Herpes Testing Blog

Reporting the results of a study published in the Lancet, GlaxoSmithKline PLC (GSK) said Tuesday that its human papillomavirus vaccine Cervarix was effective not only against HPV strains most likely to cause cervical cancer but also other strains of the STD.

The subjects of the late-stage trial were 18,644 females ages 15 to 25. They included females with evidence of past or current HPV infection or high-grade Pap smear results, plus others with no evidence of current or previous HPV infection. Case subjects received Cervarix; control subjects received hepatitis A vaccine. The shots were administered at baseline, one month and six months.

The trial sought to test the efficacy of Cervarix against HPV types 16 and 18, the strains most likely to result in cervical cancer. Women who received all three doses of the HPV vaccine achieved 92.9 percent protection. Excluding some lesions not likely caused by HPV types 16 or 18, GSK said the vaccine provided 98.1 percent protection against those strains. In addition, the researchers noted evidence that Cervarix was protective against HPV types 31, 33, and 45. GSK said this was the first time any HPV vaccine evidenced significant protection against precancerous lesions caused by other HPV strains.

Cervarix is already in use in the European Union and many other nations. A decision by the Food and Drug Administration on whether to approve the vaccine for use in the United States could come by autumn.

The report, “Efficacy of Human Papillomavirus (HPV)-16/18 AS04-Adjuvanted Vaccine Against Cervical Infection and Precancer Caused by Oncogenic HPV Types (PATRICIA): Final Analysis of a Double-Blind, Randomized Study in Young Women,” was published in the Lancet (07.07.09; doi:10.1016/S0140-6736(09)61248-4).

For the complete article, and more information from the Centers for Disease Control and Prevention, please refer to http://www.cdcnpin.org/.

The World Health Organization has approved GlaxoSmithKline’s (GSK) Cervarix, paving the way for UN agencies and partners to buy the human papillomavirus (HPV) vaccine for poor countries worldwide.

Certain HPV strains are responsible for most cases of cervical cancer. Of the 280,000 cervical cancer deaths globally, more than 80 percent occur in developing countries. Screening and treatment programs have dramatically reduced the disease’s incidence in developed countries.

Last year, GAVI, formerly known as the Global Alliance for Vaccines and Immunization, made purchasing cervical cancer vaccines for the world’s 73 poorest countries a priority. GAVI, comprising the Bill & Melinda Gates Foundation, UN agencies, and the World Bank among others, is a major buyer of vaccines for the developing world.

Though it has not been approved for use in the United States or Japan, Cervarix is available in 97 other countries. The US Food and Drug Administration is expected to decide whether to approve Cervarix in the coming months. Currently, the only HPV vaccine available for the US market is Merck & Co.’s Gardasil. Cervarix has won more contracts from government health programs beyond the United States.

Both vaccines typically cost around $360 for a three-shot dose. It is not clear whether GSK will discount Cervarix for distribution in poor countries.

For the complete article, and more information from the Centers for Disease Control and Prevention, please refer to http://www.cdcnpin.org/