FDA OKs HPV Vaccine Cervarix, New Use for Current Vaccine


2009-10-18 16:01

The FDA has approved GlaxoSmithKline's bivalent human papillomavirus (HPV) vaccine, called Cervarix. The new vaccine will be used to prevent HPV types 16 and 18 in girls and young women ages 10 to 25. These two HPV strains account for about 70% of cervical cancers. The vaccine will be available this year, according to GSK.

The vaccine has shown a 93% success rate in preventing precancerous conditions associated with HPV associated with types 16 and 18, and a 70% efficacy rate against all precancerous lesions, regardless of HPV type. Additional protection was found from HPV type 31, which is the third most common cancer-causing virus type in the United States.

According to the Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection in the nation, with at least 50% of sexually active men and women becoming infected at some point in their lives. More than 40 types of HPV can infect genital areas.

Cervical cancer is the second leading cause of cancer death in women in their twenties and thirties and almost always caused by the HPV virus. The American Cancer Society estimates that 11,270 women develop cervical cancer each year, and 4,070 die from it. The Pap test for women has decreased the incidence of cervical cancer by about 75% in the past 50 years.

The new vaccine will be administered in a three-dose schedule over a period of six months. The most serious side effect noted is syncope (fainting), and patients should be observed for 15 minutes after the vaccination is given. Other common side effects reported include pain, redness and swelling at the injection site, fatigue, headache, joint and muscle ache, and gastrointestinal symptoms.

The FDA also approved this week to allow Merck’s Gardasil vaccine to be administered to males ages 9 to 26 to prevent genital warts caused by HPV. The approval did not address claims that the vaccine may help prevent transmission to girls and women.

There is currently no test available to detect the virus in men. HPV is associated with penile, anal, and throat and neck cancers in males.

The new indication for Gardasil is based on two trials. The first included 4,055 males ages 16 through 26 that measured the vaccine’s effectiveness in preventing genital warts. Overall, the study found a 90% reduction in genital warts and pre-cancerous lesions caused by HPV. The second trial studied immune response in boys ages 9 to 15, and found that the vaccine should have similar effectiveness in younger boys as the first study found for older males.

Gardasil was originally approved in 2006 for use in girls and women from 9 to 26 years to ward off four strains of HPV. It is also given as three injections over a six-month period, with similar side effects as Cervarix. The vaccine will be given to males in the same fashion. The cost of the vaccine is $130 per dose.

Sources Include: CNN and The American Cancer Society