Newest vaccine will be available at health department by year’s end

By Scott Nicholson

nicholson@wataugademocrat.com

A new vaccine developed to help prevent cervical cancer likely won’t be available through the Watauga County Health Department until the end of the year, though private physicians may have supplies.

In June, the federal Food and Drug Administration announced the approval of Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts. The vaccine is designed to limit infection from the human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is approved for use in females 9 to 26 years of age.

Gardasil, manufactured by Merck & Co., was fast tracked by the FDA under a priority review process.

However, it’s still making its way through the distribution system and the local health department has yet to receive any vaccine.

Debbie Garrett, nursing supervisor at the health department, said the state will make the vaccines available, but it hasn’t received notification of when the supplies will arrive. Garrett said there had been few public inquiries about the vaccine.

According to the Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection in the United States.

The CDC estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives.

Two HPV types, 16 and 18, are linked to an increased risk of cervical cancer in women. There are nearly 10,000 new cases of cervical cancer and 3,700 deaths attributed to cervical cancer in the United States each year. Worldwide, it’s the second-most common cancer in women, with 233,000 deaths attributed to it each year.

According to the CDC, the body’s own defense system will clear the virus and most infected women do not develop related health problems.  However, types 16 and 18 can cause abnormal cell changes in the lining of the cervix. HPV types 6 and 11 cause about 90 percent of genital warts cases. 

Gardasil is given as three injections over a six-month period and is expected to prevent most cases of cervical cancer.  However, it doesn’t cure existing cases of HPV and doesn’t inhibit other types of HPV infection.

Garrett said once supplies do arrive, the vaccine would be administered according to state guidelines, which generally mirror CDC recommendations. She said once the vaccine was available, it would be included under regular protocol for the free vaccine program for eligible youths under the age of 19.

Amanda Dayton, public information officer with the N.C. Department of Health and Human Services immunization division, said the state is currently going through the process of securing contracts.

She said no federal or state funding was currently available and the division didn’t know how much money to expect. Until then, it’s difficult to predict when the vaccine would be available through local health departments, though Dayton indicated it could be by the end of the year.

Dayton also said the swiftness of the FDA approval led to the lack of immediate funding. However, private physicians can order doses through the manufacturer.

The recommended three-shot vaccine series would cost $360, Dayton said.

Early studies showed positive results and a nearly total effectiveness in a test involving 21,000 women aged 16 to 26. Two other studies also showed the immune response in females aged 9 to 15 was similar to those of the older females tested. Merck has agreed to continue follow-up testing as a condition of its license to monitor long-term effectiveness of the vaccine. GlaxoSmithKline is also developing an HPV vaccine.