The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine from males and females aged 9 through 26 years to include men and women aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.
The FDA’s approval of Gardasil 9 in women is based on results from a study of about 3,200 women (27 to 45 years old) followed for an average of 3.5 years: Gardasil was 88% effective in preventing a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.
The effectiveness of Gardasil 9 in men is inferred from the data described above in women, efficacy data from Gardasil in younger men 16-26 years old, and immunogenicity trial data from men 27-45 years old.
The FDA’s “approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.”
The evidence is clear. HPV vaccination is effective in preventing Cervical Cancer.
The United States Centers for Disease Control and Prevention (US CDC) stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90%of these cancers.
Men aged 9 to 45 years old who are at risk should consider taking HPV vaccination.
There are few options available for the prevention of cancers in general, and HPV prevention presents a rare and valuable opportunity. We should take every opportunity to reduce our individual risk of cancer. Get vaccinated now.
Cross Street Medical offers all HPV vaccines. Speak to our doctors about what you may need.