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| | | ![]() Health Canada Approves HPV Vaccine, Types 16 and 18 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
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