University Health Services nears 1,000th course of HPV vaccine

The Gardasil vaccine, touted as a triumph of modern medicine, protects against four strains of human papilloma virus (HPV) that commonly cause genital warts and cervical cancer.

In the two years since obtaining FDA approval and being released by Merck, however, the vaccine has faced tremendous opposition from critics who believe that it encourages sexual activity in young women.

Adel Mahmoud, a senior policy analyst at the Wilson School and a molecular biology professor, is eagerly watching the controversy and anticipating the day when Gardasil will be routinely administered to all Americans as children.

But Mahmoud is not just a casual observer. Before coming to the University, he oversaw the development of the Gardasil vaccine during his tenure as president of Merck Vaccines from 1998 to 2006.

Mahmoud said that the search for the HPV vaccine “was very high on [Merck’s] development program” since a “discovery in the ’80s and ’90s [showed] that HPV was directly related to cervical, anal, penile, head and neck cancers.”

By age 50, 80 percent of women in the United States are infected with HPV. Cervical cancer kills 233,000 women every year, including about 3,700 in the United States.

The Gardasil vaccine protects against the two strains of the disease that cause more than 70 percent of HPV-related cancers as well as against the two other strains that cause more than 90 percent of genital warts, Mahmoud said.

About 20 million Americans and at least 50 percent of sexually active people in the world have genital warts, according to a 2005 study by the Centers for Disease Control and Prevention (CDC).

Support nonprofit student journalism. Donate to the ‘Prince’. Donate now »

The vaccine was also widely hailed as a great success of scientific innovation because the HPV genome was particularly challenging to study and sequence. To develop an effective vaccine, the researchers first needed to understand what proteins were coded for by the genome.

Scientists are unable to culture HPV in vitro, a process needed to develop most vaccines. Nonetheless, “the HPV genome was sequenced, its proteins characterized, and their functions defined,” Mahmoud wrote in a May 2007 letter to Science magazine.

Distributing the vaccine

In June 2006, the vaccine was approved for distribution in the United States in a three-dose series over the course of six months.

Get the best of the ‘Prince’ delivered straight to your inbox. Subscribe now »

Merck, like many healthcare practitioners, had originally hoped that states would mandate the vaccine for school-age girls to systematically combat the most common sexually transmitted infection (STI) in the world, HPV.

Not everyone, however, thought preventing the spread of genital warts was a good enough reason to mandate vaccination.

An ongoing controversy

Texas seemed poised to lead the charge against HPV, but heated controversy greeted Gov. Rick Perry’s executive order in February 2007 requiring that 11- and 12-year-old girls receive the vaccine. Three other states — New Jersey, Massachusetts and Virginia — mandated in 2007 that girls entering sixth grade receive the Gardasil vaccine.

“Vaccines work best when they are given before exposure to the infective agent,” Mahmoud said. “So the 11-to-12 age group was targeted for the vaccine because the idea was that this was definitely before exposure and sexual activity.”

Abstinence advocates believed the vaccine encouraged sexual activity in young girls who should instead be protecting themselves against the disease by avoiding sexual activity entirely. Legislators, on the other hand, were concerned that not enough was known about the relatively new vaccine to assure them of its safety.

The backlash against mandating the vaccine was successful.

Merck announced that same month that it would stop lobbying state legislatures to mandate the vaccine, fearing that campaigns instigated protests that actually hindered widespread adoption of the vaccine.

Following this decision, the Texas House of Representatives passed a law in April 2007 that barred the state from mandating Gardasil immunizations until at least 2011.

“We did not want to be the first in offering young girls for the experiment to see if this vaccine is effective or not,’’ State Representative Dennis Bonnen told The New York Times at the time.

Mahmoud, however, disagrees, citing the six years of vaccine testing, “which is probably more than most vaccines that come to market have. It would never have been approved by the FDA or the Europeans or the Australians if it had not been rigorously tested. They absolutely know the consequences.”

In these studies, the vaccine was found to be almost 100 percent effective in preventing HPV infection and absolutely 100 percent effective in preventing the pre-cancerous changes in the lining of the cervix that signal the beginnings of cancer.

The vaccine was initially tested on more than 25,000 women up to the age of 25, and thus, the vaccine is only approved for females ages 9 to 25, Mahmoud said.

Women who have already been infected with HPV should still consider getting the shots, Mahmoud explained, because the vaccine is effective against four strains of the virus and can protect women infected with one strain against the other three.

The FDA has not approved the vaccine for males, but Merck is currently conducting a clinical trial of the vaccine with a test group of 4,000 men. Some scientists, however, believe that waiting years for the final results of this trial could mean failing to protect an entire generation of American men and their sexual partners.

Australia and countries in Europe have already decided to give the vaccine to young men, a decision that was based on preliminary data showing that Gardasil produces an immune response in boys.

What about college students?

While legislators continue to debate mandating the vaccine for girls before they enter their teenage years and become sexually active, many healthcare practitioners are advocating that high school and college students get the shots before they get any older.

This campaign has met with only limited success, Mahmoud said, because of the difficulties associated with adolescent vaccination.

In fall 2006, University Health Services (UHS) began offering the shots to members of the University community at a cost of $402. UHS has since administered almost 1,000 doses of the vaccine, UHS coordinator for women’s and men’s health Olga Hernandez said.

Mahmoud explained that one of the biggest problems is that vaccination is widely regarded as “a childhood phenomenon.” This is coupled with the additional issue that adolescents interact with the healthcare system less frequently than other age groups. “And this [HPV is] an STI, which gives it a little bit more of a twist,” he said.

A CDC study announced in March showed that one in four females aged 14 to 19 is infected with at least one of the four most common STIs: HPV, chlamydia, trichomoniasis or genital herpes. HPV was by far the most common, affecting 18 percent of the girls who took part in the study.

Mahmoud said he thinks it’s likely that the current college-aged generation won’t be as thoroughly protected as it could be against HPV. Still, he has hope for the future.

“This was exactly what happened with the hepatitis B vaccine. When it first came out, it was also recommended for adolescents, and that was problematic, but now the first dose is given at birth, and it’s done; it protects us for the rest of our lives,” he said. “I think that’s what will happen with Gardasil, and I look forward to that day.”