Merck files 9-valent HPV vaccine for FDA review

Merck has announced that the company filed the biologics license application for its investigational 9-valent human papillomavirus vaccine, which has been accepted for standard review by the FDA.

The pharmaceutical company currently markets a quadrivalent HPV vaccine, Gardasil, which has been approved for both sexes against HPV types 6, 11, 16 and 18. A bivalent vaccine (Cervarix, GlaxoSmithKline), which protects against HPV types 16 and 18, is also available.

Both vaccines have proven safe and effective in preventing HPV-related cancers, but public awareness or support of vaccination have not been sufficient, according to experts. Recently, the President’s Cancer Panel stressed the need to increase immunization among children and adolescents. Their report included data from the CDC, which indicated that an 80% vaccination rate would reduce the burden of cervical cancer by 53,000 cases among girls aged 12 years or younger in the United States. However, only one-third of girls and less than 7% of boys aged 13 to 17 years had received the recommended three does of the HPV vaccine in 2012.