FDA Approves Gardasil for Boys and Cervarix for Girls

The Food and Drug Administration has approved the drug Gardasil for boys and men aged 9–26 years, and Cervarix for girls and women aged 10–25 years.

Gardasil was approved for preventing genital warts associated with the human papillomavirus (HPV), according to a statement from the drug's manufacturer, Merck & Co. An FDA press officer confirmed the approval.

HPV vaccine offers protection against four strains of the virus (types 6, 11, 16, and 18) that have been associated with the most disease, including cervical cancer in women (types 16 and 18) and genital warts in both women and men (types 6 and 11), according to the statement.

Gardasil is not recommended for pregnant women or for individuals with hypersensitivity (including severe allergy) to yeast, according to the drug's safety information.

HPV vaccination in males "may be more relevant to dermatologists," said Dr. Stephen K. Tyring, clinical professor of dermatology at the University of Texas Health Science Center in Houston. "We don't get a lot of women asking about the HPV vaccine, but we may see more men." Pediatricians and gynecologists typically counsel and vaccinate girls and women against HPV.

This is "big news in the world of papillomavirus," Dr. Tyring said at the women's and pediatric dermatology seminar sponsored by Skin Disease Education Foundation (SDEF). Dr. Tyring is a consultant, has received grant/research support, and is on the speakers' bureau for Merck and GlaxoSmithKline. SDEF and this news organization are owned by Elsevier.

Cervarix, a recombinant bivalent HPV vaccine was also approved by the FDA for the prevention of cervical cancer and certain precancerous or dysplastic lesions caused by HPV types 16 and 18 in girls and women.

The FDA followed the advice of its Vaccines and Related Biological Products Advisory Committee, which found that data supported the efficacy of the vaccine for preventing HPV 16/18-related cervical cancer, cervical intraepithelial neoplasia (CIN) 2+, and adenocarcinoma in situ (AIS) in girls and women aged 15–25 years.

The vaccine, which will be marketed by GlaxoSmithKline Biologicals as Cervarix, is administered in a three-dose schedule at 0, 1, and 6 months.

The advisory panel also had found that an immunogenicity bridging study from the United Kingdom—which compared immune responses to the vaccine in recipients aged 10–14 years with those of older recipients—supported effectiveness of this same claim in girls aged 10–14 years. There were no efficacy data in the younger age group, but immune responses for HPV 16/18 in the younger girls were similar to those in the older group.

The majority of the panel also voted that the data supported the safety of the vaccine in girls and women aged 10–25 years but recommended that safety issues, which included spontaneous abortions, be studied further after licensure.

In the pivotal study, there were a higher number of spontaneous abortions around the time of vaccination than in the comparison group.

The company has also announced plans to conduct a postmarketing safety study.

There were more musculoskeletal and neuroinflammatory events with potential autoimmune causes—although rare—among almost 30,000 Cervarix recipients, compared with controls. The three most common adverse events associated with the vaccine were headache, injection site pain, and fever.

Heidi Splete and Damian McNamara contributed to this report