WASHINGTON – A vaccine from GlaxoSmithKline blocks the virus that causes most cases of cervical cancer, the U.S. Food and Drug Administration said Friday.
In documents posted online, the FDA said Cervarix, Glaxo's vaccine against human papilloma virus or HPV, blocked the two most cancerous strains of the virus nearly 93 percent of the time.
The main study of the vaccine enrolled more than 18,000 women who either received Cervarix or a sham treatment. The FDA said the vaccine appears to fight the HPV virus for more than six years, based on company data. Side effects were minor, such as pain and swelling at the injection site.
The agency will ask a panel of vaccine experts next week whether Cervarix should be approved for girls and women ages 10 to 25. The FDA is not required to follow the group's advice, although it usually does.
A positive review from the agency would clear the British drug maker's vaccine to compete in the United States, but it could face an uphill battle against Merck's blockbuster vaccine Gardasil, which has been on the market here since 2006.
Besides having a three-year head start, Gardasil also defends against two more HPV types that cause 90 percent of genital warts, which Cervarix does not target.
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