Magazine article Clinical Psychiatry News

Panel Backs Second HPV Vaccine for Girls, Women

Magazine article Clinical Psychiatry News

Panel Backs Second HPV Vaccine for Girls, Women

Article excerpt

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 data on the Glaxo-SmithKline Biolog-icals HPV bivalent (types 16 and 18) vaccine, recombinant, supported the efficacy of the vaccine for preventing HPV 16/ 18-re-lated 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 immuno-genicity bridging study from the United Kingdom that 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. It 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. …

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