Family physicians now have two new tools to help them protect their patients. Late last month, the FDA granted licensure to a vaccine intended to reduce the risk of herpes zoster -- commonly known as shingles -- in older patients. And just last week, the agency approved a vaccine that targets human papillomavirus strains known to cause cervical cancer.
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Newly Approved Vaccines Protect Against Shingles, Cervical Cancer
By News Staff
Herpes Zoster Vaccine
Herpes zoster affects about 20 percent of the adult population, manifesting as clusters of painful blisters with a unilateral dermatomal distribution. Pain associated with herpes zoster occurs during the prodrome, the acute eruptive phase and the postherpetic phase and may last for weeks, months or even years. The infection is caused by the varicella-zoster virus, the same virus that causes chickenpox. After a bout of chickenpox, the virus lies dormant in the dorsal root or cranial sensory ganglia until reactivated later in life.
Zostavax, a live attenuated virus vaccine, has been approved for use in patients ages 60 and older. Tested in some 38,000 older individuals, who were followed for a median of 3.1 years, the vaccine reduced the incidence of shingles by about 50 percent overall and by 64 percent in those ages 60 to 69. Among those who contracted shingles after immunization, administration of the vaccine was associated with a slight reduction in pain following disease onset.
The herpes zoster vaccine, manufactured by Merck & Co. Inc., is administered as a single subcutaneous dose and is indicated only for prevention of herpes zoster, not for treatment of active infection. Additional prescribing information is available online. (PDF file: 9 pages / 187 KB. More about PDFs.)
Human Papillomavirus Vaccine
HPV infection is the most common sexually transmitted disease in the United States, with more than 6 million women becoming infected with genital HPV each year, according to CDC estimates. More than half of all sexually active men and women will become infected during their lifetimes, says the CDC.
On June 8, FDA officials announced approval of Gardasil, a quadrivalent recombinant vaccine also manufactured by Merck, indicated for use in female patients ages 9 to 26 years to prevent cervical cancers and other sequelae of HPV infection.
The vaccine is effective against the four HPV strains (types 6, 11, 16 and 18) that have been implicated as causing genital warts, precancerous genital lesions, and cervical and other cancers. Specifically, the HPV strains contained in the vaccine cause about 90 percent of genital warts; types 16 and 18 account for about 70 percent of cervical cancers. In addition to causing squamous cell cervical cancer and cervical adenocarcinoma, these latter two types are responsible for between 35 percent and 50 percent of vulvar and vaginal cancers.
Overall, nearly 10,000 American women are diagnosed with cervical cancer annually, and about 3,700 die of the disease.
The vaccine, which is given as a series of three intramuscular injections over a six-month period, was shown to be nearly 100 percent effective in preventing development of precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts in the 20,541 non-HPV-infected women in whom it was tested.
The vaccine was evaluated and approved within six months under the FDA's priority review process. Although trials that tested the vaccine's efficacy did not last long enough for cervical cancer to develop in study participants, the researchers involved consider it highly likely that preventing precancerous cervical lesions in these women equates to preventing later cancer development.
Additional information about the vaccine, including specific dosing information, is available online.
Herpes zoster affects about 20 percent of the adult population, manifesting as clusters of painful blisters with a unilateral dermatomal distribution. Pain associated with herpes zoster occurs during the prodrome, the acute eruptive phase and the postherpetic phase and may last for weeks, months or even years. The infection is caused by the varicella-zoster virus, the same virus that causes chickenpox. After a bout of chickenpox, the virus lies dormant in the dorsal root or cranial sensory ganglia until reactivated later in life.
Zostavax, a live attenuated virus vaccine, has been approved for use in patients ages 60 and older. Tested in some 38,000 older individuals, who were followed for a median of 3.1 years, the vaccine reduced the incidence of shingles by about 50 percent overall and by 64 percent in those ages 60 to 69. Among those who contracted shingles after immunization, administration of the vaccine was associated with a slight reduction in pain following disease onset.
The herpes zoster vaccine, manufactured by Merck & Co. Inc., is administered as a single subcutaneous dose and is indicated only for prevention of herpes zoster, not for treatment of active infection. Additional prescribing information is available online. (PDF file: 9 pages / 187 KB. More about PDFs.)
Human Papillomavirus Vaccine
HPV infection is the most common sexually transmitted disease in the United States, with more than 6 million women becoming infected with genital HPV each year, according to CDC estimates. More than half of all sexually active men and women will become infected during their lifetimes, says the CDC.
On June 8, FDA officials announced approval of Gardasil, a quadrivalent recombinant vaccine also manufactured by Merck, indicated for use in female patients ages 9 to 26 years to prevent cervical cancers and other sequelae of HPV infection.
The vaccine is effective against the four HPV strains (types 6, 11, 16 and 18) that have been implicated as causing genital warts, precancerous genital lesions, and cervical and other cancers. Specifically, the HPV strains contained in the vaccine cause about 90 percent of genital warts; types 16 and 18 account for about 70 percent of cervical cancers. In addition to causing squamous cell cervical cancer and cervical adenocarcinoma, these latter two types are responsible for between 35 percent and 50 percent of vulvar and vaginal cancers.
Overall, nearly 10,000 American women are diagnosed with cervical cancer annually, and about 3,700 die of the disease.
The vaccine, which is given as a series of three intramuscular injections over a six-month period, was shown to be nearly 100 percent effective in preventing development of precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts in the 20,541 non-HPV-infected women in whom it was tested.
The vaccine was evaluated and approved within six months under the FDA's priority review process. Although trials that tested the vaccine's efficacy did not last long enough for cervical cancer to develop in study participants, the researchers involved consider it highly likely that preventing precancerous cervical lesions in these women equates to preventing later cancer development.
Additional information about the vaccine, including specific dosing information, is available online.
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