Source: DGNews  |  Posted 2 years ago

NEW YORK -- February 9, 2010 -- Health Canada has approved a new adjuvanted
(AS04) human papillomavirus (HPV) vaccine (types 16 and 18 [Cervarix]) to
protect girls and women aged 10 to 25 years against cervical cancer and
abnormal and precancerous cervical lesions.

“In Canada, more than 1 woman dies every day from cervical cancer, a disease
that is largely preventable,” said Barbara Romanowski, MD, Division of
Infectious Diseases, University of Alberta, Edmonton, Alberta. “Together with
regular Pap tests, Cervarix reduces the risk of cervical cancer caused by HPV
types 16 and 18, by 98%.”

The vaccine contains a unique adjuvant system, AS04, which has been added to
improve the immune response by providing stronger and longer protection as
compared with a traditional adjuvant.

A phase 3 trial, which included over 18,000 women, evaluated the efficacy of
HPV types 16 and 18 as well as other cancer causing HPV types. In 1 analysis
the vaccine demonstrated protection against HPV type 45 in addition to types 16
and 18. In another, the vaccine demonstrated protection against HPV type 31 in
addition to types 16 and 18.

The vaccine was generally well tolerated. The most common local adverse
reactions and general adverse events in >=20% of subjects were pain, redness,
and swelling at the injection site; fatigue, headache, myalgia,
gastrointestinal symptoms, and arthralgia.

SOURCE: GlaxoSmithKline