The US Food and Drug Administration (FDA) has approved the use of Merck’s Gardasil 9 HPV vaccine in adults aged from 27 to 45 years.
Gardasil 9 is indicated for the prevention of certain cancers and diseases caused by nine HPV types.
The FDA originally approved Gardasil vaccine in 2006 for cancers and diseases caused by four HPV types. This vaccine is currently not available in the US.
Later in 2014, the agency granted approval for Gardasil 9, which is designed to protect from the same four HPV types as Gardasil, along with an additional five types, in people aged nine to 26 years.
FDA Center for Biologics Evaluation and Research director Peter Marks said: “Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range.
“The Centers for Disease Control and Prevention has 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, or 31,200 cases every year, from ever developing.”
The effectiveness of Gardasil is considered relevant to Gardasil 9 as the vaccines are produced similarly and cover four of the same HPV types.
In a study of around 3,200 women aged 27-45 years, Gardasil was found to be 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 FDA approval of Gardasil 9 in women aged 27-45 years is based on these results and new findings from a long term follow-up of this study.
Effectiveness of Gardasil 9 in men aged 27-45 years is inferred from the same data, and efficacy data from Gardasil in younger male participants (16 through 26 years of age), as well as immunogenicity data of Gardasil from a clinical trial in 150 men aged 27-45 years.
Gardasil 9’s safety was assessed in approximately 13,000 males and females, with most common adverse reactions being injection site pain, swelling, redness and headaches.