FDA Approves Merck’s Gardasil Nine-Strain HPV Vaccine

Merck’s new Gardasil 9 human papillomavirus vaccine won FDA approval to prevent various cancers and other illnesses caused by the sexually transmitted disease in young men and women.

Gardasil 9 is indicated against nine strains of HPV to prevent cervical, vulvar, vaginal and anal cancers in females ages nine to 26 and genital warts in women and in males age nine to 15. Previously, the product was approved to combat four types of the virus.

HPV is so common that the Centers for Disease Control and Prevention say that most sexually active Americans will contract at least one type at some point in their lives.

There are more than 100 types of HPV, Merck spokeswoman Pamela Eisele said. While 30 to 40 virus types can affect the genital area, seven of the nine types covered by Gardasil 9 are responsible for 85 to 90 percent of vaginal and cervical cancers and 90 to 95 percent of anal cancers. The other two types of HPV covered by the vaccine are responsible for 90 percent of genital warts.

The new vaccine will be given in three separate shots, with one initial dose followed by boosters at two and six months. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.