When eager freshmen filed into assemblies early this month to be welcomed to Yale by their deans and masters, it is safe to say that one of the last things on their minds was cervical cancer.
But as hype began to build nationally for the new human papillomavirus (HPV) vaccination, some students, especially after presentations by Peer Health Educators, said they began to wonder why Yale was not yet administering the vaccination. Administrators at University Health Services said there are a variety of factors that have slowed the process and that it is only a matter of time before the University can offer immunization to students.
Last June, the U.S. Food and Drug Administration announced its approval of Gardasil, which is the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus, according to an FDA press release. The vaccine, which was licensed in only six months under the FDA’s priority review procedure, was approved for females 9-26 years of age. Its use has already been approved in Europe.
Just three months after approval, clinics and universities throughout the country announced that they are in the initial stages of stocking and administering the vaccine to patients, but as many freshmen noticed during their Connections Workshops earlier this month, the HPV vaccine is, so far, noticeably absent at Yale.
Paul Genecin, director of YUHS, said there are always many issues that need to be sorted out before Yale begins offering a new vaccine, particularly when it comes to a vaccine like this one, which is administered in a three-shot series over a period of six months.
“We’ll have a supply — I’m not worried about that,” he said. “The big issue is low level of compliance. The program that we need to develop in order to chase and remind literally thousands of young women has to be very big.”
Axel Schmidt ’09, one of the Peer Health Educators who spoke to groups of freshmen in early September, said he observed considerable interest in the vaccine and received a number of questions about when the University would be offering it. Still, he said he is neither surprised nor upset that it is not here yet.
“It takes time, and I don’t mind being patient as long as Yale is working on providing it reasonably soon,” Schmidt said.
HPV is a sexually transmitted virus transferred through genital contact, including vaginal and anal sex, as well as skin-to-skin contact, according to the FDA. At least half of all sexually active people will have some type of HPV at some point during their lives, but in most cases, there are no symptoms and the virus clears undetected. The danger is in certain strains — types 16 and 18, which cause about 70 percent of cervical cancer, and types 6 and 11, which cause about 90 percent of genital warts.
Race for a cure
The slow distribution of the vaccine may have initially been due to problems with supply, but this is no longer the case, YUHS Chief of Obstetrics and Gynecology David Roth and Medical Director Michael Rigsby said in a joint e-mail. In fact, they said, Yale already has a small amount of Gardasil but not enough inventory or preparation to begin administering the vaccine.
“We have some vaccine already and will obtain more as we continue to develop plans for a comprehensive vaccine program,” Roth and Rigsby said. “Because this vaccine requires three doses over six months, it is important for us to have a way of ensuring that we have both an adequate, ongoing supply and a program in place to make sure that people who begin a vaccine series complete it. We already have a very busy immunization clinic providing a number of other vaccines, including those needed for student travel — so we need to make sure we can meet everyone’s needs.”
Most students said they felt uninformed about what the University is doing to acquire and administer the vaccine. Roth and Rigsby said fewer than 10 people so far have signed up to receive the vaccine once the University is able to administer it.
But at Harvard, students who request immunization are already receiving the vaccine. Harriet Torgerson, an OB/GYN nurse at Harvard University Health Services, said the series of shots is being administered to students as they request it. But so few have been given that no official numbers have been released as yet. Princeton University Health Services declined to release information about the HPV vaccine.
Roth and Risgby said they cannot comment on what other schools are doing and that because it will take time for the University to develop a comprehensive implementation plan, students who have an urgent need to get the vaccine should speak to their primary health care clinicians.
Katie Johnson ’07, a biomedical engineering major whose senior research focuses on HPV and cervical cancer, said she was unaware the vaccine would eventually be available at Yale and is surprised that Harvard is already offering it to students. She was pleased to learn that Yale would eventually have inventory of Gardasil because she is interested in being immunized.
“Like many other women I know, I would like to have the opportunity to get this vaccine,” Johnson said.
Still, Roth and Rigsby said they do not foresee a massive rush on the vaccine as soon as it is offered. They predicted that many students would wait until there is more “real world experience” with the vaccine and statistics show that it is virtually free of side effects.
“In general, preventive health services — vaccines in particular — are often not something people rush to get, but since this is an important advance in women’s health, we expect that there will be a lot of interest,” Roth and Rigsby said.
Sorting out the facts
Scientists and administrators alike said distribution of the vaccine at a university is particularly difficult because of its cost and the possible misconceptions about the extent of protection offered by the vaccine.
Roth and Rigsby said they are concerned that the high cost might act as a barrier for some people who would benefit from immunization, so they are looking for ways of making the vaccine available to everyone who needs it.
On a larger scale, John Liao, an associate research scientist in Yale’s Department of Obstetrics, Gynecology & Reproductive Sciences, said that although the vaccine is an excellent step in the right direction, the goal of reducing cervical cancer incidence worldwide is far more challenging.
“The highest rates of cervical cancer are found in the developing world, and implementing a vaccine like this one on a global scale may prove to be difficult,” he said in an e-mail. “The current vaccine is expensive, over $350 for a complete course, and requires multiple injections over the course of six months, refrigeration for storage and transport, and trained personnel to administer needle injections — all significant barriers to health care delivery in developing nations.”
And while research has shown that the vaccine has high efficacy with a low number of safety issues, the vaccine will do nothing to help those who have already been infected, said Janet Brandsma, associate professor of comparative medicine and pathology. She also said there is more research being done to further develop the vaccine’s capabilities. As of now, however, the vaccine does not protect anyone from additional sexually transmitted infections.
When dealing with sexual health, many people equate preventative treatment with panaceas for all sexually transmitted infections, Liao said, but he stressed the importance of recognizing the limitations of the vaccine in its current state, which does not protect against all types of HPV that cause cervical cancer.
“It will not treat existing HPV infections, precancers or cancers of the cervix, so protection ideally needs to be acquired before a woman becomes sexually active,” he said. “Also, the duration of the protection provided with the vaccine has not been established, so boosters may be needed in the future.”
Although initially worried that there might be resistance from conservatives who view the vaccine as a license to have sex, Brandsma said she has been pleasantly surprised that her fears were not confirmed. Liao agreed that for the general population, the possible health benefits outweigh any socially or politically motivated arguments against the vaccine.
“I think that at the heart of it, this is a cancer vaccine, and people will recognize this,” he said.
One giant leap for womankind
Researchers, both at Yale and around the nation, have said they are confident that the vaccine will become decidedly mainstream once supply and circulation increases. Although Genecin, Roth and Rigsby said they doubt Gardasil will ever become a required vaccine, some states are already taking steps in that direction. The Michigan state senate, for example, passed a bill Wednesday on a 36-1 vote requiring girls entering the sixth grade in fall 2007 to receive the HPV vaccine. The legislation will soon be up for vote in the state House.
Genecin said the University will never independently mandate immunizations other than those required by the state of Connecticut. Currently, the only vaccines required for college students in Connecticut are for measles and meningococcus.
For now, the most important step is to begin educating the student body about the vaccination, Genecin said, a process that will begin later this year. Students at Yale are encouraged to engage in an open dialogue about everything from alcohol and unwanted sexual experiences to safer sex and sexually transmitted diseases, and Genecin said it is vital for these discussions to continue, particularly with the development of the HPV vaccination.
“Sex education and sexual health have been a huge preoccupation, not just at Yale but a lot of universities,” Genecin said. “These issues are very important for young people during their college years.”
Genecin said the University is enthusiastic about Gardasil and optimistic about its implications for women’s health all over the world.
“The HPV vaccine is an extraordinarily exciting new advance in medicine, and we hope that the experience with it [in the United States] will parallel the great results that it has had in Europe,” he said.