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PUBLIC HEALTH & EDUCATION | CDC, FDA Release Statement Saying HPV Vaccine Gardasil Remains Safe, Effective

PUBLIC HEALTH & EDUCATION | CDC, FDA Release Statement Saying HPV Vaccine Gardasil Remains Safe, Effective
[July 24, 2008]

Officials from CDC and FDA on Tuesday released a statement that says a review of available information by the two agencies has found that Merck's human papillomavirus vaccine Gardasil "continues to be safe and effective" for protecting women and girls from a virus that causes cervical cancer, and that its "benefits continue to outweigh its risks," Reuters reports.

The agencies said they reviewed more than 9,700 reports of health problems following vaccination with Gardasil. As of June 30, 6% of the reviewed cases were deemed serious events, including 20 deaths. The statement said, "There was not a common pattern to the deaths that would suggest they were caused by the vaccine." In cases where autopsy or other records were available, "the cause of death was explained by factors other than the vaccine," according to the statement. In addition, data for other serious problems that were reported -- including the rare neurological disorder Guillain-Barre Syndrome -- "do not currently suggest an association" between the vaccine and patients developing the conditions, FDA and CDC said (Richwine, Reuters, 7/22).

Gardasil in clinical trials has been shown to prevent infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and to prevent infection with HPV strains 6 and 11, which cause about 90% of genital warts cases (Daily Women's Health Policy Report, 7/11).

Report Projects Decline in HPV Infections in Australia

In related news, a study by Australia's Cancer Council published in the International Journal of Cancer projected that new cases of HPV will decline in the country over the next 18 months because of a high number of teenage girls who have received HPV vaccinations, the West Australian reports (O'Leary, West Australian, 7/23).

The study provides a projection of HPV rates among Australian women since the introduction of the national immunization program, which began in April 2007. The study found that new infections caused by HPV strains 16 and 18 should decrease by more than 50% by 2010 and fall by 92% by 2050. Lead study author Karen Canfell of the Cancer Council New South Wales said the decrease in new infections likely will be attributed to the vaccination of more than 80% of 12- to 13-year-olds in high schools. "This is great news for Australian girls and women, as we can expect the effect on [cervical] cancer rates to be marked," Canfell said. She added, "But we cannot afford to rest on our laurels. This reduction will only occur if we maintain this high vaccination coverage amongst younger age groups, as it will provide immunity against HPV before girls are exposed to the virus" (AAP/Sydney Morning Herald, 7/23).

Conference on Curbing Cervical Cancer in Africa Opens in Uganda

The second annual international conference on fighting cervical cancer -- titled "Stop Cervical Cancer in Africa: Accelerating Access to HPV Vaccines" -- opened on Monday in Kampala, Uganda, Uganda's New Vision reports. About 500,000 women worldwide develop cervical cancer annually, and about 270,000 women die from the disease each year, according to the New Vision. Nearly 85% of cervical cancer cases are in developing countries where access to routine health care is often limited.

In Uganda, 80% of women with cervical cancer are diagnosed with advanced disease that is difficult or impossible to treat, making it the leading cause of cancer-related deaths in the country, the New Vision reports. Emmanuel Mugisha, country director in Uganda for the global health group PATH, said high costs of HPV vaccines and Pap tests have hindered the fight against cervical cancer. "Cervical cancer screening is not yet widely available," Mugisha said, noting that most of the few health centers in the country that provide such services are located in the capital of Kampala. He added, "The cost makes it hard for women to go for screening, especially when they are not sick." Mugisha also said that there is a lack of awareness among the population and that voluntary screening still is unpopular in Uganda because the government has not invested in this public health care aspect.

According to Issa Makumbi, the officer in charge of immunization at Uganda's Ministry of Health, the country plans to implement vaccination of girls ages 10 to 12 with GlaxoSmithKline's HPV vaccine Cervarix. Although the vaccine is currently now affordable in some developing countries, Makumbi said that some countries have reached deals with pharmaceutical companies to purchase the vaccine at a reduced price (Nabusoba, New Vision, 7/21). Cervarix also has been shown to be 100% effective in preventing infection with HPV strains 16 and 18 (Daily Women's Health Policy Report, 7/2).