Health & Medicine / Cancer

Last year the FDA approved Gardasil, a vaccine that wards off two strains of human papillomavirus (HPV) that cause 70 percent of all cervical cancers, and the CDC recommended it for all young women ages 11 to 26. The vaccine promises to save hundreds of thousands of lives, but its hefty price tag—$360 for the three necessary doses, as well as the cost of a doctor’s visit—may make it inaccessible to many of those who need it most. Why is the HPV vaccine so expensive? Will it always be this pricey?

Gardasil took more than 20 years to develop, is complex to manufacture, and must be constantly refrigerated, but that’s not why it’s so expensive. Instead, Merck calculated the price based on the money the vaccine will save the entire health-care system—and the CDC approved the price, as it does with other vaccines. “We based the price on a number of factors, most importantly the value Gardasil brings to individuals and society,” says Jennifer Allen, a spokesperson for Merck. “HPV-related diseases cost the U.S. health-care system about $5 billion every year, and we took that into consideration.” Although Merck would not make sales projections, population data show that the vaccine would gross more than $11 billion if all women 11 to 26 in the United States were vaccinated per the CDC recommendation.

The HPV vaccine is the most expensive routine vaccine in the U.S.; in contrast, many childhood vaccines combine several immunizations in a single shot for $20 to $30 a dose. For about $1,200 an American child (more specifically, her parents) can buy protection against 14 dangerous diseases, for an average of $87 per disease. In the developing world, a less-comprehensive suite of vaccines costs just $20 to $30 thanks to discounts and international aid. Merck says Gardasil will be sold to the poorest nations without profit but declined to estimate how much it would cost.

So far, the pickup has been fast despite the price. In less than a year since FDA approval, Merck has sold more than 5 million doses of Gardasil—enough to immunize about 5 percent of young women ages 11 to 26 in the United States. Tiny New Hampshire is shelling out almost $5 million this year to offer the shot free to girls 11 to 18, and 24 other states are considering making the vaccine mandatory, which suggests that 5 million doses is just the tip of the iceberg. Most insurance companies now cover the vaccine, but the cost of each fragile vial is so high that some doctors are reluctant to risk their own money stocking Gardasil. Both directly and indirectly, Gardasil’s high price has made it less accessible, raising the distinct possibility that more people would get the vaccine if it were more affordable.

Richard Schlegel of Georgetown University—one of the developers of Gardasil—and Bob Garcea of the University of Colorado are working on a cheaper HPV vaccine. Gardasil induces an immune response with an empty HPV viral envelope built from repeating shapes, much like a soccer ball. In experiments with dogs, Schlegel and Garcea have discovered that the soccer ball doesn’t have to be in one piece to induce an immune response. The building blocks are simpler to make than the entire ball and can be built cheaply in a bacterial cell, which is easier to work with than the yeast that produces Gardasil. Perhaps most important, Schlegel’s vaccine could be reduced to an unrefrigerated powder, making it easier to distribute in the developing world than Gardasil.

The researchers have tested the vaccine only on dogs so far, but they already have a manufacturing facility available in India and hope to start clinical trials this year. “It would be great if it were tenfold cheaper than Gardasil, but we really want to get it to countries that can’t even afford $36,” Schlegel says. Garcea predicts the end cost will be less than $1 per dose but says it will be years before they know for sure. With research funding from the National Cancer Institute, Schlegel and Garcea plan to persuade big pharmaceutical companies to bring the vaccine directly to women in poor countries where Pap tests are rare and cervical cancer claims hundreds of thousands of lives each year.

The affordable vaccine will at first protect against just a single strain of HPV that accounts for 50 percent of cervical cancer. Once they have proven that the dried vaccine works, Schlegel and Garcea plan to target six cancer-causing HPV strains to protect against 90 percent of cervical cancer. The pharmaceutical companies aren't sitting still while Schlegel's affordable version catches up. Both Merck and GlaxoSmithKline are also working on vaccines that will provide more comprehensive HPV protection but declined to release details.

Last month Discover revealed how the mystery of cervical cancer was solved and a vaccine was born.