FDA Approves Cervarix

Kate Traynor

BETHESDA, MD 19 October 2009—FDA on Friday approved a license from GlaxoSmithKline to market Cervarix, a vaccine designed to protect against cancers caused by infection with human papillomavirus (HPV) types 16 or 18.

Cervarix is indicated for the prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) grade 1, CIN grade 2 or greater, and adenocarcinoma in situ in girls and women 10–25 years of age, according to the product's labeling (PDF).

GlaxoSmithKline expects to launch the vaccine in the United States near the end of this year.

Cervarix is the second U.S.-licensed HPV vaccine. Gardasil, Merck and Company's HPV vaccine, was licensed in 2006 for the prevention of cancers and other disease associated with infection by HPV types 6, 11, 16, or 18.

Fifteen of the approximately 100 known HPVs are considered oncogenic, and HPV types 16 and 18 are responsible for about 70% of all cervical cancers, according to the National Cancer Institute (NCI). NCI estimates that about 11,000 women in the United States will be diagnosed with cervical cancer this year, and about 4,000 will die from the disease.

The recommended dosage of Cervarix is three 0.5-mL i.m. injections, with the initial dose followed by an injection at one month and another at six months.

In clinical trials, Cervarix was 93% effective at preventing precancerous lesions caused by HPV 16 or 18 in women who had not been previously infected by these viruses. When data from women who were infected by one or both viruses before vaccination were included in the analysis, the vaccine's overall efficacy was about 53%, according to FDA.

A post-hoc analysis of clinical data indicated that Cervarix was 89% effective at preventing precancerous growths caused by HPV 39, a nonvaccine strain, according to the product's labeling.

The most frequent adverse reactions reported by clinical trial participants were fatigue, headache, muscle pain, gastrointestinal symptoms, and joint pain. Injection-site reactions, including pain, redness, and swelling, were also commonly reported by study participants.

The labeling for Cervarix warns that vaccinees may faint and should be observed for 15 minutes after an injection is administered to reduce the risk of falling and injury.

Cervarix contains the adjuvant AS04, which consists of 3-O-desacyl-4'-monophosphoryl lipid (MPL) A adsorbed onto aluminum as a hydroxide salt. According to FDA, Cervarix is the first vaccine licensed by the agency that contains MPL.

Cervarix will be supplied in 0.5-mL single-use vials, 10 per package, and prefilled syringes in packages of 1 or 5 each. The syringes should not be used to administer the vaccine in any patient who is sensitive to latex, according to the product's labeling.