Too costly for some: New research hints that older teens miss out on vaccination. Credit: Reuters/Jessica Rinaldi

When public health experts learned about the arrival of Gardasil, the first vaccine approved by the US Food and Drug Administration to protect against cancer, many of them enthusiastically endorsed it. Since then, however, the vaccine has been dogged by political controversy. Now a new study, the first to provide details concerning adoption rates of the vaccine, reveals that in certain communities early uptake of the vaccine has fallen below expectations.

In the preliminary study presented at the American Association for Cancer Research's Frontiers in Cancer Prevention meeting in Philadelphia last month, epidemiologist Sherri Sheinfeld-Gorin of Columbia University and her colleagues found that doctors in small private practices vaccinated fewer women than they had originally anticipated.

The vaccine, developed by the pharmaceutical company Merck and recommended for women aged 9–26, works by creating immunity to several aggressive strains of the human papilloma virus (HPV). The sexually transmitted virus can sometimes lead to cancerous growths in the cervix.

Sheinfeld-Gorin's team first surveyed physicians serving a mainly Hispanic and African-American community in New York in the first few months of 2006, well before the US approval of the vaccine in June of that year. Of the 235 doctors surveyed, 92% of them said they expected to administer the vaccine to patients. Additionally, 91% of women aged 19–26 attending the clinics said they planned to get vaccinated.

But a follow-up audit of patient charts in the same physicians' practices through early November 2007 showed a lag in actual vaccinations: only 17% of the 235 physicians had actually administered the vaccine since its approval. And data from the preliminary study show that in the first half of 2007, only ten percent of the 113 young women eligible for the vaccine who visited the surveyed practices received it.

Dose of reality: Small clinics face hurdles.

Sheinfeld-Gorin notes several factors, including cost, influencing the slow adoption of the vaccine. The vaccine's $360 price tag is reimbursed by many insurance plans and is covered by the US government's Vaccines for Children Program, which pays the cost for low-income children aged 18 and younger.

But physicians still have to pay upfront for vaccine stockpiles for patients aged 19 and above, as well as for those who are insured. That is a financial burden many inner-city physicians with small practices do not want to bear, Sheinfeld-Gorin explains.

According to Merck statistics, more than 10 million doses of the company's HPV vaccine had been distributed since its approval. And Sheinfeld-Gorin acknowledged that the coverage rate for the HPV vaccine in other communities in the US might be higher than that found in her study. One unpublished survey conducted by Rebecca Perkins and her colleagues at the Boston Medical Center during May and June 2007 found that 59% of eligible patients seen by pediatricians there have received the vaccine since its approval.

The pediatric practices at the Boston Medical Center serve a largely minority and urban population similar to that surveyed in Sheinfeld-Gorin's study. But the center receives more financial assistance from the Vaccines for Children Program because of its younger patient population. Being part of a large metropolitan hospital, the practices also have more resources to purchase the vaccine upfront.

Experts note that many vaccines are slow to catch on in their first year—unless they are government mandated. “It's usually in the second or third year when we really see what happens with uptake of a vaccine,” says Debbie Saslow, director of breast and gynecologic cancer for the American Cancer Society. “We know this vaccine is safe and it works well—so hopefully its use will increase over time.”

Ginger Gardner, a gynecologist at the Memorial Sloan-Kettering Cancer Center in New York and a member of the board of directors of the US Gynecologic Cancer Foundation, believes that more patients will seek the HPV vaccine in the future. “But there's no doubt that in poorer minority communities there are challenges. Physicians need to discuss the vaccine with a responsible adult and there's a need for repeat visits since the vaccine is given in three doses,” Gardner says. “At the same time, there's a lack of access to medical care in minority communities.”

Credit: Source: Progress for Children Report/UNICEF

The approval of GlaxoSmithKline's cervical cancer vaccine, expected in early 2008, will create market competition and likely bring down the cost of vaccination, according to Saslow. She says this will help to surmount at least one obstacle to widespread HPV vaccination, especially in poorer, minority communities.