FDA Advisory Committee supports second HPV vaccine

During its September 9 meeting, the FDA's Vaccines and Related Biological Products Advisory Committee also recommended approval of a second vaccine to prevent cervical cancer—GlaxoSmithKline's (GSK) Cervarix.

In March 2009, GSK submitted final data from its phase 3 study on the vaccine. Clinical trials were conducted in more than 30 countries and including 30,000 females. The company reported that the most common side effects were pain, redness and swelling, fatigue, headache, joint and muscle aches, gastrointestinal symptoms, and fever.

The FDA advisory committee concluded that clinical data supported the efficacy and safety of the vaccine in young women (ages 10 to 25 years) for the prevention of cervical pre-cancers and cervical cancer related to HPV types 16 and 18.

To date, Cervarix has been approved in nearly 100 countries. At press time, the FDA was expected to act on the committee's recommendations and approve Cervarix. The CDC also was scheduled to develop guidelines for the vaccine's use during its October meeting.

Deborah Arrindell, vice president of health policy for the nonprofit American Social Health Association, who testified at the FDA advisory committee meeting, noted that having a second HPVvaccine available would create an incentive for researchers to further study how each vaccine works and how they might differ.

“It is our hope that market competition created by this second vaccine will increase awareness of cervical cancer prevention, favorably impact availability, result in reduced vaccine pricing, and create more efficient economies of scale by taking advantage of additional distribution channels,” she added.