Just a few days ago, the FDA finally approved Cervarix, the second vaccine for prevention of human papilloma virus (HPV) infection. HPV is a known cause of cervical cancer in women. The high rates of HPV and increasing rates of cervical 
cancer in young women has prompted development of vaccines to fight HPV.
Cervarix has been approved for use in teenage girls and young females ages 10-25 to help prevent cervical cancer caused by HPV. Human papilloma virus is common among sexually active females and the virus is sexually transmitted. However, the majority of women who do get infected with HPV do not always develop cervical cancer.
For the past 3 years, the only HPV vaccine on the market was Gardasil and the results so far have been favorable. Gardasil targets four strains of HPV: namely HPV 6, 11, 16, and 18.
Cervarix is manufactured by GlaxoSmithKline and has been used in other countries (e.g. Australia) for the past 3 years. However, in North America the vaccine was not approved until appropriate clinical studies were completed. Laboratory studies have shown that Cervarix protects against two strains of the HPV (16 and 18) that are responsible for cervical cancer. The vaccine is formulated with ASO4, an adjuvant compound that can help enhance the immune response to various HPV strains for a longer period.
In clinical trials, all women who took Cervarix developed antibodies to HPV within seven months of receiving the vaccine. Moreover the antibodies remained detectable in the blood for more than 12 months after the last dose of vaccine. Evaluation of data from numerous centers show that the vaccine is also effective in women over the age of 26. Present studies reveal that Cervarix offers protection from HPV for at least 6.4 years. There is now a clinical trial under way to determine if Cervarix is more effective than Merck’s HPV vaccine, Gardasil.
As far as side effects were concerned, GlaxoSmithKline claims that the Cervarix vaccine is safe and is well tolerated. Cervarix should not be administered to pregnant women as there are inadequate data about its safety in this population. In accordance with FDA rules, GlaxoSmithKline will continue to maintain a registry of pregnant women who have accidentally received this vaccine.
