WASHINGTON -- The FDA approved Merck's Gardasil vaccine against human papillomavirus (HPV) for boys and men, the same day that it okayed a competing vaccine for use in females.
Gardasil was approved for males ages 9 to 26 for prevention of genital warts. The approval did not address claims that the vaccine in this population may help prevent transmission to girls and women.
Earlier Friday, the agency also approved the first competitor for Gardasil since the latter came on the market in 2006. GlaxoSmithKline's Cervarix was cleared for use in girls and women, 9 to 26 years old. (See FDA Okays Second HPV Vaccine)
The new indication for Gardasil was based on two trials: a randomized trial in 4,055 males ages 16 through 26 testing the vaccine's effectiveness in preventing genital warts, and a study in boys ages 9 to 15 that measured immune responses.
The second trial showed that the immune response was as good as that found in the older age group, indicating that the vaccine should have similar effectiveness, the FDA said.
In September, the FDA's advisory committee on vaccines voted to recommend Gardasil's approval for males when it also backed Cervarix. (See FDA Panel Votes to Approve Second HPV Vaccine)
Merck is to conduct postmarketing studies aimed at collecting more data on the vaccine's safety and efficacy in males.
Gardasil is given as three injections over a six-month period. Headache, fever, pain at the injection site, itching, redness, swelling, and bruising were the most common side effects observed in the clinical studies.