the transmission of the nine HPV types. We are delighted that the CHMP has recommended marketing authorization for GARDASIL 9, and we are looking forward to the European Commission decision.”