The FDA has approved a new vaccine, Gardasil (patented by drug-maker Merck), to prevent cervical cancer, precancerous genital lesions, and genital warts caused by Human Papilloma Virus (HPV) types 6, 11, 16 and 18.
The new vaccination schedule calls for the cervical cancer vaccine to be given to girls, ages 11 to 12, in three doses. After the first dose, the second should follow in two months and the third dose should come at least four months later. But if circumstances warrant, the CDC says the vaccinations can begin as early as age nine. Catch-up vaccination is suggested for girls between the ages of 13 and 18, if not previously vaccinated. Most doctors tend to follow vaccination guidelines set forth by the CDC.
Participants in the DES Daughters On Line Support Group had lots of questions about this new vaccine. We collected the questions and asked the Chairman of the University of Chicago Department of Obstetrics and Gynecology, Arthur Haney M.D., to help sort out fact from fiction for us. Dr. Haney has been involved with scientific research into DES for many years and is considered a leading expert on infertility issues.
(If you are a DES Daughter and a DES Action member, please consider joining our On Line Support Group).
Q. When the vaccine was studied before approval, was DES exposure considered at all?
A. In a word, “no,” there was apparently no consideration given to DES exposure in the trials done by Merck. I have seen nothing indicating that DES was segregated out. In fact, it was tested in women up to 26-years old and so they were too young to have been exposed to DES in utero. While I understand concerns in the DES community about any new medication, I want to allay anxiety in this case. I firmly believe this vaccine is safe for exposed and unexposed individuals when administered by a health care provider.
Q. Can you tell us how the new cervical cancer vaccine works?
A. This vaccine is not a toxic agent. It is designed to awaken a person’s immune system to respond to, and attack, the human papilloma virus (HPV), which is the primary cause of cervical cancer. The vaccine is not made from an active virus, but rather, it was developed from the outer membrane, or coating surrounding the DNA of the HPV virus. By taking the vaccine, a person should presumably develop antibodies against the outer shell of the sexually transmitted virus, not the virus itself. That seems to be protection enough against HPV-caused cervical cancer and genital warts.
BUT — this is important for DES Daughters to understand — the vaccine works against cervical cancer caused by HPV, and has no effect what so ever against Clear Cell Adenocarcinoma of the cervix and vagina, which is the cancer linked to DES exposure.
Q. I'd like to know the recommendations for teenagers. With a 15 1/2 year old, I am definitely planning on getting it for her. I'm assuming it should be
given ASAP, but up until what age?
A. The optimal use of the vaccine is for pre-sexually active women, which is why it is now recommended for individuals between the ages of 9-26 years old. With no exposure to sexually transmitted viruses the vaccine gives them protection against the four main subtypes of HPV viruses affecting American women. (There are different ones in other parts of the world). That said, I’m sure the upper age limit recommendation won’t hold up over time, and here is why. The vaccine provides protection against four HPV strains, subtypes 16 & 18 which are related to cervical cancer, and subtypes 6 & 11 which generate genital warts. If a more mature woman comes in with HPV caused dysplasia (abnormal cells on the cervix that can progress into cancer), it means she has definitely come into contact with at least one HPV subtype. But she might still want the vaccine to protect against the other main cancer-producing strain - presuming she has not yet been exposed to it – and, admittedly, that is difficult to know. Also, she may want to protect against genital warts by taking the vaccine. The more sexual partners a woman has had, the more likely it is that she has already been exposed to the HPV virus strains in the vaccine, so it wouldn’t do any good. That is why younger, and presumably less sexually active, is the best bet for vaccination protection.
Q. Can the vaccine be given to a young woman who is already sexually active? Is it still advisable to do so?
A. If her sexual history is fairly limited, it might make sense to seriously consider the vaccine to protect against the various strains of HPV in the vaccine. If she has already come into contact with HPV subtype 6, then she will have no protection against that strain of genital warts. But the vaccine will protect her against the other type common in America, HPV 11 if she has not yet been exposed to it. Also, she might not yet have encountered HPV subtypes 16 and 18, which means vaccination will protect her against dysplasia and possible cervical cancer. I know you are going to ask if there is any way to tell whether exposure has occurred to different strains – and the answer is no, there is no good way to do so at the moment. That’s why the vaccine is recommended for young, pre-sexually active women.
Q. Should I, as a 41-year old woman get the vaccine? Is it helpful to us at such a late age?
A. Possibly. Lifestyle is an important variable. If a woman has been monogamous for 20 years and her husband has just died, she might want to consider the vaccine before starting to date again. There is a good chance she has not been exposed to at least some of the HPV strains the vaccine protects against. Otherwise, a 41-year old married woman who is not meeting new sexual partners probably would not benefit from vaccination because she is not being exposed to the sexually transmitted HPV viruses that cause a majority of cervical cancers.
Q. As a DES Daughter I’m concerned about this new vaccine. Am I right to be?
A. I do not believe that DES Daughters will respond any differently to this vaccine than unexposed women. The vaccine is designed to stimulate a woman’s immune system. Even though early DES research indicated the possibility of a different immune response, there is no evidence in human studies, so far, that shows a significant difference in immune system functioning between exposed and unexposed women, especially when it comes to vaccines. DES Daughters successfully take all sorts of vaccinations, from rubella to pertussis to the flu vaccine. This one should be no different. Unlike, for example, the polio vaccine, which is a weakened infectious agent that could possibly spread the virus to an immuno-compromised individual, the cervical cancer vaccine we are discussing here is not an active virus at all.
Q. Will this vaccine protect against the cervical cancer that DES Daughters are at higher risk for getting?
A. No, absolutely not. Clear cell adenocarcinoma (CCA) of the cervix and vagina is a completely different type of cancer than the one this vaccination is designed to protect against. As a result, all DES Daughters should continue having annual Pap/pelvic exams to check for the DES-linked cancer. Don’t forget, even if a DES Daughter has a hysterectomy she should still have her annual exams. While her cervix was removed in the surgery her vagina is still vulnerable to clear cell adenocarcinoma.
Q. I’ve heard that DES Daughters are at higher risk for getting HPV than other women. Does that mean we are good candidates for the vaccine?
A. Many DES Daughters have a larger cervical transformation zone than unexposed women, and that’s where the HPV virus invades cells. With a bigger area, clearly DES Daughters may run an increased risk for HPV infection. But we are seeing that as DES Daughters age, their cervical transformation zones often shrink back to normal size. Then, we must remember that most DES Daughters are not teenagers anymore. They have probably been sexually active through the years and may have been exposed to some of the main strains of HPV. As a result, I don’t think a majority of DES Daughters will actually be good candidates for this vaccine.
Q. What about my teenage daughter, who is a DES Granddaughter. Is it safe to give her the vaccine?
A. This is a decision you’ll want to make in consultation with your daughter’s doctor. I understand your concerns because we know so little about how DES might have affected this group of young women. It is a case where you must balance the risks versus the benefits of the vaccine. At this point, though, I don’t see any major warning signs against giving the vaccine to DES Granddaughters.
Q. My daughter is currently on the waiting list at her doctor's office. They have not yet gotten the vaccine. Is there a shortage?
A. I have not heard of any distribution problems with the vaccine, but of course there could be sporadic and regional ones. At this point, though, nothing of a national scale problem has come to my attention. The doctors likely to be giving the most vaccinations are pediatricians because of the currently stated age recommendations. I suspect that eventually, cervical cancer vaccinations will fall into sequence right along with other childhood vaccinations, and will become fairly routine.
Q. Are there any high-risk groups which should be given/should not be given the vaccine?
A. Other than the above mentioned caveats regarding timing for optimal use, no. It is not recommended for pregnant women but that is not based on a demonstrated risk, simply the usual caution regarding any preventative medication during pregnancy that is not treating an active problem.
Q. I have read that the actual numbers of women with cervical cancer is fairly low, and that drug companies stand to make huge, huge profits by recommending all women get vaccinated. Isn't a regular Pap smear good enough?
A. The risk of actual invasive cervical cancer is lowered by the use of both screening Pap smears and treatment of pre-invasive cervical dysplasia. As a result, the incidence of cervical cancer is lower in this country than in other parts of the world because women are routinely screened. Unfortunately, HPV-related cervical dysplasia is very common and detected often, so the goal of this vaccine is to reduce the likelihood of developing cervical dysplasia and also genital warts. The intent, really, is to avoid the need for treatment of dysplasia, genital warts and ultimately cervical cancer.
Q. I hear there is a second vaccine for HPV coming out. Should women wait for the next one to see which is best?
A. That is an unanswerable question at present without a head to head comparison of the effectiveness of the vaccines. However, the currently available vaccine has been shown to be very effective against the two most common HPV subtypes associated with cervical cancer (16 & 18) as well as the two HPV subtypes associated with genital warts (6 & 11). For women who are not planning to begin sexual activity for over a year, waiting may be a rational choice, but given the effectiveness of the current vaccine, it is hard to imagine how waiting will be helpful. Remember, it takes three doses of the vaccine over six months to become maximally effective, so this should be a proactive decision well in advance of the initiation of sexual activity.