SILVER SPRING, MD. — The majority of a federal advisory panel agreed that the data on a recombinant bivalent human papillomavirus vaccine indicate that the vaccine is safe and effective in preventing cervical cancer and certain precancerous or dysplastic lesions caused by HPV types 16 and 18 in girls and women aged 10–25 years.
The FDA's Vaccines and Related Biological Products Advisory Committee voted 12–1 that the data on the GlaxoSmithKline Biologicals human papillomavirus bivalent (types 16 and 18) vaccine, recombinant, supported the efficacy of the vaccine for preventing HPV 16/18-related cervical cancer, cervical intraepithelial neoplasia (CIN) 2+, adenocarcinoma in situ (AIS), and CIN1+ in girls and women aged 15–25 years.
In a separate vote, the panel again voted 12-1 that the results of an immunogenicity bridging study from the United Kingdom, which compared immune responses to the vaccine in recipients aged 10–14 years with those of older recipients, supported effectiveness of this same claim in girls aged 10–14 years. There were no efficacy data in the younger age group, but immune responses for HPV 16/18 in the younger girls were similar to those in the older group.
If approved, GSK plans to market the vaccine as Cervarix. GSK has proposed that Cervarix be licensed for prevention of cervical cancer (squamous cell cancer and adenocarcinoma) and protection against precancerous or dysplastic lesions and persistent/incident infections caused by HPV types 16 and 18, in girls and women aged 10–25 years. It is administered in a three-dose schedule at 0, 1, and 6 months.
The majority of the panel also voted that the data supported the safety of the vaccine in girls and women aged 10–25 years but recommended that safety issues, which included spontaneous abortions, be studied further after licensure. In the pivotal study, there was a higher number of spontaneous abortions around the time of vaccination than in the comparison group.
GSK, which has a Cervarix pregnancy registry in the United Kingdom, has announced plans to combine that with a U.S. registry, pending FDA approval. The company has also announced plans to conduct a postmarketing safety study.
There were more musculoskeletal and neuroinflammatory events with potential autoimmune causes—although rare—among almost 30,000 Cervarix recipients, compared with controls. The three most common adverse events associated with the vaccine were headache, injection site pain, and fever.
The FDA usually follows the recommendations of its advisory panels. HPV 16 and 18 cause most cervical cancers in the United States. The vaccine, approved in 2007 in Australia, is now licensed in 98 countries.
Merck's quadrivalent HPV vaccine, Gardasil (human papillomavirus [types 6, 11, 16, 18] quadrivalent vaccine, recombinant), is approved for girls and women aged 9–26 years, for preventing cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 as well as associated precursor lesions and genital warts caused by HPV types 6 and 11.