FDA announces two HPV vaccine approvals

On Friday, the FDA announced that it had approved the use of the human papillomavirus vaccine Gardasil (Merck) for the prevention of genital warts due to HPV types 6 and 11 in boys and men aged 9 to 26. In addition, the agency also approved GlaxoSmithKline’s HPV vaccine, Cervarix, for the prevention of cervical precancers and cervical cancers associated with HPV types 16 and 18 in girls and young women aged 10 to 25.

The approvals come just over a month after the Vaccines and Related Biological Products Advisory Committee recommended the approval of the new indication and the new product.

The approval of Gardasil in men and boys was based upon efficacy data from a randomized trial of 4,055 men aged 16 to 26 years. The results showed that in men who were not infected by HPV types 6 and 11 at the start of the study, Gardasil was nearly 90% effective in preventing genital warts caused by infection with HPV types 6 and 11.

Studies conducted in boys aged 9 to 15 years found that the immune response was as good as that found in males aged 16 to 26, indicating a similar effectiveness.

The manufacturer will conduct postmarketing studies to obtain additional information on the safety and effectiveness of Gardasil in boys and men.

Cervarix

The approval of Cervarix was based on data from the PATRICIA trial published earlier this year. In this trial, the vaccine was shown to be 93% effective against cervical intraepithelial neoplasia 2+ associated with HPV types 16 and 18 in women who were seronegative at baseline and DNA negative at six months.

Cervarix should be commercially available in the United States in late 2009, according to the manufacturer.

Both vaccines will be given as three injections during a six-month period. Headache, fever and pain at the injection site, itching and redness were among the most commonly observed adverse effects.