FDA Approves Gardasil 9 to Expand Use in Men and Women Up to Age 45

The Food and Drug Administration (FDA) approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) to expand its use in women and men aged 27 to 45 years.

The vaccine—previously approved for use in females and males aged 9 through 26 years—prevents certain cancers and diseases caused by 9 human papillomavirus (HPV) types, including cervical, vulvar, vaginal, and anal cancers in women, and anal cancer in men.

“The Centers for Disease Control and Prevention (CDC) 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 percent of these cancers, or 31,200 cases every year, from ever developing,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

For example, there are approximately 14 million new genital HPV infections in the United States each year. In addition, about 12,000 women are diagnosed with and 4,000 die from cervical cancer caused by certain HPV viruses each year, according to the CDC.

The FDA approved the vaccine Gardasil, the predecessor to Gardasil 9, in 2006. Gardasil, which prevents malignancies causes by types of HPV, is no longer distributed in the United States. However, efficacy data for Gardasil can be extrapolated to Gardasil 9, since the 2 vaccines are manufactured similarly and Gardasil is targets 4 of the 9 HPV types covered by Gardasil 9.

In a large study of approximately 3200 women aged 27 through 45 who were given Gardasil and followed for an average of 3.5 years, the vaccine was 88 percent effective in the prevention of 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’s approval of Gardasil 9 for people up to 45 years of age is based on these results and new data on long term follow-up from this study.

The agency inferred that Gardasil 9 would be effective in men 27 to 45 based on the above women’s study, as well as on data from Gardasil use in younger men. It also relied on immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

Adverse Events

Among the 13,000 males and females evaluated, the most commonly reported adverse events were injection site pain, swelling, redness, and headaches.

The vaccination may cause syncope and patients may be at risk for fainting or falling, so they should be observed for 15 minutes after administration, according to Merck, the vaccine’s manufacturer.

In addition, the company noted that Gardasil 9 should not be given to individuals with hypersensitivity, including those with severe allergic reactions to yeast, or to a previous dose of Gardasil 9 or Gardasil.

Screening Remains Important

Lastly, Merck cautioned that Gardasil 9 does not eliminate the necessity for women to continue to stay up to date with their recommended cervical cancer screenings. Additionally, recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider.